Reliable and valid assessment of procedural skills in resuscitative endovascular balloon occlusion of the aorta.

BACKGROUND: Valid and reliable assessment of skills is essential for improved and evidence-based training concepts. In a recent study, we presented a novel tool to assess procedural skills in resuscitative endovascular balloon occlusion of the aorta (REBOA), REBOA-RATE, based on international expert consensus. Although expert consensus is a strong foundation, the performance of REBOA-RATE has not been explored. The study aimed to examine the reliability and validity of REBOA-RATE. METHODS: This was an experimental simulation-based study. We enrolled doctors with three levels of expertise to perform two REBOA procedures in a simulated scenario of out-of-hospital cardiac arrest. Procedures were video-recorded, and videos were blinded and randomized. Three clinical experts independently rated all procedures using REBOA-RATE. Data were analyzed using Messick's framework for validity evidence, including generalizability analysis of reliability and determination of a pass/fail standard. RESULTS: Forty-two doctors were enrolled: 16 novices, 13 anesthesiologists, and 13 endovascular experts. They all performed two procedures, yielding 84 procedures and 252 ratings. The REBOA-RATE assessment tool showed high internal consistency (Cronbach's α = 0.95) and excellent interrater reliability (intraclass correlation coefficient, 0.97). Assessment using one rater and three procedures could ensure overall reliability suitable for high-stakes testing (G-coefficient >0.80). Mean scores (SD) for the three groups in the second procedure were as follows: novices, 32% (24%); anesthesiologists, 55% (29%); endovascular experts, 93% (4%) (p < 0.001). The pass/fail standard was set at 81%, which all experts but no novices passed. CONCLUSION: Data strongly support the reliability and validity of REBOA-RATE, which successfully discriminated between all experience levels. The REBOA-RATE assessment tool requires minimal instruction, and one rater is sufficient for reliable assessment. Together, these are strong arguments for the use of REBOA-RATE to assess REBOA skills, allowing for competency-based training and certification concepts. LEVEL OF EVIDENCE: Diagnostic test, no or poor gold standard, level V.

A Review of UK-based National and International Scientific Meeting Published Abstracts in Response to the Draft NICE Aortic Aneurysm Guidelines.

BACKGROUND: UK National Institute for Health and Care Excellence (NICE) draft clinical guidelines (CG) (2018) regarding aortic aneurysm repair were disputed internationally. We aim to appraise the academic response to the draft CG in terms of quantity and scientific quality by reviewing published conference abstracts from three major national and international, UK meetings. METHODS: Abstracts related to aortic practice from The Vascular Societies Annual Scientific Meeting, British Society for Endovascular Therapy (BSET) & Charing Cross (CX) meetings from 2019 were reviewed for methodology, sample size, data collection period, scientific quality and conclusions that supported or conflicted the draft guideline. RESULTS: A total of 549 abstracts were identified from VSGBI, BSET and CX abstract books of which, 226 (41.2%) were related to aortic practices. Of these, 115 (50.9%) were related to EVAR. Twenty-two of these abstracts (19.1%) were identified as having findings relevant to the draft guidelines. Eighteen (15.7%) were identified as findings that potentially conflict the draft CG and 4 (3.5%) that could support the initial recommendations. Six abstracts (5.2%) made direct reference to or challenged the draft CG. The median data collection period was 4 years. The median sample size was 102 patients. In general, scientific quality was poor, with 82% of selected abstracts were graded at level 2b. CONCLUSION: We have demonstrated a concerted response to the draft NICE clinical guidelines relating to the treatment of abdominal aortic aneurysms at three large scientific meetings. As a result of which and other factors, significant changes were made to the finalized NG156. There is still paucity in evidence regarding the long-term safety and cost-effectiveness of EVAR.

Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions.

