Zanon Francesco, Martignani Cristian, Ammendola Ernesto, Menardi Endrj, Narducci Maria Lucia, DE Filippo Paolo, Santamaria Matteo, Campana Andrea, Stabile Giuseppe, Potenza Domenico Rosario, Pastore Gianni, Iori Matteo, LA Rosa Concetto, Biffi Mauro
Arrhythmia and Electrophysiology Unit, Cardiology Department, Santa Maria Della Misericordia Hospital, Rovigo, Italy.
Institute of Cardiology, University of Bologna, Policlinico S.Orsola-Malpighi, Bologna, Italy.
J Cardiovasc Electrophysiol. 2016 Jul;27(7):840-5. doi: 10.1111/jce.12990. Epub 2016 Jun 17.
The longevity of defibrillators (ICD) is extremely important from both a clinical and economic perspective. We studied the reasons for device replacement, the longevity of removed ICD, and the existence of possible factors associated with shorter service life.
Consecutive patients who underwent ICD replacement from March 2013 to May 2015 in 36 Italian centers were included in this analysis. Data on replaced devices were collected. A total of 953 patients were included in this analysis. In 813 (85%) patients the reason for replacement was battery depletion, while 88 (9%) devices were removed for clinical reasons and the remaining 52 because of system failure (i.e., lead or ICD generator failure or a safety advisory indication). The median service life was 5.9 years (25th-75th percentile, 4.9-6.9) for single- and dual-chamber ICD and 4.9 years (25th-75th percentile, 4.0-5.7) for CRT-D. On multivariate analysis, the factors CRT-D device, SC/DC ICD generator from Biotronik, percentage of ventricular pacing, and the occurrence of a system failure were positively associated with a replacement procedure. By contrast, the device from Boston Scientific was an independent protective factor against replacement. Considerable differences were seen in battery duration in both ICD and CRT-D. Specifically, Biotronik devices showed the shortest longevity among ICD and Boston Scientific showed the longest longevity among CRT-D (log-rank test, P < 0.001 for pairwise comparisons).
Several factors were associated with shorter service life of ICD devices: CRT-D, occurrence of system failure and percentage of ventricular pacing. Our results confirmed significant differences among manufacturers.
从临床和经济角度来看，植入式心脏除颤器（ICD）的使用寿命极为重要。我们研究了设备更换的原因、取出的ICD的使用寿命以及与较短使用寿命相关的可能因素。
本分析纳入了2013年3月至2015年5月在意大利36个中心接受ICD更换的连续患者。收集了更换设备的数据。本分析共纳入953例患者。在813例（85%）患者中，更换原因是电池耗尽，而88例（9%）设备因临床原因被取出，其余52例是由于系统故障（即导线或ICD发生器故障或安全咨询指示）。单腔和双腔ICD的中位使用寿命为5.9年（第25至75百分位数，4.9 - 6.9），心脏再同步化治疗除颤器（CRT-D）为4.9年（第25至75百分位数，4.0 - 5.7）。多因素分析显示，CRT-D设备、百多力公司的皮下/双腔ICD发生器、心室起搏百分比以及系统故障的发生与更换手术呈正相关。相比之下，美敦力公司的设备是防止更换的独立保护因素。ICD和CRT-D的电池续航时间存在显著差异。具体而言，百多力公司的设备在ICD中使用寿命最短，美敦力公司的设备在CRT-D中使用寿命最长（对数秩检验，两两比较P < 0.001）。
有几个因素与ICD设备的较短使用寿命相关：CRT-D、系统故障的发生以及心室起搏百分比。我们的结果证实了不同制造商之间存在显著差异。
