Consensus minimum core data elements adapted to peripheral vascular intervention in the drug-eluting era: Consensus report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways "LEAN" working group.

Registry Assessment of Peripheral Interventional Devices (RAPID) initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of paclitaxel-coated devices, including understanding the basis of the mortality signal, without a demonstrable potential biological mechanism, and whether the late mortality signal could be artifact intrinsic to multiple independent prospective randomized data sources that did not prespecify death as a long-term end point. In response to the directive, the LEAN-Case Report Form working group focused on enhancements to the RAPID Phase I Minimum Core Data set through the addition of key clinical modifiers that would be more strongly linked to longer-term mortality outcomes after peripheral arterial disease intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined.

Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischemia.

OBJECTIVE: Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions. METHODS: We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs. RESULTS: A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75). CONCLUSIONS: Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.

Reprint of: Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischemia.

OBJECTIVE: Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions. METHODS: We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs. RESULTS: A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75). CONCLUSIONS: Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.

Practice patterns surrounding the use of tibial interventions for claudication in the Medicare population.

OBJECTIVE: At present, no data are available to support the use of tibial interventions in the treatment of claudication. We characterized the practice patterns surrounding tibial peripheral vascular interventions (PVIs) for patients with claudication in the United States. METHODS: Using 100% Medicare fee-for-service claims from 2017 to 2019, we conducted a retrospective analysis of all patients who underwent an index PVI for claudication. Patients with any previous PVI, acute limb ischemia, or chronic limb-threatening ischemia in the preceding 12 months were excluded. The primary outcome was the receipt or delivery of tibial revascularization during an index PVI for claudication, defined as tibial PVI with or without concomitant femoropopliteal PVI. Univariable comparisons and multivariable hierarchical logistic regression were used to assess the patient and physician characteristics associated with the use of tibial PVI for claudication. RESULTS: Of 59,930 Medicare patients who underwent an index PVI for claudication between 2017 and 2019, 16,594 (27.7%) underwent a tibial PVI (isolated tibial PVI, 38.5%; tibial PVI with concomitant femoropopliteal PVI, 61.5%). Of the 1542 physicians included in our analysis, the median physician-level tibial PVI rate was 20.0% (interquartile range, 9.1%-37.5%). Hierarchical logistic regression suggested that patient-level characteristics associated with tibial PVI for claudication included male sex (adjusted odds ratio [aOR], 1.23), increasing age (aOR, 1.30-1.96), Black race (aOR, 1.47), Hispanic ethnicity (aOR, 1.86), diabetes (aOR, 1.36), no history of hypertension (aOR, 1.12), and never-smoking status (aOR, 1.64; P < .05 for all). Physician-level characteristics associated with tibial PVI for claudication included early-career status (aOR, 2.97), practice location in the West (aOR, 1.75), high-volume PVI practice (aOR, 1.87), majority of practice in an ambulatory surgery center or office-based laboratory setting (aOR, 2.37), and physician specialty. The odds of vascular surgeons performing tibial PVI were significantly lower compared with radiologists (aOR, 2.98) and cardiologists (aOR, 1.67; P < .05 for all). The average Medicare reimbursement per patient was dramatically higher for physicians performing high rates of tibial PVI (quartile 4 vs quartile 1-3, $12,023.96 vs $692.31 per patient; P < .001). CONCLUSIONS: Tibial PVI for claudication was performed more often by nonvascular surgeons in high-volume practices and high-reimbursement settings. Thus, a critical need exists to reevaluate the indications, education, and reimbursement policies surrounding these procedures.

Index atherectomy peripheral vascular interventions performed for claudication are associated with more reinterventions than nonatherectomy interventions.

