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National Treatment Patterns and Outcomes in Patients with End-stage RenalDisease and Chronic Limb-Threatening Ischemia
Samir K Shah, Dan Neal, Scott A Berceli, Michol A Cooper, Martin R Back, Zain Shahid, Mark S Segal, Thomas S Huber, Gilbert R Upchurch, Salvatore T Scali
University of Florida, Gainesville, FL

Background. Although there are therapies for end-stage renal disease (ESRD) and chronic limb-threatening ischemia (CLTI), amputation and mortality rates remain extraordinarily high in patients living with both diseases. Due to the increasing prevalence of ESRD, patients with both diseases will become more common. Importantly, CLTI can be associated with dismal outcomes but there are limited real-world data to further define the impact of ESRD on outcomes nationally in this subset of patients. Therefore, we sought to characterize national patterns of inpatient treatment of CLTI and compare outcomes in patients with or without ESRD.
Methods. The National Inpatient Sample was queried from 2015-2018 for all patients with CLTI. Mixed-effects linear and logistic regression models were used to estimate the effect of ESRD on each outcome (e.g. length of stay) and treatment choice (e.g. major amputation). In all models, a random effect for the hospital was included to account for the clustering of observations on medical center.
Results. A total of 11,652 patients with CLTI alone and 2,705 patients with both ESRD and CLTI were compared. Patients with ESRD were younger (66 vs. 69 years, p<0.0001), less likely to be white (39% vs. 63%, p<0.0001) and had a greater mean number of comorbidities (3.6 vs. 3.1, p<0.0001). Similarly, subjects with ESRD and concurrent CLTI were more likely to reside in lower income and large metropolitan areas compared to CLTI patients without ESRD (Table). In risk-adjusted analysis, ESRD + CLTI patients were significantly less likely to undergo open arterial reconstruction (OR 0.40, p<0.0001) but more likely to receive major limb amputation (OR 1.70, p<0.0001). Correspondingly, ESRD + CLTI subjects had a 4.5- and 1.5-fold higher odds of in-hospital death complications (Figure). These findings were also associated with a longer LOS (p<0.0001), increased probability of being discharged to rehabilitation facility (50% vs. 41%, p<0.0001) and significantly greater costs of care for ESRD CLTI patients compared to those without ESRD ($150K vs. $114K, p<0.0001).
Conclusion. Compared to patients without ESRD, patients with ESRD and CLTI were younger, more commonly non-white, resided in poorer large urban areas, and had a greater number of comorbidities. This subset of patients was less likely to receive open revascularization but more likely to undergo major limb amputations. Moreover, ESRD patients with CLTI had worse overall outcomes and greater resource utilization when compared to CLTI patients without ESRD. Due to the poor in-hospital outcomes in this patient population, national initiatives need to be developed to stimulate longitudinal investigation to help with shared decision-making and identify strategies for improvement in this vulnerable population.

Table. Chronic Limb Threatening Ischemia Patient Characteristics
Feature, No. (%)Overall(N=14,357) No ESRD(N=11,652, 81%) ESRD(N=2,705, 19%) P-value
Age, years (mean)696966<.0001
Female sex38%38%37%.07
-Asian or Pacific Islander2%2%4%<.0001
Mean # comorbiditiesa3.23.13.6<.0001
Income quartileb
Patient population location
Central metro ≥1 mil. Pop.32%30%38%<.0001
Fringe metro ≥ 1 mil. Pop.22%23%22%.5
Metro 250K-999,99920%20%20%.5
Metro 50K-249,9999%9%8%.06
Treatment Exposure
Endovascular intervention42%42%44%.05
Open revascularization27%30%13%<.0001
Major limb amputation20%18%28%<.0001
In-hospital Outcomes
Major complication20%19%23%<.0001
Length of stay, days9911<.0001
Discharge to home29%31%21%<.001
Cost of Care ($1000s)121114150<.0001
aElixhauser comorbidity index classification; bIncome quartile based upon patient's home address zip code

Figure. Risk-Adjusted Effects of ESRD on CLTI Patient Treatment and Outcomes

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