The financial burden associated with endovascular repair of thoracoabdominal and pararenal aortic aneurysms using physician-modified fenestrated-branched endografts.

OBJECTIVE/BACKGROUND: Endovascular thoracoabdominal and pararenal aortic aneurysm repair is more complex and requires more devices than infrarenal aneurysm repair. It is unclear if current reimbursement covers the cost of delivering this more advanced form of vascular care. The objective of this study was to evaluate the economics of fenestrated-branched (FB-EVAR) physician-modified endograft (PMEG) repairs. METHODS: We obtained technical and professional cost and revenue data for four consecutive fiscal years (July 1, 2017, to June 30, 2021) at our quaternary referral institution. Inclusion criteria were patients who underwent PMEG FB-EVAR in a uniform fashion by a single surgeon for thoracoabdominal/pararenal aortic aneurysms. Patients in industry-sponsored clinical trials or receiving Cook Zenith Fenestrated grafts were excluded. Financial data were analyzed for the index operation. Technical costs were divided into direct costs that included devices and billable supplies and indirect costs including overhead. RESULTS: 62 patients (79% male, mean age: 74 years, 66% thoracoabdominal aneurysms) met inclusion criteria. The mean aneurysm size was 6.0 cm, the mean total operating time was 219 minutes, and the median hospital length of stay was 2 days. PMEGs were created with a mean number of 3.7 fenestrations, using a mean of 8.6 implantable devices per case. The average technical cost per case was $71,198, and the average technical reimbursement was $57,642, providing a net negative technical margin of $13,556 per case. Of this cohort, 31 patients (50%) were insured by Medicare remunerated under diagnosis-related group code 268/269. Their respective average technical reimbursement was $41,293, with a mean negative margin of $22,989 per case, with similar findings for professional costs. The primary driver of technical cost was implantable devices, accounting for 77% of total technical cost per case over the study period. The total operating margin, including technical and professional cost and revenue, for the cohort during the study period was negative $1,560,422. CONCLUSIONS: PMEG FB-EVAR for pararenal/thoracoabdominal aortic aneurysms produces a substantially negative operating margin for the index operation driven largely by device costs. Device cost alone already exceeds total technical revenue and presents an opportunity for cost reduction. In addition, increased reimbursement for FB-EVAR, especially among Medicare beneficiaries, will be important to facilitate patient access to such innovative technology.

The financial evolution of endovascular aneurysm repair delivery in contemporary practice.

OBJECTIVE: The fiscal impact of endovascular repair (EVR) of aortic aneurysms and the requisite device costs have previously highlighted the tenuous long-term financial sustainability among Medicare beneficiaries. The Centers for Medicare & Medicaid Services have since reclassified EVR remuneration paradigms with new Medicare Severity Diagnosis-Related Groups (MS-DRGs) intended to better address the procedure's cost profile. The impact of this change remains unknown. The purpose of this analysis was to compare EVR-specific costs and revenue among Medicare beneficiaries both before and after this change. METHODS: All infrarenal EVRs performed in fiscal years (FYs) 2014 and 2015, before the MS-DRG change, and those performed in FYs 2017 and 2018, after the MS-DRG change, were identified using the DRG codes 238 (n = 108) and 269 (n = 84), respectively. We then identified those who were treated according to the instructions for use guidelines with a single manufacturer's device and billed to Medicare (n = 23 in FY14-15; n = 22 in FY17-18). From these cohorts, we determined total procedure technical costs, technical revenue, and net technical margin in conjunction with the hospital finance department. Results were then compared between these two groups. RESULTS: The two cohorts demonstrated similar demographic profiles (FY14-15 vs FY17-18 cohort: age, 78 years vs 74 years; median length of stay, 1.0 day vs 1.0 day). Mean total technical costs were slightly higher in the FY17-18 group ($24,511 in FY14-15 vs $26,445 in FY17-18). Graft implants continued to account for a significant portion of the total cost, with the device cost accounting for 56% of the total procedure costs in both cohorts. Net revenue was greater in the FY17-18 group by $5800 ($30,698 in FY14-15 vs $36,498 in FY17-18), resulting in an increased overall margin in the FY17-18 group compared with the FY14-15 group ($6188 in FY14-15 vs $10,053 in FY17-18). CONCLUSIONS: Device costs remain the single greatest cost driver associated with EVR delivery. DRG reclassification of EVR to address total procedure and implant costs appears to better address the requisite associated procedure costs and may thereby better support long-term fiscal sustainability of this procedure for hospitals and health systems alike.

