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.
Background and Aims Adjustment of treatment based on remote monitoring of pulmonary artery (PA) pressure may reduce the risk of hospital admission for heart failure (HF). We have conducted a meta-analysis of large randomized trials investigating this question. Methods A systematic literature search was performed for randomized clinical trials (RCTs) with PA pressure monitoring devices in patients with HF. The primary outcome of interest was the total number of HF hospitalizations. Other outcomes assessed were urgent visits leading to treatment with intravenous diuretics, all-cause mortality, and composites. Treatment effects are expressed as hazard ratios, and pooled effect estimates were obtained applying random effects meta-analyses. Results Three eligible RCTs were identified that included 1898 outpatients in New York Heart Association functional class II-IV, either hospitalized for HF in the prior 12 months or with elevated plasma NT-proBNP concentrations. Mean follow-up was 14.7 months, 67.8% of the patients were men, and 65.8% had an ejection fraction ≤40%. Compared to patients in the control group, the hazard ratio (95% confidence interval) for total HF hospitalizations in those randomized to PA pressure monitoring was 0.70 (0.58-0.86) (p=0.0005). The corresponding hazard ratio for the composite of total HF hospitalizations, urgent visits and all-cause mortality was 0.75 (0.61-0.91; p=0.0037) and for all-cause mortality 0.92 (0.73-1.16). Subgroup analyses, including ejection fraction phenotype, revealed no evidence of heterogeneity in the treatment effect. Conclusions The use of remote PA pressure monitoring to guide treatment of patients with HF reduces episodes of worsening HF and subsequent hospitalizations.
The CardioMEMS pulmonary artery (PA) monitoring system placed in the left lower lobe pulmonary artery is capable of measuring pulmonary artery pressure remotely as a surrogate of intracardiac filling pressures and volume status. The technique is safe and reliable. By using remote PA monitoring for proactive medical interventions, there is a growing body of clinical evidence for a substantial, robust reduction in HF hospitalizations in various populations (clinical trial setting, post-marketing studies and real-world experiences). This review summarizes the clinical evidence, outlines future perspectives, and aims for remote patient care in heart failure using CardioMEMS.
Aims Although diabetes mellitus (DM) is a common co‐morbidity in chronic heart failure (HF) patients, European data on concurrent HF and DM treatment are lacking. Therefore, we have studied the HF treatment of patients with and without DM. Additionally, with the recent breakthrough of sodium–glucose cotransporter 2 (SGLT2) inhibitors in the field of HF, we studied the potential impact of this new drug in a large cohort of HF patients. Methods and results A total of 7488 patients with chronic HF with a left ventricular ejection fraction <50% from 34 Dutch outpatient HF clinics between 2013 and 2016 were analysed on diabetic status and background HF therapy. Average age of the total population was 72.8 years (±11.7 years), and 64% of the patients were male. Diabetes was present in 29% of the patients (N = 2174). Diabetics had a worse renal function (mean estimated glomerular filtration rate 56 vs. 61 mL/min/1.73 m2, P < 0.001). Renin–angiotensin system inhibitors were less often prescribed in diabetics compared with non‐diabetics (79% vs. 82%, P = 0.001), while no significant differences regarding other guideline‐recommended HF drugs were found. Target doses of beta‐blockers (23% vs. 16%, P < 0.001), renin–angiotensin system inhibitors (47% vs. 43%, P = 0.009), and mineralocorticoid receptor antagonists (57% vs. 51%, P = 0.005) were more often prescribed in diabetics than non‐diabetics. Based on the latest trials on SGLT2 inhibitors, 31–64% of all HF patients would fulfil the eligibility or enrichment criteria (with vs. without N‐terminal prohormone BNP criterion). Conclusions In this large real‐world HF registry, a high prevalence of DM was observed and diabetics more often received guideline‐recommended target doses. Based on current evidence, the majority of patients would fulfil the enrichment criteria of SGLT2 trials in HF and the impact of this new drug class will be large.
Remote monitoring is becoming increasingly important for management of chronic heart failure patients. Recently, hemodynamic monitoring by measuring intracardiac filling pressures has been gaining attention. It is believed that hemodynamic congestion precedes clinical congestion by several weeks and that remote hemodynamic monitoring therefore enables clinicians to intervene in an early stage and prevent heart failure hospitalizations. The CardioMEMS HF system (Abbott, CA, USA) is a sensor capable of measuring pulmonary artery pressures as a surrogate of left ventricular filling pressures. Clinical evidence for CardioMEMS has been convincing in terms of efficacy and safety. This article provides detailed information on the CardioMEMS HF system and summarizes all available evidence of this promising technique.
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