OBJECTIVE: Despite limited evidence supporting atherectomy alone over stenting/angioplasty as the index peripheral vascular intervention (PVI), the use of atherectomy has rapidly increased in recent years. We previously identified a wide distribution of atherectomy practice patterns among US physicians. The aim of this study was to investigate the association of index atherectomy with reintervention. METHODS: We used 100% Medicare fee-for-service claims to identify all beneficiaries who underwent elective first-time femoropopliteal PVI for claudication between January 1, 2019, and December 31, 2019. Subsequent PVI reinterventions were examined through June 30, 2021. Kaplan-Meier curves were used to compare rates of PVI reinterventions for patients who received index atherectomy versus nonatherectomy procedures. Reintervention rates were also described for physicians by their overall atherectomy use (by quartile). A hierarchical Cox proportional hazard model was used to evaluate patient and physician-level characteristics associated with reinterventions. RESULTS: A total of 15,246 patients underwent an index PVI for claudication in 2019, of which 59.7% were atherectomy. After a median of 603 days (interquartile range, 77-784 days) of follow-up, 41.2% of patients underwent a PVI reintervention, including 48.9% of patients who underwent index atherectomy versus 29.8% of patients who underwent index nonatherectomy (P < .001). Patients treated by high physician users of atherectomy (quartile 4) received more reinterventions than patients treated by standard physician users (quartiles 1-3) (56.8% vs 39.6%; P < .001). After adjustment, patient factors association with PVI reintervention included receipt of index atherectomy (adjusted hazard ratio [aHR], 1.33; 95% confidence interval [CI], 1.21-1.46), Black race (vs White; aHR; 1.18; 95% CI, 1.03-1.34), diabetes (aHR, 1.13; 95% CI, 1.07-1.21), and urban residence (aHR, 1.11; 95% CI, 1.01-1.22). Physician factors associated with reintervention included male sex (aHR, 1.52; 95% CI, 1.12-2.04), high-volume PVI practices (aHR, 1.23; 95% CI, 1.10-1.37), and physicians with a high use of index atherectomy (aHR, 1.49; 95% CI, 1.27-1.74). Vascular surgeons had a lower risk of PVI reintervention than cardiologists (vs vascular; aHR, 1.22; 95% CI, 1.09-1.38), radiologists (aHR, 1.55; 95% CI, 1.31-1.83), and other specialties (aHR, 1.59; 95% CI, 1.20-2.11). The location of services delivered was not associated with reintervention (P > .05). CONCLUSIONS: The use of atherectomy as an index PVI for claudication is associated with higher PVI reintervention rates compared with nonatherectomy procedures. Similarly, high physician users of atherectomy perform more PVI reinterventions than their peers. The appropriateness of using atherectomy for initial treatment of claudication needs critical reevaluation.

Use of Intravascular Ultrasound During First-Time Femoropopliteal Peripheral Vascular Interventions Among Medicare Beneficiaries.

BACKGROUND: Intravascular ultrasound (IVUS) may be a useful adjunct to lower extremity peripheral vascular interventions (PVI) in certain clinical scenarios. We aimed to identify patient- and physician-level characteristics associated with the use of IVUS during first-time femoropopliteal PVI. METHODS: We included all Medicare beneficiaries undergoing elective femoropopliteal PVI for claudication or chronic limb-threatening ischemia between 01/01/2019 and 12/31/2019. We excluded patients with prior open or endovascular femoropopliteal intervention and all physicians performing ≤10 PVI during the study period. We calculated the proportion of patients who had IVUS performed as part of their index PVI for each physician. Hierarchical logistic regression was used to evaluate patient- and physician-level factors associated with use of IVUS. RESULTS: We identified 58,552 patients who underwent index femoropopliteal PVI, of whom 11,394 (19%) received IVUS. A total of 1,628 physicians performed >10 procedures during the study period, with IVUS utilization ranging from 0-100%. After hierarchical regression, claudication (versus chronic limb-threatening ischemia: OR 1.23, 95% CI 1.11-1.36), stenting (versus angioplasty alone: OR 1.57, 1.33-1.86) and atherectomy (versus angioplasty alone: OR 2.09, 1.83-2.39) were associated with higher odds of IVUS utilization. Higher-volume providers (tertile 3 vs. tertile 1: OR 3.78, 2.43-5.90) and those with high rates of service provided in an office-based laboratory (tertile 3 vs. tertile 1: OR 10.72, 6.78-19.93) were more likely to utilize IVUS. Radiologists (OR 11.23, 5.96-21.17) and cardiologists (OR 1.97, 1.32-2.93) used IVUS more frequently than vascular surgeons. CONCLUSIONS: Wide variability exists in the use of IVUS for first-time femoropopliteal PVI. The association of IVUS with claudication, atherectomy, and office-based laboratories raises concern about its potential overuse by some physicians.

Racial Disparities Associated With Reinterventions After Elective Endovascular Aortic Aneurysm Repair.

