Non-invasive stereotactic arrhythmia radiotherapy for ventricular tachycardia: results of the prospective STARNL-1 trial

Martijn H van der Ree; Jorrit Visser; S Matthijs Boekholdt; Rianne H A de Bruin-Bon; Coen R N Rasch; Wiert F Hoeksema; Rianne M A J de Jong; Michiel J B Kemme; Jippe C Balt; Arthur A M Wilde; Pieter G Postema; Edith M T Dieleman; R Nils Planken; Brian V Balgobind

doi:https://doi.org/10.1093/europace/euad020

Non-invasive stereotactic arrhythmia radiotherapy for ventricular tachycardia: results of the prospective STARNL-1 trial

Martijn H van der Ree, Jorrit Visser, S Matthijs Boekholdt, Rianne H A de Bruin-Bon, Coen R N Rasch, Wiert F Hoeksema, Rianne M A J de Jong, Michiel J B Kemme, Jippe C Balt, Arthur A M Wilde, Pieter G Postema, Edith M T Dieleman, R Nils Planken, Brian V Balgobind

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

AIMS: Stereotactic arrhythmia radiotherapy (STAR) is suggested as potentially effective and safe treatment for patients with therapy-refractory ventricular tachycardia (VT). However, the current prospective knowledge base and experience with STAR is limited. In this study we aimed to prospectively evaluate the efficacy and safety of STAR.

METHODS AND RESULTS: The StereoTactic Arrhythmia Radiotherapy in the Netherlands no.1 was a pre-post intervention study to prospectively evaluate efficacy and safety of STAR. In patients with therapy-refractory VT, the pro-arrhythmic region was treated with a 25 Gy single radiotherapy fraction. The main efficacy measure was a reduction in the number of treated VT-episodes by ≥50%, comparing the 12 months before and after treatment (or end of follow-up, excluding a 6-week blanking period). The study was deemed positive when ≥50% of patients would meet this criterion. Safety evaluation included left ventricular ejection fraction, pulmonary function, and adverse events. Six male patients with an ischaemic cardiomyopathy were enrolled, and median age was 73 years (range 54-83). Median left ventricular ejection fraction was 38% (range 24-52). The median planning target volume was 187 mL (range 93-372). Four (67%) patients completed the 12-month follow-up, and two patients died (not STAR related) during follow-up. The main efficacy measure of ≥50% reduction in treated VT-episodes at the end of follow-up was achieved in four patients (67%). The median number of treated VT-episodes was reduced by 87%. No reduction in left ventricular ejection fraction or pulmonary function was observed. No treatment related serious adverse events occurred.

CONCLUSIONS: STAR resulted in a ≥ 50% reduction in treated VT-episodes in 4/6 (67%) patients. No reduction in cardiac and pulmonary function nor treatment-related serious adverse events were observed during follow-up.

CLINICAL TRIAL REGISTRATION: Netherlands Trial Register-NL7510.

Original language	English
Pages (from-to)	1015-1024
Number of pages	10
Journal	Europace
Volume	25
Issue number	3
Early online date	7 Feb 2023
DOIs	https://doi.org/10.1093/europace/euad020
Publication status	Published - 30 Mar 2023

Keywords

Aged
Aged, 80 and over
Heart
Humans
Male
Middle Aged
Radiosurgery/adverse effects
Stroke Volume
Tachycardia, Ventricular/diagnosis
Treatment Outcome
Ventricular Function, Left

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https://doi.org/10.1093/europace/euad020

Cite this

van der Ree, M. H., Visser, J., Boekholdt, S. M., de Bruin-Bon, R. H. A., Rasch, C. R. N., Hoeksema, W. F., de Jong, R. M. A. J., Kemme, M. J. B., Balt, J. C., Wilde, A. A. M., Postema, P. G., Dieleman, E. M. T., Planken, R. N., & Balgobind, B. V. (2023). Non-invasive stereotactic arrhythmia radiotherapy for ventricular tachycardia: results of the prospective STARNL-1 trial. Europace, 25(3), 1015-1024. https://doi.org/10.1093/europace/euad020

