目的:先前的一项随机研究表明,皮下植入式心脏复律除颤器(S-ICD)在器械相关并发症和不适当电击方面不劣于经静脉ICD。然而,这是在广泛采用脉冲发生器植入肌间(IM)空间而不是传统的皮下(SC)口袋之前进行的。该分析的目的是比较与SC袋相比,接受S-ICD植入且发生器位于IM位置的患者与装置相关并发症和不适当电击的存活率。
结果:我们分析了2013年至2021年接受S-ICD植入的1577例连续患者,随访至2021年12月。皮下患者(n=290)与IM组患者(n=290)的倾向相匹配,并对其结果进行了比较。:在28个月的中位随访期间,28例(4.8%)患者报告了器械相关并发症,37例(6.4%)患者报告了不适当电击.匹配IM组的并发症风险低于SC组[风险比0.41,95%置信区间(CI)0.17-0.99,P=0.041],以及并发症和不适当电击的复合(风险比0.50,95%CI0.30-0.86,P=0.013)。适当电击的风险在组间相似(风险比0.90,95%CI0.50-1.61,P=0.721)。发电机定位与性别、年龄,身体质量指数,和射血分数。
结论:我们的数据显示了IMS-ICD发生器定位在减少与设备相关的并发症和不适当的电击方面的优越性。
背景:临床试验注册:ClinicalTrials.gov;NCT02275637。
A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket.
We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17-0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30-0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50-1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction.
Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks.
Clinical Trial Registration: ClinicalTrials.gov; NCT02275637.