Cost Analysis of Target Lesion Revascularisation in Patients With Femoropopliteal In Stent Re-Stenosis or Occlusion: The COSTLY-TLR Study.

OBJECTIVE: To report the cost of target lesion revascularisation procedures (TLR) for femoropopliteal peripheral artery disease (PAD) following stenting, from a healthcare payer's perspective. METHODS: European multicentre study involving consecutive patients requiring femoropopliteal TLR (January 2017 - December 2021). The primary outcome was overall cost (euros) associated with a TLR procedure from presentation to discharge. Exact costs per constituent, clinical characteristics, and early outcomes were reported. RESULTS: This study included 482 TLR procedures (retrospectively, 13 hospitals, six countries): 56% were female, mean age was 75 ± 2 years, 61% were Rutherford class 5 or 6, 67% had Tosaka class 3 disease, and 16% had common femoral or iliac involvement. A total of 52% were hybrid procedures and 6% involved open surgery only. Technical success was 70%, 30 day mortality rate was 1%, and the 30 day major amputation rate was 4%. Most costs were for operating time during the TLR (healthcare professionals' salaries, indirect and estate costs), with a mean of: €21 917 ± €2 110 for all procedures; €23 337 ± €8 920 for open procedures; €12 903 ± €3 108 for endovascular procedures; and €22 806 ± €3 977 for hybrid procedures. In a regression analysis, procedure duration was the main parameter associated with higher overall TLR costs (coefficient, 2.77; standard error, 0.88; p < .001). The mean cost per operating minute of TLR (indirect, estate costs, all salaried staff present included) was €177 and the mean cost per night stay in hospital (outside intensive care unit) was €356. The mean cost per overnight intensive care unit stay (minimum of 8 hours per night) was €1 193. CONCLUSION: The main driver of the considerable peri-procedure costs associated with femoropopliteal TLR was procedure time.

The impact of the Affordable Care Act Medicaid Expansion in Medicare beneficiaries with peripheral artery disease.

Background: In 2014, the Affordable Care Act Medicaid Expansion (ME) increased Medicaid eligibility for adults with an income level up to 138% of the federal poverty level. In this study, we examined the impact of ME on mortality and amputation in patients with peripheral artery disease (PAD). Methods: The 100% MedPAR and Part-B Carrier files from 2011 to 2018 were queried to identify all fee-for-service Medicare beneficiaries with PAD using International Classification of Diseases codes. Our primary exposure was whether a state had adopted the ME on January 1, 2014. Our primary outcomes were the change in all-cause 1-year mortality and leg amputation. We used a state-level difference-in-differences (DID) analysis to compare the rates of the primary outcomes among patients who were in states (including the District of Columbia) who adopted ME (n = 25) versus those who were in states that did not (n = 26). We performed a subanalysis stratifying by sex, race, region, and dual-eligibility status. Results: Over the 8-year period, we studied 37,743,929 patients. The average unadjusted 1-year mortality decreased from 2011 to 2018 in both non-ME (9.5% to 8.7%, p < 0.001) and ME (9.1% to 8.3%, p < 0.001) states. The average unadjusted 1-year amputation rate did not improve in either the non-ME (0.86% to 0.87%, p = 0.17) or ME (0.69% to 0.69%, p = 0.65) states. Across the entire cohort, the DID model revealed that ME did not lead to a significant change in mortality (p = 0.15) or amputation (p = 0.34). Conclusion: Medicaid Expansion was not associated with reduced mortality or leg amputation in Medicare beneficiaries with PAD.

Bench-to-Bedside in Vascular Medicine: Optimizing the Translational Pipeline for Patients With Peripheral Artery Disease.

Peripheral arterial disease is a growing worldwide problem with a wide spectrum of clinical severity and is projected to consume >$21 billion per year in the United States alone. While vascular researchers have brought several therapies to the clinic in recent years, few of these approaches have leveraged advances in high-throughput discovery screens, novel translational models, or innovative trial designs. In the following review, we discuss recent advances in unbiased genomics and broader omics technology platforms, along with preclinical vascular models designed to enhance our understanding of disease pathobiology and prioritize targets for additional investigation. Furthermore, we summarize novel approaches to clinical studies in subjects with claudication and ischemic ulceration, with an emphasis on streamlining and accelerating bench-to-bedside translation. By providing a framework designed to enhance each aspect of future clinical development programs, we hope to enrich the pipeline of therapies that may prevent loss of life and limb for those with peripheral arterial disease.