BACKGROUND: There are substantial racial and socioeconomic disparities underlying endovascular abdominal aortic aneurysm repair (EVAR) in the United States. To date, race-based variations in reinterventions following elective EVAR have not been studied. Here, we aim to examine racial disparities associated with reinterventions following elective EVAR in a real-world cohort. MATERIALS AND METHODS: We used the Vascular Quality Initiative EVAR dataset to identify all patients undergoing elective EVAR between January 2009 and December 2018 in the United States. We compared the association of race with reinterventions after EVAR and all-cause mortality using Welch two-sample t-tests, multivariate logistic regression, and Cox proportional hazards analyses adjusting for baseline differences between groups. RESULTS: At median follow-up of 1.1 ± 1.1 y (1.3 ± 1.4 y Black, 1.1 ± 1.1 y White; P = 0.02), a total of 1,164 of 42,481 patients (2.7%) underwent reintervention after elective EVAR, including 2.7% (n = 1,096) White versus 3.2% (n = 68) Black (P = 0.21). Black patients requiring reintervention were more frequently female, more frequently current or former smokers, and less frequently insured by Medicare/Medicaid (P < 0.05). After adjusting for baseline differences, the risk of reintervention after elective EVAR was significantly lower for Black versus White patients (HR 0.74, 95% CI 0.55-0.99; P = 0.04). All-cause mortality was comparable between groups (HR 0.81, 95% CI 0.33-2.00, P = 0.65). CONCLUSIONS: There are significant differences between Black and White patients in the risk of reintervention after elective EVAR in the United States. The etiology of this difference deserves investigation.

Use of Atherectomy During Index Peripheral Vascular Interventions.

OBJECTIVES: The aim of this study was to describe physician practice patterns and examine physician-level factors associated with the use of atherectomy during index revascularization for patients with femoropopliteal peripheral artery disease. BACKGROUND: There are minimal data to support the routine use of atherectomy over angioplasty and/or stenting for the endovascular treatment of peripheral artery disease. METHODS: Medicare fee-for-service claims (January 1 to December 31, 2019) were used to identify all beneficiaries undergoing elective first-time femoropopliteal peripheral vascular intervention (PVI) for claudication or chronic limb-threatening ischemia. Hierarchical logistic regression was used to evaluate patient- and physician-level characteristics associated with atherectomy. RESULTS: A total of 58,552 patients underwent index femoropopliteal PVI by 1,627 physicians. There was a wide distribution of physician practice patterns in the use of atherectomy, ranging from 0% to 100% (median 55.1%). Independent characteristics associated with atherectomy included treatment for claudication (vs. chronic limb-threatening ischemia; odds ratio [OR]: 1.51), patient diabetes (OR: 1.09), physician male sex (OR: 2.08), less time in practice (OR: 1.41 to 2.72), nonvascular surgery specialties (OR: 2.78 to 5.71), physicians with high volumes of femoropopliteal PVI (OR: 1.67 to 3.51), and physicians working primarily at ambulatory surgery centers or office-based laboratories (OR: 2.19 to 7.97) (p ≤ 0.03 for all). Overall, $266.8 million was reimbursed by Medicare for index femoropopliteal PVI in 2019. Of this, $240.6 million (90.2%) was reimbursed for atherectomy, which constituted 53.8% of cases. CONCLUSIONS: There is a wide distribution of physician practice patterns for the use of atherectomy during index PVI. There is a critical need for professional guidelines outlining the appropriate use of atherectomy in order to prevent overutilization of this technology, particularly in high-reimbursement settings.

Regional Market Competition is Associated with Aneurysm Diameter at the Time of EVAR.

BACKGROUND: Local market competition has been previously associated with more aggressive surgical decision-making. For example, more local competition for organs is associated with acceptance of lower quality kidney offers in transplant surgery. We hypothesized that market competition would be associated with the size of an abdominal aortic aneurysm (AAA) at the time of elective endovascular aneurysm repair (EVAR). METHODS: We included all elective EVARs reported in the Vascular Quality Initiative database (2012-2018). Small AAAs were defined as a maximum diameter <5.5 cm in men or <5.0 cm in women. We calculated the Herfindahl-Hirschman Index (HHI), a measure of physician market concentration (higher HHI = less market competition), for each US census region. Multilevel regression was used to examine the association between the size of AAA at EVAR and HHI, clustering by region. RESULTS: Of 37,914 EVARs performed, 15,379 (40.6%) were for small AAAs. There was significant variation in proportion of EVARs performed for small AAAs across regions (P < 0.001). The South had both the highest proportion of EVARs for small AAAs (44.2%) as well as the highest market competition (HHI 50), whereas the West had the lowest proportion of EVARs for small AAAs (35.0%) and the lowest market competition (HHI 107). Adjusting for patient characteristics, each 10 unit increase in HHI was associated with a 0.1 mm larger maximum AAA diameter at the time of EVAR (95% CI 0.04-0.24 mm, P = 0.005). CONCLUSIONS: Physician market concentration is independently associated with AAA diameter at time of elective EVAR. These data suggest that physician decision-making for EVAR is impacted by market competition.

