January 27, 2020
2 min read

Long-term mortality after CLI diagnosis high, urgent action needed

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Barry T. Katzen

The 4-year mortality rate after a diagnosis of critical limb ischemia is more than 50%, comparable to the deadliest cancers, which demands a nationally coordinated action plan, a speaker said at the International Symposium on Endovascular Therapy.

“Only with a coordinated and comprehensive national plan to address all aspects of CLI, including diagnosis, treatment and education of patients and health care providers, can the ever-growing impact of this deadly disease be controlled,” Barry T. Katzen, MD, founder and chief medical executive of the Miami Cardiac & Vascular Institute and clinical professor of radiology and surgery at the Herbert Wertheim College of Medicine, Florida International University, said during a presentation.

Katzen spoke on behalf of the CLI Global Society board of directors, of which he is president.

In a cohort study of more than 72,000 patients with CLI conducted by the society and published in the Journal of the American Heart Association, the rate of survival at 4 years was 46% and “only 42% were alive and free from major amputation,” Katzen said.

In the paper, the authors concluded that more efforts were needed to raise disease awareness, improve coding to better define and identify CLI, refine diagnostic algorithms, implement evidence-based treatments and address the high mortality rates, he said.

“CLI is an underdiagnosed and undertreated deadly disease that requires proper diagnostic imaging and increased awareness,” he said.

Current estimates suggest that 11% of U.S. patients with peripheral artery disease have CLI, but that is likely an underestimate because many patients with CLI do not have the appropriate CLI diagnosis code, Katzen said, noting the U.S. prevalence of PAD is estimated at 9 million to 20 million individuals.

“Because CLI is both common and deadly, more incident cases die over 5 years after a CLI diagnosis than with any type of cancer except for lung cancer,” he said, noting that CLI is responsible for 58,000 U.S. deaths during a 5-year period. “Overall, the high incidence of CLI in combination with its highly fatal course make the disease an underrecognized major threat to public health.”

While optimal medical therapy, including control of diabetes, hypertension and lipid parameters, has been shown to benefit patients with CLI, less than one-third of the CLI population receives it, Katzen said.

Also problematic is that too many patients with CLI have amputation as their initial treatment, even if revascularization is appropriate, he said.


“Compared to vascularization, amputation doubles the risk of death over the next year, even after controlling for important confounders,” Katzen said. “Furthermore, in patients with gangrene in whom many health care providers may believe amputation is the only viable first-line therapy, endovascular and surgical revascularization double patient survival compared to amputation.”

Thus, he said, every patient with suspected CLI should undergo diagnostic imaging, and major amputation should only occur if revascularization fails or is deemed futile.

The Recalcitrant Cancer Research Act of 2012 allowed government researchers to “develop a comprehensive plan of action” to lower mortality rates of the deadliest cancers, but there is no similar legislation for CLI, even though it is deadlier than all cancers except lung cancer, Katzen said.

Therefore, he said, the CLI Global Society “advocates for the formation of alliances composed of multidisciplinary health care providers who will petition lawmakers in a focused, concerted effort to designate CLI as a national public health priority in the same way as the deadliest cancers.” – by Erik Swain


Katzen BT. Session 2: Improving Outcomes and Prognosis for Critical Limb Ischemia. Presented at: the International Symposium on Endovascular Therapy (ISET); Jan. 22-25, 2020; Hollywood, Fla.

Disclosures: The CLI Global Society is supported by Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cardiovascular Systems Inc., Medtronic and Philips. Katzen reports he serves on advisory boards for Boston Scientific, EndoWays, Graftworx, Hemodynamix, Nephronyx, Philips and W.L. Gore and Associates.