Giuseppe Boriani1,2, Elena Berti3, Laura Maria Beatrice Belotti3, Mauro Biffi1, Rossana De Palma3, Vincenzo L Malavasi2, Nicola Bottoni4, Luca Rossi5, Elia De Maria6, Roberto Mantovan7, Marco Zardini8, Edoardo Casali2, Marco Marconi9, Alberto Bandini10, Corrado Tomasi11, Giulio Boggian12, Gaetano Barbato13, Tiziano Toselli14, Mauro Zennaro15, Biagio Sassone16. 1. Institute of Cardiology, University of Bologna, Azienda Ospedaliera S. Orsola-Malpighi, Bologna, Italy. 2. Division of Cardiology, Modena University Hospital, University of Modena and Reggio Emilia, Modena, Italy. 3. Agency for Health and Social Care of Emilia-Romagna, Bologna, Italy. 4. Division of Cardiology, S. Maria Nuova Hospital, Reggio Emilia, Italy. 5. Division of Cardiology, G. da Saliceto Hospital, Piacenza, Italy. 6. Division of Cardiology, Carpi Hospital, Modena, Italy. 7. Division of Cardiology, M. Bufalini Hospital, Cesena, Italy. 8. Division of Cardiology, Parma University Hospital, Parma, Italy. 9. Division of Cardiology, Local Health Unit, Rimini, Italy. 10. Division of Cardiologia, G.B. Morgagni-L. Pierantoni Hospital, Forlì, Italy. 11. Division of Cardiology, S. Maria delle Croci Hospital, Ravenna, Italy. 12. Division of Cardiology, Hospital of Bentivoglio, Bologna, Italy. 13. Division of Cardiology, Maggiore Hospital, Bologna, Italy. 14. Division of Cardiology, Ferrara University Hospital, Ferrara, Italy. 15. Division of Cardiology, Baggiovara Hospital, Modena, Italy. 16. Division of Cardiology, Cento Hospital, Ferrara, Italy.
Abstract
BACKGROUND: The impact on long-term outcomes of implantable cardioverter defibrillators (ICDs) and biventricular defibrillators for cardiac resynchronization (CRT-D) devices in 'real world' patients with heart failure (HF) needs to be assessed in terms of clinical effectiveness. METHODS AND RESULTS: A registry including consecutive HF patients who underwent a first implant of an ICD (891 patients) or a CRT-D device (709 patients) in 2006-2010 was followed (median 1487 days and 1516 days, respectively), collecting administrative data on survival, all-cause hospitalizations, cardiovascular or HF hospitalizations, and days alive and out of hospital (DAOH). Survival free from death/cardiac transplant was 61.9% and 63.8% at 5 years for ICD and CRT-D patients, respectively. Associated comorbidities (Charlson Comorbidity Index) had a significant impact on death/cardiac transplant, as well as on hospitalizations. The median values of DAOH% were 97.4% for ICD and 97.7% for CRT-D patients, but data were highly skewed, with the lower quartile of DAOH% values including values ranging between 0% and 52.8% for ICD and between 0% and 56.1% for CRT-D patients. Charlson Comorbidity Index was a very strong predictor of DAOH%. CONCLUSIONS: Patients who were implanted in 'real world' clinical practice with an ICD or a CRT-D device have, on average, a relatively favourable outcome, with a survival of around 62-64% at 5 years, but with an important burden of hospitalizations. Comorbidities, as evaluated by means of the Charlson Comorbidity Index, have a significant impact on outcomes in terms of mortality/heart transplant, hospitalizations and days spent alive and out of hospital.
BACKGROUND: The impact on long-term outcomes of implantable cardioverter defibrillators (ICDs) and biventricular defibrillators for cardiac resynchronization (CRT-D) devices in 'real world' patients with heart failure (HF) needs to be assessed in terms of clinical effectiveness. METHODS AND RESULTS: A registry including consecutive HF patients who underwent a first implant of an ICD (891 patients) or a CRT-D device (709 patients) in 2006-2010 was followed (median 1487 days and 1516 days, respectively), collecting administrative data on survival, all-cause hospitalizations, cardiovascular or HF hospitalizations, and days alive and out of hospital (DAOH). Survival free from death/cardiac transplant was 61.9% and 63.8% at 5 years for ICD and CRT-D patients, respectively. Associated comorbidities (Charlson Comorbidity Index) had a significant impact on death/cardiac transplant, as well as on hospitalizations. The median values of DAOH% were 97.4% for ICD and 97.7% for CRT-D patients, but data were highly skewed, with the lower quartile of DAOH% values including values ranging between 0% and 52.8% for ICD and between 0% and 56.1% for CRT-D patients. Charlson Comorbidity Index was a very strong predictor of DAOH%. CONCLUSIONS:Patients who were implanted in 'real world' clinical practice with an ICD or a CRT-D device have, on average, a relatively favourable outcome, with a survival of around 62-64% at 5 years, but with an important burden of hospitalizations. Comorbidities, as evaluated by means of the Charlson Comorbidity Index, have a significant impact on outcomes in terms of mortality/heart transplant, hospitalizations and days spent alive and out of hospital.
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