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

Overview

Journal JAMA Cardiol

Publisher American Medical Association

Specialty Cardiology & Vascular Diseases

Date 2020 Oct 8

PMID 33031491

Citations 46

Authors

John K Forrest

Basel Ramlawi

G Michael Deeb

Firas Zahr

Howard K Song

Neal S Kleiman

Stanley J Chetcuti

Hector I Michelena

Abeel A Mangi

Jeffrey A Skiles

Jian Huang

Jeffrey J Popma

Michael J Reardon

Affiliations

Soon will be listed here.

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.

Citing Articles

Transcatheter Aortic Valve Replacement in Patients With Quadricuspid Aortic Valve: A Case Series and Systematic Review.

Sheng W, Zhou D, Dai H, Zheng R, Aihemaiti A, Liu X Cardiol Res Pract. 2025; 2025:7815279.

PMID: 39949952 PMC: 11824809. DOI: 10.1155/crp/7815279.

Transcatheter Aortic Valve Implantation (TAVI) in Bicuspid Anatomy.

Nikas D, Lakkas L, Naka K, Michalis L J Clin Med. 2025; 14(3).

PMID: 39941442 PMC: 11818256. DOI: 10.3390/jcm14030772.

Transcatheter Versus Surgical Aortic Valve Replacement in Young, Low-risk Patients with Severe Aortic Stenosis.

Nguyen Q, Luc J, MacGillivray T, Preventza O US Cardiol. 2024; 16:e18.

PMID: 39600837 PMC: 11588169. DOI: 10.15420/usc.2022.08.

Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Bicuspid Aortic Valve Stenosis-We Need a Well-Designed Randomized Control Trial.

Grubb K, Tom S, Xie J, Kalra K, Camaj A J Clin Med. 2024; 13(21).

PMID: 39518704 PMC: 11546600. DOI: 10.3390/jcm13216565.

Four-dimensional computed tomography analysis of bicuspid aortic valves.

Fikani A, Craiem D, Boulogne C, Soulat G, Mousseaux E, Jouan J JTCVS Tech. 2024; 27:60-67.

PMID: 39478902 PMC: 11518894. DOI: 10.1016/j.xjtc.2024.06.012.

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