Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial (2024)

Abstract

Background: The effect of haemodynamic monitoring of pulmonary artery pressure has predominantly been studied in the USA. There is a clear need for randomised trial data from patients treated with contemporary guideline-directed-medical-therapy with long-term follow-up in a different health-care system. Methods: MONITOR-HF was an open-label, randomised trial, done in 25 centres in the Netherlands. Eligible patients had chronic heart failure of New York Heart Association class III and a previous heart failure hospitalisation, irrespective of ejection fraction. Patients were randomly assigned (1:1) to haemodynamic monitoring (CardioMEMS-HF system, Abbott Laboratories, Abbott Park, IL, USA) or standard care. All patients were scheduled to be seen by their clinician at 3 months and 6 months, and every 6 months thereafter, up to 48 months. The primary endpoint was the mean difference in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at 12 months. All analyses were by intention-to-treat. This trial was prospectively registered under the clinical trial registration number NTR7673 (NL7430) on the International Clinical Trials Registry Platform. Findings: Between April 1, 2019, and Jan 14, 2022, we randomly assigned 348 patients to either the CardioMEMS-HF group (n=176 [51%]) or the control group (n=172 [49%]). The median age was 69 years (IQR 61–75) and median ejection fraction was 30% (23–40). The difference in mean change in KCCQ overall summary score at 12 months was 7·13 (95% CI 1·51–12·75; p=0·013) between groups (+7·05 in the CardioMEMS group, p=0·0014, and –0·08 in the standard care group, p=0·97). In the responder analysis, the odds ratio (OR) of an improvement of at least 5 points in KCCQ overall summary score was OR 1·69 (95% CI 1·01–2·83; p=0·046) and the OR of a deterioration of at least 5 points was 0·45 (0·26–0·77; p=0·0035) in the CardioMEMS-HF group compared with in the standard care group. The freedom of device-related or system-related complications and sensor failure were 97·7% and 98·8%, respectively. Interpretation: Haemodynamic monitoring substantially improved quality of life and reduced heart failure hospitalisations in patients with moderate-to-severe heart failure treated according to contemporary guidelines. These findings contribute to the aggregate evidence for this technology and might have implications for guideline recommendations and implementation of remote pulmonary artery pressure monitoring. Funding: The Dutch Ministry of Health, Health Care Institute (Zorginstituut), and Abbott Laboratories.

Original languageEnglish
Pages (from-to)2113-2123
Number of pages11
JournalThe Lancet
Volume401
Issue number10394
DOIs
Publication statusPublished - 24 Jun 2023

Bibliographical note

Funding: The Dutch Ministry of Health, Health Care Institute (Zorginstituut), and Abbott Laboratories.

Publisher Copyright: © 2023 Elsevier Ltd

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Brugts, J. J., Radhoe, S. P., MONITOR-HF investigators, Clephas, P. R. D., Aydin, D., van Gent, M. W. F., Szymanski, M. K., Rienstra, M., van den Heuvel, M. H., da Fonseca, C. A., Linssen, G. C. M., Borleffs, C. J. W., Boersma, E., Asselbergs, F. W., Mosterd, A., Brunner-La Rocca, H. P. (2023). Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial. The Lancet, 401(10394), 2113-2123. https://doi.org/10.1016/S0140-6736(23)00923-6

Brugts, Jasper J. ; Radhoe, Sumant P. ; MONITOR-HF investigators et al. / Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF) : a randomised clinical trial. In: The Lancet. 2023 ; Vol. 401, No. 10394. pp. 2113-2123.

@article{51642ffdc67444a9826af473cd286ddd,

title = "Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial",

abstract = "Background: The effect of haemodynamic monitoring of pulmonary artery pressure has predominantly been studied in the USA. There is a clear need for randomised trial data from patients treated with contemporary guideline-directed-medical-therapy with long-term follow-up in a different health-care system. Methods: MONITOR-HF was an open-label, randomised trial, done in 25 centres in the Netherlands. Eligible patients had chronic heart failure of New York Heart Association class III and a previous heart failure hospitalisation, irrespective of ejection fraction. Patients were randomly assigned (1:1) to haemodynamic monitoring (CardioMEMS-HF system, Abbott Laboratories, Abbott Park, IL, USA) or standard care. All patients were scheduled to be seen by their clinician at 3 months and 6 months, and every 6 months thereafter, up to 48 months. The primary endpoint was the mean difference in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at 12 months. All analyses were by intention-to-treat. This trial was prospectively registered under the clinical trial registration number NTR7673 (NL7430) on the International Clinical Trials Registry Platform. Findings: Between April 1, 2019, and Jan 14, 2022, we randomly assigned 348 patients to either the CardioMEMS-HF group (n=176 [51%]) or the control group (n=172 [49%]). The median age was 69 years (IQR 61–75) and median ejection fraction was 30% (23–40). The difference in mean change in KCCQ overall summary score at 12 months was 7·13 (95% CI 1·51–12·75; p=0·013) between groups (+7·05 in the CardioMEMS group, p=0·0014, and –0·08 in the standard care group, p=0·97). In the responder analysis, the odds ratio (OR) of an improvement of at least 5 points in KCCQ overall summary score was OR 1·69 (95% CI 1·01–2·83; p=0·046) and the OR of a deterioration of at least 5 points was 0·45 (0·26–0·77; p=0·0035) in the CardioMEMS-HF group compared with in the standard care group. The freedom of device-related or system-related complications and sensor failure were 97·7% and 98·8%, respectively. Interpretation: Haemodynamic monitoring substantially improved quality of life and reduced heart failure hospitalisations in patients with moderate-to-severe heart failure treated according to contemporary guidelines. These findings contribute to the aggregate evidence for this technology and might have implications for guideline recommendations and implementation of remote pulmonary artery pressure monitoring. Funding: The Dutch Ministry of Health, Health Care Institute (Zorginstituut), and Abbott Laboratories.",

