1
Introduction
The modern electrophysiology (EP) laboratory is a complex environment providing an
array of interventions for the diagnosis and treatment of heart rhythm disorders and
is a result of many transformations over the last three decades. The EP field has
witnessed rapid expansion in the number of therapeutic procedures treating a wide
range of arrhythmias and in the new technologies available to perform these procedures.
Because of the increasing complexity of equipment and procedures and an ever-expanding
knowledge base, it was concluded that the field would benefit from a consensus document
that would define the critical components and processes of a modern EP laboratory.
To this end, the Heart Rhythm Society (HRS) convened a multidisciplinary team to review
EP laboratory design, ergonomics, personnel, equipment, occupational hazards, and
patient safety, as well as clinical and ethical issues related to diagnostic and therapeutic
EP procedures. The goal is to provide physicians, administrators, and regulatory personnel
with the recommended requirements for building, staffing, and running a modern EP
laboratory to optimize patient outcomes, minimize patient risk, and provide a safe
and positive environment for physicians and staff.
The writing committee was formed by the Scientific and Clinical Documents Committee
of the HRS, with approval by the President of the HRS and the HRS Executive Committee.
The composition of the committee was meant to represent the range of stakeholders
in the EP laboratory. The choice of the writing committee members was in accordance
with the HRS Relationships With Industry policy.
1
All members of the writing committee were required to fully disclose all potential
conflicts of interest (see Appendix 1).
Relatively little published literature addresses the EP laboratory environment, staffing,
and processes. Therefore, many of the statements in this document are the product
of expert consensus by the writing committee and reviewers. For cases in which there
were divergent opinions on a statement, a vote among writing committee members was
taken, and if a two-third majority supported the statement, it was adopted in the
document. The sections pertaining to pediatric and adult congenital heart disease
were reviewed and approved by the Pediatric and Congenital Electrophysiology Society
(PACES), a nonprofit organization dedicated to the treatment of arrhythmia disorders
in children and individuals with congenital heart disease (CHD). The final document
was approved by the Board of Trustees of the HRS. This document is directed to all
health care professionals who design, manage, and/or work in the EP laboratory environment.
2
Evolution of the EP Laboratory
The field of clinical cardiac electrophysiology (CCEP) has grown from its origin as
a field of clinical research for arrhythmogenesis to its present-day incarnation as
an important specialty offering advanced therapies for a wide variety of disorders.
Clinical EP laboratories emerged in the late 1960s, and by the early 1970s, formal
fellowships had been established and EP laboratories were taking shape. First-generation
EP laboratories often shared space with cardiac catheterization laboratories and were
typically subordinate to coronary angiographic and hemodynamic procedures. When a
space was dedicated for electrophysiological testing, it was often small, and fluoroscopy
was delivered with portable C-arm units. These laboratories were sufficient for diagnostic
EP studies and electropharmacological testing. Second-generation EP laboratories developed
in the 1980s with the introduction of catheter ablation and cardiac implantable electronic
devices (CIEDs) to the electrophysiologist’s armamentarium. Pacemaker implantation
was shifting from the domain of surgery to that of cardiac EP. With increasingly complex
procedures being performed in EP laboratories, more space was allocated to new dedicated
laboratories and fluoroscopy equipment began to be upgraded to systems commensurate
with those used in cardiac catheterization laboratories.
The third generation of interventional cardiac EP has been driven by the success of
catheter ablation and advanced device therapy. The precise anatomy and physiology
of a wide variety of arrhythmias has been elucidated through the development of advanced
mapping systems and improvements in ablation catheter technologies. Modern device
therapy incorporates multimodal multisite pacing, sophisticated therapies for tachyarrhythmias,
and advanced diagnostics. With the increasing complexity of EP procedures and equipment
has come increasing sophistication of laboratory processes and greater demands on
laboratory personnel. The cost and complexity of the modern EP laboratory now demands
that standards are developed to ensure a high level of care.
3
Laboratory Environment
Laboratory Environment Recommendations
•
Highly complex procedures or procedures on patients with certain conditions and comorbidities
that are associated with higher procedural risk should not be performed in a freestanding
laboratory (i.e., an EP laboratory that is not physically attached to a hospital).
•
Emergency cardiovascular surgical support should be immediately available in case
of life-threatening bleeding complications from the extraction of chronic device leads
and complex mapping/ablation procedures, particularly those requiring pericardial
access.
•
High-risk procedures in critically ill patients, such as ablation of ventricular tachycardia
in patients requiring extracorporeal hemodynamic support, can only be safely performed
in institutions offering comprehensive programs with active engagement from electrophysiologists,
surgeons, intensivists, and anesthesiologists.
3.1
Procedure Room Options
There are multiple options and practice settings for performing EP and implantable
device procedures. Medical centers may adopt one or more of the following laboratory
operations for their practice. The choice among the following options involves a trade-off
between increasing capability for procedure complexity and increasing construction
and operating costs.
3.1.1
Dedicated EP Laboratory
In a dedicated EP laboratory, the staff space and procedure room space are separate
from the cardiac catheterization laboratory and/or radiology laboratory, although
the staff space and procedure room space often exist within a common area. The preparatory
and recovery rooms are often shared with other subspecialties. Procedures that can
be performed in this laboratory setting include diagnostic EP studies, ablation procedures,
use of cardiac implantable devices, implantable device extractions, use of temporary
pacemakers, three-dimensional (3D) mapping, intracardiac echocardiography (ICE), and
use of robotics. The advantages of using a dedicated EP laboratory include greater
availability of more highly trained allied personnel, room equipment dedicated to
only EP procedures, and decreased overall equipment costs per room.
3.1.2
Shared EP and Catheterization Laboratory
A shared procedural laboratory program is usually in association with a cardiac catheterization
laboratory program, but can also be shared with an interventional radiology program.
A shared room allows for two or more practices to share common equipment that includes
fluoroscopic equipment, recording systems, emergency equipment, and anesthesia equipment,
as well as the space. This is helpful in circumstances of low overall volumes when
sharing a room allows for flexibility in patient care while controlling costs and
space requirements.
3.1.3
Device-Only Laboratory
These types of procedure rooms have been created at large-volume institutions that
can support a procedure room dedicated only to CIED surgery. The procedures performed
in this type of room include the use of pacemakers and defibrillators that are single
chamber, dual chamber, or biventricular in operation. Other procedures can include
the use of temporary pacemakers, the use of implantable loop recorders, and lead and
device extractions. Device and lead extractions may also be performed in a surgical
operating room (OR) on the basis of the patient’s condition or on the standard agreed
on by the institution. Advanced mapping and EP recording systems are not required,
and the costs of equipping this type of laboratory are lower, which is the key advantage
of this type of room. Device-only laboratories are appropriate for high-volume centers
that already have one or more fully outfitted EP laboratories.
3.1.4
Advanced Mapping, Ablation, and Combined Hybrid Laboratories
These procedure rooms are designed to the rigorous standards of ORs (positive airflow,
medical gas availability, surgical lighting, and substerile scrub area) but have high-quality
fixed fluoroscopy and a full complement of EP and/or cardiac catheterization equipment.
These rooms are ideal for procedures that may be combined with open or minimally invasive
cardiac surgery and for lead extraction procedures. When not being used for hybrid
surgical procedures, these laboratories can function either as fully functional ORs
or as fully functional EP/catheterization suites. Procedures that can be performed
include complex ablation procedures that involve EP and surgical components, left
atrial appendage occlusion or clipping, epicardial lead placement, and minimally invasive
valve replacement.
3.1.5
Special Procedure Rooms
Some organizations incorporate special noninvasive rooms into their practice to accommodate
patient care that does not require fluoroscopy or other specialty equipment. These
rooms are often used to perform minor procedures such as cardioversions, tilt table
studies, and noninvasive programmed stimulation defibrillation threshold testing.
Autonomic testing with head-up tilt table testing requires a procedure table that
has the capability for 70º head-up tilt, an electrocardiogram (ECG) monitor, noninvasive
blood pressure monitor, supplemental oxygen, and basic supplies. Equipping these rooms
is much less expensive than equipping a full procedural laboratory and can help improve
patient flow and volume through a busy EP department.
3.1.6
Pediatric EP Laboratory
The room and equipment standards for pediatric EP procedures are similar to those
for adult EP procedures, except for the availability of pediatric resuscitation equipment
and drug doses as well as a wider inventory of smaller catheters. Pediatric and congenital
EP patients can require a combined procedure of EP and the need for cardiac catheterization,
including angiography and possible intervention. Thus, it is optimal (although not
a necessity) for a pediatric/congenital EP laboratory to meet all the standards of
a pediatric catheterization laboratory. Pediatric EP procedures in young children
should be performed in pediatric hospitals or hospitals that have a pediatric cardiology
and EP service.
3.2
Freestanding Cardiac EP Laboratory
An EP laboratory that is not physically attached to a hospital is considered a freestanding
laboratory. Freestanding EP laboratories can be privately owned, and when owned by
physicians, there may be concerns about conflicts of interest (as discussed in Section
12). This arrangement presents challenges that stem from the separation of the laboratory
from vital hospital services. In the event of a life-threatening complication, such
as pericardial tamponade
2
or endovascular tear during lead extractions,
3
an emergency response from certain hospital-based services such as cardiothoracic
surgery can become necessary, and even possibly lifesaving. Performing EP procedures
in freestanding EP laboratories on patients with clinical conditions that confer increased
risk are relatively contraindicated. These include preexisting advanced heart failure
and severe left ventricular dysfunction
4
; recent myocardial infarction, recent stroke, chronic kidney disease, severe chronic
obstructive pulmonary disease, pulmonary hypertension, and severe/morbid obesity
5
; and severe valvular dysfunction or prosthetic heart valve, CHD (including atrial
septal defect repair), active oral anticoagulation, advanced age, and pediatric age.
Procedures that necessitate lesion creation close to coronary arteries, such as aortic
cusp ablation
6
and epicardial ablation,
7
carry a higher risk of intraprocedural myocardial infarction and should not be performed
outside a hospital. As part of the consent process, patients should be informed that
the procedure is being performed without on-site surgical backup. In order to ensure
the safety of a patient undergoing a procedure in a freestanding EP laboratory, a
functional and tested system must be in place to quickly transfer patients to a hospital
with immediate surgical support in case of an unanticipated complication. The receiving
program should be familiar with complications unique to the EP laboratory. There must
be a standing agreement between the laboratory and the receiving hospital so that
there is no unnecessary delay in the transfer process.
3.3
Hospital and EP Laboratory
The hospital environment plays an important role in shaping the structure and function
of the EP laboratory. A “closed EP laboratory” is commonly present in academic institutions
and limits physician practice to faculty members of the particular institution or
university. In contrast, “open EP laboratories” allow credentialing and the participation
of multiple physician groups, including those who do not hold faculty level appointments.
Such laboratory structuring is common in community and private institutions and is
also present in some academic settings. Whether an EP laboratory is open or closed
is determined by the institution’s leadership on the basis of economic, historical,
political, and geographical factors that are often beyond physician control. An inherent
difficulty in the open EP laboratory format lies in procedure scheduling for multiple
physicians; a centralized scheduling structure that can arrange scheduling while organizing
and prioritizing procedures on the basis of urgency and acuity is important to avoid
conflicts and optimize patient care.
The complexity and degree of invasiveness of EP procedures is dependent on the level
of support provided by the hospital or other health care organization in terms of
personnel, facilities, and equipment. Anesthesia support is desirable for the safe
performance of potentially lengthy and complex procedures. The role of anesthesia
services in the EP laboratory is detailed in Section 6. Surgery backup must be immediately
present for lead extraction procedures in which a lead to be removed is older than
1 year (or require tools other than a standard stylet to be removed if younger than
1 year from implantation)
8
, and mapping/ablation procedures require pericardial access. Complex ablation procedures,
such as atrial fibrillation and ventricular tachycardia (VT) ablation, should be performed
only in hospitals equipped and prepared to manage these types of emergencies, with
access to emergency surgical support when required. Finally, high-risk procedures
in critically ill patients, such as ablation of VT in patients requiring hemodynamic
support with extracorporeal membrane oxygenation, can only be safely performed in
institutions offering comprehensive programs with active engagement from electrophysiologists,
surgeons, and anesthesiologists. Although such collaborations were limited to advanced
tertiary care institutions in the past, the increasing availability of institutional
resources and support has expanded the range of facilities in which complex procedures
are performed to include private institutions.
3.4
Regulatory Standards Related to EP Laboratories
Federal guidelines for the construction and retrofitting of health care facilities
have been influenced by recent catastrophic events, such as the Northridge earthquake
of 1994, Hurricane Katrina in 2005, and the F5 tornado that made a direct hit on a
hospital in Joplin, MO, in 2011. In the mid-1990s, three formerly competing code writing
agencies united to form the International Code Council. Their mission was to develop
a national construction code that, among other entities, would regulate the construction
of health care facilities to mitigate the risk of damage due to seismic, wind, and
flood dangers. Known as the International Building Code, one of its versions has been
adopted by every state. In addition, the Federal Emergency Management Agency, a branch
of the Department of Homeland Security, published revised guidelines for improving
hospital safety in earthquakes, floods, and high winds.
The primary legislative avenues for controlling the dissemination of expensive health
care services are Certificate of Need (CON) laws. As of 2009, 39 states still have
a CON process, law, or set of requirements. In most cases, the approval of CON is
based on the actual or projected volume of services provided in the procedural laboratories.
As procedural volumes for percutaneous coronary arterial interventions have diminished
at most tertiary referral hospitals, many hospitals have shifted some coronary interventional
laboratory CONs to EP laboratories. Once an EP laboratory is established, the primary
government body overseeing its operations, policies, and procedures is the Joint Commission
(TJC).
4
Laboratory Design
Laboratory Design Recommendations
•
The Guidelines for Design and Construction of Hospitals and Health Care Facilities
published by the American Institute of Architects and the Facility Guidelines Institute
provide space and functionality standards for EP laboratories with a goal to improve
work flow in the EP environment. (Specific recommendations not derived from this document
are based on the consensus opinion of the writing committee.)
•
The minimal procedural area of a complete EP laboratory (not including control room
space) is 350 sq ft of clear floor area.
•
Current electrical system regulations for health care facilities should follow Article
517 of the National Electrical Code (NEC) Handbook.
•
An uninterruptible power supply for all computer equipment is required.
•
The air flow/heating, ventilation, and air conditioning design should comply with
the Guidelines for Environmental Infection Control in Health-Care Facilities Recommendations
of the Centers for Disease Control and Prevention and the Healthcare Infection Control
Practices Advisory Committee document.
•
Lighting should include an overhead light on an articulating arm, 2 × 2 ft lighting
squares to flood the main procedure area, and a dedicated workspace light for the
nursing/anesthesia area.
•
The ideal sound/communication system is an always-on, full-duplex, two-way intercom
system.
•
Network cabling and hardware should have a minimum capability of support for gigabit
Ethernet speed.
•
Electronic storage of EP data should be Health Insurance Portability and Accountability
Act (HIPAA) compliant. Data should be maintained for at least the minimum duration
as determined by each state.
The American Institute of Architects and the Facility Guidelines Institute regularly
publish the Guidelines for Design and Construction of Hospitals and Health Care Facilities.
9
This document is recognized by federal and state authorities, and recently this document
has included EP laboratories. It provides defined standards in terms of the space
and functionality of EP laboratories with a goal to specifically improve work flow
in the EP environment, acknowledging that the EP laboratory requires more space than
an angiographic/interventional laboratory for supporting equipment and supplies. Traditionally,
however, the construction of an EP laboratory had no specific guidelines because of
its special applications. The typical layout is generally derived from a cardiac catheterization
laboratory,
9
which is not ideal for the performance of the full range of EP procedures. The limitations
of direct adaptation of an angiography suite design to the practice of cardiac EP
include space constraints relative to the special equipment used in EP procedures,
the necessity to work on either side of the patient table, and the requirement to
access the patient’s upper chest for device implantation. EP laboratory plans should
take into account not only the available space within the procedure room but also
its location relative to pertinent services such as the patient prep area, recovery
area, OR, intensive care unit, the ward, and specialized resources such as an adjacent
magnetic resonance imaging (MRI) suite that might permit real-time MRI imaging during
procedures in the future. The rationale is to consider the proximity of all needed
services in the overall design during the planning stage so that enhanced patient
flow can be achieved. The aim of the planning committee should be to build a consensus
on a minimum set of specifications that will meet the needs of the clinicians and
support staff, and enable them to provide optimal patient care, while maintaining
occupational safety for the staff.
4.1
Space Requirements
The EP laboratory needs as much space as is practical to ensure the freedom of movement
of the operator and staff, to accommodate all equipment used, and to facilitate movement
of staff in emergency situations. The recommended procedural area of a complete EP
laboratory (not including control room space) is 500 sq ft or greater of clear floor
area, although 350 sq ft is the absolute minimum requirement. There should be a minimum
of 8 ft of clear space between the wall and the edges of each side of the patient
table when it is positioned at the isocenter. Enough clearance at the head of the
bed should be allocated for anesthesia equipment on either side and sterile access
to jugular vein entry sites, if employed, while allowing for free range of movement
of the fluoroscopy C-arm. The ceiling height is dependent on the requirements of the
X-ray/fluoroscopic equipment
9
(
Figure 1). Preexisting laboratories that are being renovated where it is impossible
to expand the gross area because of building and location constraints should follow
federal and state code requirements, but due caution should be taken to meet suggested
recommendations.
Figure 1
Space requirements. The sample layout of EP laboratory with adjacent control room
area. Note the availability of enough free space at the head of bed area allowing
freedom of movement of fluoroscopy arm and anesthesia equipment. EP = electrophysiology.
4.2
Room Layout
The fluoroscopic equipment plays a major role in determining the amount of ideal space
in the procedural area and could serve as the reference point. Equipment can be either
mounted on the floor or suspended from the ceiling. The latter configuration allows
for the floor to be optimally cleaned; however, because of the amount of equipment
that would need to be suspended from the ceiling (monitors, surgical lights, X-ray
barriers, equipment racks, and anesthesia gas supply), a floor-mounted configuration
may be more practical in some laboratories. It is best if X-ray generators and tanks
are located in a space separate from the procedure and control rooms. The size and
portability of the fluoroscopy unit is important in planning room size, especially
when cabinetry and other fixtures are planned for installation on the walls within
the procedural area. Installation of cabinetry at the head of the bed is discouraged
because it further limits space to allow free movement of the X-ray arm, anesthesia
supply cart, and life support equipment. Cabinetry for supplies frequently used during
cases should be positioned on the side walls for easy access. The room should be wide
enough to accommodate the cabinet and open door swing without impinging on the sterile
field and traffic flow through the laboratory.
Most peripheral equipment such as recording systems, stimulators, and radiofrequency
(RF) generators are made from multiple components, some of which need to be in a control
room and others in the laboratory itself. It is strongly recommended that none of
the modules sit on the floor. This can reduce sterility and cleanliness as well as
put the equipment at risk of being damaged by fluids. A ceiling-mounted boom removes
all equipment from the floor and reduces damage to cables by allowing them to remain
connected at all times. By placing the recording system amplifier, the RF generator,
the mapping system amplifier, the stimulator amplifier and router, and other peripheral
equipment together on a ceiling-mounted equipment boom, all cabling will be permanently
placed and connected, reducing cable wear. The removal of rolling equipment carts
from the room improves staff access to the patient. Removing cables and equipment
from the floor reduces the tripping hazard to the staff and risk of equipment damage.
Because additional portable EP equipment is often employed during a procedure, it
is necessary to have ample power outlets installed to accommodate such needs.
