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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., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Physician-oriented outcomes, such as patency and amputation-free survival (AFS), have traditionally been markers of success after lower extremity revascularization. Previous studies have defined clinical success based on a composite of patient-centered outcomes and have shown this outcome to be achieved in less than 50% of patients, far lower than standard physician-oriented outcomes. The purpose of this study is to evaluate clinical success after lower extremity bypass (LEB) or peripheral vascular intervention (PVI) for tissue loss in diabetic patients treated in a multidisciplinary setting to better understand what factors are associated with success from a patient's perspective., Methods: All patients presenting to our multidisciplinary diabetic limb preservation service from July 2012 to January 2020 were enrolled in a prospective database. Patients who underwent either LEB or PVI for ulcer or gangrene were included in the analysis. Clinical success was defined as the composite outcome of secondary patency to the point of wound healing, limb salvage for 1 year, maintenance of ambulatory status for 1 year, and survival for 6 months. Secondary outcomes included 1-year wound healing, patency, and AFS., Results: A total of 134 revascularizations were performed in 131 patients, including 91 (68%) PVI and 43 (32%) LEB. Patients were more frequently male (64%) and black (61%), and 16% were dialysis-dependent. All patients had tissue loss (53% ulcer, 47% gangrene). There were 5 (3.7%) wound, ischemia, and foot infection stage 1, 6 (6.0%) stage 2, 29 (22%) stage 3, and 92 (69%) stage 4 limbs at the time of revascularization. Overall, 76.9% of patients preserved secondary patency to the point of wound healing, 92.5% had limb salvage for 1 year, 90.3% had maintenance of ambulatory status for 1 year, and 96.3% survived for 6 months. The clinical success composite outcome was achieved in 71.6% of patients and was not statistically different between those undergoing PVI vs LEB (69.2% vs 76.7%, P = .37). Secondary patency, limb salvage, and AFS at 1 year were 80.8% ± 3.6%, 91.8% ± 2.3%, and 83.3% ± 3.1%, respectively. Wound healing at 1 year was 84.3% ± 3.4%. The only covariate associated with clinical failure on multivariable analysis was increased age (odds ratio, 0.95; 95% confidence interval, 0.91-0.99; P = .008)., Conclusions: Among diabetic patients presenting with tissue loss, the composite outcome of patient-centered clinical success is lower than traditional physician-centered outcomes after lower extremity revascularization, mostly due to low rates of secondary patency to the point of wound healing. In the current study, clinical failure was only associated with older age and was no different after PVI compared with LEB., (Copyright © 2022. Published by Elsevier Inc.)

Objective: Anatomic grading systems have historically been poor predictors of patency after endovascular tibial interventions. The Global Vascular Guidelines proposed a new Global Anatomic Staging System (GLASS) to estimate one-year limb-based patency (LBP). The purpose of this study was to determine the association of GLASS with LBP following endovascular tibial interventions., Methods: We included all patients presenting to our multidisciplinary diabetic limb preservation service between 01/2012 and 8/2020 who underwent first-time endovascular tibial revascularization for chronic limb-threatening ischemia. Diagnostic angiograms were reviewed to define the preferred target artery pathway and assign a GLASS stage to each treated limb. One-year LBP was calculated and compared across GLASS stages using Kaplan-Meier curves with log-rank tests and Cox proportional hazards models., Results: We performed tibial revascularization in 96 limbs (5.2% rest pain, 56.3% ulcer, 37.5% gangrene), including isolated tibial interventions in 61.5% and tibial + femoropopliteal interventions in 38.5%. 15.6% of limbs were GLASS stage 1, 28.1% were GLASS stage 2, and 56.3% were GLASS stage 3. Overall, one-year LBP was 43.2 ± 6.3%, and did not differ significantly across GLASS stages (P = 0.42). The hazard ratio for failed LBP was 1.94 (95% CI 0.70-5.41) for GLASS stage 2 and 1.49 (95% CI 0.56-3.94) for GLASS stage 3 limbs (versus GLASS stage 1). When analyzed excluding the calcium modifier, LBP remained similar across GLASS stages (P = 0.72). Major amputation was uncommon, occurring in 9.3 ± 3.4% of limbs at one year, and did not significantly differ by GLASS stage (P = 0.98)., Conclusion: The Global Anatomic Staging System did not predict limb-based patency following tibial endovascular interventions. Given the low major amputation rates in this cohort, anatomic complexity should not preclude endovascular limb salvage efforts below the knee., (Copyright © 2021. Published by Elsevier Inc.)