Medicare costs for endovascular abdominal aortic aneurysm treatment in the Vascular Quality Initiative.

BACKGROUND: Reintervention after endovascular repair (EVR) of abdominal aortic aneurysms is common. However, the cumulative financial impact of reintervention after EVR on a national scale is poorly defined. Our objective was to describe the cost to Medicare for aneurysm treatment (EVR plus reinterventions) among a cohort of patients with known follow-up for 5 years after repair. METHODS: We identified patients who underwent EVR within the Vascular Quality Initiative who were linked to their respective Medicare claims file (n = 13,995). We excluded patients who underwent EVR after September 30, 2010, and those who had incomplete Medicare coverage (n = 12,788). The remaining cohort (n = 1207) had complete follow-up until death or 5 years (Medicare data available through September 30, 2015). We then obtained and compiled the corresponding Medicare reimbursement data for the index EVR hospitalization and all subsequent reinterventions. RESULTS: We studied 1207 Medicare patients who underwent EVR and had known follow-up for reinterventions for 5 years. The mean age was 76.2 years (±7.1 years), 21.6% of patients were female, and 91.1% of procedures were elective. The Kaplan-Meier reintervention rate at 5 years was 18%. Among patients who underwent reintervention, 154 (73.7%) had a single reintervention, 40 (19.1%) had two reinterventions, and 15 (7.2%) had three or more reinterventions. The median cost to Medicare for the index EVR hospitalization was $25,745 (interquartile range, $21,131-$28,774). The median cost for subsequent reinterventions was $22,165 (interquartile range, $17,152-$29,605). The cumulative cost to Medicare of aneurysm treatment (EVR plus reinterventions) increased in a stepwise fashion among patients who underwent multiple reinterventions, with each reintervention being similar in cost to the index EVR. CONCLUSIONS: The overall cost incurred by Medicare to reimburse for each reintervention after EVR is roughly the same as for the initial procedure itself, meaning that Medicare cost projections would be greater than $100,000 for any individual who undergoes an EVR with three reinterventions. The long-term financial impact of EVR must be considered by surgeons, patients, and healthcare systems alike as these cumulative costs may hinder the fiscal viability of an EVR-first therapeutic approach and highlight the need for judicious patient selection paradigms.

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.

Disparity in Medicaid physician payments for vascular surgery.

OBJECTIVE: Medicare reimbursements are standardized nationwide on the basis of resource-dependent inputs of physicians' time, intensity, practice costs, and malpractice costs, whereas Medicaid payments vary and are determined by individual states. Our objectives were to determine Medicaid reimbursement to physicians for common vascular procedures for the seven states in the Northeast that compose the New England Society for Vascular Surgery and to compare Medicaid payments with Medicare. METHODS: Using publicly available data, we obtained Medicaid physician payments in Connecticut, Massachusetts, Maine, New Hampshire, New York, Rhode Island, and Vermont for 10 commonly performed vascular surgery procedures. For comparison, Medicare physician payments for these procedures were adjusted for regional differences using Medicare geographic payment cost indices. Descriptive statistics were calculated by state; Wilcoxon signed rank test was used to compare fees, and one-way analysis of variance was used to compare variance. RESULTS: Medicaid payments varied widely by state. Within individual states (except Vermont), there was no relationship between Medicaid and Medicare payments. Medicaid reimbursement for common vascular procedures ranged from 25% to 91% of Medicare rates and had up to a threefold variation in payment among states for a single procedure. The mean Medicaid payment was 60% of Medicare payment. The greatest state-to-state variance in payment was for open abdominal aortic repair (standard deviation, $227.31); the least was for femoral artery exposure (standard deviation, $31.86). For a Medicaid-based, frequency-weighted analysis of services, New Hampshire exhibited the lowest payments (43% Medicare) and Vermont the highest (80% Medicare). CONCLUSIONS: Among the seven Northeast states considered, with the exception of Vermont, there is no logical relationship between Medicaid and Medicare payments. Because Medicare payments are determined by the Centers for Medicare and Medicaid Services with consideration of resource-based inputs, we conclude that in six of the seven states, Medicaid payments bear no relationship to resource utilization. With Medicaid expansion, access to vascular procedures may be limited by payments insufficient to meet resource needs.

