Abstract
PurposeWe 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).MethodsCardiac 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.ResultsSeven 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.ConclusionThe 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.
Highlights
Radiofrequency catheter ablation (RFCA) has evolved into a first-line modality of therapy for patients with scar-related ventricular arrhythmias (VAs) [1,2,3], being effective in the prevention of ventricular tachycardia (VT) recurrences and in the reduction of implantable cardioverter defibrillator (ICD) interventions [4, 5]; RFCA has been recognized as the treatment of choice in the management of incessant VT and electrical storm (ES), where the patient is exposed to a high risk of cardiac death [6]
Patients were included if they had a structural heart disease and relapsing VT (≥ 3 VT episodes conditioning ICD intervention) refractory to any form of pharmacological and non-pharmacological therapy, and either showed a contraindication to conventional RFCA, in relation to the high risk associated with the procedure, or, alternatively, were not suitable for any interventional or surgical approach
The primary efficacy endpoint was represented by the total number of VT/ventricular fibrillation (VF) episodes detected by the ICD at 3, 6, and 12 months, compared to the 3-month period preceding stereotactic body radiotherapy (SBRT)
Summary
STRA-MI-VT is a spontaneous, prospective, single-arm, phase Ib/II single-center study. Fifteen patients are expected to be enrolled and final results will be available after September 2022
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