Index and follow-up costs of endovascular abdominal aortic aneurysm repair from the Endurant Stent Graft System Post Approval Study (ENGAGE PAS).

OBJECTIVE: Trials for endovascular aneurysm repair (EVAR) report lower perioperative mortality and morbidity, but also higher costs compared with open repair. However, few studies have examined the subsequent cost of follow-up evaluations and interventions. Therefore, we present the index and 5-year follow-up costs of EVAR from the Endurant Stent Graft System Post Approval Study. METHODS: From August 2011 to June 2012, 178 patients were enrolled in the Endurant Stent Graft System Post Approval Study de novo cohort and treated with the Medtronic Endurant stent graft system (Medtronic Vascular, Santa Rosa, Calif), of whom 171 (96%) consented for inclusion in the economic analysis and 177 participated in the quality-of-life (QOL) assessment over a 5-year follow-up period. Cost data for the index and follow-up hospitalizations were tabulated directly from hospital bills and categorized by Uniform Billing codes. Surgeon costs were calculated by Current Procedural Terminology codes for each intervention. Current Procedural Terminology codes were also used to calculate imaging and clinic follow-up reimbursement as surrogate to cost based on year-specific Medicare payment rates. Additionally, we compared aneurysm-related versus nonaneurysm-related subsequent hospitalization costs and report EuroQol 5D QOL dimensions. RESULTS: The mean hospital cost per person for the index EVAR was $45,304 (interquartile range [IQR], $25,932-$44,784). The largest contributor to the overall cost was operating room supplies, which accounted for 50% of the total cost at a mean of $22,849 per person. One hundred patients had 233 additional post index admission inpatient admissions; however, only 32 readmissions (14%) were aneurysm related, with a median cost of $13,119 (IQR, $4570-$24,153) compared with a nonaneurysm-related median cost of $6609 (IQR, $1244-$26,466). Additionally, 32 patients were admitted a total of 37 times for additional procedures after index admission, of which 14 (38%) were aneurysm-related. The median cost of hospitalization for aneurysm-related subsequent intervention was $22,023 (IQR, $13,177-$47,752), compared with a median nonaneurysm-related subsequent intervention cost of $19,007 (IQR, $8708-$33,301). After the initial 30-day visit, outpatient follow-up imaging reimbursement averaged $550 per person per year ($475 for computed tomography scans, $75 for the abdomen), whereas annual office visits averaged $107 per person per year, for a total follow-up reimbursement of $657 per person per year. There were no significant differences in the five EuroQol 5D QOL dimensions at each follow-up compared with baseline. CONCLUSIONS: Costs associated with index EVAR are driven primarily by cost of operating room supplies, including graft components. Subsequent admissions are largely not aneurysm related; however, cost of aneurysm-related hospitalizations is higher than for nonaneurysm admissions. These data will serve as a baseline for comparison with open repair and other devices.

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.

Underutilization of Routine Ultrasound Surveillance after Endovascular Aortic Aneurysm Repair.

BACKGROUND: Since 2009, the Society for Vascular Surgery has advocated annual surveillance imaging with ultrasound (US) after the first postoperative year for uncomplicated endovascular aneurysm repairs (EVARs). We sought to describe diffusion of US into long-term routine surveillance and to estimate potential cost savings among Medicare beneficiaries after EVAR. METHODS: Using Medicare claims data, we identified patients receiving EVAR from 2002 to 2010 and included only those who did not subsequently have reinterventions, late aneurysm-related complications, or death. We collected all relevant postoperative imaging (computed tomography [CT] and US) through 2011. Patients with follow-up less than 1 year were excluded. We estimated cost savings with increased use of US after the first postoperative year. RESULTS: The cohort comprised 24,615 patients with a mean follow-up of 3.9 ± 2.3 years. Mean number of images decreased from 2.23 in the first postoperative year to 0.31 in the 10th year. Utilization of US at the first postoperative year remained low but increased from 15.2% in 2003 to 28.8% in 2011 (P < 0.001). By the 10th postoperative year, the proportion of patients receiving US increased from 8.2% to 37.8%, while use of CT only remained high but decreased from 60.8% to 42.1%. Mean cost of surveillance imaging was $2,132/CT and $234/US. Performing US in 50-75% of patients beginning 1 year after EVAR would decrease costs by 14-48%/year. This translates to a mean cost savings of $338-$1135 per imaged patient per year, with an estimated savings to Medicare of $155 million to $305 million over 10 years. CONCLUSIONS: CT remains the primary modality of surveillance for up to 10 years after EVAR for patients without reinterventions or aneurysm-related complications. Increasing the use of US and decreasing the use of CT would save cost without compromising outcomes.

