GI Specialists of Delaware Newark, DE, United States
Michael Bass, MD GI Specialists of Delaware, Newark, DE
Introduction: Video Capsule Endoscopy (VCE) historically requires medically supervised in-office ingestion of a small bowel capsule due to correct assembly of equipment and potential aspiration of the capsule. However, reductions in non-emergent medical care during the COVID pandemic forced a virtual halt in the performance of VCE. To help combat this, the FDA issued a temporary emergency use authorization (EUA) for virtual ingestion (VI) of the Medtronic small bowel capsule (PillCam™ SB3). We hypothesized that physicians could leverage telehealth to enable VCE outside of a clinical office safely and satisfactorily.
Methods: Medtronic mailed the capsule and equipment to the patient. Using an electronic health record (EHR) telemedicine platform, the physician instructed the patient on the correct equipment assembly and watched the patient ingest the capsule. The physician obtained information on satisfactory completion of VI, complications, and physician and patient satisfaction via a survey. Twenty patients were selected based on an appropriate indication for VCE and without aspiration risk factors. All patients needed to have an adult present during the virtual ingestion. The patient mailed the equipment back to Medtronic, and the physician uploaded the video to a cloud-based server. The physician downloaded the video from the cloud and completed the read. The surveys were collected under Medtronic's Temporary EUA for Pillcam SB3 at Home Pilot and purposed for an application for full FDA approval. All patients provided informed consent for participation
Results: Patients and physicians reported satisfaction with the remote procedure. The VI’s were technologically and medically successful for all twenty patients. No aspiration events occurred.
Discussion: In this study, the physician was very satisfied with the logistics of delivering remote VCE and felt the patient's medical needs were met. The quality of the results was satisfactory and enabled healthcare decisions to be made under pandemic conditions. This data suggests telemedicine may be leveraged to allow for at-home VCE and could potentially be the new standard of care for select patients even after the COVID-19 pandemic ends. More extensive studies will be needed to validate the findings of this study.
Michael Bass indicated no relevant financial relationships.
Michael Bass, MD. P0926 - Leveraging Telemedicine for Video Capsule Endoscopy in the Era of COVID-19, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.