The Society for Vascular Surgery Alternative Payment Model (APM) Taskforce document explores the drivers and implications for developing objective value-based reimbursement plans for the care of patients with peripheral arterial disease (PAD). The APM is a payment approach that highlights high-quality and cost-efficient care and is a financially incentivized pathway for participation in the Quality Payment Program, which aims to replace the traditional fee-for-service payment method. At present, the participation of vascular specialists in APMs is hampered owing to the absence of dedicated models. The increasing prevalence of PAD diagnosis, technological advances in therapeutic devices, and the increasing cost of care of the affected patients have financial consequences on care delivery models and population health. The document summarizes the existing measurement methods of cost, care processes, and outcomes using payor data, patient-reported outcomes, and registry participation. The document also evaluates the existing challenges in the evaluation of PAD care, including intervention overuse, treatment disparities, varied clinical presentations, and the effects of multiple comorbid conditions on the cost potentially attributable to the vascular interventionalist. Medicare reimbursement data analysis also confirmed the prolonged need for additional healthcare services after vascular interventions. The Society for Vascular Surgery proposes that a PAD APM should provide patients with comprehensive care using a longitudinal approach with integration of multiple key medical and surgical services. It should maintain appropriate access to diagnostic and therapeutic advancements and eliminate unnecessary interventions. It should also decrease the variability in care but must also consider the varying complexity of the presenting PAD conditions. Enhanced quality of care and physician innovation should be rewarded. In addition, provisions should be present within an APM for high-risk patients who carry the risk of exclusion from care because of the naturally associated high costs. Although the document demonstrates clear opportunities for quality improvement and cost savings in PAD care, continued PAD APM development requires the assessment of more granular data for accurate risk adjustment, in addition to largescale testing before public release. Collaboration between payors and physician specialty societies remains key., (Copyright © 2020 Society for Vascular Surgery. All rights reserved.)

Background: The U.S. healthcare system is undergoing a broad transformation from the traditional fee-for-service model to value-based payments. The changes introduced by the Medicare Quality Payment Program, including the establishment of Alternative Payment Models, ensure that the practice of vascular surgery is likely to face significant reimbursement changes as payments transition to favor these models. The Society for Vascular Surgery Alternative Payment Model taskforce was formed to explore the opportunities to develop a physician-focused payment model that will allow vascular surgeons to continue to deliver the complex care required for peripheral arterial disease (PAD)., Methods: A financial analysis was performed based on Medicare beneficiaries who had undergone qualifying index procedures during fiscal year 2016 through the third quarter of 2017. Index procedures were defined using a list of Healthcare Common Procedural Coding (HCPC) procedure codes that represent open and endovascular PAD interventions. Inpatient procedures were mapped to three diagnosis-related group (DRG) families consistent with PAD conditions: other vascular procedures (codes, 252-254), aortic and heart assist procedures (codes, 268, 269), and other major vascular procedures (codes, 270-272). Patients undergoing outpatient or office-based procedures were included if the claims data were inclusive of the HCPC procedure codes. Emergent procedures, patients with end-stage renal disease, and patients undergoing interventions within the 30 days preceding the index procedure were excluded. The analysis included usage of postacute care services (PACS) and 90-day postdischarge events (PDEs). PACS are defined as rehabilitation, skilled nursing facility, and home health services. PDEs included emergency department visits, observation stays, inpatient readmissions, and reinterventions., Results: A total of 123,180 cases were included. Of these 123,180 cases, 82% had been performed in the outpatient setting. The Medicare expenditures for all periprocedural services provided at the index procedure (ie, professional, technical, and facility fees) were higher in the inpatient setting, with an average reimbursement per index case of $18,755, $34,600, and $25,245 for DRG codes 252 to 254, DRG codes 268 and 269, and DRG codes 270 to 272, respectively. Outpatient facility interventions had an average reimbursement of $11,458, and office-based index procedures had costs of $11,533. PACS were more commonly used after inpatient index procedures. In the inpatient setting, PACS usage and reimbursement were 58.6% ($5338), 57.2% ($4192), and 55.9% ($5275) for DRG codes 252 to 254, DRG codes 268 and 269, and DRG codes 270 to 272, respectively. Outpatient facility cases required PACS for 13.7% of cases (average cost, $1352), and office-based procedures required PACS in 15% of cases (average cost, $1467). The 90-day PDEs were frequent across all sites