Ascoeta Maria Soledad, Marijon Eloi, Defaye Pascal, Klug Didier, Beganton Frankie, Perier Marie-Cécile, Gras Daniel, Algalarrondo Vincent, Deharo Jean-Claude, Leclercq Christophe, Fauchier Laurent, Babuty Dominique, Bordachar Pierre, Sadoul Nicolas, Boveda Serge, Piot Olivier
Centre Cardiologique du Nord, Saint Denis, France.
European Georges Pompidou Hospital and Paris Descartes University, Paris, France.
Heart Rhythm. 2016 May;13(5):1045-1051. doi: 10.1016/j.hrthm.2015.12.046. Epub 2016 Jan 1.
The lifesaving benefit of implantable cardioverter-defibrillators (ICDs) has been demonstrated. Their use has increased considerably in the past decade, but related complications have become a major concern.
The purpose of this study was to assess the incidence and effect on outcomes of early (≤30 days) complications after ICD implantation for primary prevention in a large French population.
We analyzed data from 5539 patients from the multicenter French DAI-PP (Défibrillateur Automatique Implantable-Prévention Primaire) registry (2002-2012) who had coronary artery disease or dilated cardiomyopathy and were implanted with an ICD for primary prevention.
Overall, early complications occurred in 707 patients (13.5%), mainly related to lead dislodgment or hematoma (57%). Independent factors associated with occurrence of early complications were severe renal impairment (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.17-2.37, P = .02), age ≥75 years (OR 1.01, 95% CI 1.00-1.02, P = .03), cardiac resynchronization therapy (OR 1.58, 95% CI 1.16-2.17, P = .01), and anticoagulant therapy (OR 1.28, 95% CI 1.02-1.61, P = .03). During a mean ± SD follow-up of 3.1 ± 2.3 years, 824 (15.8%) patients experienced ≥1 late complication (>30 days), and 782 (14.9%) patients died. After adjustment, early complications remained associated with occurrence of late complications (OR 2.15, 95% CI 1.73-2.66, P < .0001) and mortality (OR 1.70, 95% CI 1.34-2.17, P = .003).
Early complications are common after ICD implantation for primary prevention, occurring in 1 in 7 patients, and are associated with an increased risk of late complications and overall mortality. Further studies are needed to investigate the underlying mechanisms of such associations.
植入式心脏复律除颤器（ICD）的挽救生命益处已得到证实。在过去十年中其使用量大幅增加，但相关并发症已成为主要关注点。
本研究的目的是评估在一大群法国人群中，ICD植入用于一级预防后早期（≤30天）并发症的发生率及其对预后的影响。
我们分析了来自法国多中心DAI-PP（植入式自动除颤器-一级预防）注册研究（2002 - 2012年）的5539例患者的数据，这些患者患有冠状动脉疾病或扩张型心肌病，并植入ICD用于一级预防。
总体而言，707例患者（13.5%）发生了早期并发症，主要与导线脱位或血肿有关（57%）。与早期并发症发生相关的独立因素包括严重肾功能损害（比值比[OR]1.66，95%置信区间[CI]1.17 - 2.37，P = .02）、年龄≥75岁（OR 1.01，95% CI 1.00 - 1.02，P = .03）、心脏再同步治疗（OR 1.58，95% CI 1.16 - 2.17，P = .01）以及抗凝治疗（OR 1.28，95% CI 1.02 - 1.61，P = .03）。在平均±标准差为3.1±2.3年的随访期间，824例（15.8%）患者发生了≥1次晚期并发症（>30天），782例（14.9%）患者死亡。调整后，早期并发症仍与晚期并发症的发生（OR 2.15，95% CI 1.73 - 2.66，P < .0001）和死亡率（OR 1.70，95% CI 1.34 - 2.17，P = .003）相关。
ICD植入用于一级预防后早期并发症很常见，7例患者中就有1例发生，且与晚期并发症风险增加和总体死亡率相关。需要进一步研究来探究此类关联的潜在机制。