Quantifying the risk-adjusted hospital costs of postoperative complications after lower extremity bypass in patients with claudication.

OBJECTIVE: Increasing evidence has shown that the risks associated with surgical revascularization for intermittent claudication outweigh the benefits. The aim of our study was to quantify the cost of care associated with perioperative complications after elective lower extremity bypass (LEB) in patients presenting with intermittent claudication. METHODS: All patients undergoing first-time LEB for claudication in the Healthcare Database (2009-2015) were included. The primary outcome was in-hospital postoperative complications, including major adverse limb events (MALE), major adverse cardiac events (MACE), acute kidney injury, and wound complications. The overall crude hospital costs are reported, and a generalized linear model with log link and inverse Gaussian distribution was used to calculate the predicted hospital costs for specific complications. RESULTS: Overall, 7154 patients had undergone elective LEB for claudication during the study period. The median age was 66 years (interquartile range, 59-73 years), 67.5% were male, and 75.3% were white. Two thirds of patients (61.2%) had Medicare insurance, followed by private insurance (26.9%), Medicaid (7.7%), and other insurance (4.2%). In-hospital complications occurred in 8.5% of patients, including acute kidney injury in 3.0%, MALE in 2.8%, wound complications in 2.3%, and MACE in 1.0%. The overall median crude hospital cost was $11,783 (interquartile range, $8911-$15,767) per patient. The incremental increase in cost associated with a postoperative complication was significant, ranging from $6183 (95% confidence interval, $4604-$7762) for MALE to $10,485 (95% confidence interval, $6529-$14,441) for MACE after risk adjustment. CONCLUSIONS: Postoperative complications after elective LEB for claudication are not uncommon and increase the in-hospital costs by 46% to 78% depending on the complication. Surgical revascularization for claudication should be used sparingly in carefully selected patients.

Race and socioeconomic differences associated with endovascular peripheral vascular interventions for newly diagnosed claudication.

BACKGROUND: Despite guidelines cautioning against the use of endovascular peripheral vascular interventions (PVI) for claudication, more than 1.3 million PVI procedures are performed annually in the United States. We aimed to describe national rates of PVI for claudication, and identify patient and county-level risk factors associated with a high rate of PVI. METHODS: We used the Medicare claims database to identify all Medicare beneficiaries with a new diagnosis of claudication between January 2015 and June 2017. A hierarchical logistic regression model accounting for patient age, sex, comorbidities; county region and setting; and a patient race-county median income interaction was used to assess the associations of race and income with a high PVI rate. RESULTS: We identified 1,201,234 patients with a new diagnosis of claudication for analysis. Of these, 15,227 (1.27%) underwent a PVI. Based on hierarchical logistic regression accounting for patient and county-level factors, black patients residing in low-income counties had a significantly higher odds of undergoing PVI than their white counterparts (odds ratio [OR], 1.30; 95% confidence interval [CI], 1.20-1.40), whereas the odds of PVI for black versus white patients was similar in high-income counties (OR, 1.06; 95% CI, 0.99-1.14). PVI rates were higher for low versus high-income counties in both the black (OR, 1.46; 95% CI, 1.31-1.64) and white (OR, 1.19; 95% CI, 1.12-1.27) groups. There were no significant associations of Hispanic, Asian, North American native, or other races with PVI in either low- or high-income counties after risk adjustment (all P ≥ .09). CONCLUSIONS: In the Medicare population, the mean rate of PVI of 12.7 per 1000 claudication patients varies significantly based on race and income. Our data suggest there are racial and socioeconomic differences in the treatment of claudication across the United States.

