Financial viability of endovascular aortic repair in the modern era.

BACKGROUND: In the current era of cost containment, the financial impact of high-cost procedures such as endovascular aneurysm repair (EVAR) remains an area of intensive interest. Previous reports suggested slim to negative operating margins with EVAR, prompting widespread initiatives to reduce cost and to improve reimbursement. In 2015, the Centers for Medicare and Medicaid Services (CMS) announced the reclassification of EVAR to more specific diagnosis-related group (DRG) coding and predicted an overall increase in hospital reimbursement. The potential impact of this change has not been described. METHODS: Patients undergoing elective EVAR at a single institution between January 2014 and December 2018 were identified retrospectively, then stratified by date. Group 1 patients underwent EVAR before DRG change in 2015 and were classified with DRG 237/238, major cardiovascular procedure. Group 2 patients underwent EVAR after the change and were classified as DRG 268/269, aortic/heart assist procedures. The total direct cost included implant cost, operating room (OR) labor, room and board, and other supply costs. Net revenue reflected real payer mix values without extrapolation based on standard Medicare rates. Hospital profit was defined as the contribution to indirect (CTI), subtracting total direct cost from net revenue. RESULTS: A total of 188 encounters were included, 67 (36%) in group 1 and 121 (64%) in group 2. Medicare patients composed 84% of group 1 and 81% of group 2. CTI (profit) increased by $4447 (+123%) from $3615 in group 1 to $8062 in group 2. Net revenue per encounter increased by $2054 (+7.1%). In group 1, the higher reimbursement DRG code 237 was applied in 5 of 67 (7.5%) patients, whereas DRG code 268 was assigned in 19 of 121 (15.1%) patients in group 2. Total direct cost per encounter decreased by $2012 (-7.9%). This decrease in cost was driven by a reduction in implant cost, from a mean $16,914 per encounter in group 1 to a mean $15,655 in group 2 (-$1259 or -7.4% per encounter) and by a decrease in OR labor cost, $2838 in group 1 to $2361 in group 2 (-$477 or -17.0% per encounter). CONCLUSIONS: A significant improvement in hospital CTI was observed for elective EVAR during the course of the study. The increased DRG reimbursement after the Centers for Medicare and Medicaid Services coding changes in 2015 was a major driver of this salutary change. Notably, efforts to reduce implant and OR cost as well as to improve coding and documentation accuracy over time had an equally important impact on financial return.

Episode-based cost reduction for endovascular aneurysm repair.

OBJECTIVE: Effective strategies to reduce costs associated with endovascular aneurysm repair (EVAR) remain elusive for many medical centers. In this study, targeted interventions to reduce inpatient EVAR costs were identified and implemented. METHODS: From June 2015 to February 2016, we analyzed the EVAR practice at a high-volume academic medical center to identify, to rank, and ultimately to reduce procedure-related costs. In this analysis, per-patient direct costs to the hospital were compared before (September 2013-May 2015) and after (March 2016-January 2017) interventions were implemented. Improvement efforts concentrated on three categories that accounted for a majority of costs: implants, rooming costs, and computed tomography scans performed during the index hospitalization. RESULTS: Costs were compared between 141 EVAR procedures before implementation (PRE period) and 47 EVAR procedures after implementation (POST period). Based on data obtained through the Society for Vascular Surgery EVAR Cost Demonstration Project, it was determined that implantable device costs were higher than those at peer institutions. New purchasing strategies were implemented, resulting in a 30.8% decrease in per-case device costs between the PRE and POST periods. Care pathways were modified to reduce use of and costs for computed tomography scans obtained during the index hospitalization. Compared with baseline, per-case imaging costs decreased by 92.9% (P < .001), including a 99.0% (P = .001) reduction in postprocessing costs. Care pathways were also implemented to reduce preprocedural rooming for patients traveling long distances the day before surgery, resulting in a 50% decrease in utilization rate (35.4% PRE to 17.0% POST; P = .021), without having a significant impact on median postprocedural length of stay (PRE, 2 days [interquartile range, 1-11 days]; POST, 2 days [1-7 days]; P = .185). Medication costs also decreased by 38.2% (P < .001) as a hospital-wide effort. CONCLUSIONS: Excessive costs associated with EVAR threaten the sustainability of these procedures in health care organizations. Targeted cost reduction efforts can effectively reduce expenses without compromising quality or limiting patients' access.

Successful percutaneous access for endovascular aneurysm repair is significantly cheaper than femoral cutdown in a prospective randomized trial.