Anesthesia gases are best supplied via a ceiling-mounted anesthesia boom, which should
include two oxygen lines, one nitrous oxide line, one medical air line, two vacuum
lines, and one waste anesthetic gas disposal line.
10
It should be equipped with at least one slide clamp for vacuum canister placement,
which should allow the canisters to be located within 4 in. of the floor for ease
of removal when full. The anesthesia boom should have a minimum of six electrical
outlets, at least some of which should be on emergency (red plug) circuits in case
of general power outage during a procedure. A mounted light controlled independently
from the room lighting for charting in a dark room is a useful option. Video can be
routed from the anesthesia boom to display data from an anesthesia cart to monitors
placed around the room.
4.3
Hybrid Laboratory
The hybrid laboratory has all the requirements of a full EP laboratory but has added
features that allow it to serve as a fully functional operating suite. These laboratories
are often larger and have the fluoroscopy equipment on a track so that it can be entirely
removed from the surgical field. It is typically located within or contiguous to the
other ORs and has a full substerile scrub and supply area. The use of a hybrid laboratory
for EP procedures is evolving. Hybrid laboratories in which EP procedures are performed
need to be outfitted with the appropriate EP-specific equipment, including EP recording
systems, mapping systems, and programmed stimulators. Procedures that might benefit
from performance in this setting would include those where surgical intervention or
extracorporeal hemodynamic support might be required, such as lead extractions, VT
ablation procedures in patients with structural heart disease, and hybrid atrial fibrillation
ablation procedures.
4.4
Control Room
Although some EP laboratories house all the monitoring and stimulating equipment in
the procedure room, it may be preferable to have a contiguous control room with an
interposed leaded wall and large viewing window so that members of the team (apart
from the primary operator, the circulating nurse, and the anesthesia professional)
can work without exposure to ionizing radiation. The control rooms can be shared among
two or more laboratories. A separate control room demands a full duplex intercom system
so that there is no barrier to communication. The space required for a control room
is not inclusive of the procedural area measurements. Adequate ventilation should
be supplied to account for excess heat production from the electronics. The counters
should be at least 30 in. deep so that the monitors can be 20 in. away from the user.
At least 160 in. of desk space is suggested for a laboratory with a single-plane fluoroscopy
system and 180 in. of desk space for a biplane fluoroscopy system to allow for fluoroscopy
monitors, a mapping system, a recording system, and a stimulator. An additional 45
in. of desk space is suggested for a two-monitor reading station or a single-monitor
workstation (
Figure 2). The participation of an ergonomics expert in the planning should be considered
as a measure to comply with Occupational Safety and Health Administration standards.
Figure 2
Control room. Example of a simplified layout of the control room and EP equipment.
Recommended counter measurements should be applied as mentioned in the text. EP =
electrophysiology; ICE = intracardiac echocardiography.
4.5
Traffic Flow
The ideal design for an EP suite should be similar to that of an OR, including a substerile
entrance with scrub sinks (dedicated or common). Patient transport from the prep area
to the EP laboratory and vice versa should be limited to a common egress that connects
to hallways leading to the hospital wards and other areas. If the EP laboratories
are placed in existing space that does not allow for OR-quality substerile entrances
and hallways, every effort should be made to prevent through traffic flow past the
entrance to the EP laboratories where sterile procedures are being performed.
4.6
Conduits and Cabling
EP suites require special consideration from electrical design engineers because there
are multiple high load and electrically sensitive pieces of equipment in this wet
environment. Conduits used as wireways should follow the specifications of Articles
376, 378, and 392 of the NEC Handbook.
11
The EP laboratory setup primarily involves the data and power cabling layout that
connects equipment between the control room and the procedural area, and the following
requirements should suffice, considering the few cables that need to be run in these
enclosures. For rooms that are not equipped with ceiling-mounted equipment booms,
the conduits should be at least two runs of 4-in.-diameter tubes that connect the
procedure room to the control room through the floor, dedicated solely to EP equipment
cabling (separate from X-ray equipment and power receptacle requirements). This conduit
should be conductive and bonded to equipotential grounding. Floor openings or ports
should be concealed by an enclosure that should be fluid tight with protective grommets
that will prevent cable insulation damage. The length/reach is dependent on the location
of each cable termination linking the equipment, as specified by the EP representative
who oversees the room project and design. For rooms equipped with ceiling-mounted
equipment booms, cabling runs through ceiling trays connecting the control room to
the procedure room boom. The trays can be used in conjunction with other equipment
that terminates at the equipment boom as long as there is enough separation between
power lines and data transmission lines to prevent electromagnetic interference (EMI)
induced by adjacent power lines running in parallel. Open trays are preferable for
ease of access above the ceiling and should be conductive and bonded to equipotential
grounding. The length/reach is dependent on the location of each cable termination
linking the equipment, as specified by the EP representative who oversees the room
project and design. Backup temporary cabling should be available in case of failure
of conduit cabling during a case.
4.7
Electrical System/Noise Immunity
Current regulations for health care facilities should follow Article 517 of the NEC
Handbook. Because the EP procedure room is classified as a “wet procedure location,”
the installation of an isolated power system with line isolation monitoring is required,
which provides a layer of protection from the hazards of electric shock with the added
benefit of line noise isolation because of its design.
9
In addition, all computer equipment directly related to the ongoing monitoring and
treatment of a patient must have an uninterruptible power supply (UPS). The UPS may
be integrated into the power for the entire suite, or individual UPS may be placed
in line for each central processing unit. The main purpose of the UPS is to prevent
the EP system, mapping system, or other critical imaging or monitoring system from
going through a hard shutdown and full reboot procedure in case of a transient power
outage or surge. Other important electrical components of the laboratory, such as
the imaging train, should be connected to emergency backup power so that cases can
be completed even if line power is lost. Power lines and data lines should be run
separately and isolated from each other in different conduits to prevent EMI from
power line wiring induced through data line wiring that could affect optimal performance
of the EP equipment. If open cable trays are used above the ceiling, careful consideration
should be given to the placement of power lines and other fixtures that can be sources
of EMI. Although power lines used on these runs do not necessarily involve enough
energy to induce heating, it is still a good rule to follow the specifications of
Article 300.20 of the NEC Handbook as a reference.
11
Adequate spacing of EP laboratory equipment in the procedural area should be followed.
Interface cables between the patient and the equipment (e.g., ECG cables and intracardiac
catheter cables) should not dangle by the X-ray tube and should be kept neatly arranged
by the side of the patient to provide easy access for troubleshooting purposes during
the procedure.
4.8
Air Flow/Heating, Ventilation, and Air Conditioning
Air flow should be of OR quality. The design should comply with the Guidelines for
Environmental Infection Control in Health-Care Facilities Recommendations from the
Centers for Disease Control and Prevention and 5, 6 of the Healthcare Infection Control
Practices Advisory Committee document.
10
Emphasis should be placed on the use of in-line filters or mechanical smoke evacuation
systems to prevent airborne infective and toxic particles from the plume produced
by electrocautery and similar equipment. The temperature control should support effective
configuration for temperatures as low as 60ºF. This allows comfort for practitioners
who are wearing sterile gowns, hats, and masks on top of lead aprons during long procedures.
Patient comfort should also be addressed, particularly as they are fully draped and
may be only lightly sedated.
4.9
Lighting
The patient table should be flanked by large lighting squares or the equivalent to
flood the main procedure area with light. Appropriate grounding is required to prevent
EMI from these lights. The lighting squares should be tied to an X-ray pedal switch
that can be turned on and off at will by the X-ray operator. Additional spotlights
that are dimmable from a distant wall switch are also recommended for procedures that
require a darker environment to optimize glare reduction and visualization of display
systems in front of the operator. There should be at least one overhead OR light of
surgical quality mounted on an articulating arm, strategically placed to be accessible
for use on the left shoulder, right shoulder, or abdomen at either side of the patient.
There should be sufficient range of motion to be able to focus light intensity at
a steeper angle toward and into the implant pocket. Two lights are optimal for reducing
shadows. The preferred OR light is mounted on a boom that extends from the ceiling
and has free range of movement to focus the beam at the angles and distance optimal
to adequately light the surgical field and device implant pockets. Anesthesia and/or
nursing should have a light over their workspace that is independent of the room lighting
on either side of the patient table, which should be oblique at a distance from the
X-ray C-arm.
9
4.10
Sound Systems/Communications Equipment
For laboratory designs that employ a separate control room, there may be difficulties
with the use of communication systems that link the operator in the procedure room
to the control room staff. Because critical processes such as timing of ablation onset
and offset require close coordination between the bedside and the control room, the
importance of good two-way communication for patient safety and quality of care cannot
be overstated. The ideal equipment is capable of a always-on, two-way system because
of the constant and instantaneous need to communicate. The ideal system is an always-on,
full-duplex, two-way intercom system, with a toggle to silence unnecessary chatter
from the control room. This requires electronic noise cancellation to prevent acoustical
feedback and has variable effectiveness depending on room acoustics. A simpler solution
is a one-way push-to-talk intercom, but this does not allow spontaneous back-and-forth
communication. The use of wireless headsets is a favorable solution, which broadcasts
spoken words directly to the headphone users, with simultaneous talk paths open as
needed. Whatever system is selected should be high fidelity, spectrum friendly, and
encrypted to prevent eavesdropping and potential HIPAA violations, making it a more
expensive solution.
4.11
Data Network
Procedural charting and operative reports should be part of the institution’s electronic
medical record. The network cabling and hardware should have a minimum capability
of support for gigabit Ethernet speed.
9
The data demands of imaging systems, including 3D electroanatomic mapping systems,
are great and require larger storage repositories in comparison with the compressed
images of major imaging equipment such as ultrasound and X-ray radiograph systems.
There is an increased use of imaging created by computed tomography (CT) and MRI,
which are 3D in nature, necessitating high transfer speeds between the picture archiving
and communication system (PACS) and the EP laboratory environment. Collaboration with
the information technology (IT) department and its infrastructure within the institution
is necessary in this venture. EP systems gather information in digitized format for
patient records and review at a later time. It will be important for industry to develop
a better and unified standard for storing and retrieving cardiac electrogram information.
Waveform information in EP is constructively different from image information and
needs to be handled in a different manner. The complexity involved in translating
the files without losing the ability to utilize the tool sets needed during review,
and to scroll through the whole EP study, is a challenge. The Digital Imaging and
Communications in Medicine standard is a more robust model to follow and should be
the preferred method, when feasible.
12
For current equipment standards and needs, the recommendation is to involve the IT
department in the safekeeping of digital records of patient information. Storing information
in an enterprise-wide network repository managed by the health care IT staff within
the institution is recommended, as they are adequately equipped to comply with policies
governing hospital data. Data storage must be HIPAA compliant
13
and must be maintained according to the laws of each individual state—typically 5–7
years for adults and 5–7 years past the age of maturity for pediatric patients. Practically,
the duration of data storage should be longer than the minimum requirement, because
old invasive study data are often important in the management of patients decades
later. Electronic storage of all EP laboratory information could require 5–10 terabytes
of space annually; therefore, the IT department must anticipate commitment of these
resources for this process. Regardless of the equipment’s capability to store to the
network, the IT department should be involved as long as they comply with the EP equipment
manufactureres’ recommendations.
5
Laboratory Equipment
Laboratory Equipment Recommendations
•
Both single-plane and biplane fluoroscopic systems are suitable for the modern EP
laboratory.
•
A basic EP laboratory should be equipped with a monitoring system that includes 12-lead
surface ECG and 24 intracardiac electrogram channels; advanced laboratories (e.g.,
those performing complex ablation procedures) require EP systems with 64–128-channel
capabilities.
•
A biphasic external defibrillator is required in each EP laboratory, with a backup
defibrillator immediately accessible.
•
An anesthesia cart that contains endotracheal intubation equipment, as well as sedative,
paralytic, and anesthetic agents, should be readily accessible for all EP procedures.
•
Emergency trays should be immediately available for pericardiocentesis, thoracentesis,
and thoracotomy.
•
Programmable electrical stimulators must provide reliable, accurate, and effective
electrical stimulation.
•
It is recommended that all EP laboratory personnel using the ablation systems are
able to demonstrate familiarity and proficiency with the setup, operation, and characteristics
of all ablation system(s) employed at their site.
•
Advanced mapping systems should be available for complex ablation procedures.
•
ICE may be useful as an adjunctive imaging modality during complex procedures.
•
Transthoracic echocardiography and transesophageal echocardiography should be readily
available for emergency use and for adjunctive imaging in selected cases.
•
Integrated data display systems provide flexibility and efficiency in data display;
it is advisable to have separate backup monitors in case of failure.
5.1
Procedure Table
Patient safety and comfort are the most important considerations for the modern EP
laboratory table. The ability to support a heavy patient is one of the most important
features of the modern EP procedure table, with tables capable of supporting more
than 200 kg being commercially available. The length and width of the table are also
important considerations. Although standard table lengths are usually sufficient to
accommodate most patients, there is growing need for the increased width provided
by bariatric surgical tables. Motorized tables with adjustable height and a tilting
capacity of up to 20º have become standard. Tilting into the Trendelenburg position
may be helpful in cases of difficult subclavian venous access or internal jugular
venous access in ablation and device procedures. Reverse Trendelenburg positioning
can be helpful for patients unable to lie flat because of musculoskeletal or respiratory
difficulties. Table rotation up to 180º facilitates patient transport but more importantly
provides better access to the table head in cases of emergency. This feature, as well
as the ability to tilt sideways, may also be helpful for maximizing surgical exposure
in hybrid OR laboratories. Given the need to perform both right- and left-sided procedures,
having rails on both sides of the table is particularly useful for mounting equipment
and tableside controls. Finally, given the length of some EP procedures, in which
patients may lay supine for several hours, a comfortable and supportive EP table pad
is important. Foam material is commonly used in EP table pads, but other materials
are also available.
5.2
Radiographic Equipment
Although fluoroscopy remains the mainstay of EP procedures, it is imperative to reduce
ionizing radiation exposure to patients, operators, and staff as best possible. Specific
issues related to radiation and limiting exposure are detailed in Section 11. The
complexity of procedures performed in the laboratory is the primary determinant of
the specific fluoroscopy features needed. Both single- and biplane fluoroscopic systems
are suitable for the modern EP laboratory, and the choice of the system is dictated
by the specific needs of the laboratory. In basic EP laboratories designed primarily
for device implantation, a single-plane system is usually sufficient. Biplane systems
are often preferred in more advanced laboratories where ablation is performed, as
these biplane systems can be converted to single-plane units for device insertion;
however, the advent of 3D mapping technology has diminished operator reliance on biplane
fluoroscopy.
The introduction of digital imaging has been the most important recent change in fluoroscopic
imaging. Digital flat panel detectors permit reduction in radiation and provide excellent
image quality with a physically smaller and thinner detector. These systems allow
greater temporal resolution and contrast ratio with less image distortion and veiling
glare and allow the acquisition of high-quality still images. The latter feature is
particularly useful for procedures depending on the imaging of vascular structures
such as coronary arteries, the coronary sinus, and its branches. Floor- and ceiling-mounted
units are available depending on the exact specifications and setup of the laboratory
space. Some digital fluoroscopic systems offer advanced imaging capabilities, which
may be useful in EP procedures including rotational angiography, rotational CT imaging,
and multimodality integration of 3D magnetic resonance and CT images. These features
are generally more suited for advanced laboratories performing complex ablation procedures.
Three-dimensional reconstructed images from CT, MRI, and rotational fluoroscopy can
guide ablation planning, catheter navigation, and catheter ablation.
14
The pattern of myocardial scarring defined by delayed enhancement MRI scanning can
influence the method of access (endocardial vs. epicardial), catheter type, and type
of mapping technology.
15
In the setting of atrial fibrillation ablation, a preprocedural 3D image can be helpful
in cases of unusual atrial or pulmonary vein anatomy. Creation of a 3D map during
the procedure using a mapping system can obviate the need for a preprocedural 3D image.
5.3
EP Systems
An EP system refers to the hardware and software programs that allow clinicians to
record, display, store, and review data acquired during EP procedures. The monitoring
system includes a computer workstation with both local and bedside high-resolution
color display monitors, a recorder, amplifiers and filters for signal acquisition
and processing, a printer, and device interface cables. The workstation contains an
integrated computer that uses data processing software with amplifiers and adjustable
filters to process and display electrogram signals and waveforms. At a minimum, the
system should contain 12-lead surface ECG and 24 intracardiac electrogram channels,
which is sufficient for the basic EP laboratory. Advanced laboratories performing
complex ablation procedures require EP systems with 64–128-channel capabilities to
simultaneously record signals from different multipolar catheters and display hemodynamic
data from arterial and/or left atrial pressure transducers. Useful features for EP
systems include a triggered sweep, template matching, and capability to save fluoroscopic
images. These data are displayed on color monitors that include both real-time and
review screens for visualization and analysis of electrogram signals during mapping
and ablation. The number of available channels displayed on color monitors is configurable
and differs among the various EP systems. Storage capabilities are often included
in EP systems with various hard disk capacities and digital media for archival purposes
and retrieval of data. Ideally, data should be stored in a central repository and
be available to any workstation over the network. Integration and interfacing with
RF-generating devices, fluoroscopy, mapping, and ablation systems are also important
components of the system. Finally, the systems should be capable of communicating
with institutional information systems and electronic medical records.
5.4
Resuscitation Equipment
Resuscitation equipment is mandatory, given the potential for induction of malignant
arrhythmias. A biphasic external defibrillator is required in each EP laboratory,
with a backup defibrillator immediately accessible. Routine preventative maintenance
of external defibrillators should be performed, according to U.S. Food and Drug Administration
(FDA) guidelines and manufacturer recommendations.
16
A crash cart containing standard advanced cardiac life support (ACLS) medications
must be available to assist with the management of tachy- and bradyarrhythmias. Standard
ACLS medications should be available, including, but not limited to, epinephrine,
atropine, dopamine, vasopressin, adenosine, amiodarone, and lidocaine, in addition
to magnesium sulfate, calcium chloride, potassium chloride, and sodium bicarbonate.
Sedative reversal agents should also be available, including flumazenil and naloxone.
It is essential that the laboratory be stocked with appropriate long needles, guide
wires, and catheters for emergency pericardiocentesis and that all operators and staff
are familiar with the use of this equipment.
Given the increasing complexity of EP procedures and the potential need for general
anesthesia, an anesthesia cart that contains endotracheal intubation equipment as
well as sedative, paralytic, and anesthetic agents is highly recommended. This includes
a resuscitator bag and mask, a non-rebreather mask, suction equipment, and arterial
blood gas kits. Such a cart should also contain a separate monitoring system for ECG
and hemodynamics, including a pressure transducer and end-tidal carbon dioxide monitor,
and should be available even in cases not staffed by an anesthesiologist. Finally,
all modern EP laboratories should possess high-flow oxygen and vacuum for suctioning
as detailed in Section 9.
5.5
Stimulators
Programmable electrical stimulators are the mainstay of EP studies and must provide
reliable, accurate, and effective electrical stimulation. Modern programmable electrical
stimulators have multiple output channels, usually ranging from two to four channels.
It is important for these channels to be independent and isolated and to accurately
provide stimuli of adjustable amplitude and pulse duration. Burst pacing and delivery
of one or more premature extrastimuli are standard features of all stimulators. In
addition, some modern stimulators are fully automated and have the capacity of delivering
several types of preprogrammed stimulation protocols to assess physiological parameters
such as thresholds, sinus node recovery times, refractory periods, and Wenckebach
periods.
