Study demonstrates remote supervision could speed adoption of new technologies into clinical practice

Burlington, Mass. – Physicians training on novel technologies and surgical devices by other already experienced physicians, known as proctoring, is a fundamental aspect of medicine. Travel and visitor restrictions intended to curb the global COVID-19 pandemic have put a temporary hold on in-person physician proctoring — which is often required by the FDA or other regulatory bodies before surgeons can introduce new technologies in their practice — thus delaying the introduction of new medical devices and techniques across multiple medical specialties.

In a new article published in the Journal of Neurointerventional Surgery, the NeuroInterventional Radiology (NIR) team at Lahey Hospital and Medical Center (LHMC) described their preliminary experience with remote supervision for the introduction in clinical practice of a new technology for the treatment of brain aneurysms. A cloud-based software allowed real time, bidirectional audiovisual streaming from the NIR operating room to an expert physician in Canada who successfully supervised the first U.S. use of a new type of flow diverting implant used to treat intracranial aneurysms. Led by Ajay K. Wakhloo, MD, PhD, the NIR team reported that the remote physician proctoring — or teleproctoring — was very successfully implemented in their practice and that it potentially could eliminate the need for in-person supervision.  “Traditionally, proctoring entails the physical presence of the supervising physician in the operating room to provide direct and real-time guidance to the operator using new technology,” said  Wakhloo, who is Chief of NeuroInterventional Radiology at LHMC. “With no clear horizon for lifting the current restrictions in place due to the global pandemic, teleproctoring could potentially allow the continuation of clinical trials and the introduction of new devices for the benefit of our patients in clinical practice.”

In May 2020, the Department of Health and Human Services and the Centers for Medicare & Medicaid Services   revised physician proctoring rules to allow it to occur via real-time interactive audio and video during the COVID-19 pandemic at least through 2021. To evaluate the usefulness of teleproctoring, Wakhloo and colleagues selected three patients with brain aneurysms who would benefit from treatment with a new flow diverting stent that is already in use in Canada. The U.S. Food and Drug Administration recently approved the use of the new stent, but also required that the device’s first use be proctored by a physician with experience using it. The physician in Canada with the most experience with the novel device was selected as proctor. Because current travel restrictions prevented the Canadian physician from supervising in person, the NIR team and LHMC administrators decided to conduct the procedures under remote supervision. “By eliminating the need for in-person proctoring, teleproctoring has a great potential to expand patient access to novel neurointerventional procedures and technologies,” said first author Emanuele Orru’, MD, a neurointerventional radiologist at LHMC. “Doctors familiar with new techniques in our field are few, and proctors routinely need to travel nationally or internationally in order to provide much needed training to other physicians, often resulting in delay of care. This technology could shorten the time patients must currently wait to schedule a procedure or enable patients who might otherwise need to travel for treatment to receive state-of-the-art care closer to home.”

All patients were provided with information about the procedure and signed consent forms specific to teleproctoring. Specialized software successfully streamed encrypted, de-identified — and thus in compliance with the U.S. health privacy law known as HIPAA — in real-time high-resolution images and vital signs between the Canadian proctor and U.S operators. With access to live video of the radiological images, as well as of the operators’ hands and of the operative table, the proctor provided uninterrupted step-by-step guidance throughout the cases and reported complete spatial and situational awareness, without any significant lag or delay in communication. The interventions went as planned with no complications, taking about as long as similar procedures carried out under routine circumstances. All three patients were discharged home the day after the procedure.

“We demonstrated that teleproctoring can be applied safely and effectively to real-world neurointerventional practice,” said Wakhloo. “We suggest telemedicine warrants further consideration not only to help mitigate the adverse effects of the global pandemic, but also to determine how a streamlined integration of high-quality image broadcasting systems and robotics can open new pathways for physician training assistance and ultimately safer and more readily available delivery of patient care, even in remote areas.” In addition to Orru’ and Wakhloo, authors include co-first authors Miklos Marosfoi and Neil V. Patel, Christoph Wald, and Nicholas Repucci of LHMC, Alexander L. Coon, of Carondelet Saint Joseph’s Hospital; and Patrick Nicholson and Vitor Mendes Pereira of Toronto Western Hospital. The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors.  Wakhloo has a research grant from Philips Medical and serves as a consultant for Stryker. For other disclosures, please consult the article text, here.

About Lahey Hospital & Medical Center

Lahey Hospital & Medical Center, a part of Beth Israel-Lahey Health, is a world-renowned tertiary medical center known for its innovative technology, pioneering medical treatment, and leading-edge research. A teaching hospital of Tufts University School of Medicine, the hospital provides quality health care in virtually every specialty and subspecialty, from primary care to cancer diagnosis and treatment to kidney and liver transplantation. It is a national leader in a number of health care areas, including stroke, weight management and lung screenings, among many others. For more information on Lahey Hospital & Medical Center, please visit www.lahey.org.

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