Clinically relevant reduction in HF hospitalisation due to haemodynamic monitoring

MONITOR-HF is a novel randomised clinical trial of remote pulmonary artery pressure monitoring. In this trial using the CardioMEMS HF system, haemodynamic monitoring not only reduced heart failure (HF) hospitalisation but also substantially improved the quality of life of patients.

Ideally, detection of worsening HF in an early phase would allow physicians to intervene timely and proactively to prevent HF-related hospitalisations. Remote monitoring of pulmonary artery pressures (PAP) has emerged as a valuable technique for ambulatory haemodynamic monitoring in HF patients [1]. PAP is a marker of haemodynamic congestion, which occurs several weeks before symptoms develop, providing a possibility for early intervention. The multicentre, clinical, open-label, randomised MONITOR-HF (NTR7672) study evaluated whether assessing haemodynamic congestion based on filling pressures instead of clinical congestion can further improve patients’ quality of life (QoL) and clinical outcomes [2,3].

The study enrolled 348 participants with chronic HF defined as NYHA class III who had at least 1 HF hospitalisation in the Netherlands in the previous 12 months. They were randomised (1:1) either to standard-of-care or pulmonary artery-guided therapy. The latter group received a small, wireless sensor implanted into the pulmonary artery via the femoral vein. All participants had a mean age of 69 and an “appropriate background therapy,” according to Prof. Jasper Brugts (Erasmus University Medical Centre, the Netherlands). Their mean ejection fraction was 30%. The primary endpoint of this open-label trial was quality of life, assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months. Total HF hospitalisations were assessed as a secondary outcome.

At 12 months, the average change in the KCCQ overall summary score improved by +7 points in the monitoring group and -0.2 points in the usual care group, yielding a mean difference between groups of 7.1 points in favour of monitoring (P=0.013). This difference persisted during the follow-up period of 1.8 years. During this time, 117 HF hospitalisations or urgent visits occurred in the monitoring group compared with 212 in the usual care group. “This is a meaningful difference and represents a 44% reduction in HF hospitalisation,” Prof. Brugts emphasised (HR 0.56; 95% CI 0.38–0.84; P<0.01; see Figure).

Figure: Reduction in the number of total HF hospitalisations in the MONITOR-HF trial [2]



Cox regression analysis Andersen-Gill method (recurring events). CI, confidence interval; CM, CardioMems heart failure system; HFH, heart failure hospitalisations; HR, hazard ratio; SoC, standard of care.

Subgroup analyses showed that this treatment benefit was consistent in subgroups with an ejection fraction of ≤40% and >40%. E.g. in patients with an ejection fraction of ≤40% the event rate/patient-year in the intervention group was 0.35 versus 0.68 in the standard of care group (HR =.53 (95% CI 0.31-0.88). Moreover, In in the intervention group, a significant reduction in NT-proBNP was seen (between-group-difference −669 pg/ml; P = 0.013).

Prof. Brugts explained that the positive effect is induced primarily by changes in diuretics. Diuretics could be optimised based on PAP as a surrogate of left ventricular filling pressures. Therefore, participants in the intervention group have been in a chronically better decongestive state. Furthermore, the implant technology showed to be safe and reliable.

1. Abraham WT, et al. The Lancet. 2011;377(9766):658–666.
2. Brugts JJ. Remote hemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): A randomised controlled clinical trial. Session Late breaking clinical trials: Chronic HF and cardiomyopathies, Heart Failure 2023, 20–23 May, Prague, Czechia.
3. Brugts JJ, et al.Lancet 2023;May 20. DOI:10.1016/S0140-6736(23)00923-6.

Posted on 8 August 20236 September 2023