{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T14:18:24Z","timestamp":1787062704149,"version":"build-2736575974"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2019,6,18]],"date-time":"2019-06-18T00:00:00Z","timestamp":1560816000000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>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\u2009years, 76% male, 55% ischaemic, 47% CRT-D) followed for 353\u2009\u00b1\u200949\u2009days. 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\u2009years lead-related, 3.4\/100\u2009years bleedings, and 1.6\/100\u2009years infective. The primary endpoint was predicted by hospitalization in the month prior to the procedure [hazard ratio (HR)\u2009=\u20092.23, 1.16\u20134.29; 0.0169] and by upgrade (HR\u2009=\u20091.75, 1.02\u20132.99, 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\u2009days prior to the procedure (HR\u2009=\u20092.07, 1.13\u20133.81; 0.0199), anticoagulation (HR\u2009=\u20091.97, 1.26\u20133.07; 0.003), and ischaemic cardiomyopathy (HR\u2009=\u20091.67, 95% confidence interval 1.06\u20132.63; P\u2009=\u20090.0276) were associated with the combined endpoint during FU.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>URL: http:\/\/clinicaltrials.gov\/ Identifier: NCT02076789.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/europace\/euz166","type":"journal-article","created":{"date-parts":[[2019,5,22]],"date-time":"2019-05-22T15:30:25Z","timestamp":1558539025000},"page":"1527-1536","source":"Crossref","is-referenced-by-count":32,"title":["Real-life outcome of implantable cardioverter-defibrillator and cardiac resynchronization defibrillator replacement\/upgrade in a contemporary population: observations from the multicentre DECODE registry"],"prefix":"10.1093","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4590-8584","authenticated-orcid":false,"given":"Mauro","family":"Biffi","sequence":"first","affiliation":[{"name":"Azienda Ospedaliero-Universitaria di Bologna, Via Massarenti n. 9, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ernesto","family":"Ammendola","sequence":"additional","affiliation":[{"name":"Monaldi Hospital, Second University of Naples, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Endrj","family":"Menardi","sequence":"additional","affiliation":[{"name":"A.S. Ospedaliera S. Croce e Carle, Cuneo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quintino","family":"Parisi","sequence":"additional","affiliation":[{"name":"Fondazione di Ricerca e Cura Giovanni Paolo II, Campobasso, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Lucia","family":"Narducci","sequence":"additional","affiliation":[{"name":"Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"De Filippo","sequence":"additional","affiliation":[{"name":"Ospedale Papa Giovanni XXIII Hospital, Bergamo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Manzo","sequence":"additional","affiliation":[{"name":"A.O. Universitaria S. Giovanni Di Dio e Ruggi D\u2019Aragona, Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Stabile","sequence":"additional","affiliation":[{"name":"Clinica Mediterranea, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domenico Rosario","family":"Potenza","sequence":"additional","affiliation":[{"name":"Ospedale Casa Sollievo Della Sofferenza, S. Giovanni Rotondo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Zanon","sequence":"additional","affiliation":[{"name":"Ospedale S. Maria Della Misericordia, Rovigo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio","family":"Quartieri","sequence":"additional","affiliation":[{"name":"A.O. IRCCS Arcispedale S. Maria Nuova Di Reggio Emilia, Reggio Emilia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariano","family":"Rillo","sequence":"additional","affiliation":[{"name":"Villa Verde Hospital, Taranto, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davide","family":"Saporito","sequence":"additional","affiliation":[{"name":"Infermi Hospital, Rimini, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valerio","family":"Zac\u00e0","sequence":"additional","affiliation":[{"name":"Arrhythmology Unit, Cardiovascular and Thoracic Department, AOU Senese, Siena, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo Zoni","family":"Berisso","sequence":"additional","affiliation":[{"name":"Ospedale P.A. Micone, Genova Sestri Ponente, Genova, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matteo","family":"Bertini","sequence":"additional","affiliation":[{"name":"Azienda Ospedaliero Universitaria Di Ferrara Arcispedale