Key result
Balloon-expandable valves match self-expandable valves for mortality but increase annulus rupture risk ~481%.
Why the study?
Data on the use of self-expandable versus balloon-expandable valves in bicuspid aortic stenosis patients undergoing TAVI are scarce.
Does balloon-expandable transcatheter aortic valve implantation compared to self-expandable valves improve outcomes in patients with bicuspid aortic stenosis?
Meta-Analysis (n=1,080)
Does balloon-expandable transcatheter aortic valve implantation compared to self-expandable valves improve outcomes in patients with bicuspid aortic stenosis?
In patients with bicuspid aortic stenosis undergoing TAVI, self-expandable and balloon-expandable valves have similar mortality up to 1 year, though BEVs carry a higher risk of annular rupture and a lower risk of paravalvular leak with newer generations.
Supports preferring self-expandable valves in bicuspid TAVI to minimize rupture risk; leaves open need for randomized confirmation.
BACKGROUND: There is a rising trend for transcatheter aortic valve implantation (TAVI) in bicuspid aortic stenosis patients. Data on the use of self-expandable (SEV) vs. balloon-expandable (BEV) valves in these patients are scarce. Therefore, we systematically compared clinical outcomes in bicuspid aortic stenosis patients treated with SEV and BEV. METHODS: Data were extracted from PubMed/MEDLINE, EMBASE, CENTRAL/CCTR, ClinicalTrials.gov, SciELO, LILACS, Google Scholar and reference lists of relevant articles. Eight studies published from 2013 to 2020 including a total of 1,080 patients (BEV: n = 620; SEV: n = 460) were selected. Primary endpoints were procedural, 30-day and 1-year mortality. Secondary endpoints were new pacemaker implantation, annular rupture, coronary obstruction, moderate-to-severe paravalvular leak, need of second valve, stroke and acute kidney injury. RESULTS: We found no statistically significant difference in mortality between patients treated with BEV vs. SEV during index procedure, at 30 days and at 1 year. BEVs showed a statistically significant higher risk of annulus rupture (2.5%) in comparison with SEV (0%) (OR 5.81 [95% CI, 3.78-8.92], p < .001). New generation BEVs were also associated with significantly less paravalvular leak when compared to new generation SEVs (OR 0.08 [95% CI, 0.02-0.35], p = .001). CONCLUSIONS: This meta-analysis of observational studies of TAVI for bicuspid valves, showed no difference in short- and mid-term TAVI mortality with BEVs and SEVs. BEVs presented a higher risk of annular rupture in comparison with SEV.
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Sá et al. (2021) conducted a meta-analysis in Bicuspid aortic valve stenosis (n=1,080). Balloon-expandable transcatheter aortic valve implantation (BEV) vs. Self-expandable transcatheter aortic valve implantation (SEV) was evaluated on Procedural, 30-day and 1-year mortality. Balloon-expandable valves showed no difference in mortality compared to self-expandable valves, but had a higher risk of annulus rupture (2.5% vs 0%; OR 5.81, 95% CI 3.78-8.92, p<0.001).
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