Association between readmission care fragmentation and outcomes after interventions for peripheral arterial disease.

OBJECTIVE: Lower extremity revascularization (LER) for peripheral artery disease is complicated by the frequent need for readmission. However, it is unclear if readmission to a nonindex LER facility (ie, a facility different from the one where the LER was performed) compared with the index LER facility is associated with worse outcomes. METHODS: This was a national cohort study of older adults who underwent open, endovascular, or hybrid LER for peripheral artery disease (January 1, 2010, to December 31, 2018) in the Vascular Quality Initiative who were readmitted within 90 days of their vascular procedure. This dataset was linked to Medicare claims and the American Hospital Association Annual Survey. The primary outcome was 90-day mortality and the secondary outcome was major amputation at 90 days after LER. The primary exposure was the location of the first readmission after LER (categorized as occurring at the index LER facility vs a nonindex LER facility). Generalized estimating equations logistic regression models were used to assess the association between readmission location and 90-day mortality and amputation. RESULTS: Among 42,429 patients who underwent LER, 33.0% were readmitted within 90 days. Of those who were readmitted, 27.3% were readmitted to a nonindex LER facility, and 42.2% of all readmissions were associated with procedure-related complications. Compared with patients readmitted to the index LER facility, those readmitted to a nonindex facility had a lower proportion of procedure-related reasons for readmission (21.5% vs 50.1%; P < .001). Most of the patients readmitted to a nonindex LER facility lived further than 31 miles from the index LER facility (39.2% vs 19.6%; P < .001) and were readmitted to a facility with a total bed size of <250 (60.1% vs 11.9%; P < .001). Readmission to a nonindex LER facility was not associated with 90-day mortality or 90-day amputation. However, readmission for a procedure-related complication was associated with major amputation (90-day amputation: adjusted odds ratio, 3.33; 95% confidence interval, 2.89-3.82). CONCLUSIONS: Readmission after LER for a procedure-related complication is associated with subsequent amputation. This finding suggests that quality improvement efforts should focus on understanding various types of procedure-related failure after LER and its role in limb salvage.

Racial Differences in Vascular Assessment Prior to Amputation in the Veterans Health Administration.

Purpose: It is unclear whether disparities in the care provided before lower extremity amputation (LEA) is driven by differences in receipt of diagnostic work-up versus revascularization attempts. Methods: We performed a national cohort study of Veterans who underwent LEA between March 2010 and February 2020 to assess receipt of vascular assessment with arterial imaging and/or revascularization in the year prior to LEA. Results: Among 19,396 veterans (mean age 66.8 years; 26.6% Black), Black veterans had diagnostic procedures more often than White veterans (47.5% vs. 44.5%) and revascularization as often (25.8% vs. 24.5%). Conclusion: We must identify patient and facility-level factors associated with LEA as disparities do not appear related to differences in attempted revascularization.

Association of Health Care Utilization and Access to Care With Vascular Assessment Before Major Lower Extremity Amputation Among US Veterans.

Importance: Patient-level characteristics alone do not account for variation in care among US veterans with peripheral artery disease (PAD). Presently, the extent to which health care utilization and regional practice variation are associated with veterans receiving vascular assessment prior to major lower extremity amputation (LEA) is unknown. Objective: To assess whether demographics, comorbidities, distance to primary care, the number of ambulatory clinic visits (primary and medical specialty care), and geographic region are associated with receipt of vascular assessment prior to LEA. Design, Setting, and Participants: This national cohort study used US Department of Veterans Affairs' Corporate Data Warehouse data from March 1, 2010, to February 28, 2020, for veterans aged 18 or older who underwent major LEA and who received care at Veterans Affairs facilities. Exposures: The number of ambulatory clinic visits (primary and medical specialty care) in the year prior to LEA, geographic region of residence, and distance to primary care. Main Outcomes and Measures: The main outcome was receipt of a vascular assessment (vascular imaging study or revascularization procedure) in the year prior to LEA. Results: Among 19 396 veterans, the mean (SD) age was 66.78 (10.20) years and 98.5% were male. In the year prior to LEA, 8.0% had no primary care visits and 30.1% did not have a vascular assessment. Compared with veterans with 4 to 11 primary care clinic visits, those with fewer visits were less likely to receive vascular assessment in the year prior to LEA (1-3 visits: adjusted odds ratio [aOR], 0.90; 95% CI, 0.82-0.99). Compared with veterans who lived less than 13 miles from the closest primary care facility, those who lived 13 miles or more from the facility were less likely to receive vascular assessment (aOR, 0.88; 95% CI, 0.80-0.95). Veterans who resided in the Midwest were most likely to undergo vascular assessment in the year prior to LEA than were those living in other regions. Conclusions and Relevance: In this cohort study, health care utilization, distance to primary care, and geographic region were associated with intensity of PAD treatment before LEA, suggesting that some veterans may be at greater risk of suboptimal PAD care practices. Development of clinical programs, such as remote patient monitoring and management, may represent potential opportunities to improve limb preservation rates and the overall quality of vascular care for veterans.

Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study.

OBJECTIVE: To evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data. DESIGN: Observational surveillance study. SETTING: 282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18). PARTICIPANTS: 20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models. MAIN OUTCOME MEASURES: Reintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both. RESULTS: Median age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017. CONCLUSIONS: The linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions.

Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment: A Scientific Statement From the American Heart Association.

