Long-term effects of varying alcohol dosing in percutaneous septal ablation for obstructive hypertrophic cardiomyopathy: a randomized study with a follow-up up to 11 years.

BACKGROUND: Highly symptomatic patients with obstructive hypertrophic cardiomyopathy (HCM) are candidates for alcohol septal ablation (ASA). We wanted to determine long-term (>60 months) clinical and echocardiographic outcomes of patients treated with low (1-2 mL) or high (>2 mL) doses of alcohol.
METHODS: Seventy-six patients were randomized into 2 arms in a 1:1 ratio, and subsequently were treated by ASA with a low (1-2 mL) or high (>2 mL) dose of alcohol. Clinical and echocardiographic examinations were performed at baseline, 1 year after the procedure, and at the end of follow-up (at least 60 months after ASA).
RESULTS: Both groups of patients matched in all baseline clinical and echocardiographic data. In a total of 76 patients, 86 septal branches were ablated in 80 ASA procedures (2 repeat procedures in each group). There were no differences in postprocedural complications. Seven patients (4 vs 3 patients; not significant) died during follow-up (60-138 months; median 85 months). Pressure gradients decreased significantly in both groups (from 74±36 to 24±32 mm Hg in the low-dose group and from 74±39 mm Hg to 18±20 mm Hg in the high-dose group). There were no significant differences between the groups, and all main hemodynamic and echocardiographic changes occurred in the first postprocedural year. At final examination, there were no patients with New York Heart Association class>2 dyspnea in either group.
CONCLUSIONS: This study demonstrates that ASA for obstructive hypertrophic cardiomyopathy is safe and effective in long-term follow-up. No differences in long-term efficacy and safety were found between low and high doses of alcohol.

RCT Entities:   Population Interventions Outcomes