Bicuspid aortic valve (BAV) stenosis is the most common congenital valve disease, affecting up to 2% of the population. Patients with BAV disease undergoing transcatheter aortic valve replacement (TAVR) account for 0.5%. In this context, TAVR data on BAV stenosis patients has been limited to observational studies on first generation valves that had resulted in higher rates of paravalvular leak definite and pacemaker implantation. Severe valve and raphe calcification are associated with lower procedural rate and worse clinical outcomes.
The aim of this multicenter prospective study was to assess valve performance and clinical outcomes of the EVOLUTE PRO in patients with BAV disease and explore the impact the the different algorithms by CT.
Primary end point was valve performance defined as aortic valve mean gradient <20 mmHg or peak velocity < 3 m/sec and no moderate or severe paravalvular regurgitation at 30 days. Secondary end point was total and cardiovascular death at 30 days and one year, and severe mismatch.
Between June 2018 and January 2020, 3777 patients were treated with TAVR, 206 (5.45%) had BAV stenosis. 149 of these patients were included in the registry. Mana age was 78, and they were mostly men. Mean STS score was 2.6%, and mean EUROSCORE II was 2.8%. In 51% (n=77) of patients, valve size was determined by annular sizing, and in 48% (n=72) by the combined annular and supra annular sizing. The most used were the 29 and 34 mm EVOLUT valves (49% and 36.9% respectively). Predilation with balloon was done in 87% of cases, while post-dilation was done in 55%.
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Primary end point outcomes were observed in 96% in the annular sizing group vs 94% in the combined sizing group (p=0.9). Paravalvular regurgitation was mostly mild (81%,), followed by mild to moderate (8.5%), trivial (7.5%), moderate (2.8%) and only one patient presented moderate to severe leak (1.6%). Prosthetic mismatch was observed in 9% of patients. Cardiovascular death at 30 days was 2.6%, and 11% at one year. Stroke rate was 4.6%, and 4% presented vascular complications. Pacemaker implantation rate was 19.5% at 30 days and 25.6% at 1 year.
BIVOLUTX has shown favorable performance and good clinical outcomes after TAVR with EVOLUT in patients with BAV disease.
Dr. Andrés Rodríguez.
Member of the editorial board of SOLACI.org.
Original Title: Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry.
Reference: D. Tichetche et al.
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