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

C Carbucicchio, B A Jereczek-Fossa, D Andreini, V Catto, G Piperno, E Conte, F Cattani, E Rondi, S Vigorito, C Piccolo, A Bonomi, A Gorini, M Pepa, S Mushtaq, G Fassini, M Moltrasio, F Tundo, G Marvaso, F Veglia, R Orecchia, E Tremoli, C Tondo, C Carbucicchio, B A Jereczek-Fossa, D Andreini, V Catto, G Piperno, E Conte, F Cattani, E Rondi, S Vigorito, C Piccolo, A Bonomi, A Gorini, M Pepa, S Mushtaq, G Fassini, M Moltrasio, F Tundo, G Marvaso, F Veglia, R Orecchia, E Tremoli, C Tondo

Abstract

Background: Ventricular 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.

Objective: In 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.

Methods: This 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.

Conclusions: We 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.

Keywords: Cardiac radiosurgery; Catheter ablation; Radioablation; Stereotactic body radiotherapy; Ventricular tachycardia.

Conflict of interest statement

The authors declare that they have no conflict of interest.

© 2020. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart of STRA-MI-VT study. Legend: CT, computed tomography; ECG, electrocardiogram; OARs, organs at risk; QoL, quality of life; SBRT stereotactic body radiotherapy; VT ventricular tachycardia
Fig. 2
Fig. 2
Diagnostic imaging obtained by cardiac CT combined with EAM to guide patient’s SBRT treatment. Upper panel: LV short axis view of cardiac CT scan obtained 8 min after iodinated contrast administration. Hyper-density on inferior and postero-lateral LV wall is well evident and represents transmural myocardial fibrosis with ischemic pattern extending from the base to the apex of LV. Central panel: High-density epicardial EAM combined with CT imaging. A large portion of the inferior wall is covered by diseased electrograms, with decreased amplitude (<< 1.0 mV, red-to-yellow in the “color-coded” map), as expression of an underlying electrical “dense scar.” In the same location, CT shows a pattern of discrete transmural fibrosis, thus perfectly matching the lesion revealed by EAM. Lower panel: The inferior panel shows the coverage (95% isodose) of the target volume obtained after optimization of treatment plan. The target volume is the result of imaging integration between simulation and diagnostic CT, and EAM. Legend: CT, computed tomography; EAM, electroanatomical mapping; LV left ventricle; SBRT stereotactic body radiotherapy