Overuse of early peripheral vascular interventions for claudication.

OBJECTIVE: Guidelines from the Society for Vascular Surgery and the Choosing Wisely campaign recommend that peripheral vascular interventions (PVIs) be limited to claudication patients with lifestyle-limiting symptoms only after a failed trial of medical and exercise therapy. We sought to explore practice patterns and physician characteristics associated with early PVI after a new claudication diagnosis to evaluate adherence to these guidelines. METHODS: We used 100% Medicare fee-for-service claims to identify patients diagnosed with claudication for the first time between 2015 and 2017. Early PVI was defined as an aortoiliac or femoropopliteal PVI performed within 6 months of initial claudication diagnosis. A physician-level PVI utilization rate was calculated for physicians who diagnosed >10 claudication patients and performed at least one PVI (regardless of indication) during the study period. Hierarchical multivariable logistic regression was used to identify physician-level factors associated with early PVI. RESULTS: Of 194,974 patients who had a first-time diagnosis of claudication during the study period, 6286 (3.2%) underwent early PVI. Among the 5664 physicians included in the analysis, the median physician-level early PVI rate was low at 0% (range, 0%-58.3%). However, there were 320 physicians (5.6%) who had an early PVI rate ≥14% (≥2 standard deviations above the mean). After accounting for patient characteristics, a higher percentage of services delivered in ambulatory surgery center or office settings was associated with higher PVI utilization (vs 0%-22%; 23%-47%: adjusted odds ratio [aOR], 1.23; 48%-68%: aOR, 1.49; 69%-100%: aOR, 1.72; all P < .05). Other risk-adjusted physician factors independently associated with high PVI utilization included male sex (aOR, 2.04), fewer years in practice (vs ≥31 years; 11-20 years: aOR, 1.23; 21-30 years: aOR, 1.13), rural location (aOR, 1.25), and lower volume claudication practice (vs ≥30 patients diagnosed during study period; ≤17 patients: aOR, 1.30; 18-29 patients: aOR, 1.35; all P < .05). CONCLUSIONS: Outlier physicians with a high early PVI rate for patients newly diagnosed with claudication are identifiable using a claims-based practice pattern measure. Given the shared Society for Vascular Surgery and Choosing Wisely initiative goal to avoid interventions for first-line treatment of claudication, confidential data-sharing programs using national benchmarks and educational guidance may be useful to address high utilization in the management of claudication.

Assessment of Use of Arteriovenous Graft vs Arteriovenous Fistula for First-time Permanent Hemodialysis Access.

Importance: Initial hemodialysis access with arteriovenous fistula (AVF) is associated with superior clinical outcomes compared with arteriovenous graft (AVG) and should be the procedure of choice whenever possible. To address the national underuse of AVF in the United States, the Centers for Medicare & Medicaid has established an AVF goal of 66% or greater in 2009. Objective: To explore contemporary practice patterns and physician characteristics associated with high AVG use compared with AVF use. Design, Setting, and Participants: This review of 100% Medicare Carrier claims between January 1, 2016, and December 31, 2017, includes both inpatient and outpatient Medicare claims data. All patients undergoing initial permanent hemodialysis access placement with an AVF or AVG were included. All surgeons performing more than 10 hemodialysis access procedures during the study period were analyzed. Exposures: Placement of an AVF or AVG for initial permanent hemodialysis access. Main Outcomes and Measures: A surgeon-level AVG (vs AVF) use rate was calculated for all included surgeons. Hierarchical logistic regression modeling was used to identify patient-level and surgeon-level factors associated with AVG use. Results: A total of 85 320 patients (median age, 70 [range, 18-103] years; 47 370 men [55.5%]) underwent first-time hemodialysis access placement, of whom 66 489 (77.9%) had an AVF and 18 831 (22.1%) had an AVG. Among the 2397 surgeons who performed more than 10 procedures per year, the median surgeon level AVG use rate was 18.2% (range, 0.0%-96.4%). However, 498 surgeons (20.8%) had an AVG use rate greater than 34%. After accounting for patient characteristics, surgeon factors that were independently associated with AVG use included more than 30 years of clinical practice (vs 21-30 years; odds ratio, 0.85 [95% CI, 0.75-0.96]), metropolitan setting (odds ratio, 1.25 [95% CI, 1.02-1.54]), and vascular surgery specialty (vs general surgery; odds ratio, 0.77 [95% CI, 0.69-0.86]). Surgeons in the Northeast region had the lowest rate of AVG use (vs the South; odds ratio, 0.83 [95% CI, 0.73-0.96]). First-time hemodialysis access benchmarking reports for individual surgeons were created for potential distribution. Conclusions and Relevance: In this study, one-fifth of surgeons had an AVG use rate above the recommended best practices guideline of 34%. Although some of these differences may be explained by patient referral practices, sharing benchmarked performance data with surgeons could be an actionable step in achieving more high-value care in hemodialysis access surgery.

