当代人群中植入式心脏复律除颤器和心脏再同步除颤器更换/升级的实际结果：来自多中心 DECODE 登记处的观察。

Real-life outcome of implantable cardioverter-defibrillator and cardiac resynchronization defibrillator replacement/upgrade in a contemporary population: observations from the multicentre DECODE registry.

机构信息

Azienda Ospedaliero-Universitaria di Bologna, Via Massarenti n. 9, Bologna, Italy.

Monaldi Hospital, Second University of Naples, Naples, Italy.

出版信息

Europace. 2019 Oct 1;21(10):1527-1536. doi: 10.1093/europace/euz166.

DOI:10.1093/europace/euz166

PMID:31209482

Abstract

AIMS

The benefit of prolonged implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) therapy following device replacement is hindered by clinical and procedure-related adverse events (AEs). Adverse events rate is highest in more complex devices and at upgrades, as per the REPLACE registry experience, but is changing owing to the improvement in device technology and medical care. We aimed at understanding the extent and type of AEs in a contemporary Italian population.

METHODS AND RESULTS

Detect long-term complications after ICD replacement (DECODE) was a prospective, single-arm, multicentre cohort study aimed at estimating medium- to long-term AEs in a large population of patients undergoing ICD/cardiac resynchronization defibrillator replacement/upgrade from 2013 to 2015. We prospectively analysed all clinical and device-related AEs at 12-month follow-up (FU) of 983 consecutive patients (median age 71 years, 76% male, 55% ischaemic, 47% CRT-D) followed for 353 ± 49 days. Seven percent of the patients died (60.6% for cardiovascular reasons), whereas 104 AEs occurred; 43 (4.4%) patients needed at least one surgical action to treat the AE. Adverse events rates were 3.3/100 years lead-related, 3.4/100 years bleedings, and 1.6/100 years infective. The primary endpoint was predicted by hospitalization in the month prior to the procedure [hazard ratio (HR) = 2.23, 1.16-4.29; 0.0169] and by upgrade (HR = 1.75, 1.02-2.99, 0.0441). One hundred and twelve (11.4%) patients met the combined endpoint of death from any cause, cardiac implantable electronic device (CIED)-related infection, and surgical action/hospitalization required to treat the AE. Hospitalization within 30 days prior to the procedure (HR = 2.07, 1.13-3.81; 0.0199), anticoagulation (HR = 1.97, 1.26-3.07; 0.003), and ischaemic cardiomyopathy (HR = 1.67, 95% confidence interval 1.06-2.63; P = 0.0276) were associated with the combined endpoint during FU.

CONCLUSIONS

Adverse events following CIED replacement/upgrade are lower than previously reported, possibly owing to improved patients care. Hospitalization in the month prior to the procedure, upgrade, and clinical profile (anticoagulation, ischaemic cardiomyopathy) hint to increased risk, suggesting an individualized planning of the procedure to minimize overall AEs.

CLINICAL TRIAL REGISTRATION

URL: http://clinicaltrials.gov/ Identifier: NCT02076789.

摘要

目的

在更换设备后，植入式心脏复律除颤器（ICD）/心脏再同步治疗除颤器（CRT-D）的延长治疗获益受到临床和程序相关不良事件（AE）的阻碍。根据 REPLACE 登记处的经验，不良事件发生率在更复杂的设备和升级时最高，但由于设备技术和医疗保健的改善，这一情况正在发生变化。我们旨在了解意大利当代人群中 AE 的程度和类型。

方法和结果

DECODE（检测 ICD 更换后的长期并发症）是一项前瞻性、单臂、多中心队列研究，旨在估计 2013 年至 2015 年期间，在接受 ICD/心脏再同步除颤器更换/升级的大量患者中，在 12 个月随访（FU）时（中位年龄 71 岁，76%为男性，55%为缺血性，47%为 CRT-D），中至长期 AE 的发生率。我们前瞻性地分析了 983 例连续患者在 353±49 天 FU 时的所有临床和器械相关 AE。7%的患者死亡（60.6%为心血管原因），发生了 104 例 AE；43 例（4.4%）患者需要至少一次手术来治疗 AE。不良事件发生率为 3.3/100 年与导联相关、3.4/100 年出血和 1.6/100 年感染。主要终点是程序前 1 个月住院（危险比[HR] = 2.23，1.16-4.29；0.0169）和升级（HR = 1.75，1.02-2.99，0.0441）预测。112 例（11.4%）患者符合任何原因死亡、心脏植入式电子设备（CIED）相关感染和治疗 AE 所需的手术/住院的联合终点。在手术前 30 天内住院（HR = 2.07，1.13-3.81；0.0199）、抗凝（HR = 1.97，1.26-3.07；0.003）和缺血性心肌病（HR = 1.67，95%置信区间 1.06-2.63；P = 0.0276）与 FU 期间的联合终点相关。