References

    1. Guandalini GS, Liang JJ, Marchlinski FE. Ventricular tachycardia ablation: past, present, and future perspectives. JACC: Clinical Electrophysiology. 2019;5(12):1363–1383.
    1. Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, et al. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm. 2018;15(10):e73–e189. doi: 10.1016/j.hrthm.2017.10.036.
    1. Coyle K, Coyle D, Nault I, Parkash R, Healey JS, Gray CJ, Gardner MJ, Sterns LD, Essebag V, Hruczkowski T, Blier L, Wells GA, Tang ASL, Stevenson WG, Sapp JL. Cost effectiveness of ventricular tachycardia ablation versus escalation of antiarrhythmic drug therapy: the VANISH trial. JACC Clin Electrophysiol. 2018;4(5):660–668. doi: 10.1016/j.jacep.2018.01.007.
    1. Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacrétaz E, Pitschner HF, Kautzner J, Schumacher B, Hansen PS. Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial. Lancet. 2010;375(9708):31–40. doi: 10.1016/S0140-6736(09)61755-4.
    1. Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007;357(26):2657–2665. doi: 10.1056/NEJMoa065457.
    1. Carbucicchio C, Santamaria M, Trevisi N, Maccabelli G, Giraldi F, Fassini G, Riva S, Moltrasio M, Cireddu M, Veglia F, Della Bella P. Catheter ablation for the treatment of electrical storm in patients with implantable cardioverter-defibrillators: short- and long-term outcomes in a prospective single-center study. Circulation. 2008;117(4):462–469. doi: 10.1161/CIRCULATIONAHA.106.686534.
    1. Tung R, Vaseghi M, Frankel DS, Vergara P, Di Biase L, Nagashima K, et al. Freedom from recurrent ventricular tachycardia after catheter ablation is associated with improved survival in patients with structural heart disease: an international VT ablation center collaborative group study. Heart Rhythm. 2015;12(9):1997–2007. doi: 10.1016/j.hrthm.2015.05.036.
    1. Muser D, Santangeli P, Castro SA, Pathak RK, Liang JJ, Hayashi T, et al. Long-term outcome after catheter ablation of ventricular tachycardia in patients with nonischemic dilated cardiomyopathy. Circ Arrhythm Electrophysiol. 2016;9(10):e004328. doi: 10.1161/CIRCEP.116.004328.
    1. Piers SR, Tao Q, van Huls van Taxis CF, Schalij MJ, van der Geest RJ, Zeppenfeld K. Contrast-enhanced MRI-derived scar patterns and associated ventricular tachycardias in nonischemic cardiomyopathy: implications for the ablation strategy. Circ Arrhythm Electrophysiol. 2013;6(5):875–883. doi: 10.1161/CIRCEP.113.000537.
    1. Desjardins B, Morady F, Bogun F. Effect of epicardial fat on electroanatomical mapping and epicardial catheter ablation. J Am Coll Cardiol. 2010;56(16):1320–1327. doi: 10.1016/j.jacc.2010.04.054.
    1. Santangeli P, Marchlinski FE, Zado ES, Benhayon D, Hutchinson MD, Lin D, Frankel DS, Riley MP, Supple GE, Garcia FC, Bala R, Desjardins B, Callans DJ, Dixit S. Percutaneous epicardial ablation of ventricular arrhythmias arising from the left ventricular summit: outcomes and electrocardiogram correlates of success. Circ Arrhythm Electrophysiol. 2015;8(2):337–343. doi: 10.1161/CIRCEP.114.002377.
    1. Zei PC, Soltys S. Ablative radiotherapy as a noninvasive alternative to catheter ablation for cardiac arrhythmias. Curr Cardiol Rep. 2017;19(9):79. doi: 10.1007/s11886-017-0886-2.
    1. Robinson CG, Samson PP, Moore KM, Hugo GD, Knutson N, Mutic S, et al. Phase I/II trial of electrophysiology-guided noninvasive cardiac radioablation for ventricular tachycardia. Circulation. 2019;139(3):313–321. doi: 10.1161/CIRCULATIONAHA.118.038261.
    1. Lehmann HI, Deisher AJ, Takami M, Kruse JJ, Song L, Anderson SE, et al. External arrhythmia ablation using photon beams: ablation of the atrioventricular junction in an intact animal model. Circ Arrhythm Electrophysiol. 2017;10(4):e004304. doi: 10.1161/CIRCEP.116.004304.
