In patients with hypertrophic cardiomyopathy, obstruction of the left ventricular outflow tract can be relieved by surgical septal myectomy or alcohol septal ablation, but uncertainty remains regarding long-term results and comparative effectiveness of alcohol septal ablation. This study aims to compare short- and long-term outcomes of the 2 procedures.
Methods
Between December 1998 and September 2016, 2407 patients underwent septal myectomy and 211 patients underwent alcohol septal ablation at our institution. After 2:1 propensity score matching, the study cohort included 334 patients who underwent myectomy and 167 patients who underwent alcohol septal ablation.
Results
Median (interquartile range) ages of patients in the myectomy and alcohol septal ablation groups were 65 (58-71) years and 64 (56-73) years (P = .9), respectively. After intervention, median resting left ventricular outflow tract gradient at predischarge transthoracic echocardiography was 0 (0-10) mm Hg in the myectomy group (n = 288) and 21 (10-60) mm Hg in the alcohol septal ablation group (n = 63) (P < .001, tested at baseline gradients of 30 and 50 mm Hg). There were no differences in survival between the 2 groups (risk of death for alcohol septal ablation vs myectomy, hazard ratio, 1.5; 95% confidence interval, 0.9-2.6; P = .1). Survival of patients undergoing septal myectomy was better than that of an age-, sex-, and race-matched US population (82% vs 75% at 12 years, P = .01). Reintervention for left ventricular outflow tract obstruction was more likely to occur in patients who received alcohol septal ablation (hazard ratio, 33.3; 95% confidence interval, 4.4-250.6; P < .001).
Conclusions
There were no differences in survival of patients undergoing myectomy or alcohol septal ablation, but freedom from reintervention and early and late reduction of left ventricular outflow tract gradient are superior in patients undergoing septal myectomy. 相似文献
Introduction: The number of grown-up congenital heart disease (GUCH) patients is steadily increasing. Unfortunately, the majority of these patients suffer from late sequelae, with heart failure being the most common cause of death. Exercise training is beneficial and safe in patients with acquired heart failure, as well as in asymptomatic GUCH patients. However, its effect remains unknown in symptomatic GUCH patients. This could cause reticence on positive sports advice, with possible counterproductive effects.
Areas covered: A review of current literature was performed to evaluate the effect of exercise training in symptomatic (NYHA≥2) GUCH patients. The search yielded a mere three studies including symptomatic patients, and another six studies including also patients in NYHA 1 without making clear distinction between the NYHA subgroups.
Expert commentary: Suboptimal trial designs, low patient numbers, and homogeneity of investigated cardiac anomalies make this review insufficient to draw definite conclusions. However, all studies describe overall positive effects of exercise training in symptomatic GUCH patients in terms of exercise capacity and quality of life. There were no safety concerns. Larger-scaled, randomized controlled trials are needed to obtain certainty. 相似文献
Cardiac resynchronization therapy (CRT) devices have been studied clinically since 1998, and have been on the U.S. market since the Food and Drug Administration (FDA) approval of the first product in 2001. Since that time, the FDA has approved many different models from three different manufacturers, representing the first and second generations of these products. All of these products have undergone the FDA pre-market approval process, which examines the safety and effectiveness of the devices for their intended use. Over the last several years, the FDA has adapted recommendations for CRT clinical trials based on an evolving understanding of what these devices can achieve. This paper will outline the dynamic nature of the FDA's approval process for CRT devices and briefly review the clinical trial designs for the first generation devices. 相似文献