Giuseppe Stabile1, Patrizia Pepi2, Pietro Palmisano3, Antonio D'Onofrio4, Antonio De Simone5, Salvatore Ivan Caico6, Domenico Pecora7, Antonio Rapacciuolo8, Giuseppe Arena9, Massimiliano Marini10, Paolo Pieragnoli11, Sandra Badolati12, Gianluca Savarese13, Giampiero Maglia14, Assunta Iuliano15, Giovanni Luca Botto16, Maurizio Malacrida17, Emanuele Bertaglia18. 1. Clinica Mediterranea, Naples, Italy. Electronic address: gmrstabile@tin.it. 2. Ospedale Carlo Poma, Mantua, Italy. 3. Ospedale Panico, Tricase (LE), Italy. 4. Ospedale Monaldi, Naples, Italy. 5. Clinica San Michele, Maddaloni (CE), Italy. 6. Ospedale Sant'Antonio Abate, Gallarate (VA), Italy. 7. Ospedale Poliambulanza, Brescia, Italy. 8. Università Federico II, Naples, Italy. 9. Department of Medicine, Cardiology, Apuane Hospital, Massa, Italy. 10. Ospedale Santa Chiara, Trento, Italy. 11. Università di Firenze, Florence, Italy. 12. Ospedale Sant'Andrea, La Spezia, Italy. 13. Ospedale San Giovanni Battista, Foligno (PG), Italy. 14. Ospedale Pugliese-Ciaccio, Catanzaro, Italy. 15. Clinica Mediterranea, Naples, Italy. 16. Ospedale Sant'Anna, San Fermo della Battaglia (CO), Italy. 17. Boston Scientific Italia, Milan, Italy. 18. Università di Padova, Padova, Italy.
Abstract
BACKGROUND: Professional guidelines are based on the best available evidence. However, patients treated in clinical practice may differ from those included in reference trials. OBJECTIVE: The aim of this study was to evaluate the effects of cardiac resynchronization therapy (CRT) in a large population of patients implanted with a CRT device stratified in accordance with the 2016 European heart failure (HF) guidelines. METHODS: We collected data on 930 consecutive patients from the Cardiac Resynchronization Therapy MOdular REgistry. The primary end point was a composite of death and HF hospitalization. RESULTS:Five hundred sixty-three (60.5%) patients met class I indications, 145 (15.6%) class IIa, 108 (11.6%) class IIb, and 114 (12.3%) class III. After a median follow-up of 1001 days, 120 (14.7%) patients who had an indication to CRT had died and 71 (8.7%) had been hospitalized for HF. The time to the end point was longer in patients with a class I indication (hazard ratio 0.55; 95% confidence interval 0.39-0.76; P = .0001). After 12 months, left ventricular (LV) end-systolic volume had decreased by ≥15% in 61.5% (320/520) of patients whereas in 57.5% (389/676) of patients the absolute LV ejection fraction improvement was ≥5%. Adherence to class I was also associated with an absolute LV ejection fraction increase of >5% (P = .0142) and an LV end-systolic volume decrease of ≥15% (P = .0055). CONCLUSION: In our population, ∼60% of patients underwent implantation according to the 2016 European HF guidelines class I indication. Adherence to class I was associated with a lower death and HF hospitalization rates and better LV reverse remodeling.
RCT Entities:
BACKGROUND: Professional guidelines are based on the best available evidence. However, patients treated in clinical practice may differ from those included in reference trials. OBJECTIVE: The aim of this study was to evaluate the effects of cardiac resynchronization therapy (CRT) in a large population of patients implanted with a CRT device stratified in accordance with the 2016 European heart failure (HF) guidelines. METHODS: We collected data on 930 consecutive patients from the Cardiac Resynchronization Therapy MOdular REgistry. The primary end point was a composite of death and HF hospitalization. RESULTS: Five hundred sixty-three (60.5%) patients met class I indications, 145 (15.6%) class IIa, 108 (11.6%) class IIb, and 114 (12.3%) class III. After a median follow-up of 1001 days, 120 (14.7%) patients who had an indication to CRT had died and 71 (8.7%) had been hospitalized for HF. The time to the end point was longer in patients with a class I indication (hazard ratio 0.55; 95% confidence interval 0.39-0.76; P = .0001). After 12 months, left ventricular (LV) end-systolic volume had decreased by ≥15% in 61.5% (320/520) of patients whereas in 57.5% (389/676) of patients the absolute LV ejection fraction improvement was ≥5%. Adherence to class I was also associated with an absolute LV ejection fraction increase of >5% (P = .0142) and an LV end-systolic volume decrease of ≥15% (P = .0055). CONCLUSION: In our population, ∼60% of patients underwent implantation according to the 2016 European HF guidelines class I indication. Adherence to class I was associated with a lower death and HF hospitalization rates and better LV reverse remodeling.
Authors: Hans Henrik Odland; Manuel Villegas-Martinez; Stian Ross; Torbjørn Holm; Richard Cornelussen; Espen W Remme; Erik Kongsgard Journal: ESC Heart Fail Date: 2021-09-12