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      Performance of re-used pacemakers and implantable cardioverter defibrillators compared with new devices at Groote Schuur Hospital in Cape Town, South Africa

      research-article
      , MB ChB, , FCP (SA), MPhil, , FCP (SA), DPhil, , PhD
      Cardiovascular Journal of Africa
      Clinics Cardive Publishing
      re-used devices, pacemakers, ICDs, performance, safety

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          Abstract

          Objectives

          Little is known about the performance of re-used pacemakers and implantable cardioverter defibrillators (ICDs) in Africa. We sought to compare the risk of infection and the rate of malfunction of re-used pacemakers and ICDs with new devices implanted at Groote Schuur Hospital in Cape Town, South Africa.

          Methods

          This was a retrospective case comparison study of the performance of re-used pacemakers and ICDs in comparison with new devices implanted at Groote Schuur Hospital over a 10-year period. The outcomes were incidence of device infection, device malfunction, early battery depletion, and device removal due to infection, malfunction, or early battery depletion.

          Results

          Data for 126 devices implanted in 126 patients between 2003 and 2013 were analysed, of which 102 (81%) were pacemakers (51 re-used and 51 new) and 24 (19%) were ICDs (12 re-used and 12 new). There was no device infection, malfunction, early battery depletion or device removal in either the re-used or new pacemaker groups over the median follow up of 15.1 months [interquartile range (IQR), 1.3–36.24 months] for the re-used pacemakers, and 55.8 months (IQR, 20.3–77.8 months) for the new pacemakers. In the ICD group, no device infection occurred over a median follow up of 35.9 months (IQR, 17.0–70.9 months) for the re-used ICDs and 45.7 months (IQR, 37.6–53.7 months) for the new ICDs. One device delivered inappropriate shocks, which resolved without intervention and with no harm to the patient. This re-used ICD subsequently needed generator replacement 14 months later. In both the pacemaker and ICD groups, there were no procedure-non-related infections documented for the respective follow-up periods.

          Conclusion

          No significant differences were found in performance between re-used and new pacemakers and ICDs with regard to infection rates, device malfunction, battery life and device removal for complications. Pacemaker and ICD re-use is feasible and safe and is a viable option for patients with bradyarrhythmias and tachyarrthythmias.

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          Most cited references28

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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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            2012 ACCF/AHA/HRS focused update of the 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. [corrected].

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              Risk factors for mortality in patients with cardiac device-related infection.

              Because of the increased use of pacemakers and implantable cardioverter defibrillators, infection has become a complication with significant morbidity and mortality. Data on risk factors for mortality in patients with cardiac-device related infection are limited. We evaluated the prognostic significance of key clinical and echocardiographic variables in a large retrospective population of patients with cardiac-device related infection. Two hundred ten patients with cardiac-device related infection were identified at the University of Michigan between 1995 and 2006. Data were abstracted on key clinical and echocardiographic variables, treatment strategy, and 6-month outcomes. We used multivariable Cox proportional hazards models to examine clinical and echocardiographic variables that were associated with 6-month mortality. Mean age for our study population was 63+/-17 years, and 72 (44%) were women. All-cause 6-month mortality was 18% (n=37). Independent variables associated with death were systemic embolization (hazard ratio 7.11; 95% CI 2.74 to 18.48), moderate or severe tricuspid regurgitation (hazard ratio 4.24; 95% CI 1.84 to 9.75), abnormal right ventricular function (hazard ratio 3.59; 95% CI 1.57 to 8.24), and abnormal renal function (hazard ratio 2.98; 95% CI 1.17 to 7.59). Size and mobility of cardiac device vegetations were not independently associated with mortality. We identified several clinical and echocardiographic variables that identify patients with cardiac-device related infection who are at high-risk for mortality and may benefit from more aggressive evaluation.
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                Author and article information

                Contributors
                Journal
                Cardiovasc J Afr
                Cardiovasc J Afr
                TBC
                Cardiovascular Journal of Africa
                Clinics Cardive Publishing
                1995-1892
                1680-0745
                Jul-Aug 2015
                : 26
                : 4
                : 181-187
                Affiliations
                The Cardiac Clinic, Department of Medicine, Groote Schuur Hospital, Cape Town, South Africa
                The Cardiac Clinic, Department of Medicine, Groote Schuur Hospital, Cape Town, South Africa
                The Cardiac Clinic, Department of Medicine, Groote Schuur Hospital, Cape Town, South Africa
                College of Medicine, King Saudi Bin, Abdulaziz University for Medical Sciences, Riyadh, Kingdom of Saudi Arabia
                Article
                10.5830/CVJA-2015-048
                4683290
                26407220
                6c22612c-b965-460d-a53e-6b12f21ed963
                Copyright © 2015 Clinics Cardive Publishing

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 17 February 2015
                : 12 April 2015
                Categories
                Cardiovascular Topics

                re-used devices,pacemakers,icds,performance,safety
                re-used devices, pacemakers, icds, performance, safety

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