Generic ICD programming and outcomes

Area of Science:

• Cardiology
• Medical Devices
• Clinical Trials

Background:

• Generic implantable cardioverter-defibrillator (ICD) programming may reduce therapies beyond randomized trials, but risks are unknown.
• Evaluating a standardized, manufacturer-agnostic programming protocol is crucial for optimizing ICD use.

Purpose of the Study:

• To assess the impact of a standardized, generic programming protocol on ICD therapies and clinical outcomes.
• To compare outcomes between patients programmed before and after protocol implementation.

Main Methods:

• Retrospective cohort study of 1003 new ICD implants (2009-2019) at a single center.
• Implementation of a standardized programming protocol in 2013 with high detection rates.
• Analysis of device therapy, ICD shock, syncope, and all-cause mortality using survival analysis.

Main Results:

• In primary prevention (n=583), guideline-compliant (GC) programming significantly increased freedom from ICD therapy (91.5% vs 73.6%) and shock (94.7% vs 84.8%) compared to pre-guideline (PS) patients.
• No significant increase in syncope or mortality was observed in GC patients.
• Secondary prevention patients showed non-significant trends towards improved therapy-free survival with GC programming.

Conclusions:

• A standardized programming protocol using generic programming effectively reduced ICD therapy burden in primary prevention.
• This protocol demonstrated improved efficacy without compromising patient safety, showing no increase in adverse events.