Exploring Limb Salvage Options In Patients With Chronic Limb Ischemia

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Here one can see hemodynamically significant stenosis at the origin of the left anterior tibial artery.
This control angiogram was taken following CryoPlasty therapy with a 3.0 mm balloon.
As one can see here, the stenosis of the left dorsalis pedis artery crosses the ankle joint.
Surgeons used a 2.5 mm diameter CryoBalloon across the dorsalis pedis artery stenosis.
Here is a control angiogram of the dorsalis pedis artery following 2.5 mm CryoPlasty therapy. As one can see, there is significant improvement in the caliber of the artery with a focal area of vasospasm several millimeters below the ankle joint.
After the patient underwent transmetatarsal amputation, the left foot showed exuberant bleeding. This signifies good blood flow to the wound site.
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Author(s): 
By John E. Aruny, MD, Peter Blume, DPM, Bauer Sumpio, MD, PhD, and Benjamin Buren, DPM

A Guide To Understanding The Cryoplasty Procedure

   After completing angiogram procedures, surgeons performed an antegrade puncture of the left common femoral artery and placed a 6-Fr sidearm sheath with its tip in the proximal superficial femoral artery. A repeat diagnostic study confirmed the previous findings.

   The team subsequently used a 4-Fr Berenstein catheter with glide coating (Boston Scientific) loaded with a .014-inch guidewire (Sparta/Core 14, Guidant Corp.) to catheterize the anterior tibial artery and cross the stenosis. The vascular surgeons performed cryoplasty therapy with a 3 mm by 20 mm PolarCath Peripheral System balloon (CryoVascular Systems, Inc.). A post-op control angiogram showed excellent results with a less than 10 percent residual stenosis and no angiographic evidence of dissection.

   The vascular surgeons proceeded to turn their attention toward the occluded segment of the anterior tibial artery. They advanced the 4-Fr glide Berenstein catheter across the aforementioned treated segment and placed the tip of the catheter just above the occluded portion of the artery. After injecting contrast, the surgeons documented reconstitution of the post-obstructed anterior tibial artery. The surgical team crossed the obstructed segment with a 0.035-inch straight, stiff Glidewire (Boston Scientific), advanced the catheter across the obstruction and confirmed its intraluminal position with a contrast injection. Using the 3.0 mm balloon, they treated the obstructed segment with cryoplasty therapy. A post-op control angiogram disclosed minimal residual stenosis and no vessel wall dissection. There was no evidence of distal embolization of plaque fragments.

   The vascular surgeons advanced the 0.014 inch guidewire through the balloon catheter and crossed the stenosis of the dorsalis pedis artery again, utilizing a roadmap technique. They treated the stenosis of the dorsalis pedis artery at and below the ankle with a 2.5 mm by 20 mm CryoPlasty balloon. A post-op control angiogram showed significant improvement in the diameter of the dorsalis pedis artery with a focal area of spasm at its mid-portion.

   The patient tolerated the procedure well and the multidisciplinary team noted a strong, palpable dorsalis pedis pulse after the procedure.

An Early Glimpse At CryoPlasty Study Results

   Preliminary findings from a prospective, multicenter trial show that CryoPlasty therapy may be beneficial for patients with critical limb ischemia.

   The preliminary results, which were reported by James D. Joye, DO, recently at the 17th Annual International Symposium on Endovascular Therapy, focused on 25 patients who had critical limb ischemia and an average age of 72.

   With an average follow-up of 45 days, researchers found that the average residual stenosis after CryoPlasty treatment (performed at 8 ATM and –10ºC) in the first 22 patients was 19.3 percent. The average baseline stenosis in these patients was 87.3 percent +/- 10.54 percent.

   Researchers also reported an improved distal pulse in 17 out of the first 20 patients. They noted that they could not measure pulses in the remaining three patients of the study due to a dressing on their leg.

Final Notes

   Subsequently, the patient underwent a transmetatarsal amputation on the left foot on Oct. 6. This allowed for ambulation without a prosthesis. The patient experienced significant bleeding postoperatively as well as bounding pulses. The patient tolerated the procedure and anesthesia well and was discharged to an intermediate care facility for physical therapy and wound care.

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