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Related Experiment Video

Updated: Dec 25, 2025

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Randomized Trials in Cardiac Surgery: JACC Review Topic of the Week.

Mario Gaudino1, A Pieter Kappetein2, Antonino Di Franco1

  • 1Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, New York.

Journal of the American College of Cardiology
|April 4, 2020
PubMed
Summary

Conducting randomized controlled trials (RCTs) in cardiac surgery is challenging due to design and execution issues. This review offers solutions for improving cardiac surgery clinical trials.

Keywords:
RCTcardiac surgeryrandomized controlled trials

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Area of Science:

  • Cardiovascular Surgery
  • Clinical Trials Methodology
  • Surgical Research

Background:

  • Randomized controlled trials (RCTs) in cardiac surgery present unique challenges compared to other medical fields.
  • Issues include equipoise, rapid technique evolution, funding difficulties, and limited surgical epidemiology education.
  • Complex interventions, learning curves, operator variability, blinding challenges, and slow recruitment further complicate trial completion.

Purpose of the Study:

  • To identify and discuss the primary challenges in designing and conducting RCTs in cardiac surgery.
  • To provide evidence-based recommendations for overcoming these obstacles.
  • To encourage the successful execution of future cardiac surgery RCTs.

Main Methods:

  • This review synthesizes the perspectives of surgeons, trialists, and epidemiologists.
  • It analyzes common difficulties encountered in the design and completion phases of cardiac surgery RCTs.
  • Key challenges and potential solutions are discussed based on expert consensus and literature review.

Main Results:

  • The number of cardiac surgery RCTs has significantly decreased over the past two decades.
  • Specific challenges identified include maintaining equipoise, managing complex interventions, and addressing the learning curve effect.
  • Difficulties in blinding participants and operators, alongside slow patient recruitment, are major hurdles.

Conclusions:

  • Cardiac surgery RCTs face substantial design and operational challenges that have led to a decline in their number.
  • Addressing issues such as funding, surgical expertise variation, and recruitment strategies is crucial.
  • Implementing practical suggestions can improve the success rate of future cardiac surgery clinical trials.