A real‐world experience of subcutaneous and transvenous implantable cardiac defibrillators—comparison with the PRAETORIAN study

Abstract

Background: PRAETORIAN is the first randomized controlled trial that demonstrated the noninferiority of subcutaneous ICD (S-ICD) in comparison with transvenous ICD (TV-ICD). We retrospectively reviewed electronic records of patients with ICD implanted over the past 6 years, with the primary objective to compare our real-world single tertiary center experience with the randomized data from the PRAETORIAN study.Methods: Seventy S-ICD patients were compared with 197 TV-ICD patients, from July 2014 to June 2020 retrospectively, over a median period of 1304 days (296-2451 days). Primary composite endpoints included inappropriate shocks and devicerelated malfunctions.Results: Patients with S-ICD implantation were younger than those who received TV-ICD (mean, 49.7 years vs 63.9 years, p < .001). About 31.4% of S-ICDs were implanted for secondary prevention, and 58.6% of S-ICD patients had ischemic cardiomyopathy (ICM) with a median left ventricular ejection fraction of 32.5% (range: 10-67%). S-ICDs and TV-ICD had statistically similar inappropriate shocks (4.3% vs 4.6%, p = .78), device-related complications (11.4% vs 9.1%, p = .93), and the overall primary endpoints (15.7% vs 13.7%, p = .68). The findings remained the same even after age and gender adjustments and time-dependent analysis. Conclusion:Although single-center experience with a small number of S-ICD patients, results of the PRAETORIAN study has been replicated in our real-world experience of S-ICD and TV-ICD implantations across diverse etiologies, indications, and age groups confirming the comparable performance of S-ICD and TV-ICD when implanted in selected patients.

Clinical outcomes of subcutaneous vs. transvenous implantable defibrillator therapy in a polymorbid patient cohort

“…Fong observed no significant difference in device-related complications (RR = 0.59; 95 % CI 0.33–1.04; p = 0.07) ( 36 ). In a single-center experience investigating 70 S-ICD patients vs. 197 TV-ICD patients on the endpoints of the PRAETORIAN study, no differences in device complications were observed ( 16 ). Of note, 30 % of the patients had a secondary preventive ICD-indication ( 16 ).…”

“…In a single-center experience investigating 70 S-ICD patients vs. 197 TV-ICD patients on the endpoints of the PRAETORIAN study, no differences in device complications were observed ( 16 ). Of note, 30 % of the patients had a secondary preventive ICD-indication ( 16 ). This is also in line with our study results as 51% of our S-ICD patients received an ICD for secondary prevention (rate in TV-ICD patients: 45%).…”

“…Of note, only patients with primary prevention indication for SCD have been included ( 14 ). Thus, there is a need for real-world data to investigate whether results of these studies can be extrapolated to daily clinical practice ( 15 , 16 ). In the present study, we aimed to investigate clinical outcomes in an all-comers cohort of patients with primary and secondary preventive indication for ICD therapy, and also patients who were implanted with a previous defibrillator, receiving either a single chamber TV-ICD or a S-ICD.…”