1-Year Prospective Evaluation of Clinical Outcomes and Shocks
| Autor: | Jay Dinerman, Raul Weiss, Martin C. Burke, Eric Bass, Mikhael F. El-Chami, Johan D Aasbo, Sam Hanon, Gauthem Kalahasty, Michael R. Gold |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Fibrillation
education.field_of_study medicine.medical_specialty Ejection fraction business.industry medicine.medical_treatment Population 030204 cardiovascular system & hematology Implantable cardioverter-defibrillator medicine.disease Ventricular tachycardia Sudden cardiac death 03 medical and health sciences 0302 clinical medicine Internal medicine Heart failure Cohort medicine Cardiology 030212 general & internal medicine medicine.symptom business education |
| Zdroj: | JACC: Clinical Electrophysiology. 6:1537-1550 |
| ISSN: | 2405-500X |
| Popis: | 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 92.2%. 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 95.5% 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) |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|