TAVR in bicuspid aortic stenosis patients with both calcified raphe and excess leaflet calcification had higher 2-year mortality than those with 1 or no features (25.7% vs 9.5% vs 5.9%; p<0.001).
Observational (n=1,034)
Yes
Does bicuspid aortic valve morphology (calcified raphe and excess leaflet calcification) affect procedural complications and mortality after transcatheter aortic valve replacement?
In patients with bicuspid aortic stenosis undergoing TAVR, specific morphological features (calcified raphe and excess leaflet calcification) independently predict procedural complications and 2-year mortality.
Absolute Event Rate: 25.7% vs 5.9%
p-value: p=<0.001
BACKGROUND Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials. OBJECTIVES This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. METHODS Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications. RESULTS A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). CONCLUSIONS Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521).
Yoon et al. (2020) conducted an observational in Bicuspid aortic valve stenosis (n=1,034). Transcatheter aortic valve replacement (TAVR) vs. 1 or no high-risk morphological features (calcified raphe, excess leaflet calcification) was evaluated on All-cause mortality at 1 and 2 years (p=<0.001). TAVR in bicuspid aortic stenosis patients with both calcified raphe and excess leaflet calcification had higher 2-year mortality than those with 1 or no features (25.7% vs 9.5% vs 5.9%; p<0.001).