PMID- 32592227 OWN - NLM STAT- MEDLINE DCOM- 20210517 LR - 20210517 IS - 1879-0844 (Electronic) IS - 1388-9842 (Linking) VI - 22 IP - 10 DP - 2020 Oct TI - Pulmonary artery pressure-guided therapy in ambulatory patients with symptomatic heart failure: the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF). PG - 1891-1901 LID - 10.1002/ejhf.1943 [doi] AB - AIMS: Heart failure (HF) leads to repeat hospitalisations and reduces the duration and quality of life. Pulmonary artery pressure (PAP)-guided HF management using the CardioMEMS HF system was shown to be safe and reduce HF hospitalisation (HFH) rates in New York Heart Association (NYHA) class III patients. However, these findings have not been replicated in health systems outside the United States. Therefore, the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) evaluated the safety, feasibility, and performance of this device in Germany, The Netherlands, and Ireland. METHODS AND RESULTS: A total of 234 NYHA class III patients (68 +/- 11 years, 22% female, >/=1 HFH in the preceding year) from 31 centres were implanted with a CardioMEMS sensor and underwent PAP-guided HF management. One-year rates of freedom from device- or system-related complications and from sensor failure (co-primary outcomes) were 98.3% [95% confidence interval (CI) 95.8-100.0] and 99.6% (95% CI 97.6-100.0), respectively. Survival rate was 86.2%. For the 12 months post- vs. pre-implant, HFHs decreased by 62% (0.60 vs. 1.55 events/patient-year; hazard ratio 0.38, 95% CI 0.31-0.48; P < 0.0001). After 12 months, mean PAP decreased by 5.1 +/- 7.4 mmHg, Kansas City Cardiomyopathy Questionnaire (KCCQ) overall/clinical summary scores increased from 47.0 +/- 24.0/51.2 +/- 24.8 to 60.5 +/- 24.3/62.4 +/- 24.1 (P < 0.0001), and the 9-item Patient Health Questionnaire sum score improved from 8.7 +/- 5.9 to 6.3 +/- 5.1 (P < 0.0001). CONCLUSION: Haemodynamic-guided HF management proved feasible and safe in the health systems of Germany, The Netherlands, and Ireland. Physician-directed treatment modifications based on remotely obtained PAP values were associated with fewer HFH, sustainable PAP decreases, marked KCCQ improvements, and remission of depressive symptoms. CI - (c) 2020 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. FAU - Angermann, Christiane E AU - Angermann CE AD - Comprehensive Heart Failure Center, University and University Hospital, Wurzburg, University Hospital Wurzburg, Wurzburg, Germany. FAU - Assmus, Birgit AU - Assmus B AD - Department of Medicine, Cardiology, Goethe University Hospital, Frankfurt, Germany. AD - Department of Medicine I, Cardiology/Angiology, University Hospital, Giessen, Germany. FAU - Anker, Stefan D AU - Anker SD AD - Division of Cardiology & 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. FAU - Asselbergs, Folkert W AU - Asselbergs FW AD - Division Heart & Lungs, Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands. FAU - Brachmann, Johannes AU - Brachmann J AD - Medical Centre Coburg GmbH II, Medical Clinic Cardiology, Angiology, Pulmonology, Coburg, Germany. FAU - Brett, Marie-Elena AU - Brett ME AD - Abbott, Sylmar, CA, USA. FAU - Brugts, Jasper J AU - Brugts JJ AD - Erasmus MC University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands. FAU - Ertl, Georg AU - Ertl G AD - Comprehensive Heart Failure Center, University and University Hospital, Wurzburg, University Hospital Wurzburg, Wurzburg, Germany. FAU - Ginn, Greg AU - Ginn G AD - Abbott, Sylmar, CA, USA. FAU - Hilker, Lutz AU - Hilker L AD - Klinikum Karlsburg, Heart and Diabetes Center Mecklenburg-Western Pommerania, Karlsburg, Germany. FAU - Koehler, Friedrich AU - Koehler F AD - Division of Cardiology and Angiology, Medical Department, Campus Charite Mitte, Centre for Cardiovascular Telemedicine, Charite Universitatsmedizin Berlin, Berlin, Germany. FAU - Rosenkranz, Stephan AU - Rosenkranz S AD - Clinic III for Internal Medicine, University of Cologne Heart Center, and Cologne Cardiovascular Research Center (CCRC), Cologne, Germany. FAU - Zhou, Qian AU - Zhou Q AD - Department of Cardiology and Angiology I, University Heart Center Freiburg - Bad Krozingen, University of Freiburg, Freiburg, Germany. AD - Department of Cardiology, University Hospital Basel, Basel, Switzerland. FAU - Adamson, Philip B AU - Adamson PB AD - Abbott, Sylmar, CA, USA. FAU - Bohm, Michael AU - Bohm M AD - Internal Medicine III Cardiology, Angiology, Intensive Care, Saarland University Medical Centre, Homburg, Germany. CN - MEMS-HF Investigators LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20200809 PL - England TA - Eur J Heart Fail JT - European journal of heart failure JID - 100887595 SB - IM CIN - Eur J Heart Fail. 2020 Oct;22(10):1902-1904. PMID: 32853486 CIN - Eur J Heart Fail. 2020 Oct;22(10):1905-1906. PMID: 32892483 MH - Aged MH - Female MH - Germany MH - *Heart Failure/epidemiology/therapy MH - Humans MH - Ireland MH - Male MH - *Micro-Electrical-Mechanical Systems MH - Middle Aged MH - Netherlands MH - Pulmonary Artery MH - Quality of Life MH - United States OTO - NOTNLM OT - CardioMEMS HF system OT - Depression OT - Haemodynamic monitoring OT - Health-related quality of life OT - Heart failure OT - Morbidity EDAT- 2020/06/28 06:00 MHDA- 2021/05/18 06:00 CRDT- 2020/06/28 06:00 PHST- 2020/04/08 00:00 [received] PHST- 2020/05/27 00:00 [revised] PHST- 2020/06/20 00:00 [accepted] PHST- 2020/06/28 06:00 [pubmed] PHST- 2021/05/18 06:00 [medline] PHST- 2020/06/28 06:00 [entrez] AID - 10.1002/ejhf.1943 [doi] PST - ppublish SO - Eur J Heart Fail. 2020 Oct;22(10):1891-1901. doi: 10.1002/ejhf.1943. Epub 2020 Aug 9.