PMID- 29777373
OWN - NLM
STAT- MEDLINE
DCOM- 20181211
LR  - 20181211
IS  - 1861-0692 (Electronic)
IS  - 1861-0684 (Linking)
VI  - 107
IP  - 11
DP  - 2018 Nov
TI  - 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).
PG  - 991-1002
LID - 10.1007/s00392-018-1281-8 [doi]
AB  - 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.
FAU - Angermann, Christiane E
AU  - Angermann CE
AD  - Department of Medicine I, Cardiology, and Comprehensive Heart Failure Center 
      Wurzburg, University and University Hospital Wurzburg, Am Schwarzenberg 15, 
      97078, Wurzburg, Germany. Angermann_C@ukw.de.
FAU - Assmus, Birgit
AU  - Assmus B
AD  - University Hospital Frankfurt, Frankfurt, Germany.
FAU - Anker, Stefan D
AU  - Anker SD
AD  - Division of Cardiology and Metabolism and Department of Cardiology & 
      Berlin-Brandenburg Center for Regenerative Therapies, and German Center for 
      Cardiovascular Research, Partner Site Berlin, Charite Universitatsmedizin Berlin, 
      Berlin, Germany.
AD  - Department of Cardiology & Pneumology, University Medicine Gottingen (UMG), 
      Gottingen, Germany.
FAU - Brachmann, Johannes
AU  - Brachmann J
AD  - Regiomed Hospital Coburg, Coburg, Germany.
FAU - Ertl, Georg
AU  - Ertl G
AD  - Department of Medicine I, Cardiology, and Comprehensive Heart Failure Center 
      Wurzburg, University and University Hospital Wurzburg, Am Schwarzenberg 15, 
      97078, Wurzburg, Germany.
FAU - Kohler, Friedrich
AU  - Kohler F
AD  - Charite-Universitatsmedizin Campus Mitte, Berlin, Germany.
FAU - Rosenkranz, Stephan
AU  - Rosenkranz S
AD  - University Hospital Cologne, Cologne, Germany.
FAU - Tschope, Carsten
AU  - Tschope C
AD  - Charite-Universitatsmedizin Campus Virchow, Berlin, Germany.
FAU - Adamson, Philip B
AU  - Adamson PB
AD  - Abbott, Austin, TX, USA.
FAU - Bohm, Michael
AU  - Bohm M
AD  - Saarland University Medical Center, Homburg, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT02693691
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20180519
PL  - Germany
TA  - Clin Res Cardiol
JT  - Clinical research in cardiology : official journal of the German Cardiac Society
JID - 101264123
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Pressure Monitoring, Ambulatory/*instrumentation
MH  - Equipment Design
MH  - Feasibility Studies
MH  - Female
MH  - Heart Failure/*physiopathology
MH  - Humans
MH  - Male
MH  - Micro-Electrical-Mechanical Systems
MH  - Middle Aged
MH  - Prospective Studies
MH  - Pulmonary Artery/*physiopathology
MH  - Pulmonary Wedge Pressure/*physiology
MH  - *Quality of Life
MH  - Reproducibility of Results
OTO - NOTNLM
OT  - CardioMEMS system
OT  - Heart failure
OT  - Hospitalization
OT  - Pulmonary artery pressure
OT  - Quality of life
OT  - Safety
EDAT- 2018/05/20 06:00
MHDA- 2018/12/12 06:00
CRDT- 2018/05/20 06:00
PHST- 2018/03/14 00:00 [received]
PHST- 2018/05/14 00:00 [accepted]
PHST- 2018/05/20 06:00 [pubmed]
PHST- 2018/12/12 06:00 [medline]
PHST- 2018/05/20 06:00 [entrez]
AID - 10.1007/s00392-018-1281-8 [pii]
AID - 10.1007/s00392-018-1281-8 [doi]
PST - ppublish
SO  - Clin Res Cardiol. 2018 Nov;107(11):991-1002. doi: 10.1007/s00392-018-1281-8. Epub 
      2018 May 19.