Why the study?
The lifesaving benefits of ICD therapy are increasingly weighed against potential harm from inappropriate and unnecessary device therapy that may impair quality of life. Whether enhanced ICD programming with prolonged detection (60/80 intervals) to further reduce therapies is safe requires investigation.
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Reports on strategies for optimizing ICD programming and details the prospective ENHANCED-ICD protocol, highlighting methods to reduce unnecessary device therapy.
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 technology(TM), 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.
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Mastenbroek et al. (2014) conducted a review in Primary or secondary prophylactic implantable cardioverter defibrillator (ICD) or CRT-D indication (n=60). Enhanced ICD programming with prolonged detection (60/80 intervals) was evaluated on Safety of enhanced programming (arrhythmic syncopes and intervention-related hospitalization, death, or other serious adverse events not exceeding safety threshold).
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