Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli - VIVA

Apr 03, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Trial Sponsor:
Fondation Famille Jacques Larivière, Foundation of the Quebec Heart & Lung Institute, and Research Center of the Quebec Heart & Lung Institute
Date Published:
02/26/2024
Date Updated:
04/03/2024
Original Posted Date:
04/03/2024
References

Contribution To Literature:

The VIVA trial showed that TAVR and SAVR resulted in similar outcomes for treating patients with severe aortic stenosis and small aortic annuli.

Description:

The goal of the trial was to evaluate transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among patients with severe aortic stenosis and a small aortic annulus.

Study Design

  • Randomized
  • Parallel
  • Blinded

Patients with severe aortic stenosis and a small aortic annulus were randomized to TAVR (n = 77) vs. SAVR (n = 74). Small aortic annulus was based on computed tomography (CT)-derived mean aortic annular diameter <23 mm and a minimal diameter ≤21.5 mm.

  • Total number of enrollees: 151
  • Duration of follow-up: median 2 years
  • Mean patient age: 76 years
  • Percentage female: 93%
  • Percentage with diabetes: 30%

Inclusion criteria:

  • Severe aortic stenosis
  • Small aortic annulus
  • At least 65 years of age

Exclusion criteria:

  • Aortic root dilatation (>45 mm)
  • Chronic coronary artery disease not amenable to percutaneous coronary intervention or coronary artery bypass grafting
  • Concomitant mitral or tricuspid valve disease
  • Previous aortic valve surgery

Other salient features/characteristics:

  • Median annulus diameter, 21.1 mm
  • Aortic root enlargement, 7.0% of the SAVR group

Principal Findings:

The primary outcome, impaired valve hemodynamics (defined as severe prosthesis-patient mismatch or moderate to severe aortic regurgitation) at 60 days was 5.6% in the TAVR group vs. 10.3% in the SAVR group (p = 0.30).

Secondary outcomes:

  • Mortality at 30 days, 1.3% with TAVR vs. 1.4% with SAVR (p = 1.00)
  • Stroke at 30 days, 0% with TAVR vs. 2.7% with SAVR (p = 0.24)
  • Clinical outcomes were similar at 2 years
  • Mean aortic gradient at 60 days, 11 mm Hg in the TAVR group vs. 11 mm Hg in the SAVR group

Interpretation:

Among patients with severe aortic stenosis and small aortic annuli, TAVR and SAVR resulted in similar outcomes. The primary outcome was impaired valve hemodynamics, which was defined as severe prosthesis-patient mismatch or moderate to severe aortic regurgitation at 60 days. The median aortic annulus was ~21 mm and 93% of participants were women. This trial was underpowered and type 2 error remains possible.

References:

Rodés-Cabau J, Ribeiro HB, Mohammadi S, et al. Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial. Circulation 2024;149:644-55.

Editorial Comment: Herrmann HC, Desai ND. Incidence, Implications, and Treatment of Patients With Severe Aortic Stenosis and Small Aortic Annulus. Circulation 2024;149:656-7.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: Aortic Valve Stenosis, Cardiac Surgical Procedures, Transcatheter Aortic Valve Replacement


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