Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia

• DOI: 10.1161/circulationaha.118.038261
• Publication Date: 2019-01-14T19:03:44Z
• Authors: Clifford G. Robinson; Pamela P. Samson; Kaitlin M.S. Moore; Geoffrey D. Hugo; Nels Knutson; Sasa Mutic; S. Murty Goddu; Adam Lang; Daniel H. Cooper; Mitchell Faddis; Amit Noheria; Timothy W. Smith; Pamela K. Woodard; Robert J. Gropler; Dennis E. Hallahan; Yoram Rudy; Phillip S. Cuculich
• Keywords: Cardiac Electrophysiology; Electrophysiology study

Case studies have suggested the efficacy of catheter-free, electrophysiology-guided noninvasive cardiac radioablation for ventricular tachycardia (VT) using stereotactic body radiation therapy, although prospective data are lacking.We conducted a phase I/II trial in adults with treatment-refractory episodes VT or cardiomyopathy related to premature contractions (PVCs). Arrhythmogenic scar regions were targeted by combining anatomic and electric imaging standard therapy workflow followed delivery single fraction 25 Gy target. The primary safety end point was treatment-related serious adverse events first 90 days. any reduction (tracked indwelling implantable cardioverter defibrillators) PVC burden (as measured 24-hour Holter monitor) comparing 6 months before after treatment (with 6-week blanking window treatment). Health-related quality life assessed Short Form-36 questionnaire.Nineteen patients enrolled (17 VT, 2 cardiomyopathy). Median ablation time 15.3 minutes (range, 5.4-32.3). In days, 2/19 (10.5%) developed event. median number reduced from 119 4-292) 3 0-31; P<0.001). Reduction observed both defibrillator shocks antitachycardia pacing. 17/18 evaluable (94%). frequency 75% 89% patients. Overall survival at 72% 12 months. Use dual antiarrhythmic medications decreased 59% 12% ( P=0.008). Quality improved 5 9 domains months.Noninvasive is associated markedly arrhythmia modest short-term risks, drug use, improvement life.URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT02919618.