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

Conflict of interest statement

Conflict of Interest Disclosures: Dr Forrest reported grants and personal fees from Medtronic Inc and Edwards Lifesciences outside the submitted work. Dr Ramlawi reported personal fees and nonfinancial support from Medtronic, Liva Nova, and AtriCure and personal fees from Boston Scientific outside the submitted work. Dr Deeb reported grants from Medtronic Inc during the conduct of the study. Dr Zahr reported grants from Medtronic Inc during the conduct of the study and grants from Edwards outside the submitted work. Dr Song reported personal fees from Medtronic outside the submitted work. Dr Kleiman reported grants from Medtronic outside the submitted work. Dr Chetcuti reported grants and personal fees from Medtronic and grants from Edwards, Gore, and Boston Scientific outside the submitted work. Dr Mangi reported grants, personal fees, nonfinancial support, consulting, proctoring, and speaking fees from Medtronic Inc and Edwards Lifesciences outside the submitted work. Dr Huang reported other support from Medtronic during the conduct of the study and outside the submitted work. Dr Popma reported grants from Medtronic during the conduct of the study and grants from Boston Scientific, Abbott, and Edwards outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Patient Enrollment Flowchart

LVOT indicates left ventricular outflow tract. aThe 7 patients withdrawn for other reasons include 4 patients owing to insurance denial and 3 patients exited from the study due to completion of enrollment. bDuring transthoracic echocardiographic imaging, a mass on the aortic valve was detected. cCoronary obstruction requiring emergent surgery.

Figure 2.. Valve Hemodynamics

A, Mean aortic valve gradient and effective orifice area at baseline and 30 days. B, Aortic regurgitation at 30 days for all patients.