Introduction: Although TAVR has been performed in patients with bicuspid aortic valves (BAV), these patients were excluded from all the US pivotal trials and therefore their postoperative outcomes are not clearly defined.
Hypothesis: Patients with BAV undergoing TAVR may achieve similar outcomes when compared with trileaflet aortic valve (TAV) stenosis.
Methods: We retrospectively evaluated the outcomes of high or extreme risk patients with BAV stenosis at our institution between April 2011 and November 2016, and compared them with those of patients with TAV stenosis. Chi-square and the Mann-Whitney U tests were used to compared the groups, and a Kaplan-Meier analysis was performed to estimate long-term survival. The study was approved by the Duke University Hospital Institutional Review Board.
Results: TAVR was performed in a total of 567 eligible patients, from which 50 (8.8%) had BAV and 517 (91.2%) TAV disease. Patients with BAV were younger (median age 70 years [64-74] vs. 81 [75-86], p<0.001), had higher prevalence of COPD (52.0% vs. 30.8, p=0.002), lower prevalence of coronary artery disease (64.0% vs 76.8, p=0.036), higher BMI (median 28 kg/m2 [25-35] vs. 27 [24-31], p=0.046) and lower STS PROM score (median 4.6% [3.0-7.7] vs. 6.7 [4.4-9.9], p=0.004) when compared with those with TAV. Overall, self-expanding and balloon-expandable TAVR devices were used in 58.4% and 41.3% of the cases, and transfemoral access was used in 86.8%. Patients with BAV had a higher mean aortic valve gradient postoperatively (median 12 mmHg [10-15] vs. 10 [7-13], p<0.001). There were no differences in the procedural characteristics or in the incidence of any of the postoperative adverse outcomes between the groups, including moderate to severe paravalvular regurgitation (4.0% vs. 3.5, p=0.541), stroke (2.0% vs. 1.5, p=0.567), and 30-day all-cause mortality (6.0% vs. 1.5, p=0.064). The 2-year survival (82.0% vs. 83.4, p=0.476) was similar between the groups.
Conclusions: This initial experience suggests that TAVR can be performed in patients with severe BAV stenosis at high or extreme risk for traditional surgical aortic valve replacement achieving similar short-term clinical outcomes and mid-term survival compared with patients with TAV.