5.6
Ablation Systems
In order to perform catheter ablation of cardiac arrhythmias, an ablation system is
required in the EP laboratory. Ablation systems generally consist of a generator,
cables, and catheters for the delivery of energy and may or may not include a ground
patch, depending on the energy source. The ablation systems should interface with
EP monitoring and electroanatomic mapping systems. Energy sources can be in the form
of RF ablation, cryoablation, ultrasound ablation, microwave ablation, and laser ablation.
RF and cryotherapy sources are the most widely clinically utilized, and a discussion
of the other sources is beyond the scope of this document.
RF ablation as a therapeutic modality is the most commonly used and has been proven
to be highly effective and safe for the treatment of a wide array of arrhythmias.
17
Irrigated RF energy ablation systems require an irrigation pump to infuse saline in
either a closed- or an open-irrigated tip catheter. Cryoablation systems consist of
a cryocatheter, a refrigeration console with nitrous oxide, a coaxial tube for the
delivery of nitrous oxide, and an electrical cable. During cryoablation, heat is removed
from the tissue by using a refrigerant (nitrous oxide) in a closed-irrigated tip catheter.
Cryoablation can be delivered at a single site (catheter based) or over a larger tissue
area (balloon device). The selection of ablation modality depends on operator preference,
patient size,
18
and ablation target. RF energy remains the most established modality for ablation.
Cooled RF technologies are generally employed where deep and/or transmural lesions
are required, such as with VT ablation. Either irrigated RF energy or the cyrothermic
balloon ablation system is commonly used for atrial fibrillation ablation procedures,
depending on operator preference.
It is desirable for an EP laboratory to have more than one type of ablation system,
but the selection of an ablation system and energy type is entirely discretionary.
Different catheters have different handling characteristics, and different ablation
systems have different strengths and weaknesses. It is recommended that all EP laboratory
personnel using the ablation systems are able to demonstrate familiarity and proficiency
with the setup, operation, and characteristics of all ablation system(s) employed
at their site.
5.7
Mapping Systems
Three-dimensional electroanatomic mapping systems are commonly used in the EP laboratory
for the acquisition of accurate and reproducible electrical and anatomic information
and display in 3D. Reconstruction of complex cardiac geometry with direct nonfluoroscopic
catheter visualization is combined with endocardial electrogram data to create a 3D
map of the cardiac chamber. Advanced signal processing can present acquired electrophysiological
data in a variety of formats to direct the operator to optimal ablation targets. In
addition, standard fluoroscopy, CT, MRI, and intracardiac ultrasound images can be
integrated with electroanatomic mapping systems to link electrogram information with
anatomical structures. This allows nonfluoroscopic catheter localization, reducing
radiation exposure during catheter ablation procedures.
19
Mapping systems consist of a workstation computer, local and bedside monitors, fiber-optic
media converter with a fiber-optic cable, an amplifier, diagnostic and ablative catheters,
and a patient interface unit that provides the central connection of the computer
system to catheters, cables, and the amplifier. The system can interface with recording
systems and integrate with ultrasound, fluoroscopy, and CT/MRI systems. The system
consists of a workstation computer, local and bedside monitors, an amplifier, fiber-optic
media converter with a fiber-optic cable, and a multielectrode array catheter.
5.8
ICE Systems
ICE is often useful as an adjunctive imaging modality during complex procedures. It
has the potential to improve both the safety and the efficacy of a procedure. Dynamic
visualization of intracardiac structures, catheters, and other procedural devices
is possible using ICE. The ability to use this modality in real time is an advantage
that improves the work flow of the procedure compared with using other pre- or postprocedural
augmentative imaging modalities. Using ICE to directly visualize and confirm the proper
position of the transseptal needle on the atrial septum can minimize procedural complications,
such as cardiac perforation. Pulmonary vein stenosis can be avoided by using ICE to
confirm an ostial position of the lasso catheter during pulmonary vein isolation.
20
Early detection of complications, such as pericardial effusion or intracardiac thrombus
formation, can lead to earlier and more effective interventions.
21
Fluoroscopic exposure and its associated risks can be minimized when navigation of
catheters and procedural devices are guided by using ICE.
22
The success of a procedure can depend on the recognition and successful navigation
of challenging anatomy that can be detectable through ICE, such as a prominent Eustachian
ridge during atrial flutter ablation, a crista terminalis ectopic tachycardia focus,
or a ventricular arrhythmia involving the papillary muscles or aortic cusps.
23
Contact of the ablation catheter with tissue can be verified before the delivery of
ablative energy, and ablative effects on the tissue can be monitored by assessing
morphological changes, including tissue swelling and increased tissue echogenicity.
Presently, two different types of ICE systems are available: systems using a linear
phased array transducer that produces a 90º image longitudinal to the catheter and
systems that use a rotational transducer to display a 360º image perpendicular to
the catheter. Each system has relative advantages and disadvantages, and their selection
is based on operator preference. Some ultrasound catheters can work with 3D electroanatomic
mapping systems and can import 2D ultrasound images to augment 3D electroanatomic
mapping.
24
Despite the potential value of ICE, reviewed in detail above, it is important to recognize
that clinical trials are not available to demonstrate that the use of ICE improves
the outcomes or safety of ablation procedures. Although some operators and centers
depend heavily on ICE, many others use it only in selective situations. ICE substantially
increases procedure costs, requires an additional site for vascular access, and requires
extensive training in order to accurately interpret the images.
25
5.9
Robotic Navigation Systems
Catheter movement can be performed using robotic navigation systems, allowing for
reproducible complex catheter manipulation, improved tissue contact and stability,
and the potential for more efficient and efficacious lesion formation. Because of
the automated nature of catheter navigation using 3D anatomic mapping systems, fluoroscopic
exposure may be reduced, especially for the primary operator, who typically performs
the ablation procedure seated in the control room. This may also translate into less
orthopedic strain from the use of lead aprons.
Two distinctly different types of robotic navigation systems are currently available.
Robotic arm systems use steerable sheaths to direct catheter movement. These systems
can use a full array of conventional catheters, including irrigated ablation catheters.
The rigidity of the sheath and the lack of tactile feedback increase the risk of cardiac
perforation and pericardial tamponade.
26
Pressure sensor technology is used to assess appropriate tissue contact and to avoid
perforation, but can be confounded by indirect forces and tortuous catheter positions.
A simpler robotic approach to control the catheter movement involves the use of a
robotic arm to remotely manipulate a steerable ablation catheter exactly as an operator
would manipulate the catheter directly.
27
Although the operator sacrifices the tactile feel of catheter manipulation with this
system, it allows the operator to move to a radiation-free space and to perform the
ablation from a seated position.
Magnetic systems use two large banks of external magnets to manipulate a magnetized
catheter. These magnets can be either solid magnets that are physically moved or electromagnets
using electromagnetic field manipulation. Specialized ablation catheters for these
systems are available, including open-irrigated tip catheters. Because the body of
the catheter has no rigidity and the catheters are directed solely by a limited low-intensity
magnetic field, the risk of cardiac perforation is virtually eliminated.
28
The constant magnetic force holds the catheter in contact with tissue, even during
cardiac and respiratory motion, translating to potentially more precise and efficacious
lesions.
29
The use of robotic navigation systems takes the primary operator away from the patient’s
side during the procedure; thus, subtle changes in clinical status that are usually
noticed in close proximity to the patient or the tactile sensation of a steam pop
may no longer be detectable. Hence, close monitoring by an anesthesiologist and the
nursing staff is of paramount importance when robotic navigation is being used.
5.10
Integrated Data Display Systems
As the breadth of technologies in the modern EP laboratory has grown, so too has the
challenge of displaying information in a meaningful and useful way. The model using
a fixed number of separate monitors, each displaying a single signal, is not well
suited for laboratories using multiple systems and performing complex procedures.
Modern advanced laboratories have increasingly taken advantage of integrated data
display systems (IDDSs). These IDDSs replace the multiple fixed monitors with a single
large screen that displays multiple signals, thereby allowing the physician and laboratory
staff to display as many images as required in whatever layout they choose. Not only
do IDDSs enhance flexibility, they also diminish the physical requirements for monitoring,
thereby liberating space within the EP laboratory. The drawback of IDDSs is the addition
of another layer between the operator and the source systems that may be susceptible
to image distortion or complete failure that would affect all signals. Thus, it is
necessary to have separate backup monitors for critical functions in case of failure.
Lastly, IDDSs should have a simple, intuitive user interface; otherwise, any benefit
they provide would be outweighed by issues relating to the complexity of use.
5.11
Telemedicine Applications
Telemedicine has grown in many areas of medicine over the past decade, and EP is no
exception. In fact, EP is better suited than most specialties to leverage this growing
trend, thanks in part to the integration of many laboratory systems into a single
interface and to advances in remote catheter navigation systems. Remote diagnostics
are already a reality because of the growth of several networks that link various
laboratories and facilities together. Physicians from a number of institutions can
broadcast live and prerecorded procedures and perform real-time consultations with
other participating facilities. Remote surgery has been demonstrated using the current
generation of remote catheter navigation technologies and has been further bolstered
by the addition of newer laboratory integration systems. While the requirements for
remote surgery are similar to those of remote diagnostics, there should be much less
tolerance for latency and system responsiveness as well as enhanced fail-safe measures
and the ability for local override. Significant gaps in state, federal, and international
regulations will need to be addressed before telemedicine can reach its full potential
in this field.
6
Laboratory Staffing
Laboratory Staffing Recommendations
•
Medical staff credentialing committees should be familiar with the training and credentialing
standards for specialists in cardiac arrhythmias.
•
Staff physicians must have prerequisite training and appropriate credentialing reflecting
expertise in the management and treatment of cardiac arrhythmias.
•
Because of the complexity of the EP procedures, patient safety and positive outcomes
are critically dependent on the skill levels of the staff. Additional staff is needed
as the complexity of the case increases and more equipment is required.
•
It is desirable that anesthesia services be an integral part of clinical practice
in the EP laboratory.
•
Advanced practice nurses (APNs) and physician assistants (PAs) should be used in areas
where they will have a maximum impact on patient care and where they can assume roles
and responsibilities unique to their training and certification.
•
At least one registered nurse should be present for every invasive procedure in the
EP laboratory.
•
Industry representatives should function according to clear policies under the direction
of the laboratory manager, staff, or physician.
6.1
Physicians
6.1.1
Qualifications
Staff physicians must have prerequisite training and appropriate credentialing reflecting
expertise in the management and treatment of cardiac arrhythmias. Training requirements
and guidelines for pacemaker/ICD selection, implantation, and follow-up as well as
catheter ablation procedures have been addressed by the American Heart Association
(AHA), American College of Cardiology (ACC), and HRS30, 31, 32, 33, 34 and are addressed
in Section 7.
Physicians performing procedures in the EP laboratory often supervise the administration
of intravenous sedatives given by the nursing personnel in the laboratory. Therefore,
all physicians in the laboratory should demonstrate proficiency in sedation pharmacology,
patient monitoring, and airway management. There should be a credentialing process
in the institution that establishes a standard for conscious sedation management.
6.1.2
EP Laboratory Medical Director
The EP laboratory medical director must be an expert in CCEP and satisfy the above
requirements, in addition to carrying out important administrative duties that include
physician leadership, patient care clinical leadership, quality of care, and education.
As a physician leader, the medical director is responsible for providing overall medical
direction and supervision within the EP laboratory. The roles and responsibilities
of the other EP staff physicians must be specifically outlined by the director so
that there are clear measures by which the EP staff physicians are evaluated. Ensuring
staff members are appropriately credentialed and that they are maintaining cognitive
and procedural competency is important for maintaining up-to-date health care provider
standards. The laboratory director should work with the institution’s leadership to
establish specific training- and volume-based credentialing and recredentialing criteria
based on published clinical care guidelines (when available). Those criteria should
be understood and adhered to by all.
The medical director must develop and implement quality measures that result in fewer
complications, reduced cost, and successful patient outcomes. Working closely with
administrative staff to develop policies, procedures, and practice guidelines impacts
accountability measures used by accreditation authorities, including TJC and the National
Committee for Quality Assurance. Additional responsibilities may include planning
or coordinating ongoing educational opportunities for all EP personnel, championing
the EP service line, identifying budgetary savings and efficiencies, participating
in or initiating purchasing of capital items that keep the service line current, and
assisting as requested with the development and review of EP-related policies and
procedures. Policies should be compatible with other areas with which the EP service
interacts, such as the prep and recovery areas, anesthesia, surgery, and the cardiac
catheterization laboratory.
6.1.3
Faculty/Teaching Attending Physician
Faculty physicians typically work in a teaching hospital or affiliate institution.
They must satisfy the same qualifications as above, in addition to those set forth
by the Accreditation Council for Graduate Medical Education (ACGME). These requirements
are quite rigorous, and failure to adhere to requirements may result in the program
being placed on probation or loss of accreditation.
6.1.4
EP Laboratory Attending Physician
Although certain components of the procedure can be delegated to a trainee or other
secondary operator, the laboratory’s attending physician of record is ultimately responsible
for all activities within the laboratory and for patient welfare. It is important
for the staff physician to recognize that patient safety and successful outcomes depend
greatly on effective communication in the EP laboratory. This communication should
include preoperative discussions with all members of the team before the case is underway
regarding specific patient needs. The physician should review the diagnosis, indications
for the procedure, anticipated equipment needed, and potential findings of the procedure.
The patient should have a clear understanding of what to expect postprocedure in order
to minimize anxiety. After the procedure, clear communication of the procedure findings,
postprocedure orders, and recommendations should be exchanged with the treatment team,
including physicians, APNs, PAs, and nurses.
6.1.5
Secondary Operators
Secondary operators are those physicians assisting with a procedure who might or might
not participate in certain aspects of EP procedures and who might bill separately
for an area of expertise not provided by the primary physician in the laboratory (
Table 1). Their role is planned and limited to nonemergency procedures. The patient
should be informed before the procedure of any secondary operators expected to be
assisting with the case.
Table 1
Secondary Operators in the Cardiac EP Laboratory
Secondary operator
Role/duties
Cardiac electrophysiologist
•
Operates the EP/mapping system and assists with cardiac stimulation and mapping while
the primary operator is manipulating the catheter
•
Manipulates the mapping/ablation catheter while the primary operator is operating
the EP/mapping system
Interventional cardiologist
•
Performs angiography for defining coronary anatomy in epicardial ablation procedures
•
Performs aortography to define location of coronary ostia in LVOT/cusp ablation procedures
•
Assists with transseptal puncture and left atrial access
•
Places intra-aortic balloon pump or other support devices
Interventional radiologist or interventional cardiologist
•
Performs angioplasty of venous vessels
Noninterventional cardiologist
•
Performs transesophageal echocardiography
•
Assists with intracardiac echocardiography
Cardiothoracic surgeon
•
Operates epicardial pacemaker or epicardial ICD systems
•
Assists with hybrid atrial fibrillation procedures
•
Assists with epicardial access via pericardial window
•
Assists with lead extraction backup
•
Assists with extracorporeal membrane oxygenation for VT storm and hemodynamically
unstable VT ablation
Anesthesiologist
•
Supports cases by providing conscious sedation or general anesthesia
EP = electrophysiology, LVOT = left ventricular outflow tract; VT = ventricular tachycardia.
6.1.6
Cardiovascular Trainee (Fellow)
The role of the fellow can be variable and dependent on the attending physician present
in the laboratory. There are specific requirements that each fellow in training must
satisfy in order to successfully complete his or her training and be eligible for
the American Board of Internal Medicine (ABIM) certification examination (or American
Board of Osteopathic Medicine for those individuals following the osteopathic route).
The fellow should begin under the direct supervision of a key clinical faculty member
from the training program. With ongoing evaluation and feedback, the fellow is given
graduating responsibility. Varying levels of supervision are appropriate depending
on skill level and level of training. It is appropriate for fellows to perform components
of the procedure without direct supervision (such as vascular access, catheter placement,
device pocket incisions, and pocket closures), but the attending physician must be
available to intervene promptly if any issues arise.
6.2
Anesthesiology
It is desirable that anesthesia services be an integral part of clinical practice
in the EP laboratory. An anesthesia group composed of anesthesiologists and certified
registered nurse anesthetists (CRNAs) can provide a high level of perioperative/periprocedural
care to patients undergoing EP procedures. Having anesthesia services readily available
for the EP service is advantageous. The anesthesia service can provide important educational
assistance to nonanesthesia staff administering conscious sedation, such as training
on the use of various sedation agents, and the use of special monitoring techniques
such as capnography. Patients undergoing EP procedures present special challenges
related to sedation. It is imperative that sedation/anesthesia personnel function
collaboratively with the electrophysiologist in the management of these patients during
procedures. Procedural issues relating to anesthesia management are discussed further
in Section 8.
6.3
Allied Professional Personnel
To ensure optimal safety and efficacy of interventional EP, it is important to emphasize
the necessity of a multidisciplinary team approach. In this respect, the term allied
professionals has been employed. Allied professionals are defined as all nonphysician
members of the health care team involved with the care of the patient in the EP laboratory.
This includes, but is not limited to, registered nurses (RNs), EP technologists, radiological
technologists, certified nurse practitioners (NPs), PAs, CRNAs, patient prep and recovery
staff, and OR staff. Other key personnel that are important for the safe and efficient
function of the laboratory include quality assurance (QA) staff; information technologists;
biomedical engineers; scheduling coordinators; purchasing, inventory, and supply personnel;
and housekeeping. Based on evidence-based practice and best practice patterns, it
is important to acknowledge that there is limited published research regarding the
roles and responsibilities inherent in EP. Recommendations as to how these positions
may be filled by any one of the several categories of personnel are discussed below.
6.3.1
Advanced Practice Nurses and Physician Assistants
APNs and PAs can play major roles and serve many functions in the EP laboratory, as
determined by the director of the laboratory. They should be placed in those areas
where they will have maximum impact on patient care and assume roles and responsibilities
unique to their training and certification. APNs are often placed in clinic settings
where they may evaluate and treat arrhythmia or device-related issues. They can make
rounds on inpatients, make assessments, develop plans for care, write histories and
physical exams, and admit and discharge patients. They can perform pre- and postprocedural
evaluations and follow-up. Particularly in nonacademic institutions or practices,
an APN or PA may function as the most experienced or skilled nonphysician practitioner
in the laboratory setting and thus function as a first assistant for many technical
aspects of the procedure. Each institution should have established policies defining
the role of the APN and/or PA in the care of hospital patients.
6.3.2
Registered Nurses
An RN should be present for every invasive procedure in the EP laboratory. The nurse
must be familiar with the overall function of the laboratory as well as coordinate
with the physician operator and the other team members. The nurse (either RN or CRNA)
is the primary individual responsible for the direct observation, sedation, and nursing
care of the patient during the EP procedure and must be prepared to respond to any
emergency. The number and type of nursing personnel required in the EP laboratory
will vary depending on the type of procedure, equipment used, and additional support
staff assigned to the procedure.
35
EP procedures are complex by their nature, and it is essential that the nursing staff
participating in such procedures provide safe, evidence-based care.
In institutions where nurses are responsible for the administration of intraprocedural
sedation, they are to follow institutional training and guidelines for the care of
the patient.
When a nurse is administering deep sedation, his or her focus should be only on monitoring
patient status, vital signs, oxygenation, and level of sedation. However, during moderate
or light sedation, this individual may assist with minor, interruptible tasks once
the patient’s level of sedation/analgesia and vital signs have stabilized, provided
that adequate monitoring of the patient’s level of sedation is maintained.
