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Clin Res Cardiol. 2018 Nov;107(11):991-1002. doi: 10.1007/s00392-018-1281-8. Epub 2018 May 19.

Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF).

Author information

1
Department of Medicine I, Cardiology, and Comprehensive Heart Failure Center Würzburg, University and University Hospital Würzburg, Am Schwarzenberg 15, 97078, Würzburg, Germany. Angermann_C@ukw.de.
2
University Hospital Frankfurt, Frankfurt, Germany.
3
Division of Cardiology and Metabolism and Department of Cardiology & Berlin-Brandenburg Center for Regenerative Therapies, and German Center for Cardiovascular Research, Partner Site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany.
4
Department of Cardiology & Pneumology, University Medicine Göttingen (UMG), Göttingen, Germany.
5
Regiomed Hospital Coburg, Coburg, Germany.
6
Department of Medicine I, Cardiology, and Comprehensive Heart Failure Center Würzburg, University and University Hospital Würzburg, Am Schwarzenberg 15, 97078, Würzburg, Germany.
7
Charité-Universitätsmedizin Campus Mitte, Berlin, Germany.
8
University Hospital Cologne, Cologne, Germany.
9
Charité-Universitätsmedizin Campus Virchow, Berlin, Germany.
10
Abbott, Austin, TX, USA.
11
Saarland University Medical Center, Homburg, Germany.

Abstract

BACKGROUND:

Wireless monitoring of pulmonary artery (PA) pressures with the CardioMEMS HF™ system is indicated in patients with New York Heart Association (NYHA) class III heart failure (HF). Randomized and observational trials have shown a reduction in HF-related hospitalizations and improved quality of life in patients using this device in the United States.

OBJECTIVE:

MEMS-HF is a prospective, non-randomized, open-label, multicenter study to characterize safety and feasibility of using remote PA pressure monitoring in a real-world setting in Germany, The Netherlands and Ireland.

METHODS AND RESULTS:

After informed consent, adult patients with NYHA class III HF and a recent HF-related hospitalization are evaluated for suitability for permanent implantation of a CardioMEMS™ sensor. Participation in MEMS-HF is open to qualifying subjects regardless of left ventricular ejection fraction (LVEF). Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy as tolerated. The study will enroll 230 patients in approximately 35 centers. Expected duration is 36 months (24-month enrolment plus ≥ 12-month follow-up). Primary endpoints are freedom from device/system-related complications and freedom from pressure sensor failure at 12-month post-implant. Secondary endpoints include the annualized rate of HF-related hospitalization at 12 months versus the rate over the 12 months preceding implant, and health-related quality of life. Endpoints will be evaluated using data obtained after each subject's 12-month visit.

CONCLUSIONS:

The MEMS-HF study will provide robust evidence on the clinical safety and feasibility of implementing haemodynamic monitoring as a novel disease management tool in routine out-patient care in selected European healthcare systems.

TRIAL REGISTRATION:

ClinicalTrials.gov; NCT02693691.

KEYWORDS:

CardioMEMS™ system; Heart failure; Hospitalization; Pulmonary artery pressure; Quality of life; Safety

PMID:
29777373
DOI:
10.1007/s00392-018-1281-8
[Indexed for MEDLINE]

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