Economic evaluation of remote monitoring of patients with an implantable cardiac defibrillator (REMOTE-CIED study).

INTRODUCTION: Remote patient monitoring (RPM) of heart failure patients has the potential to reduce healthcare resource use and costs, but current evidence has been inconclusive. This study aims assess the impact of RPM of heart failure patients with an implantable cardioverter defibrillator on medical resource use, direct medical costs, quality-adjusted life years (QALYs), and travel time of patients, and to estimate its commercial headroom in the Netherlands and Germany. METHODS: Data from the REMOTE-CIED randomized controlled trial were used to calculate differences in length of hospital stay, outpatient clinic visits, telephone consults, emergency room visits, and travel time between patients on in-clinic follow-up and RPM in the Netherlands, Germany, and France. Incremental cardiac-related healthcare costs and QALYs were calculated and used to calculate the commercial headroom of RPM in the Netherlands and Germany. The impact of imputation, parameter, and case-mix uncertainty on these outcomes was explored using probabilistic analysis. RESULTS: Length of hospitalization, number of unscheduled admissions, and number of outpatient visits were lower in the remote monitoring group in all three countries. Number of hospital admissions was higher, and number of calls was lower in the Netherlands and Germany but not in France. Costs were lower in both the Netherlands (-€1041, 95% confidence interval (CI): -€3308, €1005) and Germany (-€2865, 95% CI: -€7619, €1105), while incremental effectiveness differed: -0.003 (95% CI: -0.114, 0.107) QALY in the Netherlands and +0.086 (95% CI: -0.083, 0.256) in Germany. Commercial headroom was estimated at €881 (95% CI: -€5430, €7208) in the Netherlands and €5005 (95% CI: -€1339, €11,960) in Germany. DISCUSSION: RPM was found to result in reduced medical resource use and travel time. Whether it is cost saving or cost effective strongly depends on the costs of remote monitoring. TRIAL REGISTRATION NUMBER AND TRIAL REGISTER: ClinicalTrials.gov: NCT01691586.

The patient perspective on remote monitoring of patients with an implantable cardioverter defibrillator: Narrative review and future directions.

BACKGROUND: Studies have shown that remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) is at least comparable to in-clinic follow-up with regard to clinical outcomes and might be cost-effective, yet RPM is not standard clinical practice within Europe. Better insight into the patient perspective on RPM may aid in its acceptance, implementation, and reimbursement. This narrative review (1) summarizes existing evidence on the impact of RPM on patient-reported outcomes and (2) discusses future directions in examining the patient perspective. METHODS AND RESULTS: Literature review indicated that only five randomized trials on RPM in ICD patients included patient-reported outcomes, with inconclusive results. Observational studies show a trend toward good patient satisfaction and acceptation of RPM. Yet, results should be interpreted with caution due to a number of limitations including a potential selection bias, use of generic/nonvalidated questionnaires, relatively short follow-up durations, and a lack of subgroup identification. CONCLUSION: Although RPM seems to be safe, effective, timely, and efficient, the patient perspective has received little attention so far. The scarce evidence on patient-reported outcomes in RPM studies seems to be positive, but future trials with a follow-up of ≥12 months and validated patient-reported outcome measures are needed. The REMOTE-CIED study from our group is the first prospective randomized controlled trial primarily designed to examine the patient perspective on RPM, and is powered to identify characteristics associated with RPM satisfaction and benefit. Results are expected in 2018 and will add valuable information to the current evidence.

Impaired Mental Health-Related Quality of Life in Patients with Idiopathic Ventricular Fibrillation.

BACKGROUND: Idiopathic ventricular fibrillation (iVF) is diagnosed in cardiac arrest survivors without an identifiable cause. Data regarding the health-related quality of life (HRQoL) in iVF patients are lacking. The purpose of this study was to investigate the HRQoL of iVF patients and to compare it to patients with an implantable cardioverter defibrillator (ICD) diagnosed with an underlying disease and healthy subjects. METHODS: In 61 iVF patients with an ICD (iVF-ICD) and 59 ICD patients with a diagnosis (diagnosis-ICD), HRQoL was assessed using the 12-item Short-Form Health Survey (SF-12), the EuroQoL-5 dimensions (EQ-5D), the 9-item Patient Health Questionnaire, and the ICD Patient Concerns (ICDC) Questionnaire. In addition, 860 healthy subjects completed the SF-12. RESULTS: IVF-ICD showed similar SF-12 physical summary scores compared with diagnosis-ICD patients (50.8 [interquartile range (IQR) = 42.1-53.9] vs 54.1 [IQR = 46.5-58.3]; P = 0.080) and healthy subjects (51.8 [IQR = 45.9-54.1]; P = 0.691). The mental summary score was impaired in iVF-ICD patients compared with diagnosis-ICD patients (45.9 [IQR = 40.7-49.4] vs 54.6 [IQR = 46.0-57.9]; P < 0.001) and healthy subjects (47.7 [IQR = 43.0-50.4]; P = 0.027). Scores on all five EQ-5D domains were similar between iVF-ICD patients and diagnosis-ICD patients, as well as symptoms of severe depression (19% vs 12%; P = 0.101). ICD concerns were similar between iVF-ICD and diagnosis-ICD patients (ICDC-scores 2 vs 2; P = 0.494). CONCLUSIONS: Data suggest that there is a reduced mental HRQoL in patients with iVF compared to other cardiac arrest survivors. Screening and treatment of psychological distress should therefore be considered in iVF patients.