S. Anna, Ferrara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio","family":"Tumietto","sequence":"additional","affiliation":[{"name":"Azienda Ospedaliero-Universitaria di Bologna, Via Massarenti n. 9, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurizio","family":"Malacrida","sequence":"additional","affiliation":[{"name":"Boston Scientific Italy, Milano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Igor","family":"Diemberger","sequence":"additional","affiliation":[{"name":"Azienda Ospedaliero-Universitaria di Bologna, Via Massarenti n. 9, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,6,17]]},"reference":[{"key":"2019101107585046300_euz166-B1","doi-asserted-by":"crossref","first-page":"1349","DOI":"10.1161\/CIRCULATIONAHA.106.678664","article-title":". Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study","volume":"116","author":"Klug","year":"2007","journal-title":"Circulation"},{"key":"2019101107585046300_euz166-B2","doi-asserted-by":"crossref","first-page":"1553","DOI":"10.1161\/CIRCULATIONAHA.110.976076","article-title":"Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry","volume":"122","author":"Poole","year":"2010","journal-title":"Circulation"},{"key":"2019101107585046300_euz166-B3","doi-asserted-by":"crossref","first-page":"1013","DOI":"10.1161\/CIRCULATIONAHA.114.009081","article-title":"Rates of and factors associated with infection in 200 909 Medicare implantable cardioverter-defibrillator implants","volume":"130","author":"Prutkin","year":"2014","journal-title":"Circulation"},{"key":"2019101107585046300_euz166-B4","doi-asserted-by":"crossref","first-page":"577","DOI":"10.1002\/clc.22440","article-title":"Detect long-term complications after ICD replacement (DECODE): rationale and study design of a multicenter Italian registry","volume":"38","author":"Diemberger","year":"2015","journal-title":"Clin Cardiol"},{"key":"2019101107585046300_euz166-B5","doi-asserted-by":"crossref","first-page":"1186","DOI":"10.1093\/eurheartj\/eht511","article-title":"Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark","volume":"35","author":"Kirkfeldt","year":"2014","journal-title":"Eur Heart J"},{"key":"2019101107585046300_euz166-B6","doi-asserted-by":"crossref","first-page":"633","DOI":"10.1086\/313753","article-title":"Proposed modifications to the Duke criteria for the diagnosis of infective endocarditis","volume":"30","author":"Li","year":"2000","journal-title":"Clin Infect Dis"},{"key":"2019101107585046300_euz166-B7","doi-asserted-by":"crossref","first-page":"1251","DOI":"10.1093\/europace\/euv109","article-title":"Longevity of implantable cardioverter-defibrillators for cardiac resynchronization therapy in current clinical practice: an analysis according to influencing factors, device generation, and manufacturer","volume":"17","author":"Landolina","year":"2015","journal-title":"Europace"},{"key":"2019101107585046300_euz166-B8","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1056\/NEJMp1111467","article-title":"Time for a change\u2014a new approach to ICD replacement","volume":"366","author":"Kramer","year":"2012","journal-title":"N Engl J Med"},{"key":"2019101107585046300_euz166-B9","doi-asserted-by":"crossref","first-page":"892","DOI":"10.1002\/clc.22743","article-title":"Repeated procedures at the generator pocket are a determinant of implantable cardioverter-defibrillator infection","volume":"40","author":"Arana-Rueda","year":"2017","journal-title":"Clin Cardiol"},{"key":"2019101107585046300_euz166-B10","doi-asserted-by":"crossref","first-page":"58","DOI":"10.1093\/europace\/eup334","article-title":"Prevalence of bacterial colonization of generator pockets in implantable cardioverter defibrillator patients without signs of infection undergoing generator replacement or lead revision","volume":"12","author":"Kleemann","year":"2010","journal-title":"Europace"},{"key":"2019101107585046300_euz166-B11","doi-asserted-by":"crossref","first-page":"1300","DOI":"10.1016\/j.jacc.2016.01.009","article-title":"Clinically significant pocket hematoma increases long-term risk of device infection: BRUISE CONTROL INFECTION Study","volume":"67","author":"Essebag","year":"2016","journal-title":"J Am Coll Cardiol"},{"key":"2019101107585046300_euz166-B12","doi-asserted-by":"crossref","first-page":"1197","DOI":"10.1093\/europace\/euv190","article-title":"Antithrombotic management in patients undergoing electrophysiological procedures: a European Heart Rhythm Association (EHRA) position document endorsed by the ESC Working Group Thrombosis, Heart Rhythm Society (HRS), and Asia Pacific Heart Rhythm Society (APHRS)","volume":"17","author":"Sticherling","year":"2015","journal-title":"Europace"},{"key":"2019101107585046300_euz166-B13","doi-asserted-by":"crossref","first-page":"1036","DOI":"10.1016\/j.amjcard.2016.12.012","article-title":"Frequency of \u201cpocket\u201d hematoma in patients receiving vitamin k antagonist and antiplatelet therapy at the time of pacemaker or cardioverter defibrillator implantation (from the POCKET Study)","volume":"119","author":"Malag\u00f9","year":"2017","journal-title":"Am J Cardiol"},{"key":"2019101107585046300_euz166-B14","doi-asserted-by":"crossref","first-page":"664.","DOI":"10.1093\/eurheartj\/ehy563.P3213","article-title":"Real-world periprocedural management of antithrombotic therapy in patients undergoing electrophysiological device surgery: preliminary results of the HEMATOMA NO MORE","volume":"39","author":"Zaca","year":"2018","journal-title":"Eur Heart J"},{"key":"2019101107585046300_euz166-B15","doi-asserted-by":"crossref","first-page":"950","DOI":"10.1016\/j.hrthm.2015.01.035","article-title":"IMpact of pocKet rEvision on the rate of InfecTion and other CompLications in patients rEquiring pocket mAnipulation for generator replacement and\/or lead replacement or revisioN (MAKE IT CLEAN): a prospective randomized study","volume":"12","author":"Lakkireddy","year":"2015","journal-title":"Heart Rhythm"},{"key":"2019101107585046300_euz166-B16","doi-asserted-by":"crossref","DOI":"10.1038\/s41598-018-29167-2","article-title":"A micron-scale surface topography design reducing cell adhesion to implanted materials","volume":"8","author":"Robotti","year":"2018","journal-title":"Sci Rep"},{"key":"2019101107585046300_euz166-B17","doi-asserted-by":"crossref","first-page":"304","DOI":"10.1111\/pace.12280","article-title":"The role of prophylaxis topical antibiotics in cardiac device implantation","volume":"37","author":"Khalighi","year":"2014","journal-title":"Pacing Clin Electrophysiol"},{"key":"2019101107585046300_euz166-B18","doi-asserted-by":"crossref","first-page":"1238","DOI":"10.1002\/clc.23033","article-title":"Is ventricular sensing always right, when it is left?","volume":"4","author":"Biffi","year":"2018","journal-title":"Clin Cardiol"},{"key":"2019101107585046300_euz166-B19","doi-asserted-by":"crossref","first-page":"652","DOI":"10.1093\/eurjhf\/hfs040","article-title":"Meta-analysis of randomized controlled trials evaluating left ventricular vs. biventricular pacing in heart failure: effect on all-cause mortality and hospitalizations","volume":"14","author":"Boriani","year":"2012","journal-title":"Eur J Heart Fail"},{"key":"2019101107585046300_euz166-B20","doi-asserted-by":"crossref","first-page":"533","DOI":"10.1056\/NEJMoa1511643","article-title":"A leadless intracardiac transcatheter pacing system","volume":"374","author":"Reynolds","year":"2016","journal-title":"N Engl J Med"},{"key":"2019101107585046300_euz166-B21","doi-asserted-by":"crossref","first-page":"1475","DOI":"10.1093\/europace\/eux323","article-title":"Appropriate implantable cardioverter-defibrillator interventions in cardiac resynchronization therapy-defibrillator (CRT-D) patients undergoing device replacement: time to downgrade from CRT-D to CRT-pacemaker? Insights from real-world clinical practice in the DECODE CRT-D analysis","volume":"20","author":"Narducci","year":"2018","journal-title":"Europace"},{"key":"2019101107585046300_euz166-B22","doi-asserted-by":"crossref","first-page":"1895","DOI":"10.1056\/NEJMoa1901111","article-title":"Antibacterial envelope to prevent cardiac implantable device infection","volume":"380","author":"Tarakji","year":"2019","journal-title":"N Engl J Med"}],"container-title":["EP Europace"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/europace\/article-pdf\/21\/10\/1527\/30132588\/euz166.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/europace\/article-pdf\/21\/10\/1527\/30132588\/euz166.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,10,11]],"date-time":"2019-10-11T07:59:22Z","timestamp":1570780762000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/europace\/article\/21\/10\/1527\/5519672"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,6,17]]},"references-count":22,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2019,6,17]]},"published-print":{"date-parts":[[2019,10,1]]}},"URL":"https:\/\/doi.org\/10.1093\/europace\/euz166","relation":{},"ISSN":["1099-5129","1532-2092"],"issn-type":[{"value":"1099-5129","type":"print"},{"value":"1532-2092","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2019,10]]},"published":{"date-parts":[[2019,6,17]]}}}