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Rationale and design of the CardioMEMS Post-Market Multinational Clinical Study: COAST

Martin R Cowie1, Pascal de Groote2, Scott McKenzie3

  • 1Royal Brompton Hospital, Imperial College London, Sydney Street, London, SW3 6LY, UK.

ESC Heart Failure
|February 8, 2020
PubMed

Insights

Remote hemodynamic monitoring using the CardioMEMS device shows promise for managing chronic heart failure (HF). This approach aims to improve patient stability and reduce hospitalizations by guiding medical therapy.

Area of Science:

  • Cardiology
  • Medical Devices
  • Health Management

Background:

  • Chronic heart failure (HF) significantly impacts quality of life and healthcare costs.
  • Current guideline-directed therapy and remote management strategies for HF are often ineffective.
  • Novel remote management strategies are crucial for maintaining clinical stability and preventing acute decompensations.

Purpose of the Study:

  • To assess the feasibility of hemodynamic-guided heart failure management using an implanted pulmonary artery pressure sensor.
  • To evaluate the safety and efficacy of the CardioMEMS device in a post-market setting.
  • To investigate the generalizability of this remote management approach across different national healthcare systems.

Main Methods:

  • Prospective, international, single-arm, multicentre, open-label study (NCT02954341) enrolling up to 800 patients.
  • Utilized a permanently implanted pulmonary artery (PA) pressure sensor for daily monitoring.
  • Remotely guided medical management based on weekly review of uploaded PA pressures for patients with NYHA Class III HF and prior hospitalization.

Main Results:

  • Primary safety endpoint assesses device/system complications or sensor failures over 2 years.
  • Efficacy estimated by comparing HF hospitalization rates before and after sensor implantation at 1 year.
  • Observational endpoints include mortality, compliance, PA pressure changes, and quality of life.

Conclusions:

  • The CardioMEMS Post-Market Study investigates the generalizability of remote hemodynamic-guided HF management.
  • Results may support wider implementation of this innovative clinical management strategy.
  • This approach offers a potential solution for improving chronic heart failure care.
Abstract

Keywords:
CardioMEMSTM HF SystemClinical trialHaemodynamic monitoringHeart FailurePulmonary artery pressure

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