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Cryoplasty Effectively Treats Challenging Peripheral Artery Blockages

HeartOct 18, 05

Today, research presented at the Cardiovascular Research Foundation’s (CRF) Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, in Washington, D.C., has shown that cryoplasty, a minimally-invasive treatment that utilizes freezing-cold nitrous oxide injected into an angioplasty balloon, appears to be more effective than standard therapies in the treatment of peripheral artery disease in the lower limbs.

Peripheral artery disease (PAD) affects approximately 8 to 12 million Americans. Left untreated, PAD causes poor circulation in the legs and increases the risk of heart attack, stroke, amputation or even death. Treatment for PAD typically involves lifestyle changes or medication, but in some instances, surgery such as angioplasty is recommended because it is minimally invasive and cost-effective. However, in the arteries below the hip, angioplasty has had disappointing results - approximately 40% of patients will need to be treated again within one year because of artery re-blockage due to scar tissue accumulation, which cryoplasty has been shown to prevent.

“Blockages that occur in the lower extremities are a challenge to treat, not only because of their location in the body, but because of the extensiveness of the plaque build-up in these arteries.” said John Laird, M.D., Washington Hospital Center, Washington, D.C. “The early results of cryoplasty in these patients are very promising when compared to the effectiveness of currently available treatments.”

A total of 102 patients were enrolled in this prospective, multicenter trial and treated with cryoplasty. Following the initial cryoplasty treatment, long-term clinical follow-up measures indicating the need for revascularization or the presence of continued blockage were collected for 2 to 4 years. At 9 months, results showed that 82.2% of patients did not need additional treatment, and at 16 months, rates were similarly promising at 77.8%. Extended follow up to a mean of 31 months, the clinical patency rate was sustained at a very favorable 73.5%

“The fact that overall success rates for these patients have not significantly decreased over time is exciting,” According to Dr. Laird. “Based on these results, long-term follow-up of cryoplasty patients is critically important in order to be able to fully evaluate the durability of cryoplasty for the treatment of lower extremity PAD.”

About PAD and Cryoplasty
Millions of Americans suffer from peripheral artery disease (PAD), which causes blockage in the arteries of the legs and in more than half of patients, often goes undiagnosed. Balloon angioplasty is usually the first treatment for patients because it is minimally invasive and cost-effective, but, in the arteries below the hip, angioplasty has had disappointing durability. About 40% of patients treated with angioplasty or stenting need to be treated again or revascularized within a year. The re-blockage of treated arteries is referred to as restenosis.

During cryoplasty, a balloon inserted via catheter into the blocked artery is injected with liquid nitrous oxide, which inflates and cools the balloon in the artery. The cooling and expansion of the balloon causes the plaque clogging the artery to crack when it freezes, and is thought to allow for a more uniform opening of the blood vessel compared with standard angioplasty. The cooling also prompts apoptosis (programmed cell death), which is a natural occurrence that minimizes the growth of scar tissue, which often occurs with conventional therapies. Cryoplasty potentially inactivates those cells that produce the scar-tissue buildup of restenosis following balloon angioplasty and has reduced the number of patients needing revascularization.

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