of service (range, 38.9%-50.2%) and carried significant costs. Readmission was associated with the highest average PDE expenditure (range, $13,950-$18.934). The average readmission Medicare reimbursement exceeded that of the index procedures performed in the outpatient setting., Conclusions: The cost of PAD interventions extends beyond the index procedure and includes relevant spending during the long postoperative period. Despite the analysis challenges related to the breadth of vascular procedures and the site of service variability, the data identified potential cost-saving opportunities in the management of costly PDEs. Because of the vulnerability of the PAD patient population, alternative payment modeling using a bundled value-based approach will require reallocation of resources to provide longitudinal patient care extending beyond the initial intervention., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Randomized studies suggest that open lower extremity revascularization procedures are associated with improved outcomes compared with endovascular peripheral vascular interventions (PVIs). However, advances in endovascular technologies and treatment by multidisciplinary limb preservation teams have shown improved outcomes. The aim of our study was to compare perioperative and long-term outcomes after open versus PVI procedures in diabetic patients with chronic limb-threatening ischemia (CLTI) treated in a multidisciplinary setting., Methods: All patients presenting to our multidisciplinary diabetic limb-preservation service from 6/2012 to 07/2018 were enrolled in a prospective database. Patients who underwent either an open lower extremity bypass (LEB) or a PVI for CLTI were included in the analysis. Perioperative (30-day) complications and 4-year patency and limb salvage rates were compared between PVI and LEB using chi-squared tests, Kaplan-Meier curve analyses, and stepwise multivariable Cox proportional hazards models., Results: A total of 195 lower extremity revascularization procedures were performed in 120 patients (mean age: 65.0 ± 1.0 years, 61.7% male, 63.3% black), including 53 (27.2%) open procedures and 142 (72.8%) PVIs. Nearly two-thirds of procedures (65.6%) treated multilevel diseases, while 27.2% treated isolated tibial disease and 7.2% treated isolated femoropopliteal disease. More than half of the procedures (53.3%) were performed for Wound, Ischemia, and foot Infection (WIfI) classification stage 4 limbs, 25.1% for stage 3, and 21.6% for stage 1/2. In the LEB group, 67.9% of targets were infrapopliteal. In the PVI group, 63.4% of procedures were isolated tibial interventions or were multilevel interventions including the tibial segment. Perioperative complications occurred in 52.8% of LEB versus 12.0% of PVI (P < 0.001). At 4 years postoperatively, there was no significant difference in crude (unadjusted) primary patency for PVI versus LEB (34.5 ± 6.6% vs. 49.6 ± 8.1, P = 0.89). Secondary patency was better for the LEB group (50.3 ± 7.4% vs. 55.4 ± 7.5%; P = 0.04), but amputation-free survival was similar (65.1 ± 6.7% vs. 60.9 ± 9.7%; P = 0.79). After adjusting for baseline differences between groups, primary patency (hazard ratio [HR]: 0.61; 95% confidence interval [CI]: 0.34 to 1.10) and amputation-free survival (HR: 1.51; 95% CI: 0.71 to 2.34) remained similar for PVI versus LEB, but secondary patency was persistently lower for PVI (HR: 0.35; 95% CI: 0.14 to 0.90)., Conclusions: In this cohort of diabetic patients with CLTI undergoing predominantly tibial interventions, open revascularization was associated with a higher risk of perioperative complications than PVIs. While secondary patency rates were better after LEBs, our data suggest that an endovascular-first approach results in equivalent long-term amputation-free survival for diabetic patients treated in a multidisciplinary setting., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Existing endovascular therapies for failing infrainguinal bypass grafts are associated with modest patency rates. The use of everolimus drug-eluting stents (eDESs) for endovascular bypass graft revision has not yet been reported. The objective of this study was to describe and to compare clinical outcomes of eDESs vs percutaneous cutting balloons (PCBs) vs percutaneous transluminal angioplasty (PTA) for the treatment of infrainguinal bypass graft stenoses., Methods: A multicenter, single-institution retrospective analysis of patients with infrainguinal bypass graft stenoses treated by endovascular intervention (August 2010-December 2017) was conducted. The primary study outcome was primary patency of the treated lesion. The secondary outcome was limb salvage. Outcomes are described overall and stratified by endovascular treatment modality using Kaplan-Meier curves and log-rank tests., Results: During the 7-year study period, 43 patients with 78 infrainguinal bypass stenoses were treated by endovascular intervention (eDES, 15; PCB, 23; PTA, 40). Mean age was 63.3 ± 1.7 years, 53.5% were male, and 55.8% were black. The majority of patients were diabetic (60.5%) with a history of smoking (74.4%), and nearly all (83.7%) had two or more comorbidities. Half (48.7%) of bypasses treated were femoral-popliteal bypasses, followed by popliteal-distal (25.6%) and femoral-tibial (25.6%) configurations. The location of revision was the proximal anastomosis in 37.2%, midbypass in 25.6%, and distal anastomosis in 37.2%. There were