Physicians from around the US, and a few distinguished international guests, are gathered at the Vascular Interventional Advances (VIVA) conference in Las Vegas this week to discuss the state of peripheral vascular disease treatment in the United States. The conference gets into full swing today, but on Monday a smaller group of physicians gathered for a full day session to discuss the treatment of chronic limb ischemia (CLI).
In casual conversation, a few distinguished physicians called this ?the last frontier? of endovascular treatment. What are the specific challenges of CLI lesions?
They?re long. Classic treatments like plain old balloon angioplasty (POBA) work well only for short lesions. Still, POBA is still the most popular primary treatment.
They?re calcified. This makes it hard to cross the lesion with endovascular devices, and creates a barrier for drug absorption.
They?re unstudied. Many clinical trials exclude the difficult CLI patients from the cohort being studied. Consequently, physicians have very little randomized trial data for medical devices in CLI patients, which makes it difficult for them to make informed treatment decisions.
Useful devices are unavailable in the US. Drug coated balloons (DCBs) work well in long lesions, but US physicians won?t be seeing these devices any time soon, and can only listen with envy to stories from Europe.
The need for a new norm
There are certainly more advanced devices that the participants thought can and should be used in preference to POBA.
What are these devices? Atherectomy devices were cited the most often. These have the dual benefit of cutting the plaque (not needing to be passed through it) and not relying on drug-eluting technology that may be impeded by the hard plaque.
Drug-eluting stents received quite a good reception in the room, despite the fact that they are off label below the knee. The data available looks good, but it was also noted that most of these studies were done in short lesions.
With all these options, and even more techniques with existing devices, one presenting physician believes it possible to declare the end of the ?no option? patient.
Beyond Device Invention
But physicians can?t just wait for the creation of new devices. They have patients to treat now. How do already available devices perform in CLI lesions? As mentioned, clinical information is simply lacking.
The last recurring theme revolved around interdisciplinary treatment approaches. Complex disease requires complex care, and several presenters showed lists of 15 or more physician specialties that can or should be involved in the care of these patients. If that's unrealistic, then at least these specialties should jointly be developing a treatment algorithm for these patients. This requires not only time and resources, but a bit of a culture change as well.
No one said it would be easy.