Clinical Evidence

ClinicalEVIDENCE Newsletter

Newsletter #3 – September 2024

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

The APPRAISE ATP trial explored the role of anti-tachycardia pacing (ATP) in primary prevention patients eligible for ICDs, using modern programming parameters. While non-endovascular ICD systems have made this study highly relevant, the preliminary results have raised questions. 

Surprisingly, there was only marginal benefit seen in the ATP + shock group versus the shock-only group, with no significant difference in mortality or time to first all-cause shock.

Delve into this newsletter to learn more.

Summary

This Clinical Evidence is focused on patients with defibrillators implanted for the primary prevention of sudden cardiac death. Following the latest advances in medical and device therapy, Dr Ahmed et al.¹ investigated the persistence of the survival benefits of ICD implantation in patients with a primary prevention of sudden cardiac death (SCD). Recently, Dr Schuger² has presented preliminary findings of the APPRAISE ATP trial, a multicentre, randomised study aimed at evaluating the role of ATP as a first-line therapy in this specific patient setting. Impressive results on the safety and performance of the EMPOWER leadless pacemaker, designed to provide pacing therapy and capable of offering a modular approach for S-ICD implanted patients, are finally available in the New England Journal of Medicine.³

Key Takeaways

  1. ICD implantation benefit in primary prevention cohort: The analysis by Dr. Ahmed et al.¹ confirmed that ICD implantation in a primary prevention patients remains a valuable intervention over time to prevent SCD and is associated with significantly lower all-cause mortality compared to similar patients who did not receive an ICD
  2. The Role of ATP in Primary Prevention Patients: APPRAISE ATP , the largest head-to-head trial of ATP in primary prevention patients, has evaluated the true value of ATP. The study demonstated superiority with a 28% relative risk reduction in time to first all-cause shock for the ATP ON arm compared to the ATP OFF arm, with an absolute all-cause shock reduction in 1% of primary prevention ICD indicated patients per year². 
  3. Safety and Performance of the Modular CRM (mCRM™) System: The MODULAR ATP Trial achieved all pre-specified safety and effectiveness  6-month endpoints which included major complication free rate (97.5%), communication success rate (98.8%)  and pacing capture threshold (97.4% PCTs<= 2.0V) in the mCRM system³.

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Clinical EVIDENCE

Newsletter 2024 #3
Now Available in PDF Format

The Modular CRM (mCRM) system is pending CE Mark and not available for sale.

References:

  1. Ahmed A, Auricchio A, Mittal S, at al. Mortality Benefit Among Primary Prevention Implantable Cardioverter-Defibrillator Recipients on Contemporary Heart Failure Treatment. JACC Clin Electrophysiol. 2024 May;10(5):916-926. doi: 10.1016/j.jacep.2024.102334
  2. ​Schuger C, Joung, B., Ando, Kl, et al. Assessment of Primary Prevention Patients Receiving An ICD- Systematic Evaluation of ATP: APPRAISE ATP. Heart Rhythm Society Late Breaking Clinical Trials. May 17th, 2024 LB-469803-02​
  3. Knops RLM, Roberts PR, et al. A Modular Communicative Leadless Pacing-Defibrillator System. N Engl J Med. 2024;doi:0.1056/NEJMoa2401807

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