title: Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study.
abstract: OBJECTIVE
  The OPTION (Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator Patients Without Pacing Indications) trial sought to compare long-term rates of inappropriate shocks, mortality, and morbidity between dual-chamber and single-chamber settings in implantable cardioverter-defibrillators (ICDs) patients.
  
  
  BACKGROUND
  The use of dual-chamber ICDs potentially allows better discrimination of supraventricular arrhythmias and thereby reduces inappropriate shocks. However, it may lead to detrimental ventricular pacing.
  
  
  METHODS
  This prospective multicenter, single-blinded trial enrolled 462 patients with de novo primary or secondary prevention indications for ICD placement and with left ventricular ejection fractions ≤40% despite optimal tolerated pharmacotherapy. All patients received atrial leads and dual-chamber defibrillators that were randomized to be programmed either with dual-chamber or single-chamber settings. In the dual-chamber setting arm, the PARAD+ algorithm, which differentiates supraventricular from ventricular arrhythmias, and SafeR mode, to minimize ventricular pacing, were activated. In the single-chamber setting arm, the acceleration, stability, and long cycle search discrimination criteria were activated, and pacing was set to VVI 40 beats/min. Ventricular tachycardia detection was required at rates between 170 and 200 beats/min, and ventricular fibrillation detection was activated above 200 beats/min.
  
  
  RESULTS
  During a follow-up period of 27 months, the time to the first inappropriate shock was significantly longer in the dual-chamber setting arm (p = 0.012, log-rank test), and 4.3% of patients in the dual-chamber setting group compared with 10.3% in the single-chamber setting group experienced inappropriate shocks (p = 0.015). Rates of all-cause death or cardiovascular hospitalization were 20% for the dual-chamber setting group and 22.4% for the single-chamber setting group and satisfied the pre-defined margin for equivalence (p < 0.001).
  
  
  CONCLUSIONS
  Therapy with dual-chamber settings for ICD discrimination combined with algorithms for minimizing ventricular pacing was associated with reduced risk for inappropriate shock compared with single-chamber settings, without increases in mortality and morbidity. (Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator [ICD] Patients Without Pacing Indications [OPTION]; NCT00729703).
authors.affiliation: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Faculty of Medicine, Technische Universität München, Munich, Germany. Electronic address: kolb@dhm.mhn.de.
authors.forename: Christof
authors.initials: C
authors.lastname: Kolb
authors.affiliation: Sacre-Coeur Hospital, Université de Montréal, Montréal, Québec, Canada.
authors.forename: Marcio
authors.initials: M
authors.lastname: Sturmer
authors.affiliation: Hospital of the Order of St. John of God, Prüfeninger Straße Clinic, Regensburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Sick
authors.affiliation: Klinik für Kardiologie und Internistische Intensivmedizin, Städtisches Klinikum München-Bogenhausen, München, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Reif
authors.affiliation: Département de Cardiologie et Maladies Vasculaires, Hôpital Arnaud de Villeneuve-CHU de Montpellier, Montpellier, France.
authors.forename: Jean Marc
authors.initials: JM
authors.lastname: Davy
authors.affiliation: Cardiology Department, Ospedale Sacro Cuore, Negrar, Italy.
authors.forename: Giulio
authors.initials: G
authors.lastname: Molon
authors.affiliation: Department of Medicine, Cardiology, University Hospital, Bonn, Germany.
authors.forename: Jörg Otto
authors.initials: JO
authors.lastname: Schwab
authors.affiliation: Ospedale Civile, Desio, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mantovani
authors.affiliation: Piedmont Heart Institute, Atlanta, Georgia.
authors.forename: Dan
authors.initials: D
authors.lastname: Dan
authors.affiliation: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Faculty of Medicine, Technische Universität München, Munich, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Lennerz
authors.affiliation: Sorin CRM SAS, Saluggia, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Borri-Brunetto
authors.affiliation: University Hospital, Tours, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Babuty
mesh_terms: D001281:Atrial Fibrillation / Q000401:mortality / Q000628:therapy*; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D016037:Single-Blind Method; D013617:Tachycardia, Supraventricular / Q000401:mortality / Q000628:therapy*; D016896:Treatment Outcome
keywords: defibrillation; pacing; shock; survival; tachyarrhythmias