Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT Trial.

Defibrillation (DF) testing is recommended but carries serious risks.

推荐进行除颤（DF）测试，但其带有严重风险。

The PRAETORIAN score predicts defibrillation outcomes on the basis of chest X-ray.

PRAETORIAN评分基于胸部X光片预测除颤结果。

The PRAETORIAN-DFT (Prospective Randomized Comparative Trial of Subcutaneous Implantable Cardioverter Defibrillator Implantation With and Without Defibrillation Testing) trial evaluated whether omission of DF testing guided by the PRAETORIAN score is noninferior for first-shock efficacy.

PRAETORIAN-DFT试验（PRAETORIAN评分指导的皮下植入式心律转复除颤器植入与除颤测试的前瞻性随机比较试验）评估了在PRAETORIAN评分指导下省略除颤测试对于首次电击效果是否非劣效。

Methods

In this multinational trial, S-ICD patients from 37 centers were randomized to DF testing or no DF testing.

在这项多国试验中，来自37个中心的S-ICD患者被随机分配到DF测试组或无DF测试组。

In the No-DF testing group, the PRAETORIAN score was evaluated before discharge.

在无DF测试组中，在出院前评估了PRAETORIAN评分。

The primary end point was failed first shock for spontaneous ventricular arrhythmias, as a surrogate for defibrillation success, tested for noninferiority with a 3% absolute risk margin.

主要终点是自发性室性心律失常首次电击失败，作为除颤成功性的替代指标，以3%的绝对风险差进行非劣效性测试。

Secondary end points included mortality, potential DF testing-related complications, and S-ICD revisions.

次要终点包括死亡率、潜在的DF检测相关并发症以及S-ICD修订。

Results

The included 965 patients (No-DF testing, n=483; DF testing, n=482) were followed for a median of 41 months.

纳入的965名患者（无DF检测组，n=483；DF检测组，n=482）的中位随访时间为41个月。

Failed first shock for spontaneous ventricular arrhythmia occurred in 1.7% of the No-DF testing group versus 2.3% of the DF testing group (-0.6% [95% CI, -2.6 to 1.4], P<0.001).

在无DF检测组中，有1.7%的患者首次电击未能成功终止自发性室性心律失常，而在DF检测组中这一比例为2.3%（差异-0.6% [95% 置信区间，-2.6到1.4]，P<0.001）。

There were no significant differences in all-cause mortality (hazard ratio[HR], 0.9 [95% CI, 0.6-1.4]) or arrhythmic death (HR, 0.4 [95% CI, 0.04-3.4]).

在全因死亡率（风险比[HR]，0.9 [95% 置信区间，0.6-1.4]）或心律失常死亡率（HR，0.4 [95% 置信区间，0.04-3.4]）方面没有显著差异。

Potential DF testing-related complications occurred in 1.7% in the DF testing group.

在DF检测组中，有1.7%的患者发生了与DF检测相关的潜在并发症。

Postoperative S-ICD revisions due to inadequate positioning were identical between groups (n=2 each).

两组之间因植入位置不当导致的术后S-ICD（皮下植入型心律转复除颤器）修正手术数量相同（每组各2例）。

Conclusions

PRAETORIAN score-guided omission of DF testing after S-ICD implantation did not increase the risk of failed first shocks for spontaneous ventricular arrhythmias and reduced procedural risk without increasing S-ICD revisions.

根据PRAETORIAN评分指导，在S-ICD植入后省略了DF（除颤功能）测试，并没有增加自发性室性心律失常首次电击失败的风险，同时降低了手术风险，且没有增加S-ICD修正手术的数量。

registration

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03495297.

网址: https://www.clinicaltrials.gov; 唯一标识符: NCT03495297。