Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation--ease of use, acceptance, and organizational implications.

PURPOSE: The Medtronic CareLink allows remote implantable device follow-up. In this first European experience with CareLink, we assessed the ease of use of the system, the acceptance, and satisfaction of patients and clinicians. METHODS: Patients implanted with biventricular defibrillators for more than 6 months received the CareLink monitor and were trained to perform home device interrogation and transmission. Patient and clinician experience and preference were evaluated through specific questionnaires. RESULTS: Sixty-seven patients were enrolled and were able to perform data transmissions during the 3-month study duration. The overall duration of interrogation procedure was 7 +/- 5 minutes, and frequently the procedure did not require the assistance of a caregiver. Patients reported a general preference for remote versus in-clinic follow-up and described a sense of reassurance created by the remote monitoring capability.In the centers, the review procedure was successful; its mean duration was 5 +/- 2 minutes per transmission and the users indicated that the access and navigation of the review website were easy. At the end of the evaluation, the data available for remote review were judged complete and adequate to provide almost the same standard of care as that offered in traditional in-clinic visit. In general, the remote monitoring was seen as a potential tool to improve the clinical management of patients with device. CONCLUSIONS: The ease of use, satisfaction, and acceptance of the CareLink Network in European clinical practice appears elevated both for patients and for clinicians.

Assessment of a remote monitoring system for implantable cardioverter defibrillators.

We conducted a multicentre study in five Italian hospitals to assess the feasibility of a remote monitoring service for the follow-up of implanted cardiac devices. The system was designed to monitor device performance as well as physiological aspects of the patient's condition. Sixty-seven patients (mean age 64 years) affected by chronic heart failure and with a biventricular implantable cardioverter defibrillator for cardiac re-synchronization therapy (CRT-D) were enrolled for a three-month observation period. A total of 267 device recordings were transmitted through the ordinary telephone network, with a success rate of 99%. The telemonitoring service was more efficient than conventional face-to-face follow-up in terms of the time savings: both for physicians (4.7 minutes versus 15 minutes for remote and conventional monitoring) and for patients (6.6 minutes versus 116.3 minutes). In addition, a total of 23 clinical events occurred during the study, but only two cases required a clinic visit, thus reducing inappropriate hospital admissions. Finally, the service was well accepted by all the users.

Economic appraisal of the angioplasty procedures performed in 2004 in a high-volume diagnostic and interventional cardiology unit.

OBJECTIVE: Growing interest in the use of drug-eluting stents (DESs) in coronary angioplasty has prompted the Healthcare Agency of the Emilia Romagna Region to draw up recommendations for their appropriate clinical use in high-risk patients. Since the adoption of any new technology necessitates economic appraisal, we analysed the resource consumption of the various types of angioplasty procedures and the impact on the budget of a cardiology department. METHODS: A retrospective economic appraisal was carried out on the coronary angioplasty procedures performed in 2004 in the Department of Interventional Cardiology of Reggio Emilia. On the basis of the principles of activity-based costing, detailed hospital costs were estimated for each procedure and compared with the relevant diagnosis-related group (DRG) reimbursement. RESULTS: In 2004, the Reggio Emilia hospital performed 806 angioplasty procedures for a total expenditure of euro 5,176,268. These were 93 plain old balloon angioplasty procedures (euro 487,329), 401 procedures with bare-metal stents (euro 2,380,071), 249 procedures with DESs (euro 1,827,386) and 63 mixed procedures (euro 481,480). Reimbursements amounted to euro 5,816,748 (11% from plain old balloon angioplasty, 50% from bare-metal stent, 31% from DES and 8% from mixed procedures) with a positive margin of about euro 680,480 between costs incurred and reimbursements obtained, even if the reimbursement for DES and mixed procedures was not covering all the incurred costs. CONCLUSIONS: Analysis of the case-mix of procedures revealed that an overall positive margin between costs and DRG reimbursements was achieved. It therefore emerges that adherence to the indications of the Healthcare Agency of the Emilia Romagna Region for the appropriate clinical use of DESs is economically sustainable from the hospital enterprise point of view, although the DRG reimbursements are not able to differentiate among resource consumptions owing to the adoption of innovative technologies.

Cost-effectiveness analysis of bisoprolol treatment for heart failure.

BACKGROUND: Beta-blockers have provided evidence of improving survival in chronic heart failure patients. Specifically, the Cardiac Insufficiency Bisoprolol Study II has shown a significant reduction in mortality and morbidity among patients with moderate to severe chronic heart failure treated with bisoprolol. Our aim was to investigate the economic consequence of bisoprolol therapy in chronic heart failure patients in Italy. METHODS: Data were derived from the Cardiac Insufficiency Bisoprolol Study II trial. We conducted a cost-effectiveness analysis, comparing standard care with bisoprolol vs standard care with placebo in the perspective of the Italian National Health Service. We identified and quantified medical costs: drug costs according to the Italian National Therapeutic Formulary; specialist visits for initiation and up-titration of bisoprolol therapy and hospitalizations were quantified based on the Italian National Health Service tariffs (2005). Effects were measured in terms of mortality and morbidity reduction (number of deaths, life-years gained and frequency of hospitalizations). We considered an observational period of 1.3 years, i.e. the average follow-up recorded in the trial. Discounting was not performed because of the relatively short follow-up of patients. We conducted one- and multiway sensitivity analyses on unit cost and effectiveness. We also conducted a threshold analysis. RESULTS: The overall cost of care per 1000 patients treated for 1.3 years was estimated in Euro 2,075,548 in the bisoprolol group and in Euro 2,396,265 in the placebo group, resulting in a net saving of Euro 320,718. The number of additional patients alive with bisoprolol was 55 per 1000 patients, the number of lifeyears gained was 36 at 1.3 year. CONCLUSIONS: Bisoprolol therapy is dominant since it is both less costly and more effective than standard care. Results of sensitivity analysis showed that bisoprolol therapy remains dominant even to changes in unit cost of drug and hospitalizations.