Objective: To report on the two years outcome of Chinese multi-center study of the treatment of high risk non-calcified pure aortic regurgitation with transcatheter heart valve replacement (TAVR) using domestic made J-Valve™ system. Methods: The national multi-center clinical study of the treatment of high risk non-calcified pure aortic regurgitation with transcatheter heart valve replacement using domestic made J-Valve™ system was conducted during the period from April 2014 to July 2015. The follow-up time was up to 2 years. Forty-three cases with predominant aortic valve regurgitation were enrolled for transapical implantation of the J-Valve™ system from 3 Chinese centers, including 16 patients from Zhongshan Hospital, Fudan University, 23 patients from West China Hospital, Sichuan University, and 4 patients from Fuwai Cardiovascular Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. There were 30 males and 13 females in this cohort. The age of the patients was (74±6) years (range: 61 to 84 years). The patiens were all sympotmatic preoperatively. All patients were considered at prohibitive or high risk for surgical valve replacement (Logistic European System for Cardiac Operative Risk Evaluation of (25.5±5.3)%, range: 20.0% to 44.4%) after evaluation by an interdisciplinary heart team. Comprehensive clinical and echocardiographic assessments were scheduled before discharge and at 30 days, 12 months, and 24 months after the procedure. Results: One patients was converted to surgical aortic valve replacement (SAVR) due to valve embolism into the arch. The other 42 cases had J-Valve™ systems implanted successfully. One patient died from multi-organ disorder due to paravalvular leak (PVL) during perioperative period. There was no acute myocardial infarction, stroke or coronary obstruction during the perioperative period. The median follow-up time was 725 days (range: 6 to 1 082 days). There were 5 patients died during the 2 years, follow-up, 2 patients had stroke, 2 patients had permanent pacemaker implanted. Three patients had valve related reinterventions: One for intraoperative valve embolism into the aortic arch followed by a conversion to SAVR which was mentioned above. One patient underwent SAVR on the postoperative day 6 due to moderate PVL and ventricular dysfunction. One patient underwent SAVR 6 months after primary procedure due to prosthesis thrombosis and severe aortic valve stenosis.Thirty-six patients with J-valve™ implanted survived to the latest echocardiogram follow-up, 25 patients had trivial or less PVL, 9 patients had mild PVL, and the transvalvular gradient after valve implantation was favorable at (9.8±5.8) mmHg (1 mmHg=0.133 kPa). Conclusions: Transapical implantation of domestic made J-Valve™ transcatheter heart valve system for patients with predominant aortic regurgitation has a excellent early outcome. This novel technology is safe and effective.
目的： 探讨利用国产J-Valve™行经心尖经导管主动脉瓣置换术(TAVR)治疗高危单纯无钙化主动脉瓣关闭不全的全国多中心临床研究2年结果。 方法： 收集2014年4月至2015年7月国产J-Valve™经心尖TAVR治疗高危单纯无钙化主动脉瓣关闭不全的全国多中心临床研究资料，并对2年随访结果进行分析。共纳入43例患者，来自复旦大学附属中山医院16例，四川大学华西医院23例，中国医学科学院阜外医院4例。男性30例，女性13例；年龄(74±6)岁(范围：61～86岁)。欧洲心脏手术危险评估系统评分(25.5±5.3)%(范围：20.0%～44.4%)。 结果： 1例患者术中中转外科主动脉瓣置换术(SAVR), 42例患者成功植入J-Valve™系统。围手术期死亡1例。中位随访时间725 d。术后2年内死亡5例，卒中2例，永久起搏器植入2例。3例接受与瓣膜相关的再次手术：1例为前述术中人工瓣膜移位至主动脉弓部中转SAVR；1例为术后第6天中度瓣周漏，并发生心功能不全，遂行SAVR；1例患者术后6个月时因瓣膜血栓形成导致主动脉瓣重度狭窄，行SAVR。36例存活的TAVR患者中，25例末次随访时存在轻微及以下瓣周漏，9例存在轻度瓣周漏，跨瓣压差为(9.8±5.8)mmHg(1 mmHg＝0.133 kPa)。 结论： 利用国产J-Valve™行经心尖TAVR治疗高危单纯主动脉瓣关闭不全安全、有效，早期结果满意。.
Keywords: Aortic valve insufficiency; Heart valve prosthesis implantation; Surgical procedures, minimally invasive.