Centro Cardiologico Monzino IRCCS
Published October 4, 2021 | Version v1
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Dataset related to the article "Stereotactic radioablation for the treatment of ventricular tachycardia: preliminary data and insights from the STRA-MI-VT phase Ib/II study"

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This record contains raw data related to the article "Stereotactic radioablation for the treatment of ventricular tachycardia: preliminary data and insights from the STRA-MI-VT phase Ib/II study"

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 patients (pts) with 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 pts. showed a significant reduction of VT episodes and no electrical storm recurrence, with the complete
regression of iterative VTs in 2/2 pts.
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.


Keywords Ventricular tachycardia/ventricular arrhythmias · Stereotactic body radiotherapy/radioablation · Catheter
ablation · Structural heart disease/dilated cardiomyopathy · Multimodal imaging

 

 

 

 

 

Notes

This study was supported by the Italian Ministry of Health with 5 × 1000 funds and Ricerca Corrente (RC 2019 – EF 5A—ID 2754331 to Centro Cardiologico Monzino, IRCCS). This study was supported by a research grant from the Fondazione IEO-CCM entitled "STereotactic RadioAblation by Multimodal Imaging for Ventricular Tachicardia (STRA-MI-VT)." The sponsors did not play any role in the study design, collection, analysis, and interpretation of data, nor in the writing of the manuscript, nor in the decision to submit the manuscript for publication.

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Is supplement to
Journal article: 10.1007/s10840-021-01060-5 (DOI)