Cost-effectiveness analysis of ankle-brachial index screening in patients with coronary artery disease to optimize medical management.

INTRODUCTION: Screening for peripheral artery disease (PAD) with the ankle-brachial index (ABI) test is currently not recommended in the general population; however, previous studies advocate screening in high-risk populations. Although providers may be hesitant to prescribe low-dose rivaroxaban to patients with coronary artery disease (CAD) alone, given the reduction in cardiovascular events and death associated with rivaroxaban, screening for PAD with the ABI test and accordingly prescribing rivaroxaban may provide additional benefits. We sought to describe the cost-effectiveness of screening for PAD in patients with CAD to optimize this high-risk populations' medical management. METHODS: We used a Markov model to evaluate the ABI test in patients with CAD. We assumed that all patients screened would be candidates for low-dose rivaroxaban. We assessed the cost of ABI screening at $100 per patient and added additional charges for physician visits ($100) and rivaroxaban cost ($470 per month). We used a 30-day cycle and performed analysis over 35 years. We evaluated quality-adjusted life years (QALYs) from previous studies and determined the incremental cost-effectiveness ratio (ICER) according to our model. We performed a deterministic and probabilistic sensitivity analyses of variables with uncertainty and reported them in a Tornado diagram showing the variables with the greatest effect on the ICER. RESULTS: Our model estimates decision costs to screen or not screen at $94,953 and $82,553, respectively. The QALYs gained from screening was 0.060, generating an ICER of $207,491 per QALY. Factors most influential on the ICER were the reduction in all-cause mortality associated with rivaroxaban and the prohibitively high cost of rivaroxaban. If rivaroxaban cost less than $95 per month, this would make screening cost-effective based on a willingness to pay threshold of $50,000 per QALY. CONCLUSIONS: According to our model, screening patients with CAD for PAD to start low-dose rivaroxaban is not currently cost-effective due to insufficient reduction in all-cause mortality and high medication costs. Nevertheless, vascular surgeons have a unique opportunity to prescribe or advocate for low-dose rivaroxaban in patients with PAD to improve cardiovascular outcomes.

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.

The Society for Vascular Surgery Alternative Payment Model Task Force report on opportunities for value-based reimbursement in care for patients with peripheral artery disease.

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.

Immediate postoperative hyperglycemia after peripheral arterial bypass is associated with short-term and long-term poor outcomes.

OBJECTIVE: Although the impact of poorly controlled diabetes on surgical outcomes of patients undergoing lower extremity revascularization is well-known, it is not clear if immediate postoperative hyperglycemia (IPH) itself can be used as a surrogate for poor outcomes after peripheral arterial bypass. We sought to examine the effect of IPH in this patient population with its impact on short-term and long-term outcomes. METHODS: Retrospective review was completed for 505 patients who underwent either suprainguinal bypass surgery or infrainguinal bypass surgery between July 2002 and April 2018 for the treatment of peripheral arterial disease. All patients were undergoing first-time open bypass grafting. Patients were stratified into those who were normoglycemic or hyperglycemic (glucose ≥ 140 mg/dL) within 24 hours after surgery. A comparative analysis was performed on comorbidities and outcomes. RESULTS: Of 505 patients who underwent bypass grafting, 255 patients (50.5%) were hyperglycemic. The mean age of patients was 63.5 ± 14.1 years. The median follow-up was 5.2 years (range, 0.0-15.2 years). The distribution of procedures was as follows: femoral to popliteal bypasses (29%), femoral to femoral bypasses (17%), femoral to tibial bypasses (12%), aortobifemoral bypasses (10%), iliofemoral bypasses (9%), and axillofemoral bypasses (7%). At 30 days, hyperglycemic patients had an increased incidence of limb loss (8.3% vs 4.0%) and myocardial infarction (4.8% vs 0.8%) and incurred higher costs of hospital stay ($27,701 vs $22,990) (all P < .05). At 10 years, these patients had a higher incidence of needing major amputations (15.4% vs 9.4%; P = .025). Hyperglycemia after infrainguinal bypass was associated with nearly twice the risk of limb loss at 5 years (hazard ratio, 1.91; P = .034). Among the cohort of patients who required major amputations, the time duration between index revascularization and amputation was significantly shorter as compared with normoglycemic patients (P = .003). CONCLUSIONS: In this single-institution study with long-term follow-up, IPH was associated with increased rates of 30-day amputation and myocardial infarction, as well as an increased cost of hospital stay. In the long term, postoperative hyperglycemia was associated with greater major limb loss. Among the cohort of patients who required major amputations, the time period between revascularization and amputation was shorter for those patients who had IPH. IPH is an independent marker for poor outcomes after lower extremity revascularization procedures.

