Operating procedures, risk management and challenges during implementation of adaptive and non-adaptive MR-guided radiotherapy: 1-year single-center experience

Abstract Background Main purpose was to describe procedures and identify challenges in the implementation process of adaptive and non-adaptive MR-guided radiotherapy (MRgRT), especially new risks in workflow due to the new technique. We herein report the single center experience for the implementation of (MRgRT) and present an overview on our treatment practice. Methods Descriptive statistics were used to summarize clinical and technical characteristics of treatment and patient characteristics including sites treated between April 2019 and end of March 2020 after ethical approval. A risk analysis was performed to identify risks of the online adaptive workflow. Results A summary of the processes on the MR-Linac including workflows, quality assurance and possible pitfalls is presented. 111 patients with 124 courses were treated during the first year of MR-guided radiotherapy. The most commonly treated site was the abdomen (42% of all treatment courses). 73% of the courses were daily online adapted and a high number of treatment courses (75%) were treated with stereotactic body irradiation. Only 4/382 fractions could not be treated due to a failing online adaptive quality assurance. In the risk analysis for errors, the two risks with the highest risk priority number were both in the contouring category, making it the most critical step in the workflow. Conclusion Although challenging, establishment of MRgRT as a routinely used technique at our department was successful for all sites and daily o-ART was feasible from the first day on. However, ongoing research and reports will have to inform us on the optimal indications for MRgRT because careful patient selection is necessary as it continues to be a time-consuming treatment technique with restricted availability. After risk analysis, the most critical workflow category was the contouring process, which resembles the need of experienced staff and safety check paths.

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Non-aneurysmal non-traumatic subarachnoid hemorrhage: patient characteristics, clinical outcome and prognostic factors based on a single-center experience in 125 patients

BMC Neurology ◽

10.1186/1471-2377-14-140 ◽

2014 ◽

Vol 14 (1) ◽

Cited By ~ 36

Author(s):

Juergen Konczalla ◽

Johannes Platz ◽

Patrick Schuss ◽

Hartmut Vatter ◽

Volker Seifert ◽

...

Keyword(s):

Prognostic Factors ◽

Subarachnoid Hemorrhage ◽

Clinical Outcome ◽

Patient Characteristics ◽

Single Center ◽

Single Center Experience ◽

Traumatic Subarachnoid Hemorrhage

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The AneuRx Stent-Graft since FDA Approval: Single-Center Experience of 230 Cases

Journal of Endovascular Therapy ◽

10.1177/152660280200900413 ◽

2002 ◽

Vol 9 (4) ◽

pp. 464-469 ◽

Cited By ~ 14

Author(s):

Venkatesh G. Ramaiah ◽

Alex Westerband ◽

Charles Thompson ◽

Rajagopalan Ravi ◽

Julio A. Rodriguez ◽

...

Keyword(s):

Clinical Trial ◽

Stent Graft ◽

Phase Ii ◽

Patient Characteristics ◽

Phase Ii Clinical Trial ◽

Single Center ◽

Short Term ◽

Single Center Experience ◽

Fda Approval ◽

Aneurysm Morphology

Purpose: To compare a single-center experience with the AneuRx stent-graft system before and after FDA approval to results from the multicenter phase II clinical trial. Methods: The medical records of 230 consecutive patients (218 men; mean age 74 years) undergoing AneuRx stent-graft implantation for abdominal aortic aneurysm (AAA) exclusion since September 1999 were reviewed to collect patient characteristics, aneurysm morphology, procedure variables, perioperative morbidity, mortality, and short-term outcome. These data were compared to the 30 patients treated at our institution during the AneuRx phase II clinical trial and to the overall multicenter trial data. Stent-graft difficulty was categorized from 1 (straight neck and access of appropriate size) to 4 (proximal neck <10 mm long or angulated >60° and/or difficult access) based on aneurysm morphology. Results: Data from the 30 patients enrolled in the phase II trial at our institution were comparable in terms of patient characteristics and procedure variables to patients treated after FDA approval and to the multicenter data. However, the proportion of cases involving aneurysms with a more complex morphology (levels 3 and 4) rose 22% after FDA approval, reflecting a change in referral patterns. Our postoperative endoleak and morbidity rates increased nonsignificantly with respect to our own phase II experience (17% versus 6%, 18% versus 11%, respectively);however, they were not significantly different from the multicenter data. Reintervention was performed in 15 of 38 endoleak cases, mostly type I. Only 5 (2.1%) cases had a persistent endoleak at the time of discharge. Conclusions: Since FDA approval of the AneuRx device, our endovascular practice has changed toward the management of increasingly more complex AAAs. Although we are attempting more challenging cases, we are able to maintain similarly high short-term success rates while offering stent-grafting to an increasing number of patients. These results suggest that more patients may be candidates for endoluminal graft placement than determined by the clinical trial selection criteria, provided that strict surveillance and long-term follow-up is maintained.

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