Temporal trends and hospital costs associated with an endovascular-first approach for acute limb ischemia.

OBJECTIVE: Recent studies suggest similar perioperative outcomes for endovascular and open surgical management of acute limb ischemia (ALI). We sought to describe temporal trends, patient factors, and hospital costs associated with contemporary ALI management. METHODS: We used the weighted National Inpatient Sample to estimate primary ALI cases requiring open or endovascular intervention (2005-2014). We used multivariable regression models to examine temporal trends, patient factors, and hospital costs associated with endovascular-first vs open-first management. RESULTS: Of 116,451 admissions for ALI during the study period, 35.2% were treated by an endovascular-first approach. The percentage of admissions managed with an endovascular-first approach increased over time (P < .001). Independent predictors of endovascular-first management included younger age, male sex, renal insufficiency, and more recent calendar year of admission (P ≤ .02), whereas patients who underwent fasciotomy, those with Medicaid, and those admitted on a weekend were more likely to undergo open-first management (P ≤ .02). Endovascular-first management had higher mean hospital costs than open-first management ($29,719 vs $26,193; P < .001). After adjustment for patient, hospital, and admission characteristics, there was an increase of $981 in treatment costs per year in the endovascular-first group (95% confidence interval [CI], $571-$1392; P < .001), whereas the costs associated with an open-first approach remained relatively stable over time ($10 per year; 95% CI, -$295 to $315; P = .95; P < .001 for interaction). The risk-adjusted odds of in-hospital major amputation was similar in both groups (adjusted odds ratio, 0.99; 95% CI, 0.85-1.15; P = .88). CONCLUSIONS: Use of an endovascular-first approach for the treatment of ALI has significantly increased over time. Although major amputation rates are similar for both approaches, the costs associated with an endovascular-first approach are increasing over time, whereas the costs of open surgery have remained stable. The cost-effectiveness of modern ALI management warrants further investigation.

Contribution of 30-day readmissions to the increasing costs of care for the diabetic foot.

OBJECTIVE: The inpatient cost of care for diabetic foot ulcers (DFUs) has been estimated to be $1.4 billion annually in the United States. We have previously demonstrated that the risk of 30-day unplanned readmission for patients with DFU is nearly 22%. Our aim was to quantify the cost of readmissions for patients admitted with DFU. METHODS: All patients presenting to our multidisciplinary diabetic limb preservation service from June 2012 to June 2016 were enrolled in a prospective database. Inpatient costs and net margins were calculated overall and for index admissions vs 30-day unplanned readmissions. RESULTS: A total of 249 admissions for 150 patients were included. Of these, 206 admissions were index admissions and 43 were 30-day readmissions. The most common reason for readmission was the foot wound (49%), followed by a bypass wound (14%), renal complications (9%), and other systemic complications. Surgical interventions during readmission were common (47%) and included both podiatric (37%) and vascular (23%). The wound healing outcomes were favorable, with 78% of all wounds achieving healing by 1 year. Limb salvage was 91% overall. The median hospital cost per admission was $20,111 (interquartile range, $12,589-$33,254) and did not differ between the index and readmissions ($22,165 vs $19,408; P = .46). However, the hospital net margins were lower after readmission ($3908 vs $1975; P = .02). The overall cost of care for patients requiring readmission was significantly greater than that for patients not readmitted ($79,315 vs $28,977; P < .001). During the study period, DFU care at our institution cost $7.9 million, of which $1.2 million (16%) was attributable to readmission costs. CONCLUSIONS: Readmissions for patients with DFU are common and associated with a substantial cost burden. The cost of readmission for patients with DFU was as high as the cost of the index admission but with lower hospital net margins. When extrapolated to national data, the 15% readmission cost burden we have reported would be equivalent to $210 million hospital costs annually. Focused efforts at preventing readmissions in this high-risk patient population are essential to reducing the overall costs of care associated with DFUs.

