Pan Wenzhi, Chen Shasha, Li Wei, Liu Xianbao, Chen Yundai, Luo Jianfang, Guo Xiaogang, Yuan Yiqiang, Tao Ling, Wu Yanqing, Li Yan, Zhang Zhihui, Zhou Shenghua, Guo Zhifu, Jiang Xiaofei, Li Mingfei, Chen Shengda, Wang Jianan, Zhou Daxin, Ge Junbo
Department of Cardiology, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, Shanghai Institute of Cardiovascular Diseases, Shanghai, China.
Department of Echocardiography, Zhongshan Hospital, Fudan University, Shanghai, China.
JACC Cardiovasc Interv. 2025 Mar 24;18(6):752-764. doi: 10.1016/j.jcin.2024.12.006.
The application of transfemoral transcatheter aortic valve replacement (TAVR) for patients with severe pure native aortic regurgitation (PNAR) is limited by a lack of dedicated devices. The Hanchor Valve system is the first transfemoral balloon-expandable transcatheter heart valve with an anchor element designed for PNAR.
The aims of this report are to present the 30-day follow-up results of transfemoral TAVR using the Hanchor Valve system in patients with severe PNAR and to provide insights into the technical aspects of the procedure.
The HAVE AR (Multi-Center Trial of Hanchor Valve for Treating Patients With Severe Pure Native Aortic Regurgitation) trial is an ongoing, prospective, multicenter, single-arm, objective performance criteria registration study. Transfemoral TAVR using the Hanchor Valve system for treating severe PNAR was performed in patients with intermediate and high surgical risk. Procedural results and 30-day clinical and echocardiographic outcomes were collected and analyzed.
A total of 128 patients were enrolled at 13 centers in mainland China, with a median age of 74 years (Q1-Q3: 70-78 years) and a median Society of Thoracic Surgeons Predicted Risk of Mortality score of 4.84% (Q1-Q3: 4.21%-6.47%). Procedural success was achieved in 123 of 128 patients (96.09%), with a median oversizing ratio of 5.10% (Q1-Q3: 2.69%-6.83%) and a median implantation depth of 5 mm (Q1-Q3: 2-6 mm). Valve migration occurred in 3 of 128 cases, with 2 of 128 patients undergoing second valve implantation and 1 of 128 converting to surgery. Within the 30-day follow-up, 15 of 125 patients (12.00%) required new permanent pacemaker implantation, 1 of 128 patients (0.78%) experienced a major bleeding event, and 3 of 128 patients (2.34%) died. At 30-day follow-up, none of the patients had intravalvular aortic regurgitation or more than mild paravalvular regurgitation. The median effective orifice area was 2.50 cm (Q1-Q3: 2.20-2.98 cm). Significant improvements were observed in NYHA functional class (P < 0.001) and EQ-5D score (P < 0.001). Moreover, significant reductions were observed in left ventricular end-diastolic diameter (P < 0.001) and left ventricular end-systolic diameter (P < 0.001) at 30-day follow-up, while there was an increase in left ventricular ejection fraction (P = 0.007).
The early results of the HAVE AR trial showed a low incidence of adverse safety events, especially low permanent pacemaker implantation rate, and good efficacy of the Hanchor Valve system for treating patients with severe PNAR at intermediate or high surgical risk.
经股动脉经导管主动脉瓣置换术（TAVR）在严重单纯原发性主动脉瓣反流（PNAR）患者中的应用因缺乏专用设备而受到限制。Hanchor瓣膜系统是首个经股动脉球囊扩张式经导管心脏瓣膜，带有专为PNAR设计的锚定元件。
本报告旨在展示使用Hanchor瓣膜系统对严重PNAR患者进行经股动脉TAVR的30天随访结果，并深入探讨该手术的技术要点。
HAVE AR（Hanchor瓣膜治疗严重单纯原发性主动脉瓣反流患者的多中心试验）试验是一项正在进行的前瞻性、多中心、单臂、客观性能标准注册研究。对手术风险中高的患者使用Hanchor瓣膜系统进行经股动脉TAVR。收集并分析手术结果以及30天的临床和超声心动图结果。
中国大陆13个中心共纳入128例患者，中位年龄74岁（四分位间距：70 - 78岁），胸外科医师协会预测死亡率评分中位数为4.84%（四分位间距：4.21% - 6.47%）。128例患者中有123例（96.09%）手术成功，中位过大尺寸比例为5.10%（四分位间距：2.69% - 6.83%），中位植入深度为5 mm（四分位间距：2 - 6 mm）。128例中有3例发生瓣膜移位，128例中有2例接受二次瓣膜植入，128例中有1例转为手术治疗。在30天随访期内，125例患者中有15例（12.00%）需要植入新的永久起搏器，128例患者中有1例（0.78%）发生大出血事件，128例患者中有3例（2.34%）死亡。在30天随访时，所有患者均无瓣内主动脉瓣反流或超过轻度瓣周反流。中位有效瓣口面积为2.50 cm²（四分位间距：2.20 - 2.98 cm²）。纽约心脏协会（NYHA）心功能分级（P < 0.001）和EQ - 5D评分（P < 0.001）有显著改善。此外，在30天随访时，左心室舒张末期内径（P < 0.001）和左心室收缩末期内径（P < 0.001）显著减小，而左心室射血分数增加（P = 0.007）。
HAVE AR试验的早期结果显示不良安全事件发生率低，尤其是永久起搏器植入率低，且Hanchor瓣膜系统治疗手术风险中高的严重PNAR患者疗效良好。
