Rationale and design of the CardioMEMS Post-Market Multinational Clinical Study: COAST
File(s)
Published version
Author(s)
Cowie, Martin R
de Groote, Pascal
McKenzie, Scott
Brett, Marie-Elena
Adamson, Philip B
Type
Journal Article
Abstract
Aims
Chronic heart failure reduces quality and quantity of life and is expensive for healthcare systems. Medical treatment relies on guideline‐directed therapy, but clinical follow‐up and remote management is highly variable and poorly effective. New remote management strategies are needed to maintain clinical stability and avoid hospitalizations for acute decompensation.
Methods and results
The CardioMEMS Post‐Market Study is a prospective, international, single‐arm, multicentre, open‐label study (NCT02954341) designed to examine the feasibility of haemodynamic guided heart failure management using a small pressure sensor permanently implanted in the pulmonary artery (PA). Daily uploaded PA pressures will be reviewed weekly to remotely guide medical management of patients with persistent NYHA Class III symptoms at baseline and a hospitalization in the prior 12 months. The study will enrol up to 800 patients from 85 sites across the United Kingdom, Europe, and Australia. The primary safety endpoint will assess device or system‐related complications or sensor failures after 2 years of follow‐up. Efficacy will be estimated after 1 year of follow‐up comparing HF hospitalization rates before and after sensor implantation. Observational endpoints will include mortality, patient, and investigator monitoring compliance, PA pressure changes, quality of life, and several pre‐defined subgroup analyses.
Conclusions
The CardioMEMS Post‐Market Study will investigate the generalizability of remote haemodynamic guided HF management in a number of national settings. The results may support the more widespread implementation of this novel clinical management approach.
Chronic heart failure reduces quality and quantity of life and is expensive for healthcare systems. Medical treatment relies on guideline‐directed therapy, but clinical follow‐up and remote management is highly variable and poorly effective. New remote management strategies are needed to maintain clinical stability and avoid hospitalizations for acute decompensation.
Methods and results
The CardioMEMS Post‐Market Study is a prospective, international, single‐arm, multicentre, open‐label study (NCT02954341) designed to examine the feasibility of haemodynamic guided heart failure management using a small pressure sensor permanently implanted in the pulmonary artery (PA). Daily uploaded PA pressures will be reviewed weekly to remotely guide medical management of patients with persistent NYHA Class III symptoms at baseline and a hospitalization in the prior 12 months. The study will enrol up to 800 patients from 85 sites across the United Kingdom, Europe, and Australia. The primary safety endpoint will assess device or system‐related complications or sensor failures after 2 years of follow‐up. Efficacy will be estimated after 1 year of follow‐up comparing HF hospitalization rates before and after sensor implantation. Observational endpoints will include mortality, patient, and investigator monitoring compliance, PA pressure changes, quality of life, and several pre‐defined subgroup analyses.
Conclusions
The CardioMEMS Post‐Market Study will investigate the generalizability of remote haemodynamic guided HF management in a number of national settings. The results may support the more widespread implementation of this novel clinical management approach.
Date Issued
2020-02-07
Date Acceptance
2020-01-26
Citation
ESC Heart Failure, 2020, 7 (3), pp.865-872
ISSN
2055-5822
Publisher
Wiley Open Access
Start Page
865
End Page
872
Journal / Book Title
ESC Heart Failure
Volume
7
Issue
3
Copyright Statement
© 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology
This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000511519300001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Cardiovascular System & Cardiology
Clinical trial
CardioMEMS (TM) HF System
Haemodynamic monitoring
Heart Failure
Pulmonary artery pressure
HEART-FAILURE HOSPITALIZATIONS
HIGH-RISK
MANAGEMENT
MORTALITY
GUIDELINES
PRESSURES
MORBIDITY
NETWORK
SOCIETY
ALERTS
Publication Status
Published
Date Publish Online
2020-02-07