Critical Limb-Threatening Ischemia (CLTI)

Peripheral artery disease involves the build-up of plaque in the arteries of the trunk, arms, or legs.

This plaque can eventually slow the flow of blood and thus oxygen to the affected part, and is often complicated by diabetes or heart failure, which can contribute to the reduced flow of blood to the feet and legs.

CLTI can have a serious impact on a patient’s quality of life, leading to chronic pain, wounds that don’t heal, sepsis, and gangrene.

Unfortunately this often leads to amputation, despite the fact that earlier intervention and less invasive treatment options—such as an atherectomy to clear the blockages—can help patients improve limb function, reduce pain, and avoid amputation.

• severe pain in the toes, feet, or legs—even when resting
• shiny, smooth skin on the feet or legs
• thickening toenails
• open sores, skin infections, or ulcers that do not heal
• gangrene, usually in the toes
• diminished pulse in the feet or legs

• Tests to check the pulse and blood flow in the affected limbs – including an Ankle-Brachial Index (ABI), which compares blood pressure in the arms with that in the legs to see how well blood is flowing; a TBI or Toe Brachial Index measures the blood pressure in the toes
• Imaging – such as magnetic resonance imaging (MRI) and computed tomography (CT scan) to look for blockages in the arteries of the legs and feet
• Blood tests – to check for diabetes and high cholesterol

Every 2 minutes a leg is amputated in the U.S. and Europe.

Blockages in the arteries appears to stem from damage to the walls of the arteries in the heart, which may be due to a combination of:

• High blood pressure
• High LDL (“bad”) cholesterol
• Low HDL (“good”) cholesterol
• Smoking
• Diabetes or insulin resistance
• Obesity
• Sedentary lifestyle
• Inflammation

CLTI usually develops gradually over time in patients with a combination of conditions, especially diabetes and heart failure, that reduce blood flow to the feet and legs.

35-45% of patients go straight to amputation without CLTI diagnosis

• Medication – to reduce blood cholesterol or high blood pressure, prevent blood clots, or treat pain.
• Angioplasty and stent placement – inserting a catheter into the blocked artery and inflating a balloon to press the plaque against the artery wall to improve blood flow; a stent (wire mesh tube) may be place to keep the artery open
• Atherectomy – inserting a catheter into the blocked artery and using a special device, such as Cardio Flow’s FreedomFlow®, to remove the blockage; it may be used prior to angioplasty and stenting if the plaque is especially hard to compress
• Bypass surgery – using a blood vessel from another part of the body to re-route or bypass the blockage
• Amputation – if blood flow cannot be restored, amputation may be necessary

Peripheral artery disease is common in the United States, affecting some 8-10 million Americans, but only 10% of those will develop critical limb-threatening ischemia. Because CLTI patients are often hospitalized—often for bypass surgery or amputation—the condition has a serious impact on their quality of life and is costly for healthcare systems as well.