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Aims: Stereotactic arrhythmia radioablation (STAR) is a novel therapeutic approach for cardiac arrhythmias. The aim of this trial is to investigate the feasibility of STAR for the treatment of paroxysmal atrial fibrillation (AF) in elderly patients., Methods and Results: Inclusion criteria were age >70 years, symptomatic AF, antiarrhythmic drugs failure, or intolerance. All patients underwent to 4D cardiac computed tomography simulation. The clinical target volume was identified in the area around pulmonary veins (PV). Stereotactic arrhythmia radioablation was performed with a total dose of 25 Gy (single fraction) delivered in 3 min. Twenty patients were enrolled and 18 underwent STAR. One patient withdrew informed consent before treatment and one patient was excluded due to unfavourable oesophagus position. With a median follow-up (FU) of 16 months (range 12-23), no acute toxicity more than Grade 3 was reported. Five patients had a Grade 1 oesophagitis 24 h after STAR; eight patients had an asymptomatic Grade 1 pericardial effusion, and one patient had a torsade de pointes treated effectively by electrical cardioversion and subsequent cardiac implantable cardioverter-defibrillator implantation. Most patients had a significant reduction in AF episodes. Five patients, due to arrhythmias recurrences after STAR, performed electrophysiological study documenting successful PV isolation. Finally, a significant improvement of quality of life was documented (48 ± 15 at enrolment vs. 75 ± 15 at 12 months FU; P < 0.001)., Conclusion: The present phase II trial demonstrated the feasibility of STAR in paroxysmal AF elderly patients and its potential role in increasing the quality of life. Surely, more robust data are needed about safety and efficacy., Trial Registration: ClinicalTrials.gov: NCT04575662., Competing Interests: Conflict of interest: none declared., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims Stereotactic arrhythmia radioablation (STAR) is a novel therapeutic approach for cardiac arrhythmias. The aim of this trial is to investigate the feasibility of STAR for the treatment of paroxysmal atrial fibrillation (AF) in elderly patients. Methods and results Inclusion criteria were age >70 years, symptomatic AF, antiarrhythmic drugs failure, or intolerance. All patients underwent to 4D cardiac computed tomography simulation. The clinical target volume was identified in the area around pulmonary veins (PV). Stereotactic arrhythmia radioablation was performed with a total dose of 25 Gy (single fraction) delivered in 3 min. Twenty patients were enrolled and 18 underwent STAR. One patient withdrew informed consent before treatment and one patient was excluded due to unfavourable oesophagus position. With a median follow-up (FU) of 16 months (range 12–23), no acute toxicity more than Grade 3 was reported. Five patients had a Grade 1 oesophagitis 24 h after STAR; eight patients had an asymptomatic Grade 1 pericardial effusion, and one patient had a torsade de pointes treated effectively by electrical cardioversion and subsequent cardiac implantable cardioverter-defibrillator implantation. Most patients had a significant reduction in AF episodes. Five patients, due to arrhythmias recurrences after STAR, performed electrophysiological study documenting successful PV isolation. Finally, a significant improvement of quality of life was documented (48 ± 15 at enrolment vs. 75 ± 15 at 12 months FU; P < 0.001). Conclusion The present phase II trial demonstrated the feasibility of STAR in paroxysmal AF elderly patients and its potential role in increasing the quality of life. Surely, more robust data are needed about safety and efficacy. Trial registration ClinicalTrials.gov: NCT04575662 [ABSTRACT FROM AUTHOR]

Purpose: Approaching treatment for elderly patients with atrial fibrillation is difficult. A prospective phase II trial evaluating LINAC-based stereotactic arrhythmia radioablation (STAR) safety in this population started in 2021. Dosimetric and planning data were reported. Materials and Methods: A vac-lock bag was used for immobilization in the supine position and a computed tomography (CT, 1 mm) was performed. The clinical target volume (CTV) was defined as the area around the pulmonary veins. An internal target volume (ITV) was added to the CTV to compensate heart and respiratory movement. The planning target volume (PTV) was defined by adding 0–3 mm to the ITV. STAR was performed during free-breathing with a PTV prescription total dose (Dp) of 25 Gy/1 fraction. Flattening filter-free volumetric-modulated arc therapy plans were generated, optimized, and delivered by TrueBeamTM. Image-guided radiotherapy with cone-beam CT and surface-guided radiotherapy with Align-RT (Vision RT) were employed. Results: From May 2021 to March 2022, 10 elderly patients were treated. Mean CTVs, ITVs, and PTVs were 23.6 cc, 44.32 cc, and 62.9 cc, respectively; the mean prescription isodose level and D2% were 76.5% and 31.2 Gy, respectively. The average heart and left anterior descending artery (LAD) Dmean were 3.9 and 6.3 Gy, respectively; the mean Dmax for LAD, spinal cord, left and right bronchus, and esophagus were 11.2, 7.5, 14.3, 12.4, and 13.6 Gy, respectively. The overall treatment time (OTT) was 3 min. Conclusions: The data showed an optimal target coverage, sparing surrounding tissue, in 3 min of OTT. LINAC-based STAR for AF could represent a valid non-invasive alternative for elderly patients who were excluded from catheter ablation. [ABSTRACT FROM AUTHOR]

Aim: In elderly, paroxysmal Atrial Fibrillation (AF) is difficult to treat with drugs, or by Catheter ablation, so a non-invasive approach should be favourite. No data are published about the use or radiosurgery for AF, thus in the present analysis the preliminary data of Linac-based STereotectic Arrythmias Radioablation (STAR) for elderly affected by paroxysmal AF were reported. Methods: Inclusion criteria were: age >70 years; symptomatic paroxysmal AF; intolerance or nonresponse to anti-arhythmic therapy (AAT). All patients performed 1-week ECG-Holter monitoring, a complete transthoracic echocardiogram before and after STAR. Patients were immobilized using a vac-lock bag and Computed Tomography (CT, 1mm slice-thickness), in the supine position were performed: CT with/without contrast; 4-Dimension CT. STAR was performed in freebreathing with a PTV prescription total dose (Dp) of 25Gy/1 fraction. Flattening Filter Free (FFF), Volumetric Modulated Arc Therapy (VMAT) plan was generated, normalizing 100% Dp to 95% of the volume, while large intra-target dose heterogeneity D2% (PTV)<150%Dp was accepted. The treatment was optimized and delivered by TrueBeamTM (Varian Medical System). Image-guided radiotherapy with Cone Beam CT and Surface-Guided RadioTherapy with Align-RT were used to reduce setup error and to monitor patients during fraction. The primary endpoint is the 1-month post-STAR safety, as complete STAR delivery and no acute treatment-related adverse events more than G3, assessed according to the Common Terminology Criteria for Adverse Events (version 5.0).Results: From May 2021 to January 2022, 5 patients were treated and followed. AAT was stopped after enrollment. For primary endpoint, no acute treatmentrelated adverse events were registered (>G1). Only 1 patient experienced G1 esophagitis (7 days from STAR), improved by 5 days of medical therapy. The treatment plan was delivered with 3 no coplanar arcs, in all cases. The mean Overall Treatment Time (OTT) was 3minutes. For all treated patients with a mean follow-up of 4 months (patients 1-4), no late side effects were reported, and at 3 months, a rare atrial ectopy was documented without AF recurrences. No patients started AAT after radiotherapy Conclusion: The present collected data are promising, showing the safety of LINAC-based STAR for AF for the first 5 patients worldwide. This new ablation approach could represent a valid non-invasive alternative for elderly who were excluded from catheter ablation. [ABSTRACT FROM AUTHOR]