Defining the 90-day cost structure of lower extremity revascularization for alternative payment model assessment.

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.

Exploring the rapid expansion of office-based laboratories and peripheral vascular interventions across the United States.

OBJECTIVE: To characterize the relationship between office-based laboratory (OBL) use and Medicare payments for peripheral vascular interventions (PVI). METHODS: Using the Centers for Medicare and Medicaid Services Provider Utilization and Payment Data Public Use Files from 2014 to 2017, we identified providers who performed percutaneous transluminal angioplasty, stent placement, and atherectomy. Procedures were aggregated at the provider and hospital referral region (HRR) level. RESULTS: Between 2014 and 2017, 2641 providers performed 308,247 procedures. The mean payment for OBL stent placement in 2017 was $4383.39, and mean payment for OBL atherectomy was $13,079.63. The change in the mean payment amount varied significantly, from a decrease of $16.97 in HRR 146 to an increase of $43.77 per beneficiary over the study period in HRR 11. The change in the rate of PVI also varied substantially, and moderately correlated with change in payment across HRRs (R2 = 0.40; P < .001). The majority of HRRs experienced an increase in rate of PVI within OBLs, which strongly correlated with changes in payments (R2 = 0.85; P < .001). Furthermore, 85% of the variance in change in payment was explained by increases in OBL atherectomy (P < .001). CONCLUSIONS: A rapid shift into the office setting for PVIs occurred within some HRRs, which was highly geographically variable and was strongly correlated with payments. Policymakers should revisit the current payment structure for OBL use and, in particular atherectomy, to better align the policy with its intended goals.

The cost-effectiveness of intensive low-density lipoprotein cholesterol lowering in people with peripheral artery disease.

BACKGROUND: People with peripheral artery disease are at a high risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Randomized controlled trials suggest that intensive lowering of low-density lipoprotein cholesterol (LDL-C) with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors is an effective strategy to prevent these events. This study estimated the potential benefit and cost-effectiveness of administrating PCSK9 inhibitors to a cohort of participants with peripheral artery disease. METHODS: A total of 783 participants with intermittent claudication (IC; n = 582) or chronic limb-threatening ischemia (CLTI; n = 201) were prospectively recruited from three hospitals in Australia. Serum LDL-C was measured at recruitment, and the occurrence of MACE and MALE was recorded over a median (interquartile range) follow-up of 2.2 years (0.3-5.7 years). The potential benefit of administering a PCSK9 inhibitor was estimated by calculating the absolute risk reduction and numbers needed to treat (NNT) based on relative risk reductions reported in published randomized trials. The incremental cost-effectiveness ratio per quality-adjusted life year gained was estimated. RESULTS: Intensive LDL-C lowering was estimated to lead to an absolute risk reduction in MACE of 6.1% (95% confidence interval [CI], 2.0-9.3; NNT, 16) and MALE of 13.7% (95% CI, 4.3-21.5; NNT, 7) in people with CLTI compared with 3.2% (95% CI, 1.1-4.8; NNT, 32) and 5.3% (95% CI, 1.7-8.3; NNT, 19) in people with IC. The estimated incremental cost-effectiveness ratios over a 10-year period were $55,270 USD and $32,800 USD for participants with IC and CLTI, respectively. CONCLUSIONS: This analysis suggests that treatment with a PCSK9 inhibitor is likely to be cost-effective in people with CLTI.

Fast-track thrombolysis protocol for acute limb ischemia.

