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.