Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories
Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories
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DOI：
10.1001/jama.295.16.1907
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发表时间：
2006-04-26
影响因子：
120.7
通讯作者：
Krahn, AD
中科院分区：
文献类型：
--
作者：
Gould, PA;Krahn, AD
背景最近植入式心律转复除颤器（ICD）的故障和召回给医生带来了管理困境，特别是因为目前的管理策略没有具体的指南或数据。目的探讨ICD发生器更换的相关并发症发生率。设计与设置2004年10月至2005年10月，对加拿大17个ICD植入中心进行了调查，以评估ICD发生器更换导致的并发症发生率。结果在17个调查中心，2915例患者召回了器械，其中533例（18.3%）在初次植入后平均（SD）26.5（11.5）个月更换了咨询性ICD。在这些患者中，66%接受了二级预防ICD，45%之前接受过适当的电击。在ICD发生器更换后平均（SD）2.7（2.8）个月的随访期间，43例患者（8.1%）发生并发症。31名患者（5.8%）发生了因咨询器械更换而需要再次手术的严重并发症，2名患者因囊袋感染在取出后死亡。12例患者（2.3%）发生轻微并发症。有3个（0.1%）的手术相关的设备故障的报告，没有临床后果。结论ICD发生器更换咨询设备的患者与大量的并发症，包括死亡率。这些并发症需要在制定指南时考虑，以确定使用咨询器械的患者的适当治疗。
Context Recent implantable cardioverter-defibrillator (ICD) advisories and recalls have caused management dilemmas for physicians, particularly because there are no specific guidelines or data on outcomes from current management strategies. The risk of ICD generator replacement has not been assessed in this population.Objective To determine the complication rate associated with ICD generator replacement for the current ICD advisories.Design and Setting Seventeen ICD implanting centers in Canada were surveyed to assess complication rates as a result of generator replacements because of ICD advisories from October 2004 to October 2005.Main Outcome Measure Complications associated with elective ICD generator replacement for current device advisories.Results At the 17 surveyed centers, 2915 patients had recall devices, including 533 (18.3%) who had advisory ICDs replaced a mean (SD) of 26.5 (11.5) months after their initial implant. Of these patients, 66% had a secondary prevention ICD, and 45% had received a previous appropriate shock. During a mean (SD) of 2.7 (2.8) months' follow-up after ICD generator replacement, complications occurred in 43 patients (8.1%). Major complications attributable to advisory device replacement requiring reoperation occurred in 31 patients (5.8%), with death in 2 patients after extraction for pocket infection. Minor complications occurred in 12 patients (2.3%). There were 3 (0.1%) advisory-related device malfunctions reported, without clinical consequences.Conclusions ICD generator replacement in patients with advisory devices is associated with a substantial rate of complications, including death. These complications need to be considered in the development of guidelines determining the appropriate treatment of patients with advisory devices.