Reimbursement in hospital-based vascular surgery: Physician and practice perspective.

OBJECTIVE: The purpose of this study was to determine change in value of a vascular surgery division to the health care system during 6 years at a hospital-based academic practice and to compare physician vs hospital revenue earned during this period. METHODS: Total revenue generated by the vascular surgery service line at an academic medical center from 2010 through 2015 was evaluated. Total revenue was measured as the sum of physician (professional) and hospital (technical) net revenue for all vascular-related patient care. Adjustments were made for work performed, case complexity, and inflation. To reflect the effect of these variables, net revenue was indexed to work relative value units (wRVUs), case mix index, and consumer price index, which adjusted for work, case complexity, and inflation, respectively. Differences in physician and hospital net revenue were compared over time. RESULTS: Physician work, measured in RVUs per year, increased by 4%; case complexity, assessed with case mix index, increased by 10% for the 6-year measurement period. Despite stability in payer mix at 64% to 69% Medicare, both physician and hospital vascular-related revenue/wRVU decreased during this period. Unadjusted professional revenue/wRVU declined by 14.1% (P = .09); when considering case complexity, physician revenue/wRVU declined by 20.6% (P = .09). Taking into account both case complexity and inflation, physician revenue declined by 27.0% (P = .04). Comparatively, hospital revenue for vascular surgery services decreased by 13.8% (P = .07) when adjusting for unit work, complexity, and inflation. CONCLUSIONS: At medical centers where vascular surgeons are hospital based, vascular care reimbursement decreased substantially from 2010 to 2015 when case complexity and inflation were considered. Physician reimbursement (professional fees) decreased at a significantly greater rate than hospital reimbursement for vascular care. This trend has significant implications for salaried vascular surgeons in hospital-based settings, where the majority of revenue generated by vascular surgery care is the technical component received by the facility. Appropriate care for patients with vascular disease is increasingly resource intensive, and as a corollary, reimbursement levels must reflect this situation if high-quality care is to be maintained.

Design and Rationale of the Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial.

BACKGROUND: Critical limb ischemia (CLI) is increasing in prevalence, and remains a significant source of mortality and limb loss. The decision to recommend surgical or endovascular revascularization for patients who are candidates for both varies significantly among providers and is driven more by individual preference than scientific evidence. METHODS AND RESULTS: The Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial is a prospective, randomized, multidisciplinary, controlled, superiority trial designed to compare treatment efficacy, functional outcomes, quality of life, and cost in patients undergoing best endovascular or best open surgical revascularization. Approximately 140 clinical sites in the United States and Canada will enroll 2100 patients with CLI who are candidates for both treatment options. A pragmatic trial design requires consensus on patient eligibility by at least 2 investigators, but leaves the choice of specific procedural strategy within the assigned revascularization approach to the individual treating investigator. Patients with suitable single-segment of saphenous vein available for potential bypass will be randomized within Cohort 1 (n=1620), while patients without will be randomized within Cohort 2 (n=480). The primary efficacy end point of the trial is Major Adverse Limb Event-Free Survival. Key secondary end points include Re-intervention and Amputation-Free-Survival and Amputation Free-Survival. CONCLUSIONS: The BEST-CLI trial is the first randomized controlled trial comparing endovascular therapy to open surgical bypass in patients with CLI to be carried out in North America. This landmark comparative effectiveness trial aims to provide Level I data to clarify the appropriate role for both treatment strategies and help define an evidence-based standard of care for this challenging patient population. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02060630.

The Prevalence and Regional Variation of Major Depressive Disorder Among Patients With Peripheral Arterial Disease in the Medicare Population.

