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HVAD: The ENDURANCE Supplemental Trial.

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Blood pressure management in HeartWare HVAD System recipients reduced stroke rates. While not meeting the primary endpoint, the study showed improved secondary outcomes and fewer hemorrhagic strokes with better BP control.

Keywords:
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Area of Science:

  • Cardiology
  • Neurology
  • Medical Devices

Background:

  • The ENDURANCE trial showed HeartWare HVAD System noninferiority but higher stroke rates.
  • Increased mean arterial blood pressure was identified as a risk factor for stroke in HVAD patients.

Purpose of the Study:

  • To prospectively evaluate the impact of blood pressure management on stroke rates in HeartWare HVAD System recipients.
  • To assess stroke incidence and other clinical outcomes in patients with advanced heart failure receiving the HVAD system.

Main Methods:

  • The ENDURANCE Supplemental Trial prospectively evaluated 465 advanced heart failure patients randomized to HVAD or control.
  • A strict blood pressure protocol was implemented for the HVAD group.
  • Primary endpoint: 12-month incidence of stroke with residual deficit; Secondary endpoints: composite of death, disabling stroke, device replacement, or urgent transplantation.

Main Results:

  • The enhanced blood pressure protocol significantly reduced mean arterial blood pressure in HVAD patients.
  • The primary endpoint was not met (14.7% HVAD vs. 12.1% control).
  • HVAD subjects showed superiority in the secondary composite endpoint (76.1% vs. 66.9% control) and a significant reduction in hemorrhagic strokes (50.5%).

Conclusions:

  • The ENDURANCE Supplemental Trial did not achieve noninferiority for the primary endpoint.
  • Blood pressure management is crucial for reducing stroke rates in HeartWare HVAD System patients.
  • HVAD recipients achieved better secondary composite outcomes compared to controls.