Frederic S Resnic1,2,3, Arjun Majithia1,2,4, Sanket S Dhruva5, Henry Ssemaganda1, Susan Robbins1, Danica Marinac-Dabic6, Kathleen Hewitt7, Lucila Ohno-Machado8, Matthew R Reynolds1,2,3, Michael E Matheny9,10. 1. Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington, MA (F.S.R., A.M., H.S., S.R., M.R.R.). 2. Division of Cardiovascular Medicine, Lahey Hospital and Medical Center, Burlington, MA (F.S.R., A.M., M.R.R.). 3. Tufts School of Medicine, Boston, MA (F.S.R., M.R.R.). 4. Brigham and Women's Hospital, Boston, MA (A.M.). 5. UCSF School of Medicine and Section of Cardiology, San Francisco VA Health Care System (S.S.D.). 6. Center for Devices and Radiological Health (CDRH), FDA, Silver Spring, MD (D.M.-D.). 7. National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H.). 8. Department of Biomedical Informatics, University of California San Diego Health, La Jolla (L.O.-M.). 9. Geriatrics Research, Education, and Clinical Care Center, Tennessee Valley Healthcare System VA, Nashville (M.E.M.). 10. Departments of Biomedical Informatics, Biostatistics and Medicine, Vanderbilt University Medical Center, Nashville, TN (M.E.M.).
Abstract
BACKGROUND: Several defibrillator leads have been recalled due to early lead failure leading to significant patient harm. Confirming the safety of contemporary defibrillator leads is essential to optimizing treatment for patients receiving implantable cardioverter-defibrillators (ICDs). We therefore sought to assess the comparative long-term safety of the 4 most commonly implanted ICD leads within the National Cardiovascular Data Registry ICD Registry. METHODS AND RESULTS: A propensity-matched survival analysis of the ICD Registry was performed evaluating 4 contemporary ICD leads in patients receiving an ICD system for the first time. All patients in the ICD Registry aged ≥18 years who underwent an implant of an ICD between April 1, 2011 and March 31, 2016 were included. Monitoring of safety began with ICD implant and continued up to 5 years. A meaningful difference in ICD failure rate was defined as twice (or more) the lead failure rate observed in the propensity-matched comparator patients. Among the 374 132 patients who received a new ICD implant, no safety alerts were triggered for the primary safety end point of lead failure for any of the high energy leads studied. Estimated rates of freedom from lead failure at 5 years ranged from 97.7% to 98.9% for the 4 high-energy leads of interest. CONCLUSIONS: Though limited by incomplete long-term outcomes ascertainment, active surveillance of the ICD Registry suggests that there were no meaningful differences in the rate of ICD high-energy lead survival for the 4 most commonly used high-energy ICD leads.
BACKGROUND: Several defibrillator leads have been recalled due to early lead failure leading to significant patient harm. Confirming the safety of contemporary defibrillator leads is essential to optimizing treatment for patients receiving implantable cardioverter-defibrillators (ICDs). We therefore sought to assess the comparative long-term safety of the 4 most commonly implanted ICD leads within the National Cardiovascular Data Registry ICD Registry. METHODS AND RESULTS: A propensity-matched survival analysis of the ICD Registry was performed evaluating 4 contemporary ICD leads in patients receiving an ICD system for the first time. All patients in the ICD Registry aged ≥18 years who underwent an implant of an ICD between April 1, 2011 and March 31, 2016 were included. Monitoring of safety began with ICD implant and continued up to 5 years. A meaningful difference in ICD failure rate was defined as twice (or more) the lead failure rate observed in the propensity-matched comparator patients. Among the 374 132 patients who received a new ICD implant, no safety alerts were triggered for the primary safety end point of lead failure for any of the high energy leads studied. Estimated rates of freedom from lead failure at 5 years ranged from 97.7% to 98.9% for the 4 high-energy leads of interest. CONCLUSIONS: Though limited by incomplete long-term outcomes ascertainment, active surveillance of the ICD Registry suggests that there were no meaningful differences in the rate of ICD high-energy lead survival for the 4 most commonly used high-energy ICD leads.
Authors: Robert G Hauser; William H Maisel; Paul A Friedman; Linda M Kallinen; Andrew S Mugglin; Kapil Kumar; David O Hodge; Thomas B Morrison; David L Hayes Journal: Circulation Date: 2011-01-17 Impact factor: 29.690
Authors: Frederic S Resnic; Thomas P Gross; Danica Marinac-Dabic; Nilsa Loyo-Berrios; Sharon Donnelly; Sharon-Lise T Normand; Michael E Matheny Journal: JAMA Date: 2010-11-10 Impact factor: 56.272
Authors: Amit Kumar; Michael E Matheny; Kalon K L Ho; Robert W Yeh; Thomas C Piemonte; Howard Waldman; Pinak B Shah; Richard Cope; Sharon-Lise T Normand; Sharon Donnelly; Susan Robbins; Frederic S Resnic Journal: Circ Cardiovasc Qual Outcomes Date: 2014-12-09
Authors: Michael E Matheny; David A Morrow; Lucila Ohno-Machado; Christopher P Cannon; Marc S Sabatine; Frederic S Resnic Journal: Med Decis Making Date: 2008-11-17 Impact factor: 2.583
Authors: Michael E Matheny; Sharon-Lise T Normand; Thomas P Gross; Danica Marinac-Dabic; Nilsa Loyo-Berrios; Venkatesan D Vidi; Sharon Donnelly; Frederic S Resnic Journal: BMC Med Inform Decis Mak Date: 2011-12-14 Impact factor: 2.796
Authors: Sanket S Dhruva; Shumin Zhang; Jiajing Chen; Peter A Noseworthy; Amit A Doshi; Kolade M Agboola; Jeph Herrin; Guoqian Jiang; Yue Yu; Guy Cafri; Kimberly Collison Farr; Keondae R Ervin; Joseph S Ross; Paul M Coplan; Joseph P Drozda Journal: JAMA Netw Open Date: 2022-08-01