Park Yong-Hyun, Chon Min-Ku, Lederman Robert J, Sung Si-Chan, Je Hyung-Gon, Choo Ki-Seok, Lee Sang-Hyun, Shin Eun-Seok, Kim Jeong-Su, Hwang Ki-Won, Lee Soo-Yong, Chun Kook-Jin, Kim Cheol-Min, Kim June-Hong
Cardiovascular Center, Pusan National University Yangsan Hospital, Yangsan & Pusan National University, Yangsan, Korea.
Cardiovascular and pulmonary branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland.
JACC Cardiovasc Interv. 2017 Mar 27;10(6):597-610. doi: 10.1016/j.jcin.2016.12.282.
This is an early feasibility clinical test of mitral loop cerclage annuloplasty to treat secondary mitral valve regurgitation.
Secondary mitral regurgitation is characterized by cardiomyopathy, mitral annular enlargement, and leaflet traction contributing to malcoaptation. Transcatheter mitral loop cerclage applies circumferential compression to the mitral annulus by creating a loop through the coronary sinus across the interventricular septum, protecting entrapped coronary arteries from compression, and interactive annular reduction under echocardiographic guidance. This is the first human test of mitral loop annuloplasty.
Five subjects with severe symptomatic secondary mitral regurgitation underwent mitral loop cerclage, with echocardiographic and computed tomography follow-up over 6 months.
Mitral loop cerclage was successful in 4 of 5 subjects and aborted in 1 of the 5 because of unsuitable septal coronary vein anatomy. Immediately and over 6 months, measures of both mitral valve regurgitation (effective orifice area and regurgitation fraction) and chamber dimensions (left atrial and left ventricular volumes) were reduced progressively and ejection fractions increased. Two with persistent and permanent atrial fibrillation spontaneously reverted to sinus rhythm during follow-up. One subject experienced a small myocardial infarction from an unrecognized small branch coronary occlusion. Another, experiencing cardiogenic shock at baseline, died of intractable heart failure after 6 weeks.
In this first human test, mitral loop cerclage annuloplasty was successful in 4 of 5 attempts, caused reverse remodeling (reduction in secondary mitral regurgitation and heart chamber volumes), and suggested electrical remodeling (reversion of atrial fibrillation). Further evaluation is warranted.
这是一项关于二尖瓣环扎环缩术治疗继发性二尖瓣反流的早期可行性临床试验。
继发性二尖瓣反流的特征是心肌病、二尖瓣环扩大以及瓣叶牵拉导致对合不良。经导管二尖瓣环扎术通过经冠状窦穿过室间隔形成一个环，对二尖瓣环施加圆周压缩，保护被困冠状动脉免受压迫，并在超声心动图引导下进行交互式环缩。这是二尖瓣环扎环缩术的首次人体试验。
5例有严重症状的继发性二尖瓣反流患者接受了二尖瓣环扎术，并在6个月内进行了超声心动图和计算机断层扫描随访。
5例患者中有4例二尖瓣环扎术成功，1例因间隔冠状静脉解剖结构不合适而手术中止。在即刻及6个月期间，二尖瓣反流的指标（有效瓣口面积和反流分数）和心腔大小（左心房和左心室容积）均逐渐降低，射血分数增加。2例持续性和永久性心房颤动患者在随访期间自发恢复为窦性心律。1例患者因未识别的小分支冠状动脉闭塞发生小面积心肌梗死。另1例患者基线时出现心源性休克，6周后死于顽固性心力衰竭。
在这项首次人体试验中，二尖瓣环扎环缩术5次尝试中有4次成功，导致逆向重构（继发性二尖瓣反流和心腔容积减小），并提示电重构（心房颤动恢复）。有必要进行进一步评估。
