The progress of two “promising” new devices in the venous valve replacement space were outlined during a special session at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online) co-hosted by the American Venous Forum (AVF).
Ellen Dillavou, associate professor of vascular surgery at Duke University Medical Center in Durham, USA, placed a lens over the BlueLeaf system (InterVene) and the VenoValve (Hancock Jaff Laboratories) in “Bringing what’s new in venous to you!”
“The history of venous valve replacement is long and usually not successful,” Dillavou told attendees. Both autogenous and non-autogenous valves have been tried for years to replace those that have been damaged or congenitally absent in the leg, she continued, but “on the horizon we now have two very promising new products.”
The BlueLeaf system, Dillavou explained, is an endovascular means to create a mono- or bicuspid valve. The system “takes the thickened intima of a post-thrombotic vein that is damaged and, with a dissector, gets a wire through that thickened vein wall, and then uses hydrodissection, balloon dissection and a mechanical dissector to form a pocket,” she said, adding: “Intravascular ultrasound (IVUS) is critical during the procedure—both in choosing the vein site as well as looking at the final result.”
Early results, which are in publication, indicate a 93% technical success rate “of creating at least a monocuspid valve,” with the researchers testing the system producing a mean of 1.3 valves per patient. The investigators reported having 10 patients at one-year follow-up, with no thrombotic events recorded, Dillavou noted. “Although they didn’t have a difference in the popliteal reflux time, they did have a decrease in the Venous Clinical Severity Score (VCSS).” Additionally, nine out of nine venous ulcers either healed or improved at the last follow-up, she added.
Turning to the VenoValve—a moncusp biologic component valve mounted on a stainless steel structure, created from a porcine aortic valve—she described the device’s progress since its first-in-man placement by Jorge Ulloa (Universidad de los Andes, Bogota, Colombia) and the publication of early results in 2020.
A total of 11 patients with C5–C6 disease were studied, with Ulloa and colleagues reporting 100% technical success. One-year follow-up found that 6 out of 10 patients required patch venoplasty and five had adverse events. “At one year, the average reflux decreased by 54% across their patient population, their VCSS score decreased by an average of 56%, and the pain score had an average reduction of 76%,” said Dillavou.
Ulloa presented promising two-year results the next day at SVS VAM 2021.
The VenoValve team, now starting a pivotal trial in the USA, is aiming to enrol about 100 patients, with 18 of 20 sites confirmed. Patients will be followed for one year, with five years of postmarket follow-up planned, she added.
“The future is very bright for venous valve replacement,” Dillavou concluded. “For the first time, we have two promising options for advanced venous stasis; human trials are in progress; and hopefully the next frontier will be honing patient selection and looking at long-term maintenance of these devices.”