OBJECTIVE: Catheter-directed thrombolysis in the treatment of acute lower extremity arterial occlusions often requires several interventional sessions to generate successful outcomes. It is typically an expensive procedure, necessitating extended hospital length of stay (LOS) that may be associated with an increase in both local and systemic hemorrhagic complications. Five years ago, we created the fast-track thrombolysis protocol for arteries (FTTP-A) to deal with these concerns. The goal of our protocol is to re-establish patency during the first session of thrombolysis, thus decreasing costs and complications associated with prolonged periods of thrombolytic exposure. METHODS: A retrospective study of 42 patients who were treated for acute limb ischemia at our institution by FTTP-A from January 2014 to February 2019 was performed. FTTP-A includes periadventitial lidocaine injection at the arterial puncture site under ultrasound guidance, contrast arteriography of the entire targeted segment, pharmacomechanical rheolytic thrombectomy of the occluded arterial segment, tissue plasminogen activator infusion along the occluded segment, balloon maceration of the thrombus, and (if deemed necessary) placement of a stent in an area of significant (≥30%) stenosis that is refractory to balloon angioplasty and thrombolysis. After the stenosis or thrombus is cleared, patients are prescribed an oral anticoagulant agent. RESULTS: Primary FTTP-A (50 total interventions) was performed in 42 patients. The median age of patients was 67.2 ± 12.2 years (range, 41-98 years), and 54.8% were male; 59.5% of the procedures were performed on the left lower extremity. Initial arterial access was obtained through the common femoral artery in 39 of 42 cases (92.9%); in the remaining 3 cases, it was obtained in a left bypass access site, a right femoral-popliteal graft, and a right femoral-femoral graft. The mean operative time was 148.9 ± 62.9 minutes (range, 83-313 minutes), and the mean volume of tissue plasminogen activator infused was 9.7 ± 4.0 mg (range, 2-20 mg). The median cost including medications and interventional tools was $4673.19 per procedure. The mean postoperative LOS was 3.1 ± 4.5 days (range, 1-25 days). Median postoperative LOS was 1 day. Mean postoperative follow-up was 27 ± 19.2 months (range, 0-62 months). Single-session FTTP-A was successful in 81% (n = 34/42) of patients; the remaining 8 patients (19%) required a single additional session. Of the 42 patients, 34 (81%) required arterial stenting. Periprocedural complications consisted of one patient with hematuria, which resolved, and one patient with thrombocytopenia, which resolved. No patients experienced rethrombosis within 30 days of FTTP-A. During the 5-year study period, there was no significant local or systemic hemorrhage, limb loss, or mortality related to this protocol. CONCLUSIONS: FTTP-A appears to be a safe, efficacious, and cost-effective procedure in the resolution of acute lower extremity arterial occlusions.

Clinical Benefit, Harm, and Cost Effectiveness of Screening Men for Peripheral Artery Disease: A Markov Model Based on the VIVA Trial.

OBJECTIVE: Although screening for peripheral arterial disease (PAD) seems obvious due to its two to three times increased mortality, high prevalence in the elderly, ease of detection, and relatively harmless prevention, the evidence is sparse. METHODS: A Markov decision model was created to model the lifetime effectiveness and cost effectiveness of general population PAD screening and relevant intervention in 65 year old men. The model was informed by original estimates from the VIVA trial data except for ankle brachial systolic blood pressure index test accuracy, quality of life, and background mortality, which were adopted from the literature. A Markov model was designed for 65 year old men, who were distributed in the starting states of no/detected/undetected PAD. The main outcomes were life years, quality adjusted life years, and costs of healthcare. RESULTS: Screening for PAD reduced the rates of amputations and stroke by 10.9% and 2.4%, respectively, while it increased the rates of revascularisation, acute myocardial infarction, and major bleeding by 5.5%, 7.1%, and 4.3% respectively. The overall life expectancy was increased by 14 days per invited subject. The cost per life year/quality adjusted life year was estimated at €16 717/€20 673. On the addition of low dose rivaroxaban reduced the costs per life year gained by 40%. If the model ran for only five follow up years, screening reduced relative mortality by 1.71%, suggesting PAD screening accounts for one fourth of the reported overall 7% relative mortality risk reduction of combined abdominal aortic aneurysm, PAD, and hypertension screening. CONCLUSION: Screening of men for PAD is likely to be both clinically effective and cost effective in a lifetime perspective.

Editor's Choice - Cost Effectiveness of Primary Stenting in the Superficial Femoral Artery for Intermittent Claudication: Two Year Results of a Randomised Multicentre Trial.

