Inappropriate Shocks From Subcutaneous vs Transvenous Implantable Cardioverter-Defibrillators: Individual Participant Data Meta-Analysis of Randomized Trials.

However, they were not individually powered to assess differences in inappropriate shock.

然而，这些试验没有足够的统计能力单独评估不适当电击的差异。

The aims of this study were to compare the rates of a first inappropriate shock between subcutaneous and transvenous ICDs and to explore the underlying causes.

本研究旨在比较皮下和经静脉植入型心律转复除颤器（ICDs）首次不适当电击的发生率，并探究其潜在原因。

Methods

An individual participant data meta-analysisof PRAETORIAN and ATLAS was performed, using Cox regression models stratified by trial. The primary endpoint was time to first inappropriate shock.

对PRAETORIAN和ATLAS研究进行了个体参与者数据的荟萃分析，使用按试验分层的Cox回归模型。主要终点是首次不适当电击的时间。

Results

The pooled modified intention-to-treatpopulation included 1,342 patients (median age 58 years, 21.8% women, 77.7% with primary prevention indications) who had been randomized to subcutaneous or transvenous ICDs.

综合改良意向治疗人群包括了1,342名患者（中位年龄58岁，女性占21.8%，77.7%的患者为一级预防指征），这些患者被随机分配到皮下或经静脉植入式心律转复除颤器（ICDs）。

A proprietary algorithm aimed at reducing inappropriate shock was activated at baseline or at some point during follow-up in 77.1% of patients with subcutaneous ICDs.

在77.1%的皮下ICD患者中，旨在减少不适当电击的专有算法在基线或随访期间的某个时间点被激活。

During a median follow-up period of 3.5 years, a first inappropriate shock occurred more frequently in patients randomized to subcutaneous compared with transvenous ICDs (2.5 vs 1.5 per 100 patient-years; HR: 1.61; 95% CI: 1.06-2.45; P = 0.03).

在中位随访期为3.5年的情况下，与经静脉植入式心律转复除颤器（ICD）相比，皮下植入式ICD患者首次不适当电击的发生率更高（每100患者年2.5次对比1.5次；风险比[HR]：1.61；95%置信区间[CI]：1.06-2.45；P = 0.03）。

Patients with subcutaneous ICDs had a higher hazard of first inappropriate shock due to cardiac oversensing (HR: 15.07; 95% CI: 3.60-63.15; P < 0.001) and electromagnetic interference or myopotentials (HR: 8.19; 95% CI: 1.88-35.64; P = 0.005) but a lower hazard of first inappropriate shock due to atrial arrhythmia (HR: 0.37; 95% CI: 0.19-0.71; P = 0.003).

皮下植入式ICD患者因心脏过度感知导致首次不适当电击的风险更高（HR：15.07；95% CI：3.60-63.15；P < 0.001），因电磁干扰或肌电干扰导致首次不适当电击的风险也更高（HR：8.19；95% CI：1.88-35.64；P = 0.005），但因房性心律失常导致首次不适当电击的风险较低（HR：0.37；95% CI：0.19-0.71；P = 0.003）。

Conclusions

Although first inappropriate shocks were infrequent overall, they were more common with subcutaneous ICDs.

尽管总体上首次不适当电击的发生率较低，但与皮下植入式心脏复律除颤器（ICDs）相关的首次不适当电击更为常见。

First inappropriate shocks due to cardiac oversensing and electromagnetic interference were more common with subcutaneous ICDs, while first shocks due to atrial arrhythmia were more common with transvenous ICDs.

由于心脏过感知和电磁干扰导致的首次不适当电击在皮下ICDs中更为常见，而由于房性心律失常导致的首次电击在经静脉ICDs中更为常见。