Abstract
The lifesaving benefits of implantable cardioverter defibrillator (ICD) therapy are more and more weighted against possible harm (e.g. unnecessary device therapy, procedural complications, device malfunction etc.) which might have adverse effects on patients’ perceived health status and quality of life. Hence, there has been an increasing interest in the optimisation of ICD programming to prevent inappropriate and appropriate but unnecessary device therapy. The purpose of the current report is to give an overview of research into the optimisation of ICD programming and present the design of the on-going ENHANCED-ICD study. The ENHANCED-ICD study is a prospective, safety monitoring study enrolling 60 primary and secondary prophylactic ICD patients at the University Medical Center Utrecht. Patients implanted with any type of ICD with SmartShock technologyTM, and between 18–80 years of age, were eligible to participate. In all patients a prolonged detection of 60/80 intervals was programmed. The primary objective of the study is to investigate whether enhanced programming to further reduce ICD therapies is safe. The secondary objective is to examine the impact of enhanced programming on (i) antitachycardia pacing and shocks (both appropriate and inappropriate) and (ii) quality of life and distress. The first results of the ENHANCED-ICD study are expected in 2015.
Highlights
When implantable cardioverter defibrillator (ICD) treatment was initially introduced, ICDs were exclusively implanted in patients with documented sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) to prevent sudden cardiac death (SCD, secondary prevention)
There has been an increasing interest in the optimisation of ICD programming to prevent inappropriate and unnecessary appropriate device therapy (either antitachycardia pacing (ATP) or shock), as it is associated with heart failure and prognosis, and may lower patient-perceived health status
The fact that 34 % of detected fast VT (FVT) episodes in the shock arm of the PainFREE Rx II trial terminated during the 3.3 s of capacitor charging suggested that a longer delay would further reduce unnecessary ATP [12]
Summary
When implantable cardioverter defibrillator (ICD) treatment was initially introduced, ICDs were exclusively implanted in patients with documented sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) to prevent sudden cardiac death (SCD, secondary prevention). While in the past mortality reduction was the primary goal of ICD therapy, in the last decade this lifesaving benefit is more and more weighted against possible harm in the form of unnecessary device therapy, proarrhythmic potential, procedural complications, infection, device malfunction, and manufacturer recalls, which might have adverse effects on patients’ perceived health status and quality of life [2, 3]. There has been an increasing interest in the optimisation of ICD programming to prevent inappropriate and unnecessary appropriate device therapy (either antitachycardia pacing (ATP) or shock), as it is associated with heart failure and prognosis, and may lower patient-perceived health status. CED device programming to reduce therapies and improve quality of life in Implantable Cardioverter Defibrillator patients (ENHANCED-ICD) study, which started in April 2013
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