    1. Kim EJ, Davogustto G, Stevenson WG, John RM. Non-invasive cardiac radiation for ablation of ventricular tachycardia: a new therapeutic paradigm in electrophysiology. Arrhythmia Electrophysiol Rev. 2018;7(1):8–10. doi: 10.15420/aer.7.1.EO1.
    1. van der Ree MH, Blanck O, Limpens J, Lee CH, Balgobind BV, Dieleman EMT, Wilde AAM, Zei PC, de Groot JR, Slotman BJ, Cuculich PS, Robinson CG, Postema PG. Cardiac radioablation - a systematic review. Heart Rhythm. 2020;17:1381–1392. doi: 10.1016/j.hrthm.2020.03.013.
    1. de Bakker JM, van Capelle FJ, Janse MJ, van Hemel NM, Hauer RN, Defauw JJ, et al. Macroreentry in the infarcted human heart: the mechanism of ventricular tachycardias with a "focal" activation pattern. J Am Coll Cardiol. 1991;18(4):1005–1014. doi: 10.1016/0735-1097(91)90760-7.
    1. Talman V, Ruskoaho H. Cardiac fibrosis in myocardial infarction-from repair and remodeling to regeneration. Cell Tissue Res. 2016;365(3):563–581. doi: 10.1007/s00441-016-2431-9.
    1. Haskova J, Peichl P, Pirk J, Cvek J, Neuwirth R, Kautzner J. Stereotactic radiosurgery as a treatment for recurrent ventricular tachycardia associated with cardiac fibroma. HeartRhythm Case Reports. 2019;5:44–47. doi: 10.1016/j.hrcr.2018.10.007.
    1. Loo BW, Jr, Soltys SG, Wang L, Lo A, Fahimian BP, Iagaru A, Norton L, Shan X, Gardner E, Fogarty T, Maguire P, al-Ahmad A, Zei P. Stereotactic ablative radiotherapy for the treatment of refractory cardiac ventricular arrhythmia. Circ Arrhythm Electrophysiol. 2015;8(3):748–750. doi: 10.1161/CIRCEP.115.002765.
    1. Cuculich PS, Schill MR, Kashani R, Mutic S, Lang A, Cooper D, Faddis M, Gleva M, Noheria A, Smith TW, Hallahan D, Rudy Y, Robinson CG. Noninvasive cardiac radiation for ablation of ventricular tachycardia. N Engl J Med. 2017;377(24):2325–2336. doi: 10.1056/NEJMoa1613773.
    1. Cvek J, Neuwirth R, Knybel L, Molenda L, Otahal B, Pindor J, et al. Cardiac radiosurgery for malignant ventricular tachycardia. Cureus. 2014;6(7).
    1. Jumeau R, Ozsahin M, Schwitter J, Vallet V, Duclos F, Zeverino M, Moeckli R, Pruvot E, Bourhis J. Rescue procedure for an electrical storm using robotic non-invasive cardiac radio-ablation. Radiother Oncol. 2018;128(2):189–191. doi: 10.1016/j.radonc.2018.04.025.
    1. Neuwirth R, Cvek J, Knybel L, Jiravsky O, Molenda L, Kodaj M, Fiala M, Peichl P, Feltl D, Januška J, Hecko J, Kautzner J. Stereotactic radiosurgery for ablation of ventricular tachycardia. EP Europace. 2019;21(7):1088–1095. doi: 10.1093/europace/euz133.
    1. Wang L, Fahimian B, Soltys SG, Zei P, Lo A, Gardner EA, et al. Stereotactic arrhythmia radioablation (STAR) of ventricular tachycardia: a treatment planning study. Cureus. 2016;8(7).
    1. Bhaskaran A, Downar E, Chauhan VS, Lindsay P, Nair K, Ha A, Hope A, Nanthakumar K. Electroanatomical mapping–guided stereotactic radiotherapy for right ventricular tachycardia storm. HeartRhythm Case Reports. 2019;5(12):590–592. doi: 10.1016/j.hrcr.2019.09.007.
    1. Krug D, Blanck O, Demming T, Dottermusch M, Koch K, Hirt M, Kotzott L, Zaman A, Eidinger L, Siebert FA, Dunst J, Bonnemeier H. Stereotactic body radiotherapy for ventricular tachycardia (cardiac radiosurgery) Strahlenther Onkol. 2020;196(1):23–30. doi: 10.1007/s00066-019-01530-w.
    1. Scholz EP, Seidensaal K, Naumann P, André F, Katus HA, Debus J. Risen from the dead: cardiac stereotactic ablative radiotherapy as last rescue in a patient with refractory ventricular fibrillation storm. HeartRhythm Case Reports. 2019;5(6):329–332. doi: 10.1016/j.hrcr.2019.03.004.
    1. Zeng LJ, Huang LH, Tan H, Zhang HC, Mei J, Shi HF, Jiang CY, Tan C, Zheng JW, Liu XP. Stereotactic body radiation therapy for refractory ventricular tachycardia secondary to cardiac lipoma: a case report. Pacing Clin Electrophysiol. 2019;42(9):1276–1279. doi: 10.1111/pace.13731.
