PRAETORIAN-XL Trial: Fewer Lead-Related Complications With Subcutaneous ICDs

 Key Highlights From the Study

• PRAETORIAN-XL, an extended follow-up of the original PRAETORIAN trial, compared subcutaneous ICDs (S-ICDs) with transvenous ICDs over a median follow-up of 7.3 years.

• Primary endpoint (all major and minor device-related complications) showed no significant difference: 8.0% (S-ICD) vs 11.6% (transvenous ICD).

• S-ICDs had significantly fewer:

• Major complications needing intervention: 5.7% vs 10.2%

• Lead-related complications: 2.4% vs 8.3%

📌 Key Concepts

• S-ICD eliminates the need for intracardiac leads, reducing risks like lead failures, infections, cardiac perforation, and tamponade.

• Most S-ICD complications occurred post-crossover to another device, often CRT-D, due to heart failure progression.

• Battery-related issues arose ~5–6 years post-implantation with first-generation S-ICDs.

🩺 Clinical Takeaways

• S-ICD is favored in younger patients without pacing needs, especially those at high risk for infection or with vascular anomalies.

• Transvenous ICDs remain simpler to implant (often under conscious sedation) and allow for future pacing, which may become necessary.

• Crossover rates: ~10–12% in both groups; often due to evolving heart failure requiring device upgrade.

🧠 Expert Opinion

• Electrophysiologists urge individualized decision-making, noting:

  • ICD technology continues to evolve.

  • No definitive winner—choice should depend on patient-specific risk factors.

🔍 Bottom Line

While S-ICDs reduce major and lead-related complications, they are not yet the universal choice. Tailoring ICD therapy to individual patient profiles remains the gold standard in modern electrophysiology.