BACKGROUND: The Superficial Femoral Artery-Popliteal EvidencE Development Study Group developed contemporary objective performance goals (OPGs) for peripheral vascular interventions (PVI) for superficial femoral artery (SFA)-popliteal artery disease using the Registry Assessment of Peripheral Interventional Devices. METHODS: The Society for Vascular Surgery Vascular Quality Initiative PVI registry from January 2010 to October 2016 was used to develop OPGs based on SFA-popliteal procedures (n = 21,377) for intermittent claudication and critical limb ischemia (CLI). OPGs included 1-year rates for target lesion revascularization (TLR), major amputation, and 1 and 4-year survival rates. OPGs were calculated for the SFA and popliteal arteries and stratified by four treatments: angioplasty alone (percutaneous transluminal angioplasty [PTA]), self-expanding stenting, atherectomy, and any treatment type. Outcomes were illustrated by unadjusted Kaplan-Meier analyses. RESULTS: Cohorts included PTA (n = 7505), stenting (n = 9217), atherectomy (n = 2510) and any treatment (n = 21,377). The mean age was 69 years, 58% were male, 79% were White, and 52% had CLI. The freedom from TLR OPGs at 1 year in the SFA were 80.3% (PTA), 83.2% (stenting), 83.9% (atherectomy), and 81.9% (any treatments). The freedom from TLR OPGs at 1 year in the popliteal were 81.3% (PTA), 81.3% (stenting), 80.2% (atherectomy), and 81.1% (any treatments). The freedom from major amputation OPGs at 1 year after SFA PVI were 93.4% (PTA), 95.7% (stenting), 95.1% (atherectomy), and 94.8% (any treatments). The freedom from major amputation OPG at 1 year after popliteal PVI were 90.5% (PTA), 93.7% (stenting), 91.8% (atherectomy), and 91.8%, (any treatments). The 4-year survival OPGs after SFA PVI were 76% (PTA), 80% (stenting), 82% (atherectomy), and 79% (any treatments), and for the popliteal artery were 72% (PTA), 77% (stenting), 82% (atherectomy), and 75% (any treatment). On a multivariable analysis, which included patient-level, leg-level, and lesion-level covariates, CLI was the single independent factor associated with increased TLR, amputation, and mortality. CONCLUSIONS: The Superficial Femoral Artery-Popliteal EvidencE Development OPGs define a new, contemporary benchmark for SFA-popliteal interventions using a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision-making. It is appropriate to discuss proposals intended for regulatory approval with the US Food and Drug Administration to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance.

Editor's Choice - Assessment of Correlation Between Mean Size of Infrarenal Abdominal Aortic Aneurysm at Time of Intact Repair Against Repair and Rupture Rate in Nine Countries.

OBJECTIVE: This study aimed to analyse the mean abdominal aortic aneurysm (AAA) diameter for repair in nine countries, and to determine variation in mean AAA diameter for elective AAA repair and its relationship to rupture AAA repair rates and aneurysm related mortality in corresponding populations. METHODS: Data on intact (iAAA) and ruptured infrarenal AAA (rAAA) repair for the years 2010-2012 were collected from Denmark, England, Finland, Germany, Hungary, New Zealand, Norway, Sweden, and the USA. The rate of iAAA repair and rAAA per 100 000 inhabitants above 59 years old, mean AAA diameter for iAAA repair and rAAA repair, and the national rates of rAAA were assessed. National cause of death statistics were used to estimate aneurysm related mortality. Direct standardisation methods were applied to the national mortality data. Logistic regression and analysis of variance model adjustments were made for age groups, sex, and year. RESULTS: There was a variation in the mean diameter of iAAA repair (n = 34 566; range Germany = 57 mm, Denmark = 68 mm). The standardised iAAA repair rate per 100000 inhabitants varied from 10.4 (Hungary) to 66.5 (Norway), p<.01, and the standardised rAAA repair rate per 100 000 from 5.8 (USA) to 16.9 (England), p<.01. Overall, there was no significant correlation between mean diameter of iAAA repair and standardised iAAA rate (r2 = 0.04, p = .3). There was no significant correlation between rAAA repair rate (n = 12 628) with mean diameter of iAAA repair (r2 = 0.2, p = .1). CONCLUSION: Despite recommendations from learned society guidelines, data indicate variations in mean diameter for AAA repair. There was no significant correlation between mean diameter of AAA repair and rates of iAAA repair and rAAA repair. These analyses are subject to differences in disease prevalence, uncertainties in rupture rates, validations of vascular registries, causes of death and registrations.

Carotid Artery Stenting in Asymptomatic Carotid Artery Stenosis: JACC Review Topic of the Week.

The advance of therapies to reduce the stroke impact of asymptomatic carotid artery stenosis has proved difficult over the last decade. Disagreement concerning the underlying randomized control trials has limited entry into the care arena of endovascular therapies. Recently, advances in percutaneous therapies for carotid artery disease have been reported and provide a substantial database supporting the further incorporation of endovascular-based therapies in patients who need revascularization and meet selection criteria. With a second randomized control trial now published, it is time for a re-evaluation of endovascular therapy as a component of carotid artery care. This review describes the advances in the field in the last 5 years, clarifying the current position of these therapies in the care of the patient with asymptomatic carotid artery disease.

