![]() Subsequent to study enrollment, the US Food and Drug Administration reviewed the protocol and categorized the research as a significant risk study, which requires Investigational Device Exemption approval. All participants provided informed consent, and an independent Data and Safety Monitoring Committee reviewed data semiannually and provided guidance on study continuation. The local institutional review board approved the study without Investigational Device Exemption based on interpretation of the indications for use and risk of linear accelerators and electrocardiographic imaging technology. The ENCORE-VT trial (Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia) was a prospective single-arm phase I/II trial conducted at a single center. Here we describe the results of a prospective trial of noninvasive cardiac radioablation for the control of treatment-refractory VT. 14, 15įormal prospective evaluation of short-term risk, late toxicities, and antiarrhythmic effects of noninvasive cardiac radioablation has not been completed. 11–13 Although late toxic effects of radiotherapy to the heart have been reported in the treatment of thoracic tumors, late toxicity from high-dose SBRT applied to focal areas of a previously injured heart is unknown. Other case reports have yielded generally positive short-term results without report of significant complications. 10 The result demonstrated a strong antiarrhythmic effect that controlled VT storm and allowed reduction of antiarrhythmic medication. A pilot case series used cardiac magnetic resonance imaging, cardiac single-photon emission computed tomography, 12-lead ECG during VT, and electrocardiographic imaging (ECGI) to guide cardiac SBRT. 7–9Ĭhoosing the precise location to target for ablation, while avoiding healthy tissue and surrounding thoracic structures, requires a synthesis of anatomic and electric information. 6 Preclinical studies exploring SBRT using various forms of particle therapy (photons, protons, carbon) for cardiac ablation have demonstrated histological changes and electrophysiological effects without acute or subacute adverse effects over 6-month follow-up. 4, 5 SBRT has the potential to treat VT by delivering ablative energy noninvasively, minimizing procedural risk for the patient. 3 When used to treat tumors, SBRT can achieve high rates of tumor control and minimal toxicity, including tumors adjacent to the heart. ![]() 2 Stereotactic body radiotherapy (SBRT) is a technique that delivers precise, high doses of radiation to targets in the body with reduced exposure to adjacent normal tissue. 1 Invasive catheter procedures to treat VT first identify the circuits within the fibrosis and then deliver thermal-ablative energy to these regions. ![]() Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder that is often caused by electric re-entry within and around patches of heterogeneous myocardial fibrosis.
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