Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients

G Michael Deeb; Michael J Reardon; Basel Ramlawi; Steven J Yakubov; Stan J Chetcuti; Neal S Kleiman; Abeel A Mangi; Firas Zahr; Howard K Song; Hemal Gada; Mubashir Mumtaz; John Heiser; William Merhi; C Patrick Murrah; Thomas Noel; Merick Kirshner; Timothy Byrne; Saki Ito; Jian Huang; John K Forrest

doi:10.1016/j.jcin.2021.10.027

Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients

JACC Cardiovasc Interv. 2022 Mar 14;15(5):511-522. doi: 10.1016/j.jcin.2021.10.027.

Authors

G Michael Deeb¹, Michael J Reardon², Basel Ramlawi³, Steven J Yakubov⁴, Stan J Chetcuti⁵, Neal S Kleiman⁶, Abeel A Mangi⁷, Firas Zahr⁸, Howard K Song⁹, Hemal Gada¹⁰, Mubashir Mumtaz¹¹, John Heiser¹², William Merhi¹³, C Patrick Murrah¹⁴, Thomas Noel¹⁵, Merick Kirshner¹⁶, Timothy Byrne¹⁷, Saki Ito¹⁸, Jian Huang¹⁹, John K Forrest²⁰

Affiliations

¹ Department of Cardiac Surgery, University of Michigan Hospitals, Ann Arbor, Michigan, USA. Electronic address: mdeeb@med.umich.edu.
² Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Institute, Houston, Texas, USA.
³ Department of Cardiothoracic Surgery, Valley Health, Winchester, Virginia, USA.
⁴ Department of Interventional Cardiology, Riverside Methodist-OhioHealth, Columbus, Ohio, USA.
⁵ Department of Interventional Cardiology, University of Michigan Hospitals, Ann Arbor, Michigan, USA.
⁶ Department of Interventional Cardiology, Houston Methodist DeBakey Heart and Vascular Institute, Houston, Texas, USA.
⁷ Department of Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut, USA.
⁸ Department of Interventional Cardiology, Oregon Health and Science University, Portland, Oregon, USA.
⁹ Department of Cardiothoracic Surgery, Oregon Health and Science University, Portland, Oregon, USA.
¹⁰ Department of Interventional Cardiology, University of Pittsburgh Pinnacle, Wormsleyburg, Pennsylvania; USA.
¹¹ Department of Cardiothooracic Surgery, University of Pittsburgh Pinnacle, Wormsleyburg, Pennsylvania, USA.
¹² Department of Cardiothoracic Surgery, Spectrum Health, Grand Rapids, Michigan, USA.
¹³ Department of Interventional Cardiology, Spectrum Health, Grand Rapids, Michigan, USA.
¹⁴ Department of Cardiothoracic Surgery, Tallahassee Research Institute, Tallahassee, Florida, USA.
¹⁵ Department of Interventional Cardiology, Tallahassee Research Institute, Tallahassee, Florida, USA.
¹⁶ Department of Cardiothoracic Surgery, Abrazo Arizona Heart Hospital, Phoenix, Arizona, USA.
¹⁷ Department of Interventional Cardiology, Abrazo Arizona Heart Hospital, Phoenix, Arizona, USA.
¹⁸ Division of Cardiovascular Ultrasound, Mayo Clinic, Rochester, Minnesota, USA.
¹⁹ Department of Statistics, Medtronic, Minneapolis, Minnesota, USA.
²⁰ Department of Internal Medicine (Cardiology), Yale University School of Medicine, New Haven, Connecticut, USA. Electronic address: https://twitter.com/johnkforrest.

PMID: 35272776
DOI: 10.1016/j.jcin.2021.10.027

Abstract

Objectives: The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) in low surgical risk patients with bicuspid aortic stenosis to patients with tricuspid aortic stenosis.

Background: The pivotal TAVR trials excluded patients with bicuspid aortic valves. The Low Risk Bicuspid Study 30-day primary endpoint of death or disabling stroke was 1.3%.

Methods: The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled patients from 25 U.S. sites. A screening committee confirmed bicuspid anatomy and valve classification on computed tomography using the Sievers classification. Valve sizing was by annular measurements. An independent clinical events committee adjudicated all serious adverse events, and an independent core laboratory assessed all echocardiograms. The 150 patients from the Low Risk Bicuspid Study were propensity matched to the TAVR patients in the randomized Evolut Low Risk Trial using the 1:1 5- to-1-digit greedy method, resulting in 145 pairs.

Results: All-cause mortality or disabling stroke at 1 year was 1.4% in the bicuspid and 2.8% in the tricuspid group (P = 0.413). A pacemaker was implanted in 16.6% of bicuspid and 17.9% of tricuspid patients (P = 0.741). The effective orifice area was similar between groups at 1 year (2.2 ± 0.7 cm² vs 2.3 ± 0.6 cm², P = 0.677) as was the mean gradient (8.7 ± 3.9 mm Hg vs 8.5 ± 3.1 mm Hg, P = 0.754). Fewer patients in the bicuspid group had mild or worse paravalvular leak (21.3% vs 42.6%, P < 0.001).

Conclusions: There were no significant differences in clinical or forward flow hemodynamic outcomes between the propensity-matched groups at 1 year.

Keywords: aortic stenosis; bicuspid aortic valve; supra-annular; transcatheter aortic valve replacement.

Publication types

Clinical Trial
Multicenter Study

MeSH terms

Aortic Valve / diagnostic imaging
Aortic Valve / surgery
Aortic Valve Stenosis* / diagnostic imaging
Aortic Valve Stenosis* / etiology
Aortic Valve Stenosis* / surgery
Heart Valve Prosthesis*
Humans
Prospective Studies
Risk
Transcatheter Aortic Valve Replacement*
Treatment Outcome