Clinical Evidence

ClinicalEVIDENCE Newsletter

Newsletter #6 – July 2025

July 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

"The INSIGHT-LBBA study offers compelling new data on LBBAP with the INGEVITY+™ lead—showing high procedural success, excellent safety, and strong sensing and pacing performance. Notably, safety isn’t compromised with this stylet-driven lead. With over 1,100 patients, it's the largest registry of its kind, providing valuable real-world insights for electrophysiologists adopting or optimizing physiological pacing. A must-read in this issue of Clinical Evidence."

Summary

This edition of Clinical Evidence highlights key topics from the recent EHRA Congress in Vienna (March 30 – April 1). It features Late Breaking Clinical Trial (LBCT) results from the largest cohort (n = 450) of Brugada syndrome patients implanted with an S-ICD, along with new insights into arrhythmic episodes treated with ATP in the Modular ATP study. The issue also explores the potential simplification of the Praetorian score using the intermuscular technique in clinical practice. 

Additionally, it presents two posters: one on LUX-Dx™ ICM remote programming and another on an AF risk score derived from the combination of HeartLogic™, RDI, and physical activity data.

Key Takeaways

  1. New Insights on S-ICD and Modular System: Real-world data supports S-ICD as a safe alternative to TV-ICDs for Brugada syndrome patients¹. The modular system, combining S-ICD with the EMPOWER™ leadless pacemaker, detects and treats ventricular arrhythmias with ATP success similar to TV-ICDs².
  2. PRAETORIAN Score Simplification: The intermuscular implantation technique improves S-ICD placement consistency, simplifying the PRAETORIAN score by removing two evaluation steps³. Additionally, low-voltage impedance (LVI) now enables safer estimation of sub-coil fat without the need for high-voltage shock delivery⁴.
  3. LUX-Dx and HeartLogic Insights: ICM optimizes device management through remote programming, reducing in-person visits. Efficiency is further enhanced with an alert-based monitoring system, enabling quick action when needed⁵. Additionally, a combined risk score, using HeartLogic, RDI (sleep apnea index), and physical activity improves dynamic risk assessment for AHRE burden in HF patients and can serve as a surrogate for HEAD2TOES risk factors⁶.

Gain deeper insights by downloading the full newsletter

Clinical EVIDENCE

Newsletter #6

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.

CAUTION
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at  www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries.
This material not intended for use in France.

INGEVITY+ component pending CE Mark. Not available for sale.