OBJECTIVE: Invasive treatment of intermittent claudication (IC) is commonly performed, despite limited evidence of its cost effectiveness. IC symptoms are mainly caused by atherosclerotic lesions in the superficial femoral artery (SFA), and endovascular treatment is performed frequently. The aim of this study was to investigate its cost effectiveness vs. non-invasive treatment. METHODS: One hundred patients with IC due to lesions in the SFA were randomised to treatment with primary stenting, best medical treatment (BMT) and exercise advice (stent group), or to BMT and exercise advice alone (control group). Patients were recruited at seven hospitals in Sweden. For this analysis of cost effectiveness after 24 months, 84 patients with data on quality adjusted life years (QALY; based on the EuroQol Five Dimensions EQ-5D 3L™ questionnaire) were analysed. Patient registry and imputed cost data were used for accumulated costs regarding hospitalisation and outpatient visits. RESULTS: The mean cost per patient was €11 060 in the stent group and €4 787 in the control group, resulting in a difference of €6 273 per patient between the groups. The difference in mean QALYs between the groups was 0.26, in favour of the stent group, which resulted in an incremental cost effectiveness ratio (ICER) of € 23 785 per QALY. CONCLUSION: The costs associated with primary stenting in the SFA for the treatment of IC were higher than for exercise advice and BMT alone. With concurrent improvement in health related quality of life, primary stenting was a cost effective treatment option according to the Swedish national guidelines (ICER < €50 000 - €70 000) and approaching the UK's National Institute for Health and Care Excellence threshold for willingness to pay (ICER < £20 000 - £30 000). From a cost effectiveness standpoint, primary stenting of the SFA can, in many countries, be used as an adjunct to exercise training advice, but it must be considered that successful implementation of structured exercise programmes and longer follow up may alter these findings.

Editor's Choice - A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial.

OBJECTIVE: The AMBUVASC trial evaluated the cost effectiveness of outpatient vs. inpatient hospitalisation for endovascular repair of lower extremity arterial disease (LEAD). METHODS: AMBUVASC was a national multicentre, prospective, randomised controlled trial conducted in nine public and two private French centres. The primary endpoint was the incremental cost effectiveness ratio (ICER), defined by cost per quality adjusted life year (QALY). Analysis was conducted from a societal perspective, excluding indirect costs, and considering a one month time horizon. RESULTS: From 16 February 2016 to 29 May 2017, 160 patients were randomised (80 per group). A modified intention to treat analysis was performed with 153 patients (outpatient hospitalisation: n = 76; inpatient hospitalisation: n = 77). The patients mainly presented intermittent claudication (outpatient arm: 97%; inpatient arm: 92%). Rates of peri-operative complications were 20% (15 events) and 18% (14 events) for the outpatient and inpatient arms respectively (p = .81). Overall costs (difference: €187.83; 95% confidence interval [CI] -275.68-651.34) and QALYs (difference: 0.00277; 95% CI -0.00237 - 0.00791) were higher for outpatients due to more re-admissions than the inpatient arm. The mean ICER was €67 741 per QALY gained for the base case analysis with missing data imputed using multiple imputation by predictive mean matching. The outpatient procedure was not cost effective for a willingness to pay of €50 000 per QALY and the probability of being cost effective was only 59% for a €100 000/QALY threshold. CONCLUSION: Outpatient hospitalisation is not cost effective compared with inpatient hospitalisation for endovascular repair of patients with claudication at a €50 000/QALY threshold.

Patient and Institutional Costs of Failure of Angioplasty of the Superficial Femoral Artery.

