PMID- 31209482 OWN - NLM STAT- MEDLINE DCOM- 20201028 LR - 20201028 IS - 1532-2092 (Electronic) IS - 1099-5129 (Linking) VI - 21 IP - 10 DP - 2019 Oct 1 TI - Real-life outcome of implantable cardioverter-defibrillator and cardiac resynchronization defibrillator replacement/upgrade in a contemporary population: observations from the multicentre DECODE registry. PG - 1527-1536 LID - 10.1093/europace/euz166 [doi] AB - AIMS: The benefit of prolonged implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) therapy following device replacement is hindered by clinical and procedure-related adverse events (AEs). Adverse events rate is highest in more complex devices and at upgrades, as per the REPLACE registry experience, but is changing owing to the improvement in device technology and medical care. We aimed at understanding the extent and type of AEs in a contemporary Italian population. METHODS AND RESULTS: Detect long-term complications after ICD replacement (DECODE) was a prospective, single-arm, multicentre cohort study aimed at estimating medium- to long-term AEs in a large population of patients undergoing ICD/cardiac resynchronization defibrillator replacement/upgrade from 2013 to 2015. We prospectively analysed all clinical and device-related AEs at 12-month follow-up (FU) of 983 consecutive patients (median age 71 years, 76% male, 55% ischaemic, 47% CRT-D) followed for 353 +/- 49 days. Seven percent of the patients died (60.6% for cardiovascular reasons), whereas 104 AEs occurred; 43 (4.4%) patients needed at least one surgical action to treat the AE. Adverse events rates were 3.3/100 years lead-related, 3.4/100 years bleedings, and 1.6/100 years infective. The primary endpoint was predicted by hospitalization in the month prior to the procedure [hazard ratio (HR) = 2.23, 1.16-4.29; 0.0169] and by upgrade (HR = 1.75, 1.02-2.99, 0.0441). One hundred and twelve (11.4%) patients met the combined endpoint of death from any cause, cardiac implantable electronic device (CIED)-related infection, and surgical action/hospitalization required to treat the AE. Hospitalization within 30 days prior to the procedure (HR = 2.07, 1.13-3.81; 0.0199), anticoagulation (HR = 1.97, 1.26-3.07; 0.003), and ischaemic cardiomyopathy (HR = 1.67, 95% confidence interval 1.06-2.63; P = 0.0276) were associated with the combined endpoint during FU. CONCLUSIONS: Adverse events following CIED replacement/upgrade are lower than previously reported, possibly owing to improved patients care. Hospitalization in the month prior to the procedure, upgrade, and clinical profile (anticoagulation, ischaemic cardiomyopathy) hint to increased risk, suggesting an individualized planning of the procedure to minimize overall AEs. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/ Identifier: NCT02076789. CI - Published on behalf of the European Society of Cardiology. All rights reserved. (c) The Author(s) 2019. For permissions, please email: journals.permissions@oup.com. FAU - Biffi, Mauro AU - Biffi M AD - Azienda Ospedaliero-Universitaria di Bologna, Via Massarenti n. 9, Bologna, Italy. FAU - Ammendola, Ernesto AU - Ammendola E AD - Monaldi Hospital, Second University of Naples, Naples, Italy. FAU - Menardi, Endrj AU - Menardi E AD - A.S. Ospedaliera S. Croce e Carle, Cuneo, Italy. FAU - Parisi, Quintino AU - Parisi Q AD - Fondazione di Ricerca e Cura Giovanni Paolo II, Campobasso, Italy. FAU - Narducci, Maria Lucia AU - Narducci ML AD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy. FAU - De Filippo, Paolo AU - De Filippo P AD - Ospedale Papa Giovanni XXIII Hospital, Bergamo, Italy. FAU - Manzo, Michele AU - Manzo M AD - A.O. Universitaria S. Giovanni Di Dio e Ruggi D'Aragona, Salerno, Italy. FAU - Stabile, Giuseppe AU - Stabile G AD - Clinica Mediterranea, Naples, Italy. FAU - Potenza, Domenico Rosario AU - Potenza DR AD - Ospedale Casa Sollievo Della Sofferenza, S. Giovanni Rotondo, Italy. FAU - Zanon, Francesco AU - Zanon F AD - Ospedale S. Maria Della Misericordia, Rovigo, Italy. FAU - Quartieri, Fabio AU - Quartieri F AD - A.O. IRCCS Arcispedale S. Maria Nuova Di Reggio Emilia, Reggio Emilia, Italy. FAU - Rillo, Mariano AU - Rillo M AD - Villa Verde Hospital, Taranto, Italy. FAU - Saporito, Davide AU - Saporito D AD - Infermi Hospital, Rimini, Italy. FAU - Zaca, Valerio AU - Zaca V AD - Arrhythmology Unit, Cardiovascular and Thoracic Department, AOU Senese, Siena, Italy. FAU - Berisso, Massimo Zoni AU - Berisso MZ AD - Ospedale P.A. Micone, Genova Sestri Ponente, Genova, Italy. FAU - Bertini, Matteo AU - Bertini M AD - Azienda Ospedaliero Universitaria Di Ferrara Arcispedale S. Anna, Ferrara, Italy. FAU - Tumietto, Fabio AU - Tumietto F AD - Azienda Ospedaliero-Universitaria di Bologna, Via Massarenti n. 9, Bologna, Italy. FAU - Malacrida, Maurizio AU - Malacrida M AD - Boston Scientific Italy, Milano, Italy. FAU - Diemberger, Igor AU - Diemberger I AD - Azienda Ospedaliero-Universitaria di Bologna, Via Massarenti n. 9, Bologna, Italy. LA - eng SI - ClinicalTrials.gov/NCT02076789 PT - Journal Article PT - Multicenter Study PL - England TA - Europace JT - Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology JID - 100883649 SB - IM MH - Aged MH - Cardiac Resynchronization Therapy/*methods MH - Death, Sudden, Cardiac/epidemiology/*prevention & control MH - *Defibrillators, Implantable MH - Device Removal MH - Female MH - Follow-Up Studies MH - Heart Failure/*therapy MH - Humans MH - Incidence MH - Italy/epidemiology MH - Male MH - Middle Aged MH - Prospective Studies MH - *Registries MH - Risk Factors MH - Survival Rate/trends MH - Treatment Outcome OTO - NOTNLM OT - Cardiac resynchronisation therapy-defibrillator OT - Complication OT - Implantable cardioverter-defibrillator OT - Infection OT - Registry OT - Replacement OT - Upgrade EDAT- 2019/06/19 06:00 MHDA- 2020/10/29 06:00 CRDT- 2019/06/19 06:00 PHST- 2019/01/20 00:00 [received] PHST- 2019/05/22 00:00 [accepted] PHST- 2019/06/19 06:00 [pubmed] PHST- 2020/10/29 06:00 [medline] PHST- 2019/06/19 06:00 [entrez] AID - 5519672 [pii] AID - 10.1093/europace/euz166 [doi] PST - ppublish SO - Europace. 2019 Oct 1;21(10):1527-1536. doi: 10.1093/europace/euz166.