制造商变更与植入式心律转复除颤器更换后系统相关并发症风险：来自植入式心律转复除颤器更换后长期并发症检测登记研究的医生调查和数据。

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.

机构信息

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.

出版信息

J Cardiovasc Med (Hagerstown). 2017 Dec;18(12):968-975. doi: 10.2459/JCM.0000000000000572.

DOI:10.2459/JCM.0000000000000572

PMID:29028784

Abstract

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 = 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.

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.

摘要

目的

在更换设备时，似乎存在一些将植入式心脏复律除颤器（ICD）制造商更换的障碍。我们试图了解在接受植入式心脏复律除颤器更换后长期并发症检测登记处登记的患者队列中更换 ICD 制造商的障碍。

方法

我们分析了 36 家意大利中心在 1.5 年内进行的 784 例连续 ICD/心脏再同步治疗除颤器（CRT-D）设备更换，以评估与更换制造商和系统相关并发症相关的潜在因素。

结果

191 名患者（24%）更换了制造商：211 例单腔 ICD 中有 72 例（34%），210 例双腔 ICD 中有 52 例（25%），363 例 CRT-D 中有 67 例（18%，P<0.0001 对比单腔）。仅更换程序与制造商变更率较低，而升级程序较高（23%对 32%，P=0.02）。在单腔/双腔队列中，唯一与制造商变更相关的变量是可用制造商数量（OR=1.9；P<0.0001）和升级程序（OR=1.7；P=0.035），而中心容量与维持相同制造商相关（OR=0.5；P=0.0172）。在 CRT-D 组中，可用制造商数量[OR=2.9；P<0.0001，使用寿命低于中位数（OR=2.5；P=0.0026）]和生理设计（OR=8.4；P=0.0048）与制造商变更相关。在 6 个月随访时，17 名患者（2.2%）经历了与系统相关的并发症，所有病例均与导联有关；升级程序是并发症的唯一预测因素（风险比=6.7）。