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Bicuspid vs. Tricuspid TAVR Outcomes
Study Questions:
Are there differences in outcomes for balloon-expandable transcatheter aortic valve replacement (TAVR) for aortic stenosis (AS) among patients with a bicuspid aortic valve versus a tricuspid aortic valve?
Methods:
Propensity-matched registry-based prospective data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies (TVT) Registry including patients undergoing TAVR for AS at 552 US centers between June 2015 and November 2018 were examined based on whether patients had bicuspid versus tricuspid AS. The primary outcomes were 30-day and 1-year mortality and stroke; secondary outcomes included procedural complications, valve hemodynamics, and quality-of-life assessment.
Results:
Of 81,822 consecutive patients with AS (2,726 bicuspid, 79,096 tricuspid), 2,691 propensity-score matched pairs of bicuspid and tricuspid AS were analyzed (median age, 74 years; interquartile range [IQR], 66-81 years; 39.1% women; mean STS-predicted risk of mortality 4.9 ± 4.0% and 5.1 ± 4.2%, respectively). All-cause mortality was not significantly different between patients with bicuspid and tricuspid AS at 30 days (2.6% vs. 2.5%, hazard ratio [HR], 1.04; 95% confidence interval [CI], 0.74-1.47) and 1 year (10.5% vs. 12.0%; HR, 0.90; 95% CI, 0.73-1.10). The 30-day stroke rate was significantly higher for bicuspid versus tricuspid AS (2.5% vs. 1.6%; HR, 1.57; 95% CI, 1.06-2.33). The risk of procedural complications requiring open heart surgery was significantly higher in the bicuspid versus tricuspid cohort (0.9% vs 0.4%, respectively; absolute risk difference [RD], 0.5%; 95% CI, 0-0.9%). There were no significant differences in valve hemodynamics and there were no significant differences in moderate or severe paravalvular leak at 30 days (2.0% vs. 2.4%; absolute RD, 0.3%; 95% CI, −1.3 to 0.7%) and 1 year (3.2% vs. 2.5%; absolute RD, 0.7%; 95% CI, −1.3% to 2.7%). At 1 year, there was no significant difference in improvement in quality of life between the groups (difference in improvement in the Kansas City Cardiomyopathy Questionnaire overall summary score, −2.4; 95% CI, −5.1 to 0.3; p = 0.08).
Conclusions:
Data from this preliminary, registry-based study of propensity-matched patients who underwent TAVR for AS demonstrated that patients with bicuspid versus tricuspid AS 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, the authors concluded that randomized trials are needed to adequately assess the efficacy and safety of TAVR for bicuspid AS.
Perspective:
Although the pivotal randomized trials conducted to obtain US Food and Drug Administration approval for TAVR excluded bicuspid AS, the indications for TAVR are expanding, and an increasing number of patients with bicuspid anatomy are undergoing TAVR. This study, using propensity-matched patients from the STS/ACC TVT Registry, suggests no significant differences among patients with bicuspid AS versus tricuspid AS in terms of 30-day and 1-year mortality, valve hemodynamics, moderate or severe paravalvular leak, or quality of life measured at 1 year; but higher rates of stroke and procedural complications requiring open heart surgery associated with bicuspid anatomy. This retrospective, registry-based study cannot control for potential selection bias among patients with bicuspid AS who underwent TAVR rather than surgical AVR. However, pending prospective, randomized trials, it may be reasonable to use TAVR in at least some patients with bicuspid AS.
Keywords: Aortic Valve Stenosis, Cardiac Surgical Procedures, Constriction, Pathologic, Geriatrics, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Quality of Life, Stroke, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement, Tricuspid Valve Stenosis, National Cardiovascular Data Registries, ICD Registry
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