OBJECTIVE: Because of its minimally invasive nature, percutaneous femoral access for endovascular aneurysm repair (pEVAR) is currently undergoing rapid popularization. Compared with surgical cutdown for femoral access (cEVAR), it offers the advantage of faster recovery after surgery as well as a reduction in wound complications. Despite proposed advantages, the method is largely considered uneconomical because of its reliance on costly closure devices. METHODS: There were 50 patients undergoing EVAR who were enrolled in this randomized prospective single-center trial. Each patient randomly received percutaneous access in one groin and surgical access in the other. The primary end points were access duration and cost. Secondary end points were wound complications and the postoperative pain levels. RESULTS: Surgery was performed per protocol in 44 patients. Mean access times for pEVAR and cEVAR were 11.5 ± 3.4 minutes and 24.8 ± 12.1 minutes (P < .001), respectively. Total access costs were €559.65 ± €112.69 for pEVAR and €674.85 ± €289.55 for cEVAR (P = .016). Eight complications in six patients were attributed to cutdown, none to pEVAR (P = .02). The percutaneously accessed groin was significantly less painful at day 1 and day 5 after surgery (P < .001). An intention-to-treat analysis (N = 50 patients) included six cases of pEVAR conversion due to technical failure in three patients (6%) and change of the operative strategy in another three patients (eg, aortouni-iliac stent graft followed by crossover bypass). The intention-to-treat analysis showed shorter mean overall access time for pEVAR (pEVAR, 14.65 ± 10.20 minutes; cEVAR, 25.12 ± 11.77 minutes; P < .001) and no cost difference between the two methods (pEVAR, €651.29 ± €313.49; cEVAR, €625.53 ± €238.29; P = .65). CONCLUSIONS: Our data confirm proposed potential benefits attributable to the minimally invasive nature of pEVAR while demonstrating cost-effectiveness despite the additional cost of closure devices. Taking into account pEVAR failures still does not increase pEVAR costs over cEVAR. Further considering reduced postoperative pain and wound complications, the technique deserves consideration in suitable patients.

Variation in hospital costs and reimbursement for endovascular aneurysm repair: A Vascular Quality Initiative pilot project.

OBJECTIVE: Comparing costs between centers is difficult because of the heterogeneity of vascular procedures contained in broad diagnosis-related group (DRG) billing categories. The purpose of this pilot project was to develop a mechanism to merge Vascular Quality Initiative (VQI) clinical data with hospital billing data to allow more accurate cost and reimbursement comparison for endovascular aneurysm repair (EVAR) procedures across centers. METHODS: Eighteen VQI centers volunteered to submit UB04 billing data for 782 primary, elective infrarenal EVAR procedures performed by 108 surgeons in 2014. Procedures were categorized as standard or complex (with femoral-femoral bypass or additional arterial treatment) and without or with complications (arterial injury or embolectomy; bowel or leg ischemia; wound infection; reoperation; or cardiac, pulmonary, or renal complications), yielding four clinical groups for comparison. MedAssets, Inc, using cost to charge ratios, calculated total hospital costs and cost categories. Cost variation analyzed across centers was compared with DRG 237 (with major complication or comorbidity) and 238 (without major complication or comorbidity) coding. A multivariable model to predict DRG 237 coding was developed using VQI clinical data. RESULTS: Of the 782 EVAR procedures, 56% were standard and 15% had complications, with wide variation between centers. Mean total costs ranged from $31,100 for standard EVAR without complications to $47,400 for complex EVAR with complications and varied twofold to threefold among centers. Implant costs for standard EVAR without complications varied from $8100 to $28,200 across centers. Average Medicare reimbursement was less than total cost except for standard EVAR without complications. Only 9% of all procedures with complications in the VQI were reported in the higher reimbursed DRG 237 category (center range, 0%-21%). There was significant variation in hospitals' coding of DRG 237 compared with their expected rates. VQI clinical data accurately predict current DRG coding (C statistic, 0.87). CONCLUSIONS: VQI data allow a more precise EVAR cost comparison by identifying comparable clinical groups compared with DRG-based calculations. Total costs exceeded Medicare reimbursement, especially for patients with complications, although this varied by center. Implant costs also varied more than expected between centers for comparable cases. Incorporation of VQI data elements documenting EVAR case complexity into billing data may allow centers to better align respective DRG reimbursement to total costs.

Cost-effectiveness of endovascular repair, open repair, and conservative management of splenic artery aneurysms.

