Exploring Limb Salvage Options In Patients With Chronic Limb Ischemia
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.
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.
This case study demonstrates the suitability of delivering the small vessel cryoballoon to a distal lesion below the ankle. The patient underwent angioplasty without the creation of a prominent dissection across a 30 mm length occluded segment and two additional sites. There was vigorous bleeding during surgery, a favorable prognostic sign, and the surgical wound was healing at three weeks.
While the primary objective in this case is limb salvage and wound healing, further follow up in a controlled environment will be necessary before one can make statements regarding patency rates.