Martin C Burke1, Johan D Aasbo2, Mikhael F El-Chami3, Raul Weiss4, Jay Dinerman5, Sam Hanon6, Gauthem Kalahasty7, Eric Bass8, Michael R Gold9. 1. CorVita Science Foundation, Chicago, Illinois, USA. 2. Department of Cardiac Electrophysiology, Baptist Health Lexington, Lexington, Kentucky, USA. 3. Department of Medicine, Emory University Hospital, Atlanta, Georgia, USA. 4. Department of Medicine, Ohio State University, Columbus, Ohio, USA. 5. Heart Center Research, LLC, Huntsville, Alabama, USA. 6. Department of Medicine, Beth Israel Medical Center, New York, New York, USA. 7. Department of Internal Medicine, Virginia Commonwealth University Health System, Richmond, Virginia, USA. 8. NAMSA (Biostatistics), Minneapolis, Minnesota, USA. 9. Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA. Electronic address: goldmr@musc.edu.
Abstract
OBJECTIVES: This study evaluated spontaneous arrhythmias and clinical outcomes in the S-ICD System PAS (Subcutaneous Implantable Cardioverter-Defibrillator Post Approval Study) cohort. BACKGROUND: The U.S. S-ICD PAS trial patient population more closely resembles transvenous ICD cohorts than earlier studies, which included many patients with little structural heart disease and few comorbidities. Early outcomes and low peri-operative complication rates were demonstrated in the S-ICD PAS cohort, but there are no data detailing spontaneous arrhythmias and clinical outcomes. METHODS: The S-ICD PAS prospective registry included 1,637 de novo patients from 86 U.S. centers. Descriptive statistics, Kaplan-Meier time to event, and multivariate logistic regression were performed using data out to 365 days. RESULTS: Patients (68.5% men; mean ejection fraction of 32.0%; 42.9% ischemic; 13.4% on dialysis) underwent implantation for primary (76.6%) or secondary prevention indication. The complication-free rate was 92.5%. The appropriate shock (AS) rate was 5.3%. A total of 395 ventricular tachycardia (VT) or fibrillation (VF) episodes were appropriately sensed, with 131 (33.2%) self-terminating. First and final shock efficacy (up to 5 shocks) for the 127 discrete AS episodes were 91.3% and 100.0%, respectively. Discrete AS episodes included 67 monomorphic VT (MVT) and 60 polymorphic VT (PVT)/VF, with first shock efficacy of 95.2% and 86.7%, respectively. There were 19 storm events in 18 subjects, with 84.2% conversion success. Storm episodes were more likely PVT/VF (98 of 137). CONCLUSIONS: In the first year after implantation, a predominantly primary prevention population with low ejection fraction demonstrated a high complication-free rate and spontaneous event shock efficacy for MVT and PVT/VF arrhythmias at rapid ventricular rates. (Subcutaneous Implantable Cardioverter-Defibrillator System Post Approval Study [S-ICD PAS; NCT01736618).
OBJECTIVES: This study evaluated spontaneous arrhythmias and clinical outcomes in the S-ICD System PAS (Subcutaneous Implantable Cardioverter-Defibrillator Post Approval Study) cohort. BACKGROUND: The U.S. S-ICD PAS trial patient population more closely resembles transvenous ICD cohorts than earlier studies, which included many patients with little structural heart disease and few comorbidities. Early outcomes and low peri-operative complication rates were demonstrated in the S-ICD PAS cohort, but there are no data detailing spontaneous arrhythmias and clinical outcomes. METHODS: The S-ICD PAS prospective registry included 1,637 de novo patients from 86 U.S. centers. Descriptive statistics, Kaplan-Meier time to event, and multivariate logistic regression were performed using data out to 365 days. RESULTS:Patients (68.5% men; mean ejection fraction of 32.0%; 42.9% ischemic; 13.4% on dialysis) underwent implantation for primary (76.6%) or secondary prevention indication. The complication-free rate was 92.5%. The appropriate shock (AS) rate was 5.3%. A total of 395 ventricular tachycardia (VT) or fibrillation (VF) episodes were appropriately sensed, with 131 (33.2%) self-terminating. First and final shock efficacy (up to 5 shocks) for the 127 discrete AS episodes were 91.3% and 100.0%, respectively. Discrete AS episodes included 67 monomorphic VT (MVT) and 60 polymorphic VT (PVT)/VF, with first shock efficacy of 95.2% and 86.7%, respectively. There were 19 storm events in 18 subjects, with 84.2% conversion success. Storm episodes were more likely PVT/VF (98 of 137). CONCLUSIONS: In the first year after implantation, a predominantly primary prevention population with low ejection fraction demonstrated a high complication-free rate and spontaneous event shock efficacy for MVT and PVT/VF arrhythmias at rapid ventricular rates. (Subcutaneous Implantable Cardioverter-Defibrillator System Post Approval Study [S-ICD PAS; NCT01736618).
Authors: Pier D Lambiase; Dominic A Theuns; Francis Murgatroyd; Craig Barr; Lars Eckardt; Petr Neuzil; Marcoen Scholten; Margaret Hood; Jȕrgen Kuschyk; Amy J Brisben; Nathan Carter; Timothy M Stivland; Reinoud Knops; Lucas V A Boersma Journal: Eur Heart J Date: 2022-06-01 Impact factor: 35.855
Authors: Kevin Willy; Julia Köbe; Florian Reinke; Benjamin Rath; Christian Ellermann; Julian Wolfes; Felix K Wegner; Patrick R Leitz; Philipp S Lange; Lars Eckardt; Gerrit Frommeyer Journal: J Pers Med Date: 2022-07-28