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Preliminary Communication
June 11, 2019

Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke

Author Affiliations
  • 1Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California
  • 2Columbia University Medical Center, New York, New York
  • 3Sanger Heart and Vascular Institute, Carolinas Medical Center, Charlotte, North Carolina
  • 4Brigham and Women’s Hospital, Boston, Massachusetts
  • 5Medstar Heart and Vascular Institute, Washington, DC
  • 6Emory University School of Medicine, Atlanta, Georgia
  • 7Duke Clinical Research Institute, Durham, North Carolina
  • 8Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
  • 9Baylor Scott and White Health, Plano, Texas
  • 10Mount Sinai Health System, New York, New York
JAMA. 2019;321(22):2193-2202. doi:10.1001/jama.2019.7108
Key Points

Question  Are there differences in mortality and stroke between patients who undergo transcatheter aortic valve replacement (TAVR) for bicuspid compared with tricuspid aortic stenosis?

Findings  In this registry-based cohort study that included 2691 propensity-score matched pairs of patients undergoing TAVR for bicuspid vs tricuspid aortic stenosis, there was no statistically significant difference in 30-day mortality (2.6% vs 2.5%; respectively) or 1-year mortality (10.5% vs 12.0%). However, the 30-day risk of stroke was significantly greater among those with bicuspid aortic stenosis (2.5% vs 1.6%).

Meaning  Patients who underwent TAVR for bicuspid aortic stenosis compared with tricuspid aortic stenosis had no significant difference in mortality, but had increased 30-day risk of stroke; because of the potential for selection bias, randomized trials would be needed to adequately assess the efficacy and safety of TAVR for bicuspid aortic stenosis.

Abstract

Importance  Transcatheter aortic valve replacement (TAVR) indications are expanding, leading to an increasing number of patients with bicuspid aortic stenosis undergoing TAVR. Pivotal randomized trials conducted to obtain US Food and Drug Administration approval excluded bicuspid anatomy.

Objective  To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis.

Design, Setting, and Participants  Registry-based prospective cohort study of patients undergoing TAVR at 552 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry from June 2015 to November 2018.

Exposures  TAVR for bicuspid vs tricuspid aortic stenosis.

Main Outcomes and Measures  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 aortic stenosis (2726 bicuspid; 79 096 tricuspid), 2691 propensity-score matched pairs of bicuspid and tricuspid aortic stenosis were analyzed (median age, 74 years [interquartile range {IQR}, 66-81 years]; 39.1%, women; mean [SD] 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 aortic stenosis at 30 days (2.6% vs 2.5%; hazard ratio [HR], 1.04, [95% 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 vs tricuspid aortic stenosis (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 vs 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. 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 = .08).

Conclusions and Relevance  In this preliminary, registry-based study of propensity-matched patients who had undergone transcatheter aortic valve replacement for aortic stenosis, 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.

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