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

JACC Cardiovasc Interv. 2025 Mar 24;18(6):752-764. doi: 10.1016/j.jcin.2024.12.006.

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.

Keywords: paravalvular regurgitation; pure native aortic regurgitation; transcatheter heart valve; transfemoral transcatheter aortic valve replacement.

Publication types

  • Multicenter Study
  • Clinical Trial

MeSH terms

  • Aged
  • Aortic Valve Insufficiency* / diagnostic imaging
  • Aortic Valve Insufficiency* / mortality
  • Aortic Valve Insufficiency* / physiopathology
  • Aortic Valve Insufficiency* / surgery
  • Aortic Valve* / diagnostic imaging
  • Aortic Valve* / physiopathology
  • Aortic Valve* / surgery
  • Balloon Valvuloplasty* / adverse effects
  • Balloon Valvuloplasty* / instrumentation
  • Balloon Valvuloplasty* / mortality
  • China
  • Female
  • Heart Valve Prosthesis*
  • Hemodynamics
  • Humans
  • Male
  • Prospective Studies
  • Prosthesis Design
  • Recovery of Function
  • Risk Factors
  • Severity of Illness Index
  • Time Factors
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Transcatheter Aortic Valve Replacement* / instrumentation
  • Transcatheter Aortic Valve Replacement* / mortality
  • Treatment Outcome