Radiosurgery for ventricular tachycardia (RAVENTA): interim analysis of a multicenter multiplatform feasibility trial

David Krug; Adrian Zaman; Lina Eidinger; Melanie Grehn; Judit Boda-Heggemann; Boris Rudic; Felix Mehrhof; Leif Hendrik Boldt; Stephan Hohmann; Roland Merten; Daniel Buergy; Jens Fleckenstein; Anne Kluge; Annette Rogge; Marcus Both; Dirk Rades; Roland Richard Tilz; Denise Olbrich; Inke R. König; Frank Andre Siebert; Achim Schweikard; Reinhard Vonthein; Hendrik Bonnemeier; Jürgen Dunst; Oliver Blanck

doi:10.1007/s00066-023-02091-9

Radiosurgery for ventricular tachycardia (RAVENTA): interim analysis of a multicenter multiplatform feasibility trial

David Krug^*, Adrian Zaman, Lina Eidinger, Melanie Grehn, Judit Boda-Heggemann, Boris Rudic, Felix Mehrhof, Leif Hendrik Boldt, Stephan Hohmann, Roland Merten, Daniel Buergy, Jens Fleckenstein, Anne Kluge, Annette Rogge, Marcus Both, Dirk Rades, Roland Richard Tilz, Denise Olbrich, Inke R. König, Frank Andre SiebertAchim Schweikard, Reinhard Vonthein, Hendrik Bonnemeier, Jürgen Dunst, Oliver Blanck

^*Corresponding author for this work

3 Citations (Scopus)

Abstract

Background: Single-session cardiac stereotactic radiation therapy (SBRT) has demonstrated promising results for patients with refractory ventricular tachycardia (VT). However, the full safety profile of this novel treatment remains unknown and very limited data from prospective clinical multicenter trials are available. Methods: The prospective multicenter multiplatform RAVENTA (radiosurgery for ventricular tachycardia) study assesses high-precision image-guided cardiac SBRT with 25 Gy delivered to the VT substrate determined by high-definition endocardial and/or epicardial electrophysiological mapping in patients with refractory VT ineligible for catheter ablation and an implanted cardioverter defibrillator (ICD). Primary endpoint is the feasibility of full-dose application and procedural safety (defined as an incidence of serious [grade ≥ 3] treatment-related complications ≤ 5% within 30 days after therapy). Secondary endpoints comprise VT burden, ICD interventions, treatment-related toxicity, and quality of life. We present the results of a protocol-defined interim analysis. Results: Between 10/2019 and 12/2021, a total of five patients were included at three university medical centers. In all cases, the treatment was carried out without complications. There were no serious potentially treatment-related adverse events and no deterioration of left ventricular ejection fraction upon echocardiography. Three patients had a decrease in VT episodes during follow-up. One patient underwent subsequent catheter ablation for a new VT with different morphology. One patient with local VT recurrence died 6 weeks after treatment in cardiogenic shock. Conclusion: The interim analysis of the RAVENTA trial demonstrates early initial feasibility of this new treatment without serious complications within 30 days after treatment in five patients. Recruitment will continue as planned and the study has been expanded to further university medical centers. Trial registration number: NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. Study start: October 1, 2019.

Original language	English
Journal	Strahlentherapie und Onkologie
Volume	199
Issue number	7
Pages (from-to)	621-630
Number of pages	10
ISSN	0179-7158
DOIs	https://doi.org/10.1007/s00066-023-02091-9
Publication status	Published - 07.2023

Research Areas and Centers

Research Area: Luebeck Integrated Oncology Network (LION)
Centers: University Cancer Center Schleswig-Holstein (UCCSH)
Academic Focus: Biomedical Engineering

DFG Research Classification Scheme

205-30 Radiology, Nuclear Medicine, Radiation Therapy and Radiobiology
205-12 Cardiology, Angiology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1007/s00066-023-02091-9

