PROPHYLACTIC CARDICA SYMPATHETIC DENERVATION FOR PREVENTION OF VENTRICULAR TACHYARRHYTHMIAS (PREVENT VT)

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ABSTRACT Ventricular tacharrhythmias (VT/VF) are a common cause of mortality in patients with structural heart disease, resulting in implantation of ICDs to reduce risk of sudden cardiac death. Over 150,000 ICDs are implanted in the U.S. each year. Although a life-saving therapy, many patients experience recurrent ICD shocks despite optimal medical therapy, resulting in decreased quality of life and increased morbidity. Furthermore, recurrent VT and ICD shocks are associated with increased mortality over time. Therefore, catheter ablation of VT has become standard-of-care for patients with recurrent shocks. Yet, up to 30-50% of patients experience recurrent VT/VF and shocks within 12 months of their procedure, despite medical and anti-arrhythmic therapy, resulting in multiple attempts at ablation, repeat hospitalizations, and referral for ventricular assist device placement or heart transplantation. The sympathetic nervous system is known to play a critical role in the genesis and maintenance of VT/VF, and neuraxial modulation represents a new course-altering avenue for treatment of these arrhythmias in patients with structural heart disease. Medications that target the sympathetic nervous system, including β- adrenergic receptor blockers, have been shown to reduce the risk of sudden cardiac death and improve outcomes of heart failure patients. Bilateral cardiac sympathetic denervation (CSD), by interrupting sympathetic efferent and afferent fibers, can have a similar potential impact, and has been reported to significantly reduce the burden of ICD shocks in retrospective observational studies of patients with structural heart disease and VT. However, the value of this potentially important therapy is unknown and needs to be tested in a randomized fashion. We propose a clinical pilot study of 40 patients randomized to CSD plus routine care or routine care alone. The goal of this pilot study is to obtain important feasibility, efficacy, and safety data to allow for the design of a large-scale multi-center trial that can then determine whether bilateral CSD can increase the time to ICD shock/VT/VF and decrease burden of ICD shocks as compared to routine care alone. The proposed pilot study will provide essential data on patient recruitment, power, and analysis of side-effects and complications related to the procedure. Bilateral CSD is an approach that has the potential for a global impact, given the prohibitive high cost and resources needed for catheter ablation procedures, ventricular assist device implantation, and heart transplantion. The results of this pilot study will allow for the design of a proper randomized trial to test the value of this potentially life-saving therapy.