The HONEST Cohort Study: Rationale and Design of a Nationwide Subcutaneous Implantable Cardioverter-Defibrillator...

Area of Science:

• Cardiology
• Medical Devices
• Public Health

Background:

• Subcutaneous implantable cardioverter-defibrillators (S-ICD) aim to reduce transvenous lead complications while maintaining efficacy for ventricular arrhythmias.
• Existing S-ICD evidence often comes from industry-sponsored trials in specialized centers.
• A comprehensive, nationwide, real-world assessment is needed to evaluate S-ICD performance across diverse patient populations.

Purpose of the Study:

• To conduct a nationwide, real-world assessment of S-ICD implantation in France.
• To evaluate patient characteristics and outcomes in a large, unselected cohort.
• To identify areas for improvement in S-ICD implantation strategies and sudden cardiac death prevention.

Main Methods:

• The HONEST (coHOrte fraNcaise des dEfibrillateurs Sous cuTanés) study is a French nationwide, single-arm, observational cohort.
• Included patients who underwent S-ICD implantation (EMBLEM, Boston Scientific) between October 2012 and December 2019.
• Central adjudication of clinical endpoints for all enrolled patients.

Main Results:

• 4,924 patients were included, representing 98.2% of all S-ICD implantations in France during the study period.
• The cohort comprised 77% males with a mean age of 49.9 years.
• This study provides the first nationwide cohort data on S-ICD recipients in a real-world setting.

Conclusions:

• The HONEST study offers contemporary, real-world data on S-ICD use in France.
• Findings will aid in refining strategies for sudden cardiac death prevention.
• This research highlights the importance of large-scale, nationwide registries for evaluating medical device performance.