No abstract

Background Assessing haemodynamic congestion based on filling pressures instead of clinical congestion can be a way to further improve quality of life (QoL) and clinical outcome by intervening before symptoms or weight gain occur in heart failure (HF) patients. The clinical efficacy of remote monitoring of pulmonary artery (PA) pressures (CardioMEMS; Abbott Inc., Atlanta, GA, USA) has been demonstrated in the USA. Currently, the PA sensor is not reimbursed in the European Union as its benefit when applied in addition to standard HF care is unknown in Western European countries, including the Netherlands. Aims To demonstrate the efficacy and cost-effectiveness of haemodynamic PA monitoring in addition to contemporary standard HF care in a high-quality Western European health care system. Methods The current study is a prospective, multicentre, randomised clinical trial in 340 patients with chronic HF (New York Heart Association functional class III) randomised to HF care including remote monitoring with the CardioMEMS PA sensor or standard HF care alone. Eligible patients have at least one hospitalisation for HF in 12 months before enrolment and will be randomised in a 1:1 ratio. Minimum follow-up will be 1 year. The primary endpoint is the change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Secondary endpoints are the number of HF hospital admissions and changes in health status assessed by EQ-5D-5L questionnaire including health care utilisation and formal cost-effectiveness analysis. Conclusion The MONITOR HF trial will evaluate the efficacy and cost-effectiveness of haemodynamic monitoring by CardioMEMS in addition to standard HF care in patients with chronic HF. Clinical Trial Registration number NTR7672.

Heart failure (HF) is a major health care issue, and the incidence of HF is only expected to grow further. Due to the frequent hospitalizations, HF places a major burden on the available hospital and healthcare resources. In the future, HF care should not only be organized solely at the clinical ward and outpatient clinics, but remote monitoring strategies are urgently needed to guide, monitor, and treat chronic HF patients remotely from their homes as well. The intuitiveness and relatively low costs of non-invasive remote monitoring tools make them an appealing and emerging concept for developing new medical apps and devices. The recent COVID-19 pandemic and the associated transition of patient care outside the hospital will boost the development of remote monitoring tools, and many strategies will be reinvented with modern tools. However, it is important to look carefully at the inconsistencies that have been reported in non-invasive remote monitoring effectiveness. With this review, we provide an up-to-date overview of the available evidence on non-invasive remote monitoring in chronic HF patients and provide future perspectives that may significantly benefit the broader group of HF patients.

The large and growing burden of chronic heart failure (CHF) on healthcare systems and economies is mainly caused by a high hospital admission rate for acute decompensated heart failure (HF). Several remote monitoring techniques have been developed for early detection of worsening disease, potentially limiting the number of hospitalizations. Over the last years, the scope has been shifting towards the relatively novel invasive sensors capable of measuring intracardiac filling pressures, because it is believed that hemodynamic congestion precedes clinical congestion. Monitoring intracardiac pressures may therefore enable clinicians to intervene and avert hospitalizations in a pre-symptomatic phase. Several techniques have been discussed in this review, and thus far, remote monitoring of pulmonary artery pressures (PAP) by the CardioMEMS (CardioMicroelectromechanical system) HF System is the only technique with proven safety as well as efficacy with regard to the prevention of HF-related hospital admissions. Efforts are currently aimed to further develop existing techniques and new sensors capable of measuring left atrial pressures (LAP). With the growing body of evidence and need for remote care, it is expected that remote monitoring by invasive sensors will play a larger role in HF care in the near future.