A key investigator in efforts to tackle chronic venous insufficiency (CVI) with an bioprosthetic venous valve replacement talks about progress being made with surgical and endovascular versions of the device—and surgical community skepticism.
Jorge Ulloa, MD, has not long since produced the latest data from a first-in-human (FIH) trial for emerging stainless-steel frame-based surgical implant, the VenoValve device, intended to treat patients with C5–C6 disease on the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification scale.
He is talking on the sidelines of the 2023 annual meeting of the American Venous Forum (AVF) in San Antonio, Texas (Feb. 22–25), where he has just presented the latest update on what the 36-month data from the FIH is showing.
Those results, he says, for the investigational device continue to be promising, but the U.S. pivotal trial, the SAVVE study, or Surgical anti-reflux venous valve endoprosthesis, is also approaching a crucial tipping point, he tells Vascular Specialist. “We’re getting into 40-plus patients, more than half of what is required by the Food and Drug Administration [FDA],” he explains. “We’re at 24 sites. The goal is to end up with 75 cases. That data needs to be analyzed in order to know that the experience we had with the small number [of FIH patients] we got in Colombia, which was 13 at the beginning and now eight under the last cut of the follow-up, is replicated. That is the position we are in right now.”
Attention is turning, too, to the early stages of a catheter-delivered version of the valve, Ulloa says. The Fundacion Santa Fe-Universidad de los Andes, Bogota, Colombia, vascular surgeon has, of course, been at the vanguard of the early research efforts around the surgical valve replacement. He will play a similar role as the FIH trial of the endovascularly delivered bioprosthetic gets underway, also in Colombia.
“This endovascular approach, which is a miniaturization of the valve—the same one that we placed and have been placing in Colombia and the U.S.—in order to accommodate it in a catheter and allow it to be placed, involves a different process in that it goes under nitinol, the material of stents. It will go into a catheter and then be delivered via the popliteal vein, and then deployed at the femoral vein level, in the very same way that we are doing so far with the open and surgical approach.
“The advantages of this are that, of course, delivery is an endovascular process— the morbidity of the surgical approach goes almost toward zero—we don’t make incisions, we don’t do dissections, we don’t have to deal much with bleeding.”
If all goes to plan, the TAVVE (Transcatheter anti-reflux, venous valve endoprosthesis) FIH trial will commence within a couple months, potentially with up to 20, Ulloa adds.
Yet, he is aware of skepticism over results recorded thus far among some within the vascular surgical community. “There have been a series of attempts for the last 60 years or so, with the first report of a prosthetic valve going back to the 1960s,” he says. “The first implantation in the human body was sometime around the late 1980s, early 1990s. The number of cases was very low, and the follow-up was very short and not very promising. Therefore, I understand, we all understand, that there is going to be a whole field of skeptical surgeons.”
Rather, Ulloa argues the medical landscape is more conducive to success now. “Materials are way better than they were 20, 30, 40 years ago,” he continues. “The surgical approaches are better now. We understand physiology way better. We can assess the behavior of a valve right after and during the surgery, and right after the surgery we can check it and can see it; we can measure it, we can get a lot of physiological data out of each and every one of the patients or cases. Also, the numbers we got are a little higher than the historical average, and the follow-up we got [in the FIH VenoValve trial] is the longest we’ve got in history—the longest we had before was six months.”
The valve, Ulloa says, is not going to be perfect, nor cure the underlying problem—“but it will manage the problem, and will improve the quality of life, and the data is supporting all those ideas.” He points to decreased reflux, reduced pain and healed ulcers. “Of course, we have to continue the follow-up to see what is going to happen, and continue to add numbers.”
There might be no more skeptical a group than those investigating the device themselves, Ulloa says. “We want to know that this really working, we want to see how it is working, we want to assess each and every measurement that we can, and that’s what we have been doing so far with it. Yes, probably we are approaching the end of the road, and we are getting into the field of a lifelong problem that has been facing vascular surgeons—really difficult to manage—which is the post-phlebitic syndrome. For the first time, it has real possibility of treatment that will, at least for three years, see a dramatic improvement in symptoms and dramatic increase in quality of life.”