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

Abstract

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 device‐related 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.

Keywords

• device‐related complications
• inappropriate shocks
• PRAETORIAN study
• subcutaneous ICD
• transvenous ICD