STRA-MI-VT (STereotactic RadioAblation by Multimodal Imaging for Ventricular Tachycardia): rationale and design of an Italian experimental prospective study

Corrado Carbucicchio ,E Rondi,Alessandra Gorini ,Edoardo Conte ,Alice Bonomi ,Gaetano Fassini ,Roberto Orecchia ,Matteo Pepa ,B.a Jereczek-Fossa ,S Vigorito,Elena Tremoli ,Saima Mushtaq ,Valentina Catto ,Federica Cattani ,Fabrizio Veglia ,Giulia Marvaso ,Daniele Andreini ,Gaia Piperno ,Massimo Moltrasio ,Consiglia Piccolo ,Fabrizio Tundo ,Claudio Tondo

doi:10.1007/s10840-020-00855-2

Abstract

BackgroundVentricular tachycardia (VT) is a life-threatening condition, which usually implies the need of an implantable cardioverter defibrillator in combination with antiarrhythmic drugs and catheter ablation. Stereotactic body radiotherapy (SBRT) represents a common form of therapy in oncology, which has emerged as a well-tolerated and promising alternative option for the treatment of refractory VT in patients with structural heart disease.ObjectiveIn the STRA-MI-VT trial, we will investigate as primary endpoints safety and efficacy of SBRT for the treatment of recurrent VT in patients not eligible for catheter ablation. Secondary aim will be to evaluate SBRT effects on global mortality, changes in heart function, and in the quality of life during follow-up.MethodsThis is a spontaneous, prospective, experimental (phase Ib/II), open-label study (NCT04066517); 15 patients with structural heart disease and intractable VT will be enrolled within a 2-year period. Advanced multimodal cardiac imaging preceding chest CT-simulation will serve to elaborate the treatment plan on different linear accelerators with target and organs-at-risk definition. SBRT will consist in a single radioablation session of 25 Gy. Follow-up will last up to 12 months.ConclusionsWe test the hypothesis that SBRT reduces the VT burden in a safe and effective way, leading to an improvement in quality of life and survival. If the results will be favorable, radioablation will turn into a potential alternative option for selected patients with an indication to VT ablation, based on the opportunity to treat ventricular arrhythmogenic substrates in a convenient and less-invasive manner.

Highlights

In patients with structural heart disease, catheter ablation by radiofrequency (RF) energy delivery is effective in the treatment of ventricular tachycardia (VT) recurrences, and is considered of pivotal importance in combination with implantable cardioverter defibrillator (ICD) and antiarrhythmic drugs to prevent sudden cardiac death [1,2,3,4,5,6,7]
The existing research confirms that Stereotactic body radiotherapy (SBRT) might represent a relatively effective and well-tolerated therapeutic option in patients with Ventricular tachycardia (VT) who have failed other approaches [37]
STRA-MI-VT study aims at demonstrating that SBRT may represent an alternative therapeutic option in selected patients with substrate-related VT, thanks to a potentially favorable cost-effectiveness ratio

Summary

Introduction

In patients with structural heart disease, catheter ablation by radiofrequency (RF) energy delivery is effective in the treatment of ventricular tachycardia (VT) recurrences, and is considered of pivotal importance in combination with implantable cardioverter defibrillator (ICD) and antiarrhythmic drugs to prevent sudden cardiac death [1,2,3,4,5,6,7]. Advanced imaging techniques for the characterization of the substrate and the definition of the anatomical target are employed This noninvasive approach minimizes the procedural risk associated with the insertion, positioning, and manipulation of the catheters, during both mapping and ablation. In this regard, radioablation allows the delivery of energy to any theoretical target in a threedimensional system without the need for anatomical contact; the prospect of simulating the lesion produced on the diagnostic model provides a patient’s “tailored” therapy, enhancing safety and effectiveness [15].

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