OBJECTIVE: Open repair (OPEN) and conservative management (CONS) have been the treatments of choice for splenic artery aneurysms (SAAs) for many years. Endovascular repair (EV) has been increasingly used with good short-term results. In this study, we evaluated the cost-effectiveness of OPEN, EV, and CONS for the treatment of SAAs. METHODS: A decision analysis model was developed using TreeAge Pro 2013 software (TreeAge Inc, Williamstown, Mass) to evaluate the cost-effectiveness of the different treatments for SAAs. A hypothetical cohort of 10,000 55-year-old female patients with SAAs was assessed in the reference-case analysis. Perioperative mortality, disease-specific mortality rates, complications, rupture risks, and reinterventions were retrieved from a recent and extensive meta-analysis. Costs were analyzed with the 2014 Medicare database. The willingness to pay was set to $60,000/quality-adjusted life years (QALYs). Outcomes evaluated were QALYs, costs from the health care perspective, and the incremental cost-effectiveness ratio (ICER). Extensive sensitivity analyses were performed and different clinical scenarios evaluated. Probabilistic sensitivity analysis was performed to include the uncertainty around the variables. A flowchart for clinical decision-making was developed. RESULTS: For a 55-year-old female patient with a SAA, EV has the highest QALYs (11.32; 95% credibility interval [CI], 9.52-13.17), followed by OPEN (10.48; 95% CI, 8.75-12.25) and CONS (10.39; 95% CI, 8.96-11.87). The difference in effect for 55-year-old female patients between EV and OPEN is 0.84 QALY (95% CI, 0.42-1.34), comparable with 10 months in perfect health. EV is more effective and less costly than OPEN and more effective and more expensive compared with CONS, with an ICER of $17,154/QALY. Moreover, OPEN, with an ICER of $223,166/QALY, is not cost-effective compared with CONS. In elderly individuals (age >78 years), the ICER of EV vs CONS is $60,503/QALY and increases further with age, making EV no longer cost-effective. Very elderly patients (age >93 years) have higher QALYs and lower costs when treated with CONS. The EV group has the highest number of expected reinterventions, followed by CONS and OPEN, and the number of expected reinterventions decreases with age. CONCLUSIONS: EV is the most cost-effective treatment for most patient groups with SAAs, independent of the sex and risk profile of the patient. EV is superior to OPEN, being both cost-saving and more effective in all age groups. Elderly patients should be considered for CONS, based on the high costs in relation to the very small gain in health when treated with EV. The very elderly should be treated with CONS.

Using vascular quality initiative as a platform for organizing multicenter, prospective, randomized clinical trials: OVERPAR trial.

BACKGROUND: We describe the organization of a prospective, randomized, multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair (OPAR) and endovascular popliteal artery aneurysm repair (EPAR) of asymptomatic popliteal artery aneurysms (PAAs) as an example for how to use the Vascular Quality Initiative (VQI) framework. Given that many centers participate in the VQI, this model can be used to perform multicenters' prospective trials on very modest budget. METHODS: VQI prospectively collects data on many vascular procedures. These data include many important perioperative, intraoperative, and postoperative details regarding both patients and their procedures. We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question. Data will be collected using modified VQI forms within the existing VQI data reporting structure. We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts. Patients from participating VQI centers will be randomized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years. Our primary hypothesis is that major adverse limb event-free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions, improved quality of life, and decreased length of stay. The budget for this trial is fixed at $10,000/year for the course of the study, and the trial is judged to be feasible because of the functionality of the VQI platform. CONCLUSIONS: Using the existing VQI infrastructure, Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget. The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates.

Decision analysis model of open repair versus endovascular treatment in patients with asymptomatic popliteal artery aneurysms.

