BACKGROUND: 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. METHODS: We conducted a prospective phase I/II trial of noninvasive cardiac radioablation in adults with treatment-refractory episodes of VT or cardiomyopathy related to premature ventricular contractions (PVCs). Arrhythmogenic scar regions were targeted by combining noninvasive anatomic and electric cardiac imaging with a standard stereotactic body radiation therapy workflow followed by delivery of a single fraction of 25 Gy to the target. The primary safety end point was treatment-related serious adverse events in the first 90 days. The primary efficacy end point was any reduction in VT episodes (tracked by indwelling implantable cardioverter defibrillators) or any reduction in PVC burden (as measured by a 24-hour Holter monitor) comparing the 6 months before and after treatment (with a 6-week blanking window after treatment). Health-related quality of life was assessed using the Short Form-36 questionnaire. RESULTS: Nineteen patients were enrolled (17 for VT, 2 for PVC cardiomyopathy). Median noninvasive ablation time was 15.3 minutes (range, 5.4-32.3). In the first 90 days, 2/19 patients (10.5%) developed a treatment-related serious adverse event. The median number of VT episodes was reduced from 119 (range, 4-292) to 3 (range, 0-31; P<0.001). Reduction was observed for both implantable cardioverter defibrillator shocks and antitachycardia pacing. VT episodes or PVC burden were reduced in 17/18 evaluable patients (94%). The frequency of VT episodes or PVC burden was reduced by 75% in 89% of patients. Overall survival was 89% at 6 months and 72% at 12 months. Use of dual antiarrhythmic medications decreased from 59% to 12% ( P=0.008). Quality of life improved in 5 of 9 Short Form-36 domains at 6 months. CONCLUSIONS: Noninvasive electrophysiology-guided cardiac radioablation is associated with markedly reduced ventricular arrhythmia burden with modest short-term risks, reduction in antiarrhythmic drug use, and improvement in quality of life. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT02919618.
BACKGROUND: 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. METHODS: We conducted a prospective phase I/II trial of noninvasive cardiac radioablation in adults with treatment-refractory episodes of VT or cardiomyopathy related to premature ventricular contractions (PVCs). Arrhythmogenic scar regions were targeted by combining noninvasive anatomic and electric cardiac imaging with a standard stereotactic body radiation therapy workflow followed by delivery of a single fraction of 25 Gy to the target. The primary safety end point was treatment-related serious adverse events in the first 90 days. The primary efficacy end point was any reduction in VT episodes (tracked by indwelling implantable cardioverter defibrillators) or any reduction in PVC burden (as measured by a 24-hour Holter monitor) comparing the 6 months before and after treatment (with a 6-week blanking window after treatment). Health-related quality of life was assessed using the Short Form-36 questionnaire. RESULTS: Nineteen patients were enrolled (17 for VT, 2 for PVC cardiomyopathy). Median noninvasive ablation time was 15.3 minutes (range, 5.4-32.3). In the first 90 days, 2/19 patients (10.5%) developed a treatment-related serious adverse event. The median number of VT episodes was reduced from 119 (range, 4-292) to 3 (range, 0-31; P<0.001). Reduction was observed for both implantable cardioverter defibrillator shocks and antitachycardia pacing. VT episodes or PVC burden were reduced in 17/18 evaluable patients (94%). The frequency of VT episodes or PVC burden was reduced by 75% in 89% of patients. Overall survival was 89% at 6 months and 72% at 12 months. Use of dual antiarrhythmic medications decreased from 59% to 12% ( P=0.008). Quality of life improved in 5 of 9 Short Form-36 domains at 6 months. CONCLUSIONS: Noninvasive electrophysiology-guided cardiac radioablation is associated with markedly reduced ventricular arrhythmia burden with modest short-term risks, reduction in antiarrhythmic drug use, and improvement in quality of life. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT02919618.
Authors: Pasquale Santangeli; David S Frankel; Roderick Tung; Marmar Vaseghi; William H Sauer; Wendy S Tzou; Nilesh Mathuria; Shiro Nakahara; Timm M Dickfeldt; Dhanunjaya Lakkireddy; T Jared Bunch; Luigi Di Biase; Andrea Natale; Venkat Tholakanahalli; Usha B Tedrow; Saurabh Kumar; William G Stevenson; Paolo Della Bella; Kalyanam Shivkumar; Francis E Marchlinski; David J Callans Journal: J Am Coll Cardiol Date: 2017-05-02 Impact factor: 24.094
Authors: Arjun Sharma; Douglas Wong; Georg Weidlich; Thomas Fogarty; Alice Jack; Thilaka Sumanaweera; Patrick Maguire Journal: Heart Rhythm Date: 2010-02-13 Impact factor: 6.343
Authors: Srinivas R Dukkipati; Jacob S Koruth; Subbarao Choudry; Marc A Miller; William Whang; Vivek Y Reddy Journal: J Am Coll Cardiol Date: 2017-12-12 Impact factor: 24.094
Authors: Junjie Zhang; Daniel H Cooper; Kavit A Desouza; Phillip S Cuculich; Pamela K Woodard; Timothy W Smith; Yoram Rudy Journal: Pacing Clin Electrophysiol Date: 2016-06-06 Impact factor: 1.976
Authors: H Immo Lehmann; Christian Graeff; Palma Simoniello; Anna Constantinescu; Mitsuru Takami; Patrick Lugenbiel; Daniel Richter; Anna Eichhorn; Matthias Prall; Robert Kaderka; Fine Fiedler; Stephan Helmbrecht; Claudia Fournier; Nadine Erbeldinger; Ann-Kathrin Rahm; Rasmus Rivinius; Dierk Thomas; Hugo A Katus; Susan B Johnson; Kay D Parker; Jürgen Debus; Samuel J Asirvatham; Christoph Bert; Marco Durante; Douglas L Packer Journal: Sci Rep Date: 2016-12-20 Impact factor: 4.379
Authors: Pasquale Santangeli; Matthew C Hyman; Daniele Muser; David J Callans; Kalyanam Shivkumar; Francis E Marchlinski Journal: JAMA Cardiol Date: 2020-09-30 Impact factor: 14.676
Authors: David Krug; Oliver Blanck; Thomas Demming; Matthias Dottermusch; Karoline Koch; Markus Hirt; Laura Kotzott; Adrian Zaman; Lina Eidinger; Frank-Andre Siebert; Jürgen Dunst; Hendrik Bonnemeier Journal: Strahlenther Onkol Date: 2019-10-31 Impact factor: 3.621
Authors: Ian J Gerard; Martin Bernier; Tarek Hijal; Neil Kopek; Piotr Pater; Jordan Stosky; Gabriela Stroian; Bruno Toscani; Joanne Alfieri Journal: Adv Radiat Oncol Date: 2021-04-20