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Original Investigation
September 21, 2021

Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke Among Patients at Low Surgical Risk

Author Affiliations
  • 1Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California
  • 2Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
  • 3Brigham and Women’s Hospital, Boston, Massachusetts
  • 4Sanger Heart and Vascular Institute, Carolinas Medical Center, Charlotte, North Carolina
  • 5Emory University School of Medicine, Atlanta, Georgia
  • 6Duke University Medical Center, Durham, North Carolina
  • 7Columbia University Medical Center, New York, New York
  • 8Baylor Scott and White Health, Plano, Texas
  • 9Piedmont Heart Institute, Atlanta, Georgia
JAMA. 2021;326(11):1034-1044. doi:10.1001/jama.2021.13346
Key Points

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

Findings  In this registry-based cohort study that included 3168 propensity-matched pairs of patients at low surgical risk undergoing TAVR for bicuspid vs tricuspid aortic stenosis, there was no significant difference in death at 30 days (0.9% vs 0.8%), death at 1 year (4.6% vs 6.6%), stroke at 30 days (1.4% vs 1.2%), or stroke at 1 year (2.0% vs 2.1%).

Meaning  Patients at low surgical risk who underwent TAVR for bicuspid aortic stenosis compared with tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. 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  There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk.

Objective  To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk.

Design, Setting, and Participants  Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis.

Exposures  TAVR for bicuspid vs tricuspid aortic stenosis.

Main Outcomes and Measures  Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics.

Results  Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups’ rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, −0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, −0.6% to 3.2%]).

Conclusions and Relevance  In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.

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