OBJECTIVE: Repair is indicated of asymptomatic popliteal artery aneurysms (aPAAs) that are >2 cm. Endovascular PAA repair with covered stents (stenting) is increasingly used. It is, however, unclear when an endovascular approach is preferred to traditional open repair with great saphenous vein bypass (GSVB). The goal of this study was to assess the treatment options for aPAAs using decision analysis. METHODS: A Markov model was developed and a hypothetic cohort of patients with aPAAs was analyzed. GSVB, stenting, and nonoperative management with optimal medical treatment (OMT) were compared. Operative mortality, patency rates, quality-of-life values, and costs were determined by comprehensive review of the best available evidence. The main outcome was quality-adjusted life-years (QALYs). Secondary outcomes were cost-effectiveness and number of reinterventions. RESULTS: For a 65-year-old male patient with a 2.0-cm aPAA and without significant comorbidities, probabilistic sensitivity analysis shows that intervention is preferred over OMT (5.77 QALYs, 95% credibility interval [CI], 5.43-6.11; OMT). GSVB treatment for this patient results in slightly higher QALYs than stent placement, with a predicted 8.43 QALYs (GSVB: 95% CI, 8.21-8.64) vs 8.07 QALYs (stenting: 95% CI, 7.84-8.29), a difference of 0.36 QALYs (95% CI, 0.14-0.58). Furthermore, costs are higher for stenting ($40,464; 95% CI, $34,814-$46,242) vs GSVB ($21,618; 95% CI, $15,932-$28,070), and more reinterventions are required after stenting (1.03 per patient) vs GSVB (0.52 per patient), making GSVB the preferred strategy for all outcomes considered. Stenting is preferred in patients who are at high risk for open repair (>6% 30-day mortality) or if the 5-year primary patency rates of stenting increase to 80%. For very old patients (>95 years) and patients with a very short life expectancy (<1.5 years), OMT yields higher QALYs. CONCLUSIONS: GSVB is the preferred treatment in 65-year-old patients with aPAAs for all outcomes considered. However, patients at high risk for open repair or without suitable vein should be considered as candidates for endovascular repair. Very elderly patients and patients with a short life expectancy are best treated with OMT. Further improvement of endovascular techniques that increase patency rates of endovascular stents could make this the preferred therapy for more patients in the future.

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.

Endovascular versus open repair of popliteal artery aneurysms: outcomes in the US Medicare population.

OBJECTIVE: The management of popliteal artery aneurysms (PAAs) has undergone significant transition from open surgery to endovascular graft placement with few longitudinal data evaluating outcomes. METHODS: The Centers of Medicare & Medicaid Services Inpatient claims (2005-2007) were queried with a diagnosis of lower extremity artery aneurysm in association with elective Current Procedural Terminology codes for open (OPEN group) and endovascular (ENDO group) repair. RESULTS: A total of 2962 patients were identified. Endovascular interventions significantly increased over the time of the study (11.7% vs 23.6%, P < .0001). Overall complication rates for OPEN and ENDO groups did not differ significantly (11.3% vs 9.3%; P = .017). No differences in the 30- and 90-day mortality rates were found between OPEN versus ENDO groups. The ENDO group had greater 30- and 90-day reinterventions (4.6% vs 2.1%, P = .001 and 11.8% vs 7.4%, P = .0007, respectively). Length of stay (4.5 days vs 2.5 days, P < .0001) and charges ($43 180 vs $35 540, P < .0001) were greater for OPEN group. CONCLUSION: Despite a significant increase in the utilization of endovascular repair of PAAs, endovascular repair was associated with greater reinterventions over time and did not offer a mortality or cost benefit.

Long-term postplacement cost after endovascular aneurysm repair.

BACKGROUND: Previous studies have demonstrated that the initial hospital cost associated with endovascular aneurysm repair (EVAR) is approximately $20,000. However, the cost of long-term surveillance and secondary procedures is poorly characterized. METHODS: Between December 1998 and June 2006, 259 patients underwent EVAR for infrarenal aneurysms at a single institution. Follow-up costs were calculated using a relative value unit based hospital cost accounting system, which incorporates departmental direct and indirect costs. Institutional overhead costs were included using a conversion factor. Costs for professional services were determined by a cost-to-charge ratio, and outpatient visits were calculated with a time-based formula. Year 2006 costs were applied to prior years. To minimize costs associated with the early learning curve, the initial 50 EVAR patients between December 1995 and 1998 were excluded. Patients with <1 year follow-up were also excluded. Data are expressed as mean +/- standard error. RESULTS: The mean follow-up after EVAR for 136 patients was 34.7 +/- 1.8 months. The cumulative 5-year postplacement cost per patient was $11,351. The 27 patients (19.9%) who required secondary procedures had a 5-year cumulative cost of $31,696 compared with $3668 for 109 patients without secondary procedures (8.6-fold increase, P < .05). The 5-year cost for patients with endoleak was $26,739 compared with $5706 for those without endoleak (4.7-fold increase, P < .05). Overall, major cost components were 57.4% for secondary procedures and 32.5% for radiologic studies. CONCLUSIONS: During a 5-year period, the postplacement cost of EVAR increases the global cost by 44%. The subgroups of patients with endoleaks and those requiring secondary procedures generate a disproportionate share of postplacement costs. Efforts at minimizing cost should emphasize technical and device modifications aimed at reducing endoleaks and the need for secondary procedures.