A Latin American registry of implantable cardioverter defibrillators: the ICD-LABOR study.

OBJECTIVE: Despite the progress that has been reached in emergency medical systems and resuscitation, sudden cardiac death (SCD) continues to be the major cause of the death, and remains a significant public health problem. In this publication we are reporting our Latin American experience in the secondary prevention of SCD, by means of an ongoing registry involving seven Latin American countries and 770 patients.
METHODS: Every individual within the present registry to date has presented with antecedents of aborted sudden death or cardiac arrest due to ventricular tachycardia or ventricular fibrillation. Patients included have fulfilled the Class I indication for implantable cardioverter defibrillator (ICD) and they were implanted with a Biotronik ICD (all models). The study was not sponsored by Biotronik, nor did they have access to the data. A specific protocol was designed for implantation and follow-up of patients. The database was completely registered through the Internet and a personal password was assigned to each group of investigators. The primary end point was death from all causes. Secondary end points were SCD and death due to congestive heart failure (CHF).
RESULTS: The etiology of cardiac disease was found to be predominantly coronary artery disease (CAD) 39.7% (306 patients), followed by Chagas disease (ChD), 26.1% (201 patients), and idiopathic dilated cardiomyopathy (DCM), 17% (131 patients). Any remaining pathologies were included as miscellaneous 13.2% (101 patients). In 31 patients (4%) the etiology was unknown. The age did not differ within the principal pathologies, but was significantly older than the miscellaneous group (62.0 +/- 11.3 years vs 48.2 +/- 18.9 years, P < 0.0001). The follow-up period was 27 +/- 25 months (1-113 months) for the whole group. The mortality in functional classes I-II was significantly lower than mortality for functional classes III-IV (relative risk 1.46, CI 95%, P < 0.0001). Mean left ventricular ejection fraction (LVEF) for the whole group was 37.7 +/- 14.3%. Male LVEF was 36.1 +/- 14.1% and female LVEF was 42.2 +/- 13.8% P < 0.0001. During the follow-up period, 130 deaths were reported (global mortality 16.9 +/- 9.7%), out of which 84 (64.6%) were attributed to cardiac causes (10.9 +/- 5.1% of the total population). The annual adjusted cardiac mortality was 5.2 +/- 1.72% (range 3.5-7.0%). Among cardiac deaths the most common cause was progressive heart failure, 48 patients (57%) including 3 patients with pulmonary embolism. The second main cause of cardiac death was SCD, 36 patients (43%), including 4 patients with electrical storm and 3 patients with electromechanical dissociation after multiple shock therapy treatments.
CONCLUSIONS: Despite the differences in terms of pathologies between the ICD-LABOR (Latin American bioelectronic ongoing registry) and randomized ICD trials, a parallel evolution in all cause mortality and cardiac mortality was observed. Independent risk factors for mortality included age >70 years, male gender, NYHA III/IV, and ejection fraction <0.30. The etiology of heart disease (Chagas vs Coronary Disease) was not found to be a risk factor.