First-in-Human Transapical Beating-Heart Septal Myectomy in Patients with Hypertrophic Obstructive Cardiomyopathy
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AbstractBACKGROUND To simplify surgical septal reduction therapy for hypertrophic obstructive cardiomyopathy (HOCM), we developed a novel transapical beating-heart septal myectomy (TA-BSM) procedure.
OBJECTIVES In this study, we sought to evaluate the clinical utility of TA-BSM in a first-in-human trial.
METHODS 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 #1þ (of 4þ) at 3-month follow-up.
RESULTS 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 #1þ 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.
CONCLUSIONS 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)
OBJECTIVES In this study, we sought to evaluate the clinical utility of TA-BSM in a first-in-human trial.
METHODS 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 #1þ (of 4þ) at 3-month follow-up.
RESULTS 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 #1þ 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.
CONCLUSIONS 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)
Acceptance Date15/05/2023
All Author(s) ListJing Fang, Yani Liu, Ying Zhu, Rui Li, Rui Wang, Dao Wen Wang, Yunhu Song, Chenhe Li, Yue Chen, Lin Cheng, Kangchao Zheng, Yun Zhao, Shiliang Li, Cai Cheng, Liming Xia, Xiaoping Chen, Song Wan, Xiang Wei
Journal nameJournal of the American College of Cardiology
Year2023
Month8
Volume Number82
Issue Number7
PublisherElsevier
Place of PublicationUSA
Pages575 - 586
ISSN0735-1097
eISSN1558-3597
LanguagesEnglish-United States
KeywordsHypertrophic obstructive cardiomyopathy, left ventricular outflow tract obstruction, mitral regurgitation, septal myectomy, systolic anterior motion.
