Can Endovascular Atherectomy Be Beneficial In Diabetic Limb Salvage?

By Peter Wilusz, DPM, and Guy Pupp, DPM

What The Research Reveals About The Endovascular Atherectomy

Many study models have investigated the longer-term results of the Silverhawk procedure. The TALON study is a national registry which tracks outcomes after treatment with the Silverhawk system, and has over 506 patients and 1,099 lesions enrolled to date.9 Thirty-two percent of the patients had critical limb ischemia with ABIs below 0.6. Minimal lumen diameter improved from 1.6 mm pre-procedure to 4.5 mm post-procedure and the diameter stenosis improved from 87.1 percent to 9.9 percent. The mean pre-surgical ABI was 0.61 + 0.12 and improved to a post-op ABI of 0.79 + 0.11. The overall patency rate at six months was 90.4 percent.9

     The Arizona Heart Hospital 12-month outcomes data involved 181 patients and 202 limbs.10 The mean ABI increase was 0.27. Ninety-two patients (45.5 percent) of patients completed the six-month follow up, resulting in a primary patency rate of 96 percent.10 More recently, researchers reported an 86 patency rate at 12 months for 104 patients with peripheral vascular disease treated with Silverhawk. These findings are encouraging evidence that the Silverhawk system also provides good long-term benefit.

     The Cardiovascular Institute of the South conducted a six-month follow-up study investigating the rate of restenosis following the Silverhawk procedure.11 From Sept. 2, 2003 to June 1, 2004, researchers treated 133 superficial femoral artery lesions (64 patients) with the Silverhawk system. At six months, they examined all 64 patients with Duplex ultrasound and examined 42 (65 percent) of the patients via CT angiogram (CTA). Using the Duplex ultrasound, investigators observed a 9.4 percent (6 of 64) restenosis rate, which was very close to the 9.6 percent (5 of 42) restenosis rate observed with CTA.

In Conclusion

     The cases submitted to the TALON registry, as well as more recent 12-month reports from the Arizona Heart Hospital, indicate a high level of safety and efficacy associated with using the Silverhawk device for lower extremity lesions. This evidence has been confirmed in numerous single-center studies in high volume facilities across the country. Physicians at these facilities have observed high rates of procedural success in above-the-knee and below-the-knee lesions with very low complication rates.
The remarkable observation in many centers was the increasing number of patients who were at one time scheduled for a significant lower extremity amputation but had successful limb salvage procedures with the Silverhawk system.
Peripheral arterial disease in high-risk patient groups, such as those with diabetes mellitus, now may have a reliable, lower risk alternative for treatment and limb salvage. However, specific cohort studies investigating the long-term benefit of the Silverhawk procedure, particularly in the diabetic population, are still needed.

     Dr. Wilusz is a Clinical and Surgical Instructor at the Foot and Ankle Clinic at the Southeastern Michigan Surgical Hospital in Warren, Mich. He is a Diplomate of the American College of Foot and Ankle Surgeons, and is certified in forefoot and rearfoot reconstructive foot and ankle surgery. He is in private practice in Dearborn, Mich.

     Dr. Pupp is a Fellow of the American College of Foot and Ankle Surgeons. He is the Clinical Director of the Foot and Ankle Clinic at the Southeast Michigan Surgical Hospital in Warren, Mich.

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