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BACKGROUND: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients' preferences, or outcomes, as seen from patients' perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI. METHODS: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers. RESULTS: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American. CONCLUSIONS: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes.ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.
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BACKGROUND: While it is anticipated that decubitus ulcers are detrimental to outcomes after vascular operations, the contemporary influence of perioperative decubitus ulcers in vascular surgery remains unknown. METHODS: Using the National Impatient Survey, all adult patients who underwent vascular operation were selected. Patients were stratified by the presence or absence (non-decubitus ulcers) of decubitus ulcer. Case-mix adjusted hierarchical mixed-models examined in-hospital mortality, the occurrence of any complication, and discharge disposition. RESULTS: A total of 538,808 cases were analyzed. Decubitus ulcers were most prevalent among Caucasian male Medicare beneficiaries (P < .001). Decubitus ulcer patients also underwent more nonelective vascular operations (P < .001). Wound, infectious, and procedural complications were more common in patients with decubitus ulcers (P < .001). Failure to rescue, defined as mortality after any complication, was more than doubled in decubitus ulcers (non-decubitus ulcers: 1.5%, decubitus ulcers: 3.2%, P < .001). Similarly, unadjusted mortality was also doubled in patients undergoing vascular operation with decubitus ulcers (non-decubitus ulcers: 3%, decubitus ulcers: 6%, P < .001). After risk adjustment among all patients, neither the presence of a decubitus ulcer nor specific ulcer staging increased the adjusted odds of death. Having a decubitus ulcer increased the adjusted odds of discharge to an intermediate care facility (odds ratio 2.9, P < .001). These patients also had 1.6 times the total charges compared to their non-decubitus ulcer cohort (non-decubitus ulcers: $49,460 ± $281 vs decubitus ulcers: $81,149 ± $5,855, P < .001). CONCLUSION: Contrary to common perception, perioperative decubitus ulcer does not adversely affect mortality after vascular operation in patients proceeding to operative intervention. Patients with decubitus ulcers are, however, at higher risk for complications and incur sizeable additional charges.