Stereotactic management of arrhythmia – radiosurgery in treatment of ventricular tachycardia (SMART-VT) – clinical trial protocol and study rationale Original article

Main Article Content

Marcin Miszczyk
Tomasz Jadczyk
Bartłomiej Tomasik
Tomasz Latusek
Jacek Bednarek
Radosław Kurzelowski
Krzysztof Gołba
Wojciech Wojakowski
Krystian Wita
Łukasz Dolla
Aleksandra Grządziel
Sławomir Blamek

Abstract

Patients with ventricular tachycardia are usually treated with antiarrhythmic drugs and ablation if the arrhythmia substrate is available for invasive treatment. Despite high efficiency of this treatment there is a significant group of patients who do not benefit from available treatment methods, either because they cannot be applied or do not allow for durable control of the disease. For that reason a novel treatment method, STereotactic Arrhythmia Radioablation (STAR) has been proposed and its safety and efficiency is extensively studied throughout the world. The method is based on irradiation of the arrhythmia substrate identified with electrophysiological examination with high-precision image-guided radiosurgical methods usually used for ablation of malignant tumors. Here we present the protocol of the first Polish study on STAR in patients with intractable ventricular tachycardia (STARVT, NCT04642963), designed to test the safety of the method. Secondary endpoints include measures of the treatment efficiency.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Article Details

How to Cite
1.
Miszczyk M, Jadczyk T, Tomasik B, Latusek T, Bednarek J, Kurzelowski R, Gołba K, Wojakowski W, Wita K, Dolla Łukasz, Grządziel A, Blamek S. Stereotactic management of arrhythmia – radiosurgery in treatment of ventricular tachycardia (SMART-VT) – clinical trial protocol and study rationale. OncoReview [Internet]. 2021Feb.14 [cited 2024Nov.22];10(4(40):123-9. Available from: https://journalsmededu.pl/index.php/OncoReview/article/view/1147
Section
CARDIO-ONCOLOGY

