Updated estimates for the burden of chronic limb-threatening ischemia in the Medicare population

Objective: Estimates of chronic limb-threatening ischemia (CLTI) based on diagnosis codes of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) suggest a prevalence of 0.23%-0.32% and incidence of 0.20%-0.26% among Medicare patients. ICD-10-CM includes 144 CLTI diagnosis codes, allowing improved specificity in identifying affected patients. We sought to use ICD-10-CM diagnosis codes to determine the prevalence of CLTI among Medicare patients and describe the patient cohort affected by this condition.

Methods: Using two years of data from Centers for Medicare and Medicaid Services, we identified all patients that had at least one CLTI diagnosis code to determine prevalence and incidence rates. Sensitivity analyses were performed to compare our methodology to prior publications and quantify the extent of missed diagnoses. The number and type of vascular procedures that occurred after diagnosis were tabulated. A cohort of patients with two or more CLTI diagnosis codes were then identified for further descriptive analysis. Associations between patient demographics and survival were analyzed using Cox proportional hazards models.

Results: Over 65 million patients were enrolled in Medicare in 2017 to 2018. Of these, 480,227 had diagnosis of CLTI, with a corresponding to a 1-year incidence of 0.33% and a 2-year prevalence of 0.74%. Patients underwent an average of 43.6 vascular procedures per 100 person-years. Sensitivity analyses identified 89,805 additional patients that had a diagnosis code of peripheral arterial disease who underwent revascularization or amputation. Patients with CLTI were predominantly male (56.2%), white (76.4%), and qualified for Medicare due to age (64.0%). Thirty-seven percent were dual-eligible. One-year survival was 77.7%, significantly lower than estimated actuarial survival adjusted for age, sex, and race (95.1%; P < .001). Cox proportional hazards models demonstrate significantly increased mortality for men vs women (hazard ratio, 1.07; 95% confidence interval, 1.04-1.10; P < .001), but no association between race and overall survival (hazard ratio, 0.99; 95% confidence interval, 0.98-1.01; P = .83).

Conclusions: Using ICD-10-CM diagnosis codes, we demonstrated slightly higher incidence and prevalence of CLTI than in published literature, reflecting our more complete methodology. Sensitivity analyses suggest that increased complexity of the highly specific ICD-10-CM coding may diminish capture of CLTI. Inclusion of patients with non-CLTI peripheral arterial disease diagnoses produces moderate increases in incidence and prevalence at the cost of decreased specificity in identifying patients with CLTI. Medicare patients with CLTI are older, and more commonly male, black, and dual eligible compared with the general Medicare population. Observed mid-term survival for patients with CLTI is significantly lower than actuarial estimates, confirming the importance of focused efforts on identifying and aligning goals of care in this complex patient population.