Expert: Physicians have ‘long way to go’ in CLI management

HOLLYWOOD, Fla. — The epidemic of critical limb ischemia has serious implications, but clearer definitions of the disease, more data on the effectiveness of treatments and a push for revascularization before amputation are needed, according to a speaker at the International Symposium on Endovascular Therapy.

“Our knee-jerk reaction must be, on behalf of our patients, an urgent sense of revascularization, either surgical or catheter-based. Optimal adjuvant medical therapy is also critical, not only for optimizing outcomes but also for prolonging life,” Michael R. Jaff, DO, FACC, FSCAI, president of Newton-Wellesley Hospital, Newton, Massachusetts, professor of medicine at Harvard Medical School and a Cardiology Today’s Intervention Editorial Board member, said during a presentation.

In practice, Jaff said, he is quick to treat because of CLI’s “devastating” prognosis. At 1 year after diagnosis, at least one-quarter of patients will have died and one-third will be alive but will have had a major amputation. For patients with chronic CLI, the 3-year limb loss rate is approximately 40%. Moreover, quality-of-life indices for patients with CLI are similar to those for patients with terminal cancer.

Michael R. Jaff

Because of the poor prognosis, when seeing a patient, physicians should try to figure out what the best revascularization strategy is, not whether revascularization should be performed, according to Jaff. However, he said, this is not necessarily the case in the United States. For example, he noted that in a Medicare review of more than 20,000 patients who had undergone a major lower-extremity amputation, more than half underwent amputation without an attempt at revascularization during the previous year.

“It’s incredible to note that even in the segments of the country in which they are very intensely aligned in looking for revascularization, only 58% of patients who underwent an amputation had an attempted revascularization in the year prior,” Jaff said.

Patients with CLI present a significant challenge for a number of reasons, including conflicting definitions and objective measures of the disease, he said. In an analysis of the IN.PACT Deep trial that enrolled 358 patients, 237 had isolated infrapopliteal disease with an ankle-brachial index that could be evaluated. Forty patients also had a toe-brachial index. Although patients were enrolled in the trial to be treated for below-knee CLI, only 24 of 40 patients met societal guidelines for toe pressures and, of those, only 14 had abnormal ankle-brachial index.

“The fact is that it makes it harder for us to speak the same language when we can’t even agree on what the objective definitions are,” he said.

Jaff also reviewed the most recent guidelines from the American College of Cardiology/American Heart Association on peripheral artery disease interventions. In 2017, he noted, the effectiveness of various interventions, including uncoated balloons, atherectomy, cutting balloons, lasers and more, is not well-established. Currently, for infrapopliteal lesions, uncoated balloon angioplasty is the preferred technique.

“We still have a long way to go,” he said.

Additionally, despite the introduction of new technologies, CLI remains a problem, according to Jaff. One study showed that, during 8 years, there was no change in CLI admission rates despite optimal medical therapy and the introduction of newer technologies. Further, although results showed a slight decrease in amputation rates and an increase in rates of endovascular intervention, mortality rates continued to be high.

Consequently, Jaff and colleagues published an expert consensus state-of-the-art review in the Journal of the American College of Cardiology that included an algorithm highlighting the need to aggressively consider revascularization options for patients with CLI. In the review, recommendations are made for endovascular revascularization as well as surgical revascularization. – by Melissa Foster

Reference:

Jaff MR. Opening Session: Town hall: Managing the epidemic of critical limb ischemia. Presented at: International Symposium on Endovascular Therapy; Feb. 4-8, 2017; Hollywood, Fla.

Shishehbor MH, et al. J Am Coll Cardiol. 2016;doi:10.1016/j.jacc.2016.04.071.

Disclosure: Jaff reports financial ties with Abbott Vascular, American Orthotics/Prosthetics Association, Boston Scientific, Cordis, Embolitech, Janacare Inc., MC10, Medtronic, Micell, Northwind Medical Inc., Novella, PQ Bypass Inc., Primacea, Sano V Inc. Valiant, Vascular Therapies Inc. and Volcano.