Key result
Subcutaneous ICD shows comparable complication and inappropriate shock rates to transvenous ICD in real-world practice.
Why the study?
Following the PRAETORIAN trial demonstrating noninferiority of S-ICD to TV-ICD, the authors sought to compare real-world single tertiary center experience with the randomized trial data.
Does the subcutaneous ICD compared to the transvenous ICD prevent inappropriate shocks and device-related malfunctions in patients requiring ICD implantation in a real-world setting?
Cohort (n=267)
No
Does the subcutaneous ICD compared to the transvenous ICD prevent inappropriate shocks and device-related malfunctions in patients requiring ICD implantation in a real-world setting?
Odds Ratio: 1.1 (95% CI 0.5–2.5)
Absolute Event Rate: 15.7% vs 13.7%
p-value: p=0.68
Real-world, single-center data confirms the findings of the PRAETORIAN trial, demonstrating comparable rates of inappropriate shocks and device-related complications between subcutaneous and transvenous ICDs.
Comparable rates observed in real-world cohort; supports PRAETORIAN findings but leaves open larger prospective trials for device selection.
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.
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Khanra et al. (2022) conducted a cohort in Implantable cardiac defibrillator indication (n=267). Subcutaneous ICD (S-ICD) vs. Transvenous ICD (TV-ICD) was evaluated on Composite of inappropriate shocks and device-related malfunctions (OR 1.1, 95% CI 0.5-2.5, p=0.68). Subcutaneous ICD demonstrated comparable rates of composite inappropriate shocks and device-related complications to transvenous ICD (15.7% vs 13.7%, OR 1.1) in real-world practice.
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