Ultra low-dose chest ct with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery (CRICKET study): Rationale and design of a multicenter randomized trial.

BACKGROUND: Stroke after cardiac surgery is a severe complication with a persistently high incidence of 1.4 - 9.7%. Postoperative strokes are mainly embolic and can be provoked by manipulation and clamping of the aorta during cardiac surgery, resulting in the mobilization of atherothrombotic material and calcifications from the aortic wall. Computed tomography (CT) can offer preoperative visualization of aortic calcifications with low radiation exposure. We hypothesize that preoperative knowledge regarding the location and extent of aortic calcifications can be used to optimize surgical strategy and decrease postoperative stroke rate. METHODS/DESIGN: The CRICKET study (ultra low-dose chest CT with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery) is a prospective multicenter randomized clinical trial to evaluate whether non-contrast chest CT before cardiac surgery can decrease postoperative stroke rate by optimizing surgical strategy. Patients scheduled to undergo cardiac surgery aged 18 years and older are eligible for inclusion. Exclusion criteria are pregnancy, a chest/cardiac CT in the past three months, emergency surgery, concomitant or prior participation in a study with ionizing radiation and unwillingness to be informed about incidental findings. Subjects (n = 1.724) are randomized between routine care, including a chest x-ray, or routine care with an additional low dose chest CT. The primary objective is to investigate whether the postoperative in-hospital stroke rate is reduced in the CT arm compared to the routine care arm of the randomized trial. The secondary outcome measures are altered surgical approach based on CT findings and cost-effectiveness.

Economic analysis of endovascular repair versus surveillance for patients with small abdominal aortic aneurysms.

BACKGROUND: The Positive Impact of EndoVascular Options for Treating Aneurysms Early (PIVOTAL) trial enrolled individuals with small (4.0- to 5.0-cm diameter) abdominal aortic aneurysms (AAA) and reported no difference in rupture or aneurysm-related death for patients who received early endovascular repair (EVAR) vs surveillance with serial imaging studies. We evaluated resource use, medical cost, and quality of life outcomes associated with the PIVOTAL treatment strategies. METHODS: This prospective economic and quality of life study was conducted within a randomized trial, with PIVOTAL sites participating in the quality of life (n = 67) and economic (n = 63) studies. The PIVOTAL trial randomized 728 patients (366 early EVAR and 362 surveillance). We used information from 701 quality of life (351 early EVAR and 350 surveillance) and 614 economic (314 early EVAR and 300 surveillance) study participants enrolled in the PIVOTAL trial. The main outcome measures were total medical costs and the aneurysm repair rate at 48 months. RESULTS: After 6 months, the rate of aneurysm repair was 96 vs 10 per 100 patients in the early EVAR and surveillance groups, respectively (difference, 86; 95% confidence interval [CI], 82-90; P < .0001), and total medical costs were greater in the early EVAR group ($33,471 vs $5520; difference, $27,951; 95% CI, $25,156-$30,746; P < .0001). In months 7 through 48, however, the rate of aneurysm repair was 54 per 100 patients in the surveillance group, and total medical costs were higher for patients in the surveillance vs the early EVAR group ($40,592 vs $15,197; difference, $25,394; 95% CI, $15,184-$35,605; P < .0001). At 48 months' follow-up, early EVAR patients had greater cumulative use of AAA repair (97 vs 64 per 100 patients; difference, 34; 95% CI, 21-46; P < .0001), but there was no difference in total medical costs ($48,669 vs $46,112; difference, $2557; 95% CI, -$8043 to $13,156; P = .64). After discounting at 3% per annum, total medical costs for early EVAR and surveillance patients remained similar ($47,765 vs $43,532; difference, 4232; 95% CI, -$5561 to $14,025; P = .40). There were no treatment-related differences in quality of life at 24 months. CONCLUSIONS: A treatment strategy involving early repair of smaller AAA with EVAR is associated with no difference in total medical costs at 48 months vs surveillance with serial imaging studies. Longer follow-up is required to determine whether the late medical cost increases observed for surveillance will persist beyond 48 months.