BACKGROUND: Current evidence suggests an association between coronary artery disease and major depressive disorder (MDD). Data to support a similar association between peripheral arterial disease (PAD) and MDD are more limited. This study examines the prevalence and regional variation of both PAD and MDD in a large contemporary patient sample. METHODS: All Medicare claims, part A and B, from January 2009 until December 2011 were queried using diagnosis codes specific for a previously validated clinical algorithm for PAD and major depression. Codes for PAD included those specific to cerebrovascular disease, abdominal aortic aneurysm, and peripheral vascular disease. Peripheral arterial disease prevalence, major depression prevalence, and coprevalence rates were determined, respectively. Regional variation of both conditions was determined using zip code data to identify potential endemic areas of disease intensity for both diagnoses. RESULTS: Over the study interval, the percentage of Medicare beneficiaries with a diagnosis of PAD remained relatively constant (3.0%-3.7%, n = 0.85-1.06 million in part A and 17.4%-17.5%, n = 4.82-4.93 million in part B), and MDD showed a similar trend (1.6%-2.7%, n = 0.46-0.79 million in part A and 6.1%-6.7%, n = 1.69-1.90 million in part B). The observed rate of MDD in those with an established diagnosis of PAD was 5-fold higher than those without PAD in part A claims (1.8-fold in part B claims). Moreover, there was a significant linear geographic correlation among patients with PAD and MDD (r = .54, P ≤ .01). CONCLUSIONS: This study documents a correlation between PAD and MDD and may, therefore, identify an at-risk population susceptible to inferior clinical outcomes. Significant regional variation exists in the prevalence of PAD and MDD, though there appear to be specific endemic regions notable for both disorders. Accordingly, health-care resource allocation toward endemic regions may help improve population health among this at-risk cohort.

Physician specialty and variation in carotid revascularization technique selected for Medicare patients.

OBJECTIVE: Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy (CEA) for select patients with carotid atherosclerosis. We hypothesized that the choice of CAS vs CEA varies as a function of treating physician specialty, which would result in regional variation in the relative use of these treatment types. METHODS: We used Medicare claims (2002-2010) to calculate annual rates of CAS and CEA and examined changes by procedure type over time. To assess regional preferences surrounding CAS, we calculated the proportion of revascularizations by CAS, across hospital referral regions, defined according to the Dartmouth Atlas of Healthcare. We then examined relationships between patient factors, physician specialty, and regional use of CAS. RESULTS: The annual number of all carotid revascularization procedures decreased by 30% from 2002 to 2010 (3.2 to 2.3 per 1000; P = .005). Whereas rates of CEA declined by 35% during these 8 years (3.0 to 1.9 per 1000; P < .001), CAS utilization increased by 5% during the same interval (0.30 to 0.32 per 1000; P = .014). Variation in utilization of carotid revascularization varied across the Unites States, with some regions performing as few as 0.7 carotid procedure per 1000 beneficiaries (Honolulu, Hawaii) and others performing nearly 8 times as many (5.3 per 1000 in Houma, La). Variation in procedure type (CEA vs CAS) was evident as well, as the proportion of carotid revascularization procedures that were constituted by CAS varied from 0% (Casper, Wyo, and Meridian, Miss) to 53% (Bend, Ore). The majority of CAS procedures were performed by cardiologists (49% of all CAS cases), who doubled their rates of CAS during the study period from 0.07 per 1000 in 2002 to 0.15 per 1000 in 2010. CONCLUSIONS: Variation in rates of carotid revascularization exists. Whereas rates of carotid revascularization have declined by more than 30% in recent years, utilization of CAS has increased. The proportion of all carotid revascularization procedures performed as CAS varies markedly by geographic region, and regions with the highest proportion of cardiologists perform the most CAS procedures. Evidence-based guidelines for carotid revascularization will require a multidisciplinary approach to ensure uniform adoption across specialties that care for patients with carotid artery disease.

Lesion complexity drives the cost of superficial femoral artery endovascular interventions.

OBJECTIVE: Patients who undergo endovascular treatment of superficial femoral artery (SFA) disease vary greatly in lesion complexity and treatment options. This study examined the association of lesion severity and cost of SFA stenting and to determine if procedure cost affects primary patency at 1 year. METHODS: A retrospective record review identified patients undergoing initial SFA stenting between January 1, 2010, and February 1, 2012. Medical records were reviewed to collect data on demographics, comorbidities, indication for the procedure, TransAtlantic Inter-Society Consensus (TASC) II severity, and primary patency. The interventional radiology database and hospital accounting database were queried to determine cost drivers of SFA stenting. Procedure supply cost included any item with a bar code used for the procedure. Associations between cost drivers and lesion characteristics were explored. Primary patency was determined using Kaplan-Meier survival curves and a log-rank test. RESULTS: During the study period, 95 patients underwent stenting in 98 extremities; of these, 61% of SFA stents were performed for claudication, with 80% of lesions classified as TASC II A or B. Primary patency at 1 year was 79% for the entire cohort. The mean total cost per case was $10,333. Increased procedure supply cost was associated with adjunct device use, the number of stents, and TASC II severity. Despite higher costs of treating more complex lesions, primary patency at 1 year was similar at 80% for high-cost (supply cost >$4000) vs 78% for low-cost (supply cost <$4000) interventions. CONCLUSIONS: SFA lesion complexity, as defined by TASC II severity, drives the cost of endovascular interventions but does not appear to disadvantage patency at 1 year. Reimbursement agencies should consider incorporating disease severity into reimbursement algorithms for lower extremity endovascular interventions.

