Alessandro Capucci1, Antonio De Simone2, Mario Luzi1, Valeria Calvi3, Giuseppe Stabile4, Antonio D'Onofrio5, Simone Maffei1, Loira Leoni6, Giovanni Morani7, Raffaele Sangiuolo8, Claudia Amellone9, Catia Checchinato10, Ernesto Ammendola11, Gianfranco Buja6. 1. Cardiology and Arrhythmology Clinic, Università Politecnica delle Marche, Via Conca 71, 60126 Ancona, Italy. 2. Cardiology Department, Clinica San Michele, Maddaloni (CE), Italy. 3. Cardiology Department, A.O.U.P. "Vittorio Emanuele", Ospedale Ferrarotto, Catania, Italy. 4. Cardiology Department, Clinica Mediterranea, Naples, Italy. 5. Cardiology Department, Ospedale Monaldi, Naples, Italy. 6. Cardiology Department, Policlinico Universitario, Padua, Italy. 7. Cardiology Department, Ospedale Civile Maggiore - Borgo Trento, Verona, Italy. 8. Cardiology Department, Ospedale Buon Consiglio - Fatebenefratelli, Naples, Italy. 9. Cardiology Department, Ospedale di Ciriè - ASL TO 4, Ciriè (TO), Italy. 10. Cardiology Department, Ospedale Santa Croce, Moncalieri (TO), Italy. 11. Cardiology Department, Ospedale Monaldi SUN, Naples, Italy.
Abstract
AIMS: Heart failure (HF) patients with implantable cardioverter-defibrillators (ICD) require admissions for disease management and out-patient visits for disease management and assessment of device performance. These admissions place a significant burden on the National Health Service. Remote monitoring (RM) is an effective alternative to frequent hospital visits. The EFFECT study was a multicentre observational investigation aiming to evaluate the clinical effectiveness of RM compared with in-office visits standard management (SM). The present analysis is an economic evaluation of the results of the EFFECT trial. METHODS AND RESULTS: The present analysis considered the direct consumption of healthcare resources over 12-month follow-up. Standard tariffs were applied to hospitalizations, in-office visits and remote device interrogations. Economic comparisons were also carried out by means of propensity score (PS) analysis to take into account the lack of randomization in the study design. The analysis involved 858 patients with ICD or CRT-D. Of these, 401 (47%) were followed up via an SM approach, while 457 (53%) were assigned to RM. The rate of hospitalizations was 0.27/year in the SM group and 0.16/year in the RM group (risk reduction =0.59; P = 0.0004). In the non-adjusted analysis, the annual cost for each patient was €817 in the SM group and €604 in the RM group (P = 0.014). Propensity score analysis, in which 292 RM patients were matched with 292 SM patients, confirmed the results of the non-adjusted analysis (€872 in the SM group vs. €757 in the RM group; P < 0.0001). CONCLUSION: There is a reduction in direct healthcare costs of RM for HF patients with ICDs, particularly CRT-D, compared with standard monitoring. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/Identifier, NCT01723865. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: Heart failure (HF) patients with implantable cardioverter-defibrillators (ICD) require admissions for disease management and out-patient visits for disease management and assessment of device performance. These admissions place a significant burden on the National Health Service. Remote monitoring (RM) is an effective alternative to frequent hospital visits. The EFFECT study was a multicentre observational investigation aiming to evaluate the clinical effectiveness of RM compared with in-office visits standard management (SM). The present analysis is an economic evaluation of the results of the EFFECT trial. METHODS AND RESULTS: The present analysis considered the direct consumption of healthcare resources over 12-month follow-up. Standard tariffs were applied to hospitalizations, in-office visits and remote device interrogations. Economic comparisons were also carried out by means of propensity score (PS) analysis to take into account the lack of randomization in the study design. The analysis involved 858 patients with ICD or CRT-D. Of these, 401 (47%) were followed up via an SM approach, while 457 (53%) were assigned to RM. The rate of hospitalizations was 0.27/year in the SM group and 0.16/year in the RM group (risk reduction =0.59; P = 0.0004). In the non-adjusted analysis, the annual cost for each patient was €817 in the SM group and €604 in the RM group (P = 0.014). Propensity score analysis, in which 292 RM patients were matched with 292 SM patients, confirmed the results of the non-adjusted analysis (€872 in the SM group vs. €757 in the RM group; P < 0.0001). CONCLUSION: There is a reduction in direct healthcare costs of RM for HF patients with ICDs, particularly CRT-D, compared with standard monitoring. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/Identifier, NCT01723865. Published on behalf of the European Society of Cardiology. All rights reserved.
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