Key result
VitaFlow TAVR is linked to ~29% higher procedural success versus VenusA-Valve in severe aortic regurgitation.
Why the study?
The procedural success rate of transfemoral TAVR with self-expanding valves in patients with pure native aortic regurgitation is low, and the relationship between preprocedural CT anatomy, valve type, and success rate is unknown.
Does the use of a non-A-shaped self-expanding valve (VitaFlow) compared to an A-shaped valve (VenusA-Valve) improve procedural success in patients with severe pure native aortic regurgitation undergoing transfemoral TAVR?
Observational (n=77)
No
Does the use of a non-A-shaped self-expanding valve (VitaFlow) compared to an A-shaped valve (VenusA-Valve) improve procedural success in patients with severe pure native aortic regurgitation undergoing transfemoral TAVR?
Absolute Event Rate: 93.3% vs 72.3%
p-value: p=0.048
In patients with severe pure native aortic regurgitation, transfemoral TAVR using a non-A-shaped self-expanding valve (VitaFlow) resulted in a higher procedural success rate compared to an A-shaped valve (VenusA-Valve), and success was associated with smaller aortic root dimensions and leaflet thickening.
May support non-A-shaped valves for higher success in pure AR TAVR; leaves open randomized confirmation of design effects.
Background: The rate of procedural success of transfemoral transcatheter aortic valve replacement (TAVR) with self-expanding valves in patients with pure native aortic regurgitation (PNAR) is quite low. Which anatomy evaluated by computed tomography (CT) as well as which kind of self-expanding valve is associated with higher success rate remain unknown. The aims of this study were to evaluate the relationship between preprocedural CT indexes and procedural success rate and to compare the procedural success rates between 2 kinds of self-expanding valves with different shaped frameworks. Methods: This was a retrospective comparative study. The study enrolled the symptomatic patients with severe PNAR, who were treated by transfemoral TAVR using a VenusA-Valve (Venus Medtech, Hangzhou, China) or a VitaFlow valve (Microport, Shanghai, China) at Zhongshan Hospital, Fudan University from October 2018 to December 2020. The procedural success rate (VARC-2 standard) was recorded. Preprocedural CT data were collected, including the perimeters of the aortic annulus (AA), left ventricular outflow tract (LVOT), sinotubular junction (STJ), and ascending aorta (AAO) and the angle of the aortic root. Leaflet thickening was evaluated qualitatively. Results: A total of 77 patients with a mean Society of Thoracic Surgeons (STS) score of 7.7±5.9 underwent TAVR. The total rate of procedural success was 80.5%. In the successful procedure group, the circumferences of the AA, LVOT, and STJ measured by CT were significant smaller than those in the failed procedure group (P=0.02, P=0.002 and P=0.045, respectively). Meanwhile, there were more patients with leaflet thickening in the successful procedure group (58.1% vs. 20.0%; P=0.02). The VenusA-Valve and the Vita-Flow valve were used in 47 patients and 30 patients, respectively. The procedural success rate was significantly higher in the VitaFlow group than in the VenusA-Valve group (93.3% vs. 72.3%; P=0.048), which was mainly due to the lower incidence of second transcatheter heart valves implantations in the VitaFlow group (6.7% vs. 27.7%; P=0.048). Conclusions: Severe PNAR patients with a smaller AA, LVOT, and STJ and leaflet thickening might have a higher success rate in transfemoral TAVR using a self-expanding valve. The self-expanding valve with a non-A-shaped framework might be a better choice for improved procedural outcomes.
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Chen et al. (2022) conducted an observational in pure native aortic regurgitation (n=77). VitaFlow valve vs. VenusA-Valve was evaluated on procedural success rate (VARC-2 standard) (p=0.048). Transfemoral TAVR using the VitaFlow valve yielded a higher procedural success rate than the VenusA-Valve (93.3% vs. 72.3%; P=0.048) in patients with severe pure native aortic regurgitation.
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