36
The nurse can also manage point-of-care testing for activated clotting times (ACTs),
oxygen saturation, and blood gas measurements. In most states, only RNs may administer
medications and blood products. The nurse optimizes patient safety by adhering to
policies, protocols, and procedures, such as completing the “active time-out” preprocedure
and ensuring that the proper airway assessments are completed before the administration
of sedation. Keeping a record or charting during the procedure is generally the responsibility
of nurses. In addition, training on the use of stimulators, infusers, and ablation
generators is recommended so that nurses are able to function in multiple roles. Overall,
nurses are coordinators of all patient care in the laboratory and they oversee the
care other allied professional-EP personnel are providing.
6.3.3
Technologists
Because of the extremely complex and technical aspects of many EP procedures, there
should be at least one additional person involved in the more complex procedures,
in addition to the nurse who provides direct patient care. Depending on the complexity
of the procedure, there may need to be more than one additional person. In this arena,
specific training, experience, and certifications may determine which team member
occupies each role. For example, a nurse and a technologist may be equally capable
of performing a certain duty or responsibility but economics, staffing availability,
and the simultaneous performance of multiple duties can dictate who does each job
in the laboratory. Because of the multiplicity of roles, it is useful for members
of the EP team to be cross-trained and be able to function in multiple roles and situations.
There is a wide array of additional equipment that requires training to operate. This
includes, but is not limited to, lasers, energy source generators, electroanatomic
mapping systems, robotic and magnetic catheter navigation systems, echocardiography
(transesophageal and intracardiac), and CT and MRI imaging.
In many laboratories, it is the technologist or nurse who monitors and operates the
recording system. This activity requires a thorough understanding and knowledge of
the electrophysiological properties of the heart as well as pacing protocols and ablation.
The operator must be able to troubleshoot pacing problems and remain calm and functional
in emergency situations. All technologists must have basic cardiac life support certification,
and ACLS certification is preferred. In the pediatric laboratory, pediatric cardiac
life support certification is required. As with the nurse, the technologist should
have the ability to review, understand, and synthesize into practice new knowledge
and practices.
EP technologists perform as essential team members. They may be a first assistant,
which requires in-depth knowledge of percutaneous procedures, catheters, sterile technique,
energy generators, and integrated noninvasive imaging. They should be trained in the
use, maintenance, and troubleshooting of all the equipment. EP technologists should
be skilled in sterile technique, passing sterile supplies, and obtaining and performing
point-of-care testing on blood samples. They are often the person who assists on device
implant cases and lead extractions—roles that require fastidious adherence to sterile
technique and an in-depth understanding of the implant process along with its risks
and goals. A technologist or nurse may serve as the first assistant for an invasive
case. The circulator is typically a nurse, but this role can be filled by a technologist,
depending on the staffing mix in the laboratory, the scope of practice in this job
description, and the institutional requirements.
At least one department member should be a certified radiological technologist or
equivalent technologist with expertise in the operation of fluoroscopic equipment
as well as expertise in radiographic and angiographic imaging principles and techniques.
Requirements for the participation of a radiological technologist in fluoroscopic
procedures vary from state to state. In conjunction with a qualified medical physicist,
the radiological technologist should monitor radiation safety techniques for patients
and laboratory personnel. In many states, the Nuclear Regulatory Commission has specific
regulations for who may operate ionizing radiation equipment and under what circumstances.
It is imperative that these regulations are understood and followed in the laboratory
for the protection of patients and staff.
6.3.4
Industry Employed Allied Professionals
Device programmers, mapping and recording systems, and some ablation systems may sometimes
be operated by industry representatives. Industry representatives must function according
to clear policies under the direction of the laboratory manager, staff, or physician.
They are often required to provide the institution with evidence of appropriate immunizations,
competency documentation, and endorsement from their company before being allowed
in the laboratory. They are generally allowed to have patient contact only under direct
staff supervision.
25
During device implants or other device-related procedures, a clinical industry representative
may be present under the direct supervision of the attending physician. They may bring
device equipment to the laboratory, provide intraprocedural programming and testing,
and may even be asked to participate in data collection related to device registries.
A member of the EP laboratory staff, however, should be assigned the ultimate responsibility
for the accurate and complete submission of data to national device registries. These
industry representatives are often excellent sources of information and education
for the regular EP laboratory staff. They may assist in the provision of formal training
and education on device-related issues.
25
6.3.5
Staffing Patterns
To ensure optimal safety and efficacy of interventional EP, it is important to emphasize
the necessity of a multidisciplinary team approach. EP procedures are complex and
include diagnostic, interventional, and therapeutic measures and should be performed
by experienced personnel. Because of the complexity of the EP procedures, patient
safety and positive outcomes are highly dependent on the skill levels of the staff
(
Table 2). Therefore, personnel dedicated to EP laboratory procedures are recommended.
Additional personnel are needed as the complexity of the case increases, and more
equipment is required. The staffing mix may be influenced by regulations, regional
practice patterns, type of institution (academic vs. nonacademic), credentialing bodies,
and economics. Cross-training of staff within the EP department maximizes staffing
flexibility and is strongly recommended.
Table 2
Staffing Recommendations for Electrophysiology Procedures
Type of procedure
Recommended personnel (Alternatives/additional ad hoc personnel)
Pediatric laboratory staffing personnel (Alternatives/additional ad hoc personnel)
Basic EP study
1 EP credentialed MD performing the procedure
1 EP credentialed MD performing the procedure
(Fellow, NP, PA, and technician performing under the supervision of an MD responsible
for the procedure [as approved by the institution])
1 CRNA administering anesthesia under the supervision of an MD anesthesiologist, or
1 nurse trained and credentialed in procedural sedation
1 CRNA administering anesthesia under the supervision of an MD anesthesiologist, or
1 nurse trained and credentialed in procedural sedation⁎
1 Nurse
1 cardiovascular technologist/radiology technologist
(1 nurse or 1 cardiovascular technologist/radiology technologist
⁎
)
Tilt table tests
1 nurse, NP, or PA
1 nurse, NP, or PA
MD must be on the premises, readily available, and aware that testing is occurring
Pediatric cardiologist must be on the premises, readily available, and aware that
testing is occurring
(1 tilt table technician)
(1 tilt table technician)
Cardioversions
1 CRNA administering anesthesia under the supervision of an MD anesthesiologist, or
1 nurse trained and credentialed in procedural sedation
1 CRNA administering anesthesia under the supervision of an MD anesthesiologist, or
1 nurse trained and credentialed in procedural sedation
Noninvasive programmed stimulation
Defibrillation threshold testing
1 MD performing/supervising the procedure
1 MD performing/supervising the procedure
(1 nurse or technologist circulating and documenting)
1 nurse monitoring and recovering the patient
Ablation procedures
1 EP credentialed MD performing the procedure
1 specialist in pediatric EP performing the procedure
(Secondary MD operators may be desirable to perform certain parts of the procedure)
(Many laboratories have a working standard of a secondary MD operator for all cases)
(Fellow, NP, PA, and technician performing under the supervision of an MD responsible
for the procedure [as approved by the institution])
(Fellows or other students assisting or observing)
1 CRNA administering anesthesia under the supervision of an MD anesthesiologist, or
1 nurse trained and credentialed in procedural sedation
1 CRNA administering anesthesia under the supervision of an MD anesthesiologist, or
1 nurse trained and credentialed in procedural sedation
(1 nurse giving medications, and patient care during the procedure may do charting)
1 nurse giving medications, and patient care during the procedure, may do charting
(Physician extenders such as an NP or PA)
(Physician extenders such as an NP or PA)
1 technologist or nurse running the recording system, stimulator, and ablation system;
may be a radiation technologist
1 technologist or nurse running the recording system, stimulator, and ablation system;
may be a radiation technologist
(Vendor representative running the mapping system)
(Vendor representative running the mapping system)
(Vendor representative or hospital technologist assisting with echocardiography)
(Vendor representative or hospital technologist assisting with echocardiography)
(Vendor representatives assisting with the operation of other specialized equipment,
such as lasers, cryoablation generators, and intracardiac echo machines)
(Vendor representatives assisting with the operation of other specialized equipment,
such as lasers, cryoablation generators, and intracardiac echo machines)
Device implant procedure
1 EP or device-credentialed MD performing the procedure
1 specialist in pediatric EP performing the procedure
(Fellow, NP, PA, and technician performing under the supervision of an MD responsible
for the procedure [as approved by the institution])
(Secondary operator, including physician extenders)
(Fellows or other students assisting or observing)
1 CRNA administering anesthesia under the supervision of an MD anesthesiologist, or
1 nurse trained and credentialed in procedural sedation⁎
1 CRNA administering anesthesia under the supervision of an MD anesthesiologist, or
1 nurse trained and credentialed in procedural sedation
(1 nurse or technologist circulating
⁎)
1 nurse circulating
(1 technologist or nurse may be a surgical assistant)
1 technologist or nurse may be a surgical assistant
(Vendor representative from the device manufacturer)
(Vendor representative from the device manufacturer)
(Vendor representative assisting with the operation of other specialized equipment,
such as lasers and other extraction equipment)
(Vendor representative assisting with the operation of other specialized equipment,
such as lasers and other extraction equipment)
Lead extraction procedure
1 EP or device-credentialed MD performing the procedure
1 MD specialist in pediatric EP performing the procedure )
(Secondary operator including physician extenders)
(Secondary operator, including physician extenders
(Fellow, NP, PA, and technician performing under the supervision of an MD responsible
for the procedure [as approved by the institution])
(Fellows or other students assisting or observing)
1 CRNA administering anesthesia under the supervision of an MD anesthesiologist, or
1 nurse trained and credentialed in procedural sedation
1 CRNA administering anesthesia under the supervision of an MD anesthesiologist
1 CV surgeon to be immediately available (may be required to be in the room for the
critical part of the procedure)
1 congenital CV surgeon in the operating room at the time of extraction and immediately
available periprocedure
1 CV surgery fellow on call for surgical assistance
1 nurse circulating
1 perfusionist
(1 technologist or nurse scrubbing)
1 nurse
1 cardiovascular technologist/radiology technologist
(May require a second scrub person for the surgical procedure)
1 CV OR scrub nurse
1 CV OR circulating nurse
(An operator to monitor a TEE that may be in place. This function is sometimes performed
by the anesthesiologist)
(An operator to monitor a TEE that may be in place. This function is sometimes performed
by the anesthesiologist)
(Vendor representative from the device manufacturer)
(Vendor representative from the device manufacturer)
(Vendor representative assisting with the operation of other specialized equipment,
such as lasers and other extraction equipment)
(Vendor representative assisting with the operation of other specialized equipment,
such as lasers and other extraction equipment)
CRNA = certified registered nurse anesthetist; CV = cardiovascular; EP = electrophysiology;
MD = physician; NP = nurse practitioner; PA = physician assistant; TEE = transesophageal
echocardiography.
⁎
In procedures performed with deep sedation/analgesia, the CRNA or nurse administering
sedation/anesthesia should have no responsibilities other than monitoring the patient.
A second nurse or technologist must be available to circulate and document. However,
in procedures performed with moderate or light sedation, this individual may assist
with minor, interruptible tasks once the patient’s level of sedation/analgesia and
vital signs have stabilized, provided that adequate monitoring for the patient’s level
of sedation is maintained.
52
6.4
Administrator/Manager
The role of the EP department administrator is typically held by someone with broad
knowledge of the field of EP. Depending on the size and volume of the laboratory,
the administrator may have no clinical obligations or may serve as the head nurse
of the laboratory. The responsibilities can include, but are not limited to, the following:
strategic planning in association with the medical director, managing operational
issues, capital planning, budgeting, hiring, planning orientations and training programs
for allied professionals, and other general administration duties. A nurse or a cardiovascular
technologist, preferably with some business training or experience, is best suited
for this role. In shared or combined cardiac catheterization laboratories and EP laboratories,
there may be a common administrator overseeing both areas.
In many departments, the manager is a nurse. The responsibilities of a nurse manager
include an overall understanding of the day-to-day operations of the laboratory, management
of pre- and postprocedural care areas, and direct participation in the observation
and care of patients undergoing EP procedures. Additional areas of responsibility
include application of institutional guidelines for patient monitoring, medication
administration, procedural sedation, and patient safety. Staff competencies and proficiency
in performing tasks required before, during, and after the procedure must be developed,
updated, and reviewed on a regular basis. The nurse manager will collaborate with
anesthesia, pharmacy, biomedical engineering, purchasing, equipment vendors, and housekeeping
to coordinate the operation of the EP laboratory.
7
Laboratory Personnel Credentialing
Laboratory Personnel Credentialing Recommendations
•
All clinicians working in the EP laboratory have a responsibility to achieve and maintain
the recommended credentials and continue medical education to optimize patient care.
•
It is recommended that any non–CCEP-certified physician who wants privileges for implantable
cardioverter-defibrillator implantation should complete formal training in this field
as defined by the COCATS criteria, achieve certification of Competency in Cardiac
Rhythm Device Therapy for the Physician (CCDS) from the International Board of Heart
Rhythm Examiners (IBHRE), and maintain an adequate volume of device implants to meet
hospital-based credentialing criteria.
•
For the benefit of patients, it is paramount that physicians be held to a high performance
standard and that remediation, withholding recredentialing, or revocation of privileges
occurs if criteria are not met.
7.1
Attending Physicians
7.1.1
Credentialing
A range of procedures is performed in cardiac EP suites. Procedures that fall within
the domain of physicians trained and ABIM certified in cardiovascular diseases include
performance of electrical cardioversions and placement of temporary pacemaker wires.
Invasive cardiac EP procedures in adults, including diagnostic electrophysiological
testing and catheter ablation, should be restricted to physicians who are ABIM certified
in CCEP.
31
All CCEP board–certified physicians have completed at least 1 year of comprehensive
subspecialty training in CCEP at an ACGME-approved training program
30
or had substantial experience and a career focus in CCEP if they trained in an era
before the development of formal CCEP training programs. The majority of programs
encourage a second year non-ACGME advanced fellowship. The 2013 guidelines for advanced
training in pediatric and congenital EP represent procedural requirements for those
completing training.
37
The clinical competence statement on invasive electrophysiology studies, catheter
ablation, and cardioversion,
34
supplemented by expert consensus statements on transvenous lead extraction,
8
catheter and surgical ablation of atrial fibrillation,
38
and catheter ablation of ventricular arrhythmias,
39
provides guidelines for appropriate training in CCEP. This document is scheduled to
be updated in the near future. As training standards evolve, these minimum requirements
will be updated regularly. A successful passage of the ABIM CCEP board examination
is required to receive the Certificate of Added Qualification in CCEP. A similar but
alternate pathway is available for doctors of osteopathy through the American Board
of Osteopathic Medicine. Physicians for whom these pathways are unavailable because
of international training or pathway choices and who are actively involved in the
clinical management of EP patients may choose to certify through the IBHRE with the
Certification Examination for Competency in Cardiac Electrophysiology. Physicians
performing complex catheter ablation procedures, such as atrial fibrillation/complex
atrial tachycardia ablation and VT ablation, should treat at least 25 cases of each
with an experienced mentor before becoming independent. Alternatively, they should
perform these procedures during their CCEP training program, as recommended by the
2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of
atrial fibrillation
38
and the 2009 EHRA/HRS expert consensus on catheter ablation of ventricular arrhythmias.
39
A number of training pathways can lead to the practice of implanting CIEDs. Although
physicians who are board certified in CCEP have met minimum training standards for
CIED implantation, some cardiovascular diseases (CVD) board–certified physicians and
some American Board of Surgery–certified cardiac, thoracic, and general surgeons also
devote a substantial portion of their practice to the prescription, implantation,
and follow-up of CIEDs. The criteria established by the ABIM program requirements
28
and the Recommendations for Training in Adult Cardiovascular Medicine Core Cardiology
Training document
33
strongly recommend that any non–CCEP-certified physician who wants privileges for
ICD implantation in adults completes formal training in this field. Achieving CCDS
from the IBHRE for CIED prescription, implantation, and follow-up is strongly recommended.
Credentialing is ultimately the responsibility of the credentialing committee of the
individual hospital, who should be familiar with the training and credentialing standards
for specialists in cardiac arrhythmias. Although most major centers already follow
the guidelines above, some centers allow less qualified practitioners to perform these
EP laboratory procedures. Unfortunately, hospital credentialing committees have substantial
conflicts of interest that could lead to granting privileges to physicians without
appropriate board certification and experience, as refusal of these credentials usually
results in a loss of patients and revenues to competing institutions. Ultimately,
the patient pays the price when inappropriate credentials are allowed.
7.1.2
Evaluation and Recredentialing
All EP laboratory physicians should be subject to periodic peer review and recredentialing.
Important components in the recredentialing process should include a review of ABIM
board certification and IBHRE CCDS status, case volume, patient outcomes, peer evaluation,
and continuing medical education (CME). The specific criteria for recredentialing
are determined by each individual hospital, but should generally parallel the following
recommendations: ABIM CCEP board certification and IBHRE certification are limited
to 10 years; to stay current for CCEP, the physician must complete a series of CME
and/or practice improvement activities
9
; recertification examination for CCEP and CCDS are each required at 10-year intervals;
to ensure that cognitive and technical skills are maintained, the physician’s clinical
competence must be evaluated and documented on a regular basis; it is the responsibility
of the medical staff credentialing committee to ensure that physicians perform the
necessary number of evaluations and procedures needed to maintain their expertise
31
and also that they participate in regular CME activities. The EP laboratory should
have a robust QA process (see Section 9), and physician outcomes should be compared
with national benchmarks derived from the literature or databases such as the National
Cardiovascular Data Registry (NCDR) on a regular basis; regular 360º evaluations,
including evaluations from physician coworkers, fellows, nursing staff, technical
staff, and patients, should be considered as part of the recredentialing review process.
For the benefit of patients, it is paramount that physicians be held to a high performance
standard and that remediation, withholding recredentialing, or revocation of privileges
occurs if criteria are not met. The physician leaders must be committed to working
aggressively to maintain the highest standards of patient care in their laboratories.
40
7.1.3
Pediatric Training and Credentialing
PACES, working in conjunction with HRS, has developed guidelines for advanced training
in EP focused on pediatric patients and patients of any age with CHD. The original
guidelines, endorsed by the HRS and published in 2005, required at least 12 months
of specialized training, and were followed by a 2008 document focused on the implantation
of pacemakers and defibrillators in these populations.41, 42 There are currently no
third-tier board examinations for diplomates of the pediatric cardiology subboard
of the American Board of Pediatrics. However, pediatric electrophysiologists are eligible
to take the IBHRE examination for physicians with special competency in EP, as that
examination includes a pediatric module. PACES has recently written a competency statement
for training in this field.
43
That competency statement strongly recommended that all graduating fellows and active
pediatric EP clinicians take the IBHRE EP examination.
7.1.4
Adult Congenital Heart Disease Training and Credentialing
The field of adult congenital heart disease (ACHD) is an important and expanding clinical
domain that is typically staffed by clinicians who are competent in both pediatrics
and internal medicine. Cardiologists providing invasive EP care for this unique patient
population can enter the field from either specialty, but a portion of their formal
training must be focused on the complex anatomy and unique EP of ACHD. Further recommendations
on the expertise necessary to care for this patient group can be found in a recent
consensus statement supported by AHA/ACC/HRS.
44
A board certification process for ACHD is being developed and is scheduled for implementation
by 2015.
7.2
Nurses
7.2.1
Training and Credentialing
Nursing licensure, credentialing, recredentialing, continuing education, and laboratory
training are affected by the requirements of multiple agencies, including federal
and state governments, the health care organization, and Occupational Safety and Health
Administration.