Endovascular aneurysm repair delivery redesign leads to quality improvement and cost reduction.

OBJECTIVE: Endovascular aneurysm repair (EVAR) is now a mainstay of therapy for abdominal aortic aneurysm, although it remains associated with significant expense. We performed a comprehensive analysis of EVAR delivery at an academic medical center to identify targets for quality improvement and cost reduction in light of impending health care reform. METHODS: All infrarenal EVARs performed from April 2011 to March 2012 were identified (N = 127). Procedures were included if they met standard commercial instructions for use guidelines, used a single manufacturer, and were billed to Medicare diagnosis-related group 238 (n = 49). By use of DMAIC (define, measure, analyze, improve, and control) quality improvement methodology (define, measure, analyze, improve, control), targets for EVAR quality improvement were identified and high-yield changes were implemented. Procedure technical costs were calculated before and after process redesign. RESULTS: Perioperative services and clinic visits were identified as targets for quality improvement efforts and cost reduction. Mean technical costs before the intervention were $31,672, with endograft implants accounting for 52%. Pricing redesign in collaboration with hospital purchasing reduced mean EVAR technical costs to $28,607, a 10% reduction in overall cost, with endograft implants now accounting for 46%. Perioperative implementation of instrument tray redesign reduced instrument use by 32% (184 vs 132 instruments), saving $50,000 annually. Unnecessary clinic visits were reduced by 39% (1.6 vs 1.1 clinic visits per patient) through implementation of a preclinic imaging protocol. There was no difference in mean length of stay after the intervention. CONCLUSIONS: Comprehensive EVAR delivery redesign leads to cost reduction and waste elimination while preserving quality. Future efforts to achieve more competitive and transparent device pricing will make EVAR more cost neutral and enhance its financial sustainability for health care systems.

National trends in utilization, mortality, and survival after repair of type B aortic dissection in the Medicare population.

OBJECTIVE: The application of thoracic endovascular aortic repair (TEVAR) has changed treatment paradigms for thoracic aortic disease. We sought to better define specific treatment patterns and outcomes for type B aortic dissection treated with TEVAR or open surgical repair (OSR). METHODS: Medicare patients undergoing type B thoracic aortic dissection repair (2000-2010) were identified by use of a validated International Classification of Diseases, Ninth Revision diagnostic and procedural code-based algorithm. Trends in utilization were analyzed by procedure type (OSR vs TEVAR), and patterns in patient characteristics and outcomes were examined. RESULTS: Total thoracic aortic dissection repairs increased by 21% between 2000 and 2010 (2.5 to 3 per 100,000 Medicare patients; P = .001). A concomitant increase in TEVAR was seen during the same interval (0.03 to 0.8 per 100,000; P < .001). By 2010, TEVAR represented 27% of all repairs. TEVAR patients had higher rates of comorbid congestive heart failure (12% vs 9%; P < .001), chronic obstructive pulmonary disease (17% vs 10%; P < .001), diabetes (8% vs 5%; P < .001), and chronic renal failure (8% vs 3%; P < .001) compared with OSR patients. For all repairs, patient comorbidity burden increased over time (mean Charlson comorbidity score of 0.79 in 2000, 1.10 in 2010; P = .04). During this same interval, in-hospital mortality rates declined from 47% to 23% (P < .001), a trend seen in both TEVAR and OSR patients. Whereas in-hospital mortality rates and 3-year survival were similar between patients selected for TEVAR and OSR, there was a trend toward women having slightly lower 3-year survival after TEVAR (60% women vs 63% men; P = .07). CONCLUSIONS: Surgical treatment of type B aortic dissection has increased over time, reflecting an increase in the utilization of TEVAR. Overall, type B dissection repairs are currently performed at lower mortality risk in patients with more comorbidities.

