NATURAL HISTORY OF PRIMARY PREVENTION ICDS: RESULTS
Transcription
NATURAL HISTORY OF PRIMARY PREVENTION ICDS: RESULTS
NATURAL HISTORY OF PRIMARY PREVENTION ICDS: RESULTS OF A FRENCH MULTI-CENTRIC REGISTRY. Serge Boveda (1), Rui Providência (1), Pascal Defaye (2), Olivier Piot (3), Cristophe Leclercq (4), Nicolas Sadoul (5), Marie Cecile Perier (6), Daniel Gras (7), Didier Klug (8), Vincent Algalarrondo (9), Pierre Bordachar (10), Dominique Babuty (11), Jean-Claude Deharo (12), Eloi Marijon (6) 1Clinique Pasteur, Toulouse, France; 2- CHU Hôpital Michallon, Grenoble, France; 3- Centre Cardiologique du Nord, Paris, France; 4- CHU Pontchaillou, Rennes, France; 5- CHU Brabois, Nancy, France; 6- Paris Cardiovascular Research Center, Paris, France; 7- Nouvelles Cliniques Nantaises, Nantes, France; 8- CHRU Lille, Lille, France; 9-Clamart University Hospital, Clamart, France; 10- CHU Haut Lévêque, Bordeaux, France; 11- CHU Trousseau, Tours, France; 12- CHU La Timone, Marseille, France Background: The indication of implantable cardioverter defibrillator (ICD) therapy for primary prevention of sudden cardiac death has been introduced later in France than in other parts of the World. We aimed to assess the risk-benefit ratio of this strategy over a 10 year period in France. Methods: Multi-centric survey evaluating all patients implanted with an ICD in the setting of primary prevention, from 2002 to 2012 in 12 centers. Both benefit from ICD (first appropriate therapy, either anti-tachycardia pacing or shock for each patient) and ICD-related morbidity (ICD-related complications, including fatal events) during follow-up were assessed through a median follow-up of 1000 days [470-1680]. Results: Of the 5,540 patients (overall 17,098 person-years) enrolled in the survey, the implanted ICD devices were: 22.9% single-chamber, 23.6% double-chamber and 53.5% CRT. Average age was 62.4±11 years (15.2% female gender; 60.3% ischemic cardiopathy). During follow-up, the proportion of patients with at least one appropriate therapy was 22.4% (median occurrence time 435 days IQR 153-956). Per-procedural complications were observed in 13.5%. Complications during follow-up occurred in 15.6% of pts (including inappropriate shock in 6.7%). Death occurred in 832 patients (15.2%), including 66 (7.9%) ICD-refractory sudden cardiac death and 14 (1.7%) ICD-related death. In addition, 3.2% of pts were transplanted. During this same period of time, 708 patients (12.8%) underwent elective replacement of the generator due to exhaustion and 164 (3.0%) were upgraded to CRT. On Cox regression, advanced age, atrial fibrillation, ischemic cardiomyopathy, higher NYHA class, low ejection fraction, per-procedural complications, and appropriate therapies were independent predictors of mortality. Conclusion: Our findings suggest that ICD therapy displayed a favorable risk-benefit profile in this large cohort of primary prevention pts, with almost one quarter of patients with at least one appropriate therapy, contra balancing with 16% of significant complications (mainly inappropriate shocks) during follow-up.