Disease-specific health status as a predictor of mortality in patients with heart failure: a systematic literature review and meta-analysis of prospective cohort studies.

AIMS: Some, but not all, studies have shown that patient-reported health status, including symptoms, functioning, and health-related quality of life, provides additional information to traditional clinical factors in predicting prognosis in heart failure patients. To evaluate the overall evidence, the association of disease-specific health status on mortality in heart failure was examined through a systematic review and meta-analysis. METHODS AND RESULTS: Prospective cohort studies that assessed the independent association of disease-specific health status with mortality in heart failure were selected. Searching PubMed (until March 2013) resulted in 17 articles in the systematic review and 17 studies in the meta-analysis. About half of the studies reported a significant relationship between disease-specific health status and mortality in heart failure, while the remainder found no association. A larger sample size increased the chance of identification of a significant association. The results of the meta-analysis (including studies using a dichotomized heart failure-specific health status variable as predictor) showed that heart failure patients reporting poor disease-specific health status had a 39% increased risk of dying [hazard ratio 1.39 (1.25­1.54)] when compared with patients experiencing moderate or good disease-specific health status. CONCLUSION: Patient-reported health status was an independent risk indicator for mortality in heart failure patients and may facilitate the identification of patients at high risk for poor prognosis above and beyond traditional risk variables. These findings suggest that patient-reported health status should be routinely assessed in determining prognosis, as this information cannot be captured from patients' medical records.

Poor health status and distress in cardiac patients: the role of device therapy vs. underlying heart disease.

AIMS: Implantable cardioverter defibrillator (ICD) therapy, which includes the risk of shocks, is considered the primary culprit of reductions in patient reported outcomes (PROs; e.g. health status and distress), thereby negating the role of underlying disease severity. We examined the relative influence of living with an ICD vs. congestive heart failure (CHF) on PROs and compared (i) ICD patients without CHF (ICD only), (ii) CHF patients without an ICD (CHF-only), and (iii) CHF patients with an ICD (ICD + CHF). METHODS AND RESULTS: Separate cohorts of ICD and CHF patients (N = 435; 75% men) completed PROs at baseline, 6 and 12 months. Groups differed on physical health status only at baseline (F((2,415)) = 7.15, P = 0.001) and on anxiety at 12 months (F((2,415)) = 4.04, P = 0.01); ICD + CHF patients had the most impaired physical health status but the lowest anxiety level followed by the ICD only and CHF only patients. Congestive heart failure only patients had the most impaired mental health status and reported the highest level of anxiety as compared to the ICD only (P < 0.001) and ICD + CHF groups (P = 0.009), while the two latter groups did not differ. The effect sizes ranged from very small (0.03) to moderate-large (0.69). Groups did not differ in depression scores. CONCLUSION: Congestive heart failure patients reported worse PROs as compared to ICD patients, although the magnitude of the differences was relatively small. This suggests that the well being of patients is not necessarily negatively influenced by the implantation of an ICD, and that underlying heart disease may have at least an equal if not greater influence on PROs.

Response to cardiac resynchronization therapy: is it time to expand the criteria?

BACKGROUND: Cardiac resynchronization therapy (CRT) is a promising treatment for a subgroup of patients with advanced congestive heart failure and a prolonged QRS interval. Despite the majority of patients benefiting from CRT, 10-40% of patients do not respond to this treatment and are labeled as nonresponders. Given that there is a lack of consensus on how to define response to CRT, the purpose of this viewpoint is to discuss currently used definitions and their shortcomings, and to provide recommendations as to how an expansion of the criteria for CRT response may be useful to clinicians. METHODS AND RESULTS: Analysis of the literature and case reports indicates that the majority of established measures of CRT response, including New York Heart Association functional class and echocardiographic, hemodynamic, and neurohormonal parameters, are poor associates of patient-reported symptoms and quality of life. Moreover, the potential moderating role of psychological factors in determining health outcomes after CRT has largely been neglected. CONCLUSIONS: It is recommended to routinely assess health status after CRT with a disease-specific questionnaire in standard clinical practice and to examine its determinants, including psychological factors such as personality traits and depression. This may lead to improved (secondary) treatment and prognosis in CHF patients treated with CRT.

Negative and positive affect are independently associated with patient-reported health status following percutaneous coronary intervention.

PURPOSE: We examined the association between negative and positive affect and 12-month health status in patients treated with percutaneous coronary intervention (PCI) with drug-eluting stents. METHODS: Consecutive PCI patients (n = 562) completed the Global Mood Scale at baseline to assess affect and the EuroQoL-5D (EQ-5D) at baseline and 12-month follow-up to assess health status. RESULTS: Negative affect [F(1, 522) = 17.14, P < .001] and positive affect [F(1, 522) = 5.11, P = .02] at baseline were independent associates of overall health status at 12-month follow-up, adjusting for demographic and clinical factors. Moreover, there was a significant interaction for negative by positive affect [F(1, 522) = 6.11, P = .01]. In domain-specific analyses, high negative affect was associated with problems in mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with the risk being two to fivefold. Low positive affect was only associated with problems in self-care (OR: 8.14; 95% CI: 1.85-35.9; P = .006) and usual activities (OR: 1.87; 95% CI: 1.17-3.00; P = .009). CONCLUSIONS: Baseline negative and positive affect contribute independently to patient-reported health status 12 months post PCI. Positive affect moderated the detrimental effects of negative affect on overall health status. Enhancing positive affect might be an important target to improve patient-centered outcomes in coronary artery disease.