Use of colour duplex ultrasound as a first line surveillance tool following EVAR is associated with a reduction in cost without compromising accuracy.

INTRODUCTION: CT scanning remains the postoperative surveillance imaging modality of choice following EVAR. Concerns regarding cost, exposure to ionising radiation and intravenous contrast have led to a search for a less expensive, equally efficacious and safer method of monitoring EVAR patients after endograft deployment. This study evaluated the cost saving obtained if CDUS was employed as a first line surveillance tool following EVAR, as well as comparing the two entities in terms of efficacy. PATIENTS & METHODS: Postoperative surveillance CTs and CDUS scans in the 145 patients who have undergone EVAR from 1st June 2003 to 1st July 2010 were compared for the detection of endoleak and determination of residual sac size. RESULTS: Adopting a protocol where CDUS was employed as the first line surveillance tool following EVAR would result in a reduction in the number of postoperative CTs required in 2010 from 235 to 36. Based on 2010 costings, this would equate to an estimated reduction in expenditure from €117,500 to €34,915 a saving of €82,585. CDUS had a sensitivity of 100% and a specificity of 85% in the detection of endoleaks compared to CT. The positive predictive value was 28% and negative predictive value 100%. The Pearson Coefficient correlation of 0.96 indicates a large degree of correlation between CDUS and CT when measuring residual aneurysm size following EVAR. CONCLUSION: CDUS can replace CT as the first line surveillance tool following EVAR. This is associated with a significant reduction in the cost of surveillance without any loss of imaging accuracy.

Anatomic severity grading score predicts technical difficulty, early outcomes, and hospital resource utilization of endovascular aortic aneurysm repair.

BACKGROUND: In 2002, a system for the grading of abdominal aortic aneurysms (AAAs) was developed by the Society for Vascular Surgery (SVS). Because the correlation of the anatomic severity grading (ASG) score to patient outcomes has yet to be validated, we provide our experience with calculating the ASG score using three-dimensional (3-D) image-rendering software and provide the practical translation of this score into early outcomes and hospital charges. METHODS: All patients who underwent an endovascular aneurysm repair (EVAR) for infrarenal AAAs between 2009 and 2010 were retrospectively reviewed for demographics, intraoperative data, and 30-day outcomes. ASG scores were calculated from morphologic measurements, and two independent patient groups were created: those with a low ASG score (score <14) and a high ASG score (score ≥14). RESULTS: We identified 108 patients (mean age, 75 years), of whom 56 were in the low-score ASG group and 52 were in the high-score ASG group. Operative outcomes significantly different in the low-score group vs high-score group were number of endograft implants (three vs four, P = .001), operative time (113 vs 210 minutes, P < .0001), blood loss (227 vs 866 mL, P = .0002), and contrast volume (100 vs 131 mL, P = .032). In the low-score group compared with the high-score group, access site adjuncts were 14% vs 50% (P < .0001), and intraoperative adjuncts were 54% vs 80% (P = .004). Most adjuncts (75%) were endovascular. No EVARs were converted to open. Mean hospital stay was 2 days for the low-score group and 5 days for the high-score group (P = .012). The 30-day operative mortality was zero. No aneurysm-related deaths occurred during follow-up. In the low-score vs high-score groups, mean operating room supply charge was $16,646 vs $25,765 (P = .006), and the mean total hospital charge was $70,956 vs $105,153 (P = .016). CONCLUSION: The anatomic severity grading score can be easily and rapidly calculated from computed tomography images with the aid of 3-D image-rendering software. The anatomic severity grading score correlates with the technical difficulty of EVAR and the extent of hospital resource utilization.

