A Comprehensive Approach to Critical Limb Ischemia: An Interview With Carlos Mena, MD

Carlos Mena, MD, is an interventional cardiologist and assistant professor of medicine at Yale School of Medicine and Yale New Haven Hospital, a tertiary referral center in Connecticut that is the 4th largest hospital system in the United States. The peripheral vascular program at Yale New Haven Hospital is a large endovascular program with a clinical component that performs 1,200 intravascular interventions per year, an educational component with a large endovascular fellowship, and a research component that is currently involved in more than 20 clinical trials investigating new devices and approaches for peripheral vascular disease. 

At the 15th annual New Cardiovascular Horizons meeting in New Orleans, Dr. Mena presented information on below-the-knee endovascular solutions as well as laser therapy for in-stent restenosis. Vascular Disease Management spoke with Dr. Mena about his presentations.

Carlos Mena, MD, is Assistant Professor of Medicine (Cardiology) and Medical Director of Vascular Medicine at Yale New Haven Hospital. He reports no disclosures related to the content herein. 

 Q: Could you give a short summary of the presentation that you gave on below-the-knee solutions?

A:New Cardiovascular Horizons has become one of the major venues to discuss all these topics pertaining to peripheral vascular disease. I was able to talk about below-the-knee interventions. I am quite involved in critical limb ischemia (CLI) initiatives both here in the United States and overseas and I was able to discuss the current approaches, including both antegrade and retrograde access. I discussed a more comprehensive approach to critical limb ischemia in terms of different modalities of therapy including below-the-knee and atherectomy. More importantly, a multidisciplinary approach has led to a significant reduction in the number of amputations in our institution.

Q: Could you tell us more about solutions below-the-knee? Is there anything new that’s particularly exciting to you? 

A:The major issue that we struggle with is restenosis and patency. That obviously affects our ability to preserve limbs. Currently the most exciting thing happening is drug-coated balloons. There are several companies in the race to be first for marketing in the United States. There are several ongoing clinical trials and the most relevant right now is the Lutonix BTK clinical trial, which is sponsored by Bard Peripheral Vascular. The trial is a randomized controlled clinical trial where we’re treating patients with CLI and randomizing patients in a 2:1 fashion between drug-coated balloon and plain balloon angioplasty. There have been other trials completed recently including one by Medtronic that raised some concerns because the safety endpoint was not met. But we’re very excited about the Lutonix trial and what it is going to tell us about this therapy. 

In addition to that, we are hopeful about the idea of bioresorbable scaffolds; there is still a ways to go in terms of clinical trials here in the United States, but it’s another potential therapy for these patients. 

Q: And you also presented on lasers for in-stent re-stenosis. Could you explain a little more about that? 

A:Restenosis is one of the major problems for endovascular therapy, specifically for the superficial femoral artery. Currently most of the patients, at least here in the United States because we don’t have drug-coated technology, will be stented given the fact that a plain balloon angioplasty has a high incidence of restenosis. So because of this we see many of these patients come back due to significant neointimal hyperplasia. To avoid this we are looking for alternatives in terms of therapy to treat these patients. There is not an FDA approved device currently for this type of therapy. There are several of them looking for that indication—the laser by Spectranetics is one and the Viabahn by Gore is another. There is a drug-coated balloon trial that recently started looking for the same indication and I was able to discuss the pathophysiology of in-stent restenosis as well as the potential role of laser in that therapy. A clinical trial called EXCITE for which Dr. Eric Dippel is the national primary investigator recently finished and I think that he’s going to be able to present all those results soon and shed some light on what the real role of laser will be for those patients.