The shifting care and outcomes for patients with endangered limbs - Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale.

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.

Endovascular Versus Surgical Revascularization for Acute Limb Ischemia: A Propensity-Score Matched Analysis.

BACKGROUND: The optimal revascularization strategy for acute limb ischemia (ALI) remains unclear, and contemporary comparative effectiveness data on endovascular versus surgical revascularization are lacking. METHODS: We used the 2010 to 2014 National Inpatient Sample databases to identify hospitalizations with a primary diagnosis of ALI. Patients were propensity-score matched on the likelihood of undergoing endovascular versus surgical revascularization using a logistic regression model. The primary outcome was in-hospital mortality. Secondary outcomes included myocardial infarction, stroke, composite of death/myocardial infarction/stroke, any amputation, fasciotomy, acute kidney injury, major bleeding, transfusion, vascular complications, length of stay, and hospital costs. RESULTS: Of 10 484 (weighted national estimate=51 914) hospitalizations for ALI, endovascular revascularization was performed in 5008 (47.8%) and surgical revascularization in 5476 (52.2%). In the propensity-score matched cohort (n=7746; 3873 per group), patients who underwent endovascular revascularization had significantly lower in-hospital mortality (2.8% versus 4.0%; P=0.002), myocardial infarction (1.9% versus 2.7%; P=0.022), composite of death/myocardial infarction/stroke (5.2% versus 7.5%; P<0.001), acute kidney injury (10.5% versus 11.9%; P=0.043), fasciotomy (1.9% versus 8.9%; P<0.001), major bleeding (16.7% versus 21.0%; P<0.001), and transfusion (10.3% versus 18.5%; P<0.001), but higher vascular complications (1.4% versus 0.7%; P=0.002), compared with those undergoing surgical revascularization. Rates of any amputation were similar between the 2 groups (4.7% versus 5.1%; P=0.43). Median length of stay was shorter and hospital costs higher with endovascular versus surgical revascularization. CONCLUSIONS: In patients with ALI, endovascular revascularization was associated with better in-hospital clinical outcomes compared with surgical revascularization. Contemporary randomized controlled trials are needed to determine the optimal revascularization strategy for ALI.

Association between health status and sociodemographic, clinical and treatment disparities in the Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) registry.

Patients with peripheral artery disease (PAD) and intermittent claudication (IC) have impaired functional status and quality of life. However, little is known about which factors are associated with poorer health status at the time of initial presentation for PAD specialty care. Characterization of such features might provide insight into disparities that impact health status in this population. A total of 1258 patients from the United States, the Netherlands and Australia with new or worsened IC were enrolled at their first PAD specialty care visit between June 2011 and December 2015. The mean Peripheral Artery Questionnaire (PAQ) Summary Score (range 0-100), a disease-specific health status measure, was 49.2 ± 21.9. Hierarchical, multivariable linear regression was used to relate patient characteristics to baseline PAQ. Patient characteristics independently associated with poorer health status were age ( p < 0.001), female sex ( p < 0.001), not being married ( p = 0.02), economic burden (moderate/severe vs none, moderate/severe vs some; p = 0.03), difficulty getting care (moderate/severe vs none, moderate/severe vs some; p < 0.001), chronic lung disease ( p = 0.02), back pain ( p < 0.001), bilateral vs unilateral PAD ( p = 0.02), intermittent claudication severity (moderate vs mild, severe vs mild, p < 0.001), and lack of prior participation in an exercise program ( p = 0.005). Disparities in both vascular and non-vascular factors were associated with patients' health status at the time of presentation and should be addressed by all who care for patients with vascular disease.

Endovascular Versus Surgical Revascularization for Chronic Mesenteric Ischemia: Insights From the National Inpatient Sample Database.

OBJECTIVES: This study sought to compare in-hospital major adverse cardiac and cerebrovascular events (MACCE) following endovascular therapy with open surgery for chronic mesenteric ischemia (CMI). BACKGROUND: There are limited contemporary data on in-hospital cardiovascular outcomes among patients with CMI undergoing revascularization via endovascular therapy versus open surgery in the United States. METHODS: Patients with CMI undergoing endovascular or surgical (mesenteric bypass or endarterectomy) revascularization between 2007 and 2014 were identified from the National Inpatient Sample. Weighted national estimates were obtained. Primary and secondary endpoints were MACCE (death, myocardial infarction, stroke, cardiac post-operative complications) and composite in-hospital complications (MACCE + post-operative peripheral vascular complications, gastrointestinal hemorrhage, major bleeding, and bowel resection), respectively. Propensity score matching was used to obtain a balanced cohort of 880 unweighted patients in each group. RESULTS: Of 4,150 patients with CMI, 3,206 (77.2%) underwent endovascular therapy and 944 (22.8%) underwent surgery (weighted national estimates of 15,850 and 4,687, respectively). In the propensity-matched cohort, MACCE and composite in-hospital complications occurred significantly less often after endovascular therapy than surgery (8.6% vs. 15.9%; p < 0.001; and 15.3% vs. 20.3%; p < 0.006). Endovascular therapy was also associated with lower median hospital costs ($20,807.00 [interquartile range: $13,640.20 to $32.754.50] vs. $31,137.00 [interquartile range: $21,680.40 to $52,152.20]; p < 0.001, respectively) and shorter length of stay (5 [interquartile range: 2 to 10] vs. 10 [interquartile range: 7 to 17] days, respectively; p < 0.001) compared with open surgery. CONCLUSIONS: In a large, retrospective analysis of patients with CMI, endovascular therapy remained the dominant revascularization modality, and was associated with lower rates of MACCE, composite in-hospital complications, lower costs, and shorter length of stay compared with surgery.

Sex differences in disease-specific health status measures in patients with symptomatic peripheral artery disease: Data from the PORTRAIT study.

Peripheral artery disease (PAD) is associated with poor health status (symptoms, functioning, quality of life (QOL)). Whether sex differences exist in PAD-specific health status is unknown. In patients presenting to a specialty clinic with new-onset or recent exacerbation of PAD, we examined sex differences as assessed by the Peripheral Artery Questionnaire (PAQ). The Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study is a multicenter, international prospective study of patients with new or worsening PAD symptoms. Baseline characteristics and mean PAQ scores were compared among women ( n=481) and men ( n=793) before they underwent treatment. The independent association of sex with health status was assessed with multivariable linear regression. As compared with men, women were less often Caucasian, married and employed, and more often lacking health insurance, living alone (36.2% vs 23.6%, p<0.001), had depression and avoided care due to cost (17.0% vs 12.3%, p=0.018). Women and men were of a similar age and education level, and had similar ankle-brachial index (ABI) values (0.7 ± 0.2 in both groups, p=0.052). Female sex was independently associated with lower PAQ scores on all domains (physical functioning adjusted mean difference of -8.40, p<0.001; social functioning adjusted mean difference of -6.8, p<0.001; QOL adjusted mean difference of -6.7, p<0.001), although no differences were observed in treatment satisfaction (adjusted mean difference -0.20, p=0.904). Despite similar ABIs, women presenting with symptoms of PAD had poorer PAD-specific functioning as compared with men, impacting all major health status domains, independent of socio-economic and clinical characteristics.