A grant from the SVS Foundation has helped amputees in the Fresno, Calif. area get up and walking more quickly than is typical.[[{"fid":"3679","view_mode":"default","fields":{"format":"default","alignment":"","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"link_text":null,"type":"media","field_deltas":{"1":{"format":"default","alignment":"","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"attributes":{"height":4813,"width":5345,"style":"height: 279px; width: 310px; float: right; margin: 6px;","class":"media-element file-default","data-delta":"1"}}]]
SVS member and researcher Leigh Ann O’Banion now hopes this success can be duplicated across the country.
All patients were treated following the LEAP – Lower Extremity Amputation Pathway – protocol. LEAP mandates not only a multidisciplinary approach with consultations involving a raft of providers, but also post-operative discharge into an acute rehabilitation facility.
Dr. O’Banion created the LEAP protocol and is overseeing the study, with assistance from a 2019 SVS Foundation Community Awareness and Prevention Project Grant. The project involves a prospective study of all dysvascular patients who have undergone major lower-extremity amputations at University of California Fresno from January 2018 onward. To date, 11 patients have been enrolled; however, enrollment was abruptly halted by the COVID-19 pandemic. UCSF-Fresno is anticipating completion of enrollment of the project once clinical research can safely resume.
Under LEAP, vascular patients at risk for major lower extremity amputations consult with anesthesiologists, surgeons, social workers, physical therapists, rehab personnel and prosthetists. Patients are discharged into an acute rehabilitation facility as opposed to a nursing home or home, a key component, said Dr. O’Banion. Additionally, all patients received physical therapy “on or before the day of their amputation,” she said.
The results thus far, she said, “are extremely promising.”
LEAP patients all received physical therapy two days sooner than a retrospective cohort of 130 amputees and hospital length of stay was decreased on average of 3 days. LEAP patients received their prosthetics and ambulated, on average 56 days sooner than the retrospective cohort (p=0.002).
LEAP patients also were matched to a subset of patients in the retrospective cohort who were discharged to an acute rehab facility. LEAP patients had a 50 percent reduction in post-operative hospital length of stay (three vs six days) and had a significantly higher rate of receiving a prosthetic (100 percent vs. 54 percent). In addition, the LEAP patients received their prosthetics and ambulated on average a month sooner than their historical controls.
Fresno and the Central Valley is an area underserved in vascular care and previously was at the top of California’s amputation rankings, Dr. O’Banion said. “There is a true need for the LEAP protocol and improved outcomes in vascular patients requiring amputation” she said.
Such a standardized peri-operative protocol does not currently exist for dysvascular patients, who account for more than 80 percent of all major lower extremity amputations in the United States. This specific patient population is older, with increased medical co-morbidities and therefore predisposed to deconditioning faster than the younger traumatic and oncologic amputee population, said Dr. O’Banion.
She will continue enrollment to the planned-for 20+ patients, when research restrictions ease, anticipating continued success. She feels the project has momentum now that early results are in, and that the elements for success are already in place.
“This is a protocol that utilizes resources available to most hospital systems nationwide,” she said. “It is our goal that the protocol can be duplicated and adopted across the country. There’s a real potential to impact our vascular patients’ lives all over the country.”