Patient vulnerability in stereotactic arrhythmia radioablation (STAR): a preliminary ethical appraisal from the STOPSTORM.eu consortium

Botrugno, Carlo; Crico, Chiara; Iori, Mauro; Blanck, Oliver; Blamek, Slawomir; Postema, Pieter G.; Quesada, Aurelio; Pruvot, Etienne; Verhoeff, Joost J. C.; De Panfilis, Ludovica

doi:10.1007/s00066-024-02230-w

Strahlenther Onkol

2024

DOI: 10.1007/s00066-024-02230-w

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Patient vulnerability in stereotactic arrhythmia radioablation (STAR): a preliminary ethical appraisal from the STOPSTORM.eu consortium

Carlo Botrugno,

Chiara Crico,

Mauro Iori

et al.

Abstract: This preliminary ethical appraisal from the STOPSTORM.eu consortium is meant to raise critical points that clinicians administering stereotactic arrhythmia radioablation should consider to meet the highest standards in medical ethics and thus promote quality of life of patients recruited for radiotherapy treatments at a stage in which they experience a significant degree of vulnerability.

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Implementing stereotactic arrhythmia radioablation with STOPSTORM.eu consortium support: intermediate results of a prospective Israeli single-institutional trial

Borzov,

Efraim,

Suleiman

et al. 2024

Strahlenther Onkol

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Background Ventricular tachycardia (VT) is a life-threatening arrhythmia originating from the heart’s ventricles. Traditional treatments include antiarrhythmic medications, implantable cardioverter-defibrillators (ICDs), and catheter ablation. Stereotactic body radiation therapy (SBRT) targeting the arrhythmogenic focus in the left ventricle—stereotactic arrhythmia radioablation (STAR)—is an emerging treatment and may offer a potential solution for patients with refractory VT. Objective We designed an interventional prospective clinical trial in Israel aligned with the STOPSTORM.eu consortium’s benchmarks, recommendations, and directives to assess the safety and efficacy of STAR in patients with refractory VT. Methods Our phase I/II single-institutional trial was approved by the Ministry of Health of Israel for 10 patients, initially assessing safety in the first 3 patients. We included patients with ICDs experiencing symptomatic monomorphic VT after an inadequate response to previous therapies. The primary endpoints were treatment-related serious adverse events and a reduction in VT burden as assessed by ICD interrogation. Secondary outcomes included a reduction in antiarrhythmic medications and changes in quality of life. Results From August 2023 to August 2024, 3 patients underwent STAR treatment. The prescription dose was a single fraction of 25 Gy. Planning target volumes were 47.8, 49.7, and 91.8 cc, and treatment was successfully delivered with no grade 3 or higher adverse events reported. Over a follow-up period of 12 months for the first patient and 8 months for the second one, no VT events were recorded after treatment. The third patient died from progressive heart failure 3 months after treatment. Left ventricular ejection fraction remained stable, and no significant radiation-induced inflammatory changes were noted. Conclusion The initial results of this trial suggest that STAR can reduce VT episodes in patients with refractory VT without severe adverse effects. The study highlights the importance of international collaboration and standardization in pioneering new treatments. Further follow-up and additional patient data will be necessary to confirm these findings and evaluate long-term outcomes, including potential adjustments to antiarrhythmic medication regimens.

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Implementing stereotactic arrhythmia radioablation with STOPSTORM.eu consortium support: intermediate results of a prospective Israeli single-institutional trial

Borzov,

Efraim,

Suleiman

et al. 2024

Strahlenther Onkol

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Refining Treatment Planning in STereotactic Arrhythmia Radioablation: Benchmark Results and Consensus Statement From the STOPSTORM.eu Consortium

Trojani,

Grehn,

Botti

et al. 2025

International Journal of Radiation Oncology*Biology*Physics

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Patient vulnerability in stereotactic arrhythmia radioablation (STAR): a preliminary ethical appraisal from the STOPSTORM.eu consortium

Cited by 2 publications

References 22 publications

Implementing stereotactic arrhythmia radioablation with STOPSTORM.eu consortium support: intermediate results of a prospective Israeli single-institutional trial

Implementing stereotactic arrhythmia radioablation with STOPSTORM.eu consortium support: intermediate results of a prospective Israeli single-institutional trial

Refining Treatment Planning in STereotactic Arrhythmia Radioablation: Benchmark Results and Consensus Statement From the STOPSTORM.eu Consortium

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