Department of Cardiology, St. Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands.
Catheter Cardiovasc Interv. 2021 Feb 15;97(3):488-492. doi: 10.1002/ccd.29178. Epub 2020 Aug 18.
The aim of this study is to evaluate the impact of percutaneous transluminal septal myocardial ablation (PTSMA) on remodeling in asymptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM) and severe left ventricular outflow tract (LVOT) obstruction.
Symptoms justify invasive treatment in HOCM patients with LVOT obstruction. Adverse structural and functional changes (remodeling) in the heart occur preceding heart failure and sudden cardiac death. Early invasive treatment in asymptomatic patients may reverse adverse remodeling to the same extent as in symptomatic patients.
Reverse remodeling after PTSMA in severe but asymptomatic LVOT obstruction (RASTA) study is a prospective single-blind randomized trial (ClinicalTrials.gov number: NCT04230551). Ten asymptomatic HOCM patients with an exertional LVOT gradient ≥50 mmHg (or >30 mmHg in rest) are randomized 1:1 to PTSMA versus conservative therapy, in the absence of mitral valve disease or other indications for cardiac surgery. Five symptomatic (reference group) will undergo PTSMA according to the current guidelines.
Remodeling is assessed using extensive cardiac imaging with transthoracic echocardiography and late gadolinium enhancement cardiac magnetic resonance at baseline and during follow-up at 1, 12, and 24 months. Extracellular volume fraction, global, and regional strain analysis, geometry, pressure gradients and changes in four-dimensional velocity mapping are primary parameters to study (reversal of) adverse remodeling.
The RASTA study gives insight in cardiac remodeling that may occur in asymptomatic patients after PTSMA. It will provide arguments whether to pursue (or not) a larger trial with clinical endpoints in asymptomatic HOCM patients with severe LVOT obstruction.
本研究旨在评估经皮腔内室间隔心肌消融术（PTSMA）对无症状肥厚型梗阻性心肌病（HOCM）伴严重左心室流出道（LVOT）梗阻患者重塑的影响。
LVOT 梗阻的 HOCM 患者出现症状需要进行有创治疗。心脏发生不良的结构和功能改变（重塑）早于心力衰竭和心脏性猝死。无症状患者早期进行有创治疗可能会使不良重塑得到与有症状患者相同程度的逆转。
严重但无症状的 LVOT 梗阻（RASTA）研究中的 PTSMA 后逆转重构是一项前瞻性单盲随机试验（ClinicalTrials.gov 编号：NCT04230551）。10 例静息时 LVOT 梯度≥50mmHg（或≥30mmHg 时运动后）的无症状 HOCM 患者，随机分为 PTSMA 组和保守治疗组，每组 5 例。无二尖瓣疾病或其他心脏手术指征的患者行 PTSMA。5 例有症状的患者（参照组）根据现行指南行 PTSMA。
采用经胸超声心动图和心脏磁共振钆延迟增强成像对患者进行全面的心脏影像学评估，在基线和 1、12、24 个月时进行随访，评估重构。细胞外容积分数、整体和局部应变分析、几何形状、压力梯度以及四维速度图的变化是研究（逆转）不良重构的主要参数。
RASTA 研究深入了解了无症状患者行 PTSMA 后可能发生的心脏重构。该研究为无症状伴严重 LVOT 梗阻的 HOCM 患者是否进行更大规模的临床试验以获得临床终点提供了依据。
