Reinterventions After CoreValve/Evolut Transcatheter or Surgical Aortic Valve Replacement for Treatment of Severe Aortic Stenosis

Kendra J Grubb; John C Lisko; Daniel O'Hair; William Merhi; John K Forrest; Paul Mahoney; Nicolas M Van Mieghem; Stephan Windecker; Steven J Yakubov; Mathew R Williams; Stanley J Chetcuti; G Michael Deeb; Neal S Kleiman; Andrew D Althouse; Michael J Reardon

doi:10.1016/j.jcin.2024.01.292

Reinterventions After CoreValve/Evolut Transcatheter or Surgical Aortic Valve Replacement for Treatment of Severe Aortic Stenosis

JACC Cardiovasc Interv. 2024 Apr 22;17(8):1007-1016. doi: 10.1016/j.jcin.2024.01.292. Epub 2024 Apr 3.

Authors

Affiliations

¹ Division of Cardiothoracic Surgery, Emory University, Atlanta, Georgia, USA. Electronic address: kjgrubb@emory.edu.
² Division of Cardiology, Emory University, Atlanta, Georgia, USA.
³ Cardiovascular Service Line, Boulder Community Health, Boulder, Colorado, USA.
⁴ Department of Interventional Cardiology, Corewell Health, Grand Rapids, Michigan, USA; Department of Cardiothoracic Surgery, Corewell Health, Grand Rapids, Michigan, USA.
⁵ Yale University School of Medicine, New Haven, Connecticut, USA.
⁶ University of Pittsburgh Medical Center Harrisburg, Harrisburg, Pennsylvania, USA.
⁷ Erasmus University Medical Centre, Rotterdam, the Netherlands.
⁸ Department of Cardiology, Bern University Hospital, Bern, Switzerland.
⁹ OhioHealth Riverside Methodist Hospital, Columbus, Ohio, USA.
¹⁰ New York University Langone Medical Center, New York, New York, USA.
¹¹ University of Michigan Health Systems-University Hospital, Ann Arbor, Michigan, USA.
¹² Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA.
¹³ Medtronic, Mounds View, Minnesota, USA.

PMID: 38573257
DOI: 10.1016/j.jcin.2024.01.292

Abstract

Background: Data on valve reintervention after transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) are limited.

Objectives: The authors compared the 5-year incidence of valve reintervention after self-expanding CoreValve/Evolut TAVR vs SAVR.

Methods: Pooled data from CoreValve and Evolut R/PRO (Medtronic) randomized trials and single-arm studies encompassed 5,925 TAVR (4,478 CoreValve and 1,447 Evolut R/PRO) and 1,832 SAVR patients. Reinterventions were categorized by indication, timing, and treatment. The cumulative incidence of reintervention was compared between TAVR vs SAVR, Evolut vs CoreValve, and Evolut vs SAVR.

Results: There were 99 reinterventions (80 TAVR and 19 SAVR). The cumulative incidence of reintervention through 5 years was higher with TAVR vs SAVR (2.2% vs 1.5%; P = 0.017), with differences observed early (≤1 year; adjusted subdistribution HR: 3.50; 95% CI: 1.53-8.02) but not from >1 to 5 years (adjusted subdistribution HR: 1.05; 95% CI: 0.48-2.28). The most common reason for reintervention was paravalvular regurgitation after TAVR and endocarditis after SAVR. Evolut had a significantly lower incidence of reintervention than CoreValve (0.9% vs 1.6%; P = 0.006) at 5 years with differences observed early (adjusted subdistribution HR: 0.30; 95% CI: 0.12-0.73) but not from >1 to 5 years (adjusted subdistribution HR: 0.61; 95% CI: 0.21-1.74). The 5-year incidence of reintervention was similar for Evolut vs SAVR (0.9% vs 1.5%; P = 0.41).

Conclusions: A low incidence of reintervention was observed for CoreValve/Evolut R/PRO and SAVR through 5 years. Reintervention occurred most often at ≤1 year for TAVR and >1 year for SAVR. Most early reinterventions were with the first-generation CoreValve and managed percutaneously. Reinterventions were more common following CoreValve TAVR compared with Evolut TAVR or SAVR.

Keywords: CoreValve; Evolut; TAV-in-TAV; redo-TAVR; surgical aortic valve replacement; transcatheter aortic valve replacement; valve-in-valve TAVR.

Publication types

Research Support, Non-U.S. Gov't
Comparative Study
Meta-Analysis

MeSH terms

Aged
Aged, 80 and over
Aortic Valve / diagnostic imaging
Aortic Valve / physiopathology
Aortic Valve / surgery
Aortic Valve Stenosis* / diagnostic imaging
Aortic Valve Stenosis* / physiopathology
Aortic Valve Stenosis* / surgery
Female
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation* / adverse effects
Heart Valve Prosthesis Implantation* / instrumentation
Humans
Incidence
Male
Postoperative Complications* / surgery
Prosthesis Design
Randomized Controlled Trials as Topic
Retreatment
Risk Assessment
Risk Factors
Severity of Illness Index
Time Factors
Transcatheter Aortic Valve Replacement* / adverse effects
Transcatheter Aortic Valve Replacement* / instrumentation
Treatment Outcome