“Every so often in vascular disease, disruptive technologies come along and the question really is, ‘Is this going to make a big impact on patient care?’” These were the words of CX Executive Board member Robert Hinchliffe, MBChB, clinical professor of vascular surgery at the University of Bristol, England, setting the scene for a series of presentations, discussion, and polling on deep venous arterialization (DVA) at the 2024 Charing Cross (CX) International Symposium in London, England (April 23–25).
Polling both before and after seven podium presentations—including podium firsts from the CLariTI study and PROMISE UK trial, as well as “a word of caution” from CX Executive Board member Thomas Zeller, MD, from Bad Krozingen, Germany—saw the audience vote split on the current evidence base for DVA.
Around half of the audience, down only three percentage points from 51% to 48% before and after the presentations and subsequent discussion, voted that the current evidence suggests DVA should be considered in “no-option” chronic limb-threatening ischemia (CLTI) patients. The remaining half voted that DVA either has insufficient evidence to suggest a role in clinical practice (up from 22% to 25%); should be considered in expanded indications besides no-option patients (up from 14% to 16%); or should be considered in expanded indications besides no-option patients (down from 14% to 11%).
Daniel Clair, MD, from Nashville, Tennessee, introduced the topic of transcatheter arterialization of the deep veins (TADV) with an overview presentation outlining highlights of the PROMISE trials, before Anahita Dua, MD, from Boston, shared new data from the CLariTI study.
Dua, who is the national principal investigator of the CLariTI study, noted that this prospective, single-arm, observational registry was designed to track the clinical progression of CLTI and the incidence of death, amputation, and revascularization attempts over a one-year period. She outlined that 180 per-protocol patients were enrolled at 22 sites across the U.S. The primary endpoint was amputation-free survival at 12 months.
“CLariTI provides an exciting dataset of real-world outcomes,” Dua shared in her conclusion. The presenter revealed that two-thirds of no-option patients received a major amputation or died at 12 months, stressing that there is an “imminent need for new therapies in this understudied population.”
Hany Zayed, MD, from London, then revealed final results from the multicenter PROMISE UK trial. He reported that TADV using the LimFlow system in no-option CLTI patients resulted in a 67% amputation-free survival rate, an 81% limb-salvage rate, and a 100% rate of fully healed or healing wounds at 12 months. This led him to conclude that TADV with the LimFlow system “is safe and effective with 96% technical success in no-option CLTI patients.”
Following these first-time data presentations, Bruno Migliara, MD, from Peschiera del Garda, Italy, Steven Kum, from Singapore, and Uei Pua, MD, also from Singapore, took to the podium to present on the PiPeR DVA technique, new considerations in DVA, and post-DVA management, respectively.
Closing the session, Zeller played “Devil’s advocate” by offering “a word of caution” on DVA. He argued that a primary below-the-knee amputation with appropriate prosthetic supply is a better alternative for many patients. “Amputation is not the end of the story,” he said. “The key question is what gets our patients into daily life with full ambulation sooner, with full quality of life, and I’m of course aiming to preserve the patient’s limb as much as I can, but I have enough patients in my daily practice telling me: ‘Well if I would have known the long history of recurrent revascularization attempts, I would have voted for primary amputation.’”
