Date: 3/14/2005

Community Hospital’s participation in national study is helping save life and limb

MUNSTER — Research being done at Community Hospital is helping to save lives and limbs, and may one day lead to better treatments for a disease that often results in the amputation of a foot or leg.

There is hope to improve the lives of patients with Peripheral Arterial Disease (PAD) like never before here in Northwest Indiana thanks to the work Cardiologist Prakash Makam, M.D., is doing in conjunction with Community Hospital as one of only 12 TALON research sites in the nation.

TALON, an acronym for Treating PeripherAls with SiLverHawk: Outcomes CollectioN, is a study sponsored by Fox Hollow, the manufacturer of a new PAD treatment device. As one of the study’s 12 principal investigators, Makam is also one of the most experienced physicians in the country for this procedure.

For the procedure, a guide wire is threaded into the diseased leg artery to guide the SilverHawk device into place. Then, at a very high rotation per minute, the device works by shaving plaque from the artery wall and pushing it into a nose cone for collection.

Podiatrist Christopher Grandfield, D.P.M., has sent many patients to Makam for the procedure. “It’s very impressive,” he said. “Just about everyone I send has a non-palpable pulse in the foot and the foot is cold. When they come back the foot is warm and they have palpable arteries.

“The first person I sent was about to lose a foot to gangrene,” Grandfield added. “It’s very low risk for very high gain.”

As a part of the research study being conducted at Community Hospital, the plaque collected and removed during the procedure is sent out for a histology and genomic analysis. Through this work, physicians and scientists hope to gain a better understanding of the causes of PAD that will ultimately lead to advances in treatments.

The TALON Study will closely monitor patients for the first year following their treatment. Community Hospital Cardiologists Arvind Gandhi, M.D., and A. Arif Khalil, M.D., are also investigators in the TALON Study.

The SilverHawk procedure is a variation on atherectomy — the cleaning out of an artery through excision. It works by shaving the plaque from artery walls with a tiny blade the size of a grain of rice. Originally developed to clean out heart arteries, atherectomy is proving to be an even more effective treatment for blocked arteries in the leg, Makam said.

After six months, only 10 percent of patients who had undergone the SilverHawk procedure needed to have the procedure repeated. The reintervention rate is 30 to 40 percent when a balloon is used to flatten plaque against the artery walls, and 20 percent when stents are used to reopen the femoral artery.

“To open blocked arteries in the knee and below is particularly difficult with a balloon or stents and in my opinion those locations do best with atherectomy,” Makam said.

Peripheral arterial disease, also known as peripheral vascular disease (PVD), affects 8 to 12 million Americans and can have startling consequences such as amputation and death. PAD is identified as poor blood flow to the arms and legs, but the majority of diagnoses are in the legs.

Poor circulation to the lower extremities makes it difficult or impossible for wounds there to heal. Severe pain, ulcers and gangrene have often been precursors to amputation of the feet and legs. Losing a limb is traumatic enough, but when coupled with the statistics that only 50 percent of diabetics live three or more years following a lower-limb amputation, there’s all the more motivation to find better treatments through research initiatives such as the TALON study, Makam said.

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