Atherectomy offers another option for endovascular specialists for treating patients with femoropopliteal disease, although its use is controversial. Some endovascular specialists say there are insufficient data from randomized trials comparing atherectomy with nitinol stents and/or balloon angioplasty and proof of long-term benefit to support its use.
Others argue that in clinical practice the approach is proving effective, particularly for heavily calcified lesions and diffuse disease that may require multiple overlapping stents.
“Atherectomy has been the orphan baby that many have not embraced,” says Jihad A. Mustapha, MD, director of peripheral intervention and cardiovascular research at Metro Health Heart & Vascular in Wyoming, Mich. He says improvements in the debulking technologies have expanded physicians’ treatment options while filter devices now reduce the risk of distal embolization.
Nor is Mustapha alone in his view. An analysis of Medicare beneficiaries who received either a lower extremity endovascular intervention, bypass surgery or major amputation between 1996 and 2006 found percutaneous atherectomy had increased from three procedures per 100,000 to 118 per 100,000 (J Vasc Surg online May 28, 2009). “The majority of us who perform high volume in this area do atherectomy first, and if that works, we leave it alone,” Mustapha says. “We have had some great results with that.”
Evidence is beginning to trickle in for the use of atheretomy to treat femoropopliteal disease. Results from the Covidien DEFINITIVE trial, presented at the International Symposium on Endovascular Therapy (ISET) conference in Miami in January 2012, reportedly showed low rates of major adverse events and bailout stenting. The study enrolled 133 patients with 168 lesions, with severe calcification in 81 percent of the lesions and occlusion in 17.9 percent. The results showed a favorable 30-day freedom from major adverse event rate, no early limb loss and preservation of runoff in 98.3 percent of the patients.
Metro Health performed 484 peripheral interventions in 2011, with 40 percent using atherectomy. Mustapha says that careful patient selection, operator experience and a thorough understanding of devices are key to a successful procedure. He acknowledges there is a learning curve with atherectomy devices and a need to understand both vascular and technical nuances.
“Today there isn’t one form of therapy as the standard of care, especially when it comes down to the femoropopliteal and tibial vessels,” he says. “In this highly progressive and evolving disease, interventionalists must be open-minded to use any form of therapy that is best for the patient at the time.”