1. Stereotactic radioablation for the treatment of ventricular tachycardia: preliminary data and insights from the STRA-MI-VT phase Ib/II study
- Author
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Roberto Orecchia, Leonardo Calò, Edoardo Conte, Saima Mushtaq, Barbara Alicja Jereczek-Fossa, Elena Rondi, Elena Tremoli, Giulio Pompilio, Valentina Catto, Corrado Carbucicchio, Alessandra Gorini, Antonio Scarà, Gianluca Pontone, Gaia Piperno, S. Vigorito, Consiglia Piccolo, Daniele Andreini, Federica Cattani, Matteo Pepa, Fabrizio Veglia, Annamaria Ferrari, Mauro Pepi, Alice Bonomi, Mattia Giuliani, and Claudio Tondo
- Subjects
Male ,medicine.medical_specialty ,Heart disease ,medicine.medical_treatment ,Catheter ablation ,Ventricular tachycardia ,Article ,Multimodal imaging ,Physiology (medical) ,Internal medicine ,medicine ,Humans ,In patient ,Adverse effect ,Aged ,Ejection fraction ,business.industry ,Ventricular tachycardia/ventricular arrhythmias ,Arrhythmias, Cardiac ,Middle Aged ,Stereotactic body radiotherapy/radioablation ,Implantable cardioverter-defibrillator ,medicine.disease ,Volumetric modulated arc therapy ,Defibrillators, Implantable ,Treatment Outcome ,Catheter Ablation ,Tachycardia, Ventricular ,Cardiology ,Structural heart disease/dilated cardiomyopathy ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies ,Preliminary Data - Abstract
Purpose We present the preliminary results of the STRA-MI-VT Study (NCT04066517), a spontaneous, phase Ib/II study, designed to prospectively test the safety and efficacy of stereotactic body radiotherapy (SBRT) in patientswith advanced cardiac disease and intractable ventricular tachycardia (VT). Methods Cardiac computed tomography (CT) integrated by electroanatomical mapping was used for substrate identification and merged with dedicated CT scans for treatment plan preparation. A single 25-Gy radioablation dose was delivered by a LINAC-based volumetric modulated arc therapy technique in a non-invasive matter. The primary safety endpoint was treatment-related adverse effects during acute and long-term follow-up (FU), obtained by regular in-hospital controls and implantable cardioverter defibrillator (ICD) remote monitoring. The primary efficacy endpoint was the reduction at 3 and 6 months of VT episodes and ICD shocks. Results Seven out of eight patients (men; age, 70 ± 7 years; ejection fraction, 27 ± 11%; 3 ischemic, 4 non-ischemic cardiomyopathies) underwent SBRT. At a median 8-month FU, no treatment-related serious adverse event occurred. Three patients died from non-SBRT-related causes. Four patients completed the 6-month FU: the number of VT decreased from 29 ± 33 to 11 ± 9 (p = .05) and 2 ± 2 (p = .08), at 3 and 6 months, respectively; shocks decreased from 11 to 0 and 2, respectively. At 6 months, all patients. showed a significant reduction of VT episodes and no electrical storm recurrence, with the complete regression of iterative VTs in 2/2 patients. Conclusion The STRA-MI-VT Study suggests that SBRT can be considered an alternative option for the treatment of VT in patients with structural heart disease and highlights the need for further clinical investigation addressing safety and efficacy.
- Published
- 2021
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