• J Cardiovasc Med (Hagerstown) · Dec 2017

    Multicenter Study

    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, Endrj Menardi, Maria L Narducci, Ernesto Ammendola, Loredana Messano, Fabrizio Giofrè, Claudia Baiocchi, Davide Saporito, Fabio Lissoni, Matteo Bertini, Attilio Pierantozzi, Gianluca Zingarini, Maurizio Malacrida, and Matteo Ziacchi.
    • aUniversity of Bologna, Policlinico S.Orsola-Malpighi, BolognabSanta Croce e Carle Hospital, CuneocCatholic University of the Sacred Heart - Institute of Cardiology, RomedSecond University of Naples, A.O. Monaldi, NapleseGiovanni Paolo II Research & Care Foundation, CampobassofHospital Papa Giovanni XXIII, BergamogSanta Maria alle Scotte Hospital, SienahInfermi Hospital, RiminiiHospital of Lodi, LodijUniversity Hospital of Ferrara, FerrarakS. Salvatore Hospital, PesarolS. Maria della Misericordia Hospital, PerugiamBoston Scientific Italia, Milan, Italy.
    • J Cardiovasc Med (Hagerstown). 2017 Dec 1; 18 (12): 968-975.

    AimsSome 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.MethodsWe 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.ResultsManufacturer 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 = 0.02). In the single-chamber/dual-chamber cohort, the only variables associated with manufacturer change were the number of available manufacturers (OR = 1.9; P < 0.0001) and an upgrade procedure (OR = 1.7; P = 0.035), whereas the center volume was associated with maintenance of the same manufacturer (OR = 0.5; P = 0.0172). In the CRT-D group, the number of available manufacturers [OR = 2.9; P < 0.0001, service life below the median value (OR = 2.5; P = 0.0026)], and physiological design (OR = 8.4; P = 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 = 6.7) of complications.ConclusionAt 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.

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