Optimized Intraoperative Imaging for Stereotactic Planning with a Multiaxial Robotic C-arm System: Technical Note and Case Series

Background The preoperative preparation of the planning dataset for frame-based stereotactic brain biopsy is often associated with logistical effort and burden on the patient. Intraoperative imaging modalities need to be investigated to overcome these limitations. Objective The objective of the study was to develop and apply a new method for the intraoperative acquisition of the planning dataset with the multiaxial robotic C-arm system Artis zeego. Methods An indication-customized dose-reduced protocol for Artis zeego was developed and implemented into the workflow. A sample of 14 patients who had undergone intraoperative imaging with Artis zeego was analyzed. A sample of 10 patients with conventional preoperative imaging by cranial computed tomography (CT) was used as a control group. Outcomes were compared with regard to target deviation, diagnostic value of the biopsies, complications, and procedure time. Results In all patients, a suitable intraoperative planning dataset could be acquired with Artis zeego. Total procedure time was shorter for the Artis zeego group (p = 0.01), whereas time in the operating room area was longer in the Artis zeego group (p = 0.04). Biopsy results were diagnostic in 12 patients (86%) in the Artis zeego group and in 8 patients (80%) in the control group. There were no significant differences in target size, trajectory length, or target deviation. Conclusion Intraoperative imaging for frame-based stereotactic brain biopsy with Artis zeego is an easy and feasible method. Accuracy is comparable to conventional CT, whereas radiation exposure could be additionally reduced. It allows a significant reduction of the total procedure length and improves the comfort for the patient and staff.

Standard manual reprocessing of angiographic systems in the hybrid OR

A current FDA guidance demands the validation of cleaning and disinfecting protocols even for non-sterile medical devices. The aim of this work is to clarify whether this is already possible using the guidance itself as well as the German DIN EN ISO 17664. An angiography system (Artis Zeego / Pheno - Siemens) was selected as a test object for the validation of a cleaning and disinfection protocol for medical devices in a hybrid operating room. In pilot study prior to the trial, critical points of the system were evaluated by means of questionnaires to clinical users (OTA, surgical technicians). An initial assessment of the in-house cleaning protocols used in the hospitals was done by using a fluorescence assay. The microbiological examination took place subsequently by contact plates and swabbing to determine the amount and type of germs on the surfaces of the system. These experiments were done at three different clinical sites. It was found that there was a significant germ count on several surfaces of the product even after in-house cleaning and disinfection (C&D). After application of an enhanced C&D plan, these germs could be greatly reduced at all verified sites. In addition, it could be shown that DIN EN ISO 17664 can in principle be applied to non-sterile medical products.