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There are no prospective randomized trials in the world comparing the long-term results of surgical myoectomy and alcohol septal ablation. We present a pilot single-center, prospective, randomized study comparing the efficacy and safety of treatment of patients with HOCM. We evaluated the results of treatment of 76 patients with obstructive form of HOCM. Before the intervention, patients were randomized into two equal groups (n = 38). All patients in pre- and postoperative period were assesed for clinical status, including transthoracic ECG and contrast MRI.
The primary, composite endpoint was safety including complications in the long-term postoperative 12-month follow-up (mortality, stroke, ventricular tachycardia / ventricular fibrillation, relapse of the left ventricular outflow obstruction requiring reintervention), pacemaker / cardioverter-defibrillator implantation frequency. Secondary endpoints were: a decrease in the pressure gradient (efficacy), clinically indicated reintervention and clinical and functional status.
According to the results of the study, after 12 months 5(13%) of patients in the myoectomy group and 18 (47%) in the ASA group reached the primary endpoint (p = 0.0021; log test, OR 4.11; 95% CI 1.52-11.1, p = 0.005, Cox regression analysis). The main complications in both groups were rhythm abnormalities that required the implantation of an ICD / ECS (log-rank test, p = 0.0029; regression analysis of Cox: RR 4.92; 95% CI 1.06-22.74; p = 0.042). The pressure gradient in the left ventricular outlet before treatment was 90.04 ± 18.83 mm Hg in the ASA group and 80.9 ± 13.2 mm Hg in the myoectomy group, p = 0.2. In both groups, a decrease in the pressure gradient in the left ventricular outlet was significant by 89.23% (p <0.001) in the myoectomy group and by 60.4% (p <0.001) in the ASA group. It is also important to note that the average residual pressure gradient in the long-term postoperative period in the alcohol reduction group was not only higher (35.65 ± 21.22 mm Hg) than in the septal myoectomy group (10.24 ± 2, 37 mm Hg), p <0.001, but also slightly above the upper limit of the norm. Groups were comparable according to baseline clinical and functional characteristics.
This study showed comparable results of treatment with ASA and surgical myoectomy in the long-term postoperative period. Nevertheless, the number of cardiac arrhythmias requiring pacemaker implantation or a cardioverter defibrillator was significantly higher in the ASA group. Due to the small number of patients in the groups and the combined primary endpoint, it is safe to speak of the need for larger, multicenter studies.
STRUCTURAL: Alcohol Septal Ablation/HOCM