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Single Center Experience with the Use of Cryopreserved Allografts for Limb Salvage
Neeta V. Karani, M.D., Brian J. Wheatley, M.D..
Carle Foundation Hospital, Urbana, IL, USA.

Single Center Experience with the Use of Cryopreserved Allografts for Limb Salvage
Karani, N., Wheatley, B.
OBJECTIVE - This is a single-institution experience, evaluating the short and long term clinical outcomes of patients with critical limb ischemia (CLI) who received a cryopreserved saphenous vein allograft as their primary open bypass conduit for peripheral arterial revascularization to a below the knee outflow artery.
METHODS - Patients with CLI being evaluated for open peripheral arterial revascularization were screened for the study, if they met all inclusion and exclusion criteria. Operative data and adverse events were recorded. An antiplatelet/anticoagulation regimen was administered. The candidates were followed prospectively for up to 24 months with scheduled follow up evaluations. The primary endpoint was limb salvage. The secondary endpoints were primary patency, secondary patency and mortality.
RESULTS - Nine subjects were consented and enrolled from February 2013 to December 2015 after screening of more than 300 potential study candidates. Of these, one subject had bilateral limb enrollment for a total of 10 allograft implantations. The subjects were followed for an average of 445 days (range 78 to 750 days). Limb salvage was noted to be 100% at 24 months. Primary patency and secondary patency results are as follows:
6 months12 months18 months24 months
Primary Patency68%68%68%44%
Primary Assisted Patency78%78%58%39%
Secondary Patency89%89%89%89%
MortalityNoneNoneNoneNone

CONCLUSIONS - The use of cryopreserved vascular allografts for peripheral vascular reconstructions in patients with CLI, were historically placed for limb salvage operations as an alternative to amputation. Despite various factors such as disease progression that influence patency rates, allograft use has demonstrated much clinical utility and efficacy. Our limb salvage rates are higher than those described in most studies despite the similarities in patency rates. Though not an endpoint, ulcers present on the involved limb showed 100% wound healing within 6 months after surgery. This study is limited by a small sample size, however the results are encouraging to potentially utilize cryopreserved vascular allografts on a broader scale in patients with CLI.


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