Laurence D Sterns1, Mathias Meine2, Takashi Kurita3, Albert Meijer4, Angelo Auricchio5, Kenji Ando6, Charles T Leng7, Ken Okumura8, John L Sapp9, Mark L Brown10, Daniel R Lexcen10, Bart Gerritse11, Edward J Schloss12. 1. Royal Jubilee Hospital, Victoria, Canada. Electronic address: LDSterns@gmail.com. 2. Cardiologie, University Medical Center, Utrecht, Netherlands. 3. Cardiology Division, Kinkl University, Osaka, Japan. 4. Catharina Ziekenhuis, Eindhoven, Netherlands. 5. Fondazione Cardiocentro Ticino, Lugano, Switzerland. 6. Kokura Memorial Hospital, Kitakyushu, Japan. 7. Penn-Presbyterian Medical Center, University of Pennsylvania Health Systems, Timonium, Maryland. 8. Hirosaki University Graduate School of Medicine, Aomori, Japan. 9. QE II Health Sciences Centre, Halifax, Canada. 10. Medtronic Inc, Minneapolis, Minnesota. 11. Medtronic Bakken Research Center, Maastricht, Netherlands. 12. The Christ Hospital/The Ohio Heart & Vascular Center, Cincinnati, Ohio.
Abstract
BACKGROUND:Prolonged ventricular fibrillation (VF) detection has been shown to reduce implantable cardioverter-defibrillator (ICD) therapies and improve prognosis in primary prevention ICD patients. Data in secondary prevention patients are limited. OBJECTIVE: The PainFree SST secondary prevention study is the largest trial of secondary prevention patients randomized between standard and prolonged detection to assess the safety of this strategy in these patients. METHODS: A total of 705 secondary prevention patients implanted with an ICD in the PainFree SST trial were enrolled in this substudy; 353 patients were randomized to VF detection of 18/24 intervals and 352 patients to 30/40. All other VF parameters were standardized by protocol. RESULTS: The 1-year arrhythmic syncope-free rates in the standard and prolonged groups were 97.7% vs 96.9%, respectively, (P = .0034 for noninferiority). Freedom from all-cause syncope was 96% in both arms (P = .0013 for noninferiority). There was no difference in the time to first appropriate or inappropriate VF therapy. However, the rates of treated VF episodes were lower in the prolonged arm (1.48 per patient per year vs 0.44 per patient per year, P = .0001). A trend toward lower mortality in the prolonged group was not statistically different (5.6% 1 year, 12% 2 years vs 3.8% 1 year, 7.7% 2 years, adjusted hazard ratio = 0.60, P = .061). CONCLUSION: This large prospective randomized study shows that prolonged detection can safely be programmed in secondary prevention ICD patients with new or existing devices. This programming strategy decreases the rate of treated events and is not associated with an increased risk of syncope or mortality.
RCT Entities:
BACKGROUND: Prolonged ventricular fibrillation (VF) detection has been shown to reduce implantable cardioverter-defibrillator (ICD) therapies and improve prognosis in primary prevention ICDpatients. Data in secondary prevention patients are limited. OBJECTIVE: The PainFree SST secondary prevention study is the largest trial of secondary prevention patients randomized between standard and prolonged detection to assess the safety of this strategy in these patients. METHODS: A total of 705 secondary prevention patients implanted with an ICD in the PainFree SST trial were enrolled in this substudy; 353 patients were randomized to VF detection of 18/24 intervals and 352 patients to 30/40. All other VF parameters were standardized by protocol. RESULTS: The 1-year arrhythmic syncope-free rates in the standard and prolonged groups were 97.7% vs 96.9%, respectively, (P = .0034 for noninferiority). Freedom from all-cause syncope was 96% in both arms (P = .0013 for noninferiority). There was no difference in the time to first appropriate or inappropriate VF therapy. However, the rates of treated VF episodes were lower in the prolonged arm (1.48 per patient per year vs 0.44 per patient per year, P = .0001). A trend toward lower mortality in the prolonged group was not statistically different (5.6% 1 year, 12% 2 years vs 3.8% 1 year, 7.7% 2 years, adjusted hazard ratio = 0.60, P = .061). CONCLUSION: This large prospective randomized study shows that prolonged detection can safely be programmed in secondary prevention ICDpatients with new or existing devices. This programming strategy decreases the rate of treated events and is not associated with an increased risk of syncope or mortality.
Authors: Giovanni Luca Botto; Giovanni B Forleo; Alessandro Capucci; Francesco Solimene; Antonello Vado; Giovanni Bertero; Pietro Palmisano; Ennio Pisanò; Antonio Rapacciuolo; Tommaso Infusino; Alessandro Vicentini; Miguel Viscusi; Paola Ferrari; Antonello Talarico; Giovanni Russo; Giuseppe Boriani; Luigi Padeletti; Mariolina Lovecchio; Sergio Valsecchi; Antonio D'Onofrio Journal: Europace Date: 2017-11-01 Impact factor: 5.214
Authors: Mehmet K Aktas; Amanda L Bennett; Arwa Younis; Valentina Kutyifa; Bronislava Polonsky; Scott McNitt; Wojciech Zareba; Spencer Rosero; Ilan Goldenberg Journal: Heart Rhythm O2 Date: 2020-05-11
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