@article{e563af9b0247470991fe56aa77a3ffe4,

title = "Non-invasive stereotactic arrhythmia radiotherapy for ventricular tachycardia: results of the prospective STARNL-1 trial",

abstract = "AIMS: Stereotactic arrhythmia radiotherapy (STAR) is suggested as potentially effective and safe treatment for patients with therapy-refractory ventricular tachycardia (VT). However, the current prospective knowledge base and experience with STAR is limited. In this study we aimed to prospectively evaluate the efficacy and safety of STAR.METHODS AND RESULTS: The StereoTactic Arrhythmia Radiotherapy in the Netherlands no.1 was a pre-post intervention study to prospectively evaluate efficacy and safety of STAR. In patients with therapy-refractory VT, the pro-arrhythmic region was treated with a 25 Gy single radiotherapy fraction. The main efficacy measure was a reduction in the number of treated VT-episodes by ≥50%, comparing the 12 months before and after treatment (or end of follow-up, excluding a 6-week blanking period). The study was deemed positive when ≥50% of patients would meet this criterion. Safety evaluation included left ventricular ejection fraction, pulmonary function, and adverse events. Six male patients with an ischaemic cardiomyopathy were enrolled, and median age was 73 years (range 54-83). Median left ventricular ejection fraction was 38% (range 24-52). The median planning target volume was 187 mL (range 93-372). Four (67%) patients completed the 12-month follow-up, and two patients died (not STAR related) during follow-up. The main efficacy measure of ≥50% reduction in treated VT-episodes at the end of follow-up was achieved in four patients (67%). The median number of treated VT-episodes was reduced by 87%. No reduction in left ventricular ejection fraction or pulmonary function was observed. No treatment related serious adverse events occurred.CONCLUSIONS: STAR resulted in a ≥ 50% reduction in treated VT-episodes in 4/6 (67%) patients. No reduction in cardiac and pulmonary function nor treatment-related serious adverse events were observed during follow-up.CLINICAL TRIAL REGISTRATION: Netherlands Trial Register-NL7510.",

keywords = "Aged, Aged, 80 and over, Heart, Humans, Male, Middle Aged, Radiosurgery/adverse effects, Stroke Volume, Tachycardia, Ventricular/diagnosis, Treatment Outcome, Ventricular Function, Left",

author = "{van der Ree}, {Martijn H} and Jorrit Visser and Boekholdt, {S Matthijs} and {de Bruin-Bon}, {Rianne H A} and Rasch, {Coen R N} and Hoeksema, {Wiert F} and {de Jong}, {Rianne M A J} and Kemme, {Michiel J B} and Balt, {Jippe C} and Wilde, {Arthur A M} and Postema, {Pieter G} and Dieleman, {Edith M T} and Planken, {R Nils} and Balgobind, {Brian V}",

note = "{\textcopyright} The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.",

year = "2023",

month = mar,

day = "30",

doi = "https://doi.org/10.1093/europace/euad020",

language = "English",

volume = "25",

pages = "1015--1024",

journal = "Europace",

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publisher = "Oxford University Press",

number = "3",

}

van der Ree, MH , Visser, J , Boekholdt, SM , de Bruin-Bon, RHA, Rasch, CRN, Hoeksema, WF, de Jong, RMAJ, Kemme, MJB, Balt, JC, Wilde, AAM, Postema, PG, Dieleman, EMT , Planken, RN & Balgobind, BV 2023, 'Non-invasive stereotactic arrhythmia radiotherapy for ventricular tachycardia: results of the prospective STARNL-1 trial', Europace, vol. 25, no. 3, pp. 1015-1024. https://doi.org/10.1093/europace/euad020

TY - JOUR

T1 - Non-invasive stereotactic arrhythmia radiotherapy for ventricular tachycardia

T2 - results of the prospective STARNL-1 trial

AU - van der Ree, Martijn H

AU - Visser, Jorrit

AU - Boekholdt, S Matthijs

AU - de Bruin-Bon, Rianne H A

AU - Rasch, Coen R N

AU - Hoeksema, Wiert F

AU - de Jong, Rianne M A J

AU - Kemme, Michiel J B

AU - Balt, Jippe C

AU - Wilde, Arthur A M

AU - Postema, Pieter G

AU - Dieleman, Edith M T

AU - Planken, R Nils

AU - Balgobind, Brian V

N1 - © The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.

