February 06, 2017
2 min read

Aggressive treatment to prevent amputation important for CLI

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HOLLYWOOD, Fla. — The strong association between amputation and mortality in patients with critical limb ischemia means that patients must be treated aggressively to prevent amputation, according to a presenter at the International Symposium on Endovascular Therapy.

CLI affects 1 million Medicare-eligible patients per year at an estimated annual cost of $3 billion, and 25% of patients receive amputation as a first-line treatment, said Jihad A. Mustapha, MD, FACC, FSCAI, director of cardiovascular research at Metro Health University of Michigan Health in Wyoming, Michigan.

One year after diagnosis, 25% of patients with CLI die and 30% are alive but have undergone amputation, Mustapha said.

Jihad A. Mustapha

He noted that the estimated number of amputations in the United States per year is 120,000 and the estimated direct lifetime health care costs of a patient who has undergone amputation are $794,027, for a lifetime expected cost for all patients with amputation estimated at $95.2 billion.

Prognosis after amputation is often poor, according to Mustapha. At 1 year, 27% of those who had a lower-extremity amputation for a vascular cause will have had at least one more amputation and 40% (62% among those with diabetes) will progress to a higher level of limb loss. In addition, he said, 55% of those with peripheral artery disease who have had one limb amputated will have the other amputated within 2 or 3 years.

“Why is there so much focus on amputation? Because we have learned from the data that we have seen so far that amputation is associated with mortality,” Mustapha said. Mortality rates for patients with CLI have been estimated at 4.2% to 10.4% perioperative, 9.1% to 33% at 1 year and 25.6% to 81.5% at 5 years, with the strongest link being for patients with both diabetes and PAD, he said.

“We don’t think of CLI as a killer, but when compared to other malignancies we hear about” the mortality rates are comparable, he said, noting that the 5-year survival rate is between that for lung/bronchus cancer and that for pancreatic cancer. “The mortality rate associated with it is extremely real, and something has to be done.”


Although intensity of vascular care provided to patients with amputation risk varies, the regions with the most intensive vascular care have the lowest amputation rates, Mustapha said.

An important component of intensive vascular care is using endovascular treatment to achieve and maintain arterial flow to the foot to relieve ischemic pain and enable healing of wounds and minor amputations, he said.

According to Mustapha, an ongoing debate is what to do for patients with rest pain but not tissue loss. “If you don’t do anything for patients with rest pain, I believe they can quickly become a tissue-loss patient, and patients with tissue loss have worse outcomes than patients with rest pain,” he said.

Also crucial is that comorbidities associated with CLI must be treated aggressively before, during and after revascularization. “The mortality rate can be elevated if we don’t address them properly,” he said. “In patients with significant comorbidities, we tend to be very aggressive, knowing that the comorbidities are going to add to the amputation risk, which leads to mortality risk.”

He cited one case in which a patient without serious tissue loss was not treated aggressively, their disease state worsened and the patient died, and another in which a patient with serious tissue loss was treated aggressively, wound healing occurred and the patient survived. – by Erik Swain


Mustapha JA. Townhall: Managing the epic of critical limb ischemia. Presented at: International Symposium on Endovascular Therapy; Feb. 4-8, 2017; Hollywood, Fla.

Disclosure: Mustapha reports consulting for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cardiovascular Systems Inc., Cook Medical, Medtronic, Spectranetics and Terumo.