Angioplasty and Atherectomy

In the last 20 years has seen a major shift in the treatment of arterial disease, away from large invasive procedures requiring long incisions and extended stays in the hospital. Current technology allows treatment of many of the diseased arteries using tiny incisions and catheters inserted directly into these arteries to open areas of narrowing, and in some cases re-establishing flow in arteries that are completely occluded.

Catheter Directed Atherectomy is one of the most promising technologies. This allows the surgeon to actually remove areas of atheroscerotic plaque from the diseased artery, giving the artery improved flow, and allowing healing of ulceration and skin breakdown, and resolution of leg discomfort when walking (claudication).

Peripheral Artery Disease (PAD)

Peripheral Artery Disease (PAD) is a condition which most commonly affects arteries in the legs. PAD occurs when harmful plaque buildup causes a narrowing of the artery, eventually constricting normal blood flow to the body’s extremities.

PAD can be extremely painful, debilitating and can eventually lead to amputation and death. If a patient has symptoms associated with PAD, several tests can be performed to make a diagnosis. An ankle brachial index (ABI) is used to measure the rate of blood pressure in the ankle to that in the arm. A lower pressure in the ankle may indicate PAD. This is a simple, non-invasive test, which can be done in the doctor’s office. Another non-invasive test is called a Doppler Ultrasound, which uses sound waves to measure blood flow in a vessel and can determine if there is a blockage.

To make a final assessment, the patient undergoes angiography. This minimally invasive procedure involves injecting a dye into the arteries. Typically, the physician can see the blockage on the angiogram images.

General Facts about PAD:

  • PAD affects over 12 million people in the U.S.
  • Patients with PAD face a 10-year drop in life expectancy.
  • 40% of Coronary Artery Disease (CAD) patients have PAD.
  • The prevalence of PAD is 20% higher in the diabetic population.
  • Patients with PAD have approximately the same 5-year mortality rate as those patients with breast and colorectal cancer.
  • 40% of amputees die within 2 years of amputation.
  • 150,000 PAD sufferers undergo limb amputation.
  • 86% of patients who were given an ABI test said that it took less than 15 minutes.

PAD Risk Factors

Researchers have identified several risk factors that can be attributed to the development of PAD. These include:

  • Coronary artery disease
  • High blood pressure
  • Hyperlipidemia or high cholesterol
  • Over the age of 65
  • Diabetes
  • Obesity
  • Smoking
  • Family history
  • Lack of exercise
  • PAD Symptoms

PAD symptoms can include, but are not limited to the following:

  • Claudication: dull, cramping pain in the hips, thighs, calves or buttocks
  • Numbness or tingling in the leg, foot or toes
  • Changes in skin temperature: cold to the touch
  • Changes in skin color: bluish or reddish coloration
  • Impotence
  • Sores or infections that do not heal
  • Weakness in legs or arms
  • Historical PAD Treatment

Treatment options for PAD have traditionally included angioplasty, stenting and open bypass surgery, which is an invasive procedure, requiring a large incision and a hospital stay. Both angioplasty and stenting clear a channel in the artery for blood flow by pushing plaque up against the artery walls. However, patients often return within six months to have the procedure repeated because plaque has crept back into the artery and blocked it again. Today, a new minimally invasive procedure called plaque excision allows the blockage to be removed altogether. The procedure is performed using the SilverHawk™ Plaque Excision System, which cleans out the artery by removing the plaque. Note: Patients treated with the SilverHawk may also require repeat procedures.

SilverHawk™ Plaque Excision System

The SilverHawk Plaque Excision System is a unique device, which uses a tiny rotating blade the size of a grain of rice to shave away large quantities of plaque from inside the artery. As it is excised, the plaque collects in the tip of the device and then is removed from the patient. Removing harmful plaque from the artery restores normal blood flow to the legs and can return patients to an active lifestyle.

Since receiving clearance from the FDA, the SilverHawk device has been used in thousands of peripheral vascular procedures in the United States. In hospitals across the U.S., plaque excision has successfully saved the legs of patients who were scheduled for limb amputation after other peripheral interventions failed.

HOW IT WORKS

1) The device, which is delivered through a catheter, is inserted into the patient’s groin through a small puncture site and is moved through the artery to the site of the blockage.

2) A tiny rotating blade is activated and the physician advances the SilverHawk through the vessel, shaving plaque from the artery walls as it moves forward.

3) The plaque is collected in the tip of the catheter and then completely removed from the patient’s body.

The SilverHawk catheter is inserted into the body through a small puncture site and is advanced through the artery to the site of the blockage.

Once the SilverHawk catheter is at the site of the blockage, a tiny rotating blade is activated. The physician advances the catheter through the lesion, shaving plaque off of the artery walls.

The plaque collects in the tip of the catheter and then is completely removed from the body. The physician may need to repeat these steps until enough plaque is removed to restore normal blood flow to the legs.

Plaque Excision Facts

  • Cleans out blocked arteries to alleviate severe leg pain
  • FDA-cleared for use in peripheral arteries
  • Minimally invasive procedure
  • Covered by Medicare and private medical insurance

For more information: http://www.ev3.net/peripheral/us/plaque-excision/turbohawk.htm