Researchers found no significant difference in 30-day and 1-year mortality in patients undergoing transcatheter aortic valve replacement (TAVR) for bicuspid vs tricuspid aortic stenosis, but the 30-day risk of stroke was significantly higher for patients having TAVR for bicuspid aortic stenosis compared with tricuspid stenosis, according to a study published in in JAMA.
Investigators analyzed data for 2691 pairs of participants (propensity-score matched bicuspid/tricuspid from a total 81,822 consecutive aortic stenosis patients) treated at 552 different US centers between June 2015 and November 2018. All participants were enrolled in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry. Primary study endpoints were 30-day and 1-year stroke and mortality. Secondary study endpoints were quality of life, valve hemodynamics, and procedural complications.
Of the 2691 pairs of participants (39.7% women; median age 74 [interquartile range 66-81]), the mean (plus standard deviation) Society of Thoracic Surgeons-predicted risk of mortality was 4.9% (4.0%) for bicuspid vs 5.1% (4.2%) for tricuspid TAVR.
At 30 days, between-group all-cause mortality was not significantly different for bicuspid vs tricuspid aortic stenosis (2.6% vs 2.5%; hazard ratio [HR], 1.04; 95% CI, 0.74-1.47), nor was there a significant all-cause mortality difference at 1 year (10.5% vs 12.0%; HR, 0.90; 95% CI, 0.73-1.10).
However, the 30-day rate of stroke was significantly higher for bicuspid compared with tricuspid stenosis (2.5% vs 1.6%; HR, 1.57; 95% CI, 1.06-2.33).
Moreover, the risk of procedural complications that required conversion to open heart surgery was significantly greater in the bicuspid group compared to the tricuspid group (0.9% vs 0.4%, respectively; absolute risk difference [RD], 0.5%; 95% CI, 0-0.9).
No significant between-group differences were observed for valve hemodynamics or moderate or severe paravalvular leak at 30 days (2.0% vs 2.4%; absolute RD, 0.3%; 95% CI, −1.3 to 0.7]) or 1 year (3.2% vs 2.5%; absolute RD, 0.7%; 95% CI, −1.3 to 2.7).
There were also no significant between-group differences in quality of life improvements at 1 year (difference in Kansas City Cardiomyopathy Questionnaire overall summary score improvement, −2.4; 95% CI, −5.1 to 0.3; P =.08).
Study investigators concluded, “patients with bicuspid vs tricuspid aortic stenosis had no significant difference in 30-day or 1-year mortality but had increased 30-day risk for stroke. Because of the potential for selection bias and the absence of a control group treated surgically for bicuspid stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis.”
Disclosure: Study funding was provided by Edwards Lifesciences. Multiple authors declared associations with the pharmaceutical companies. Please see original reference for a full list of authors’ disclosures.
Makkar RR, Yoon SH, Leon MB, et al. Association between transcatheter aortic valve replacement for bicuspid vs tricuspid aortic stenosis and mortality or stroke. JAMA. 2019;321(22):2193–2202.