Peripheral artery disease (PAD) is chronic in nature, and individualized chronic disease management is a central focus of care. To accommodate this reality, tools to measure the impact and quality of the PAD care delivered are necessary. Patient-reported outcomes (PROs) and instruments to measure them, that is, PRO measures, have been well studied in the research and clinical trial context, but a shift toward integrating them into clinical practice has yet to take place. A framework to use PRO measures as indicators of the quality of PAD care delivered, that is, PRO performance measures (PRO-PMs), is provided in this scientific statement. Measurement goals to consider by PAD clinical phenotypes are provided, as well as an overview of potential benefits of adopting PRO-PMs in the clinical practice of PAD care, including reducing unwanted variability and promoting health equity. A central discussion with considerations for risk adjustment of PRO-PMs, individualized PAD care, and the need for patient engagement strategies is offered. Furthermore, necessary conditions in terms of required competencies and training to handle PRO-PM data are discussed because the interpretation and handling of these data come with great responsibility and consequences for designing care that adopts a broader framework of risk that goes beyond the inclusion of biomedical variables. To conclude, health system perspectives and an agenda to reach the next steps in the implementation of PRO-PMs in PAD care are offered.

Patient-level and external factors in the use of drug-coated balloons and drug-eluting stents in femoropopliteal endovascular interventions.

OBJECTIVE: Drug-coated balloons (DCB) and drug-eluting stents (DES) have been rapidly adopted for femoropopliteal endovascular interventions due to their favorable patency rates. It is unclear whether choice of using drug coated devices versus bare metal stents (BMS) or plain balloon angioplasty (POBA) as primary treatment in femoropopliteal disease is mostly associated with patient-level factors, safety concerns, or by operator preferences. This study sought to evaluate factors associated with their use in a contemporary dataset. METHODS: All femoropopliteal lesions treated with endovascular interventions between 2016 and 2019 from the Vascular Quality Initiative registry were included. For each procedure, a primary treatment was identified based on the following hierarchy: DES > DCB > BMS > POBA. A hierarchical logistic regression model predicting DCB or DES use included patient-level characteristics, key events (period after Centers for Medicare and Medicaid Services reimbursement change, January 2018 [vs before] and period after Katsanos meta-analysis December 2018 [vs before]), and random effects for site and operator. Operator-level variability for DCB and DES use was summarized with an adjusted median odds ratio (MOR). RESULTS: A total of 57,753 femoropopliteal endovascular procedures were included. Poor functional status (odds ratio [OR], 0.92; 95% confidence interval [CI], 0.90-0.94), prior anticoagulant use (OR, 0.92; 95% CI, 0.87-0.97), higher Rutherford classification (OR, 0.86; 95% CI, 0.84-0.88), chronic kidney disease stage 4 or 5 (OR, 0.92; 95% CI, 0.86-0.98), and the period after the Katsanos meta-analysis publication (OR, 0.3; 95% CI, 0.29-0.32) were associated with a lower odds of DCB or DES use; whereas female sex (OR, 1.12; 95% CI,1.08-1.17), prior lesion treatment (OR, 1.17; 95% CI, 1.11-1.22), diabetes (OR, 1.07; 95% CI, 1.02-1.12), Trans-Atlantic Inter-Society Consensus class B (OR, 1.16; 95% CI, 1.09-1.24) and C (OR, 1.2; 95% CI, 1.12-1.28), and the period after the Centers for Medicare and Medicaid Services reimbursement change (OR, 1.08; 95% CI, 1.03-1.14) were associated with a higher odds of DCB or DES use. Significant variability in use was found across operators (adjusted MOR, 2.70; 95% CI, 2.55-2.85) and centers (adjusted MOR, 2.89; 95% CI, 2.50-3.27). CONCLUSIONS: DCB or DES use in femoropopliteal disease demonstrates wide variability across operators and is linked strongly with external factors, followed by anatomic lesion characteristics and a history of previous interventions. Future work needs to focus on tailoring DCB or DES use to patient and lesion characteristics and to develop appropriate use guidelines integrating these factors.

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.

Moving forward: Recommendations to overcome existing structural racism.

A critical need exists to address structural racism within academic and community medicine and surgery and determine methods that will serve to repair its long-standing effects and alleviate the associated negative consequences. Because of our broad skillset and the populations we serve, vascular surgeons are uniquely positioned to identify and address the effects of structural racism in our places of work and for the populations we treat. Our goal is to discuss the effects of racism on healthcare outcomes and provide recommendations on how to combat these through equitable practices such as the diversification of the vascular surgery workforce, inclusivity as partners and leaders, and the promotion of improved outcomes among our most vulnerable patients from racial and ethnic minority groups. It is imperative that we stand for antiracism within our field through our societies, journals, clinical trials, training programs, clinical practice groups, and leadership.

Quality-of-life assessment as an outcomes measure in critical limb ischemia.

Critical limb ischemia (CLI) is a diagnosis plagued by significant comorbidity and high mortality rates. Overall survival remains poor in this population regardless of the procedure-related success as demonstrated by freedom from amputation, intervention, and patency. The literature has traditionally focused on physician-centered and lesion-centered outcomes with regards to limb salvage procedures, but there remains a relative paucity of studies of CLI patients describing patient-centered outcomes such as quality of life (QoL), independent living, and ambulation status. Review of the available literature indicates patients do not always experience significant gains in their QoL after limb salvage interventions, despite reasonable graft patency, amputation-free survival, and limb salvage rates. Further research is required using QoL tools in a measurable and clinically relevant fashion to guide optimal quality care that maximizes patient-centered outcomes.