Zoran Olivari1, Sara Giacomelli2, Lorenzo Gubian3, Silvia Mancin4, Elisa Visentin4, Vincenzo Di Francesco5, Sabino Iliceto6, Michelangelo Penzo7, Albino Zanocco8, Carlo Marcon9, Maurizio Anselmi10, Domenico Marchese11, Panagiotis Stafylas12. 1. Dipartimento Cardiovascolare, Ospedale Cà Foncello, Piazzale Ospedale, 1, Treviso, Italy. Electronic address: zoran.olivari@gmail.com. 2. Dipartimento Cardiovascolare, Ospedale Cà Foncello, Piazzale Ospedale, 1, Treviso, Italy. 3. Veneto Region Health Information System, Via Pacinotti, 4, Marghera, Venezia, Italy. 4. Arsenàl.IT, Veneto's Research Centre for eHealth Innovation, viale Oberdan, 5, Treviso, Italy. 5. U.O.C. Geriatria A, Azienda Ospedaliera Universitaria Integrata di Verona, Piazzale A. Stefani, 1,Verona, Italy. 6. Clinica Cardiologica e Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari Università degli Studi di Padova, via Giustiniani, 2, Padova, Italy. 7. UOC Cardiologia UTIC, Ospedale SS. Giovanni e Paolo, Castello, 6777 Venezia, Italy. 8. Dipartimento di Cardiologia e Medicina dello Sport, Ospedale di Mirano, via Don Giacobbe Sartor, 4, Mirano, Venezia, Italy. 9. U.O. Cardiologia, Ospedale S. Maria dei Battuti, via Brigata Bisagno, 4,Conegliano, Treviso, Italy. 10. U.O.C. Cardiologia, Ospedale G. Fracastoro, San Bonifacio, via Circonvallazione, 1, Verona, Italy. 11. U.O.C. Cardiologia, Ospedale di Piove di Sacco, via San Rocco, 8, Piove di Sacco, Padova, Italy. 12. Health Information Management SA, Boulevard Lambermont, 84, Brussels, Belgium.
Abstract
Background: The effectiveness of remote monitoring (RM) in the management of the elderly after hospitalisation for heart failure (HF) is uncertain. Methods and results: Randomized trial (2:1 design) comparing RM with usual care (UC) in patients >65 years old, hospitalised in the previous 3 months for HF with left ventricular ejection fraction <40% or >40% plus BNP > 400 (or NT-proBNP >1500); the primary end-point (PE) was the combined 12-month incidence of death by any cause or at least one hospital readmission for HF. Overall, 229 and 110 pts were enrolled in the RM and UC group, respectively; in the intention-to-treat analysis, the PE was reached in 101 (44.1%) and 51 (46.4%) patients in the RM and UC group respectively (p = 0.78), with no difference in mortality (24.0% vs 21.8%, p = 0.097) or in the proportion of patients with at least one rehospitalisation for HF (34.5% vs 39.1%, p = 0.48). Quality of life, secondary end-point measured by SF36v2 scores, was significantly improved in the RM group, both in physical (2.63 score difference, p < 0.0001) and mental (1.69 score difference, p = 0.04) components. In the on-treatment analysis comparing 190 patients that ultimately received RM with the 149 remaining patients, the primary end-point was reached in 40.0% vs 51.0% (p = 0.055), respectively. Conclusion: In the intention-to-treat analysis, during the 12-month follow up of elderly patients hospitalised for HF, remote monitoring had no impact on the primary end-point but it significantly improved patients' quality of life. In the on-treatment analysis a trend for improving the PE was observed in the RM group.
RCT Entities:
Background: The effectiveness of remote monitoring (RM) in the management of the elderly after hospitalisation for heart failure (HF) is uncertain. Methods and results: Randomized trial (2:1 design) comparing RM with usual care (UC) in patients >65 years old, hospitalised in the previous 3 months for HF with left ventricular ejection fraction <40% or >40% plus BNP > 400 (or NT-proBNP >1500); the primary end-point (PE) was the combined 12-month incidence of death by any cause or at least one hospital readmission for HF. Overall, 229 and 110 pts were enrolled in the RM and UC group, respectively; in the intention-to-treat analysis, the PE was reached in 101 (44.1%) and 51 (46.4%) patients in the RM and UC group respectively (p = 0.78), with no difference in mortality (24.0% vs 21.8%, p = 0.097) or in the proportion of patients with at least one rehospitalisation for HF (34.5% vs 39.1%, p = 0.48). Quality of life, secondary end-point measured by SF36v2 scores, was significantly improved in the RM group, both in physical (2.63 score difference, p < 0.0001) and mental (1.69 score difference, p = 0.04) components. In the on-treatment analysis comparing 190 patients that ultimately received RM with the 149 remaining patients, the primary end-point was reached in 40.0% vs 51.0% (p = 0.055), respectively. Conclusion: In the intention-to-treat analysis, during the 12-month follow up of elderly patients hospitalised for HF, remote monitoring had no impact on the primary end-point but it significantly improved patients' quality of life. In the on-treatment analysis a trend for improving the PE was observed in the RM group.
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