eP823 - Post-operative monitoring of intestinal motility, ischemia, and inflammation for early detection of anastomotic leaks

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Purpose/Background: Postoperative anastomotic leak can be a catastrophic event and current diagnostic modalities fail to provide timely detection. This failure to rescue directly leads to increased mortality, morbidity and worse outcomes. A new medical device (xBar by Exero Medical) is a diagnostic device intended to continuously monitor local intestinal function following GI surgery. The objective of this multi-center pilot study was to evaluate if this device can reliably detect anastomotic leaks earlier than the current standard of care.Methods/Interventions: The device’s platform technology is based on an electrode array collecting information from the surgical site representing physiological processes such as local inflammation and ischemia. Data recorded is relayed to a cloud database where a machine learning algorithm continuously classifies the accumulating stream of data into several “Leak States”. Here, a set of electrodes were embedded in a standard surgical drain. The device collected data for a duration of 3 to 10 days, while the surgical drain was in use. Our primary endpoints were safety and performance analysis – sensitivity, specificity, and time to detect severe anastomotic leaks.Results/Outcomes: We included 50 patients undergoing elective anterior resection were included (Nf44 cancer patients, Nf4 Diverticulitis and Nf2 Prolapse). The average age was 63.6±13.3 years and 38% males. The average anastomotic height was 9.1±5.3cm from the anal verge. The surgical technique used was laparoscopic (Nf26), Robotic (Nf16) or open (Nf8). Grade C anastomotic leak was observed in 6.0% (Nf3) of the patients. The hospitalization time for the patients without leaks was 7.7±5.3 versus 15.0±7.9 days in patients with severe leak. The device had a sensitivity of 100% and Specificity of 91.5% at POD 2 and 100% sensitivity and 100% specificity at POD3. Notably, the clinical team diagnosed the leak after 6, 16 and 5 days in the three severe leak cases (9.0±6.1 days on average), in contrast to the earlier detection using the device (2.3±0.6 days on average, and at least 2 days before the clinical team). No device related serious adverse events were observed during the study and the device did not alter the patient outcomes.Conclusion/

Discussion: This study demonstrates clinical feasibility of the xBar system. Local electrophysiological parameters are highly sensitive to the physiological processes underlying anastomotic leaks enabling early post-op monitoring ahead of systemic clinical signs. The drain proved to be a reliable form factor for the technology. During this study the algorithm was adaptive and learning from ongoing data – in an upcoming pivotal trial the system will be tested with fixed settings to validate xBar’s performance with sufficient statistical power.