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Atherectomy for limb ischemia has good results.

NEW YORK -- The largest and longest study to date of the Silverhawk percutaneous excisional atherectomy device showed that it is "an essential tool" for surgeons treating patients with lower-extremity peripheral artery disease, according to a vascular surgeon at New York Presbyterian Hospital.

The Silverhawk device uses an 8,000-rpm carbide cutting burr to excise atherosclerotic plaque while largely avoiding the trauma to the arterial wall that is inherent to angioplasty. This is the most likely explanation for the excisional procedure's high long-term patency and limb salvage rates, Dr. James F. McKinsey said at the annual meeting of the American Surgical Association.

Atherectomy is a minimally invasive alternative to surgical bypass, until recently the preferred treatment for lower-extremity ischemia, he continued. The complication rate with atherectomy is lower, and long-term patency is markedly better than with synthetic bypass conduits. In addition, the endovascular procedure is done under local anesthesia in a 1-day hospitalization, an important consideration because most patients with lower-extremity ischemia have multiple comorbidities and are less than ideal candidates for major surgery.

Dr. McKinsey reported on 579 consecutive atherectomy-treated lesions in the tibial, superficial femoral, and popliteal arteries in 275 patients (mean age 70 years). Among these patients, 37% had claudication and 63% had severe limb is-chemia. Two-thirds had diabetes. Hypertension and coronary artery disease also were highly prevalent.

Overall, 65% of the atherectomies were done as stand alone procedures. The rest were accompanied by angioplasty or stenting.

Atherectomy's chief complication was groin hematoma, which occurred in 4.1% of patients. That compares quite favorably with surgical bypass, which in several published series has entailed complication rates of 17%-19%, and climbed as high as 44% with distal bypass, he said.

The periprocedural mortality rate in the atherectomy series was 1.1%, and the 30-day mortality rate was 1.8%, Dr. McKinsey said.

The primary patency rate at 18 months--that is, patency with no reinterventions and no severe restenosis--was 53% for all lesions and 80% for superficial femoral artery lesions. The overall secondary patency rate was 75%. Primary and secondary patency rates were markedly higher in claudicants than in patients treated for critical limb ischemia. The overall limb salvage rate at 18 months was 88%. Of the claudicants, 2% ended up losing a limb within 18 months.

Reintervention was required within 18 months in 29% of lesions. More than 70% of those reinterventions were endovascular, and involved either repeat atherectomy or angioplasty. Surgical bypass was required by 12 patients, but 3 of these patients had a patent atherectomy-treated site at the time. Amputation was performed in 21 patients, Dr. McKinsey said.

Of the atherectomy-treated patients who developed moderate restenosis as shown on routine duplex ultrasound, 40 did not undergo reintervention because they lacked clinical symptoms, Dr. McKinsey said.

"These are very difficult patients where something needs to be done or they can lose their leg. The fact that your results demonstrate they did not get worse--even the ones who required reintervention--makes me think [atherectomy] is worthwhile in trying to save their limb," said discussant Dr. Gregorio A. Sicard, professor of surgery and director of the vascular service at Washington University, St. Louis.

However, he and others indicated that, in their view, when and how to intervene in claudicants remain a somewhat gray area.

The highly favorable outcomes Dr. McKinsey has obtained with the Silverhawk device has led him to deemphasize surgical bypass. Endovascular therapy is his first-line intervention in patients who fail conservative measures, even when good-quality veins are available for bypass.

He said that in patients with poor-quality veins who have an unsatisfactory result with endovascular therapy, he now typically performs a repeat endovascular intervention rather than resort to surgical bypass with a synthetic conduit because of the artificial graft's poor chance of long-term success. "Our use of synthetic bypass has gone down dramatically," he observed.

Dr. McKinsey disclosed he is on the speakers bureau for FoxHollow Technologies, which markets the Silverhawk device, as well as on the bureaus for most of the other endovascular device manufacturers.


Denver Bureau
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Title Annotation:Cardiovascular Medicine
Author:Jancin, Bruce
Publication:Internal Medicine News
Geographic Code:1U2NY
Date:Sep 1, 2008
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