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Defining Utility and Predicting Outcome of Cadaveric Lower Extremity Bypass Grafts
Catherine K. Chang, M.D., Salvatore T. Scali, MD, Robert J. Feezor, MD, Adam W. Beck, MD, Alyson L. Waterman, MD, Thomas S. Huber, MD, Scott A. Berceli, MD.
University of Florida, Gainesville, FL, USA.
Introduction: Acceptable limb salvage rates have been reported with infrainguinal cryopreserved vein bypass (CVB) for various indications despite poor long-term patency. The utility of CVB in patients with critical limb ischemia (CLI) remains undefined. Our purpose was to determine the role of CVB in CLI patients and identify predictors of successful outcomes.
Methods: A retrospective review was performed of all lower extremity bypass(LEB) procedures at a single institution. CVB patients CVB were further analyzed. The primary-end point was amputation-free survival(AFS). Secondary end-points included primary patency and limb salvage. Life tables were used to estimate occurrence of endpoints and cox regression analysis used to determine predictors of major amputation.
Results: From 2000-2012, 112 of 1059 patients undergoing LEB underwent CVB[mean age±standard deviation:66±10; male 53%(N=60); diabetes 47%(N=53); hemodialysis dependence 9%(N=10)]. A majority (65%, N=73) had a history of failed ipsilateral LEB. None had sufficient autogenous conduit for even a composite vein bypass. CVB to an infrainguinal target (infrapopliteal-90%, N=102) was completed for a variety of indications including: acute limb ischemia 13%(N=15), graft infection 23%(N=26), and ischemic rest pain/tissue loss 63%(N=71). Intraoperative adjuncts (e.g. profundaplasty, proximal stent/bypass) were used in 59%(N=66) of cases. Complications occurred in 45.9%(N=50) with 30-day and in-hospital mortality of 7.1%(N=8) and 9.9%(N=11), respectively.
Median follow-up time for CLI patients was 11.8(interquartile range:0.4-28.4) months with corresponding 1 and 3 year actuarial estimated survival of 84±4% and 62±6%. Primary patency (±standard error mean) of CVB for CLI was 36±6% and 19±6% at 1 and 3 years, respectively. One and 3-year AFS was significantly greater for ischemic rest pain (59±9%, 36±10%) compared to tissue loss (31±7%, 14±7%, log-rank P=.04). Freedom from major amputation after CVB for CLI was 58±5% and 47±6% at 1 and 3 years, respectively.
Multivariable predictors for successful limb salvage included: postoperative coumadin(HR 0.3, 95% CI:0.1-0.7), dyslipidemia(HR 0.4;0.2-9), and rest pain(HR 0.4;0.2-0.9). Predictors of major amputation included graft infection(HR 3.1;1.1-9.0).
Conclusions: The role for CVB appears limited, even in CLI patients with no autologous options and prior failed infrainguinal bypass. Outcomes are better in patients with rest pain and without graft infection but other studies suggest that there are more cost effective alternatives for these patients with equivalent outcomes. Graft or wound infection without autologous conduit may be one important indication for CVB.
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