Significant differences in the expected versus observed longevity of implantable cardioverter defibrillators (ICDs)
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Implantable cardioverter defibrillator (ICD) is a life-saving therapy for patients at risk of ventricular arrhythmias. Due to its high cost, its cost-effectiveness is highly dependent on its longevity, which is currently only based upon the manufacturer’s predicted device life span.
We sought to assess the ICDs’ longevity and the factors influencing it, and to compare the observed (real life) to the expected (manufacturer’s prediction) life span at a device level.
We retrospectively identified all patients who underwent an ICD implantation in a tertiary care medical center. For each device, an expected longevity was assigned based on the manufacturer/model, pacing percentage, and number of shocks per year. We defined device failure if the observed survival was shorter than 80 % of the expected. Only devices with follow-up time that exceeded the expected longevity were included.
Of the 275 devices in the cohort, 79 (29 %) failed. Median device longevity was 5 years and varied markedly between manufacturers (4.3, 4.8, 5.1, and 6.3 years for Biotronik, St. Jude Medical, Boston Scientific, and Medtronic, respectively). There were significant differences among the manufacturers in device failure rates: 48, 17, 22, and 14 % for Biotronik, St. Jude Medical, Boston Scientific, and Medtronic, respectively). In multivariate analysis, manufacturer, earlier year of implantation, congestive heart failure and chronic renal failure significantly predicted device failure.
In conclusion, there is a significant device failure rate among ICDs, with variability among manufacturers, impacting both patients and the medical economic systems.
KeywordsImplantable cardioverter defibrillator Device failure Longevity Battery performance
Implantable cardioverter defibrillator
Single chamber ICD
Dual chamber ICD
Cardiac resynchronization therapy bi-ventricular ICD
Elective replacement indication
- 1.Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins ST, Klein H et al (1996) Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med 335:1933–1940PubMedCrossRefGoogle Scholar
- 2.Moss AJ, Zareba W, Hall WJ, Klein H, Wilber D, Cannom DS et al (2002) Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 346:877–883PubMedCrossRefGoogle Scholar
- 11.Medtronic, Inc. (2011) Cardiac rhythm disease management product performance report: important patient management information for physicians. First edition, issue 64. Available at: http://wwwp.medtronic.com/productperformance-files/Issue64_MDT_CRDM_PPR_2011_1st_Edition.pdf
- 12.St. Jude Medical (2011) Product performance report: cardiac rhythm management. Available at: http://www.sjmprofessional.com/Resources/product-performance-reports/Product-Performance-Report.aspx
- 13.Boston Scientific (2011) CRM Product Performance Report Q2. Available at: http://www.bostonscientific.com/templatedata/imports/HTML/PPR/ppr/index.shtml
- 14.Biotronik. Product Performance Report (2011). Available at: http://www.biotronik.com/sixcms/media.php/162/ppr_january_2011.13959.pdf
- 17.FDA. Medical & Radiation Emitting Device Recalls. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&event_id=28982 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&event_id=27417 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=907751
- 18.FDA. Medical & Radiation Emitting Device Recalls. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=39931&CREATE_DT=2005-06-30 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40302 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37338
- 19.Thijssen J, Borleffs CJ, Van Rees JB, Man S, De Bie MK, Venlet J, et al. (2011) Implantable cardioverter-defibrillator longevity under clinical circumstances: an analysis according to device type, generation, and manufacturer. Heart Rhythm (Epub ahead of print)Google Scholar