author = "Brugts, {Jasper J.} and Radhoe, {Sumant P.} and {MONITOR-HF investigators} and Clephas, {Pascal R.D.} and Dilan Aydin and {van Gent}, {Marco W.F.} and Szymanski, {Mariusz K.} and Michiel Rienstra and {van den Heuvel}, {Mieke H.} and {da Fonseca}, {Carlos A.} and Linssen, {Gerard C.M.} and Borleffs, {C. Jan Willem} and Eric Boersma and Asselbergs, {Folkert W.} and Arend Mosterd and {Brunner-La Rocca}, {Hans Peter} and {de Boer}, {Rudolf A.} and Emans, {M. E.} and Beeres, {S. L.M.A.} and L. Heerebeek and C. Kirchhof and {Van Ramshorst}, J. and R. Spee and T. Smilde and {Van Eck}, M. and E. Kaplan and R. Hazeleger and R. Tukkie and M. Feenema and W. Kok and {Van Halm}, V. and Handoko, {M. L.} and {Van Kimmenade}, R. and M. Post and {Van Mieghem}, N. and Manintveld, {O. C.}",

note = "Funding: The Dutch Ministry of Health, Health Care Institute (Zorginstituut), and Abbott Laboratories. Publisher Copyright: {\textcopyright} 2023 Elsevier Ltd",

year = "2023",

month = jun,

day = "24",

doi = "10.1016/S0140-6736(23)00923-6",

language = "English",

volume = "401",

pages = "2113--2123",

journal = "The Lancet",

issn = "0140-6736",

publisher = "Elsevier Ltd.",

number = "10394",

}

Brugts, JJ, Radhoe, SP, MONITOR-HF investigators, Clephas, PRD, Aydin, D, van Gent, MWF, Szymanski, MK, Rienstra, M, van den Heuvel, MH, da Fonseca, CA, Linssen, GCM, Borleffs, CJW, Boersma, E, Asselbergs, FW, Mosterd, A, Brunner-La Rocca, HP 2023, 'Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial', The Lancet, vol. 401, no. 10394, pp. 2113-2123. https://doi.org/10.1016/S0140-6736(23)00923-6

Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial. / Brugts, Jasper J.; Radhoe, Sumant P.; MONITOR-HF investigators et al.
In: The Lancet, Vol. 401, No. 10394, 24.06.2023, p. 2113-2123.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF)

T2 - a randomised clinical trial

AU - Brugts, Jasper J.

AU - Radhoe, Sumant P.

AU - MONITOR-HF investigators

AU - Clephas, Pascal R.D.

AU - Aydin, Dilan

AU - van Gent, Marco W.F.

AU - Szymanski, Mariusz K.

AU - Rienstra, Michiel

AU - van den Heuvel, Mieke H.

AU - da Fonseca, Carlos A.

AU - Linssen, Gerard C.M.

AU - Borleffs, C. Jan Willem

AU - Boersma, Eric

AU - Asselbergs, Folkert W.

AU - Mosterd, Arend

AU - Brunner-La Rocca, Hans Peter

AU - de Boer, Rudolf A.

AU - Emans, M. E.

AU - Beeres, S. L.M.A.

AU - Heerebeek, L.

AU - Kirchhof, C.

AU - Van Ramshorst, J.

AU - Spee, R.

AU - Smilde, T.

AU - Van Eck, M.

AU - Kaplan, E.

AU - Hazeleger, R.

AU - Tukkie, R.

AU - Feenema, M.

AU - Kok, W.

AU - Van Halm, V.

AU - Handoko, M. L.

AU - Van Kimmenade, R.

AU - Post, M.

AU - Van Mieghem, N.

AU - Manintveld, O. C.

