November 22, 2024
A novel “on-the-table” (OTT) therapeutic strategy with a total procedure time of less than one hour can safely reduce the size of blood clots lodged in the pulmonary arteries and eliminate the need for post-procedural drug infusion in an intensive care unit (ICU), according to new research at the Lewis Katz School of Medicine at Temple University. Researchers from the Katz School of Medicine described the strategy and its safety and effectiveness in the Innovations in Endovascular Therapies session at the 2024 Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C. The OTT protocol was carried out using the BASHIR™ Endovascular Catheter, a cutting-edge technology developed by the Temple team in collaboration with Thrombolex, Inc.
Researchers at the Katz School of Medicine investigated the OTT protocol as part of the RESCUE-II Trial, a Commonwealth of Pennsylvania Department of Health-sponsored clinical study that evaluated the safety and effectiveness of the BASHIR™ device for pharmaco-mechanical catheter-directed pulse spray administration of a clot-dissolving drug known as recombinant tissue plasminogen activator (r-tPA). The trial enrolled nine patients with acute intermediate high-risk pulmonary embolism. Primary endpoints for the study included a reduction in the ratio of right ventricular to left ventricular diameter and a reduction in pulmonary artery obstruction.
“We successfully demonstrate that our OTT treatment protocol is a safe and feasible treatment for pulmonary embolism,” said Riyaz Bashir, MD, FACC, Professor of Medicine at the Katz School of Medicine, Director of Vascular and Endovascular Medicine at Temple University Hospital, and co-inventor of the BASHIR™ Endovascular Catheter. THROMBOLEX™ Inc., a co-inventor of the BASHIRTM Endovascular Catheter platform technology, has partnered with Temple in developing and commercializing the device. “Using our new protocol, treatment is completed in under an hour, versus five hours for procedures requiring ICU infusion.”
Data assessment performed by the independent core laboratory NAMSA shows that the OTT strategy reduced the right ventricular to left ventricular diameter ratio by 24 percent within 48 hours of treatment. In addition, a 29 percent reduction in pulmonary artery obstruction was observed, as measured by the refined Modified Miller Index, and segmental pulmonary artery occlusions decreased by 55 percent. Device placement and treatment time were 17 minutes, and the total procedure time was 39 minutes.
The OTT approach used in the RESCUE-II trial has key advantages as a treatment strategy for acute pulmonary embolism. Notably, catheter-directed pulse spray with r-tPA effectively breaks up blockages by facilitating the dispersion of drug throughout the clot, reducing treatment duration and requiring relatively small doses of the drug, helping to minimize risks of bleeding. These effects significantly shorten procedure time and decrease resource utilization, promising to alleviate burdens associated with care for acute pulmonary embolism within diverse healthcare settings. The OTT treatment protocol is also very easy and safe, allowing rapid expansion into resource-limited settings worldwide.
“The trial represents a potentially major advance in treating acute pulmonary embolism,” said Parth Rali, MD, Associate Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine, Director of the Pulmonary Embolism Response Team (PERT) Program at Temple University Hospital and the principal investigator on the RESCUE II trial. “This unique OTT treatment protocol is safe and effective, maximizing clot lysis with small doses of a thrombolytic while helping healthcare systems manage their limited resources.”
"This breakthrough 'on-the-table' treatment protocol has the potential to redefine care for patients with pulmonary embolism," said Amy J. Goldberg, MD FASC, The Marjorie Joy Katz Dean of the Lewis Katz School of Medicine. "I’m incredibly proud of our team’s innovative work in advancing therapies that are not only effective but also accessible, paving the way for better care here, in North Philadelphia and around the world."
The OTT procedure is being rolled out to additional institutions as part of a national multicenter trial involving 500 patients.
The BASHIR™ catheter was approved by the U.S. Food and Drug Administration (FDA) for the treatment of blood clots in pulmonary arteries and in the peripheral vasculature. THROMBOLEXTM now has FDA clearance on eight devices in the BASHIRTM family of catheters, all of which are currently on the market in the United States.
Editor's Note: Dr. Bashir is a co-founder and has an equity interest in Thrombolex, Inc., a medical device company developing interventional catheter-based therapies for the rapid and effective treatment of acute venous thromboembolic disorders. Since 2022 Dr. Parth Rali has had an ongoing consulting relationship with Thrombolex. Temple University also holds financial interests in the BASHIR™ Endovascular Catheter and other Thrombolex products pursuant to the license granted to Thrombolex for the University's interest in patents co-invented by Dr. Riyaz Bashir. As a result of these interests, Temple University could ultimately potentially benefit financially from the outcome of this research. These interests have been reviewed and approved by Temple University in accordance with its Institutional Conflict of Interest policy. Questions about this can be directed to [click-for-email]. Questions regarding individual Lewis Katz School of Medicine researcher interests may be directed to [click-for-email].