Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2016 May;13(5):1045-1051.
doi: 10.1016/j.hrthm.2015.12.046. Epub 2016 Jan 1.

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 , Laurent Fauchier  10 , Dominique Babuty  10 , Pierre Bordachar  11 , Nicolas Sadoul  12 , Serge Boveda  13 , Olivier Piot  14 ; DAI-PP Investigators  2
Affiliations
Free article
Multicenter Study

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

Maria Soledad Ascoeta et al. Heart Rhythm. 2016 May.
Free article

Abstract

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

PubMed Disclaimer

Publication types

MeSH terms