Outcomes and perspectives on treatment for critical limb ischemia in patients with end-stage renal disease

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Project Summary/Abstract Amputation and mortality rates are extraordinarily high for patients living with both advanced peripheral arterial disease, or critical limb ischemia (CLI), and end-stage renal disease (ESRD). Treatment choices for patients with CLI include catheter-based procedures (e.g. vascular stenting), surgery (e.g. bypass), primary amputation, or symptom control alone (e.g. pain management and wound care). Overall, CLI has dismal outcomes with a 25% mortality and a 30% major amputation rate at one year from diagnosis. Limited data suggest even worse outcomes for patients with ESRD – for example, approximately 50% mortality at 18 months. The existing literature on outcomes is limited by small sample sizes, short follow-up, and a focus on only two of the treatment options, catheter-based interventions and surgery. Patients with ESRD and CLI are often faced with difficult treatment decisions that are complicated by a lack of 1) robust real-world evidence on outcomes and 2) clinical care guidelines. Shared decision-making often relies on these types of information. ESRD is a life-limiting disease and treatment of CLI is resource-intensive. Nevertheless, there are no existing cardiovascular or nephrology society guidelines regarding CLI treatment in patients with ESRD. Knowledge of outcomes of CLI treatment in patients with ESRD, factors affecting CLI treatment selection, and guidelines to direct care would unequivocally improve care by helping to align patient values and preferences with treatment decisions. Owing to these gaps in knowledge, I propose a mixed methods approach using the national Medicare data 2017-2019 to understand 1) factors affecting treatment selection, and 2) traditional and patient-centered outcomes after treatment of CLI in patients with ESRD, complemented by 3) a Delphi panel of expert health care providers and patients to help inform the establishment of care guidelines and identification of research priorities. In addition to helping develop critical data on patients with ESRD and CLI, this proposal will be an essential step in my development as an independent investigator. My long-term career goals are to develop a research program focusing on outcomes of treatment and decision-making surrounding peripheral arterial disease. I hope to advance the field of vascular surgery health services research to improve patient outcomes and aid physicians and patients in aligning decision-making with patient goals and values. This proposal will immediately contribute to my short-term career objectives: increasing expertise with use of Medicare fee-for- service claims data, understanding the practice of nephrology as it applies to ESRD and comorbid conditions such as CLI, learning relevant advanced quantitative and qualitative techniques, and improving grant writing, leadership, and other career development skills. This proposal will take place in the resource-rich environment of the University of Florida College of Medicine under the guidance of an expert mentoring team.