The financial implications of endovascular aneurysm repair in the cost containment era.

OBJECTIVE: Endovascular aneurysm repair (EVAR) is associated with significant direct device costs. Such costs place EVAR at odds with efforts to constrain healthcare expenditures. This study examines the procedure-associated costs and operating margins associated with EVAR at a tertiary care academic medical center. METHODS: All infrarenal EVARs performed from April 2011 to March 2012 were identified (n = 127). Among this cohort, 49 patients met standard commercial instruction for use guidelines, were treated using a single manufacturer device, and billed to Medicare diagnosis-related group (DRG) 238. Of these 49 patients, net technical operating margins (technical revenue minus technical cost) were calculated in conjunction with the hospital finance department. EVAR implant costs were determined for each procedure. DRG 238-associated costs and length of stay were benchmarked against other academic medical centers using University Health System Consortium 2012 data. RESULTS: Among the studied EVAR cohort (age 75, 82% male, mean length of stay, 1.7 days), mean technical costs totaled $31,672. Graft implants accounted for 52% of the allocated technical costs. Institutional overhead was 17% ($5495) of total technical costs. Net mean total technical EVAR-associated operating margins were -$4015 per procedure. Our institutional costs and length of stay, when benchmarked against comparable centers, remained in the lowest quartile nationally using University Health System Consortium costs for DRG 238. Stent graft price did not correlate with total EVAR market share. CONCLUSIONS: EVAR is currently associated with significant negative operating margins among Medicare beneficiaries. Currently, device costs account for over 50% of EVAR-associated technical costs and did not impact EVAR market share, reflecting an unawareness of cost differential among surgeons. These data indicate that EVAR must undergo dramatic care delivery redesign for this practice to remain sustainable.

Lean principles optimize on-time vascular surgery operating room starts and decrease resident work hours.

OBJECTIVE: Lean process improvement techniques are used in industry to improve efficiency and quality while controlling costs. These techniques are less commonly applied in health care. This study assessed the effectiveness of Lean principles on first case on-time operating room starts and quantified effects on resident work hours. METHODS: Standard process improvement techniques (DMAIC methodology: define, measure, analyze, improve, control) were used to identify causes of delayed vascular surgery first case starts. Value stream maps and process flow diagrams were created. Process data were analyzed with Pareto and control charts. High-yield changes were identified and simulated in computer and live settings prior to implementation. The primary outcome measure was the proportion of on-time first case starts; secondary outcomes included hospital costs, resident rounding time, and work hours. Data were compared with existing benchmarks. RESULTS: Prior to implementation, 39% of first cases started on time. Process mapping identified late resident arrival in preoperative holding as a cause of delayed first case starts. Resident rounding process inefficiencies were identified and changed through the use of checklists, standardization, and elimination of nonvalue-added activity. Following implementation of process improvements, first case on-time starts improved to 71% at 6 weeks (P = .002). Improvement was sustained with an 86% on-time rate at 1 year (P < .001). Resident rounding time was reduced by 33% (from 70 to 47 minutes). At 9 weeks following implementation, these changes generated an opportunity cost potential of $12,582. CONCLUSIONS: Use of Lean principles allowed rapid identification and implementation of perioperative process changes that improved efficiency and resulted in significant cost savings. This improvement was sustained at 1 year. Downstream effects included improved resident efficiency with decreased work hours.

Early discharge does not increase readmission or mortality after high-risk vascular surgery.

