Clinical Evidence

ClinicalEVIDENCE Newsletter

Newsletter #7 – September 2025

September Issue

Welcome to the ClinicalEVIDENCE newsletter, your go-to source for the latest clinical data on heart diseases, diagnostics, and monitoring.

Our aim is to provide you with cutting-edge information that will keep you up to date on the most recent advancements in the field of heart failure management and sudden cardiac death prevention.

NEW: Prof Matteo Bertini’s comment on this edition of the ClinicalEVIDENCE newsletter:

Matteo Bertini, M.D, PhD, FAIAC
Professor of Cardiology, Head of EP lab, Cardiological Center, Sant’ Anna University Hospital

“Quality of life with ICD is key. Sub-analyses of ATLAS and PRAETORIAN found no significant QoL differences between TV-ICD and S-ICD, helping align device choice with patient values and lifestyle.

Long-term outcomes differ: PRAETORIAN-XL (8 years) showed lower overall complications with S-ICD (11.6% vs 8.0%, p=0.15, trend only). When focusing on major complications, S-ICD was significantly lower (10.2% vs 5.7%, p=0.03), mainly from fewer lead-related issues (8.3% vs 2.4%, p<0.001).

The takeaway? S-ICD should be considered for all patients, especially young, without pacing indications whenever feasible.

Learn more in the newsletter.”

Summary

This edition of Clinical Evidence presents new findings on S-ICD, confirming its safety during physical activity and strong patient acceptance across clinical profiles. Data from the ATLAS and PRAETORIAN trials, along with long-term results from PRAETORIAN XL, support the use of S-ICD in patients without pacing indications by showing lower rates of lead-related and major complications compared to transvenous ICDs.

Additionally, recent evidence reinforces the value of HeartLogic™ in identifying patients at higher risk of heart failure readmissions and supporting efficient care delivery.

Key Takeaways

  1. Physical activity and S-ICD safety: Real-world data from 602 young patients show that an active lifestyle does not increase the risk of arrhythmias or inappropriate shocks¹.
  2. Patient experience and quality of life with S-ICD: ATLAS² and PRAETORIAN³ trial sub-analyses confirm comparable quality of life and device acceptance between S-ICD and TV-ICD recipients.
  3. Long-term safety outcomes from PRAETORIAN XL: Over 8 years of follow-up, S-ICD patients experienced fewer major and lead-related complications than those with TV-ICD⁴.
  4. HeartLogic and readmission risk: New evidence supports HeartLogic’s role in predicting heart failure events and enabling proactive care with efficient use of clinical resources⁵,⁶.

Gain deeper insights by downloading the full newsletter

Clinical EVIDENCE

Newsletter #7

Now Available in PDF Format


References:

  1. Migliore F, Ottaviano L, Arestia A, et al. Subcutaneous Implantable Defibrillator Therapy in Patients With Brugada Syndrome: Data From a Large Multicenter Registry. JACC Clin Electrophysiol. 2025 Mar 23:S2405-500X(25)00158-6. doi: 10.1016/j.jacep.2025.03.003.
  2. Llyod M.S. et al. Spontaneous arrhythmic episodes in the study of a modular, communicative, leadleass defibrillator system (MODULAR ATP Trial). Presented at EHRA Congress 2025 and available on ESC 365 platform.
  3. Ziacchi M, Ottaviano L, Checchi L, et al. The risk of failure of subcutaneous implantable cardioverter defibrillator therapy: from PRAETORIAN score to clinical practice. Europace. 2025 Feb 5;27(2):euaf011. doi: 10.1093/europace/euaf011.
  4. Mugnai G. et al. Long-term Low-Voltage Impedance Measurements in Subcutaneous Implantable Cardioverter-Defibrillators. Presented at EHRA Congress 2025 and available on ESC 365 platform.
  5. Fareh et al. Real-world Use of Insertable Cardiac Monitor Remote Programming, Presented at EHRA Congress 2025 and available on ESC 365 platform.
  6. Dell’Aquila et al. Dynamic Evaluation of Atrial Fibrillation Risk Factors Using Multiple Sensors of Implantable Cardioverter Defibrillators, Presented at EHRA Congress 2025 and available on ESC 365 platform.

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