Weight telemonitoring of heart failure versus standard of care in a real-world setting: Results on mortality and hospitalizations in a 6-month nationwide matched cohort study.

AIMS: Evaluating the benefit of telemonitoring in heart failure (HF) management in real-world settings is crucial for optimizing the healthcare pathway. The aim of this study was to assess the association between a 6-month application of the telemonitoring solution Chronic Care Connect™ (CCC) and mortality, HF hospitalizations, and associated costs compared with standard of care (SOC) in patients with a diagnosis of HF. METHODS AND RESULTS: From February 2018 to March 2020, a retrospective cohort study was conducted using the largest healthcare insurance system claims database in France (Système National des Données de Santé) linked to the CCC telemonitoring database of adult patients with an ICD-10-coded diagnosis of HF. Patients from the telemonitoring group were matched with up to two patients from the SOC group based on their high-dimensional propensity score, without replacement, using the nearest-neighbour method. A total of 1358 telemonitored patients were matched to 2456 SOC patients. The cohorts consisted of high-risk patients with median times from last HF hospitalization to index date of 17.0 (interquartile range: 7.0-66.0) days for the telemonitoring group and 27.0 (15.0-70.0) days for the SOC group. After 6 months, telemonitoring was associated with mortality risk reduction (hazard ratio [HR] 0.71, 95% confidence interval [CI] 0.56-0.89), a higher risk of first HF hospitalization (HR 1.81, 95% CI 1.55-2.13), and higher HF healthcare costs (relative cost 1.38, 95% CI 1.26-1.51). Compared with the SOC group, the telemonitoring group experienced a shorter average length of overnight HF hospitalization and fewer emergency visits preceding HF hospitalizations. CONCLUSION: The results of this nationwide cohort study highlight a valuable role for telemonitoring solutions such as CCC in the management of high-risk HF patients. However, for telemonitoring solutions based on weight and symptoms, consideration should be given to implement additional methods of assessment to recognize imminent worsening of HF, such as impedance changes, as a way to reduce mortality risk and the need for HF hospitalizations. Further studies are warranted to refine selection of patients who could benefit from a telemonitoring system and to confirm long-term benefits in high-risk and stable HF patients.

Should people with type 2 diabetes treated by multiple daily insulin injections with home health care support be switched to hybrid closed-loop? The CLOSE AP+ randomized controlled trial.

AIM: The study aim was to evaluate the feasibility, safety and efficacy of automated insulin delivery (AID) assisted by home health care (HHC) services in people with type 2 diabetes unable to manage multiple daily insulin injections (MDI) at home on their own. PATIENTS AND METHODS: This was an open label, multicentre, randomized, parallel group trial. In total, 30 adults with type 2 diabetes using MDI and requiring nursing support were randomly allocated to AID or kept their usual therapy over a 12-week period. Both treatments were managed with the support of HHC services. The primary outcome was the percentage time in the target glucose range of 70-180 mg/dl (TIR). Secondary outcomes included other continuous glucose monitoring metrics, glycated haemoglobin (HbA1c) levels, daily insulin doses, body weight, and of quality of life scores, fear of hypoglycaemia and satisfaction questionnaires. RESULTS: Age (69.7 vs. 69.3 years) and HbA1c (9.25 vs. 9.0) did not differ in MDI and AID at baseline. Compared with MDI, AID resulted in a significant increase in TIR by 27.4% [95% CI (15.0-39.8); p < .001], a decrease in time above range by 27.7% and an unchanged time below range of <1%. A between-group difference in HbA1c was 1.3% favouring AID. Neither severe hypoglycaemia nor ketoacidosis occurred in either group. Patient and caregiver satisfaction with AID was high. CONCLUSIONS: AID combined with tailored HHC services significantly improved glycaemic control with no safety issues in people with type 2 diabetes previously under an MDI regimen with HHC. AID should be considered a safe option in these people when lacking acceptable glucose control.

Organisational Impact of a Remote Patient Monitoring System for Heart Failure Management: The Experience of 29 Cardiology Departments in France.

Remote patient monitoring (RPM) for the management of patients with chronic heart failure (CHF) has been widely studied from clinical and health-economic points of view. In contrast, data on the organisational impact of this type of RPM are scarce. The objective of the present study of cardiology departments (CDs) in France was to describe the organisational impact of the Chronic Care ConnectTM (CCCTM) RPM system for CHF. An organisational impact map for health technology assessment was used to identify and define the criteria evaluated in the present survey, including the care process, equipment, infrastructure, training, skill transfers, and the stakeholders' abilities to implement the care process. In April 2021, an online questionnaire was sent to 31 French CDs that were using CCCTM for CHF management: 29 (94%) completed the questionnaire. The survey results showed that CDs progressively modified their organisational structures upon or shortly after the implementation of the RPM device. Twenty-four departments (83%) had created a dedicated team, sixteen (55%) had provided dedicated outpatient consultations for patients with an emergency alert, and twenty-five (86%) admitted patients directly (i.e., avoiding the need to attend the emergency department). The present survey is the first to have assessed the organisational impact of the implementation of the CCCTM RPM device for CHF management. The results highlighted the variety of organisational structures, which tended to structure with the use of the device.

