Impact of early complications on outcomes in patients with implantable cardioverter-defibrillator for primary prevention

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• 作者：Maria Soledad Ascoeta ; MD^* ; Eloi Marijon ; MD ; PhD^&dagger ; ; Pascal Defaye ; MD^&Dagger ; ; Didier Klug ; MD ; PhD^§ ; ; Frankie Beganton ; MS^¶ ; ; Marie-Cé ; cile Perier ; MPH^¶ ; ; Daniel Gras ; MD^║ ; Vincent Algalarrondo ; MD ; PhD^# ; Jean-Claude Deharo ; MD ; PhD^** ; Christophe Leclercq ; MD ; PhD^&dagger ; &dagger ; ; Laurent Fauchier ; MD ; PhD^&Dagger ; &Dagger ; ; Dominique Babuty ; MD ; PhD^&Dagger ; &Dagger ; ; Pierre Bordachar ; MD ; PhD^§ ; § ; ; Nicolas Sadoul ; MD ; PhD^¶ ; ¶ ; ; Serge Boveda ; MD^║║ ; Olivier Piot ; MD^* ; ^{o.piot@ccncardio.com" class="auth_mail" title="E-mail the corresponding author} ; on behalf of the DAI-PP Investigators^&dagger ;
• 关键词：Implantable cardiac-defibrillator ; Complication ; Primary prevention ; Mortality ; Morbidity ; Sudden death
• 刊名：Heart Rhythm
• 出版年：2016
• 出版时间：May 2016
• 年：2016
• 卷：13
• 期：5
• 页码：1045-1051
• 全文大小：397 K

文摘

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.

Objective

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.

Methods

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.

Results

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).

Conclusion

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.