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Original Investigation
October 7, 2020

Transcatheter Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis

Author Affiliations
  • 1Departments of Internal Medicine (Cardiology) and Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut
  • 2Department of Cardiothoracic Surgery and Cardiology, Valley Health System, Winchester, Virginia
  • 3Departments of Cardiac Surgery and Interventional Cardiology, University of Michigan Hospitals, Ann Arbor
  • 4Departments of Interventional Cardiology and Cardiothoracic Surgery, Oregon Health and Science University, Portland
  • 5Departments of Interventional Cardiology and Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Institute, Houston, Texas
  • 6Division of Cardiovascular Ultrasound, Mayo Clinic, Rochester, Minnesota
  • 7Department of Statistics, Medtronic, Minneapolis, Minnesota
  • 8Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
JAMA Cardiol. 2021;6(1):50-57. doi:10.1001/jamacardio.2020.4738
Key Points

Question  What are the procedural and short-term outcomes of transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic valve stenosis?

Findings  In this single-arm prospective study of 150 low-risk patients with bicuspid aortic valve stenosis undergoing TAVR using a self-expanding valve and a standardized sizing strategy, there was high device success with a low rate of death or disabling stroke at 30 days. Outcomes did not vary significantly by bicuspid type (Sievers classification), with excellent hemodynamics and low rates of significant paravalvular leak for both Sievers type 0 and type I bicuspid valves.

Meaning  In this study, low-risk patients with bicuspid aortic valve stenosis undergoing TAVR had excellent procedural and 30-day outcomes, but longer-term outcomes are needed prior to widespread adoption of TAVR in low-risk patients with bicuspid severe aortic stenosis.

Abstract

Importance  The outcomes of transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic valve stenosis have not been studied in a large scale, multicentered, prospective fashion.

Objective  To evaluate the procedural safety, efficacy, and 30-day outcomes of TAVR in patients with bicuspid aortic stenosis at low surgical risk.

Design, Setting, and Participants  The Low Risk Bicuspid Study is a prospective, single-arm trial study with inclusion/exclusion criteria developed from the Evolut Low Risk Randomized Trial. Follow-up is planned for 10 years. Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018 to October 2019. Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement.

Interventions  Patients underwent attempted implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements.

Main Outcomes and Measures  The prespecified primary end point was the incidence of all-cause mortality or disabling stroke at 30 days. The prespecified primary efficacy end point was device success defined as the absence of procedural mortality, the correct position of 1 bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation postprocedure.

Results  A total of 150 patients underwent an attempted implant. Baseline characteristics include mean age of 70.3 (5.5) years, 48.0% female (n = 72), and a mean Society of Thoracic Surgeons score of 1.4 (0.6%). Most patients (136; 90.7%) had Sievers type I valve morphology. The incidence of all-cause mortality or disabling stroke was 1.3% (95% CI, 0.3%-5.3%) at 30 days. The device success rate was 95.3% (95% CI, 90.5%-98.1%). At 30 days, the mean (SD) AV gradient was 7.6 (3.7) mm Hg and effective orifice area was 2.3 (0.7) cm2. A new permanent pacemaker was implanted in 22 patients (15.1%). No patients had greater than mild paravalvular leak.

Conclusions and Relevance  Transcatheter aortic valve replacement in low–surgical risk patients with bicuspid aortic valve stenosis achieved favorable 30-day results, with low rates of death and stroke and high device success rate.

Trial Registration  ClinicalTrials.gov Identifier: NCT03635424

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