The standards of professional practice for nurses employed in the EP laboratory environment
have been defined.
33
All EP nurses should have a critical care or a strong cardiology background, ACLS
certification, and, in the pediatric EP laboratory, pediatric ACLS. An extensive knowledge
of cardiac anatomy and physiology, electrocardiography, pharmacology, and training
in sterile technique is also required. Nurses need to have a thorough understanding
of catheter-based interventions and surgical procedures, cardioversion, arrhythmia
discrimination, and emergency treatment of life-threatening arrhythmias and complications/emergencies.
Familiarity with fluoroscopic, electroanatomic, and echocardiographic imaging is a
required skill set. Annual or biannual competencies required for nurses working in
heart rhythm service operations should include basic life support, ACLS, infection
control, emergency and TJC preparedness, training in conscious sedation, charting,
and patient safety. Demonstration of competency in radiation safety, sterile technique,
external defibrillator operation, unit-specific nursing protocols, ACT operation,
and temporary pacemaker operation should also be mandatory. Depending on the roles
and responsibilities assumed by RNs, competencies may be needed in the EP recording
system and programmed stimulator operation, ablation, generator operation, mobile
laboratory operations, sheath insertion/removal, operation of vascular ultrasound,
3D mapping operation, and ICE operation.
Certification offered by the (IBHRE is an integral part of heart rhythm education,
training expectations, and requirements. In addition to the standard certification
requirements for being an RN, the IBHRE offers two certification examinations for
allied professionals designed to demonstrate a mastery of knowledge in cardiac rhythm
management.
7.2.2
Evaluation and Recredentialing
Continuing education requirements are highly variable by state and nurse specialty.
Nurses need to review requirements for the state in which they are practicing to ensure
proper compliance and maintenance of certification, as requirements can range from
no required continuing education to as many as 30 hours every 2 years.
45
The Certification Examination for Competency in Cardiac Rhythm Device Therapy and
the Certification Examination for Competency in Cardiac Electrophysiology are required
at 10-year intervals.
7.3
Advanced Practice Nurses
7.3.1
Training and Credentialing
The APN (usually a NP) is educated through a certified graduate level NP program,
meets the requirements of the state credentialing bodies, and practices according
to the American Nurses Association consensus model.
46
An NP is trained to perform preprocedural evaluation, order and interpret diagnostic
tests, and conduct postprocedural follow-up. After on-the-job training, NPs may assist
in diagnostic EP studies, catheter ablation procedures, and device implants but cannot
serve as a primary operator. NPs working in heart rhythm services should be certified
in basic and advanced cardiac life support and have knowledge of radiation safety,
sterile technique, external defibrillator operation, ICE operation, and temporary
pacemaker operation. Among laboratories represented by writing committee members,
NPs (or PAs) are involved in pre- and postprocedural care in more than 75% of the
centers but only 19% of the centers employ these individuals for assistance in the
procedural laboratory.
7.3.2
Evaluation and Recredentialing
There are no uniform recredentialing criteria for NPs in the EP laboratory. NPs are
expected to maintain certification and licensure as per certification and state guidelines.
The institution should establish volume criteria for the maintenance of procedural
competencies.
7.4
Technologists
7.4.1
Training and Credentialing
Individuals with a variety of backgrounds and qualifications can work in an EP laboratory
as a cardiovascular technologist or technician. There is no professional regulatory
body for cardiac technologists, although efforts are underway in some regions to achieve
this goal. Most technologists have postsecondary education (university degree or college
diploma) with extensive on-the-job training. Industry-sponsored courses often provide
supplemental education specific to technologies used in the EP laboratory environment.
Some cardiovascular technologist programs offer EP as a component within a cardiovascular
technology program; there are also certificate programs available at some accredited
colleges.
47
Cardiovascular technologists can be credentialed as a registered cardiovascular invasive
specialist, registered cardiology technologist, registered cardiopulmonary technologist,
or registered cardiac electrophysiology specialist through an accredited association
such as Cardiovascular Credentialing International.
46
Advanced EP specialty certification is achieved through the IBHRE.
7.4.2
Evaluation and Recredentialing
Satisfactory institutional performance appraisals (e.g., through 360º assessments
of skills, competency, professional development, decision making, and leadership)
are recommended. The individual should treat a sufficient volume of cases to maintain
competency. If the technologist is IBHRE certified, then the maintenance of certification
through continuing education or certification examination is required.
7.5
Physician Assistants
7.5.1
Training and Credentialing
The PA is an advanced practice professional who is trained through a graduate level
university program to perform many tasks, including preprocedural evaluation (history
and physical examination and diagnostic tests) and postprocedural follow-up under
the direct supervision of the physician.48, 49 After on-the-job training, PAs may
assist in diagnostic EP studies, 3D mapping, catheter ablation procedures, and device
implants, but cannot serve as a primary operator. Institutional internal certification,
minimum volume of annual cases to maintain competency in invasive EP, performance
appraisal, and maintenance of continuing education should be a requirement for a PA
practicing in the clinical EP laboratory.
7.5.2
Evaluation and Recredentialing
There are no uniform recredentialing criteria for PAs. They should perform a minimum
number of procedures as determined by the EP laboratory director and EP laboratory
manager and demonstrate current competence on the basis of the results of ongoing
professional practice evaluation and outcomes.
7.6
Industry Employed Allied Professionals
Industry Employed Allied Professionals (IEAPs) are hired employees of a medical device
company who may serve as assistants in the EP laboratory. The HRS published a statement
on the clinical role of IEAPs in 2008. IEAPs should provide technical assistance only
on the manufacturer-specific products they represent, and they must work under the
direct supervision of the responsible physician.
25
Although IEAPs may contribute substantially to patient care in some settings, overreliance
on their service may lead to a lack of continuity of care, suboptimal patient education
and counseling, and issues with liability and accountability. Among laboratories represented
by writing committee members, approximately 90% of the laboratories use IEAP support
in most or all device implant cases, and two thirds of the laboratories use IEAP support
in most or all 3D mapping cases.
8
Procedural Issues
Procedural Recommendations
•
Preparation for EP procedures requires a preprocedural history and physical examination
by a physician, NP, or PA.
•
As many management strategies for arrhythmias require chronic and/or periprocedural
anticoagulation, careful evaluation, assessment, and planning are needed.
•
In patients undergoing pacemaker or defibrillator lead extraction, or who require
pericardial access for epicardial ablation or left atrial ablation ligation, additional
preparation may be required on a case-by-case basis, such as typing and crossmatching
of blood products in select patients and immediate availability of thoracic surgical
backup.
•
In most diagnostic and ablation cases, rhythm active drugs (including β-blockers and
calcium-channel blockers) are discontinued five half-lives before the procedure to
allow the target arrhythmia to be induced, mapped, and ablated.
•
A complete description of the procedure, including the anticipated success rates and
possible complications, is best delivered in the outpatient setting before the EP
procedure.
•
A “time-out” must be performed immediately before the initiation of the procedure
when all key personnel are present.
•
Health care facilities should insist that clinicians administering or supervising
the administration of moderate sedation meet the requirements of the American Society
of Anesthesiologists.
•
Anticoagulation is necessary for all left heart procedures with heparin (activated
clotting time ≥250–350 seconds) or with bivalirudin in patients allergic to heparin.
•
It is important to achieve the lowest possible noise signal with all recording systems.
•
All physicians and staff are required to be familiar with identifying all potential
procedural complications and to understand their role in managing them.
•
The decision for patient discharge takes into account procedural detail, patient age
and health status, potential for complications (such as blood loss), and the ability
of the patient (or caregivers) to evaluate signs of concern.
•
The procedure report should include, at minimum, all the following: the primary and
secondary operators, the indication for the procedure, names and doses of any medications
administered, catheter/pacing/ICD lead model and serial numbers, insertion sites and
intracardiac destinations, findings and procedure performed, complications encountered,
and fluoroscopic exposure (fluoroscopy time, radiation dose, and the dose-area product)
by an Advanced Cardiac Life Support (ACLS)/Pediatric Advanced Life Support (PALS)-certified
nurse.
8.1
Patient Preparation
8.1.1
History, Physical Examination, and Laboratory Examination
Preparation for EP procedures requires a careful preprocedural history and physical
examination by a physician, NP, or PA to confirm the reason for the procedure that
day and identify all comorbidities that could adversely impact procedure outcome.
A thorough medication history, including allergies, must be gathered. The patient
needs to be evaluated for factors that will impact anesthesia management (adequacy
of airway, history of anesthesia experiences, obstructive sleep apnea, and physical
indicators for difficult intubation). All adult patients should have recent (usually
within 2 weeks) laboratory work, including electrolytes, blood urea nitrogen, creatinine,
complete blood count, and, if taking anticoagulants, prothrombin time. All women of
childbearing potential, including girls older than 12 years, should have serum or
urine pregnancy testing within 2 weeks before the procedure. The need for a preprocedure
laboratory exam in healthy children undergoing elective electrophysiological testing
is not clear and is not common practice.
8.1.2
Patients Receiving Oral Anticoagulants or Antiplatelet Medications
As many management strategies for arrhythmias require chronic and/or periprocedural
anticoagulation, careful evaluation, assessment, and planning are needed. Among the
considerations are the agent used, thromboembolic risk, bleeding risk, comorbidities,
laboratory values, and availability of reversal agents or blood products such as fresh
frozen plasma. Consideration should be given to performing additional preprocedural
transesophageal echocardiograms or the use of intracardiac ultrasound to reduce the
risk of complications. In patients undergoing pacemaker or defibrillator lead extraction
or who require pericardial access for epicardial ablation or left atrial ablation
ligation, additional preparations may be required, including typing and crossmatching
of blood products, availability of thoracic surgical backup and/or OR, and, in some
cases, intraprocedural transesophageal echocardiogram.
8.1.3
Patients Receiving Antiarrhythmic Drugs
Many patients are taking one or more medications to control the heart rate and/or
rhythm at the time of an EP procedure. In most cases, rhythm active drugs (including
β-blockers and calcium-channel blockers) are discontinued five half-lives before the
procedure to allow the target arrhythmia to be induced, mapped, and ablated. In patients
undergoing anatomically based ablation, withholding these drugs may not be necessary.
8.1.4
Patient Education and Consent
For most patients, the EP laboratory is an unfamiliar and intimidating environment,
one in which an equally unfamiliar procedure is about to be performed. A complete
description of the anticipated events is best delivered in the outpatient setting
before the procedure day. Education as to the planned agenda, the other participants
(nurses, technologists, EP doctors, and anesthetists/anesthesiologists), and the nature
of some of the equipment in the laboratory is important to ease the patient’s anxiety
and aid in their cooperation during the procedure. Many of the technical terms used
to describe the procedure are foreign to the patient; the staff must take care to
use lay language in their descriptions, to evaluate the patient’s ability to learn
and preference how to learn, and to assess the patient’s comprehension. This role
is usually filled by an RN familiar with the procedure. The requisite process for
informed consent is detailed in Section 12. Critical components include ensuring patient
understanding, full disclosure of the risks and alternatives to the planned procedure,
and the opportunity for the patients to ask questions and fully discuss their concerns.
The patient education and consent process must be completed before the administration
of any sedative or anxiolytic agents. In the case of pediatric patients or adult patients
with cognitive impairment, education must be given and consent requested of the patient
and the legal guardian.
8.1.5
Time-Out
A time-out must be performed immediately before the initiation of the procedure when
all key personnel are present. All members of the team are to cease their activities
while one member recites two patient identifiers (i.e., name, date of birth, and medical
record number), the type and laterality of the procedure, the name of the operator,
and any known allergies. All members of the team must agree on all points before the
procedure can commence.
50
8.2
Procedural Issues—EP Catheter Procedures
8.2.1
Sedative agents, Relaxants, and Anesthesia
The goal of analgesia and anesthesia in the EP laboratory should be to provide a safe,
nontraumatic experience for the patient. The administration of anesthesia varies among
case types and among institutions, from anxiolysis or moderate procedural sedation
by an Advanced Cardiac Life Support (ACLS)/Pediatric Advanced Life Support (PALS)-certified
nurse under the supervision of the cardiac electrophysiologist51, 52 to monitored
anesthesia care or general anesthesia administered by an anesthesiologist or CRNA
under the supervision of the anesthesiologist. The health care institution must require
those administering or supervising moderate sedation who are not anesthesiologists
to meet the requirements of the American Society of Anesthesiologists to obtain privileges.
53
Credentialing for this privilege must be periodically renewed. If intravenous procedural
sedation will be used, the physician must establish an American Society of Anesthesiologists
classification and Mallampati score for the patient before the procedure.
36
It is necessary to have these assessments done before the procedure so that, if necessary,
alternate plans for sedation may be arranged to optimize patient safety and minimize
procedural delays. Medications typically employed include etomidate, propofol, ketamine,
fentanyl, midazolam, methohexital, and inhalational agents. Individual states regulate
what medications can be administered by nonanesthesiologists. As the provision of
sedation is a continuum and the depth of sedation may vary, best practice is that
all patients receiving moderate or deep sedation be evaluated by continual observation
of qualitative clinical signs, pulse oximetry, noninvasive blood pressure monitoring,
heart rate and rhythm, and monitoring for the presence of exhaled carbon dioxide to
ensure the adequacy of ventilation unless precluded or invalidated by the nature of
the patient, procedure, or equipment.
51
Monitoring equipment should be in working order and have appropriate audible alarms.
In pediatric cases, factors to be considered for the choice of sedation or general
anesthesia include young age, preexisting medical conditions, presence of CHD, airway
issues, physician or family choice, and the length and complexity of the procedure.
The 2002 NASPE Position Statement on Pediatric Ablation delineated the types of anesthesia
(conscious sedation, moderate sedation, and general anesthesia), and these remain
applicable.
54
Regardless of whether the administration of sedative agents is under the control of
the electrophysiologist or another caregiver, the electrophysiologist must have a
working knowledge of the effects of the agents used and how they might impact the
electrical aspects of the procedure (such as arrhythmia inducibility and effects on
blood pressure) or interact with other medications that may be given. Deep sedation
or general anesthesia can minimize patient discomfort, can benefit the EP procedure
by preventing patient movement, and is necessary during defibrillation threshold testing.
An immobile patient facilitates accurate and precise 3D mapping and reduces risk during
transseptal puncture, pericardial access, or ablation in close proximity to critical
structures. Note that in cases where the assessment of phrenic nerve function is important
for a favorable case outcome (such as placement of a coronary vein branch pacing lead
or ablation within the right superior pulmonary vein), paralytic dosing should be
reduced or eliminated. Improved safety, efficacy, and procedure times have been shown
with the use of general anesthesia with certain procedures such as atrial fibrillation
ablation.
55
Using high-frequency ventilation can further minimize respiration-related cardiac
movement during ablation.
56
Although adequate sedation should be administered to ensure patient comfort because
certain arrhythmias such as atrial tachycardias and outflow tract VTs can be dependent
on adrenergic tone, excessive sedation can result in the inability to induce the clinical
arrhythmia. In cases in which an adrenergic-dependent arrhythmia is suspected, sedation
must be minimized until the clinical arrhythmia is induced and mapped. Deep sedation
is usually administered while performing ablation to prevent patient movement. When
assessing the end point in these cases, care must be used to differentiate the effect
of sedation from the actual elimination of the arrhythmia.
8.2.2
Sterile Preparation of the Access Site and Vascular Access
Although the risk of infection is extremely low with EP catheter procedures,
57
appropriate sterile techniques should be maintained. This includes sterile preparation
of all access sites, such as the groin and neck. If there is the potential for pericardial
access, the subxiphoid region, and possibly the parasternal and apical regions, should
also be prepped and draped. In cases with a higher risk of cardiac tamponade, sterile
preparation of the subxiphoid region can be considered at the onset of the procedure.
8.2.3
Diagnostic Catheter Selection
Catheters with a smaller French size and fewer electrodes are more flexible, exert
lower axial force, and may carry a lower risk of perforation,
58
but should perhaps be avoided because of difficulty maintaining stable catheter position.
Catheters with more electrodes can facilitate rapid recognition of arrhythmia activation
patterns and are particularly beneficial at sites such as the coronary sinus. Smaller
electrodes and narrower interelectrode spacing detect a more local activation signal
and can provide more precise activation mapping, but may be less maneuverable. Activation
confined to a small structure or circuit, such as the His bundle or an accessory pathway,
however, may be difficult to localize with narrow electrode spacing. The field of
signal detection can be increased either by changing to a catheter with wider electrode
spacing or by reconfiguring the electrode pairing. With this wider field of view,
anatomical localization is decreased. Some diagnostic catheters are designed with
electrodes in a specialized spatial configuration, such as circular/ring, basket,
or star-shaped catheters. These catheters can enable rapid deciphering of an activation
pattern even with a paucity of arrhythmia. The number of catheters and recording sites
should be adequate to achieve the desired end points of the procedure, but not so
many that vascular damage or obstruction or intracardiac entanglement could occur.
8.2.4
Anticoagulation
Anticoagulation is necessary for all left heart procedures with heparin or bivalirudin
in patients allergic to heparin.38, 39 Even in patients with therapeutic international
normalized ratio on warfarin, heparin must be administered for left heart procedures,
though typically in lower doses than in patients not taking warfarin. For right heart
procedures, there is no evidence favoring routine use of anticoagulation; in cases
where there is concern that the patient is at an increased risk for thromboembolic
complications (prolonged procedure, known or discovered patent foramen ovale), some
centers administer heparin for anticoagulation.
8.2.5
Selection of Ablation Catheters
Selection of the mode and catheter for catheter ablation is operator dependent. Catheter
factors such as torque delivery, axial stiffness, steerability, and introducer diameter
affect device selection. Ablation modes, including RF, cooled RF, laser, and cryothermy
all have their strengths and weaknesses. The goal is to achieve a therapeutic ablation
by identifying the ablation target, maneuvering to that site, and then destroying
enough tissue to prevent arrhythmia initiation/propagation while minimizing the risk
of collateral injury. The use of open-irrigated tip catheter ablation may result in
the infusion of 2–3 L of volume during the case, which can precipitate heart failure
in susceptible patients.
59
Multielectrode or “single-shot” ablation systems are being developed for the treatment
of complex substrates such as atrial fibrillation. Experience with many of these technologies
is limited. A preferred device for these applications may emerge in the future as
our experience increases. Selecting the appropriate ablation catheter is a process
that involves a correct interpretation of the arrhythmia mechanism, a firm understanding
of the advantages and disadvantages of the different catheters and energy sources,
and the need for the responsible use of resources.
60
8.2.6
Optimizing Signal Recording
Bipolar intracardiac recordings are standard in most laboratories because they theoretically
detect only near-field signals, unlike unipolar recordings that incorporate both near
and far-field components.61, 62 Far-field signals can still be detected in bipolar
recordings but are typically a lower amplitude and frequency. Unipolar recordings
can be helpful in mapping sites of focal activation, such as ventricular insertion
sites of accessory pathways in preexcitation syndromes and idiopathic outflow tract
ventricular arrhythmias, in which deep sharp QS configurations signify a site from
which activation emanates (i.e., site of the earliest ventricular activation). The
unipolar signal can help clarify the content of the bipolar electrogram (near vs.
far-field), the timing of actual local depolarization (intrinsicoid deflection of
the unipolar signal), and the relative proximity of the tip vs. the ring electrode
to the ablation target.