Surveillance after EVAR based on duplex ultrasound and abdominal radiography.

INTRODUCTION: Computed tomography angiography (CTA) is considered the gold standard imaging technique for surveillance following endovascular aneurysm repair (EVAR). Limitations of CTA include cost, risk of contrast nephropathy and radiation exposure. A modified surveillance protocol involving annual duplex ultrasound (DUS) and abdominal radiography (AXR) was introduced, with CTA performed only if abnormalities were identified or DUS was undiagnostic. METHODS: Prospective records were maintained on patients undergoing infra-renal EVAR at a UK, tertiary referral centre. All patients enrolled with at least one-year follow-up were reviewed. Primary outcomes identified were aneurysm rupture and aneurysm-related complications. Secondary outcomes included number of CTAs avoided and cost. RESULTS: Median follow-up was 36 months (range 12-57) for 194 patients. The total number of sets of surveillance imaging was 412 of which 70 (17%) required CTA. Abnormalities were found in 30 patients, 18 confirmed by CTA. Eleven patients required secondary intervention, three initially identified by AXR, three by DUS, three by both DUS and AXR, and two by CTA following undiagnostic DUS. No patient presented with rupture or aneurysm-related complications not identified by modified surveillance. Mean annual savings were €223. CONCLUSION: EVAR surveillance based on DUS and AXR is feasible and safe. The complimentary nature of AXR and DUS is demonstrated.

Duplex ultrasound imaging alone is sufficient for midterm endovascular aneurysm repair surveillance: a cost analysis study and prospective comparison with computed tomography scan.

OBJECTIVE: Early in our experience with endovascular aortic aneurysm repair (EVAR) we performed both serial computed tomography scans and duplex ultrasound (DU) imaging in our post-EVAR surveillance regimen. Later we conducted a prospective study with DU imaging as the sole surveillance study and determined cost savings and outcome using this strategy. METHODS: From September 21, 1998, to May 30, 2008, 250 patients underwent EVAR at our hospital. Before July 1, 2004, EVAR patients underwent CT and DU imaging performed every 6 months during the first year and then annually if no problems were identified (group 1). We compared aneurysm sac size, presence of endoleak, and graft patency between the two scanning modalities. After July 1, 2004, patients underwent surveillance using DU imaging as the sole surveillance study unless a problem was detected (group 2). CT and DU imaging charges for each regimen were compared using our 2008 health system pricing and Medicare reimbursements. All DU examinations were performed in our accredited noninvasive vascular laboratory by experienced technologists. Statistical analysis was performed using Pearson correlation coefficient. RESULTS: DU and CT scans were equivalent in determining aneurysm sac diameter after EVAR (P < .001). DU and CT were each as likely to falsely suggest an endoleak when none existed and were as likely to miss an endoleak. Using DU imaging alone would have reduced cost of EVAR surveillance by 29% ($534,356) in group 1. Cost savings of $1595 per patient per year were realized in group 2 by eliminating CT scan surveillance. None of the group 2 patients sustained an adverse event such as rupture, graft migration, or limb occlusion as a result of having DU imaging performed as the sole follow-up modality. CONCLUSION: Surveillance of EVAR patients can be performed accurately, safely, and cost-effectively with DU as the sole imaging study.