Cite this

Krug, D., Zaman, A., Eidinger, L., Grehn, M., Boda-Heggemann, J., Rudic, B., Mehrhof, F., Boldt, L. H., Hohmann, S., Merten, R., Buergy, D., Fleckenstein, J., Kluge, A., Rogge, A., Both, M., Rades, D., Tilz, R. R., Olbrich, D., König, I. R., ... Blanck, O. (2023). Radiosurgery for ventricular tachycardia (RAVENTA): interim analysis of a multicenter multiplatform feasibility trial. Strahlentherapie und Onkologie, 199(7), 621-630. https://doi.org/10.1007/s00066-023-02091-9

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title = "Radiosurgery for ventricular tachycardia (RAVENTA): interim analysis of a multicenter multiplatform feasibility trial",

abstract = "Background: Single-session cardiac stereotactic radiation therapy (SBRT) has demonstrated promising results for patients with refractory ventricular tachycardia (VT). However, the full safety profile of this novel treatment remains unknown and very limited data from prospective clinical multicenter trials are available. Methods: The prospective multicenter multiplatform RAVENTA (radiosurgery for ventricular tachycardia) study assesses high-precision image-guided cardiac SBRT with 25 Gy delivered to the VT substrate determined by high-definition endocardial and/or epicardial electrophysiological mapping in patients with refractory VT ineligible for catheter ablation and an implanted cardioverter defibrillator (ICD). Primary endpoint is the feasibility of full-dose application and procedural safety (defined as an incidence of serious [grade ≥ 3] treatment-related complications ≤ 5% within 30 days after therapy). Secondary endpoints comprise VT burden, ICD interventions, treatment-related toxicity, and quality of life. We present the results of a protocol-defined interim analysis. Results: Between 10/2019 and 12/2021, a total of five patients were included at three university medical centers. In all cases, the treatment was carried out without complications. There were no serious potentially treatment-related adverse events and no deterioration of left ventricular ejection fraction upon echocardiography. Three patients had a decrease in VT episodes during follow-up. One patient underwent subsequent catheter ablation for a new VT with different morphology. One patient with local VT recurrence died 6 weeks after treatment in cardiogenic shock. Conclusion: The interim analysis of the RAVENTA trial demonstrates early initial feasibility of this new treatment without serious complications within 30 days after treatment in five patients. Recruitment will continue as planned and the study has been expanded to further university medical centers. Trial registration number: NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. Study start: October 1, 2019.",

author = "David Krug and Adrian Zaman and Lina Eidinger and Melanie Grehn and Judit Boda-Heggemann and Boris Rudic and Felix Mehrhof and Boldt, {Leif Hendrik} and Stephan Hohmann and Roland Merten and Daniel Buergy and Jens Fleckenstein and Anne Kluge and Annette Rogge and Marcus Both and Dirk Rades and Tilz, {Roland Richard} and Denise Olbrich and K{\"o}nig, {Inke R.} and Siebert, {Frank Andre} and Achim Schweikard and Reinhard Vonthein and Hendrik Bonnemeier and J{\"u}rgen Dunst and Oliver Blanck",

note = "Publisher Copyright: {\textcopyright} 2023, The Author(s).",

year = "2023",

month = jul,

doi = "10.1007/s00066-023-02091-9",

language = "English",

volume = "199",

pages = "621--630",

journal = "Strahlentherapie und Onkologie",

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Krug, D, Zaman, A, Eidinger, L, Grehn, M, Boda-Heggemann, J, Rudic, B, Mehrhof, F, Boldt, LH, Hohmann, S, Merten, R, Buergy, D, Fleckenstein, J, Kluge, A, Rogge, A, Both, M, Rades, D , Tilz, RR , Olbrich, D , König, IR, Siebert, FA, Schweikard, A , Vonthein, R, Bonnemeier, H, Dunst, J & Blanck, O 2023, 'Radiosurgery for ventricular tachycardia (RAVENTA): interim analysis of a multicenter multiplatform feasibility trial', Strahlentherapie und Onkologie, vol. 199, no. 7, pp. 621-630. https://doi.org/10.1007/s00066-023-02091-9

TY - JOUR

T1 - Radiosurgery for ventricular tachycardia (RAVENTA)

T2 - interim analysis of a multicenter multiplatform feasibility trial

AU - Krug, David

AU - Zaman, Adrian

AU - Eidinger, Lina

AU - Grehn, Melanie

AU - Boda-Heggemann, Judit

AU - Rudic, Boris

AU - Mehrhof, Felix

AU - Boldt, Leif Hendrik

AU - Hohmann, Stephan

AU - Merten, Roland

AU - Buergy, Daniel

AU - Fleckenstein, Jens

AU - Kluge, Anne

AU - Rogge, Annette

AU - Both, Marcus

AU - Rades, Dirk

AU - Tilz, Roland Richard

AU - Olbrich, Denise

AU - König, Inke R.