The accurate interpretation of potential ablation target sites involves correctly
differentiating local from distant activation as well as from electrical noise. Noise
troubleshooting is a complex issue and involves many variables. It is necessary to
be familiar with the basics of signal acquisition provided in Appendix 1 to correct
noise issues. An inadequate signal-to-noise ratio will result in physiological signals
being obscured by ambient noise with loss of critical information. At the onset of
the procedure, steps should be taken to ensure that the signal quality is optimized
for successful mapping. This should include the following: (1) choosing the appropriate
electrode spacing, (2) setting the high-pass filter high enough to exclude low-frequency
artifacts, such as respiratory drift, (3) setting the low-pass filter low enough to
exclude high-frequency noise artifacts, (4) turning on the notch filter that excludes
the 50–60-Hz bandwidth typical of electrical interference, and (5) gaining the signal
appropriately to visualize low-amplitude signals of interest while minimizing the
magnification of noise artifacts. It should be noted that using the notch filter on
bipolar intracardiac signals can introduce ringing to sharp simple signals, making
them appear fractionated. This is a particular concern when targeting fractionated
potentials in cases of VT and atrial fibrillation. If the laboratory and equipment
are properly grounded and the electricity in the laboratory is conditioned, there
should be no 50–60 Hz noise on the intracardiac signals. Lower gain recording should
be employed if the electrogram signals exceed the recording range of the amplifier.
Efforts should be made, working with the facility’s biomedical engineering personnel,
to achieve the lowest noise signals possible. Steps toward this goal include appropriate
equipment grounding and shielding of cables, scheduled maintenance of connecting cables
with replacement if contact plugs lose continuity, maintaining the shortest distance
traveled by all electrical cables, ensuring that cables are off the floor and removed
from potential hazards such as wheeled carts and cleaning solutions, and maintaining
separation between high-voltage lines, such as power cables, and low-voltage lines
used for transmitting the patient’s electrical signals.
8.3
Acute EP Catheter Procedural Complications
Dealing with complications in the EP laboratory has several components: avoidance,
recognition, and response. To the extent possible, complications should be avoided
by adhering to standard techniques and practices. When a complication occurs, the
outcome for the patient hinges on how quickly a problem is recognized and appropriately
evaluated as well as how quickly and appropriately the response to the incident rectifies
the situation. Even the most careful and skilled operator will have occasional unavoidable
complications (Table 3)63, 64, 65, 66, 67, 68.
Table 3
Procedural Complications
Complication
Prevention
Diagnosis
Treatment
EP catheter procedural complications
Pericardial effusion/tamponade
Avoid excess catheter force
Fluoroscopy of cardiac border,
63
2D echocardiography
Reversal of anticoagulation, urgent pericardiocentesis
AV nodal block
Monitor for accelerated junctional rhythm, VA block, AV block during overdrive atrial
pacing
ECG
Pacemaker
Phrenic nerve palsy
Phrenic nerve mapping, phrenic nerve pacing during RSPV, SVC, and LAA ablation64,
65, 66
Fluoroscopy, chest radiography
Conservative therapy
Stroke
Anticoagulation (ACT >300 or 350 s in the LA), avoid char formation
Neurological exam, MRI scan (DWI and FLAIR imaging)
Conservative therapy, Merci thrombectomy
Coronary artery injury
Avoid excess power delivery in the CS, coronary angiography before epicardial ablation,
coronary ostia visualization by angiography and ICE before ablation in the aortic
root
ECG
Percutaneous intervention
Access site complications (hematoma, AV fistula, pseudoaneurysm)
Site selection, excellent technique, vascular ultrasound to guide puncture,
67
micropuncture
Physical exam, ultrasound
Manual pressure, bed rest
Radiation burn
Minimize radiation exposure
Physical exam (presentation typically 2–8 wk postprocedure, but can be >40 wk)
Avoid repeat exposure
CIED implant procedural complications
Pneumothorax
Extrathoracic vascular access (axillary or cephalic vein)
Chest radiography
100% oxygen rebreather, chest tube
Lead dislodgement
Test lead for acute fixation (“tug test”)
ECG, device interrogation, chest radiography
Reoperation and repositioning
Pericardial effusion/tamponade
Avoid excess forward pressure during lead placement
Fluoroscopy of the cardiac border,
63
2D echocardiography
Urgent pericardiocentesis
Pocket hematoma
Avoid heparin and clopidogrel
Exam
Conservative therapy, pressure wrap, reoperation for pocket evacuation
Infection
Preoperative antibiotics, prevent hematoma,
67
score or excise chronic pocket fibrosis
Exam, wound culture, blood culture
Antibiotics, extraction of the entire system (unless superficial)
Air embolism
Use introducer sheaths with hemostatic valves
Fluoroscopy
100% oxygen rebreather
Postprocedural complications
Hematoma
Avoid heparin and clopidogrel
Exam
Conservative therapy
Infection
Good wound care
Exam, wound culture, blood culture
Antibiotics, extraction of entire system (unless superficial)
Late pericardial effusion/tamponade
None
2D echocardiography
Pericardiocentesis
Phrenic nerve palsy
Phrenic nerve mapping, phrenic nerve pacing during RSPV, SVC, and LAA ablation64,
65, 66
Loss of diaphragmatic motion on fluoroscopy, elevated hemidiaphragm
Conservative therapy
Stroke
Postprocedure anticoagulation
68
Neurological exam, MRI scan (DWI and FLAIR imaging)
Conservative therapy, consider Merci thrombectomy
Myocardial infarction
Appropriate anticoagulation
ECG, biomarkers
Medical therapy, percutaneous intervention
Atrial-esophageal fistula
Limit power, time, temperature, pressure during posterior wall ablation, monitor esophageal
temperature
Fever, malaise, leukocytosis, systemic embolism, CT or MRI findings
Surgery
New arrhythmias
Avoid creation of gaps in linear ablation
ECG, ambulatory monitor
Antiarrhythmic drugs, repeat catheter ablation
Radiation burn
Minimize radiation exposure
Physical exam (presentation typically 2–8 wk postprocedure, but can be >40 wk)
Avoid repeat exposure
2D = two-dimensional; ACT = activated clotting time; AV = atrioventricular; CS = coronary
sinus; CT = computed tomography; DWI = diffusion weighted imaging; ECG = electrocardiogram;
EP = electrophysiology; FLAIR = fluid-attenuated inversion recovery; ICE = intracardiac
echocardiography; LA = left atrium; LAA = left atrial appendage; MRI = magnetic resonance
imaging; RSPV = right superior pulmonary vein; SVC = superior vena cava; VA = ventricular
atrial.
8.4
Procedural Issues—CIED Implantation
8.4.1
The OR Environment
One of the most important risks in device implantation procedures is infection. The
device implantation laboratory should be regarded as an OR, with the same attention
to sterile technique. Hats, masks, and shoe covers should be worn in the procedure
room when the sterile field is exposed. Efforts should be made to restrict traffic
in and out of the procedure rooms and minimize the number of personnel in the room.
Studies have demonstrated that microbial counts increase significantly in unoccupied
ORs when the door is left open to the hallway.
69
After explanation of a device from an infected pocket, the room should undergo cleaning
according to standard procedures employed in the OR for contaminated cases.
8.4.2
Antibiotic Prophylaxis
The use of preoperative antibiotics has been conclusively proven to reduce CIED infection.
70
Administration of an antibiotic, usually a first-generation cephalosporin, 1 hour
before implantation is required. In light of the prevalence of the colonization with
methicillin-resistant strains of Staphylococcus, some operators choose vancomycin
in patients at higher risk of infection, although data are lacking to support this
practice. Vancomycin is a suitable choice for patients with penicillin allergies.
If vancomycin is selected, it should be administered within 2 hours of the procedure.
71
8.4.3
Sterile Technique
The instruments and components used in the device implant laboratory must be opened
in a clean air environment. By doing so, bacterial contamination of these instruments
and components will be kept to a minimum. All personnel in the room must wear a cap
and mask at all times, and all who are in contact with the sterile field must perform
a complete surgical scrub and must be gowned and gloved.
8.4.4
Sterile Preparation of the Surgical Site
The operative site(s) should be prepared with an antiseptic agent. Although these
agents eliminate the immediate bacterial count on the skin surface at the operative
site, hair follicles may prevent complete sterilization of the skin. Hair clipping
close to the skin in the prep room, rather than shaving, is recommended because bacteria
on the skin surface begin to recolonize within 30 minutes in the presence of hair
follicles despite complete sterilization.
72
Some centers instruct patients to use preprocedural home cleansing kits. Site preparation
with alcohol-based solutions should be allowed to dry completely before draping. The
combination of evaporating alcohol, supplemental oxygen, and electrocautery poses
a significant fire risk in the surgical field.
8.4.5
Concomitant Groin Access During Implant Procedures
In some cases, additional femoral venous access for the placement of a temporary pacing
catheter may be warranted (e.g., lead extraction and pacemaker-dependent patients
with an inadequate escape rhythm who are undergoing generator change).
8
Large-bore venous sheaths are useful for rapid volume resuscitation in the event of
vascular tears during lead extraction, and arterial access facilitates beat-to-beat
monitoring of blood pressure.
8.5
Acute CIED Implant Procedural Complications (Table 4)
Complications associated with acute CIED implantation are often technique related.
Attention to detail will minimize the risk of difficulties related to the implant
procedure.
Table 4
Definitions and Terminology Used in Clinical Fluoroscopy
Roentgen (R) is the unit of radiation exposure in air. The total charge produced in
air per unit mass by ionizing radiation is easily measurable with survey instruments.
Gray (Gy) is the International System of Units (SI) of absorbed radiation dose of
ionizing radiation, which has replaced the term radiation absorbed dose (in rad).
One gray is the absorption of 1 J of ionizing radiation by 1 kg of matter (equivalent
to 100 rad), and it assesses the potential biological risk to that tissue. The U.S.
unit for absorbed dose is rad. 1 Gy = 100 rad.
Equivalent dose Sievert (Sv) is a measure of equivalent dose, and is also an SI unit.
It takes into account the different probability of effects that occur when the same
amount of absorbed dose is delivered by different types of radiation (protons vs.
X-rays). It is equal to the absorbed dose in Gy multiplied by the radiation weighting
factor, WR, and other modifying factors. The WR is 1 for X-rays. The equivalent dose
can be used to assess radiation risk if the person’s whole body is uniformly irradiated.
For partial body exposure, such as cardiac electrophysiology, additional correction
is necessary to assess the radiation risk.
Effective dose is used to assess the risk when only a part of the body absorbs energy
from radiation. Since some organs in the body are more sensitive to radiation effects
than others, the equivalent dose is multiplied by the appropriate tissue weighting
factors. This terminology is used to assess the risk of radiation-induced cancer and
hereditary effects. For example, the effective dose for a typical chest X-ray radiograph
is 0.0001 Sv (0.1 mSv). The U.S. unit for sievert (Sv) is rem. 1 Sv = 100 rem.
As low as reasonably achievable (ALARA) standard is a system for limiting the amount
of radiation a person receives. Radiation exposure should be justified on the basis
of the assumption that there is no threshold below which ionizing radiation is free
from harmful biological effects and that shielding from radiation exposure is needed,
no matter how low the dose.
Kerma is an acronym for kinetic energy released in the material. Kerma is measured
in Gy.
Kerma-area product (P
KA
) is the integral of air kerma (absorbed dose to air) across the entire X-ray beam
emitted from the X-ray tube. PKA is a surrogate measurement for the entire amount
of energy delivered to the patient by the beam. PKA is measured in Gy·cm2. Another
term for this is the dose-area product (in Gy·cm2).
Reference air kerma (K
a,r
) is the kerma-area product at a specific point in space relative to the fluoroscopic
gantry (the interventional reference point) during a procedure. It is measured in
Gy.
Peak skin dose is the highest dose of radiation exposure on any portion of a patient’s
skin during a procedure.
8.6
Postprocedural Issues
8.6.1
Vascular Hemostasis
Venous sheaths may be removed at the end of the procedure if no anticoagulant has
been administered, with pressure held for 10–20 minutes. If heparin has been administered,
waiting until the ACT is more than 175 seconds (<250 seconds if the patient is receiving
therapeutic warfarin) before sheaths are removed decreases the likelihood of bleeding
and hematoma formation. Reversal of heparin effect with protamine is employed in many
laboratories to more rapidly reverse heparin effect and allow almost immediate sheath
removal, although one must be prepared to treat uncommon but sometimes severe protamine
reactions.
64
Vascular closure devices are uncommonly used in EP,64, 65 but are an appropriate choice
for arterial closure. After atrial fibrillation ablation, the reestablishment of therapeutic
anticoagulation soon after sheath removal is desirable to lessen periprocedural stroke
risk but there is no consensus on the optimal regimen or timing.
8.6.2
Postanesthesia Recovery
When mild anesthesia is used, vital signs and oxygen saturation should be monitored
continuously until the patient is conscious and communicative. Access sites, cardiac
rhythm, and neurological state should be assessed every 15 minutes during the first
hour and then periodically thereafter. Late complications, such as access site hematomas
and hemodynamically significant pericardial effusion, can develop after the patient
leaves the postprocedural recovery area. If a patient received midazolam during the
procedure and a dose of its antidote (Romazicon/flumazenil) was administered, the
patient must be monitored for a rebound effect of midazolam. If general anesthesia
was used, patients usually recover in a postanesthesia care unit.
8.6.3
Postprocedural Complications
Procedural complications that can arise after the patient leaves the laboratory area
(or even after hospital discharge) are listed in Table 4. A process for tracking postprocedural
complications should be in place as part of the laboratory’s QA process (see Section
9).
8.6.4
Medication
Postprocedure anticoagulation is recommended in patients who are at high risk of stroke
on the basis of evaluation tools such as CHADS2 or CHA2DS2-VASc scores. In many laboratories,
chronic warfarin therapy is not interrupted during either device implantation or ablation
procedures in patients who are taking it for stroke prevention in the setting of atrial
fibrillation or mechanical heart valves; the procedure is safe, with the international
normalized ratio ranging from 2.0 to 3.5.35, 65
In patients with insulin-dependent diabetes, the morning insulin dose is typically
halved on the day of the procedure and glucose is periodically monitored during the
procedure and the patient is treated accordingly.
8.7
Hospital Discharge
The setting for EP procedures may be outpatient, 23-hour observation, or inpatient.
The decision for discharge takes into account procedural detail, patient age, and
health status, the potential for complications (such as blood loss), and the ability
of the patient (or caregivers) to evaluate signs of concern.
67
This is a medical decision and should be determined irrespective of reimbursement
issues.
8.8
Reporting Procedural Results
The procedure report should include, at a minimum, the following: the primary and
secondary operators; the indication for the procedure; names and doses of any medications
administered; intake, output, and estimated blood loss; catheter/pacing/ICD lead model
numbers, serial numbers, insertion sites, and intracardiac destinations; findings
and procedure performed; complications encountered; and fluoroscopic exposure (minutes;
mGy; dose-area product). Patients who receive excessive radiation exposure during
a procedure (typically >3000 mGy, but requirements vary by state) must be notified
and followed up for evidence of skin damage. Ideally, this information is stored in
a database for QA purposes. Recordings made during the procedure (electrograms and
fluoroscopic and mapping system images) should be archived on digital media (ideally
on a network, or alternatively on a CD or DVD) for future reference, if needed.
64
9
Pediatric and Adult Congenital Heart Disease
Pediatric and Adult Congenital Heart Disease Recommendations
•
Pediatric EP procedures on small and young children should be performed in centers
where there is pediatric surgical backup.
•
Procedures on adult patients with CHD can be performed in pediatric or adult facilities
by physicians who have expertise in the area of CHD and the potential arrhythmia substrates
of patients with CHD.
•
There are special considerations for performing pediatric EP procedures, including
unusual arrhythmia mechanisms, small patient size, and the effect on future patient
growth.
9.1
Patient Factors Different From Adults
Issues that pertain to EP laboratory standards and practice for pediatric EP and patients
with pediatric and adult CHD with rhythm abnormalities differ from those pertaining
to adults and are not confined to issues of patient and cardiac size compared with
the adult patient. The decision-making process for interventions has implications
for patient quality of life and development. Success, failure, and procedural factors
related to intervention therefore span many decades. A significant factor in treating
cases involving young patients in the EP laboratory is the need for age-appropriate
supportive care.
9.1.1
Arrhythmia Substrate, Patient Size, and Future Patient Growth
Arrhythmia mechanisms in young patients vary by age
72
and influence decision making. Patient size can dictate the use of and expertise with
smaller ablation catheter sizes or the use of esophageal pacing if vascular access
is limited, such as is the case in neonates. Knowledge of ablation lesion formation
and potential expansion in an immature myocardium is critical to the care of pediatric
patients.
73
Children and young adults will experience decades of device-related issues compared
with the typical adult patient. These issues should affect decision making in terms
of timing and location of cardiac EP devices, accounting for growth, potential need
for multiple extractions and replacements, and issues of venous occlusion. For patients
with CHD, these factors are complex and affect the decision to intervene. Surgical
interventions for all forms of CHD have resulted in improved survival rates,
72
and the details of these surgical interventions are critical in the analysis of rhythm
substrates in the EP laboratory. More complex pediatric CHD survivors comprise an
increasing percentage of the adult CHD population.
72
It is recommended that procedures in pediatrics and patients with CHD be performed
by (1) pediatric cardiologists, (2) a collaboration of adult and pediatric cardiologists,
or (3) an adult cardiologist with established interest and expertise in adult CHD.
9.2
Indications for EP Procedures in Pediatric Patients and Patients With CHD
The indications for catheter ablation in the pediatric population derived from an
understanding of the natural history of arrhythmias in young patients, likely rates
of procedural success and complications, and the risk of recurrence and have been
reviewed in prior publications.54, 74 The guidelines for the assessment of the asymptomatic
young patient with Wolff-Parkinson-White syndrome are published as a joint PACES/HRS
statement.
75
In the pediatric population, the presence of CHD affects the expected results of ablation
and recommendations for intervention. The guidelines for the implantation of cardiac
rhythm devices in young patients and patients with CHD were last updated in 2008.
76
Epicardial pacing is used for those in whom transvenous pacing is contraindicated,
such as prosthetic tricuspid valves, right-to-left intracardiac shunts, and small
patient size, or for those undergoing concomitant heart surgery. The majority of ICDs
are implanted via the transvenous route, but this may not be possible in some individuals
because of anatomical constraints. Because ICD leads are larger and prone to fibrosis,
patient size limitations for transvenous systems are considerable. Although established
in adults, the indications for cardiac resynchronization therapy in children are less
certain and are based on retrospective reviews, rather than randomized trials.77,
78
9.3
Patient Safety Concerns
Because younger patients may have a longer life span after EP procedures than do adults,
the lifetime risks of malignancy and birth defects (stochastic risks) are higher.
Adult patients with CHD incur increased radiation exposure resulting from the electroanatomic
complexity of cases and the need for multiple procedures. Strategies for radiation
dose reduction as detailed in Section 11 should be aggressively implemented. The most
significant complications in small children include pericardial effusion, pneumothorax,
atrioventricular block, and death.79, 80 Animal and clinical studies have shown the
potential expansion of scar tissue with maturation
70
and the risk of late coronary artery injury
79
potentially related to ablation location. The risk of atrioventricular block is increased
by small patient size and septal pathways, presumably because of the smaller anatomical
dimensions of structures. Smaller tip catheters, lowered RF energy, shorter lesion
duration, and the use of apnea and pacing techniques may diminish risk.
81
Cryoablation is perceived as being safer, but may have a higher recurrence rate compared
with RF lesions.
82
It is recommended that EP laboratories conducting procedures on pediatric patients
have cryoablation capability.
