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

Maria Soledad Ascoeta (1) , Eloi Marijon (2) , Pascal Defaye (3) , Didier Klug (4) , Frankie Beganton (5) , Marie-Cécile Perier (5) , Daniel Gras (6) , Vincent Algalarrondo (7) , Jean-Claude Deharo (8) , Christophe Leclercq (9, 10) , Laurent Fauchier (11) , Dominique Babuty (11) , Pierre Bordachar (12) , Nicolas Sadoul (13) , Serge Boveda (14) , Olivier Piot (1)

1 CCN - Centre cardiologique du Nord
2 HEGP - Hôpital Européen Georges Pompidou [APHP]
3 CHU - Centre Hospitalier Universitaire [Grenoble]
4 Hôpital cardiologique
5 PARCC - UMR-S U970 - Paris-Centre de Recherche Cardiovasculaire
6 Nouvelles Cliniques Nantaises
7 Hôpital Antoine Béclère
8 Service de cardiologie
9 LTSI - Laboratoire Traitement du Signal et de l'Image
10 Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes]
11 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
12 Hôpital Haut-Lévêque
13 Service de Cardiologie [CHRU Nancy]
14 Clinique Pasteur et Groupe Rythmologie Stimulation Cardiaque/SFC

Background - 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.

Keywords: Implantable cardiac-defibrillator; Complication; Primary prevention; Mortality; Morbidity; Sudden death

Domains: Life Sciences [q-bio]

Maria Soledad Ascoeta, Eloi Marijon, Pascal Defaye, Didier Klug, Frankie Beganton, et al.. Impact of early complications on outcomes in patients with implantable cardioverter-defibrillator for primary prevention. Heart Rhythm, 2016, 13 (5), pp.1045-1051. ⟨10.1016/j.hrthm.2015.12.046⟩. ⟨hal-01272165⟩