no significant differences in baseline characteristics, bypass configuration, or revision location between treatment groups (P ≥ .19). Technical success for endovascular bypass intervention was 100%. At 2 years after intervention, primary patency was significantly better for patients treated with eDES (81.8%) compared with PCB (54.7%) or PTA (33.2%; log-rank, P = .03). Limb salvage was achieved in 93.6% of patients, including 86.7%, 91.3%, and 97.5% for eDES, PCB, and PTA, respectively (P = .30)., Conclusions: This is the first study reporting the results of eDESs for the treatment of infrainguinal bypass graft stenoses. Use of eDESs for endovascular bypass graft revision not only is feasible but may have better primary patency than other endovascular therapies. These data suggest that eDESs may be considered a safe and efficacious endovascular technique in the armamentarium for treatment of infrainguinal bypass graft stenoses., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The burden of metabolic syndrome (MetS) is increasing in the United States and is pervasive among patients with peripheral arterial disease. Whereas MetS has been implicated in the development of all types of cardiovascular disease and adverse outcomes after vascular interventions, little is known about how MetS influences perioperative outcomes of lower extremity bypass surgery and whether any negative effects can be modified by use of cardiovascular risk-modifying medications., Methods: We used the National Surgical Quality Improvement Program vascular procedure-targeted database to capture patients undergoing infrainguinal bypass surgery between 2011 and 2015. We defined MetS using the modified MetS criteria: concomitant diabetes, hypertension, and body mass index >30 kg/m 2 . We used multivariable logistic regression analyses to examine the association between MetS and 30-day postoperative morbidity and mortality. We also examined whether preoperative aspirin, statin, and beta blockade modify the effects of MetS on 30-day postoperative outcomes., Results: Of 10,053 patients who underwent infrainguinal bypass, 16% (1693) met criteria for MetS. After adjusting for covariates, MetS was significantly (P ≤ .05) associated with higher odds of postoperative myocardial infarction (odds ratio [OR], 1.66), infection (OR, 1.76), renal dysfunction (OR, 2.42), and length of stay (0.34 days). Within the MetS subgroup, there were no significant associations between use of preoperative cardiovascular risk-modifying agents and postoperative outcomes, with the exception of beta blockade and an increase in length of stay (0.33 days)., Conclusions: Patients with MetS undergoing infrainguinal bypass surgery are at an increased risk of postoperative complications, including myocardial infarction. This elevated risk persists despite medical therapy with preoperative aspirin, statin, and beta blockade., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Smoking has been implicated as the single most important risk factor for the development of peripheral arterial disease. Whereas previous studies have found poor long-term outcomes in smokers undergoing lower extremity bypass, there is a lack of consistent reports describing the effects of persistent tobacco abuse on early outcomes after infrainguinal bypass., Methods: The American College of Surgeons National Surgical Quality Improvement Program database from 2005 to 2011 was queried for primary infrainguinal bypasses. A bivariate analysis was done to assess preoperative and intraoperative risk factors for the primary outcome of 30-day graft failure comparing active smokers with nonsmokers, defined as patients who did not smoke within the 12 months before surgery. Multivariable logistic regression was conducted to assess the independent association of active smoking with graft failure., Results: In 6614 (40.0%) active smokers and 9920 (60.0%) nonsmokers, 16,534 infrainguinal bypasses were performed. Active smokers were more likely to be younger, male, and of nonwhite race and to have a history of chronic obstructive pulmonary disease (P < .001, all). Nonsmokers were more likely to be functionally dependent and had significantly more comorbidities (ie, hypertension, diabetes, obesity, congestive heart failure, history of previous cardiac surgery or intervention, and dialysis; P < .001, all). The presence of critical limb ischemia was similar in both groups (53.1% of active smokers vs 53.5% of nonsmokers; P = .61). More nonsmokers received a tibial-level bypass than did active smokers (47.8% vs 33.9%; P < .001). There was a trend toward increased early graft failure in active smokers compared with nonsmokers (5.3% vs 4.7%; P = .08). With adjustment for other variables, especially bypass level and graft type, there was an independent association between active smoking and early graft failure (adjusted odds ratio, 1.21; 95% confidence interval, 1.02-1.43; P = .03)., Conclusions: Although nonsmokers were significantly older, had more comorbidities, and required more distal revascularization, active smokers still had an increased risk for development of early graft failure. These results stress the need for immediate smoking cessation before lower extremity bypass. Further research is warranted to determine an optimal period of abstinence among smokers with peripheral arterial disease to reduce their risk for early graft failure., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)