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Comparison of Outcomes Between Low-Risk Aortic Valve Replacement Trials and a Surgical Registry

Makoto Mori1,2, Kayoko Shioda3,4, Christina Waldron1

  • 1Division of Cardiac Surgery, Yale School of Medicine, New Haven, Connecticut.

JAMA Network Open
|January 6, 2025
PubMed

Insights

Surgical aortic valve replacement (SAVR) in real-world settings showed similar 30-day mortality but lower stroke rates compared to low-risk trials like PARTNER 3 and Evolut Low Risk.

Area of Science:

  • Cardiovascular Surgery
  • Interventional Cardiology
  • Health Services Research

Background:

  • Outcomes of low-risk aortic valve replacement trials may not fully represent real-world surgical results.
  • Concomitant cardiac operations add complexity to surgical aortic valve replacement (SAVR) outcomes in non-trial settings.

Purpose of the Study:

  • To compare 30-day mortality and stroke rates between patients undergoing SAVR in a national surgical database and those in low-risk aortic valve replacement trials.
  • To assess the generalizability of findings from the PARTNER 3 and Evolut Low Risk trials to a broader surgical population.

Main Methods:

  • A cross-sectional study used the US Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS ACSD) from 2016-2018.
  • Probability-based sampling created 1000 patient cohorts from the STS ACSD, matched to trial participants' predicted risk of mortality (PROM).
  • 30-day mortality and stroke rates from sampled STS ACSD cohorts were compared to the SAVR arms of the PARTNER 3 and Evolut Low Risk trials.

Main Results:

  • The study analyzed 25,811 low-risk patients undergoing SAVR, with a mean age of 71 years and 65% male.
  • The sampled STS ACSD cohorts had a mean 30-day mortality of 1.39%, comparable to PARTNER 3 (1.1%) and Evolut Low Risk (1.3%).
  • The stroke rate in sampled cohorts was 1.25%, significantly lower than in PARTNER 3 (2.4%) and Evolut Low Risk (3.4%).

Conclusions:

  • Real-world SAVR in low-risk patients demonstrated 30-day mortality comparable to major clinical trials.
  • Incidence of stroke was lower in the real-world SAVR cohort compared to trial data.
  • Findings suggest that the outcomes reported in low-risk SAVR trials are generalizable to the broader national surgical population.
Abstract

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