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      Multi‐Center, Community‐Based Cardiac Implantable Electronic Devices Registry: Population, Device Utilization, and Outcomes

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          Abstract

          Background

          The purpose of this study is to describe key elements, clinical outcomes, and potential uses of the Kaiser Permanente–Cardiac Device Registry.

          Methods and Results

          This is a cohort study of implantable cardioverter defibrillators ( ICD), pacemakers ( PM), and cardiac resynchronization therapy ( CRT) devices implanted between January 1, 2007 and December 31, 2013 by ≈400 physicians in 6 US geographical regions. Registry data variables, including patient characteristics, comorbidities, indication for procedures, complications, and revisions, were captured using the healthcare system's electronic medical record. Outcomes were identified using electronic screening algorithms and adjudicated via chart review. There were 11 924 ICDs, 33 519 PMs, 4472 CRTs, and 66 067 leads registered. A higher proportion of devices were implanted in males: 75.1% ( ICD), 55.0% ( PM), and 66.7% ( CRT), with mean patient age 63.2 years ( ICD), 75.2 ( PM), and 67.2 ( CRT). The 30‐day postoperative incidence of tamponade, hematoma, and pneumothorax were ≤0.3% ( ICD), ≤0.6% ( PM), and ≤0.4% ( CRT). Device failures requiring revision occurred at a rate of 2.17% for ICDs, 0.85% for PMs, and 4.93% for CRTs, per 100 patient observation years. Superficial infection rates were <0.03% for all devices; deep infection rates were 0.6% ( ICD), 0.5% ( PM), and 1.0% ( CRT). Results were used to monitor vendor‐specific variations and were systematically shared with individual regions to address potential variations in outcomes, utilization, and to assist with the management of device recalls.

          Conclusions

          The Kaiser Permanente–Cardiac Device Registry is a robust tool to monitor postprocedural patient outcomes and postmarket surveillance of implants and potentially change practice patterns.

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          Most cited references 11

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          The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009--a World Society of Arrhythmia's project.

          A worldwide cardiac pacing and implantable cardioverter-defibrillator (ICD) survey was undertaken for calendar year 2009 and compared to a similar survey conducted in 2005. There were contributions from 61 countries: 25 from Europe, 20 from the Asia Pacific region, seven from the Middle East and Africa, and nine from the Americas. The 2009 survey involved 1,002,664 pacemakers, with 737,840 new implants and 264,824 replacements. The United States of America (USA) had the largest number of cardiac pacemaker implants (225,567) and Germany the highest new implants per million population (927). Virtually all countries showed increases in implant numbers over the 4 years between surveys. High-degree atrioventricular block and sick sinus syndrome remain the major indications for implantation of a cardiac pacemaker. There remains a high percentage of VVI(R) pacing in the developing countries, although compared to the 2005 survey, virtually all countries had increased the percentage of DDDR implants. Pacing leads were predominantly transvenous, bipolar, and active fixation. The survey also involved 328,027 ICDs, with 222,407 new implants and 105,620 replacements. Virtually all countries surveyed showed a significant rise in the use of ICDs with the largest implanter being the USA (133,262) with 434 new implants per million population. This was the largest pacing and ICD survey ever performed, because of mainly a group of loyal enthusiastic survey coordinators. It encompasses more than 80% of all the pacemakers and ICDs implanted worldwide during 2009. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.
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            Ethnic disparities in diabetic complications in an insured population.

             Andrew Karter (2002)
            Higher rates of microvascular complications have been reported for minorities. Disparate access to quality health care is a common explanation for ethnic disparities in diabetic complication rates in the US population. Examining an ethnically diverse population with uniform health care coverage may be useful. To assess ethnic disparities in the incidence of diabetic complications within a nonprofit prepaid health care organization. Longitudinal observational study conducted January 1, 1995, through December 31, 1998, at Kaiser Permanente Medical Care Program in northern California. A total of 62 432 diabetic patients, including Asians (12%), blacks (14%), Latinos (10%), and whites (64%). Incident myocardial infarction (MI), stroke, congestive heart failure (CHF), and nontraumatic lower extremity amputation (LEA), defined by primary hospitalization discharge diagnosis, procedures, or underlying cause of death; and end-stage renal disease (ESRD), defined as renal insufficiency requiring renal replacement therapy or transplantation for survival or by underlying cause of death. Patterns of ethnic differences were not consistent across complications and frequently persisted despite adjustment for a wide range of demographic, socioeconomic, behavioral, and clinical factors. Adjusted hazard ratios (relative to that of whites) were 0.56, 0.68, and 0.68 for blacks, Asians, and Latinos, respectively (P<.001), for MI; 0.76 and 0.72 for Asians and Latinos, respectively (P<.01), for stroke; 0.70 and 0.61 for Asians and Latinos, respectively (P<.01), for CHF; 0.40 for Asians (P<.001) for LEA; and 2.03, 1.85, and 1.46 for blacks, Asians, and Latinos, respectively (P<.01), for ESRD. There were no statistically significant black-white differences for stroke, CHF, or LEA and no Latino-white differences for LEA. This study confirms previous reports of elevated incidence of ESRD among ethnic minorities, despite uniform medical care coverage, and provides new evidence that rates of other complications are similar or lower relative to those of whites. The persistence of ethnic disparities after adjustment suggests a possible genetic origin, the contribution of unmeasured environmental factors, or a combination of these factors.
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              2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society.

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                Author and article information

                Journal
                J Am Heart Assoc
                J Am Heart Assoc
                10.1002/(ISSN)2047-9980
                JAH3
                ahaoa
                Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
                John Wiley and Sons Inc. (Hoboken )
                2047-9980
                09 March 2016
                March 2016
                : 5
                : 3 ( doiID: 10.1002/jah3.2016.5.issue-3 )
                Affiliations
                [ 1 ] Department of ElectrophysiologySouthern CA Permanente Medical Group Los Angeles CA
                [ 2 ] Surgical Outcomes & Analysis DepartmentKaiser Permanente San Diego CA
                [ 3 ] Department of ElectrophysiologyThe Permanente Medical Group Santa Clara CA
                [ 4 ] Department of CardiologyHawaii Permanente Medical Group Honolulu HI
                Author notes
                [* ] Correspondence to: Nigel Gupta, MD, Department of Electrophysiology, Southern CA Permanente Medical Group, 4867 Sunset Blvd, Los Angeles, CA 90027. E‐mail: nigel.x.gupta@ 123456kp.org
                Article
                JAH31378
                10.1161/JAHA.115.002798
                4943256
                26961369
                © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                Page count
                Pages: 8
                Product
                Categories
                Original Research
                Original Research
                Arrhythmia and Electrophysiology
                Custom metadata
                2.0
                jah31378
                March 2016
                Converter:WILEY_ML3GV2_TO_NLMPMC version:4.8.9 mode:remove_FC converted:05.05.2016

                Cardiovascular Medicine

                electrophysiology, pacemakers, registries, quality and outcomes

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