KEY POINTS
- A multidisciplinary team developed a failure modes and effects analysis and fault tree analysis for a C-arm linear accelerator-based stereotactic arrhythmia radioablation workflow delivering 25 Gy in one fraction. Initial scoring involved 30 experts across five disciplines.
- The analysis identified 79 failure modes, of which 17 were classified as high risk based on risk priority ranking or a severity score of at least 8.
- The highest-risk failures were inaccurate multimodal image registration (risk priority number 432), improper motion evaluation or management (336), and diagnostic error in defining the arrhythmogenic substrate (320).
- Proposed measures including checklists, standardized procedures, independent verification, and double checks produced a projected median risk priority number reduction of 50.0%. These reductions were expert estimates and were not prospectively validated.
- In an exploratory anatomical analysis of eight patients with ventricular tachycardia, left ventricular segments 4, 5, and 10 were each within 2 cm of both the stomach and esophagus. One patient with a lateral free-wall target developed post-treatment gastritis.
CLINICAL TAKEAWAY
For centres implementing linear accelerator-based stereotactic arrhythmia radioablation, target definition, multimodal image registration, and motion management appear to require the strongest standardization and independent review. The framework is technically useful but remains hypothesis-generating because scoring was consensus-based, mitigation effects were projected, and the anatomical analysis included only eight patients.