Christiane E Angermann1, Birgit Assmus2,3, Stefan D Anker4, Folkert W Asselbergs5, Johannes Brachmann6, Marie-Elena Brett7, Jasper J Brugts8, Georg Ertl1, Greg Ginn7, Lutz Hilker9, Friedrich Koehler10, Stephan Rosenkranz11, Qian Zhou12,13, Philip B Adamson7, Michael Böhm14. 1. Comprehensive Heart Failure Center, University and University Hospital, Würzburg, University Hospital Würzburg, Würzburg, Germany. 2. Department of Medicine, Cardiology, Goethe University Hospital, Frankfurt, Germany. 3. Department of Medicine I, Cardiology/Angiology, University Hospital, Giessen, Germany. 4. Division of Cardiology & 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. 5. Division Heart & Lungs, Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands. 6. Medical Centre Coburg GmbH II, Medical Clinic Cardiology, Angiology, Pulmonology, Coburg, Germany. 7. Abbott, Sylmar, CA, USA. 8. Erasmus MC University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands. 9. Klinikum Karlsburg, Heart and Diabetes Center Mecklenburg-Western Pommerania, Karlsburg, Germany. 10. Division of Cardiology and Angiology, Medical Department, Campus Charité Mitte, Centre for Cardiovascular Telemedicine, Charité Universitätsmedizin Berlin, Berlin, Germany. 11. Clinic III for Internal Medicine, University of Cologne Heart Center, and Cologne Cardiovascular Research Center (CCRC), Cologne, Germany. 12. Department of Cardiology and Angiology I, University Heart Center Freiburg - Bad Krozingen, University of Freiburg, Freiburg, Germany. 13. Department of Cardiology, University Hospital Basel, Basel, Switzerland. 14. Internal Medicine III Cardiology, Angiology, Intensive Care, Saarland University Medical Centre, Homburg, Germany.
Abstract
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.
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.
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