Early Results of Multicenter Trial of a Novel Balloon-Expandable Valve With Anchor for Aortic Regurgitation

IF 11.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions Pub Date : 2025-03-24 DOI:10.1016/j.jcin.2024.12.006

Wenzhi Pan MD , Shasha Chen MD , Wei Li MD , Xianbao Liu MD , Yundai Chen MD , Jianfang Luo MD , Xiaogang Guo MD , Yiqiang Yuan MD , Ling Tao MD , Yanqing Wu MD , Yan Li MD , Zhihui Zhang MD , Shenghua Zhou MD , Zhifu Guo MD , Xiaofei Jiang MD , Mingfei Li MD , Shengda Chen PhD , Jianan Wang MD, PhD , Daxin Zhou MD , Junbo Ge MD, PhD

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引用次数: 0

Abstract

Background

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.

Objectives

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.

Methods

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.

Results

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 cm² (Q1-Q3: 2.20-2.98 cm²). 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).

Conclusions

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.

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来源期刊

JACC. Cardiovascular interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

11.60

自引率

8.80%

发文量

756

审稿时长

4-8 weeks

期刊介绍： JACC: Cardiovascular Interventions is a specialist journal launched by the Journal of the American College of Cardiology (JACC). It covers the entire field of interventional cardiovascular medicine, including cardiac, peripheral, and cerebrovascular interventions. The journal publishes studies that will impact the practice of interventional cardiovascular medicine, including clinical trials, experimental studies, and in-depth discussions by respected experts. To enhance visual understanding, the journal is published both in print and electronically, utilizing the latest technologies.