Remote pulmonary artery pressure (PAP) monitoring met all primary and secondary endpoints in the MONITOR-HF trial. This was the first positive study of remote monitoring in European patients.
Remote monitoring of pulmonary artery pressure (PAP) has emerged as the most successful technique for ambulatory hemodynamic monitoring in heart failure (HF) patients. PAP is a marker of hemodynamic congestion, which occurs several weeks before symptoms develop, providing a possibility for early intervention. But can assessing hemodynamic congestion based on filling pressure instead of clinical congestion help improve quality of life and clinical outcomes? MONITOR-HF (NTR7672), a multicenter, open-label, randomized clinical study, sought to answer this question. MONITOR-HF included 348 participants with chronic HF in the Netherlands. All participants had New York Heart Association (NYHA) class III HF and at least 1 HF hospitalization in the previous 12 months. They were randomly assigned (1:1) to receive either standard of care or PAP-guided therapy. The latter group received a small, wireless sensor implanted into the pulmonary artery via the femoral vein.
The primary endpoint was quality of life, assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months. Total number of HF hospitalizations was a secondary endpoint.
The median age of participants was 69 and the median ejection fraction was 30%. All participants had an “appropriate background therapy,” said Jasper Brugts, MD, PhD.
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 favor of monitoring (P=.013). This difference persisted during the follow-up period of 1.8 years. In this time, there were 117 HF hospitalizations or urgent visits in the intervention group compared with 212 in the usual care group. “This is a meaningful difference and represents a 44% reduction in HF hospitalization,” Dr. Brugts emphasized (HR 0.56; 95% CI, 0.38–0.84; P<.01).
Subgroup analyses showed that this treatment benefit was consistent in subgroups with an ejection fraction of 40% or less and greater than 40%. In the intervention group, a significant reduction in NT-proBNP was seen.
Dr. Brugts explained that the positive effect is induced primarily by changes in diuretics. Diuretics could be optimized based on PAP as a surrogate of left ventricular filling pressure. Therefore, patients in the intervention group have been in a chronically better decongestive state. Moreover, the implant technology was shown to be safe and reliable.
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