2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter‐defibrillator programming and testing

Implantable cardioverter-defibrillator (ICD) therapy is clearly an effective therapy for selected patients in definable populations. The benefits and risks of ICD therapy are directly impacted by programming and surgical decisions. This flexibility is both a great strength and a weakness, for which there has been no prior official discussion or guidance. It is the consensus of the 4 continental electrophysiology societies that there are 4 important clinical issues for which there are sufficient ICD clinical and trial data to provide evidence-based expert guidance. This document systematically describes the greater than 80% (83%–100%, mean 96%) required consensus achieved for each recommendation by official balloting in regard to the programming of (1) bradycardia mode and rate, (2) tachycardia detection, (3) tachycardia therapy, and (4) the intraprocedural testing of defibrillation efficacy. Representatives nominated by the Heart Rhythm Society (HRS), European Heart Rhythm Association (EHRA), Asian Pacific Heart Rhythm Society (APHRS), and the Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLAECE-Latin American Society of Cardiac Pacing and Electrophysiology) participated in the project definition, the literature review, the recommendation development, the writing of the document, and its approval. The 32 recommendations were balloted by the 35 writing committee members and were approved by an average of 96%. The classification of the recommendations and the level of evidence follow the recently updated ACC/AHA standard [1], [2]. Class I is a strong recommendation, denoting a benefit greatly exceeding risk. Class IIa is a somewhat weaker recommendation, with a benefit probably exceeding risk, and Class IIb denotes a benefit equivalent to or possibly exceeding risk. Class III is a recommendation against a specific treatment because either there is no net benefit or there is net harm. Level of Evidence A denotes the highest level of evidence from more than 1 high-quality randomized clinical trial (RCT), a meta-analysis of high-quality RCTs, or RCTs corroborated by high-quality registry studies. Level of evidence B indicates moderate-quality evidence from either RCTs with a meta-analysis (B-R) or well-executed nonrandomized trials with a meta-analysis (B-NR). Level of evidence C indicates randomized or nonrandomized observational or registry studies with limited data (C-LD) or from expert opinions (C-EO) based clinical in the of recommendations were to a and the document and and is in The of patients in of specific clinical and the data that the recommendations in document provide for a to ICD an or and clinical the programming of and of the ICD and clinical to the programming for each The recommendations in document patients and to programming that each ICD has specific that by the 32 recommendations in the writing specific to each and is to the for each ICD the ICD is for tachycardia therapy, there bradycardia for ICD from clinical studies the mode than the of the of or the patients required bradycardia It is of that has been from and patients are from ICD and has been with or in patients with bradycardia in randomized in 1 meta-analysis of randomized and in 1 that randomized and 4 to with in benefits in patients with in has been and with 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