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

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Title: Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial.
Authors: Brugts, Jasper J (AUTHOR), Radhoe, Sumant P (AUTHOR), Clephas, Pascal R D (AUTHOR), Aydin, Dilan (AUTHOR), van Gent, Marco W F (AUTHOR), Szymanski, Mariusz K (AUTHOR), Rienstra, Michiel (AUTHOR), van den Heuvel, Mieke H (AUTHOR), da Fonseca, Carlos A (AUTHOR), Linssen, Gerard C M (AUTHOR), Borleffs, C Jan Willem (AUTHOR), Boersma, Eric (AUTHOR), Asselbergs, Folkert W (AUTHOR), Mosterd, Arend (AUTHOR), Brunner-La Rocca, Hans-Peter (AUTHOR), de Boer, Rudolf A (AUTHOR)
Source: Lancet. Jun2023, Vol. 401 Issue 10394, p2113-2123. 11p.
Subjects: Heart failure patients, Abbott Laboratories Inc., Pulmonary artery, Hemodynamics, Clinical trials monitoring, Clinical trials, Hemodynamic monitoring, Ventricular ejection fraction, Heart failure
Geographic Terms: Kansas City (Kan.), Netherlands
Abstract: 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. 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. 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. 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. The Dutch Ministry of Health, Health Care Institute (Zorginstituut), and Abbott Laboratories. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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DbLabel: Psychology and Behavioral Sciences Collection
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  Data: Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial.
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  Data: <searchLink fieldCode="AR" term="%22Brugts%2C+Jasper+J%22">Brugts, Jasper J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Radhoe%2C+Sumant+P%22">Radhoe, Sumant P</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Clephas%2C+Pascal+R+D%22">Clephas, Pascal R D</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Aydin%2C+Dilan%22">Aydin, Dilan</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22van+Gent%2C+Marco+W+F%22">van Gent, Marco W F</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Szymanski%2C+Mariusz+K%22">Szymanski, Mariusz K</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Rienstra%2C+Michiel%22">Rienstra, Michiel</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22van+den+Heuvel%2C+Mieke+H%22">van den Heuvel, Mieke H</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22da+Fonseca%2C+Carlos+A%22">da Fonseca, Carlos A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Linssen%2C+Gerard+C+M%22">Linssen, Gerard C M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Borleffs%2C+C+Jan+Willem%22">Borleffs, C Jan Willem</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Boersma%2C+Eric%22">Boersma, Eric</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Asselbergs%2C+Folkert+W%22">Asselbergs, Folkert W</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mosterd%2C+Arend%22">Mosterd, Arend</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Brunner-La+Rocca%2C+Hans-Peter%22">Brunner-La Rocca, Hans-Peter</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22de+Boer%2C+Rudolf+A%22">de Boer, Rudolf A</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. Jun2023, Vol. 401 Issue 10394, p2113-2123. 11p.
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  Data: <searchLink fieldCode="DE" term="%22Heart+failure+patients%22">Heart failure patients</searchLink><br /><searchLink fieldCode="DE" term="%22Abbott+Laboratories+Inc%2E%22">Abbott Laboratories Inc.</searchLink><br /><searchLink fieldCode="DE" term="%22Pulmonary+artery%22">Pulmonary artery</searchLink><br /><searchLink fieldCode="DE" term="%22Hemodynamics%22">Hemodynamics</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials+monitoring%22">Clinical trials monitoring</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Hemodynamic+monitoring%22">Hemodynamic monitoring</searchLink><br /><searchLink fieldCode="DE" term="%22Ventricular+ejection+fraction%22">Ventricular ejection fraction</searchLink><br /><searchLink fieldCode="DE" term="%22Heart+failure%22">Heart failure</searchLink>
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  Data: <searchLink fieldCode="DE" term="%22Kansas+City+%28Kan%2E%29%22">Kansas City (Kan.)</searchLink><br /><searchLink fieldCode="DE" term="%22Netherlands%22">Netherlands</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: 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. 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. 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. 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. The Dutch Ministry of Health, Health Care Institute (Zorginstituut), and Abbott Laboratories. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=164459702
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      – Type: doi
        Value: 10.1016/S0140-6736(23)00923-6
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      – Code: eng
        Text: English
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        PageCount: 11
        StartPage: 2113
    Subjects:
      – SubjectFull: Heart failure patients
        Type: general
      – SubjectFull: Abbott Laboratories Inc.
        Type: general
      – SubjectFull: Pulmonary artery
        Type: general
      – SubjectFull: Hemodynamics
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      – SubjectFull: Clinical trials monitoring
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      – SubjectFull: Ventricular ejection fraction
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      – SubjectFull: Heart failure
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      – SubjectFull: Kansas City (Kan.)
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      – SubjectFull: Netherlands
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