Purpose: To compare the objective performance goals (OPGs) and patient-centered outcomes of isolated tibial interventions in patients with tissue loss who were on hemodialysis (HD) to patients with tissue loss who were not on HD. Methods: Interrogation of a prospectively maintained database identified 242 critical limb ischemia (CLI) patients who underwent isolated tibial interventions for tissue loss in a single limb between 2007 and 2012. The 78 patients (mean age 66±12 years; 44 men) on HD were compared with 164 patients (mean age 50±13 years; 82 men) who were not on HD. There was an equal distribution of the tibial vessels treated; 152 (63%) patients had more than one treated tibial vessel. Patient-centered outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and no major amputation), amputation-free survival (AFS), and freedom from major adverse limb events (MALE) were evaluated. The Society for Vascular Surgery OPGs were defined at 30 days and 1 year. Results: The 30-day major adverse cardiac events was significantly higher (p=0.004) in the HD group (5, 5%) compared with the no-HD group (0%), but both remained under the stated OPG of ≤10%. The 30-day MALE rates were significantly higher than the stated ≤9% OPG at 13% and 18% for the no-HD and HD groups, respectively. At 1 year, the rates for AFS, freedom from MALE, limb salvage, and survival did not achieve the stated Society for Vascular Surgery OPGs in the HD group. Clinical efficacy was 61% and 25% at 3 years for the no-HD and HD groups, respectively (p<0.01). Overall, AFS was 54% and 22% and freedom from MALE was 56% and 27% at 3 years for the no-HD and HD groups, respectively (both p<0.01). Conclusion: Tibial intervention for tissue loss in patients on HD is a valid treatment option but is associated with a high MALE rate. Three-year outcomes remain relatively poor, with <25% success in terms of clinical efficacy and AFS.
RobinsonBMFullerDS. The DOPPS practice monitor for US dialysis care: trends through April 2011. Am J Kidney Dis. 2012;59:309–312.
2.
O’HareAMSidawyANFeinglassJ. Influence of renal insufficiency on limb loss and mortality after initial lower extremity surgical revascularization. J Vasc Surg. 2004;39:709–716.
3.
O’HareAMBertenthalDSidawyAN. Renal insufficiency and use of revascularization among a national cohort of men with advanced lower extremity peripheral arterial disease. Clin J Am Soc Nephrol. 2006;1:297–304.
4.
O’HareAMFeinglassJSidawyAN. Impact of renal insufficiency on short-term morbidity and mortality after lower extremity revascularization: data from the Department of Veterans Affairs’ National Surgical Quality Improvement Program. J Am Soc Nephrol. 2003;14:1287–1295.
5.
GoodneyPPBeckAWNagleJ. National trends in lower extremity bypass surgery, endovascular interventions, and major amputations. J Vasc Surg. 2009;50:54–60.
6.
SmolockCJAnaya-AyalaJEBismuthJ. Impact of metabolic syndrome on the outcomes of superficial femoral artery interventions. J Vasc Surg. 2012;55:985–993.e1.
7.
LeeTHMarcantonioERMangioneCM. Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery. Circulation. 1999;100:1043–1049.
8.
GrundySMBrewerHBCleemanJI. Definition of metabolic syndrome: report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004;109:433–438.
9.
NorgrenLHiattWRDormandyJA. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45(suppl S):S5–S67.
10.
DaviesMGSaadWEPedenEK. Impact of runoff on superficial femoral artery endoluminal interventions for rest pain and tissue loss. J Vasc Surg. 2008;48:619–626.
11.
ToursarkissianBD’AyalaMStefanidisD. Angiographic scoring of vascular occlusive disease in the diabetic foot: relevance to bypass graft patency and limb salvage. J Vasc Surg. 2002;35:494–500.
12.
SchanzerAGoodneyPPLiY. Validation of the PIII CLI risk score for the prediction of amputation-free survival in patients undergoing infrainguinal autogenous vein bypass for critical limb ischemia. J Vasc Surg. 2009;50:769–775.
13.
BiancariFSaleniusJPHeikkinenM. Risk-scoring method for prediction of 30-day postoperative outcome after infrainguinal surgical revascularization for critical lower-limb ischemia: a FinnVasc registry study. World J Surg. 2007;31:217–225.
14.
ConteMSGeraghtyPJBradburyAW. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009;50:1462–1473.
15.
RutherfordRBBakerJDErnstC. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997;26:517–538.
16.
KawaradaOFujiharaMHigashimoriA. Predictors of adverse clinical outcomes after successful infrapopliteal intervention. Catheter Cardiovasc Interv. 2012;80:861–871.
17.
SilverbergDYalonTRimonU. Endovascular treatment of lower extremity ischemia in chronic renal failure patients on dialysis: early and intermediate term results. Isr Med Assoc J. 2013;15:734–738.
18.
Bianchini MassoniCFreyrieAMucciniN. Endovascular treatment of the infrapopliteal arteries in hemodialysis patients with critical limb ischemia: is it justified?Ann Vasc Surg. 2014;28:152–158.
19.
JohnsonBLGlickmanMHBandykDF. Failure of foot salvage in patients with end-stage renal disease after surgical revascularization. J Vasc Surg. 1995;22:280–286.
20.
NakanoMHiranoKIidaO. Prognosis of critical limb ischemia in hemodialysis patients after isolated infrapopliteal balloon angioplasty: results from the Japan Below-the-knee Artery Treatment (J-BEAT) registry. J Endovasc Ther. 2013;20:113–124.
21.
SchanzerAMegaJMeadowsJ. Risk stratification in critical limb ischemia: derivation and validation of a model to predict amputation-free survival using multicenter surgical outcomes data. J Vasc Surg. 2008;48:1464–1471.
22.
SeegerJMPretusHACarltonLC. Potential predictors of outcome in patients with tissue loss who undergo infrainguinal vein bypass grafting. J Vasc Surg. 1999;30:427–435.
23.
LantisJConteMSBelkinM. Infrainguinal bypass grafting in patients with end-stage renal disease: improving outcomes?J Vasc Surg. 2001;33:1171–1178.