Quantifying the costs and profitability of care for diabetic foot ulcers treated in a multidisciplinary setting.

OBJECTIVE: Increasing Wound, Ischemia, and foot Infection (WIfI) stage has previously been shown to be associated with prolonged wound healing time, higher number of surgical procedures, and increased cost of care in patients with diabetic foot ulcers (DFUs) treated in a multidisciplinary setting. However, the profitability of this care model is unknown. We aimed to quantify the hospital costs and net margins associated with multidisciplinary DFU care. METHODS: All patients presenting to our multidisciplinary diabetic limb preservation service (January 2012-June 2016) were enrolled in a prospective database. Inpatient and outpatient costs and net margin (U.S. dollars) were calculated for each wound episode (initial visit until complete wound healing) overall and per day of care according to WIfI classification. RESULTS: A total of 319 wound episodes in 248 patients were captured. Patients required an average of 2.6 ± 0.2 inpatient admissions and 0.9 ± 0.1 outpatient procedures to achieve complete healing. Limb salvage at 1 year was 95.0% ± 2.4%. The overall mean cost of care per wound episode was $24,226 ± $2176, including $41,420 ± $3318 for inpatient admissions and $11,265 ± $1038 for outpatient procedures. The mean net margin was $2412 ± $375 per wound episode, including $5128 ± $622 for inpatient admissions and a net loss ($-3730 ± $596) for outpatient procedures. Mean time to wound healing was 136.3 ± 7.9 days, ranging from 106.5 ± 13.1 days for WIfI stage 1 wounds to 229.5 ± 20.0 days for WIfI stage 4 wounds (P < .001). When adjusted for days of care, the net margin ranged from $2.6 ± $1.3 per day (WIfI stage 1) to $23.6 ± $18.8 (WIfI stage 4). CONCLUSIONS: The costs associated with multidisciplinary DFU care are substantial, especially with advanced-stage wounds. Whereas hospitals can operate at a profit overall, the net margins associated with outpatient procedures performed in a hospital-based facility are prohibitive, and the overall net margins are relatively low, given the labor required to achieve good outcomes. Thus, reimbursement for the multidisciplinary care of DFUs should be re-examined.

Duplex Ultrasound Assessment and Outcomes of Renal Malperfusion Syndromes after Acute Aortic Dissection.

BACKGROUND: We investigated the feasibility of renal duplex ultrasound in the identification of renal malperfusion in acute aortic dissection and evaluated whether intervention for renal malperfusion improved outcomes over best medical management alone. METHODS: All patients with acute aortic dissections involving the renovisceral aorta who underwent a duplex ultrasound were included (2004-2016). We assessed duplex findings among patients who developed acute kidney injury (AKI; 50% increase in serum creatinine) and compared AKI, 30-day mortality, and overall survival among patients who underwent a procedure to treat malperfusion versus those who did not. RESULTS: Of 37 patients with acute dissection involving the renovisceral aorta (73% were male, 59% had type B dissection, mean follow-up 4.6 ± 0.6 years), 70% developed AKI, 11% required dialysis, and 5% developed permanent dialysis dependence. AKI was correlated with higher peak creatinine levels (4.2 vs. 2.2 mg/dL, P < 0.001), although 30-day mortality and overall survival were similar (both, P ≥ 0.24). Progression to AKI was associated with significantly lower end-diastolic velocity (EDV) measurements on renal duplex (17 vs. 27 cm/sec, P = 0.03); an EDV threshold of 23 cm/sec had a positive predictive value of 85% for AKI. Operative intervention (n = 10) was associated with lower follow-up creatinine (0.9 vs. 2.1 mg/dL, P = 0.002), although there was no difference in progression to dialysis dependence, 30-day mortality, or overall survival (all, P ≥ 0.34). CONCLUSIONS: Patients who developed AKI demonstrated characteristic renal duplex ultrasound findings with lower EDV measurements in the distal renal arteries bilaterally. Performing a renal malperfusion procedure was associated with normalization of postoperative creatinine without affecting 30-day mortality or overall survival.

Aortic Surgery Outcomes of Marfan Syndrome and Ehlers-Danlos Syndrome Patients at Teaching and Nonteaching Hospitals.