Long-term postplacement cost comparison of AneuRx and Zenith endografts.

Long-term postplacement costs increase the global cost of endovascular aneurysm repair (EVAR) by 44%. Secondary procedures and endoleaks significantly increase long-term expense. This study evaluates device-specific long-term postplacement costs using two different endografts. AneuRx and Zenith endografts were used to treat 250 patients with abdominal aortic aneurysms between December 1998 and June 2006 at a single institution. A relative value unit-based hospital cost accounting system was used to calculate both direct and indirect hospital departmental costs. Institutional overhead expenses, costs of professional services, and outpatient visits were also included in cost determinations. All costs were valued in 2006 dollars. To examine long-term costs, patients with <1 year follow-up were excluded. The initial 50 EVAR patients between December 1995 and 1998 were also excluded, to limit the effect of the learning curve on postplacement cost. The cumulative 5-year postplacement costs per patient were $12,465 (AneuRx) and $10,606 (Zenith, p = 0.22). Mean durations of follow-up were 38.5 +/- 5.2 months (AneuRx) and 32.8 +/- 3.8 months (Zenith, p = 0.12). For both devices, the largest cost components were secondary procedures (59.5% AneuRx vs. 56.4% Zenith) and radiologic studies (29.2% AneuRx vs. 34.9% Zenith). Freedom from secondary procedures (80% vs. 51%, p < 0.05) and endoleaks (83% vs. 58%, p = 0.05) was higher in patients treated with Zenith vs. AneuRx endografts, respectively. There was a reduction in secondary procedures and endoleaks in patients treated with Zenith compared to AneuRx. The corresponding 15% reduction in cost, however, was not statistically significant. Additional device-related cost reductions may be possible through improvements in device and technique and alterations in surveillance imaging.

Can chest CT be used to exclude aortic injury?

PURPOSE: To determine whether chest computed tomography (CT) can be used to exclude aortic injury. MATERIALS AND METHODS: Patients in whom there was very high suspicion of traumatic aortic injury were examined with aortography only. Other patients were examined with contrast material-enhanced CT. Follow-up aortography was performed in all patients with moderate to high suspicion of traumatic aortic injury and in all patients with CT scans that were positive for traumatic aortic injury. CT scans were regarded as positive when they showed mediastinal hematoma or direct findings of aortic injury. During a 4 1/2-year period, 1,009 patients (263 female, 746 male; age range, 3-90 years) were evaluated for possible traumatic aortic injury. RESULTS: Of the 207 patients who underwent aortography directly without CT, 10 had traumatic aortic injury. Of the 802 patients who were examined with CT, 382 underwent follow-up aortography. In this group, there were 10 true-positive and no false-negative CT scans. CT had 100% sensitivity and a 100% negative predictive value for the detection of traumatic aortic injury.

Blunt thoracic aortic trauma. A cost-utility approach for injury detection.

OBJECTIVE: To evaluate the influences of patient preference and treatment costs on the diagnostic approach to blunt aortic trauma. METHODS: Decision and cost-utility analysis. DATA SOURCES: A MEDLINE search of all literature dealing with the diagnosis and management of blunt aortic injury was used to establish assumptions and assign baseline probability estimates. Utility assignments were made from published data and our own assignments. We obtained institution-specific cost data. STUDY SELECTION: Only randomized, prospective trials that used aortography as the gold standard test were used to assign baseline accuracy of transesophageal echocardiography and dynamic chest computed tomography. Other baseline estimates were taken from class II and class III published data. DATA SYNTHESIS: A decision tree compared 4 diagnostic approaches for blunt chest trauma after an initial normal chest radiograph: observation with follow-up chest radiography, aortography, transesophageal echocardiography, and dynamic chest computed tomography. Utility (a quality-of-life measure) was assigned to ultimate health states to incorporate patient preference. Chest radiography and aortography had similar utility. Aortography gained 1 quality-adjusted life year for minimal cost. Transesophageal echocardiography and dynamic chest computed tomography lose quality-adjusted life-years at increased cost. No variable changed the relative cost-utility of the screening methods in 2-way sensitivity analyses. CONCLUSIONS: Aortography gains additional quality life at minimal cost when used as a screening method for all patients with blunt chest trauma regardless of the results of the initial chest radiograph. With a normal initial chest radiograph, transesophageal echocardiography and dynamic chest computed tomography are associated with increased cost and loss of quality-adjusted life.

