Mid-Term Outcomes of Balloon-Expandable Aortic Valve-in-Valve Replacement in the United States

Department

Cardiology

Document Type

Article

Publication Title

JACC. Cardiovascular Interventions

Abstract

Background: Aortic valve-in-valve (AViV) replacement for is approved for patients with degenerated surgical valves at high or prohibitive surgical risk, mostly on the basis of small series with short-term follow-up.

Objectives: The aim of this study was to analyze the outcomes of AViV therapy using contemporary balloon-expandable valves (BEVs) in a large series with mid-term outcomes.

Methods: BEV AViV patients (June 2015 to December 2023) in the Society for Thoracic Surgeons (STS)/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were propensity matched to native transcatheter aortic valve replacement (TAVR) patients. Primary analysis included death and stroke at 5 years. Comparisons were also made on the basis of STS score, BEV subtype, and stented vs stentless index surgical valve type.

Results: In total, 14,474 AViV patients were matched to 385,556 TAVR patients (13,638 pairs). The mean age was 74 years, and the mean STS Predicted Risk of Mortality was 6.1%. Emergency cardiac surgery (0.2%) and bioprosthetic valve fracture (22%) were infrequent. Death (43.1% vs 55.2%; P < 0.001), stroke (10.5% vs 11.8%; P < 0.001), and their composite were lower for AViV compared with TAVR at 5 years with similar findings at each STS tertile. The SAPIEN 3 Ultra RESILIA device demonstrated lower discharge echo gradients for all sizes (20 mm, 19.4 mm Hg vs 23.8 mm Hg; 23 mm, 15.1 mm Hg vs 19.2 mm Hg; 26 mm, 12.1 mm Hg vs 15.1 mm Hg; and 29 mm, 8.6 mm Hg vs 12.1 mm Hg). There was no difference in death or stroke at 5 years for stentless vs stented surgical valves (42.9% vs 46.0%; P = 0.12).

Conclusions: This large, real-world analysis confirms the safety and durability of AViV compared with TAVR at all surgical risk levels at mid-term follow-up. Consideration may be given to broadening the indication for AViV.

First Page

1989

Last Page

2000

DOI

10.1016/j.jcin.2025.06.039

Volume

18

Issue

16

Publication Date

8-25-2025

Medical Subject Headings

Aged; Aged, 80 and over; Female; Humans; Male; Aortic Valve (physiopathology, surgery, diagnostic imaging); Aortic Valve Stenosis (mortality, physiopathology, diagnostic imaging, surgery); Balloon Valvuloplasty (adverse effects, mortality, instrumentation); Heart Valve Prosthesis; Heart Valve Prosthesis Implantation (adverse effects, instrumentation, mortality); Prosthesis Design; Prosthesis Failure; Recovery of Function; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Stroke (etiology, mortality); Time Factors; Transcatheter Aortic Valve Replacement (adverse effects, mortality, instrumentation); Treatment Outcome; United States

PubMed ID

40866029

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