PURPOSE: Clinical pathways aimed at reducing hospital length of stay following vascular surgery have been broadly implemented to reduce costs. However, early hospital discharge may adversely affect the risk of readmission or mortality. To address this question, we examined the relationship between early discharge and 30-day outcomes among patients undergoing a high-risk vascular surgery procedure, thoracic aortic aneurysm (TAA) repair. METHODS: Using Medicare claims from 2000 to 2007, we identified all patients who were discharged home following elective thoracic endovascular aneurysm repair (TEVAR) and open repair for nonruptured TAAs. For each procedure, we examined the correlation between early discharge (<3 days for TEVAR, <7 days for open TAA repair) and 30-day readmission, 30-day mortality, and hospital costs. Predictors of readmission were evaluated using logistic regression models controlling for patient comorbidities, perioperative complications, and discharge location. RESULTS: Our sample included 9764 patients, of which 7850 (80%) underwent open TAA repair, and 1914 (20%) underwent TEVAR. Patients discharged to home early were more likely to be female (66% early vs 56% late), Caucasian (94% early vs 91% late), younger (73 years early vs 74 years late), and have fewer comorbidities (mean Charlson score: 0.7 early vs 1.0 late) than patients discharged home late (all P < .01). As compared with patients who were discharged late, patients discharged home early following uncomplicated open TAA repair and TEVAR had significantly lower 30-day readmission rates ([open: 17% vs 24%; P < .001] [TEVAR: 12% vs 23%; P < .001]) and hospital costs ([open: $73,061 vs $136,480; P < .001] [TEVAR: $58,667 vs $128,478; P < .001]), without an observed increase in 30-day postdischarge mortality. In multivariable analysis, early hospital discharge was associated with a significantly lower likelihood of readmission following both open TAA repair (odds ratio, 0.70; 95% confidence interval, 0.57-0.85; P < .001) and TEVAR (odds ratio, 0.57; 95% confidence interval, 0.38-0.85; P < .01) procedures. CONCLUSIONS: Discharging patients home early following uncomplicated TEVAR or open TAA repair is associated with reduced hospital costs without adversely impacting 30-day readmission or mortality rates. These data support the safety and cost-effectiveness of programs aimed at early hospital discharge in selected vascular surgery patients.

Role of interleukin-6 in a patient with tumor necrosis factor receptor-associated periodic syndrome: assessment of outcomes following treatment with the anti-interleukin-6 receptor monoclonal antibody tocilizumab.

In this report, we describe treatment outcomes in the first case of a patient with tumor necrosis factor receptor-associated periodic syndrome (TRAPS) treated with the anti-interleukin-6 (anti-IL-6) receptor monoclonal antibody tocilizumab. Since IL-6 levels are elevated in TRAPS, we hypothesized that tocilizumab might be effective. The patient, a 52-year-old man with lifelong TRAPS in whom treatment with etanercept and anakinra had failed, was administered tocilizumab for 6 months, and the therapeutic response was assessed by measurement of monocyte CD16 expression and cytokine levels. Following treatment, the evolving acute attack was aborted and further attacks of TRAPS were prevented. The patient did not require corticosteroids and showed significant clinical improvement in scores for pain, stiffness, and well-being. Moreover, the acute-phase response diminished significantly with treatment. Monocyte CD16 expression was reduced and the numbers of circulating CD14+CD16+ and CD14++CD16- monocytes were transiently decreased. However, cytokine levels were not reduced. This case supports the notion of a prominent role for IL-6 in mediating the inflammatory attacks in TRAPS, but blockade of IL-6 did not affect the underlying pathogenesis. These preliminary findings require confirmation.

The value of 3D-CT angiographic assessment prior to carotid stenting.

OBJECTIVE: Anatomic suitability for carotid artery stenting (CAS) is determined by arteriography, but this has a discrete stroke risk. We evaluated the use of multidetector CT angiography with three-dimensional reconstruction (3D-CTA) as a noninvasive screening tool for prospective CAS patients. METHODS: Between 2003 and 2006, 90 CAS procedures were performed by vascular surgeons at our institution. At the discretion of the operating surgeon, 59 of the potential candidates for CAS underwent screening 3D-CTA of the aortic arch and carotid arteries. Results were used in patient selection and then analyzed retrospectively to determine clinical utility. RESULTS: Analysis of 3D-CTA data by the operating surgeon allowed stratification of patients into four groups: (1) appropriate for CAS via femoral approach (n = 37, 63%); (2) appropriate for CAS with transcervical access due to adverse arch anatomy (n = 2, 3%); (3) borderline anatomy for CAS (n = 5, 9%); or (4) not appropriate anatomy for CAS (n = 15, 25%). Group 1 had 100% technical success with one minor stroke. Group 2 had successful transcervical CAS without stroke. Group 3 patients underwent arteriography but CAS was aborted in four out of five cases for the same reason that had been identified by 3D-CTA (internal carotid artery [ICA] tortuosity n = 2, ICA string sign with distal disease n = 2). The one failure in group 3 was the result of a previously placed common carotid stent extending into an already unfavorable aortic arch. Group 4 patients underwent endarterectomy (n = 7) or continued medical management (n = 8) instead of CAS (without arteriography) because of the following reasons, cited alone or in combination: common carotid tandem stenosis n = 5, difficult arch anatomy n = 2, ICA tortuosity n = 2, extreme lesion calcification or length n = 4, ICA string sign or occlusion n = 3, concomitant intracranial disease n = 2, and stenosis overestimated by duplex n = 3. The overall 30-day stroke rate, on an intention to treat basis, for patients that underwent preprocedural 3D-CTA was 2.3% (one major [NIH stroke scale >3] and one minor stroke). CONCLUSIONS: In our initial experience, 3D-CTA reconstruction of the aortic arch and carotid arteries significantly influenced the plan for CAS in 37% of patients. Patients with clear anatomic contraindications to CAS can be excluded without the risks of arteriography. 3D-CTA further facilitates the CAS procedure by anticipating potential procedural. The cost-effectiveness and potential impact of this imaging modality on CAS outcomes deserve further study.

