title: Impact of early complications on outcomes in patients with implantable cardioverter-defibrillator for primary prevention.
abstract: 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.
authors.affiliation: Centre Cardiologique du Nord, Saint Denis, France.
authors.forename: Maria Soledad
authors.initials: MS
authors.lastname: Ascoeta
authors.affiliation: European Georges Pompidou Hospital and Paris Descartes University, Paris, France.
authors.forename: Eloi
authors.initials: E
authors.lastname: Marijon
authors.affiliation: CHU Michallon, Grenoble, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Defaye
authors.affiliation: CHRU Lille, Lille, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Klug
authors.affiliation: Paris Cardiovascular Research Center, Inserm U(††#), Paris, France.
authors.forename: Frankie
authors.initials: F
authors.lastname: Beganton
authors.affiliation: Paris Cardiovascular Research Center, Inserm U(††#), Paris, France.
authors.forename: Marie-Cécile
authors.initials: MC
authors.lastname: Perier
authors.affiliation: Nouvelles Cliniques Nantaises, Nantes, France.
authors.forename: Daniel
authors.initials: D
authors.lastname: Gras
authors.affiliation: CHU Antoine Béclère, Clamart, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Algalarrondo
authors.affiliation: CHU La Timone, Marseille, France.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Deharo
authors.affiliation: CHU Pontchaillou, Rennes, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Leclercq
authors.affiliation: CHU Trousseau, Tours, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Fauchier
authors.affiliation: CHU Trousseau, Tours, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Babuty
authors.affiliation: CHU Haut Lévêque, Bordeaux, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Bordachar
authors.affiliation: CHU Brabois, Nancy, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Sadoul
authors.affiliation: Clinique Pasteur, Toulouse, France.
authors.forename: Serge
authors.initials: S
authors.lastname: Boveda
authors.affiliation: Centre Cardiologique du Nord, Saint Denis, France. Electronic address: o.piot@ccncardio.com.
authors.forename: Olivier
authors.initials: O
authors.lastname: Piot
authors.affiliation: European Georges Pompidou Hospital and Paris Descartes University, Paris, France.
mesh_terms: D000368:Aged; D002311:Cardiomyopathy, Dilated / Q000150:complications; D003324:Coronary Artery Disease / Q000150:complications; D016757:Death, Sudden, Cardiac / Q000209:etiology / Q000517:prevention & control; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D019544:Equipment Failure Analysis; D005260:Female; D005602:France / Q000453:epidemiology; D006406:Hematoma / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D011322:Primary Prevention / Q000379:methods / Q000706:statistics & numerical data; D012042:Registries / Q000706:statistics & numerical data; D018570:Risk Assessment; D012307:Risk Factors; D016019:Survival Analysis; D017180:Tachycardia, Ventricular / Q000209:etiology / Q000517:prevention & control*
keywords: Complication; Implantable cardiac-defibrillator; Morbidity; Mortality; Primary prevention; Sudden death