Meet the Trialist: Innovating cardiac monitoring with MONITOR-HF

Medicom spoke with principal investigator Dr Jasper Brugts (Erasmus University Medical Center, the Netherlands) about the MONITOR-HF trial, where patients were equipped with the CardioMEMS HF System, a device designed to continuously monitor pulmonary artery pressures, providing real-time data that can guide more tailored and timely treatment decisions [1]. The recently published results from this trial have the potential to transform how patients with heart failure are managed [2].

The MONITOR-HF trial enrolled 348 participants with class III heart failure, as classified by the New York Heart Association (NYHA), across 25 centres. The participants were randomly assigned to receive standard guideline-directed medical therapy (GDMT) or GDMT plus haemodynamic monitoring using the CardioMEMS HF System. The study's primary endpoint was the change in quality of life, quantified by the Kansas City Cardiomyopathy Questionnaire (KCCQ), but the researchers also hoped to reduce the frequency of hospital admissions due to heart failure exacerbations. Results showed a meaningful improvement in the group equipped with the CardioMEMS sensor, evidenced by a mean increase of 7 points in their KCCQ scores, contrasted with a decline in the control group. The CardioMEMS device is a small sensor implanted in the pulmonary artery that monitors pressure changes signalling worsening heart failure and transmits this data wirelessly, enabling real-time management. The findings suggest that the addition of this remote monitoring system can significantly improve the quality of life of those already receiving high-quality care.

The findings have sparked discussions about the integration of such technologies into standard care, signalling a potential shift in heart failure management strategies. Medicom interviewed Dr Brugts to share the consideration of remote haemodynamic monitoring for patients with chronic heart failure.

Could you give us an overview of the key findings from MONITOR-HF that you presented at the Heart Failure Congress?

“I presented results from a subgroup analysis of the Monitor-HF trial, which tested the consistency of pulmonary pressure monitoring's treatment effect across several clinical endpoints like quality of life, heart failure events, mortality, and pulmonary artery pressure reductions [3]. We found that the treatment effect was consistent across all subgroups and clinical endpoints. There was no clinically relevant heterogeneity, meaning no specific subgroup of patients benefited more or less.”

Based on your research, how do you see remote monitoring technologies evolving in the near future?

"The heart failure community faces a great challenge with high morbidity and mortality. Remote monitoring is promising for reducing hospitalisations by delivering care outside the hospital. The evidence for pulmonary artery monitoring is robust, with trials like CHAMPION and GUIDE, and several real-world studies confirming its benefits [4,5]. In the coming years, I expect the technology to evolve, integrating into clinical pathways and health records, supported by e-health, AI, and algorithms. Involving patients in self-management through apps could further enhance efficiency and efficacy."

The results showed significant improvements in KCCQ overall summary score. What impact does this have on patients' day-to-day activities and overall health management?

"Monitor-HF had quality of life as a primary endpoint, showing significant improvements both short-term and long-term. Patients feel better and more confident with remote monitoring and personalised care. By monitoring and intervening on haemodynamic congestion early, even before symptoms appear, we provide reassurance and better management for patients."

Did you observe any safety signals about the CardioMEMS HF System or complications?

"The CardioMEMS HF system was safe and durable. In MONITOR-HF, we reported 2.3% procedure-related complications, comparable with other trials and right heart catheterisation. It's a low-risk procedure through the femoral vein. We also reported 2 sensor failures over the long term, about 1%, demonstrating high durability. Overall, the technology is safe with low complication rates."

1. 
   
   1. Brugts JJ, et al. The consistency of the treatment benefit of remote hemodynamic monitoring in chronic heart failure: a predefined subgroup analysis of the randomised clinical trial MONITOR-HF. Late breaking clinical trials I, Heart Failure 2024, 11–14 May, Lisbon, Portugal.
   2. Clephas PRD, et al. Eur Heart J. 2024 May 11:ehae323.
   3. Brugts JJ, et al; Lancet. 2023;401(10394):2113-2123.
   4. Abraham WT, et al. Lancet. 2016;387(10017):453-61.
   5. Lindenfeld J, et al. Lancet. 2021;398(10304):991-1001.

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Posted on 22 May 202422 May 2024