Challenges of Telemonitoring Programs for Complex Chronic Conditions: Randomized Controlled Trial With an Embedded Qualitative Study.

BACKGROUND: Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on telemonitoring for this population. OBJECTIVE: This randomized controlled trial and embedded qualitative study aims to evaluate the impact on and experiences of patients and health care providers (HCPs) using a telemonitoring system with decision support to manage patients with complex conditions, including those with multiple chronic conditions, compared with the standard of care. METHODS: A pragmatic, unblinded, 6-month randomized controlled trial sought to recruit 146 patients with ≥1 diagnosis of heart failure (HF), uncontrolled hypertension (HT), and insulin-requiring diabetes mellitus (DM) from outpatient specialty settings in Toronto, Ontario, Canada. Participants were randomized into the control and telemonitoring groups, with the latter being instructed to take readings relevant to their conditions. The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status (36-Item Short Form Health Survey questionnaire). Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported health service use. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group was interviewed about their experiences. RESULTS: A total of 96 patients were recruited and randomized. Recruitment was terminated early because of implementation challenges and the onset of the COVID-19 pandemic. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of patients with HF found improvements in self-care maintenance (P=.04) and physical quality of life (P=.046). Opinions expressed by the 5 HCPs and 13 patients who were interviewed differed based on the monitored conditions. Although patients with HF reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care and the design of the decision support, whereby fluctuations in the status of HT and DM typically required less urgent interventions compared with patients with HF. CONCLUSIONS: We recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary but not sufficient components of such programs for patients with complex conditions and lower acuity. We conclude that telemonitoring for patients with complex conditions or within multidisciplinary care settings may be best operationalized through nurse-led models of care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.8367.

The Added Value of Exercise Variables in Heart Failure Prognosis.

INTRODUCTION: Diminished exercise capacity is a key symptom in heart failure (HF). Exercise predictors (peak VO2, VE/VCO2 slope, and oxygen uptake efficiency slope [OUES]) are prognostic markers but studied in isolation. We evaluated if these exercise variables offer additional prognostic value to clinical predictors in HF. METHODS AND RESULTS: This was a single-institution retrospective cohort study of 517 consecutive HF patients. We used Cox proportional hazards modeling to determine the additional prognostic value of exercise variables on mortality, HF hospital admissions, and a composite outcome of ventricular assistance device (VAD) implantation, heart transplantation (HT), and death. During a mean follow-up of 2.7 years, 52 deaths, 47 HTs, and 19 VAD implantations occurred. After adjusting for age, New York Heart Association functional class, ejection fraction, body mass index, creatinine, and B-type natriuretic peptide, peak VO2 (hazard ratio [HR] 0.91, 95% confidence interval [CI] 0.85-0.96), OUES (HR 0.92, 95% CI 0.87-0.97), and VE/VCO2 (HR 1.03, 95% CI 1.01-1.05) were independent predictors of the composite outcome. Similar discriminatory capacity existed between the exercise variables (c-statistics 0.77, 0.78, and 0.78, respectively). Only VE/VCO2 was an independent predictor of admissions (HR 1.04, 95% CI 1.01-1.07), and only peak VO2 was an independent predictor of mortality (HR 0.90, 95% CI 0.84-0.98). CONCLUSIONS: Peak VO2, OUES, and VE/VCO2 are independent predictors of HF prognosis over recognized clinical variables. However, no single exercise variable was superior.

Use of Free-Living Step Count Monitoring for Heart Failure Functional Classification: Validation Study.

BACKGROUND: The New York Heart Association (NYHA) functional classification system has poor inter-rater reproducibility. A previously published pilot study showed a statistically significant difference between the daily step counts of heart failure (with reduced ejection fraction) patients classified as NYHA functional class II and III as measured by wrist-worn activity monitors. However, the study's small sample size severely limits scientific confidence in the generalizability of this finding to a larger heart failure (HF) population. OBJECTIVE: This study aimed to validate the pilot study on a larger sample of patients with HF with reduced ejection fraction (HFrEF) and attempt to characterize the step count distribution to gain insight into a more objective method of assessing NYHA functional class. METHODS: We repeated the analysis performed during the pilot study on an independently recorded dataset comprising a total of 50 patients with HFrEF (35 NYHA II and 15 NYHA III) patients. Participants were monitored for step count with a Fitbit Flex for a period of 2 weeks in a free-living environment. RESULTS: Comparing group medians, patients exhibiting NYHA class III symptoms had significantly lower recorded 2-week mean daily total step count (3541 vs 5729 [steps], P=.04), lower 2-week maximum daily total step count (10,792 vs 5904 [steps], P=.03), lower 2-week recorded mean daily mean step count (4.0 vs 2.5 [steps/minute], P=.04,), and lower 2-week mean and 2-week maximum daily per minute step count maximums (88.1 vs 96.1 and 111.0 vs 123.0 [steps/minute]; P=.02 and .004, respectively). CONCLUSIONS: Patients with NYHA II and III symptoms differed significantly by various aggregate measures of free-living step count including the (1) mean and (2) maximum daily total step count as well as by the (3) mean of daily mean step count and by the (4) mean and (5) maximum of the daily per minute step count maximum. These findings affirm that the degree of exercise intolerance of NYHA II and III patients as a group is quantifiable in a replicable manner. This is a novel and promising finding that suggests the existence of a possible, completely objective measure of assessing HF functional class, something which would be a great boon in the continuing quest to improve patient outcomes for this burdensome and costly disease.

