Christof Kolb1, Marcio Sturmer2, Peter Sick3, Sebastian Reif4, Jean Marc Davy5, Giulio Molon6, Jörg Otto Schwab7, Giuseppe Mantovani8, Dan Dan9, Carsten Lennerz10, Alberto Borri-Brunetto11, Dominique Babuty12. 1. Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Faculty of Medicine, Technische Universität München, Munich, Germany. Electronic address: kolb@dhm.mhn.de. 2. Sacre-Coeur Hospital, Université de Montréal, Montréal, Québec, Canada. 3. Hospital of the Order of St. John of God, Prüfeninger Straße Clinic, Regensburg, Germany. 4. Klinik für Kardiologie und Internistische Intensivmedizin, Städtisches Klinikum München-Bogenhausen, München, Germany. 5. Département de Cardiologie et Maladies Vasculaires, Hôpital Arnaud de Villeneuve-CHU de Montpellier, Montpellier, France. 6. Cardiology Department, Ospedale Sacro Cuore, Negrar, Italy. 7. Department of Medicine, Cardiology, University Hospital, Bonn, Germany. 8. Ospedale Civile, Desio, Italy. 9. Piedmont Heart Institute, Atlanta, Georgia. 10. Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Faculty of Medicine, Technische Universität München, Munich, Germany. 11. Sorin CRM SAS, Saluggia, Italy. 12. University Hospital, Tours, France.
Abstract
OBJECTIVES: 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).
RCT Entities:
OBJECTIVES: 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: Mohammed Shurrab; Amir Janmohamed; Jean-François Sarrazin; Felix Ayala-Paredes; Marcio Sturmer; Randall Williams; Satish Toal; Chris Lane; Kevin E Thorpe; Jeff S Healey; Eugene Crystal Journal: J Interv Card Electrophysiol Date: 2017-07-27 Impact factor: 1.900
Authors: Emily P Zeitler; Gillian D Sanders; Kavisha Singh; Ruth Ann Greenfield; Anne M Gillis; Bruce L Wilkoff; Jonathan P Piccini; Sana M Al-Khatib Journal: Europace Date: 2018-10-01 Impact factor: 5.214