Division of Cardiovascular Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Key Laboratory of Organ Transplantation, Ministry of Education, Wuhan, China; NHC Key Laboratory of Organ Transplantation, Ministry of Health, Wuhan, China.
Department of Medical Ultrasound, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
J Am Coll Cardiol. 2023 Aug 15;82(7):575-586. doi: 10.1016/j.jacc.2023.05.052.
To simplify surgical septal reduction therapy for hypertrophic obstructive cardiomyopathy (HOCM), we developed a novel transapical beating-heart septal myectomy (TA-BSM) procedure.
In this study, we sought to evaluate the clinical utility of TA-BSM in a first-in-human trial.
Patients with HOCM were enrolled if they presented with drug-refractory disabling symptoms. TA-BSM was performed via minithoracotomy with the use of our beating-heart myectomy device under echocardiographic guidance, without the use of cardiopulmonary bypass. Repeated resections were performed to tailor the extent of the septal myectomy for sufficient abolishment of left ventricular outflow tract (LVOT) obstruction and mitral regurgitation (MR). The primary outcome measure was procedural success, defined by resting/provoked LVOT gradient <30/50 mm Hg and residual MR grade ≤1+ (of 4+) at 3-month follow-up.
A total of 47 patients aged 12 to 77 years were enrolled. Of the 46 patients who were followed for 3 months, 42 achieved procedural success. The maximal LVOT gradient decreased from 86 mm Hg (IQR: 67-114 mm Hg) at baseline to 19 mm Hg (IQR: 14-28 mm Hg) at 3 months. MR grade was ≤1+ in 3 patients at baseline and in 45 patients at 3 months. One patient died on postoperative day 10 owing to device-unrelated reasons. Other major adverse events included 1 delayed ventricular septal perforation and 1 intraoperative left ventricular apical tear.
TA-BSM is a safe and efficient minimally invasive procedure for septal reduction of heterogeneous HOCM. Compared with conventional septal myectomy, TA-BSM provides real-time evaluation to guide resection while reducing surgical trauma. (Transapical Beating-Heart Septal Myectomy in Patients With Hypertrophic Obstructive Cardiomyopathy; NCT05332691).
为简化肥厚型梗阻性心肌病（HOCM）的外科室间隔减容治疗，我们开发了一种新的经心尖跳动心脏室间隔切除术（TA-BSM）。
在首例人体试验中，我们旨在评估 TA-BSM 的临床应用价值。
如果患者出现药物难治性致残性症状，则将其招募入组患有 HOCM。TA-BSM 通过小开胸术进行，在超声心动图引导下使用我们的跳动心脏切除术装置，无需体外循环。重复切除以定制室间隔切除术的范围，以充分消除左心室流出道（LVOT）梗阻和二尖瓣反流（MR）。主要终点是程序成功，定义为静息/激发性 LVOT 梯度<30/50mmHg 和 3 个月随访时残余 MR 分级≤1+（4 级）。
共纳入 47 名年龄在 12 至 77 岁之间的患者。在 46 名随访 3 个月的患者中，42 名达到了程序成功。最大 LVOT 梯度从基线时的 86mmHg（IQR：67-114mmHg）降至 3 个月时的 19mmHg（IQR：14-28mmHg）。基线时有 3 名患者的 MR 分级≤1+，而在 3 个月时有 45 名患者的 MR 分级≤1+。1 名患者术后第 10 天因与器械无关的原因死亡。其他主要不良事件包括 1 例迟发性室间隔穿孔和 1 例术中左心室心尖撕裂。
TA-BSM 是一种安全有效的微创术式，用于治疗异质性 HOCM 的室间隔减少。与传统的室间隔切除术相比，TA-BSM 提供了实时评估，可在减少手术创伤的同时指导切除。（经心尖跳动心脏室间隔切除术治疗肥厚型梗阻性心肌病；NCT05332691）。
