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Diagnosing acute coronary syndrome or ACS begins with a thorough patient history. Notable symptoms include central, crushing chest pain radiating to the left arm, neck, jaw, or back, along with shortness of breath, sweating (diaphoresis), nausea, vomiting, dizziness, and palpitations.It is crucial to note any history of cardiac illnesses and assess risk factors, including age, gender, smoking, hypertension, diabetes, hyperlipidemia, and a sedentary lifestyle.During physical examination, vital...
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Updated: Nov 7, 2025

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STS INTERMACS Database: The Key to Conduct Single-Arm Trials in Advanced Heart Failure Patients.

Trever Symalla1, Miroslav P Peev1, Tae Song1

  • 1Section of Cardiac Surgery, Department of Surgery, University of Chicago Medical Center, Chicago Illinois.

The Annals of Thoracic Surgery
|April 30, 2021
PubMed
Summary
This summary is machine-generated.

The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database can establish performance criteria for single-arm trials. This supports regulatory approval for new mechanical circulatory support (MCS) devices by providing reliable outcome comparisons.

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Area of Science:

  • Cardiology
  • Medical Devices
  • Clinical Trials

Background:

  • Introducing new mechanical circulatory support (MCS) devices requires rigorous evaluation.
  • Single-arm trials with historical control data are a viable regulatory approval pathway.
  • The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database's utility for this purpose was assessed.

Purpose of the Study:

  • To determine if the INTERMACS database can establish objective performance criteria for single-arm trials.
  • To identify suitable patient populations within INTERMACS for future single-arm MCS trials.
  • To evaluate the INTERMACS database's capability to serve as a control arm for regulatory submissions.

Main Methods:

  • Analyzed 7907 patients with isolated left ventricular assist devices from 2014-2017, stratified by INTERMACS profiles (IM1-2, IM3-5) and shock status.
  • Utilized surrogate markers (ECMO, temporary VAD, vasopressors) to define shock and non-shock groups.
  • Compared survival, transplantation rates, adverse events, 6-minute walk test, and quality of life at 6 and 12 months.

Main Results:

  • Patients in the shock group (n=3469) showed similar 1-year survival (86%) to the IM1-2 group (n=3909, 85%).
  • Patients in the non-shock group (n=3040) demonstrated comparable 1-year survival (90%) to the IM3-5 group (n=3998, 90%).
  • 11% of IM3-5 patients were reclassified into the shock group, highlighting the importance of shock markers.

Conclusions:

  • The INTERMACS database effectively establishes objective performance criteria for single-arm trials.
  • It provides a reliable concurrent control group for regulatory approval of novel MCS devices.
  • INTERMACS data facilitate robust comparisons of outcomes and adverse events for new devices.