BACKGROUND: Debate surrounds the optimal management of superficial femoral artery (SFA) disease. Randomized trial data rarely reflect real world findings, specifically the consequences to the patient of angioplasty failure. We observed the effect of a failed SFA angioplasty on the need for repeated clinic visits, hospital readmissions, imaging requirements, and reinterventions. METHODS: We reviewed a consecutive series of 148 patients (94 men, median age 72 years) undergoing solely SFA angioplasty over a 2-year period. Patient preangioplasty demographics and 2-year post-PTA follow-up data were collated, including hospital attendances (inpatient/outpatient), further imaging (including radiation exposure) and revascularization attempts. We defined "failed angioplasty" as presence of clinical symptoms with radiological evidence of significant restenosis after an initial successful primary SFA angioplasty. RESULTS: Fifty-four patients represented with a failed angioplasty (median time of 4 months after index PTA). In this group, failure of index angioplasty resulted in a further 185 restenosis-related clinic visits and a total of 537 bed days of inpatient stay. This group underwent a further 149 imaging events and required a further 34 endovascular revascularization procedures and 12 infrainguinal bypass procedures. These interventions and investigations corresponded to overall effective radiation dose across all patients of 190.69 mSv. Of the cohort of 99 patients who did not have a "failed angioplasty," they required 100 clinic visits, 21 further scans (total radiation dose 6.42 mSv), and 36 bed days of inpatient admission. CONCLUSIONS: Failed angioplasty results in significant additional consequences for patients and health-care systems. Further work should focus on refining decision-making, providing the right procedure to the right patient at the right time.

"Failure-to-Cross" in Patients Undergoing Percutaneous Peripheral Intervention: The Nonreimbursed Procedure.

BACKGROUND: Percutaneous peripheral intervention (PPI) is often the first mode of therapy for patients with symptomatic arterial occlusive disease. Technical success generally remains high although "failure-to-cross" still complicates 5-20% of cases. Extended efforts to cross long, occlusive lesions can utilize significant hospital and practitioner resources. The hospital is typically reimbursed for this effort as facility fees are charged by the hour and materials are charged per use. However, given the lack of a CPT® code for "failure-to-cross," practitioners are rarely appropriately compensated. The purpose of this study is to analyze the predictors, technical details, outcomes, and costs of "failure-to-cross" during PPI. METHODS: All PPI procedures over a 2-year period at a single institution were retrospectively reviewed. Clinical characteristics, results, costs, and reimbursements obtained from hospital cost accounting were compared among successful therapeutic interventions, crossing failures, and diagnostic angiograms without attempted intervention. RESULTS: A total of 146 consecutive PPIs were identified; the rate of "failure-to-cross" was 11.6% (17 patients). The majority of patients with "failure-to-cross" were male (82%) with single-vessel runoff (53%). Compared to successful interventions, the incidences of chronic limb-threatening ischemia (82% vs. 70%, P = 0.34) and infrapopliteal occlusive disease were similar (47% vs. 31%, P = 0.20). "Failure-to-cross" procedures were just as long as successful procedures; there were no significant differences in fluoroscopy time (27 ± 10 vs. 24 ± 14 min, P = 0.52), in-room time (106 ± 98 vs. 103 ± 44 min, P = 0.84), or contrast dye volume utilization (73 ± 37 vs. 96 ± 54 mL, P = 0.12). As expected, "failure-to-cross" procedures incurred far higher hospital charges and costs compared to noninterventional diagnostic angiograms (charges $13,311 ± 6,067 vs. $7,690 ± 1,942, P < 0.01; costs $5,289 ± 2,099 vs. $2,826 ± 1,198, P < 0.01). Despite the additional time and effort spent attempting to cross difficult lesions, the operators were reimbursed at the same low rate as a purely diagnostic procedure (average fee charge $7,360; average reimbursement $992). After 1 year, the 17 patients in whom lesions could not be crossed were treated with advanced interventional procedures with success (n = 2), surgical bypass grafting (n = 5), extremity amputation (n = 4), or no additional intervention in their salvaged limb (n = 6). CONCLUSIONS: Patients whose lesions cannot be crossed during PPI fare worse than patients undergoing successful interventions. Hospital costs and charges appropriately reflect the high technical difficulty and resource utilization of extended attempts at endovascular therapy. For practitioners, crossing lesions during PPI is truly a "pay-for-performance" procedure in that only successful procedures are reasonably reimbursed.

Lower Limb Revascularization for Peripheral Arterial Disease in 10,951 Procedures over 11 years in a Public Health System: A Descriptive Analysis of the Largest Brazilian City.