    1. Martí-Almor J, Jiménez-López J, Rodríguez DD, Tizón H, Vallés E, Algara M. Noninvasive ablation of ventricular tachycardia with stereotactic radiotherapy in a patient with arrhythmogenic right ventricular cardiomyopathy. Revista Espanola de Cardiologia (English ed) 2020;73(1):97. doi: 10.1016/j.rec.2019.06.004.
    1. Gerber BL, Belge B, Legros GJ, Lim P, Poncelet A, Pasquet A, et al. Characterization of acute and chronic myocardial infarcts by multidetector computed tomography: comparison with contrast-enhanced magnetic resonance. Circulation. 2006;113(6):823–833. doi: 10.1161/CIRCULATIONAHA.104.529511.
    1. Nieman K, Shapiro MD, Ferencik M, Nomura CH, Abbara S, Hoffmann U, Gold HK, Jang IK, Brady TJ, Cury RC. Reperfused myocardial infarction: contrast-enhanced 64-section CT in comparison to MR imaging. Radiology. 2008;247(1):49–56. doi: 10.1148/radiol.2471070332.
    1. Sato A, Nozato T, Hikita H, Akiyama D, Nishina H, Hoshi T, Aihara H, Kakefuda Y, Watabe H, Hiroe M, Aonuma K. Prognostic value of myocardial contrast delayed enhancement with 64-slice multidetector computed tomography after acute myocardial infarction. J Am Coll Cardiol. 2012;59(8):730–738. doi: 10.1016/j.jacc.2011.10.890.
    1. Cuculich P, Kashani R, Mutic S, Hallahan DE, Robinson CG. Myocardial performance after EP-guided noninvasive cardiac radioablation (ENCORE) for ventricular tachycardia (VT) international. J Radiat Oncol Biol Physics. 2017;99(2):E511–E512. doi: 10.1016/j.ijrobp.2017.06.1827.
    1. John RM, Shinohara ET, Price M, Stevenson WG. Radiotherapy for ablation of ventricular tachycardia: assessing collateral dosing. Comput Biol Med. 2018;102:376–380. doi: 10.1016/j.compbiomed.2018.08.010.
    1. Weidlich GA, Hacker F, Bellezza D, Maguire P, Gardner EA. Ventricular tachycardia: a treatment comparison study of the CyberKnife with conventional linear accelerators. Cureus. 2018;10(10).
    1. Refaat MM, Zakka P, Youssef B, Zeidan YH, Geara F, Al-Ahmad A. Noninvasive Cardioablation. Card Electrophysiol Clin. 2019;11(3):481–485. doi: 10.1016/j.ccep.2019.05.008.
    1. Gianni C, Rivera D, Burkhardt JD, Pollard B, Gardner E, Maguire P, et al. Stereotactic arrhythmia radioablation for refractory scar-related ventricular tachycardia. Heart Rhythm. 2020;17:1241–8.
    1. Zecchin M, Severgnini M, Fiorentino A, Malavasi VL, Menegotti L, Alongi F, et al. Management of patients with cardiac implantable electronic devices (CIED) undergoing radiotherapy: a consensus document from Associazione Italiana Aritmologia e Cardiostimolazione (AIAC), Associazione Italiana Radioterapia Oncologica (AIRO), Associazione Italiana Fisica Medica (AIFM) Int J Cardiol. 2018;255:175–183. doi: 10.1016/j.ijcard.2017.12.061.
    1. Riva G, Alessandro O, Spoto R, Ferrari A, Garibaldi C, Cattani F, Luraschi R, Rondi E, Colombo N, Giovenzana FLF, Cipolla CM, Winnicki M, Persiani M, Castelluccia F, Fiore MS, Orecchia R, Jereczek-Fossa BA. Radiotherapy in patients with cardiac implantable electronic devices: clinical and dosimetric aspects. Med Oncol. 2018;35(5):73. doi: 10.1007/s12032-018-1126-3.
    1. Kobiela J, Spychalski P, Marvaso G, Ciardo D, Dell’Acqua V, Kraja F, Błażyńska-Spychalska A, Łachiński AJ, Surgo A, Glynne-Jones R, Jereczek-Fossa BA. Ablative stereotactic radiotherapy for oligometastatic colorectal cancer: systematic review. Crit Rev Oncol Hematol. 2018;129:91–101. doi: 10.1016/j.critrevonc.2018.06.005.
    1. Buss EJ, Wang TJ, Sisti MB. Stereotactic radiosurgery for management of vestibular schwannoma: a short review. Neurosurg Rev. 2020. 10.1007/s10143-020-01279-2.

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