Carotid artery stenting: what have we learned from the clinical trials and registries and where do we go from here?

As with other minimally invasive surgical procedures, carotid angioplasty and stenting (CAS) has developed rapidly over the last decade. Although many believe equivalency with carotid endarterectomy has been established in high-risk patients, the effectiveness of CAS in lower-risk patients is not yet established. This report aims to provide a comprehensive and critical review of the trials and registries of CAS and to offer insight into future directions of this emerging technology.

Cost determinants of percutaneous and surgical interventions for treatment of intermittent claudication from the perspective of the hospital.

PURPOSE: To identify pretreatment predictors of procedural costs in percutaneous and surgical interventions for intermittent claudication due to aortoiliac and/or femoropopliteal disease. METHODS: A retrospective study was conducted in 97 consecutive patients who underwent percutaneous or surgical interventions over 15 months at a tertiary care center. Nineteen clinical predictive variables were collected at baseline. Procedural costs (outcome) were assessed from the perspective of the hospital by direct calculation, not based on ratios of costs-to-charges. A multivariable regression model was built to identify significant cost predictors. Follow-up information was obtained to provide multidimensional assessment of clinical outcome, including technical success (arteriographic score) and clinical result (changes in ankle-brachial pressure index; cumulative patency, mortality, and complication rates). RESULTS: The linear regression model shows that procedural costs per patient are 25% lower in percutaneous patients (versus surgical), 42% lower for patients without rest pain than for those with, 28% lower if treated lesions are unilateral (versus bilateral), 12% lower if the treated lesion is stenotic rather than occlusive, 34% higher in sedentary patients, and 11% higher in patients with a history of cardiac disease. After a mean clinical follow-up >2 years, between-group differences between percutaneous and surgical patients were small and of limited significance in all dimensions of clinical outcome. CONCLUSION: Predictors of clinical outcome are different from predictors of costs, and one should include both types of variables in the decision-making process. The choice of percutaneous versus surgical strategy, the presence of rest pain, and the bilaterality of the culprit lesions were the main pretreatment determinants of procedural costs. When possible choices of treatment strategy overlap, percutaneous treatment should provide an acceptable result that is less expensive (although not equal to surgery).

Current status of carotid artery stenting.

This Clinical Update summarizes the results of larger case series, industry-sponsored registries, and randomized trials of carotid artery stenting (CAS). In >20 case series that studied >24,000 patients undergoing CAS, 51% of patients were symptomatic, most procedures (97%) resulted in successful stent deployment, and 30-day stroke rates varied from 1% to 8%, with a trend toward lower rates as experience and embolic protection device (EPD) use increased. In 12 industry-sponsored registries (none were published in peer-reviewed journals), 30-day stroke rates varied from 2% to 7%, and 30-day combined adverse events, including stroke, death, and myocardial infarction, were 3% to 9%. More than 12 randomized trials comparing CAS and carotid endarterectomy (CEA) have been initiated since 1998. Results have varied over time, depending on the population studied and the technology used. However, the largest and most recent results of the completed SAPPHIRE trial in high-risk patients undergoing CAS with the use of EPDs demonstrated that CAS is at least not inferior to CEA, with a 1-year combined adverse event rate of 12% for CAS and 20% for CEA (P = .05). Other ongoing trials will address not only whether CAS could be superior to CEA in high-risk patients but also, more importantly, whether CAS is beneficial in other subgroups, such as low-risk and asymptomatic patients.