BACKGROUND: Worldwide, peripheral arterial disease (PAD) is a disease with high morbidity, affecting more than 200 million people. Our objective was to analyze the surgical treatment for PAD performed in the Unified Health System of the city of São Paulo during the last 11 years based on publicly available data. METHODS: The study was conducted with data analysis available on the TabNet platform, belonging to the DATASUS. Public data (government health system) from procedures performed in São Paulo between 2008 and 2018 were extracted. Sex, age, municipality of residence, operative technique, number of surgeries (total and per hospital), mortality during hospitalization, mean length of stay in the intensive care unit and amount paid by the government system were analyzed. RESULTS: A total of 10,951 procedures were analyzed (either for claudicants or critical ischemia-proportion unknown); 55.4% of the procedures were performed on males, and in 50.60%, the patient was older than 65 years. Approximately two-thirds of the patients undergoing these procedures had residential addresses in São Paulo. There were 363 in-hospital deaths (mortality of 3.31%). The hospital with the highest number of surgeries (n = 2,777) had lower in-hospital mortality (1.51%) than the other hospitals. A total of $20,655,272.70 was paid for all revascularizations. CONCLUSIONS: Revascularization for PAD treatment has cost the government system more than $20 million over 11 years. Endovascular surgeries were performed more often than open surgeries and resulted in shorter hospital stays and lower perioperative mortality rates.

Characteristics of high-cost inpatients with peripheral artery disease.

OBJECTIVE: Inpatient treatment of peripheral artery disease (PAD) is more than six times as costly as that of the general inpatient population. Our objective was to describe factors associated with hospital cost for patients admitted for PAD, the characteristics of high-cost patients, and their outcomes including amputations and death. METHODS: We performed a retrospective cohort study of admitted patients receiving a procedure for PAD at The Ottawa Hospital between 2007 and 2016. Demographics, comorbidity, inpatient events, and hospital cost data during the index admission were collected. We defined high-cost patients as those whose total costs of index admission were in the tenth percentile and above. Features associated with high-cost status were examined using logistic regression with elastic net regularization. We used generalized linear models to examine overall drivers of cost. RESULTS: We identified 3084 eligible patients, incurring $72.2 million in hospital costs. The mean cost of the most expensive 10% of patients was $88,076 (standard deviation, $54,720), more than five times the mean cost of $16,217 (standard deviation, $10,322) for nonhigh-cost patients. High-cost patients were more likely to present urgently (odds ratio [OR], 1.63; 95% confidence interval [CI], 1.16-2.25; P < .01). After adjustment for preadmission factors, high-cost patients were more likely to have experienced an adverse patient safety incident (OR, 13.49; 95% CI, 6.97-24.8; P < .01), amputation (OR, 2.79; 95% CI, 1.68-4.49; P <.01), intensive care unit admission (OR, 6.42; 95% CI, 3.62-10.2; P < .01), and disposition barriers requiring alternate level of care status (OR, 10.44; 95% CI, 6.42-15.2; P < .01). The high-cost group was more likely to have received hybrid revascularization (OR, 7.07; 95% CI, 3.34-13.6; P < .01). High-cost patients had higher than predicted in-hospital mortality (18% vs 9.2% predicted) compared with the low-cost group (3.0% vs 2.7%; P < .001), and fewer than half of high-cost patients were discharged home. CONCLUSIONS: Providing hospital care for the top 10% most expensive patients in our cohort was more than five times as costly per patient than providing care for the nonhigh-cost patients. Whereas pre-existing factors may predispose a patient to require expensive care, there are potentially modifiable factors during the admission that could reduce costs of these patients.

Economic burden and clinical impact of preoperative opioid dependence for patients undergoing lower extremity bypass surgery.