9.4
Procedural Issues
9.4.1
Inpatient vs. Outpatient Setting
The procedure setting for invasive EP studies and ablation for pediatric and congenital
EP patients may be outpatient or inpatient. The decision for discharge takes into
account procedural detail, patient size, potential for complications, and the ability
of the parents to evaluate signs of concern. The protocol for EP device placement
or revision is mostly less than 1 day of observation, but generator changes in older
patients may not require more than 6 hours. Young patients with new devices are monitored
overnight to administer periprocedural antibiotics, evaluate for pneumothorax or hemothorax,
evaluate the device parameters, check lead location, and manage pain.
9.4.2
Sedation, Anesthesia, and Medications
The goal of sedation in the pediatric and congenital EP laboratory should be to provide
a safe, nontraumatic experience for the patient by considering young age, preexisting
conditions, presence of CHD, airway issues, family choice, and complexity of the procedure.
The 2002 NASPE Position Statement on Pediatric Ablation delineated the types of anesthesia
(e.g., conscious sedation, moderate sedation, and general anesthesia), and these remain
applicable.
54
Personnel responsible for sedation, anesthesia, and administration of medications
must be experienced with pediatric and congenital EP patients, and PALS and ACLS certification
should be maintained. All physicians performing EP procedures should be knowledgeable
regarding sedation, monitoring, and airway management. Allied health professionals
(e.g., nurses, APNs, and PAs) can be involved with sedation of a patient, if directly
supervised by a physician.
9.4.3
Facilities
The room and equipment standards for pediatric EP procedures are similar to those
for adult EP procedures (see 4, 5) but must have a cardiac defibrillator specifically
for use with children, a code cart meeting pediatric needs, and age-appropriate anesthesia
equipment. Pediatric and congenital EP patients may require a combined procedure of
EP and hemodynamic catheterization, including angiography and possible intervention.
Thus, it is desirable that a pediatric/CHD EP laboratory meet the same standards as
a pediatric catheterization laboratory.
9.5
Lab Staffing
General recommendations for EP laboratory staffing are detailed in Section 6 and Table
2. Pediatric and congenital EP guidelines recommend that the facility and laboratory
staff should be appropriate for the patient population and pediatric and CHD interventional
and surgical experts be urgently available during laboratory procedures.
42
All members of the team should be trained in PALS (when treating a child/infant) and
ACLS (if treating an adult).
9.5.1
Physicians
Training and board certification pathways employed by physicians who perform EP procedures
on pediatric and congenital EP patients include the pediatrics and internal medicine
pathways (see 6, 7).
9.5.2
EP Laboratory Personnel
Recommended staffing for pediatric cases is detailed in Table 3. While laboratory
staff roles are similar to those outlined in Section 6 for pediatric cases, these
staff should have expertise in performing cardiac procedures in pediatric and congenital
EP patients.
9.6
Emergency Supportive Care and Surgical/Intensive Care Unit Backup
Pediatric EP procedures should be performed (earlier than the teenage years) in centers
where there is pediatric cardiovascular surgical availability. For procedures performed
on patients in their teenage years or procedures on adult patients with CHD that are
performed in adult or mixed pediatric and adult institutions, a CV surgical plan should
be formalized to accommodate on-site emergencies (notably, cardiac perforation) and
a rapid transfer made to a pediatric cardiovascular center should the anatomy of the
patient require this expertise.
9.7
Postprocedural Care
The postprocedural care can be performed in a separate periprocedural area, the general
cardiology floor, or the intensive care unit. Continuous telemetry should be available
for the evaluation of heart rhythm. The environment for postprocedural care should
be appropriate for patient age and development. The nursing and physician staff should
be experienced in the care of pediatric and congenital EP patients.
10
Quality
Quality Recommendations
•
A process for tracking postprocedural complications should be in place as part of
the laboratory’s QA process.
•
An essential component of a successful EP laboratory is to have an internal QA/quality
improvement (QI) process in place, in addition to public reporting requirements.
•
Components of the QA/QI process should include national requirements for tracking
(e.g., device implants), minimum acceptable complication rates (e.g., infections),
and compliance with national registries, including the NCDR ICD Registry.
•
It is the responsibility of each institution to ensure that staff credentialing, maintenance
of certification, and necessary continuing medical education requirements are met.
•
Procedure outcomes, including success rates and complications, should be documented
and recorded. Data acquired from the EP laboratory QA process should be used to benchmark
the complication rates and outcomes of both individual practitioners and the overall
EP laboratory.
•
Physicians should participate in regularly scheduled QI and/or peer review meetings
to maintain privileges and evaluate procedural appropriateness.
•
A quarterly EP laboratory morbidity and mortality conference should be mandatory,
with attendance documented.
•
A QA process for the equipment should be established that provides a mechanism to
demonstrate optimal function and operation of the equipment and that offers staff
training in equipment maintenance, setup, and operation.
•
Given the often poorly defined relationship between case volumes and outcomes, a more
appropriate measure is to ensure that all major complications are reviewed by the
QA committee and handled as described in the previous section.
10.1
The QA/QI Process
High-quality, consistent care delivery in a busy cardiac EP laboratory requires standard
protocols for procedures, communication channels, and documentation. An essential
component of a successful EP laboratory is to have an internal QA/QI process in place,
in addition to public reporting requirements. This requires a commitment from facility
administrators to provide adequate staffing, including a committee chair, staff coordinator,
and funding for collecting and managing data. The goal of the program should be to
motivate and encourage physicians and staff to participate and to take initiative
in the QA/QI process and overall success of the laboratory. It is acknowledged that
there is little published data on the QA/QI process in the EP laboratory and that
expert consensus is the primary basis for our recommendations. Further research and
development of quality metrics specific to the practice of cardiac EP is ongoing.
To begin the QA/QI process, its components should be identified. These components
include national requirements for tracking (e.g., device implants), minimum acceptable
complication rates (e.g., infections), and compliance with national registries, including
the NCDR ICD Registry. A QA/QI program must ensure that key data are collected prospectively
and systematically. When the QA/QI team is identifying potential quality metrics,
either strong scientific evidence or expert consensus must support the metric. The
metric must measure areas important to patient care, and it is best if it covers an
aspect of practice where there is a gap in patient care. The data must be available
in a usable format for future analysis. These data allow the laboratory to benchmark
its performance and provides a reference by which appropriate changes can be made.
Provider qualifications are typically well established by national guidelines and
certification bodies. It is the responsibility of each institution to ensure staff
credentialing, maintenance of certification, and necessary CME requirements are met
(see Section 7). Practitioners should be expected to adhere to published practice
guidelines unless the reason for deviation is documented. Clinical situations not
directly addressed by the guidelines inevitably arise and require judgment and skill
to address. Periodic peer review of cases that fall outside the guidelines is recommended
to ensure appropriate delivery of care. The guidelines evolve and, by definition,
require a consensus of data before they can be written and revised. The writing group
recognizes and encourages the development of new clinical pathways and tools. This
development is best achieved through research protocols that adequately capture patient
demographic characteristics, procedure characteristics, and outcomes. The research
consent process ensures that patients are aware that the treatment being offered is
beyond the current recommendations of the practice guidelines.
Procedure outcomes, including success rates and complications (and ideally including
30-day outcomes), should be documented and recorded. The writing group recognizes
that success for some procedures requires clinical follow-up (particularly atrial
fibrillation and VT ablation procedures). In these instances, an acute end point for
the procedure should be specified (e.g., pulmonary vein isolation, noninducibility
for VT, or creation of a planned RF ablation lesion set based on the results of an
endocardial voltage scar map) and documentation should indicate if the end point was
achieved. An assessment of freedom from arrhythmia recurrence after 1 year of follow-up
should be performed. Risk-adjusted models are not well developed by which the relative
frequency of complications and successful outcomes among different patient populations
can be interpreted and physician results compared. Therefore, the interpretation of
success rates and complication rates requires judgment by peers. Physicians should
participate in regularly scheduled QI and/or peer review meetings to maintain privileges
and evaluate procedural appropriateness. A quarterly EP laboratory morbidity and mortality
conference (stand-alone or as a component of another conference) should be mandatory,
with attendance documented.
The modern cardiac EP laboratory depends on many complex hemodynamic and physiological
recording systems, advanced imaging systems, advanced mapping systems, and multiple
ablation systems. Rigorous processes must be established to ensure that (1) a QA process
for equipment is established; (2) equipment is tested and demonstrated to be functioning
appropriately, both on a routine basis and immediately before a case in which the
specific item will be used; verification of equipment function should be included
in the time-out procedure; (3) EP laboratory staff are appropriately trained in the
maintenance, setup, and operation of the equipment; and/or (4) representatives from
the vendor are available, qualified, and cleared by administration and occupational
health to participate in the operation of the equipment before, during, and after
the procedures. Competencies in clinical skills, ACLS, PALS (when appropriate), sterile
technique, radiation safety, and fire safety should be assessed on a regular basis.
The EP laboratory requires processes be in place to ensure proper communication within
the EP laboratory and with other hospital services. Within the laboratory, protocols
for emergency situations (such as tamponade or ventricular fibrillation refractory
to defibrillation) can make the difference between an organized, streamlined, successful
resuscitation effort and a chaotic effort during which leadership is absent, team
members duplicate some activities and neglect others, and ultimately a tragic but
potentially avoidable outcome occurs. Beyond the boundaries of the EP laboratory,
communication between the EP team and other health care professionals is essential,
particularly during handoffs from one care team to another and at the time of patient
discharge. It is the role of the QA/QI committee to oversee that excellent communication
processes are developed, maintained, and adhered to by the staff.
10.2
Clinical Outcomes and Complications
Data acquired from the EP laboratory QA process should be used to benchmark the complication
rates and outcomes of both individual practitioners and the overall EP laboratory.
For practitioners with complication rates above the benchmark, an objective unbiased
peer review of the relevant cases is critical to determining whether a deviation in
the standard of care occurred. Because event rates are low and risk-adjusted models
are not well developed for the EP laboratory, peer review is particularly important.
Practitioners should not be penalized for accepting higher risk and/or more challenging
cases. However, if reckless behavior or inadequate skills or knowledge is deemed to
be present and a deviation in care occurs, verbal and written communication by the
chair of QA is imperative. This communication should include a clear plan for corrective
action and documentation of potential future actions if corrective action is not successful.
10.3
Case Volumes
A link between operator case volume, skills, and outcomes has been documented in some
but not all areas of cardiac EP, yet controversy and conflicting data remain. Specific
case volumes for training are outlined by the ABIM
29
(Table 3), and for clinical competency they are available in the HRS clinical competency
statements.8, 17, 33, 38, 39, 42 Given the often poorly defined relationship between
case volumes and outcomes, a more appropriate measure is to ensure that all major
complications (see Table 3) are reviewed by the QA committee and handled as described
in the previous section.
10.4
Database
A prospective plan to acquire data in an accessible and functional database is an
essential building block for any QA/QI process. Without objective, reliable data to
measure outcomes, no meaningful effort at QI can be undertaken. Minimum data that
should be recorded in a searchable aggregate form include patient demographic characteristics,
relevant history of present illness, medications, CIED product information data, and
data on outcome and complications from any invasive procedures. Patients with CIED
should be identifiable by the device that has been implanted to permit rapid identification
of patients who may have received defective hardware in the event of a recall or other
notification from the manufacturer or FDA.
The field of medical informatics is on the verge of exponential growth. Registries
such as the ACC/NCDR ICD Registry have identified specific data fields that should
be captured for participation in the registry and compliance with payer mandates.
83
Beyond these basic requirements, recommendations for more detailed database fields
are included in clinical guidance documents for the management of patients with atrial
fibrillation and for the management of patients with VT.38, 39 These standard data
elements provide an opportunity for EP laboratories invested in research to aggregate
and/or compare their data with that of other laboratories working in the same field.
10.5
Pediatric and Adult Congenital Heart Disease
To date, QA efforts in pediatric and congenital EP have centered on the creation of
large EP procedural registries.84, 85 In late 2010, a PACES taskforce began to develop
and implement a self-sustaining multicenter QI registry known as MAP-IT. Presently,
the MAP-IT taskforce is creating a registry of patient-centered late outcome measures
of catheter ablation procedures. For the first time, an empirical and data-derived
method of risk/complexity adjustment for pediatric and CHD EP procedures, known as
the COMPASS score, has been developed. The future of QA efforts for procedure-based
subspecialties will require the benchmarking and reporting of risk-adjusted “patient-centered”
outcome measures. Widespread implementation of the MAP-IT initiative within PACES
should satisfy this need.
11
Occupational Health Concerns
Occupational Health Concern Recommendations
•
Fluoroscopy equipment should report three parameters: fluoroscopy time; radiation
dose (air kerma, in Gy), a measure of deterministic injury potential; and the dose-area
product (in cGy·cm2), a measure of stochastic injury potential. A minimum of 0.5-mm
lead-equivalent protective apron, thyroid shield, and eye protection should be used
by EP laboratory personnel.
•
All lead should be tested at 6-month intervals to check for cracks or leaks.
•
Risks of acquisition of infectious diseases by health care workers can be minimized
by adherence to current infection control guidelines.
11.1
Radiation Safety
The field of cardiac EP is greatly dependent on fluoroscopic imaging for the placement
of catheters and device leads into the heart. This results in significant radiation
exposure to the patient, the operator, and the laboratory staff. While this exposure
cannot be eliminated in most cases, attention to fluoroscopic technique can minimize
radiation dose. Competencies in radiation safety should be completed yearly by the
EP laboratory staff. Some states mandate fluoroscopy licenses be obtained by all personnel
using fluoroscopy and renewed periodically, including physicians and radiation technologists.
11.1.1
Terms for Understanding Radiation Exposure in the Cardiac EP Laboratory
Nonionizing radiation, such as microwave or infrared radiation, can cause heating
but not molecular damage to cells. Ionizing radiation, such as β, γ, and X radiation,
strips electrons from atoms and causes molecular injury to DNA. Ionizing radiation
has great potential for damage to tissue, including burns and malignancy. Understanding
the basic definitions and terminology used to describe ionizing radiation is helpful
when trying to understand the potential effects on the human body (see Table 4).
86
11.1.2
Biological Risks From Radiation Exposure
Radiation effects are described by their deterministic and stochastic effects.
87
Deterministic effects are harmful tissue reactions that are determined by an absorbed
threshold dose. Radiation-induced skin burns are an example of deterministic effects.
88
Stochastic effects include malignancy and heritable effects and are not determined
directly by the dose, but a higher dose increases the probability of an adverse outcome.
Human tissue radiosensitivity varies directly with the rate of cellular proliferation
and number of future divisions and indirectly with the degree of morphological and
functional differentiation. The most sensitive tissues include the bone marrow, spermatocytes,
and intestinal crypt cells.
87
Local skin injury is the most commonly encountered deterministic effect in cardiovascular
medicine, with changes noted at doses above 2 Gy. Findings often do not appear until
weeks after exposure.
Radiation exposure increases lifetime risk of fatal malignancy. The as low as reasonably
achievable standard was derived from the Biological Effects of Ionizing Radiation
VII Report.
89
This report makes the assumption that cancer risk increases proportionally with radiation
exposure and that there is no radiation dose that is without risk. All personnel working
in the laboratory must be aware of the as low as reasonably achievable standard. A
skin threshold dose of 2 Sv should not be exceeded. Because the prevalence of fatal
malignancies continues to increase over time after radiation exposure, children and
young adults are more susceptible to these complications in their lifetimes. Adult
patients with CHD incur increased radiation exposure resulting from the electroanatomic
complexity of cases and the need for multiple procedures.
11.1.3
Measuring Radiation Exposure
A normalized X-ray dose at a specific kilovolt peak 1 m from the source, total fluoroscopic
time, backscatter correction factor, and source-to-skin distance can be used to estimate
radiation exposure.
90
A direct measurement of radiation doses at multiple sites can be performed with lithium
fluoride thermoluminescent dosimeter sensors and optically stimulated luminescence.
The highest exposure to patients has been observed with a median skin entrance dose
of 7.26 rem (range 0.31-135.7 rem) at the ninth vertebral body. This dose is predicted
to be associated with a lifetime excess risk of malignancy to the female breast, active
bone marrow, and lung of greater than 700 cases per million undergoing routine catheter
ablation. Operator exposure was highest at the left hand, waist, and left maxilla.
91
Fluoroscopy equipment should report three parameters: fluoroscopy time; radiation
dose (air kerma, in Gy), a measure of deterministic injury potential; and the dose-area
product (in cGy·cm2), a measure of stochastic injury potential. Radiation exposure
is a superior metric to fluoroscopy time; reliance on fluoroscopy time is discouraged.
The United States Nuclear Regulatory Commission annual dose limits for radiation are
0.50 Sv for skin, arms, and legs; 0.15 Sv for eyes; and 0.05 Sv for the whole body.
The fluoroscopy dose for each case should be recorded in the medical record and accessible
to patients.
11.1.4
Minimizing Radiation Exposure to Patients
The predominant strategy for minimizing radiation exposure to patients is to minimize
the radiation dose.86, 92 The most effective approach is to minimize fluoroscopy pedal
time. Operators should develop the habit of tapping the fluoroscopy pedal rather than
standing on the pedal for a long period of time. If the eyes stray from the fluoroscopy
screen, the foot should come off the pedal immediately. Decreasing the fluoroscopy
pulse rate will significantly reduce dose at the cost of temporal resolution of the
image. Supplementation of fluoroscopic imaging with nonfluoroscopic electroanatomic
guidance systems by using stored fluoroscopy loops rather than cine loops and using
pulsed fluoroscopy will reduce the total procedural dose. As the X-ray tube gets closer
to the patient, X-rays at the skin entry point increase and the risk of deterministic
injury also increases; thus, the operator should position the table at a comfortable
height with some distance between the tube and the patient. If the image intensifier
is not positioned as close to the patient as possible, the image will be magnified
but the radiation dose will be much higher. To magnify the image, use the appropriate
magnification mode. Both geometric and electronic magnification increases dose to
the patient. Doses may be limited effectively by collimation, limiting the field of
view with shutters as much as possible. For example, reducing the diameter of the
field of view by 29% will reduce the radiation dose by half. Steeply angulated projections
should be avoided, and if used, the C-arm should be repositioned somewhat throughout
the procedure to avoid delivering radiation to the identical skin entry site. Depending
on which procedure is being performed, local shielding of the patient’s thyroid and
gonads can be employed.
93
Since the stochastic effects of radiation exposure are cumulative, the caregiver should
be sensitive to the lifetime exposure of the patient to ionizing radiation. There
has been active discussion among regulators on implementing a system for lifetime
tracking of radiation exposure to patients, but the tools for this type of system
are not available, and therefore it is not presently mandated.
94
It is important to emphasize that radiation exposure is dependent on the age and condition
of the equipment. Thus, aggressive limitation of fluoroscopy pedal time is desirable,
but those efforts may be futile if the dose rate is high because of a high frame rate
or employment of an old imaging train. It is now an accepted standard that fluoroscopy
dose, not only fluoroscopy time, is entered in the permanent medical record for each
fluoroscopic procedure. Ideally, the peak skin dose, the reference air kerma, the
kerma-area product, and the fluoroscopy time should be recorded for every case.
95
A review of fluoroscopy use by individual operators should be part of every laboratory’s
QA process.
11.1.5
Minimizing Occupational Radiation Exposure
The primary approaches used to reduce radiation exposure to the operator and laboratory
staff are increasing distance from the source, scatter reduction, and dose limitation.