PY - 2023/3/30

Y1 - 2023/3/30

N2 - AIMS: Stereotactic arrhythmia radiotherapy (STAR) is suggested as potentially effective and safe treatment for patients with therapy-refractory ventricular tachycardia (VT). However, the current prospective knowledge base and experience with STAR is limited. In this study we aimed to prospectively evaluate the efficacy and safety of STAR.METHODS AND RESULTS: The StereoTactic Arrhythmia Radiotherapy in the Netherlands no.1 was a pre-post intervention study to prospectively evaluate efficacy and safety of STAR. In patients with therapy-refractory VT, the pro-arrhythmic region was treated with a 25 Gy single radiotherapy fraction. The main efficacy measure was a reduction in the number of treated VT-episodes by ≥50%, comparing the 12 months before and after treatment (or end of follow-up, excluding a 6-week blanking period). The study was deemed positive when ≥50% of patients would meet this criterion. Safety evaluation included left ventricular ejection fraction, pulmonary function, and adverse events. Six male patients with an ischaemic cardiomyopathy were enrolled, and median age was 73 years (range 54-83). Median left ventricular ejection fraction was 38% (range 24-52). The median planning target volume was 187 mL (range 93-372). Four (67%) patients completed the 12-month follow-up, and two patients died (not STAR related) during follow-up. The main efficacy measure of ≥50% reduction in treated VT-episodes at the end of follow-up was achieved in four patients (67%). The median number of treated VT-episodes was reduced by 87%. No reduction in left ventricular ejection fraction or pulmonary function was observed. No treatment related serious adverse events occurred.CONCLUSIONS: STAR resulted in a ≥ 50% reduction in treated VT-episodes in 4/6 (67%) patients. No reduction in cardiac and pulmonary function nor treatment-related serious adverse events were observed during follow-up.CLINICAL TRIAL REGISTRATION: Netherlands Trial Register-NL7510.

AB - AIMS: Stereotactic arrhythmia radiotherapy (STAR) is suggested as potentially effective and safe treatment for patients with therapy-refractory ventricular tachycardia (VT). However, the current prospective knowledge base and experience with STAR is limited. In this study we aimed to prospectively evaluate the efficacy and safety of STAR.METHODS AND RESULTS: The StereoTactic Arrhythmia Radiotherapy in the Netherlands no.1 was a pre-post intervention study to prospectively evaluate efficacy and safety of STAR. In patients with therapy-refractory VT, the pro-arrhythmic region was treated with a 25 Gy single radiotherapy fraction. The main efficacy measure was a reduction in the number of treated VT-episodes by ≥50%, comparing the 12 months before and after treatment (or end of follow-up, excluding a 6-week blanking period). The study was deemed positive when ≥50% of patients would meet this criterion. Safety evaluation included left ventricular ejection fraction, pulmonary function, and adverse events. Six male patients with an ischaemic cardiomyopathy were enrolled, and median age was 73 years (range 54-83). Median left ventricular ejection fraction was 38% (range 24-52). The median planning target volume was 187 mL (range 93-372). Four (67%) patients completed the 12-month follow-up, and two patients died (not STAR related) during follow-up. The main efficacy measure of ≥50% reduction in treated VT-episodes at the end of follow-up was achieved in four patients (67%). The median number of treated VT-episodes was reduced by 87%. No reduction in left ventricular ejection fraction or pulmonary function was observed. No treatment related serious adverse events occurred.CONCLUSIONS: STAR resulted in a ≥ 50% reduction in treated VT-episodes in 4/6 (67%) patients. No reduction in cardiac and pulmonary function nor treatment-related serious adverse events were observed during follow-up.CLINICAL TRIAL REGISTRATION: Netherlands Trial Register-NL7510.

KW - Aged

KW - Aged, 80 and over

KW - Heart

KW - Humans

KW - Male

KW - Middle Aged

KW - Radiosurgery/adverse effects

KW - Stroke Volume

KW - Tachycardia, Ventricular/diagnosis

KW - Treatment Outcome

KW - Ventricular Function, Left

U2 - https://doi.org/10.1093/europace/euad020

DO - https://doi.org/10.1093/europace/euad020

M3 - Article

C2 - 36746553

SN - 1099-5129

VL - 25

SP - 1015

EP - 1024

JO - Europace

JF - Europace

IS - 3

ER -