OBJECTIVE: Surgeons' prescription practices and the opioid epidemic have received significant attention in the media. Limited data exist, however, on the impact of prior or coexistent opioid use on vascular surgery outcomes. This study aimed to quantify the incidence, economic burden, and clinical impact of pre-existing opioid dependency in patients undergoing lower extremity bypass (LEB) surgery. METHODS: Data were collected from 1,132,645 weighted (230,858 unweighted) patient admissions for LEB in the National Inpatient Sample for the years 2002 to 2015. Patients with a concomitant diagnosis of opioid abuse or dependency were identified using International Classification of Diseases, Ninth Revision codes. Matched cohorts of patients with (n = 606 unweighted) and without (n = 32,343 unweighted) opioid dependence were created using coarsened exact matching to control for patient demographics. Linear regression was used to control for hospital-level factors and to identify differential outcomes for patients with opioid dependency. Our primary end points were hospital cost and length of stay. Our secondary end points were surgical complications and in-hospital mortality. RESULTS: There were 1,132,645 (230,858 unweighted) patient admissions for LEB in the National Inpatient Sample during 2002 to 2015. There were 3190 (0.3%) patients (643 unweighted) who had a diagnosis of pre-existing opioid dependency. The incidence of opioid dependency rose over time (2002, 0.13%; 2015, 0.63%; R2 = 0.90; P < .001). Before matching, opioid-dependent patients were younger (53.9 ± 12.3 years vs 66.7 ± 12.1 years; P < .001) and more likely to be male (65.2% vs 61.9%; P < .001), to be nonwhite (37.9% vs 24.1%; P < .001), to pay with Medicaid (29.6% vs 7.4%; P < .001), and to fall in the lowest income quartile based on ZIP code (39.6% vs 27.5%; P < .001). After matching, opioid-dependent patients (n = 606 unweighted vs n = 32,343 unweighted nonopioid-dependent patients) were at increased risk of surgical site infections (odds ratio [OR], 1.61; P = .006), major bleeding (OR, 1.56; P = .04), acute kidney injury (OR, 1.46; P = .02), and deep venous thrombosis (OR, 2.53; P = .005). Linear regression of matched cohorts revealed that opioid-dependent patients had an increased length of hospital stay (11.76 days vs 9.80 days; P < .001) and an increased mean inflation-adjusted in-hospital cost of U.S. $7032 ($37,522 vs $30,490; P < .001). CONCLUSIONS: The incidence of pre-existing opioid dependency in patients undergoing LEB continues to rise. Patients with opioid use disorder undergoing LEB surgery have substantial increases in length of hospital stay and costs. These findings highlight the importance of early preoperative recognition of this disorder in vascular surgery patients and open the opportunity for early intervention in that cohort.

Medicare reimbursement of lower extremity bypass does not cover cost of care for most patients with critical limb ischemia.

OBJECTIVE: Lower extremity bypass surgery remains an important treatment option for patients with critical limb ischemia (CLI), but is resource intensive. We sought to evaluate the cost and Medicare reimbursement for lower extremity bypass surgery in patients with CLI. METHODS: Hospital cost accounting systems were queried for total technical and professional costs incurred and reimbursement received for patients with CLI undergoing lower extremity bypass at our center between 2011 and 2017. Patients were identified by assignment to Diagnosis-Related Group (DRG) 252, 253, or 254 (other vascular procedure with major complication/comorbidity, with complication/comorbidity, and without complication/comorbidity, respectively). Additional clinical data were incorporated from the Vascular Quality Initiative clinical registry. For non-Medicare patients, reimbursement was indexed to Medicare rates. Contribution margins (reimbursement minus cost) from technical and professional services were analyzed for each patient and summarized by DRG. We compared technical, professional, and total costs; reimbursement; and contribution margins across DRGs using univariate statistics and evaluated factors associated with total contribution margin using median quantile regression. RESULTS: We analyzed 68 patients with hemodynamically confirmed CLI (46% rest pain, 54% tissue loss), of whom 25% received a prosthetic graft. Mean age was 66.1 ± 11.6 years, 69% were male, 49% diabetic, 44% current smokers, and 4% on dialysis. In general, total infrainguinal bypass cost was adequately compensated for patients assigned only the most complex DRG 252 (median, $2490; interquartile range [IQR], -$1,621 to $10,080). In the majority of patients with less complex DRG 253 (median, -$3,100; IQR, -$8499 to $109) and DRG 254 (median, -$4902; IQR, -$9259 to $1059), reimbursement did not cover the cost of care. Both technical costs and professional costs varied significantly with the complexity of DRG. Although reimbursement from technical services increased alongside increasing complexity of DRG, there was insignificant variation in professional reimbursement as DRG complexity increased. On multivariable modeling, longer length of stay (-$2547 per additional day) and preoperative dialysis (-$5555) were significantly associated with negative margins. CONCLUSIONS: For the majority of patients with CLI, current Medicare reimbursement does not adequately cover the cost of providing care after open bypass surgery. As commercial insurers move toward Medicare reimbursement rates, more granular risk stratification profiles are needed to ensure open surgical care for patients with CLI remains financially sustainable.