Diemberger Igor, Parisi Quintino, De Filippo Paolo, Narducci Maria Lucia, Zanon Francesco, Potenza Domenico Rosario, Ciaramitaro Gianfranco, Malacrida Maurizio, Boriani Giuseppe, Biffi Mauro
Institute of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.
Cardiovascular Department, Fondazione di Ricerca e Cura "Giovanni Paolo II," Catholic University of the Sacred Heart, Campobasso, Italy.
Clin Cardiol. 2015 Oct;38(10):577-84. doi: 10.1002/clc.22440. Epub 2015 Aug 18.
The replacement of implantable cardioverter-defibrillators (ICDs) may give rise to considerable clinical consequences, the importance of which is underrated by the medical community. Replacement-related adverse events are difficult to identify and require monitoring of both short-term complications and long-term patient outcome. The aim of this study is to perform a structured evaluation of both short- and long-term adverse events and a cost analysis of consecutive ICD replacement procedures. Detect Long-term Complications After ICD Replacement (DECODE) is a prospective, single-arm, multicenter cohort study designed to estimate long-term complication rates (at 12 months and 5 years) in patients undergoing ICD generator replacement. The study will also evaluate predictors of complications, patient management before and during the replacement procedure in clinical practice, and the costs related to use of health care resources. About 800 consecutive patients with standard indications for ICD generator replacement will be enrolled in this study. The decision to undertake generator replacement/upgrade will be made according to the investigators' own judgment (which will be recorded). Patients will be followed for 60 months through periodic in-hospital examinations or remote monitoring. Detailed data on complications related to ICD replacement in current clinical practice are still lacking. The analysis of adverse events will reveal the value of new preventive strategies, thereby yielding both clinical and economic benefits. Moreover, assessment of complication rates after ICD replacement in a real-life setting will help estimate the actual long-term cost of ICD therapy and assess the real impact of increasing ICD longevity on cost-effectiveness.
植入式心脏复律除颤器（ICD）的更换可能会引发相当严重的临床后果，而其重要性却被医学界低估了。与更换相关的不良事件难以识别，需要对短期并发症和患者长期预后进行监测。本研究的目的是对短期和长期不良事件进行结构化评估，并对连续的ICD更换程序进行成本分析。检测ICD更换后的长期并发症（DECODE）是一项前瞻性、单臂、多中心队列研究，旨在估计接受ICD发生器更换的患者的长期并发症发生率（12个月和5年时）。该研究还将评估并发症的预测因素、临床实践中更换手术前和手术期间的患者管理，以及与使用医疗保健资源相关的成本。约800例有ICD发生器更换标准适应证的连续患者将被纳入本研究。进行发生器更换/升级的决定将根据研究者自己的判断做出（并将记录在案）。将通过定期的住院检查或远程监测对患者进行60个月的随访。目前临床实践中仍缺乏关于ICD更换相关并发症的详细数据。对不良事件的分析将揭示新预防策略的价值，从而产生临床和经济效益。此外，在实际环境中评估ICD更换后的并发症发生率将有助于估计ICD治疗的实际长期成本，并评估延长ICD使用寿命对成本效益的实际影响。
