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Randomized Controlled Trial
. 2023 Jun 24;401(10394):2113-2123.
doi: 10.1016/S0140-6736(23)00923-6. Epub 2023 May 20.

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

Jasper J Brugts  1 , Sumant P Radhoe  1 , Pascal R D Clephas  1 , Dilan Aydin  1 , Marco W F van Gent  2 , Mariusz K Szymanski  3 , Michiel Rienstra  4 , Mieke H van den Heuvel  5 , Carlos A da Fonseca  6 , Gerard C M Linssen  7 , C Jan Willem Borleffs  8 , Eric Boersma  1 , Folkert W Asselbergs  9 , Arend Mosterd  10 , Hans-Peter Brunner-La Rocca  11 , Rudolf A de Boer  12 ; MONITOR-HF investigators
Collaborators, Affiliations
Randomized Controlled Trial

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

Jasper J Brugts et al. Lancet. .

Erratum in

  • Department of Error.
    [No authors listed] [No authors listed] Lancet. 2023 Jun 24;401(10394):2112. doi: 10.1016/S0140-6736(23)01256-4. Lancet. 2023. PMID: 37355291 No abstract available.

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.

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Conflict of interest statement

Declaration of interests JJB received an independent research grant from Abbott for investigator-initiated studies to the hospital and reports speaker engagement or advisory board fees from Astra Zeneca, Abbott, Boehringer Ingelheim, Bayer, Daiichi Sankyo, Novartis, and Vifor. CAdF received consulting or speaker fees from Astra Zeneca, Abbott, Boehringer Ingelheim, Novartis, Pfizer, Bristol Myers Squibb, Philips, and Servier. CJWB served on advisory boards, or had speaker engagements with Abbott, AstraZeneca, Boehringer Ingelheim, and Novartis. HPB-LR reports unrestricted research grants from Vifor, Novartis, and Roche Diagnostics, and reports consultancy fees and payments for lectures from Vifor, Novartis, Boehringer Ingelheim, AstraZeneca, and Roche Diagnostic. RAdB has received research grants or fees from AstraZeneca, Abbott, Boehringer Ingelheim, Cardior Pharmaceuticals, Ionis Pharmaceuticals, Novo Nordisk, and Roche; and has had speaker engagements with Abbott, AstraZeneca, Bayer, Bristol Myers Squibb, Novartis, and Roche. All other authors declare no competing interests.

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