Computed tomography vs clinical and multidisciplinary procedures for early evaluation of severe abdomen and chest trauma--a cost analysis approach.

OBJECTIVE: To compare contrast computed tomography (CT) for evaluating abdominal and vascular chest injuries after emergency room resuscitation with multidisciplinary management based on bedside procedure (BP), e.g., peritoneal lavage, abdomen ultrasonography urography and, if indicated, CT and/or aortography or transesophageal echocardiography. DESIGN: Randomized study. SETTING: Emergency, critical care and radiology departments in a trauma center. PATIENTS: The study was performed in 103 severe blunt trauma patients with a revised trauma index < 8, admitted over a 16 month period and divided into group (G1, n = 52, CT management) and group 2 (G2, n = 51, BP management). INTERVENTIONS: A relative direct cost scale used in our trauma center was applied, and cost units (U) were assigned to each diagnostic test for cost-minimization analysis (abdomen ultrasonograph = 7.5 U, peritoneal lavage = 8 U, urography = 9 U, computed tomography = 9 U, transesophageal echocardiography = 13.5 U, and aortography = 15 U). One unit is approximately equivalent to $43.7. RESULTS: Injury severity score (ISS) was 31.7 +/- 15.4 in G1 and 33.8 +/- 18.3 in G2. Sensitivity for CT was 90.4% (G1) vs 72.5% for BP (G2) in abdomen (P < 0.01) and 60% in chest for evaluating mediastinal hematoma etiology (G1). As Table 2 shows, G1 needed 59 tests for evaluating injuries (1.1 +/- 0.3 tests patient) while G2 required 81 tests (1.68 +/- 0.8 tests/patient) (P < 0.01). The total relative cost was 538 U for G1, 7.04 +/- 2.2 U cost/injury and 10.3 +/- 3.3 U/evaluation of trauma vs 698 U for G2, 9.84 +/- 5.03 U cost/injury and 13.68 +/- 8.5 U/evaluation (P < 0.05). CONCLUSIONS: This cost-minimization study suggests that CT is a more cost-effective method for the post-emergency room resuscitation evaluation of severe abdominal blunt trauma than the multidisciplinary BP. Chest CT is a screening method for mediastinal hematoma but not for etiology.

Cost-effectiveness of colour duplex sonography compared with angiography of the pelvis and lower limb.

The present investigation was performed to assess the clinical consequences, utility and efficacy of colour duplex sonography (CDS) compared with angiography as a preoperative examination in aorta, pelvis and lower limb, and thus to estimate the cost-effectiveness of CDS. CDS was additionally performed in 53 consecutive patients referred for preoperative angiography of the lower limb. The results for 49 patients were reviewed and compared to assess the technique's clinical utility. The costs of the two methods and the consequences of inappropriate treatment were assessed. In 15 patients inadequate diagnoses were obtained at CDS. If surgery had been performed solely on the basis of the ultrasonographic diagnosis, repeat surgery would have been necessary in 9 patients. In a further 3 patients necessary surgery would not have been performed. Two patients would have been overtreated (unnecessary surgery instead of percutaneous transluminal balloon angioplasty). To correct the initial incorrect diagnosis the estimated yearly cost would be approximately 1.3 million Swedish crowns. In addition, complications and discomfort could be anticipated for the patients. Because of its low sensitivity CDS ist not cost-effective as a preoperative investigation of arteries of the pelvis and lower limb.