The Role Of Subintimal Angioplasty In the Treatment Of Lower Extremity Ischemic Ulcers and Gangrene

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Hosam F. El Sayed, MD, George H. Meier, III, MD, Greg Rushing, MD, Bernardo Mendoza, MD, Rasesh M. Shah, MD, Michael J. Marcinczyk, MD, John O. Colonna, MD, Gregory A. Barber, MD, Gordon K. Stokes, MD, Martin A. Fogle, MD.
Eastern Virginia Medical School, Norfolk, VA, USA.

BACKGROUND:
Subintimal angioplasty (SIA) has been advocated to treat peripheral arterial occlusions. This relatively new technique has been shown by some studies to be a safe alternative to traditional bypass, especially in those patients who are not surgical candidates due to co-morbid diseases common in this patient population. The ability of this procedure to heal ulcers or prevent amputation due to gangrene has not yet been fully evaluated. The use of SIA seems to be a powerful tool in the armamentarium of vascular surgeons to treat ulcers/gangrene and prevent limb loss, perhaps even more beneficial in patients in whom traditional bypass is not an option.
METHODS: During a 20 month period (12/02-08/04) all patients with chronic lower extremity (LE) ischemia treated using SIA by our group for LE ulcers or gangrene as primary indications for performing the procedure were retrospectively reviewed. .SIA was considered successful if the lesion (ulcer/gangrene) was healed without need for further intervention. Secondary measurement of success was the ability of SIA to prevent major amputation.
RESULTS:
During the specified period, there were 102 patients treated for LE ulcer or gangrene secondary to severe chronic ischemia using SIA. Of those, only 87 patients had adequate follow up after the procedure. There were 43 males and 44 females. Their age ranged from 48.9 to 88.1 (mean 70.2) years. Follow up ranged between 0.1 and 17.2 months (mean 3.4 months).Technical success was achieved in 69 patients (79.3%). The segment treated was less than 10 cm only in 4 patients with a range of 5 to 40 cm and mean of 29.8cm in length. Of the 87 included patients, there were 4 (4.6%) deaths, none directly as a result of subintimal angioplasty, 18 major amputations (20.7%) and 7 required redo revascularization with bypass (10 patients), remote endarterectomy (3 patients) or repeat SIA (4 patients) (19.5%). Forty eight patients (55.1%) experienced healing of their wounds or gangrene. Twenty-seven of the patients who underwent SIA for healing of ulcer or gangrene were considered non-operative candidates (31%). In this subset of patients, limb salvage was 63%. In the 10 patients who were successfully bypassed, all avoided amputation.
CONCLUSIONS:
In our study subintimal angioplasty was effective at healing patients with severe LE ischemia as manifested by ulcer or gangrene. SIA was also effective as a limb salvage procedure in 63% of patients who would otherwise have required amputation due to their non-operative status. Furthermore, SIA did not interfere with the extent of revascularization procedure if healing did not occur. SIA was not associated with procedure related mortality or major complications, making it an attractive primary therapeutic procedure for this subset of challenging patients.