Key result
Down-sizing TAVR in bicuspid valves shows no significant difference in procedural mortality vs. tricuspid sizing.
Why the study?
In bicuspid aortic valves, TAVR increases risks of perivalvular leakage and conduction block, prompting exploration of a down-size interventional valve strategy using the VenusA-valve system.
Does a "down-size" interventional valve strategy provide safe and effective outcomes for transcatheter aortic valve replacement in patients with bicuspid aortic stenosis compared to tricuspid aortic stenosis?
Cohort (n=65)
No
Does a "down-size" interventional valve strategy provide safe and effective outcomes for transcatheter aortic valve replacement in patients with bicuspid aortic stenosis compared to tricuspid aortic stenosis?
Absolute Event Rate: 13.8% vs 0%
p-value: p=0.08
A "down-size" valve selection strategy for transcatheter aortic valve replacement in bicuspid aortic stenosis using the VenusA-valve system is feasible and yields similar hemodynamic outcomes to tricuspid aortic stenosis.
May warrant caution with down-sizing for bicuspid TAVR given 13.8% procedural mortality; leaves open need for randomized trials versus standard sizing.
Background: Due to the influence of anatomical structure, replacing the bicuspid valve using transcatheter aortic valve replacement (TAVR) would increase the risk of perivalvular leakage and conduction block, affecting the hemodynamic effect of the interventional valve. In this study, for bicuspid and tricuspid valves, we implemented different valve selection strategies to explore the safety and effectiveness of TAVR in the treatment of bicuspid aortic stenosis with “down-size” interventional valves using the VenusA-valve system. Methods: The operation was performed with the VenusA-valve via transfemoral approach. The selected valves were appropriately sized based on the results of transthoracic echocardiography (TTE), contrast-enhanced computed tomography (CT), and the morphology of intraoperative pre-dilation balloons. For tricuspid valve cases, the VenusA valve is usually larger than the annulus diameter, whereas the “down-size” approach was adopted for bicuspid aortic valve (BAV) cases. The shape of the pre-dilation balloon allowed further sizing of the annulus diameter by the degree of lumbar constriction of the balloon, aiding in intervention valve size selection, particularly in cases of BAVs. Results: A total of 65 patients underwent TAVR for aortic stenosis with VenusA-valve systems. Of these, 29 cases had a BAV and 36 cases had a tricuspid aortic valve (TAV). The distribution of VenusA-valve sizes differed between TAV and BAV cases (P=0.007). Furthermore, there was a significant decrease in the average mean gradient in TAV patients from 54.7 to 12.2 mmHg (P<0.001), and in BAV patients from 61.6 to 14.3 mmHg (P<0.001). The percentage of paravalvular leakage greater than mild was 6.90% in the BAVs and 5.56% in the TAVs at procedural outcomes (P=0.955). The mean follow-up period was 22.23 months (range, 12 to 39 months). The proportion of New York Heart Association (NYHA) class III/IV decreased from 78.5% preoperatively to 11.3% at the last follow-up (P<0.001). A total of 27 patients with TAV and 19 patients with BAV underwent TTE at 1-year follow-up after operation. There was no significant contrast in the average pressure difference between TAVs and BAVs at 1-year follow-up (11.9 vs. 14.3 mmHg, P=0.18). Conclusions: The VenusA-valve for TAVR produced positive clinical outcomes and valve functionality in both BAVs and TAVs. In the case of BAVs, selecting a smaller interventional valve size was deemed viable.
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Liu et al. (2024) conducted a cohort in Severe aortic stenosis (n=65). TAVR with "down-size" VenusA-valve sizing strategy vs. TAVR with standard oversized VenusA-valve sizing strategy for tricuspid valves was evaluated on Procedural death (clinical death) (p=0.08). In patients undergoing TAVR, a "down-sizing" valve strategy for bicuspid aortic valves resulted in a 13.8% procedural mortality compared to 0% for standard sizing in tricuspid valves (P=0.08), though both groups achieved significant reductions in transvalvular gradient.
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