Radiation dissipates in proportion to the square of the distance from the source,
and so even a modest effort to move away from the tube will significantly reduce exposure.
Radiation scatter occurs as radiation from the generator tube enters the patient and
is partially reflected or refracted by body tissues. Scatter from the patient is the
main source of radiation exposure to the patient outside the imaging field and to
the operator. The operator and laboratory personnel must be protected from exposure
to the scatter radiation with shielding. A minimum of 0.5-mm lead-equivalent protective
apron, thyroid shield, and eye protection should be used.
Proper table shielding can dramatically reduce the scatter radiation escaping into
the environment. Scattered radiation exits the body at all angles but is greatest
on the same side of the patient as the X-ray source because only 1%–5% of radiation
completely penetrates the patient’s body and exits on the other side.
91
Therefore, proper undertable shielding is paramount. Shield extensions above the table
rail and a contoured ceiling-mounted shield in contact with the patient’s torso will
substantially reduce operator exposure. Since radiation doses decrease with the square
of the distance from the source, the operator should perform the procedure as far
from the radiation tube as is practical. Barium-impregnated drapes can further reduce
radiation scatter in the procedure field.
96
All recommendations described above for limiting total fluoroscopy dose will also
reduce the operator and laboratory staff radiation exposure.
Radiation exposure to a pregnant EP laboratory worker is a special situation and should
be resolved on a case-by-case basis. It is recommended that radiation exposure to
the pregnant staff member, as measured by a waist dosimeter (under the lead apron),
should not exceed 0.05 rem/mo, or 0.5 rem for the entire pregnancy.
35
Additional layers of lead can be worn over the abdomen to further protect the fetus.
11.1.6
Quality Management
The FDA regulates fluoroscopy equipment manufacturing and has dose limits for systems
with automatic exposure control.
97
States regulate the safe use and operation of radiation-producing machines, such as
fluoroscopic imaging systems. TJC’s sentinel event is an unexpected occurrence involving
death or serious injury. Prolonged fluoroscopy that exceeds doses of 1500 rad (15
Gy) to the skin is a reportable sentinel event and requires an institutional response.
A qualified medical physicist should perform initial acceptance testing and annual
testing to ensure optimal image quality and radiation dose. Unfortunately, assuming
that fluoroscopic equipment is functioning properly, the most important factor in
radiation exposure to patients and staff is operator knowledge and behavior. TJC recommended
(but did not mandate) credentialing standards for fluoroscopists,
98
and the recommended curriculum was endorsed by HRS, American College of Cardiology
Foundation, AHA, and the Society for Cardiovascular Angiography and Interventions
(SCAI).
86
The training of EP physicians and staff in radiation physics, radiation biology, and
technological developments in X-ray imaging systems and X-ray dose management is highly
variable, and physician credentialing and recredentialing has no requirement regarding
knowledge of radiation safety. It is therefore incumbent on the hospital leaders to
establish high local standards and to track fluoroscopy use and behavior.
11.2
Occupational Health Risks of Wearing Lead
11.2.1
Lead Aprons
Lead-equivalent aprons required for radiation protection of staff are heavy and present
a substantial physical burden to the interventional cardiologist.
99
Historically, lead aprons were made using 0.5-mm lead-equivalent materials, with
weight per unit area of these garments being 7 kg/m2.
98
An increased risk of cervical spondylosis is a known consequence for cardiologists
who wear protective garments while standing for long hours performing procedures.
87
Orthopedic problems and user fatigue associated with the continued use of heavy aprons
contributed to the development of lower-weight lead-equivalent materials that are
commonly used for protective garments today. Modern nonlead 0.5-mm lead-equivalent
protective garments have a weight reduction of 30% or more than do traditional lead
aprons.
98
That modern aprons are lighter might be expected to lessen, but not eliminate, orthopedic
discomfort and injury. It is important to emphasize that all lead should be tested
at 6-month intervals to check for cracks or leaks.
Along with weight, there are several other physical and ergonomic aspects of radiation
protection garments that should be considered. To minimize discomfort, garments must
fit correctly and should be tightened around the midsection to shift weight from the
shoulders to the hips as much as possible. There are several garment designs that
are customized for various uses. Many interventional cardiologists choose a two-piece
garment consisting of a skirt and vest (including internal frame), both of which should
be snugly tightened around the midsection. Such garments are frequently designed to
“wraparound” the wearer and typically provide the fully specified lead-equivalent
protection from radiation only in the front where the garment overlaps. A thyroid
shield should always be used,
100
and leaded glasses should be worn to minimize the risk of developing cataracts.
101
11.2.2
Alternatives to Wearing Lead
Tableside alternatives to lead-equivalent garments include a floor-mounted radiation
protection cabin and a ceiling- or gantry-mounted suspended radiation protection system.99,
102, 103 Both these systems are designed to remove the weight burden of radiation
protection while allowing tableside access in a sterile working environment. Because
the weight of the shielding is not borne by the operator, thicker, heavier materials
can be used. This results in a 16–78-fold decrease in radiation exposure to the operator.
103
The disadvantages of these systems are that they restrict the motion of the operator
to some degree, and they increase the equipment that is present in an already crowded
procedure laboratory environment.
Robotic manipulation of ablation catheters can be accomplished using external magnetic
fields to guide magnetic tipped catheters or robotic armatures that actuate sheath
and catheter movement remotely. These systems allow electrophysiologists to perform
most of the procedure behind fixed radiation barriers, thereby eliminating exposure
to scattered radiation for the operator (but not the patient or in-laboratory staff)
and eliminating the need to wear protective lead.26, 104, 105 Although there is a
learning curve associated with these technologies, they appear to yield results equivalent
to conventional manual catheter procedures. Recent developments in electroanatomic
mapping and ICE have been used to perform catheter ablation of atrial fibrillation
22
with minimal use of X-ray imaging. Future developments of these and other imaging
technologies that do not use ionizing radiation may obviate the need for radiation
protection garments in the EP laboratory of the future.
11.3
Laboratory Ergonomics
The physical stresses associated with working in the EP/interventional laboratory
have been identified as a high prevalence of orthopedic problems, particularly those
related to the spine, hips, knees, and ankles.102, 106 The primary contributor to
orthopedic problems is wearing personal radiation protection apparel. Other factors
may be those related to ergonomic design, increasing complexity and duration of interventional
procedures, falls, and lengthy careers. A Multi-Specialty Occupational Health Group
has been formed to evaluate risks and hazards and advocate for efforts to reduce these
hazards.
107
Table 5 provides a list of measures to be considered in laboratory design and procedural
processes to reduce the incidence of ergonomic stresses on the EP laboratory physicians
and staff.
11.4
Operator Safety During Cardiac EP in Patients With Communicable Diseases
Preventing the transmission of infectious agents to ensure the safety of the operator
and other staff in the EP laboratory as much as possible involves, first and foremost,
adherence to standardized uniformly applied universal precautions in every aspect
of patient care. Risks of acquisition of infectious diseases by health care workers
can be minimized by adherence to current infection control guidelines.
108
11.4.1
Individual Personal Precautions
Institutions have policies on required annual or biannual staff inoculations. These
may include inoculations such as hepatitis B, influenza, pertussis, and rubeola (measles).
Such inoculations can provide immunity from certain highly transmissible diseases,
enabling staff to care for these patients without inordinate risk. For example, health
care workers not immune to chicken pox should not be required to care for patients
with chicken pox.
109
Because of the specialization of staff in the EP laboratory, it can be difficult to
provide adequate staffing if multiple concessions have to be made for noncompliant
staff. The interval for regular testing of staff for tuberculosis is defined by every
institution. In special situations, staff may be fitted for N95 filter masks, which
are particulate respirators that are used to prevent inhalation of small infectious
airborne particles transmitted by patients with active tuberculosis. Institutional
policies should be followed closely in these situations.
11.4.2
Standard Precautions
The major features of universal precautions and body substance isolation are incorporated
in standard precautions and are used universally to prevent transmission of highly
contagious or virulent infectious agents that may be spread by air and/or contact.
The basic principle is that all blood, body fluids, secretions, excretions (except
sweat), nonintact skin, and mucous membranes may contain transmissible infectious
agents. Since it is impossible to identify all sources of all infectious agents, the
same precautions are applied to every patient at every encounter. Each institution
has a detailed description of how standard precautions are implemented. The following
text highlights certain aspects particularly pertinent to EP laboratory processes.
Hand hygiene is the single most important factor in controlling and preventing the
transmission of germs. Additional protection is offered by the appropriate use of
medical gloves; however, the unnecessary and inappropriate use of gloves results in
a waste of resources and may increase the risk of germ transmission.
110
Hands are washed each time after gloves are removed. Hand-washing supplies should
be readily accessible in the EP laboratory and environments. Sterile gloves are indicated
for any surgical procedure, invasive radiologic procedure, and procedures involving
vascular access (central lines). Examination gloves are indicated in clinical situations
where there is potential for touching blood, body fluids, secretions, excretions,
and items visibly soiled by body fluids. Splash protection with masks and eye shields
is recommended when working with arterial and venous catheterization. Gloves are not
indicated (except for contact precautions) for tasks involving direct patient exposure,
including taking blood pressure, pulse, and temperature; administering intramuscular
and subcutaneous injections; bathing and dressing the patient; transporting the patient;
and any vascular line manipulation in the absence of blood leakage, or with indirect
patient exposure, including using the phone, writing in the chart, removing and replacing
linen for the patient’s bed, and placing noninvasive ventilation equipment and oxygen
cannula.
110
Safe injection practices, including the use of needleless injection systems and proper
disposal of any sharps and other equipment used for invasive procedures, are paramount.
Single-dose vials are preferable to multiple-dose vials, particularly if the vial
will be used for multiple patients.
Transmission-based precautions are as described in each institution’s infection control
policies. Contact precautions require the use of gowns and gloves when there is any
contact with the patient or the surrounding area. Droplet precautions are invoked
when infectious respiratory droplets can travel directly from the patient’s respiratory
tract to the recipient, generally over short distances. This necessitates facial protection,
such as surgical mask, eye protection, and/or face shield. Personal eyeglasses and
contact lenses are not considered adequate eye protection.
110
Historically, the area of defined risk has been a distance of 3 ft or more around
the patient, although depending on the size of the droplets (smallpox and SARS are
examples of small droplets), the infective area may be up to 6 ft from the patient.
Droplets do not remain infectious over long periods of time and therefore do not require
special air handling and ventilation. Airborne infection isolation precautions prevent
transmission of infectious agents that remain infectious over long distances when
suspended in the air (e.g., rubeola virus [measles], varicella virus [chicken pox],
Mycobacterium tuberculosis, and possibly SARS coronavirus). If at all possible, EP
procedures should be deferred in these patients unless a negative airflow procedure
room is available. If an EP procedure is unavoidable, a regular positive pressure
procedure room with airflow similar to an OR and a portable high-efficiency particulate
air filtration unit may be used.110, 111 The patient should wear a surgical mask,
and the staff should wear N95 filter masks. The procedure should be the last case
of the day, and the room left empty until adequate air exchange has taken place to
clear the room.
11.4.3
Laboratory Processes
Protocols and regulations as established by the institution for the disposal or processing
of infectious material, drapes, and fluids should be followed. Care should be taken
to avoid shaking drapes or linens, which can aerosolize contaminants. All sharps that
are to be reprocessed should be placed in puncture-resistant containers, leak proof
on all sides and bottom, and labeled with a biohazard label. Blood, suction material,
or other contaminated liquids can be converted to a solid by the addition of a gel-forming
substance to avoid risk of fluid leaking out of containers. “Clean” and “dirty” areas
of the laboratory should be maintained during procedures. Personnel touching a contaminated
patient/wound/area should try to avoid touching surrounding objects before removing
gloves and washing hands. After procedures, all touched surfaces need to be cleaned
with a hospital-approved disinfectant, leaving the surfaces wet for the amount of
time as directed on the bottle. This cleaning includes monitoring cables, intravenous
pumps, transfer equipment, and all nondisposable objects within 3–6 ft of a patient
on droplet precautions and within 6 ft if the patient has been coughing.
11.4.4
Catheter Reprocessing
Catheter reprocessing is being adopted by many EP laboratories nationwide, which is
aimed at reducing the cost of expensive single-use device and to lessen the environmental
impact from discarded supplies. With the passage and enactment of the Medical Device
User Fee and Modernization Act of 2002, the reprocessing of single-use devices is
now supported in federal law. Physicians and the entire EP team must come to an agreement
on whether reprocessing is going to positively impact their clinical operation and
patient care from the financial, legal, and/or ethical point of view. Ablation catheters
are classified by the FDA as class III devices; therefore, they cannot be reprocessed
at this time. There are a few third-party FDA-approved reprocessors used by many EP
and catheterization laboratories. In choosing a vendor for reprocessing, each team
should consider not only the price of the reprocessed catheters but also the particular
vendor’s turnaround time, catheter collection logistics, and reprocessing success
rate.
11.4.5
Transportation
When a patient must be transported to other units or departments, the referring area
should communicate the patient’s isolation needs to the receiving area before transporting
the patient. All precautions should be followed throughout the transport process.
Gloves and other appropriate barriers should be worn by the patient and/or health
care worker during all transfers. Protective equipment is then to be removed, the
hands washed, and the patient is to be transported to or from the laboratory. Patients
on droplet precautions must have their mouths and/or tracheostomy covered with a surgical
mask. Transporting a patient on airborne precautions should be discouraged, but if
absolutely necessary, consult with the infection control officer as to specific transportation
methods.
12
Ethical Concerns
Laboratory Environment Recommendations
•
Obtaining an informed consent is necessary for all procedures.
12.1
Informed Consent
Obtaining an informed consent is a process whereby communication between a patient
and a physician results in the patient authorizing the medical procedure. This is
an integral procedure that safeguards patient autonomy and provides the patient with
information about the procedure that allows them to understand and agree to the procedure
being recommended. This process is not only a legal requirement but also an ethical
obligation.
To ensure appropriate communication, sufficient time should be allocated to this process.
A physician, APN, or PA that is part of the EP team should obtain the informed consent,
and it should be made clear if trainees, PAs, or APNs will be operators. The process
must take place before premedication with sedation so that the patient is able to
understand the discussion and communicate a decision. The discussion should take place
out of the procedure room and be in a language that the patient adequately understands,
with a qualified interpreter when needed. Common risks, even if not considered serious,
should be discussed, as should serious risks that are potentially life-threatening,
even if exceedingly rare. All aspects of the procedure that can be reasonably anticipated
should be included in the discussion.
Informed consent in the majority of pediatric cases will be granted by the parent
or guardian acting on the patient’s behalf. Adult patients with CHD are similar to
other adults except in cases of cognitive handicaps, as in some genetic syndromes.
A minor should be invited to participate in the process, but the consent should be
obtained from a legal guardian. Consent/assent forms for young patients older than
12 years are frequently used. Serum or urine pregnancy testing is generally applied
for females older than 12 years within 2 weeks before the procedure.
The physician should be aware that they can have a substantial influence on their
patient’s decision. As an expert, the patient looks to the physician for guidance.
It is an ethical obligation for the physician to present a rational argument for undergoing
the procedure. In contrast, any form of coercion with the use of verbal or nonverbal
threat or manipulation through the incomplete or nontruthful presentation of information
is always unethical. Patients should be given ample opportunity to discuss their concerns
about the procedure and to have their questions answered satisfactorily. If the patient
is incapacitated, every effort should be made to seek out and obtain consent from
an appropriate surrogate.
12.2
Ethics of Teaching in the EP Laboratory Setting
Teaching invasive procedural skills is a necessary part of maintaining the availability
of widespread medical expertise to patients. The use of simulators can be a helpful
adjunct to teaching invasive procedures but cannot replace the experience gained from
actual patient procedures.
112
Although teaching is the charge of institutions with postgraduate training programs
and affiliations with medical schools, the teaching of invasive procedures can occur
in any type of institution.
It is the ethical duty of physicians to communicate to patients when and in what way
trainees will be involved in their procedures. When asked before the procedure, the
majority of patients consent to allowing trainees to practice their skills.
113
Most teaching institutions have patients sign a form during the admission process
that acknowledges their implicit consent to allow trainees to perform procedures under
the supervision of senior physicians. Although this may be sufficient communication
to patients for minor procedures such as venipuncture or acquisition of a surface
ECG, in more invasive procedures it is mandatory that a separate discussion takes
places during the informed consent process that clearly states the participation and
the role of the trainee. Allowing a trainee to practice on a patient under general
anesthesia without the patient’s explicit consent does not respect the patient’s autonomy
and compromises the trainee’s moral integrity. Trainees should be invited to participate
in the procedure only as an integral part of their training, not for mere curiosity.
It is the responsibility of the supervising physician to allow the trainee to participate
in the capacity that they are capable. The trainee should not be left performing the
procedure unsupervised.
12.3
Clinical Research Studies During Clinical Procedures
Without clinical research, promising potentially lifesaving technologies and therapies
cannot be safely made available for patients. Our understanding of disease processes
progresses because of ongoing research. Clinical research, however, exposes patients
to some risk without proven direct benefit. As a researcher, the operator’s primary
responsibility is generating knowledge, whereas as a physician, the operator’s primary
responsibility is the well-being of the patient. When there is a conflict between
these two roles, the role of the physician must override the role of the researcher.
Patients should be considered for a research protocol if they are looking for improved
outcomes compared with those of current therapies. Recruitment of patients should
be carried out in a manner that does not coerce participation. Similarly, the opportunity
for participation in available investigation protocols should be presented to all
patients fulfilling inclusion and exclusion criteria even if the attending physician
does not believe that the patient is an ideal candidate. A necessary amount of time
should be given to the informed consent process in sufficient advance of the procedure
so that the patient is not unduly pressured into making a decision. When children
or adult patients unable to provide an informed consent are being considered for a
research protocol, it may be helpful to have an independent advocate ensure that parents
or legally authorized representatives are making a rational decision exposing the
subject to risk.
It is not enough to obtain a patient’s consent to participate in a study. It is the
ethical duty of an investigator to ensure that the research protocol does not place
the participants at unreasonable risk that is disproportionate to the expected benefits
of the research study. The protocol must have scientific merit with an adequate likelihood
of success as well as an expectation of social benefit. All research protocols performed
in the EP laboratory must be reviewed and approved by an independent group, such as
an institutional review board, to ensure that the study is ethically acceptable. Results
must be reported honestly, not only to honor the risk that research participants took
but also to protect future recipients of the technology and therapies made available
through research.
12.4
Physician-Industry Relations
Industry can partner with physicians to promote medical knowledge and improve patient
care through examples such as supporting CME programs, physician training, and clinical
research. Although physicians and industry may share a common goal of advancing medical
care, the primary interest of the physician is the well-being of the patient whereas
that of the industry is profitability. Any interaction with industry, therefore, has
the potential to influence a physician’s decision regarding a company’s product or
service and a physician must stay vigilant to avoid being biased by these interactions.
1
Any gift or amenity that is offered has the potential to exert influence.
114
Institutions and physician groups may define policies regarding the acceptance of
industry gifts, but anyone approached by industry must be able to judge whether accepting
the gift carries the danger of biasing a medical decision and compromising patient
care. It is unethical to accept any gift that is predicated on using a particular
product or service. It is imperative that the conflict of interest disclosures to
employers, editors, professional organizations, and audiences be accurate and up to
date. The conflict of interest policies of each physician’s institution and professional
organization must be followed. Physicians who are on product review and new product
introduction committees for their hospital or professional organization and who have
consulting or other relationships with industry must disclose those relationships
and recuse themselves from product decisions in those cases.