References

1. Lydiard S, Hugo G, O’Brien R et al. A review of cardiac radioablation (CR) for arrhythmias: procedures, technology and future opportunities. Int J Radiat Oncol.; 0. Epub ahead of print November 2020. http://doi.org/10.1016/j.ijrobp.2020.10.036.
2. Tokuda M, Kojodjojo P, Tung S et al. Acute failure of catheter ablation for ventricular tachycardia due to structural heart disease: Causes and significance. J Am Heart Assoc. Epub ahead of print 2013. http://doi.org/10.1161/JAHA.113.000072.
3. Sharma A, Wong D, Weidlich G et al. Noninvasive stereotactic radiosurgery (CyberHeart) for creation of ablation lesions in the atrium. Hear Rhythm. 2010; 7: 802-10. https://doi.org/10.1016/j.hrthm.2010.02.010.
4. Maguire PJ, Gardner E, Jack AB et al. Cardiac Radiosurgery (CyberHeartTM) for Treatment of Arrhythmia: Physiologic and Histopathologic Correlation in the Porcine Model. Cureus. Epub ahead of print 24 July 2012. http://doi.org/10.7759/cureus.32.
5. Loo BW, Soltys SG, Wang L et al. Stereotactic Ablative Radiotherapy for the Treatment of Refractory Cardiac Ventricular Arrhythmia. Circ Arrhythmia Electrophysiol. 2015; 8: 748-50. https://doi.org/10.1161/CIRCEP.115.002765.
6. Cvek J, Neuwirth R, Knybel L et al. Cardiac Radiosurgery for Malignant Ventricular Tachycardia. Cureus. Epub ahead of print 22 July 2014. http://doi.org/10.7759/cureus.190.
7. Jumeau R, Ozsahin M, Schwitter J et al. Rescue procedure for an electrical storm using robotic non-invasive cardiac radio-ablation. Radiother Oncol. 2018; 128: 189-91. https://doi.org/10.1016/j.radonc.2018.04.025.
8. Cuculich PS, Schill MR, Kashani R et al. Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia. N Engl J Med. Epub ahead of print 2017. http://doi.org/10.1056/NEJMoa1613773.
9. Neuwirth R, Cvek J, Knybel L et al. Stereotactic radiosurgery for ablation of ventricular tachycardia. EP Eur. 2019; 21: 1088-95. https://doi.org/10.1093/europace/euz133.
10. Lloyd MS, Wight J, Schneider F et al. Clinical experience of stereotactic body radiation for refractory ventricular tachycardia in advanced heart failure patients. Hear Rhythm. Epub ahead of print 1 October 2019. http://doi.org/10.1016/j.hrthm.2019.09.028.
11. Chin R, Hayase J, Hu P et al. Non-invasive stereotactic body radiation therapy for refractory ventricular arrhythmias: an institutional experience. J Interv Card Electrophysiol. Epub ahead of print 2020. http://doi.org/10.1007/s10840-020-00849-0.
12. Robinson CG, Samson PP, Moore KMS et al. Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. Circulation. 2019; 139: 313-21. https://doi.org/10.1161/CIRCULATIONAHA.118.038261.
13. Gianni C, Rivera D, Burkhardt JD et al. Stereotactic arrhythmia radioablation for refractory scar-related ventricular tachycardia. Hear Rhythm. Epub ahead of print 6 March 2020. http://doi.org/10.1016/j.hrthm.2020.02.036.
14. Haskova J, Peichl P, Pirk J et al. Stereotactic radiosurgery as a treatment for recurrent ventricular tachycardia associated with cardiac fibroma. Hear Case Reports. 2019; 5: 44-7. https://doi.org/10.1016/j.hrcr.2018.10.007.
15. Scholz EP, Seidensaal K, Naumann P et al. Risen from the dead: Cardiac stereotactic ablative radiotherapy as last rescue in a patient with refractory ventricular fibrillation storm. Hear Case Reports. 2019; 5: 329-32. https://doi.org/10.1016/j.hrcr.2019.03.004.
16. Zeng L, Huang L, Tan H et al. Stereotactic body radiation therapy for refractory ventricular tachycardia secondary to cardiac lipoma: A case report. Pacing Clin Electrophysiol. 2019; 42: 1276-9. https://doi.org/10.1111/pace.13731.
17. Martí-Almor J, Jiménez-López J, Rodríguez de Dios N et al. Noninvasive ablation of ventricular tachycardia with stereotactic radiotherapy in a patient with arrhythmogenic right ventricular cardiomyopathy. Rev Esp Cardiol (Engl Ed). Epub ahead of print 30 July 2019. http://doi.org/10.1016/j.rec.2019.06.004.
18. Bhaskaran A, Downar E, Chauhan VS et al. Electroanatomical mapping–guided stereotactic radiotherapy for right ventricular tachycardia storm. Hear Case Reports 2019; 5: 590-2. https://doi.org/10.1016/j.hrcr.2019.09.007.
19. Krug D, Blanck O, Demming T et al. Stereotactic body radiotherapy for ventricular tachycardia (cardiac radiosurgery): First-in-patient treatment in Germany. Strahlentherapie und Onkol. 2020; 196: 23-30. https://doi.org/10.1007/s00066-019-01530-w.
20. Mayinger M, Kovacs B, Tanadini-Lang S et al. First magnetic resonance imaging-guided cardiac radioablation of sustained ventricular tachycardia. Radiother Oncol. Epub ahead of print 2020. http://doi.org/10.1016/j.radonc.2020.01.008.
21. Park JS, Choi Y. Stereotactic cardiac radiation to control ventricular tachycardia and fibrillation storm in a patient with apical hypertrophic cardiomyopathy at burnout stage: Case report. J Korean Med Sci; 35. Epub ahead of print 13 July 2020. http://doi.org/10.3346/jkms.2020.35.e200.
22. Fleming TR. One-Sample Multiple Testing Procedure for Phase II Clinical Trials. Biometrics. 1982; 38(1): 143-151. http://doi.org/10.2307/2530297.
23. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989; 10(1): 1-10. http://doi.org/10.1016/0197-2456(89)90015-9.
24. Cerqueira MD, Weissman NJ, Dilsizian V et al; American Heart Association Writing Group on Myocardial Segmentation and Registration for Cardiac Imaging. Standardized myocardial segmentation and nomenclature for tomographic imaging of the heart. A statement for healthcare professionals from the Cardiac Imaging Committee of the Council on Clinical Cardiology of the American Heart Association. Circulation. 2002; 105(4): 539-42. http://doi.org/10.1161/hc0402.102975.
25. Hohmann S, Henkenberens C, Zormpas C et al. A novel open-source software-based high-precision workflow for target definition in cardiac radioablation. J Cardiovasc Electrophysiol. Epub ahead of print 2020. http://doi.org/10.1111/jce.14660.
26. Wang L, Fahimian B, Soltys SG, et al. Stereotactic Arrhythmia Radioablation (STAR) of Ventricular Tachycardia: A Treatment Planning Study. Cureus. 2016; 8(7): e694. doi:10.7759/cureus.694.
27. Tajstra M, Blamek S, Niedziela JT et al. Patients with cardiac implantable electronic devices undergoing radiotherapy in Poland. Expert opinion of the Heart Rhythm Section of the Polish Cardiac Society and the Polish Society of Radiation Oncology. Kardiol Pol. 2019; 77(11): 1106-16. Epub 2019 Nov 19. http://doi.org/10.33963/KP.15063.