Manufacturer change and risk of system-related complications after implantable cardioverter defibrillator replacement: physicians’ survey and data from the Detect Long-term Complications After Implantable Cardioverter Defibrillator Replacement Registry Mauro Biffi a , Endrj Menardi b , Maria L. Narducci c , Ernesto Ammendola d , Loredana Messano e , Fabrizio Giofre ` f , Claudia Baiocchi g , Davide Saporito h , Fabio Lissoni i , Matteo Bertini j , Attilio Pierantozzi k , Gianluca Zingarini l , Maurizio Malacrida m and Matteo Ziacchi a Aims Some barriers seem to exist in changing implantable cardioverter defibrillator (ICD) manufacturer at the time of device replacement. We sought to understand the obstacles to changing ICD manufacturer within the cohort of patients enrolled in the Detect Long-term Complications After ICD Replacement Registry. Methods We analyzed 784 consecutive ICD/cardiac resynchronization therapy defibrillator (CRT-D) device replacements within a 1.5-year time-frame in 36 Italian centers to evaluate potential factors associated with changing manufacturers and system-related complications. Results Manufacturer change occurred in 191 patients (24%): 72/211 single-chamber ICDs (34%), 52/210 dual- chamber ICDs (25%) and 67/363 CRT-D (18%, P < 0.0001 vs. single-chamber). Replacement-only procedures were associated with a lower rate of manufacturer change than upgrading procedures (23 vs. 32%, P U 0.02). In the single- chamber/dual-chamber cohort, the only variables associated with manufacturer change were the number of available manufacturers (OR U 1.9; P < 0.0001) and an upgrade procedure (OR U 1.7; P U 0.035), whereas the center volume was associated with maintenance of the same manufacturer (OR U 0.5; P U 0.0172). In the CRT-D group, the number of available manufacturers [OR U 2.9; P < 0.0001, service life below the median value (OR U 2.5; P U 0.0026)], and physiological design (OR U 8.4; P U 0.0048) were associated with manufacturer change. At 6-month follow-up, 17 patients (2.2%) experienced a system complication that was lead-related in all cases; upgrade procedure was the only predictor (hazard ratio U 6.7) of complications. Conclusion At the time of ICD replacement, a manufacturer change occurred in 24% of patients and it was less likely in CRT-D devices, which are equipped with more specific technology and less frequently require the addition of features. System-related complications are strongly associated to upgrade procedures rather than to manufacturer change. J Cardiovasc Med 2017, 18:968–975 Keywords: device replacement, implantable cardioverter defibrillator, lead- related complications, physicians preference, system interchangeability a University of Bologna, Policlinico S.Orsola-Malpighi, Bologna, b Santa Croce e Carle Hospital, Cuneo, c Catholic University of the Sacred Heart – Institute of Cardiology, Rome, d Second University of Naples, A.O. Monaldi, Naples, e Giovanni Paolo II Research & Care Foundation, Campobasso, f Hospital Papa Giovanni XXIII, Bergamo, g Santa Maria alle Scotte Hospital, Siena, h Infermi Hospital, Rimini, i Hospital of Lodi, Lodi, j University Hospital of Ferrara, Ferrara, k S. Salvatore Hospital, Pesaro, l S. Maria della Misericordia Hospital, Perugia and m Boston Scientific Italia, Milan, Italy Correspondence to Mauro Biffi, MD, Department of Experimental, Institute of Cardiology, Diagnostic and Specialty Medicine, University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n. 9, 40138 Bologna, Italy Tel: +39 051349858; fax: +39 051344859; e-mail: mauro.biffi@aosp.bo.it Received 9 June 2017 Revised 11 August 2017 Accepted 25 August 2017 Introduction Implantable cardioverter defibrillator (ICD) therapy is a broadly accepted treatment for the prevention of sudden cardiac death. 1 Owing to continued technological improvements, ICDs can treat cardiac rhythm diseases and heart failure. At the time of device replacement or system upgrade, device and lead choice becomes part of a complex process that requires familiarity with device features and a tailored strategy to minimize long-term risks. 2–6 In this context, the best choice for each specific patient must enable optimization of device performance to achieve maximal clinical effectiveness and minimiza- tion of procedure-related complications. Both stem from an individually tailored selection process that evaluates all the technologies from the available manufacturers. Although the interchangeability of ICD and cardiac resynchronization therapy defibrillator (CRT-D) systems is ensured by established and codified specifications, Original article 1558-2027 ß 2017 Italian Federation of Cardiology. All rights reserved. DOI:10.2459/JCM.0000000000000572 © 2017 Italian Federation of Cardiology. All rights reserved.