Correction: Assessing the Use of Wrist-Worn Devices in Patients with Heart Failure: Feasibility Study.

[This corrects the article DOI: 10.2196/cardio.8301.].

Assessing the Use of Wrist-Worn Devices in Patients With Heart Failure: Feasibility Study.

BACKGROUND: Exercise capacity and raised heart rate (HR) are important prognostic markers in patients with heart failure (HF). There has been significant interest in wrist-worn devices that track activity and HR. OBJECTIVE: We aimed to assess the feasibility and accuracy of HR and activity tracking of the Fitbit and Apple Watch. METHODS: We conducted a two-phase study assessing the accuracy of HR by Apple Watch and Fitbit in healthy participants. In Phase 1, 10 healthy individuals wore a Fitbit, an Apple Watch, and a GE SEER Light 5-electrode Holter monitor while exercising on a cycle ergometer with a 10-watt step ramp protocol from 0-100 watts. In Phase 2, 10 patients with HF and New York Heart Association (NYHA) Class II-III symptoms wore wrist devices for 14 days to capture overall step count/exercise levels. RESULTS: Recorded HR by both wrist-worn devices had the best agreement with Holter readings at a workload of 60-100 watts when the rate of change of HR is less dynamic. Fitbit recorded a mean 8866 steps/day for NYHA II patients versus 4845 steps/day for NYHA III patients (P=.04). In contrast, Apple Watch recorded a mean 7027 steps/day for NYHA II patients and 4187 steps/day for NYHA III patients (P=.08). CONCLUSIONS: Both wrist-based devices are best suited for static HR rate measurements. In an outpatient setting, these devices may be adequate for average HR in patients with HF. When assessing exercise capacity, the Fitbit better differentiated patients with NYHA II versus NYHA III by the total number of steps recorded. This exploratory study indicates that these wrist-worn devices show promise in prognostication of HF in the continuous monitoring of outpatients.

Outcomes in adult congenital heart disease patients undergoing heart transplantation: A systematic review and meta-analysis.

BACKGROUND: Studies assessing mortality and morbidity in adult transplant recipients with congenital heart disease (CHD) are limited. We conducted a systematic review and meta-analysis comparing post-transplant outcomes in these 2 populations. METHODS: After conducting an electronic database search, we selected studies evaluating mortality, cause-specific mortality, and risk of reoperation and dialysis in adult CHD vs non-CHD patients. We used random-effects models for the meta-analysis. RESULTS: Thirty-day mortality was significantly higher in CHD vs non-CHD patients (risk ratio [RR], 2.18; 95% confidence interval [CI], 1.62-2.93; I2 = 41%). This was influenced by increased mortality in Fontan/Glenn patients compared with non-CHD patients (RR, 3.3; 95% CI, 1.89-5.77; I2 = 0%). Mortality at 1 and 5 years was higher in the CHD population, although neither achieved statistical significance. Ten-year mortality was significantly lower in CHD patients (RR, 0.75; 95% CI, 0.60-0.95, I2 = 42%). Deaths caused by malignancy, infection, rejection, and cardiac allograft vasculopathy were decreased in CHD patients, although only death from malignancy achieved significance. Death secondary to primary graft failure, stroke, and hemorrhage was significantly higher in CHD patients. Risk of reoperation and dialysis were not statistically different between the 2 groups. CONCLUSIONS: Although adult CHD patients have higher early mortality, post-transplantation long-term survival is superior to non-CHD recipients. The challenge is to identify the CHD patients who will benefit from transplantation vs those who are higher risk.

Are endothelial progenitor cells a prognostic factor in patients with heart failure?

For the last two decades, endothelial progenitor cells (EPCs) have been proposed as a novel prognostic marker and potential therapeutic target in patients with cardiovascular diseases. EPCs are involved in the process of adult vasculogenesis and repair of dysfunctional endothelium. Endothelial dysfunction has been documented in the peripheral and coronary arteries of chronic heart failure (HF) patients, and has proved to be an independent predictor of morbidity and mortality in HF patients. This has led researchers to analyze the association of EPCs and disease severity in HF patients. In this paper, we review studies analyzing the prognostic role of EPCs in patients with HF. Through a systematic search, we identified 14 relevant studies. Only one study analyzed mortality as an outcome; the others evaluated the association between EPC levels and patients' characteristics. Overall, results were inconsistent and suggested that levels of EPCs may vary according to factors such as disease severity, underlying cause of cardiomyopathy and medical therapy.