Outcomes of Isolated Tibial Endovascular Interventions for Tissue Loss in CLI Patients on Hemodialysis.
OBJECTIVE
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).


CONCLUSIONS
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.
Division of Vascular and Endovascular Surgery, Department of Surgery, University of Texas Health Science Center at San Antonio, TX, USA daviesm@uthscsa.edu.
Mark G
MG
Davies
Division of Vascular Diseases and Surgery, Wexner Medical Center, Ohio State University, Columbus, OH, USA.
Hosam F
HF
El-Sayed
D000328:Adult; D000368:Aged; D000671:Amputation, Surgical; D016638:Critical Illness; D016208:Databases, Factual; D018450:Disease Progression; D018572:Disease-Free Survival; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D005260:Female; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D007676:Kidney Failure, Chronic / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D018802:Patient-Centered Care; D016491:Peripheral Vascular Diseases / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D016016:Proportional Hazards Models; D012008:Recurrence; D006435:Renal Dialysis / Q000009:adverse effects / Q000401:mortality; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D016909:Tibial Arteries / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
amputation; angioplasty; complications; critical limb ischemia; end-stage renal disease; endovascular intervention; hemodialysis; limb salvage; mortality; tibial artery; tissue loss