Title

Three-year outcomes after transcatheter or surgical aortic valve replacement in low-risk patients with aortic stenosis

Authors

John K. Forrest, Yale University School of Medicine, New Haven, CT. Electronic address: john.k.forrest@yale.edu.
G Michael Deeb, University of Michigan Health Systems Ok - University Hospital, Ann Arbor, MI.
Steven J. Yakubov, OhioHealth Riverside Methodist Hospital, Columbus, OH.
Hemal Gada, University of Pittsburgh Medical Center, Harrisburg, PA.
Mubashir A. Mumtaz, University of Pittsburgh Medical Center, Harrisburg, PA.
Basel Ramlawi, Lankenau Heart Institute, Philadelphia, PA.
Tanvir Bajwa, Advocate Aurora HealthFollow
Paul S. Teirstein, Scripps Clinic, La Jolla, CA.
Michael DeFrain, HealthPark Medical Center, Fort Myers, FL.
Murali Muppala, HealthPark Medical Center, Fort Myers, FL.
Bruce J. Rutkin, North Shore University Hospital, Manhasset, NY.
Atul Chawla, Mercy Medical Center, Iowa Heart, Des Moines, IA.
Bart Jenson, Mercy Medical Center, Iowa Heart, Des Moines, IA.
Stanley J. Chetcuti, University of Michigan Health Systems Ok - University Hospital, Ann Arbor, MI.
Robert C. Stoler, Baylor Heart and Vascular Hospital, Dallas, TX.
Marie-France Poulin, Beth Israel Deaconess Medical Center, Boston, MA.
Kamal Khabbaz, Beth Israel Deaconess Medical Center, Boston, MA.
Melissa Levack, Vanderbilt University Medical Center, Nashville, TN.
Kashish Goel, Vanderbilt University Medical Center, Nashville, TN.
Didier Tchétché, Clinique Pasteur, Toulouse, France.
Ka Yan Lam, Catharina Ziekenhuis, Eindhoven, Netherlands.
Pim A. Tonino, Catharina Ziekenhuis, Eindhoven, Netherlands.
Saki Ito, Echocardiography Core Laboratory, Mayo Clinic, Rochester, MN.
Jae K. Oh, Echocardiography Core Laboratory, Mayo Clinic, Rochester, MN.
Jian Huang, Medtronic, Mounds View, MN.
Jeffrey J. Popma, Medtronic, Mounds View, MN.
Neal Kleiman, Methodist DeBakey Heart and Vascular Center, Houston, TX.
Michael J. Reardon, Methodist DeBakey Heart and Vascular Center, Houston, TX.

Affiliations

Aurora St Luke's Medical Center

Abstract

Background: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) to surgery in low surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process.

Objective: We evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial.

Methods: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years.

Results: There were 1414 attempted implants (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR, 0.70; 95% CI, 0.49-1.00; p=0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs. 2.5% surgery) and pacemaker placement (23.2% TAVR vs. 9.1% surgery; p<0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1mmHg TAVR vs. 12.1mmHg surgery; p<0.001) at 3 years.

Conclusions: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared to surgery with respect to all-cause mortality or disabling stroke.

Type

Article

PubMed ID

36882136


 

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