Cardiology Unit, 'Card. G. Panico' Hospital, Tricase (Le), Italy.
Europace. 2013 Apr;15(4):531-40. doi: 10.1093/europace/eus337. Epub 2013 Feb 13.
The long-term impact of implantable device-related complications on the patient outcome has not been thoroughly evaluated. The aims of this retrospective, bi-centre study were to analyse the rate and nature of device-related complications requiring surgical revision in a large series of patients undergoing device implantation, elective generator replacement and pacing system upgrade and to systematically assess the impact of such complications on patient outcome and healthcare utilization.
Data from 2671 consecutive procedures (1511 device implantations, 1034 elective generator replacements, and 126 pacing system upgrades) performed between January 2006 and March 2011 were retrospectively analysed. The outcome measures recorded were complication-related mortality, number of re-operations, need for complex surgical procedures, number of re-hospitalizations, and additional hospital treatment days. Over a median follow-up of 27 months, the overall rate of complications was 2.8% per procedure-year [9.5% in cardiac resynchronisation therapy (CRT) device implantation, 6.1% in pacing system upgrade, 3.5% in implantable cardioverter defibrillator implantation, 1.7% in pacemaker implantation, and 1.7% in generator replacement). The procedure with the highest risk of complications was CRT device implantation (odds ratio: 6.6; P < 0.001); these complications primarily involved coronary sinus lead dislodgement and device infection. Patients with complications had a significantly higher number of device-related hospitalizations (2.3 ± 0.6 vs. 1.0 ± 0.1; P < 0.001) and hospital treatment days (15.7 ± 25.1 vs. 3.6 ± 1.1; P < 0.001) than those without complications. Device infection was the complication with the greatest negative impact on patient outcome.
Cardiac resynchronisation therapy implantation was the procedure with the highest risk of complications requiring surgical revision. Complications were associated with substantial clinical consequences and a significant increase in the number and length of hospitalizations.
植入设备相关并发症对患者预后的长期影响尚未得到充分评估。本回顾性、双中心研究的目的是分析在大量接受设备植入、选择性发电机更换和起搏系统升级的患者中，需要手术修正的设备相关并发症的发生率和性质，并系统评估这些并发症对患者预后和医疗保健利用的影响。
分析了 2006 年 1 月至 2011 年 3 月期间进行的 2671 例连续手术（1511 例设备植入、1034 例选择性发电机更换和 126 例起搏系统升级）的数据。记录的结果测量包括与并发症相关的死亡率、再手术次数、需要复杂手术的次数、再住院次数和额外的住院治疗天数。在中位数为 27 个月的随访中，每例手术的并发症发生率为 2.8%/年[心脏再同步治疗（CRT）设备植入的发生率为 9.5%，起搏系统升级的发生率为 6.1%，植入式心律转复除颤器植入的发生率为 3.5%，起搏器植入的发生率为 1.7%，发电机更换的发生率为 1.7%]。并发症风险最高的手术是 CRT 设备植入（优势比：6.6；P<0.001）；这些并发症主要涉及冠状窦导联脱位和设备感染。有并发症的患者与无并发症的患者相比，设备相关住院次数（2.3±0.6 与 1.0±0.1；P<0.001）和住院治疗天数（15.7±25.1 与 3.6±1.1；P<0.001）明显更多。设备感染是对患者预后影响最大的并发症。
心脏再同步治疗植入是需要手术修正的并发症风险最高的手术。并发症与重大临床后果相关，并显著增加了住院次数和住院时间。
