The CardioMEMS Heart Failure System for chronic heart failure–a European perspective

Sumant P. Radhoe, Pascal R.D. Clephas, Hamraz Mokri, Jasper J. Brugts*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

1 Citation (Scopus)

Abstract

Introduction: Chronic heart failure (HF) is characterized by high hospital admission rates. The CardioMEMSTM HF System is a pulmonary artery pressure sensor developed for remote hemodynamic monitoring to reduce HF hospitalizations. The device is FDA approved and CE marked, but clinical evidence for the CardioMEMS system is mainly based upon U.S. studies. Because of structural differences in HF care between the U.S. and Europe, it is important to study CardioMEMS efficacy in European setting on top of usual HF care and contemporary therapy. Several observational studies have been performed in Europe, but there is an unmet need for randomized clinical trials. Areas covered: This review focuses on safety and efficacy data for CardioMEMS remote hemodynamic monitoring in European HF setting, and discusses important upcoming studies. Expert opinion: For safety, data from European studies are in line with U.S. studies. Efficacy with regard to reduction of HF hospitalizations seems promising, but is merely based upon observational studies comparing pre- and post-implantation event rates. The first European randomized clinical trial (MONITOR HF) will provide efficacy data compared to actual standard care in a high-quality healthcare system with contemporary HF treatment and will provide important generalizable information to other European countries.

Original languageEnglish
Pages (from-to)349-356
Number of pages8
JournalExpert Review of Medical Devices
Volume20
Issue number5
Early online date18 Apr 2023
DOIs
Publication statusPublished - 2023

Bibliographical note

Funding Information:
JJ Brugts reports independent research grants from Abbott and speaker fees. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Publisher Copyright:
© 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

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