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Clinical Evidence behind Stereotactic Radiotherapy for the Treatment of Ventricular Tachycardia (STAR)-A Comprehensive Review.

ABSTRACT: The electrophysiology-guided noninvasive cardiac radioablation, also known as STAR (stereotactic arrhythmia radioablation) is an emerging treatment method for persistent ventricular tachycardia. Since its first application in 2012 in Stanford Cancer Institute, and a year later in University Hospital Ostrava, Czech Republic, the authors from all around the world have published case reports and case series, and several prospective trials were established. In this article, we would like to discuss the available clinical evidence, analyze the potentially clinically relevant differences in methodology, and address some of the unique challenges that come with this treatment method.

SUBMITTER: Miszczyk M

PROVIDER: S-EPMC8002399 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Clinical Evidence behind Stereotactic Radiotherapy for the Treatment of Ventricular Tachycardia (STAR)-A Comprehensive Review.

Miszczyk Marcin M Jadczyk Tomasz T Gołba Krzysztof K Wojakowski Wojciech W Wita Krystian K Bednarek Jacek J Blamek Sławomir S

Journal of clinical medicine 20210317 6

The electrophysiology-guided noninvasive cardiac radioablation, also known as STAR (stereotactic arrhythmia radioablation) is an emerging treatment method for persistent ventricular tachycardia. Since its first application in 2012 in Stanford Cancer Institute, and a year later in University Hospital Ostrava, Czech Republic, the authors from all around the world have published case reports and case series, and several prospective trials were established. In this article, we would like to discuss ...[more]

PMID: 33802802

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Project description:AimsAmong patients with structural heart disease with ventricular tachycardia (VT) refractory to medical therapy and catheter ablation, cardiac stereotactic body radiotherapy (SBRT) is a paradigm-changing treatment option. This study aims to assess the efficacy of cardiac SBRT in refractory VT by comparing the rates of VT episodes, anti-tachycardia pacing (ATP) therapies, and implantable cardioverter-defibrillator (ICD) shocks post-SBRT with pre-SBRT.Methods and resultsWe performed a comprehensive literature search and included all clinical studies reporting outcomes on cardiac SBRT for VT. Treatment efficacy was evaluated as random-effects pooled rate-ratios of VT episodes, ATP therapies and ICD shocks post-SBRT (after 6-week blanking) and pre-SBRT, with patients serving as their own controls. Post-SBRT overall survival was assessed using Kaplan-Meier method. We included 23 studies published 2017-24 reporting on 225 patients who received cardiac SBRT, with median follow-up 5.8-28 months. There was significant heterogeneity among the studies for all three efficacy endpoints (P < 0.00001). The random-effects pooled rate-ratios of VT episodes, ATP therapies and ICD shocks post- vs. pre-SBRT were 0.10 (95% CI 0.06, 0.16), 0.09 (0.05, 0.15), and 0.09 (0.05, 0.17), respectively (all P < 0.00001). The most common reported complications included pericardial (8.0%, including 0.9% late oesophagogastro-pericardial fistula) and pulmonary (5.8%). There was no change in left ventricular ejection fraction post-SBRT (P = 0.3) but some studies reported an increase in mitral regurgitation. The combined 3-, 12-, and 24-month overall patient survival was 0.86 (0.80, 0.90), 0.72 (0.65, 0.78), and 0.57 (0.47, 0.67), respectively.ConclusionAmong patients with refractory VT in context of structural heart disease, VT burden and ICD shocks are dramatically reduced following cardiac SBRT. The overall mortality in this population with heart failure and refractory VT receiving palliative cardiac SBRT remains high.

Project description:BackgroundThe standard of care for neovascular age-related macular degeneration (nAMD) involves ongoing intravitreal injections of anti-angiogenic drugs targeting vascular endothelial growth factor (VEGF). The most commonly used anti-VEGF drugs are ranibizumab, bevacizumab and aflibercept. The main objective of the STAR trial is to determine if stereotactic radiotherapy can reduce the number of anti-VEGF injections that patients with nAMD require.Methods/designSTAR is a multicentre, double-masked, randomised, sham-controlled clinical trial. It evaluates a new device (manufactured by Oraya, Newark, CA, USA) designed to deliver stereotactic radiotherapy (SRT) to nAMD lesions. The trial enrols participants with chronic, active nAMD. Participants receive a single SRT treatment (16 Gy or sham) with a concomitant baseline intravitreal injection of 0.5 mg ranibizumab. Thereafter, they attend every month for 24 months, and ranibizumab is administered at the visit if retreatment criteria are met. The primary outcome is the number of pro re nata ranibizumab injections during the first 24 months. Secondary outcomes include visual acuity, lesion morphology, quality of life and safety. Additional visits occur at 36 and 48 months to inspect for radiation retinopathy. The target sample size of 411 participants (randomised 2:1 in favour of radiation) is designed to detect a reduction of 2.5 injections against ranibizumab monotherapy, at 90% power, and a significance level (alpha) of 0.025 (one-sided two-sample t test). This gives 97% power to detect non-inferiority of visual acuity at a five-letter margin. The primary analyses will be by intention to treat.DiscussionThe safety and efficacy outcomes will help determine the role of SRT in the management of chronic, active nAMD.Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN12884465. Registered on 28 November 2014. ClinicalTrials.gov: NCT02243878 . Registered on 17 September 2014.

Dataset Information

Clinical Evidence behind Stereotactic Radiotherapy for the Treatment of Ventricular Tachycardia (STAR)-A Comprehensive Review.

Publications

Clinical Evidence behind Stereotactic Radiotherapy for the Treatment of Ventricular Tachycardia (STAR)-A Comprehensive Review.

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