ISET and the Exciting Developments in CLI Therapy

The International Symposium on Endovascular Therapy (ISET) 2016 will be held February 6-10, 2016, at The Diplomat Hotel, Hollywood, Florida.

It is not often we get the honor to dive into the knowledge of someone who has shaped the therapeutic options that are available today for patients with CLI. Dr. Katzen began CLI therapy simply from using dilators to dilate occluded tibial vessels all the way to low profile balloons. This should teach us something important.  Perseverance, optimism, and remaining relentless are paramount to achieving our goal. That goal is to one day conquer the epidemic of CLI by getting to a point where we can address it with a broad spectrum including public awareness, successful technical procedures, exceptional post-procedural medical therapy, consistent wound care follow-up, and podiatric surveillance. Interestingly, as you will read, Dr. Katzen started this approach decades ago and circles back today with the message that the only way to succeed is to continue forward from the work that he started.  He is an open-minded visionary and exceptional leader in the field of CLI.

J.A. Mustapha, MD: Are you optimistic about the current trend in therapy for critical limb ischemia (CLI)?

Barry Katzen, MD: Yes, I am. It is a very exciting time for treatment of critical limb ischemia, for two reasons. One, we are making some progress with increased public awareness. Two, we are developing and using new technologies to treat disease that only five years ago would not have been treated. 

Dr. Mustapha: If your hands could talk, what would they say about the tools you used for CLI 20 years ago vs today?

Dr. Katzen: I can actually go back longer than that! For a long time, we were treating tibial disease using some of the earlier technologies that actually preceded balloons. In the initial days, when we would try and save patients’ legs, we would use very small coaxial catheters. We would put in an .035-inch wire and a progressive dilatation catheter — just a Teflon catheter, no balloon. We were effective probably about 50% to 60% of the time. Early angioplasty balloons then came along and of course, were bigger sizes than they are today. We had not adopted coronary technology to the tibials. Early balloon technology probably improved the success rate to maybe 60% to 65%. Once low-profile balloons became available, some landmark articles published 80% to 85% limb salvage rate at one year. We made a lot of progress over those early decades, leading into the late 1990s. The past decade, however, has really brought a number of technologies to address those patients where we still had limitations: those with the presence of calcification, long-segment disease, and the ability to create channels in very long segments of disease. We continue to make great strides moving forward.

Dr. Mustapha: Is CLI one of those subspecialties that require repetitive experience to maintain a high level of competency and good outcomes? Or can we get by doing only a few scattered procedures with the same good outcomes?

Dr. Katzen: The endovascular treatment of CLI should be performed by specialists who have clinical experience with it and with these technologies, and more importantly, experience managing the long-term issues of critical limb ischemia. There is a lot of attention being focused on CLI because of the procedure itself, but these patients really require a lot more care. CLI requires wound care, long-term care, and decisions to be made on when a patient does and does not need to be treated. I think people shouldn’t be dabbling, let’s say, in critical limb ischemia. Patients should go to specialists who have an interest, but I am not sure it has the depth to truly merit what we would call a “subspecialty”, based on current organized medicine structure. I think there is room for an organization with a focused emphasis on critical limb ischemia, because it allows physicians of different interests and disciplines to lead and focus on a specific problem. I definitely would support that concept and any initiative surrounding it.

Dr. Mustapha: Could you describe how CLI patients are treated at Miami Cardiac & Vascular Institute?

Dr. Katzen: Critical limb ischemia is a disease, not an anatomic entity. It describes a specific patient with a specific type of problem. We basically employ a teamwork approach. Each patient is seen by an interventionalist and a vascular surgeon. The patient may have already been seen by a wound care specialist. If not, and if wounds are a problem — and wounds represent a significant percentage of the problems with critical limb ischemia — we get wound care specialists engaged from the start. This team is generally involved with clinical decision-making in terms of when and which type of interventions are done, when endovascular therapy is better than surgery or vice versa, and when some combined solutions might be necessary. So we have the entire smorgasbord of options available to the patient from the beginning. One of the things we find very important is identifying the physiologic endpoint of treatment; in other words, defining what the goal is. Of course, in the end, it is amputation prevention. We understand that. For any specific patient, we use some physiologic measures, either use pulsatile recordings or digital PPGs, that we combine with our anatomic description to try and define what a good endpoint would be. If endovascular therapy is selected, we of course go through the process of deciding what procedure, what approach, and what technology, and tailor a unique solution for each patient.

Dr. Mustapha: What do you think about drug-coated balloons (DCB) and their use for CLI treatment?

Dr. Katzen: Drug-coated balloons, specifically as related to CLI, not intervention in general, require a more significant amount of study. We are very optimistic about what DCBs can offer. We are a little concerned about the effects of anti-proliferative agents being used in patients who have ulcers and whether those agents affect wound healing. We actually don’t think it is a significant risk, but others have raised that concern and I think it requires further study. Patients with CLI can have lesions anywhere. DCB are very important in helping us treat superficial femoral artery (SFA) disease, regardless of the presence of CLI, to try to get more durable results. One of the real controversies in CLI is defining the importance of patency. In general, when we treat patients, we want the longest patency possible. If DCBs or other drug-coated technologies can get that, it is very desirable. I think there is great opportunity for scientific work to identify the most effective use of drug-coated balloons, and to be honest, to identify the most cost-effective way to treat CLI patients. In the changing healthcare environment in the United States, there is a great deal of pressure to understand the costs of care and understand which patients will involve repeat care. There can be some cost reductions from using technology that might be more expensive on the front end, but ultimately reduce overall cost if we can prevent secondary interventions, i.e., restenosis. There is a great potential for benefit, but we have to do the studies to prove it.

Dr. Mustapha: In the past, live cases at the International Symposium for Endovascular Therapy (ISET) have shown a thoracic stent being sutured onto a stent graft and over the years, has demonstrated the evolution of technology. What new highlights does ISET have this year, as it continues to be a premier meeting for new and upcoming technologies?

Dr. Katzen: We are very excited about ISET, as the first big vascular meeting of the year, and we always identify topics that are going to be changing your practice or perspective in the next year. This year, the Town Hall meeting is focusing on reducing the occupational hazards to the interventional therapist. Occupational hazards to those of us who do these procedures can come from a number of different areas. Hazards can come from both short and long-term radiation exposure, and we think there is a lot of opportunity and work going on in that space. Occupational hazards can also come from orthopedic problems and the non-ergonomic environments in which we work, including the positions we put our head and back in, how we look at images, procedure times, and so on. The Town Hall meeting will be of interest to anyone who does endovascular therapy. Of course, we are going to be focusing on CLI this year, putting the latest data out there and exposing our registrants to techniques they can go home with and apply in their own practices.