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      Superior Vena Cava Echocardiography as a Screening Tool to Predict Cardiovascular Implantable Electronic Device Lead Fibrosis

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          Abstract

          Background

          Currently there is no noninvasive imaging modality used to risk stratify patients requiring lead extractions. We report the novel use of superior vena cava (SVC) echocardiography to identify lead fibrosis and complex cardiac implantable electronic device (CIED) lead extraction. With an aging population and expanding indications for cardiac device implantation, the ability to deal with the complications associated with chronically implanted device has also increased.

          Methods

          This was a retrospective analysis of Doppler echocardiography recorded in our outpatient Electrophysiology/Device Clinic office over 6 months. Images from 109 consecutive patients were reviewed.

          Results

          62% (68/109) did not have a CIED and 38% (41/109) had a CIED. In patients without a CIED, 6% (4/68) displayed turbulent color flow by Doppler in the SVC, while 22% (9/41) of patients with a CIED displayed turbulent flow. Fisher's exact test found a statistically significant difference between the two groups ( p value < 0.05). The CIED group was subdivided into 2 groups based on device implant duration (< 2 years vs. ≥ 2 years). Of the CIED implanted for ≥ 2 years, 27% (9/33) had turbulent flow in the SVC by Doppler, while no patients (0/8) with implant durations < 2 years demonstrated turbulent flow. Nine patients underwent subsequent lead extraction. A turbulent color pattern successfully identified all 3 patients that had significant fibrosis in the SVC found during extraction.

          Conclusion

          Our data suggests that assessing turbulent flow using color Doppler in the SVC may be a valuable noninvasive screening tool prior to lead extraction in predicting complex procedures.

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          Most cited references21

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          Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA).

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            Deaths and cardiovascular injuries due to device-assisted implantable cardioverter–defibrillator and pacemaker lead extraction

            Aims An estimated 10 000–15 000 pacemaker and implantable cardioverter–defibrillator (ICD) leads are extracted annually worldwide using specialized tools that disrupt encapsulating fibrous tissue. Additional information is needed regarding the safety of the devices that have been approved for lead extraction. The aim of this study was to determine whether complications due to device-assisted lead extraction might be more hazardous than published data suggest, and whether procedural safety precautions are effective. Methods and results We searched the US Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database from 1995 to 2008 using the search terms ‘lead extraction and death’ and ‘lead extraction and injury’. Additional product specific searches were performed for the terms ‘death’ and ‘injury’. Between 1995 and 2008, 57 deaths and 48 serious cardiovascular injuries associated with device-assisted lead extraction were reported to the FDA. Owing to underreporting, the FDA database does not contain all adverse events that occurred during this period. Of the 105 events, 27 deaths and 13 injuries occurred in 2007–2008. During these 2 years, 23 deaths were linked with excimer laser or mechanical dilator sheath extractions. The majority of deaths and injuries involved ICD leads, and most were caused by lacerations of the right atrium, superior vena cava, or innominate vein. Overall, 62 patients underwent emergency surgical repair of myocardial perforations and venous lacerations and 35 (56%) survived. Conclusion These findings suggest that device-assisted lead extraction is a high-risk procedure and that serious complications including death may not be mitigated by emergency surgery. However, skilled standby cardiothoracic surgery is essential when performing pacemaker and ICD lead extractions. Although the incidence of these complications is unknown, the results of our study imply that device-assisted lead extractions should be performed by highly qualified physicians and their teams in specialized centres.
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              Implantation trends and patient profiles for pacemakers and implantable cardioverter defibrillators in the United States: 1993-2006.

              Prior studies of cardiac rhythm management devices (pacemakers [PM] and implantable cardioverter defibrillators [ICD]) utilization in the United States have been limited to the Medicare population. We evaluated the national trends for the implantation of PMs and ICDs including the burden of device replacement. The Nationwide Inpatient Sample was queried to identify PM and ICD patients between 1993 and 2006 using ICD-9-CM codes, including demographics, health profile, and economic data. The Charlson Comorbidity Index (CCI) and replacement burden were calculated, and changes over time studied. From 1993 to 2006, 2.4 million patients received a primary PM and 0.8 million received an ICD, while there were 369,000 PM replacements and 74,000 ICD replacements. Women comprised 49% of PM and 24% of ICD patients. The mean ICD replacement burden was 8.4% (range 5-22%) and decreased significantly over time (P < 0.0001) while the replacement burden for PMs was constant (mean = 13.4%, range 11-16%). ICD patients had more comorbidities than PM patients (CCI: 0.8 vs 1.1, P < 0.0001). The replacement burden for PMs has remained constant, while the replacement burden for ICDs has decreased. This is likely due to the stability of the patient population receiving PMs and technology maturity. Alternatively, the indications for ICD implantation have broadened, resulting in an increased number of primary ICD implantations. The age and comorbidities are increasing in those patients receiving ICDs while the PM population is stable. These data suggest that monitoring of replacement burden is warranted, given the changing populations, their disparate clinical outcomes, and economic implications to the health care system.
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                Author and article information

                Journal
                J Cardiovasc Ultrasound
                J Cardiovasc Ultrasound
                JCU
                Journal of Cardiovascular Ultrasound
                Korean Society of Echocardiography
                1975-4612
                2005-9655
                March 2015
                30 March 2015
                : 23
                : 1
                : 27-31
                Affiliations
                [1 ]Department of Medicine, Drexel University College of Medicine, Philadelphia, PA, USA.
                [2 ]Department of Medicine, Division of Cardiology, Drexel University College of Medicine, Philadelphia, PA, USA.
                Author notes
                Address for Correspondence: Andrew Kohut, Department of Medicine, Division of Cardiology, Drexel University College of Medicine, Mail Stop 470, 245 North 15th Street, Philadelphia, PA 19102-1192, USA. Tel: +1-215-762-3559, Fax: +1-215-762-7555, Andrew.Kohut@ 123456drexelmed.edu
                Article
                10.4250/jcu.2015.23.1.27
                4398781
                3db33789-9216-470f-bf0b-4b0055e60138
                Copyright © 2015 Korean Society of Echocardiography

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 04 December 2014
                : 09 March 2015
                : 10 March 2015
                Categories
                Original Article

                Cardiovascular Medicine
                lead extraction,echocardiography,cardiac implantable electronic device

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