N1 - Funding: The Dutch Ministry of Health, Health Care Institute (Zorginstituut), and Abbott Laboratories. Publisher Copyright: © 2023 Elsevier Ltd

PY - 2023/6/24

Y1 - 2023/6/24

N2 - Background: The effect of haemodynamic monitoring of pulmonary artery pressure has predominantly been studied in the USA. There is a clear need for randomised trial data from patients treated with contemporary guideline-directed-medical-therapy with long-term follow-up in a different health-care system. Methods: MONITOR-HF was an open-label, randomised trial, done in 25 centres in the Netherlands. Eligible patients had chronic heart failure of New York Heart Association class III and a previous heart failure hospitalisation, irrespective of ejection fraction. Patients were randomly assigned (1:1) to haemodynamic monitoring (CardioMEMS-HF system, Abbott Laboratories, Abbott Park, IL, USA) or standard care. All patients were scheduled to be seen by their clinician at 3 months and 6 months, and every 6 months thereafter, up to 48 months. The primary endpoint was the mean difference in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at 12 months. All analyses were by intention-to-treat. This trial was prospectively registered under the clinical trial registration number NTR7673 (NL7430) on the International Clinical Trials Registry Platform. Findings: Between April 1, 2019, and Jan 14, 2022, we randomly assigned 348 patients to either the CardioMEMS-HF group (n=176 [51%]) or the control group (n=172 [49%]). The median age was 69 years (IQR 61–75) and median ejection fraction was 30% (23–40). The difference in mean change in KCCQ overall summary score at 12 months was 7·13 (95% CI 1·51–12·75; p=0·013) between groups (+7·05 in the CardioMEMS group, p=0·0014, and –0·08 in the standard care group, p=0·97). In the responder analysis, the odds ratio (OR) of an improvement of at least 5 points in KCCQ overall summary score was OR 1·69 (95% CI 1·01–2·83; p=0·046) and the OR of a deterioration of at least 5 points was 0·45 (0·26–0·77; p=0·0035) in the CardioMEMS-HF group compared with in the standard care group. The freedom of device-related or system-related complications and sensor failure were 97·7% and 98·8%, respectively. Interpretation: Haemodynamic monitoring substantially improved quality of life and reduced heart failure hospitalisations in patients with moderate-to-severe heart failure treated according to contemporary guidelines. These findings contribute to the aggregate evidence for this technology and might have implications for guideline recommendations and implementation of remote pulmonary artery pressure monitoring. Funding: The Dutch Ministry of Health, Health Care Institute (Zorginstituut), and Abbott Laboratories.

AB - Background: The effect of haemodynamic monitoring of pulmonary artery pressure has predominantly been studied in the USA. There is a clear need for randomised trial data from patients treated with contemporary guideline-directed-medical-therapy with long-term follow-up in a different health-care system. Methods: MONITOR-HF was an open-label, randomised trial, done in 25 centres in the Netherlands. Eligible patients had chronic heart failure of New York Heart Association class III and a previous heart failure hospitalisation, irrespective of ejection fraction. Patients were randomly assigned (1:1) to haemodynamic monitoring (CardioMEMS-HF system, Abbott Laboratories, Abbott Park, IL, USA) or standard care. All patients were scheduled to be seen by their clinician at 3 months and 6 months, and every 6 months thereafter, up to 48 months. The primary endpoint was the mean difference in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at 12 months. All analyses were by intention-to-treat. This trial was prospectively registered under the clinical trial registration number NTR7673 (NL7430) on the International Clinical Trials Registry Platform. Findings: Between April 1, 2019, and Jan 14, 2022, we randomly assigned 348 patients to either the CardioMEMS-HF group (n=176 [51%]) or the control group (n=172 [49%]). The median age was 69 years (IQR 61–75) and median ejection fraction was 30% (23–40). The difference in mean change in KCCQ overall summary score at 12 months was 7·13 (95% CI 1·51–12·75; p=0·013) between groups (+7·05 in the CardioMEMS group, p=0·0014, and –0·08 in the standard care group, p=0·97). In the responder analysis, the odds ratio (OR) of an improvement of at least 5 points in KCCQ overall summary score was OR 1·69 (95% CI 1·01–2·83; p=0·046) and the OR of a deterioration of at least 5 points was 0·45 (0·26–0·77; p=0·0035) in the CardioMEMS-HF group compared with in the standard care group. The freedom of device-related or system-related complications and sensor failure were 97·7% and 98·8%, respectively. Interpretation: Haemodynamic monitoring substantially improved quality of life and reduced heart failure hospitalisations in patients with moderate-to-severe heart failure treated according to contemporary guidelines. These findings contribute to the aggregate evidence for this technology and might have implications for guideline recommendations and implementation of remote pulmonary artery pressure monitoring. Funding: The Dutch Ministry of Health, Health Care Institute (Zorginstituut), and Abbott Laboratories.

UR - http://www.scopus.com/inward/record.url?scp=85160950863&partnerID=8YFLogxK

U2 - 10.1016/S0140-6736(23)00923-6

DO - 10.1016/S0140-6736(23)00923-6

M3 - Article

C2 - 37220768

AN - SCOPUS:85160950863

SN - 0140-6736

VL - 401

SP - 2113

EP - 2123

JO - The Lancet

JF - The Lancet

IS - 10394

ER -

Brugts JJ, Radhoe SP, MONITOR-HF investigators, Clephas PRD, Aydin D, van Gent MWF et al. Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial. The Lancet. 2023 Jun 24;401(10394):2113-2123. doi: 10.1016/S0140-6736(23)00923-6

Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial (2024)
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