Healthcare costs of a telemonitoring programme for heart failure: indirect deterministic data linkage analysis.

AIMS: We aim to evaluate the costs associated with healthcare resource consumption for chronic heart failure (HF) management in patients allocated to telemonitoring versus standard of care (SC). METHODS AND RESULTS: OSICAT-ECO involved 745 patients from the OSICAT trial (NCT02068118) who were successfully linked to the French national healthcare database through an indirect deterministic data linkage approach. OSICAT compared a telemonitoring programme with SC follow-up in adults hospitalized for acute HF ≤ 12 months. Healthcare resource costs included those related to hospital and ambulatory expenditure for HF and were restricted to direct costs determined from the French health data system over 18 months of follow-up. Most of the total costs (69.4%) were due to hospitalization for HF decompensation, followed by ambulatory nursing fees (11.8%). During 18-month follow-up, total costs were 2% lower in the telemonitoring versus the SC group, due primarily to a 21% reduction in nurse fees. Among patients with NYHA class III/IV, a 15% reduction in total costs (€3131 decrease) was observed over 18-month follow-up in the telemonitoring versus the SC group, with the highest difference in hospital expenditure during the first 6 months, followed by a shift in costs from hospital to ambulatory at 12 months. CONCLUSIONS: HF hospitalization and ambulatory nursing fees represented most of the costs related to HF. No benefit was observed for telemonitoring versus SC with regard to cost reductions over 18 months. Patients with severe HF showed a non-significant 15% reduction in costs, largely related to hospitalization for HF decompensation, nurse fees, and medical transport.

Telemonitoring versus standard care in heart failure: a randomised multicentre trial.

AIMS: The aim was to assess the effect of a telemonitoring programme vs. standard care (SC) in preventing all-cause deaths or unplanned hospitalisations in heart failure (HF) at 18 months. METHODS AND RESULTS: OSICAT was a randomised, multicentre, open-label French study in 937 patients hospitalised for acute HF ≤12 months before inclusion. Patients were randomised to telemonitoring (daily body weight measurement, daily recording of HF symptoms, and personalised education) (n = 482) or to SC (n = 455). Mean ± standard deviation number of events for the primary outcome was 1.30 ± 1.85 for telemonitoring and 1.46 ± 1.98 for SC [rate ratio 0.97, 95% confidence interval (CI) 0.77-1.23; P = 0.80]. In New York Heart Association (NYHA) class III or IV HF, median time to all-cause death or first unplanned hospitalisation was 82 days in the telemonitoring group and 67 days in the SC group (P = 0.03). After adjustment for known predictive factors, telemonitoring was associated with a 21% relative risk reduction in first unplanned hospitalisation for HF [hazard ratio (HR) 0.79, 95% CI 0.62-0.99; P = 0.044); the relative risk reduction was 29% in patients with NYHA class III or IV HF (HR 0.71, 95% CI 0.53-0.95; P = 0.02), 38% in socially isolated patients (HR 0.62, 95% CI 0.39-0.98; P = 0.043), and 37% in patients who were ≥70% adherent to body weight measurement (HR 0.63, 95% CI 0.45-0.88; P = 0.006). CONCLUSION: Telemonitoring did not result in a significantly lower rate of all-cause deaths or unplanned hospitalisations in HF patients. The pre-specified subgroup results suggest the telemonitoring approach improves clinical outcomes in selected populations but need further confirmation.

Passive transfer of serum antibodies induced by BBG2Na, a subunit vaccine, in the elderly protects SCID mouse lungs against respiratory syncytial virus challenge.

Respiratory syncytial virus (RSV) is responsible for severe low respiratory tract infections in young infants and the elderly. To investigate whether BBG2Na, a recombinant subunit vaccine comprising aa 130-230 of the RSV G protein, induced protective Abs in subjects over 60 years during phase II clinical trial, pre- and postimmunization sera of individuals immunized with BBG2Na or placebo were transferred into SCID mice before RSV challenge. These sera dose-dependently reduced lung RSV titers. However at some points of serial dilutions, postimmunization sera of BBG2Na-immunized subjects only were significantly more efficient than the corresponding preimmunization sera, in agreement with the induction of an increased Ab response against multiple epitopes on RSV-A G protein. Thus, BBG2Na is immunogenic in the elderly and confers passive protection in mice after serum transfer. To our knowledge, this is the first description of protective Abs induced by a subunit vaccine in human.