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

Autor:	Brugts JJ; Department of Cardiology, Erasmus MC University Medical Centre, Rotterdam, Netherlands., Radhoe SP; Department of Cardiology, Erasmus MC University Medical Centre, Rotterdam, Netherlands., Clephas PRD; Department of Cardiology, Erasmus MC University Medical Centre, Rotterdam, Netherlands., Aydin D; Department of Cardiology, Erasmus MC University Medical Centre, Rotterdam, Netherlands., van Gent MWF; Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, Netherlands., Szymanski MK; Department of Cardiology, Utrecht University Medical Centre, Utrecht, Netherlands., Rienstra M; Department of Cardiology, University Medical Centre Groningen, Groningen, Netherlands., van den Heuvel MH; Department of Cardiology, Medisch Spectrum Twente, Enschede, Netherlands., da Fonseca CA; Department of Cardiology, Medisch Centrum Leeuwarden, Leeuwarden, Netherlands., Linssen GCM; Department of Cardiology, Hospital Group Twente, Almelo, Netherlands., Borleffs CJW; Department of Cardiology, HAGA Hospital, Den Haag, Netherlands., Boersma E; Department of Cardiology, Erasmus MC University Medical Centre, Rotterdam, Netherlands., Asselbergs FW; Department of Cardiology, Amsterdam University Medical Centre, Amsterdam, Netherlands., Mosterd A; Department of Cardiology, Meander Medical Centre, Amersfoort, Netherlands., Brunner-La Rocca HP; Department of Cardiology, Maastricht University Medical Centre, Maastricht, Netherlands., de Boer RA; Department of Cardiology, Erasmus MC University Medical Centre, Rotterdam, Netherlands. Electronic address: r.a.deboer@erasmusmc.nl.
Jazyk:	angličtina
Zdroj:	Lancet (London, England) [Lancet] 2023 Jun 24; Vol. 401 (10394), pp. 2113-2123. Date of Electronic Publication: 2023 May 20.
DOI:	10.1016/S0140-6736(23)00923-6
Abstrakt:	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. Competing Interests: 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. (Copyright © 2023 Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
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