Background-Heart failure patients with implantable cardioverter-defibrillators (ICDs) or an ICD for resynchronization therapy often visit the hospital for unscheduled examinations, placing a great burden on healthcare providers. We hypothesized that Internet-based remote interrogation systems could reduce emergency healthcare visits. Methods and Results-This multicenter randomized trial involving 200 patients compared remote monitoring with standard patient management consisting of scheduled visits and patient response to audible ICD alerts. The primary end point was the rate of emergency department or urgent in-office visits for heart failure, arrhythmias, or ICD-related events. Over 16 months, such visits were 35% less frequent in the remote arm (75 versus 117; incidence density, 0.59 versus 0.93 events per year; Pϭ0.005). A 21% difference was observed in the rates of total healthcare visits for heart failure, arrhythmias, or ICD-related events (4.40 versus 5.74 events per year; PϽ0.001). The time from an ICD alert condition to review of the data was reduced from 24.8 days in the standard arm to 1.4 days in the remote arm (PϽ0.001). The patients' clinical status, as measured by the Clinical Composite Score, was similar in the 2 groups, whereas a more favorable change in quality of life (Minnesota Living With Heart Failure Questionnaire) was observed from the baseline to the 16th month in the remote arm (Pϭ0.026). Conclusions-Remote monitoring reduces emergency department/urgent in-office visits and, in general, total healthcare use in patients with ICD or defibrillators for resynchronization therapy. Compared with standard follow-up through in-office visits and audible ICD alerts, remote monitoring results in increased efficiency for healthcare providers and improved quality of care for patients. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00873899.

In patients with COPD non-naïve to rehabilitation we tested the feasibility, adherence and satisfaction of a home-based reinforcement telerehabilitation program (TRP). Outcomes were compared with a standard outpatient rehabilitation program (ORP). Then 18 TRP patients underwent 28 sessions of strength exercises (60 min) and cycle training (40 min) using a satellite platform provided telemonitoring, tele-prescription, video-assistance and phone-calls, patients were equipped with an oximeter, steps-counter, bicycle, remote control and interactive TV software. 18 matched ORP, retrospectively identified from our hospital ORP database, were used as controls. At baseline and end of program, the 6-min walking test (6MWT), Medical Research Council (MRC) scale and Saint George's Respiratory Questionnaire (SGRQ) were administered. In TRP only, we assessed platform use, incremental exercise, steps walked/day and patient satisfaction. TRP patients completed all sessions without side effects, used the remote control 1,394 ± 2,329 times being in the 84% of the cases satisfied with the service. In 22% of the cases patients found the technology unfriendly. Each health-professional performed 46 ± 65 actions, 14.6 ± 2.12 phone calls and 1 ± 1.67 videoconference sessions per patient. TRP patients increased physical activity (3,412 vs. 1,863 steps/day, p = 0.0002). Both programs produced significant (all, p < 0.01) gains in 6MWT [meters, TRP +34.22 ± 50.79; ORP +33.61 ± 39.25], dyspnea [TRP - 0.72 ± 0.89; ORP - 0.94 ± 0.53] and SGRQ [TRP - 6.9 ± 9.96, ORP - 9.9 ± 12.92] without between-group differences. In conclusion, TRP is feasible and well accepted by patients, although sometimes technology was perceived as difficult. It seems to improve walking capacity, dyspnea, quality of life and daily physical activity. Future RCTs will demonstrate cost-effectiveness.

Occult hepatitis B virus (HBV) infection is common in chronic hepatitis C patient. However, its significance and consequences are still unclear. The aim of this study was to evaluate the prevalence of occult HBV among HCV chronic carriers in France and to assess its impact on liver histology and response to antiviral therapy. To this end a cohort of 203 patients with chronic hepatitis C without hepatitis B surface antigen (HBsAg) has been examined. Serum HBV-DNA was detected using a highly sensitive PCR with primers located in the S and X genes. HBV viraemia levels were further determined by real-time PCR. Results showed that 47 of 203 (23%) patients had occult HBV infection with a low HBV load (10(2)-10(4) copies/ml) but significantly higher HCV-RNA titers (P < 0.05). No significant difference in age, gender, serum ALT level, HCV genotypes, and the presence of anti-HBc was observed between patients with or without HBV-DNA. When compared histologically, patients with occult HBV infection had higher activity (A2-A3 in 53% vs. 38%, P < 0.01) and more advanced fibrosis (60% vs. 33%, P < 0.001) than HBV-DNA negative cases. Sustained response to combination therapy against Chronic hepatitis C was achieved in 11 (28%) of 40 HBV-DNA positive cases, compared with 65 (45%) of the 144 HBV-DNA negative cases (P < 0.05). Among the 144 HBV-DNA negative HCV patients those with genotype 1 responded less frequently to therapy as compared to other genotypes infected patients (38% vs. 55%, P < 0.05). Surprisingly, when considering all patients studied, irrespective to the HBV-DNA status no significant difference was observed in response to combination therapy regarding HCV genotypes (39% vs. 44%, P > 0.05). In conclusion, HBV-DNA is found in 1/4 of French chronic hepatitis C patients regardless of the presence of anti-HBc. Such an occult HBV co-infection is associated with more severe liver disease, higher HCV viral load and decreased response to antiviral therapy irrespective of HCV genotypes.

BackgroundHeart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up.ObjectiveWe hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators.MethodsTwo hundred patients implanted with a wireless transmission–enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained.ResultsOverall, remote monitoring did not show significant annual cost savings for the health care system (€1962.78 versus €2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (€291.36 versus €381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of €888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution.ConclusionsRemote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations.Trial RegistrationClinicalTrials.gov NCT00873899; http://clinicaltrials.gov/show/NCT00873899 (Archived by WebCite at http://www.webcitation.org/6H0BOA29f).

BackgroundNowadays, new organisational strategies should be indentified to improve primary care and its link with secondary care in terms of efficacy and timeliness of interventions thus preventing unnecessary hospital accesses and costs saving for the health system. The purpose of this study is to assess the effects of the use of teleconsultation by general practitioners in rural areas.MethodsGeneral practitioners were provided with a teleconsultation service from 2006 to 2008 to obtain a second opinion for cardiac, dermatological and diabetic problems. Access, acceptance, organisational impact, effectiveness and economics data were collected. Clinical and access data were systematically entered in a database while acceptance and organisational data were evaluated through ad hoc questionnaires.ResultsThere were 957 teleconsultation contacts which resulted in access to health care services for 812 symptomatic patients living in 30 rural communities. Through the teleconsultation service, 48 general practitioners improved the appropriateness of primary care and the integration with secondary care. In fact, the level of concordance between intentions and consultations for cardiac problems was equal to 9%, in 86% of the cases the service entailed a saving of resources and in 5% of the cases, it improved the timeliness. 95% of the GPs considered the overall quality positively. For a future routine use of this service, trust in specialists, duration and workload of teleconsultations and reimbursement should be taken into account.ConclusionsManagerial and policy implications emerged mainly related to the support to GPs in the provision of high quality primary care and decision-making processes in promoting similar services.