To assess the diagnostic value of automatic embolus detection software (AEDS) in transcranial Doppler (TCD) monitoring for the detection of solid microemboli in patients at risk for perioperative stroke during carotid endarterectomy (CEA). In 50 patients undergoing CEA, perioperative TCD registration was recorded. All recorded events, identified and saved by the AEDS, were analyzed off-line doubly by two human experts (HEs) within a time frame of> 4 months. The inter- and intraobserver variability was assessed. The overall agreement with the HEs, the sensitivity, specificity, negative and positive predictive values (NPV and PPV) of the AEDS were computed for different cut-offs (patient displaying perioperative 5, 10, 20, 25, or 50 microemboli). 77 233 events were analyzed. The inter- and intraobserver variability was good (min κ = 0.72, max κ = 0.79). AEDS and the HEs identified 760 and 470 solid emboli, respectively. The agreement between AEDS and the HEs for solid emboli detection was poor (κ = 0.24, SE = 0.016). The specificity and NPV were high (99.2 % and 99.6 %) but the sensitivity and PPV were low (30.6 % and 19.8 %). Applying a threshold of> 20 microemboli resulted in the best sensitivity (100.0 %), specificity (84.4 %), PPV (42.7 %), NPV (100.0 %) and area under the curve (0.898). However, 58.3 % of the patients were false positive as classified by AEDS. In this validation cohort, AEDS has insufficient agreement with HEs in the identification of solid emboli. AEDS and HEs disagree with respect to the identification of specific patients at risk. Therefore, AEDS cannot be used as a standalone system to identify patients at risk for perioperative stroke during CEA.

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The primary objective of this study was to assess the safety and performance of the TrackCath system and to establish clinical evidence in patients with thoraco-abdominal and abdominal aortic aneurysm requiring endovascular intervention. Methods: The target subject population were male or female participants over 18 years of age who have been diagnosed with an aortic aneurysm requiring endovascular intervention. Enrolled patients required at least one cannulation during EVAR (e.g. fenestration of endograft, aortic side-branch or contralateral leg of endograft). The study was conducted in four study sites with broad experience of complex EVAR procedures. A sample size calculation showed that at least 24 patients with 42 target orifices are necessary to prove the expected procedural success rate, defined as successful TrackCath system delivery of the distal end of the guidewire or catheter to the selected targeted orifice. The safety was examined by reporting all device-related adverse events in the full analysis set, including additionally at least two roll-in patients at each study site. Secondary aimed to obtain additional scientific data about the use of the TrackCath system regarding e.g. procedure duration, contrast dye consumption, x-ray exposure, the patient's physical parameters and blood values and surgeons' satisfaction rate. Results: Between March 2018 and February 2019, a total of 40 patients were enrolled in the study. Preliminary statistical analysis of the study has evidenced successful achievement of primary endpoints for safety (100%) and performance (98%). During the study, no device-related serious adverse event occurred. In the statistical study population, 50 orifices were assessed concerning the successful TrackCath performance to deliver of the distal end of the guidewire or of the 4 French catheter to the selected targeted orifice. Analysis of clinical data recorded during the study evidenced as well the performance of the technology to identify side branches localisation using the blood flow velocity changes. Conclusion: The use of the TrackCath system is a safe procedure and does not increase the intra-or postoperative risks of EVAR Disclosure: Nothing to disclose

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