The Pioneer Valve achieved a technical success rate of 99.1% in 110 patients with severe pure aortic regurgitation and maintained stable hemodynamic performance at 30 days.
Does a novel self-expanding transfemoral TAVR device (Pioneer Valve) provide safe and effective treatment for high-risk patients with severe pure native aortic regurgitation?
The Pioneer Valve system demonstrated 99.1% technical success and stable 30-day hemodynamics, offering a viable TAVR option for high-risk patients with severe pure native aortic regurgitation.
Absolute Event Rate: 0% vs 0%
BACKGROUND: Patients with severe aortic regurgitation (AR) frequently face high surgical risks, rendering them ineligible for surgery. Transcatheter aortic valve replacement (TAVR) is now a primary therapy for aortic valve stenosis. However, its application in pure native AR has been relatively limited. OBJECTIVES: The aim of this study was to evaluate the mid-term efficacy and safety of a novel self-expanding transfemoral TAVR device designed for treating pure native AR. METHODS: A prospective, single-arm clinical trial (ChiCTR2300075152) enrolled 110 consecutive patients with severe pure AR from 15 centers. The Pioneer Valve system with a rotatable feature and 3 independently angle-adjustable locators was used. Outcomes up to 1-year follow-up were reported per Valve Academic Research Consortium 3 criteria. The median clinical follow-up duration was 348 days (Q1-Q3: 342-357 days). RESULTS: The mean age was 73.37 ± 4.21 years, with a median Society of Thoracic Surgeons score of 5.97% (Q1-Q3: 4.04%-8.63%). Technical success was achieved in 109 of 110 cases (99.1%), and valve migration occurred in 1 case. Mean aortic valve gradient and mean effective orifice area at 30 days were 7.88 ± 2.7 mm Hg and 2.2 ± 0.64 cm CONCLUSIONS: This study demonstrates that the Pioneer Valve provides a safe and effective alternative for high-risk or inoperable patients with severe pure AR, achieving favorable mid-term outcomes with stable hemodynamic performance.
Xiao et al. (Mon,) reported a other. The Pioneer Valve achieved a technical success rate of 99.1% in 110 patients with severe pure aortic regurgitation and maintained stable hemodynamic performance at 30 days.
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