title: Rationale and design of the OPTION study: optimal antitachycardia therapy in ICD patients without pacing indications.
abstract: BACKGROUND
  Implantable cardioverter-defibrillators (ICDs) represent the treatment of choice for primary and secondary prevention of sudden cardiac death but ICD therapy is also plagued by inappropriate shocks due to supraventricular tachyarrhythmias. Dual-chamber (DC) ICDs are considered to exhibit an enhanced discrimination performance in comparison to single-chamber (SC) ICDs, which results in reduction of inappropriate detections in a short- to mid-term follow-up. Comparative data on long-term follow-up and especially on inappropriate shocks are limited.
  
  
  METHODS
  The aim of the OPTION study is to assess whether an optimized treatment with DC ICDs improves patient outcome and decreases the rate of inappropriate shocks in comparison to SC ICDs. DC ICD therapy optimization is achieved by optimal customizing of antitachycardia therapy parameters, activation of discrimination algorithms, antitachycardia pacing in the slow ventricular tachycardia zone, and avoidance of right ventricular pacing with the SafeR algorithm mode. The OPTION study, a prospective, multicenter, randomized, single-blinded, parallel study, will randomize 450 patients on a 1:1 allocation to either an SC arm with backup pacing at VVI 40 beats per minute (bpm) or to the DC arm with SafeR pacing at 60 bpm. Patients will be followed for 27 months. Primary outcome measure is the time to first occurrence of inappropriate shock and a combined endpoint of cardiovascular morbidity and all-cause mortality.
  
  
  CONCLUSIONS
  The study will evaluate the relative performance of DC in comparison to SC ICDs in terms of inappropriate shock reduction and patient outcome.
authors.affiliation: Deutsches Herzzentrum und 1, Faculty of Medicine, Technische Universität München, Munich, Germany. kolb@dhm.mhn.de
authors.forename: Christof
authors.initials: C
authors.lastname: Kolb
authors.forename: Stylianos
authors.initials: S
authors.lastname: Tzeis
authors.forename: Marcio
authors.initials: M
authors.lastname: Sturmer
authors.forename: Dominique
authors.initials: D
authors.lastname: Babuty
authors.forename: Jörg O
authors.initials: JO
authors.lastname: Schwab
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mantovani
authors.forename: Sabine
authors.initials: S
authors.lastname: Janko
authors.forename: Ezio
authors.initials: E
authors.lastname: Aimé
authors.forename: Rolf
authors.initials: R
authors.lastname: Ocklenburg
authors.forename: Peter
authors.initials: P
authors.lastname: Sick
mesh_terms: D001145:Arrhythmias, Cardiac / Q000628:therapy*; D002304:Cardiac Pacing, Artificial; D002985:Clinical Protocols; D016757:Death, Sudden, Cardiac / Q000517:prevention & control; D017147:Defibrillators, Implantable; D006801:Humans; D018579:Patient Selection; D012107:Research Design; D016037:Single-Blind Method; D013610:Tachycardia / Q000628:therapy*