AU - Siebert, Frank Andre

AU - Schweikard, Achim

AU - Vonthein, Reinhard

AU - Bonnemeier, Hendrik

AU - Dunst, Jürgen

AU - Blanck, Oliver

PY - 2023/7

Y1 - 2023/7

N2 - Background: Single-session cardiac stereotactic radiation therapy (SBRT) has demonstrated promising results for patients with refractory ventricular tachycardia (VT). However, the full safety profile of this novel treatment remains unknown and very limited data from prospective clinical multicenter trials are available. Methods: The prospective multicenter multiplatform RAVENTA (radiosurgery for ventricular tachycardia) study assesses high-precision image-guided cardiac SBRT with 25 Gy delivered to the VT substrate determined by high-definition endocardial and/or epicardial electrophysiological mapping in patients with refractory VT ineligible for catheter ablation and an implanted cardioverter defibrillator (ICD). Primary endpoint is the feasibility of full-dose application and procedural safety (defined as an incidence of serious [grade ≥ 3] treatment-related complications ≤ 5% within 30 days after therapy). Secondary endpoints comprise VT burden, ICD interventions, treatment-related toxicity, and quality of life. We present the results of a protocol-defined interim analysis. Results: Between 10/2019 and 12/2021, a total of five patients were included at three university medical centers. In all cases, the treatment was carried out without complications. There were no serious potentially treatment-related adverse events and no deterioration of left ventricular ejection fraction upon echocardiography. Three patients had a decrease in VT episodes during follow-up. One patient underwent subsequent catheter ablation for a new VT with different morphology. One patient with local VT recurrence died 6 weeks after treatment in cardiogenic shock. Conclusion: The interim analysis of the RAVENTA trial demonstrates early initial feasibility of this new treatment without serious complications within 30 days after treatment in five patients. Recruitment will continue as planned and the study has been expanded to further university medical centers. Trial registration number: NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. Study start: October 1, 2019.

AB - Background: Single-session cardiac stereotactic radiation therapy (SBRT) has demonstrated promising results for patients with refractory ventricular tachycardia (VT). However, the full safety profile of this novel treatment remains unknown and very limited data from prospective clinical multicenter trials are available. Methods: The prospective multicenter multiplatform RAVENTA (radiosurgery for ventricular tachycardia) study assesses high-precision image-guided cardiac SBRT with 25 Gy delivered to the VT substrate determined by high-definition endocardial and/or epicardial electrophysiological mapping in patients with refractory VT ineligible for catheter ablation and an implanted cardioverter defibrillator (ICD). Primary endpoint is the feasibility of full-dose application and procedural safety (defined as an incidence of serious [grade ≥ 3] treatment-related complications ≤ 5% within 30 days after therapy). Secondary endpoints comprise VT burden, ICD interventions, treatment-related toxicity, and quality of life. We present the results of a protocol-defined interim analysis. Results: Between 10/2019 and 12/2021, a total of five patients were included at three university medical centers. In all cases, the treatment was carried out without complications. There were no serious potentially treatment-related adverse events and no deterioration of left ventricular ejection fraction upon echocardiography. Three patients had a decrease in VT episodes during follow-up. One patient underwent subsequent catheter ablation for a new VT with different morphology. One patient with local VT recurrence died 6 weeks after treatment in cardiogenic shock. Conclusion: The interim analysis of the RAVENTA trial demonstrates early initial feasibility of this new treatment without serious complications within 30 days after treatment in five patients. Recruitment will continue as planned and the study has been expanded to further university medical centers. Trial registration number: NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. Study start: October 1, 2019.

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U2 - 10.1007/s00066-023-02091-9

DO - 10.1007/s00066-023-02091-9

M3 - Journal articles

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AN - SCOPUS:85161345678

SN - 0179-7158

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