TY - JOUR
T1 - Pulmonary artery pressure-guided therapy in ambulatory patients with symptomatic heart failure
T2 - the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF)
AU - Angermann, Christiane E
AU - Assmus, Birgit
AU - Anker, Stefan D
AU - Asselbergs, Folkert W
AU - Brachmann, Johannes
AU - Brett, Marie-Elena
AU - Brugts, Jasper J
AU - Ertl, Georg
AU - Ginn, Greg
AU - Hilker, Lutz
AU - Koehler, Friedrich
AU - Rosenkranz, Stephan
AU - Zhou, Qian
AU - Adamson, Philip B
AU - Böhm, Michael
N1 - Funding Information:
This work was supported by Abbott, Sylmar, CA, USA.
Funding Information:
C.E.A., S.D.A., B.A., J.B., G.E., F.K., S.R., and M.B. served on the MEMS‐HF steering committee. F.W.A. and J.J.B. were on the steering committee of the Abbott‐sponsored MONITOR‐HF study. P.B.A., M.E.B., and G.G. are employees and shareholders of Abbott. C.E.A. is also/has been a member of steering committees for trials sponsored by Boehringer Ingelheim, Novartis, ResMed, Vifor and the CTSU Oxford, and reports honoraria for consultancy and speaker fees from Abbott, Boehringer Ingelheim, Medtronic, Novartis, ResMed, Servier and Vifor; S.D.A. reports receiving fees from Abbott Vascular, Actimed, Bayer, Boehringer Ingelheim, Cardiac Dimension, Impulse Dynamics, Novartis, Servier, and Vifor Pharma, and grant support from Abbott Vascular and Vifor Pharma; B.A. reports honoraria for consultancy and an unrestricted research grant from St Jude Medical, and speaker fees from Novartis, St Jude Medical and Vifor. M.B. reports honoraria for consultancy and speaker fees from Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Cytogenetics, Medtronic, Servier and Vifor. J.B. reports honoraria for consultancy and speakers fees and scientific support by Abbott, Medtronic and Biotronik. G.E. reports honoraria for consultancy and speakers fees from Bayer, Boehringer Ingelheim, St Jude Medical, Novartis, Servier, and Vifor. F.K. reports research funding by the German Federal Ministry of Economics and Technology, the European Commission, and the German Federal Ministry of Education and Research. S.R. reports honoraria for consultancy, speaker fees and scientific support by Abbott; and has received remuneration for lectures and/or consultancy from Actelion, Bayer, BMS, MSD, Novartis, Pfizer, Vifor and United Therapeutics, and his institution has received research grants from Actelion, Bayer, Novartis, and United Therapeutics. C.T. reports honoraria for consultancy and speakers fees from Abbott, and Novartis. L.H. and Q.Z. report no conflicts of interest. Conflict of interest:
Funding Information:
This work was supported by Abbott, Sylmar, CA, USA. Conflict of interest: C.E.A., S.D.A., B.A., J.B., G.E., F.K., S.R., and M.B. served on the MEMS-HF steering committee. F.W.A. and J.J.B. were on the steering committee of the Abbott-sponsored MONITOR-HF study. P.B.A., M.E.B., and G.G. are employees and shareholders of Abbott. C.E.A. is also/has been a member of steering committees for trials sponsored by Boehringer Ingelheim, Novartis, ResMed, Vifor and the CTSU Oxford, and reports honoraria for consultancy and speaker fees from Abbott, Boehringer Ingelheim, Medtronic, Novartis, ResMed, Servier and Vifor; S.D.A. reports receiving fees from Abbott Vascular, Actimed, Bayer, Boehringer Ingelheim, Cardiac Dimension, Impulse Dynamics, Novartis, Servier, and Vifor Pharma, and grant support from Abbott Vascular and Vifor Pharma; B.A. reports honoraria for consultancy and an unrestricted research grant from St Jude Medical, and speaker fees from Novartis, St Jude Medical and Vifor. M.B. reports honoraria for consultancy and speaker fees from Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Cytogenetics, Medtronic, Servier and Vifor. J.B. reports honoraria for consultancy and speakers fees and scientific support by Abbott, Medtronic and Biotronik. G.E. reports honoraria for consultancy and speakers fees from Bayer, Boehringer Ingelheim, St Jude Medical, Novartis, Servier, and Vifor. F.K. reports research funding by the German Federal Ministry of Economics and Technology, the European Commission, and the German Federal Ministry of Education and Research. S.R. reports honoraria for consultancy, speaker fees and scientific support by Abbott; and has received remuneration for lectures and/or consultancy from Actelion, Bayer, BMS, MSD, Novartis, Pfizer, Vifor and United Therapeutics, and his institution has received research grants from Actelion, Bayer, Novartis, and United Therapeutics. C.T. reports honoraria for consultancy and speakers fees from Abbott, and Novartis. L.H. and Q.Z. report no conflicts of interest. Open access funding enabled and organized by Projekt DEAL.
Publisher Copyright:
© 2020 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
PY - 2020/10
Y1 - 2020/10
N2 - 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.
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.
KW - CardioMEMS™ HF system
KW - Depression
KW - Haemodynamic monitoring
KW - Health-related quality of life
KW - Heart failure
KW - Morbidity
UR - http://www.scopus.com/inward/record.url?scp=85089096774&partnerID=8YFLogxK
U2 - 10.1002/ejhf.1943
DO - 10.1002/ejhf.1943
M3 - Article
C2 - 32592227
SN - 1388-9842
VL - 22
SP - 1891
EP - 1901
JO - European Journal of Heart Failure
JF - European Journal of Heart Failure
IS - 10
ER -