BACKGROUND: Despite improvements in prevention and management, aortic aneurysm repair remains a high-risk operation for patients with Marfan syndrome (MFS) and Ehlers-Danlos syndrome (EDS). The goal of this study was to examine differences in characteristics and outcomes of patients with MFS or EDS undergoing aortic aneurysm repair at teaching versus nonteaching hospitals. METHODS: We used the National Inpatient Sample to study patients with MFS or EDS undergoing open or endovascular aortic aneurysm repair from 2000 to 2014. RESULTS: Of 3487 patients (MFS = 3375, EDS = 112), 2974 (85%) had repair at a teaching hospital. Patients who underwent repair at a teaching hospital were slightly younger than those who underwent repair at a nonteaching hospital (38 vs. 43 years, P < 0.01) but otherwise were similar in gender (29% vs. 28% female), race (70% vs. 78% white), and connective tissue disorder diagnosis (97% vs. 97% MFS, all P ≥ 0.1). There were no differences in anatomy (17% vs. 19% abdominal, 67% vs. 66% thoracic, and 15% vs. 15% thoracoabdominal, all P ≥ 0.1) or type of repair (5% vs. 5% endovascular), but patients at nonteaching hospitals were more likely to have a dissection (49% vs. 38%, P = 0.02). There was no difference in perioperative mortality (4% vs. 6%, P = 0.5) or length of stay (median 8 days vs. 7 days, P = 0.3) between teaching and nonteaching hospitals. There was also no difference in hemorrhagic (47% vs. 43%), pulmonary (9% vs. 16%), renal (12% vs. 14%), or neurologic (5% vs. 6%) complications between teaching and nonteaching hospitals, respectively (all P ≥ 0.05). In analysis stratified by anatomic extent of repair, there was a lower prevalence of pulmonary complications in thoracic aorta repairs at teaching hospitals (8.1% vs. 18.4%, P = 0.01) but a higher prevalence of hemorrhage in abdominal aortic repairs at teaching hospitals (45.6% vs. 20.6%, P = 0.04) as compared with nonteaching hospitals. CONCLUSIONS: Patients with MFS and EDS who undergo aortic aneurysm repair have their operations predominantly at teaching hospitals, but those patients who undergo repair at nonteaching hospitals do not have worse mortality or morbidity despite a higher incidence of dissection.

High Reintervention and Amputation Rates After Outpatient Atherectomy for Claudication.

Outpatient use of atherectomy for peripheral arterial disease has grown rapidly and outcomes are poorly understood. We analyzed outcomes of atherectomy done for claudication, comparing office and hospital outpatient settings. Analysis of Medicare Part B claims data was performed for incident femoral-popliteal or tibial-peroneal atherectomy from 2012 to 2014. Longitudinal analysis assessed services 18 months before, during, and up to 18 months after the incident peripheral vascular intervention (PVI). Differences between office-based and hospital outpatient-based settings were assessed using χ2 and Fisher exact tests. Comparing procedure settings, significant differences in race (femoral-popliteal: P = .04, tibial-peroneal: P = .001), chronic renal failure (femoral-popliteal: P = .002), and hypertension (femoral-popliteal: P = .01, tibial-peroneal: P = .006) were found. Nine hundred twenty-four patients undergoing femoral-popliteal atherectomy were analyzed (262 office based, 662 hospital outpatient based); 42.7% of office-based and 36.9% of hospital outpatient-based femoral-popliteal atherectomy patients had repeat PVI within 18 months ( P = .10). Major amputation was performed in 2.3% and 3.2% of patients in office and hospital outpatient settings, respectively ( P = .47). Four hundred twenty-three patients undergoing tibial-peroneal atherectomy were analyzed (202 office based, 221 hospital outpatient based); 46.5% of office-based and 38.9% of hospital outpatient-based tibial-peroneal atherectomy patients had repeat PVI within 1 year ( P = .11). Major amputation was performed in 5.0% and 8.1% of patients in office and hospital outpatient settings, respectively ( P = .19). Our study demonstrates higher than expected rates of major amputation for patients undergoing peripheral arterial atherectomy with regard to previously reported rates. Further studies may be required to prove the efficacy and safety of atherectomy for occlusive disease in the femoral-popliteal and tibial-peroneal segments to ensure outcomes are not worse than the natural history of medically managed claudicants.