In the first randomized clinical trial of remote pulmonary artery pressure–guided monitoring and management of chronic heart failure (HF) in Europe, the intervention “substantially” improved quality of life (QoL) and reduced HF hospitalizations, new data show.
The CardioMEMS-HF system (Abbot Laboratories) used in the trial, called MONITOR-HF, remotely monitors changes in pulmonary artery pressure and provides an early warning of worsening HF.
Jasper Brugts, MD, PhD, of Erasmus MC University Medical Centre, Rotterdam, the Netherlands, told theheart.org | Medscape Cardiology, “The concordance on outcomes of the three CardioMEMS trials across different eras, evolving GDMT [guideline-directed medical therapy], different conditions (pandemic), and different healthcare systems is reassuring and supportive of technologies such as CardioMEMS to improve patient monitoring to prevent HF hospitalizations and improve QoL.”
Brugts presented the study on May 20 at the Heart Failure Association of the European Society of Cardiology (HFA-ESC) 2023.
The system “improved QoL in all six domains of the Kansas City Cardiomyopathy Questionnaire” and resulted in fewer HF-related hospitalizations (117 vs 212) and fewer urgent visits (11 vs 17) in comparison with standard of care, Brugts told meeting attendees.
Furthermore, CardioMEMS monitors hypervolemia as well as hypovolemia, enabling “fine-tuning of diuretics.”
The presentation drew such applause that one chairperson described it as “close to a standing ovation.” The study was published simultaneously in The Lancet.
Early clinical evidence of the benefits of remote monitoring with the CardioMEMS-HF system was provided by the CHAMPION trial, which included patients with New York Heart Association (NYHA) class III heart failure.
Results of the subsequent GUIDE-HF trial, which aimed to test a broader population of patients with NYHA class II–IV heart failure and either increased N-terminal-pro-B-type natriuretic peptide (NT-proBNP) concentrations or hospitalization, were inconclusive.
However, a pre-COVID-19 impact analysis of GUIDE-HF indicated a possible benefit, which was primarily driven by a lower HF hospitalization rate compared with the control group. That finding was the basis for an expanded indication for the system from the US Food and Drug Administration (FDA).
The 2022 FDA indication permits the use of CardioMEMS for patients with NYHA class II HF and for those with worsening HF, as assessed by elevated natriuretic peptide levels.
From US to Europe
Aware that most CardioMEMS data came from US trials, the investigators embarked on the current trial, MONITOR-HF, an open-label, randomized trial in 25 centers in the Netherlands. Eligible patients had chronic NYHA class III HF, irrespective of ejection fraction, and had previously undergone hospitalization for HF.
A total of 348 patients were randomly assigned to either CardioMEMS-HF or standard of care (SoC) between 2019 and 2022.The median age of the patients was 69 years, and the median ejection fraction was 30%.
All patients were scheduled to be seen by their clinician at 3 months, 6 months, and every 6 months thereafter for up to 48 months.
The primary endpoint was the mean difference in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score at 12 months
That difference between groups was 7.13 (+7.05 in the CardioMEMS group and -0.08 in the SoC group).
In the responder analysis, the odds ratio (OR) of an improvement of at least 5 points in the KCCQ overall summary score was 1.69 in the CardioMEMS group vs the SoC group; the OR of a deterioration of at least 5 points was 0.45.
Subgroup analyses showed no relevant heterogeneity in the treatment effect on total HF hospitalizations and, notably, no significant interaction in patients with an EF below 40% and an EF above 40%.
There was a significant reduction in the median NT-proBNP change from baseline only in the remote monitoring group (800 pg/mL) and a smaller, nonsignificant difference with SoC.
Both groups received highly appropriate background guideline–directed medical therapy throughout the study. There were no significant between-group differences at 12 months.
Freedom from device-related or system-related complications and sensor failure were 97.7% and 98.8%, respectively.
Two sensor failures occurred during a mean follow-up 1.8 years. The percentage of failures (98.8%) was comparable to CHAMPION and GUIDE-HF trials.
The trial was not powered to assess a mortality benefit.
Pick the Right Patients
“As in the US trials, there will be side effects, so select the right patients, because [remote monitoring] is not without risk,” Brugts told meeting attendees.
That point also was made by Christiane E. Angermann of University and University Hospital Würzburg, Würzburg, Germany, in a related editorial in The Lancet.
“To reproduce these results on a large scale in real-life health care, diligent patient selection should identify those at high risk of heart failure-related hospitalization who agree with the concept of daily data collection and are able and motivated to comply with treatment recommendations even if asymptomatic, Angermann writes.
“Without direct interaction between health-care providers and patients, and timely treatment modification triggered by abnormal monitoring results, the care cycle might break and the potential benefits from early detection of decompensation would be lost.”
Val Rakita, MD, assistant professor of medicine at the Lewis Katz School of Medicine at Temple University, Philadelphia, a specialist in advanced heart failure and main implanter of the CardioMEMS device at Temple University Hospital, commented on the study for theheart.org | Medscape Cardiology.
“This study confirms the previous data that the device is very safe and effective in preventing HF hospitalizations and improving patients’ quality of life, even in a different population with more modern background guideline–directed medical therapy.”
Nevertheless, he noted, “Studies have yet to confirm a mortality benefit, despite logic telling us that preventing heart failure hospitalizations should also improve patient survival. More studies are needed to see if a survival benefit can be proven over a longer follow-up period.”
Overall, he said, “Remote monitoring allows more precise management of medications, prevention of hospitalizations, and improvement in quality of life, and I am an advocate for it in my practice.”
Not everyone is an advocate, however. In a commentary published on Medscape last year, John M. Mandrola, MD, a cardiac electrophysiologist at Baptist Medical Associates in Louisville, Kentucky, said the expanded FDA indication for the device is the result of “dubious trial analysis, spin, lax regulation, and the growth of low-value care.”
Others also have questioned the device’s value in the clinic.
But at least for now, as Angermann writes, “Scientific evidence supports the use of the CardioMEMS-HF system to enhance remote patient management in heart failure care. For more widespread application, technological advancements are desirable to provide more comfort for patients and re-usable external device components, thereby improving care experience and saving resources.”
The MONITOR-HF trial is funded by the Dutch Ministry of Health and Health Care institute. Brugts has an independent research grant from Abbott (investigator-sponsored study) and has had speaker engagements or has participated in advisory boards for Abbott and other pharmaceutical companies. Angermann has received personal fees from Abbott for serving as chair of the steering committee for the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) and consulting fees, honoraria, and travel costs from Abbott. Rakita has disclosed no relevant financial relationships.
Heart Failure Association of the European Society of Cardiology (HFA-ESC) 2023: Presented May 20, 2023.
Lancet. Published online May 20, 2023. Abstract, Editorial
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