Endovascular Thrombectomy for Acute Ischemic Strokes: Current US Access Paradigms and Optimization Methodology.

Background and Purpose- Timely access to endovascular thrombectomy (EVT) centers is vital for best acute ischemic stroke outcomes. Methods- US stroke-treating centers were mapped utilizing geo-mapping and stratified into non-EVT or EVT if they reported ≥1 acute ischemic stroke thrombectomy code in 2017 to Center for Medicare and Medicaid Services. Direct EVT-access, defined as the population with the closest facility being an EVT-center, was calculated from validated trauma-models adapted for stroke. Current 15- and 30-minute access were described nationwide and at state-level with emphasis on 4 states (TX, NY, CA, IL). Two optimization models were utilized. Model-A used a greedy algorithm to capture the largest population with direct access when flipping 10% and 20% non-EVT to EVT-centers to maximize access. Model-B used bypassing methodology to directly transport patients to the nearest EVT centers if the drive-time difference from the geo-centroid to hospital was within 15 minutes from the geo-centroid to the closest non-EVT center. Results- Of 1941 stroke-centers, 713 (37%) were EVT. Approximately 61 million (19.8%) Americans have direct EVT access within 15 minutes while 95 million (30.9%) within 30 minutes. There were 65 (43%) EVT centers in TX with 22% of the population currently within 15-minute access. Flipping 10% hospitals with top population density improved access to 30.8%, while bypassing resulted in 45.5% having direct access to EVT centers. Similar results were found in NY (current, 20.9%; flipping, 34.7%; bypassing, 50.4%), CA (current, 25.5%; flipping, 37.3%; bypassing, 53.9%), and IL (current, 15.3%; flipping, 21.9%; bypassing, 34.6%). Nationwide, the current direct access within 15 minutes of 19.8% increased by 7.5% by flipping the top 10% non-EVT to EVT-capable in all states. Bypassing non-EVT centers by 15 minutes resulted in a 16.7% gain in coverage. Conclusions- EVT-access within 15 minutes is limited to less than one-fifth of the US population. Optimization methodologies that increase EVT centers or bypass non-EVT to the closest EVT center both showed enhanced access. Results varied by states based on the population size and density. However, bypass showed more potential for maximizing direct EVT-access. National and state efforts should focus on identifying gaps and tailoring solutions to improve EVT-access.

Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia.

GUIDELINE SUMMARY: Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.

Inter- and intraobserver reliability for angiographic leptomeningeal collateral flow assessment by the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) scale.

BACKGROUND: The adequacy of leptomeningeal collateral flow has a pivotal role in determining clinical outcome in acute ischemic stroke. The American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) collateral score is among the most commonly used scales for measuring this flow. It is based on the extent and rate of retrograde collateral flow to the impaired territory on angiography. OBJECTIVE: To evaluate inter- and intraobserver agreementin angiographic leptomeningeal collateral flow assessment. MATERIALS AND METHODS: Thirty pretreatment angiogram video loops (frontal and lateral view), chosen from the randomized controlled trial THRombectomie des Artères CErebrales (THRACE), were sent for grading in an electronic file. 19 readers participated, including eight who had access to a training set before the first grading. 13 readers made a double evaluation, 3 months apart. RESULTS: Overall agreement among the 19 observers was poor (κ = 0,16 ± 6,5.10 -3), and not improved with prior training (κ = 0,14 ± 0,016). Grade 4 showed the poorest interobserver agreement (κ=0.18±0.002) while grades 0 and 1 were associated with the best results (κ=0.52±0.001 and κ=0.43±0.004, respectively). Interobserver agreement increased (κ = 0,27± 0,014) when a dichotomized score, 'poor collaterals' (score of 0, 1 or 2) versus 'good collaterals' (score of 3 or 4) was used. The intraobserver agreements varied between slight (κ=0.18±0.13) and substantial (κ=0.74±0.1), and were slightly improved with the dichotomized score (from κ=0.19±0.2 to κ=0.79±0.11). CONCLUSION: Inter- and intraobserver agreement of collateral circulation grading using the ASITN/SIR score was poor, raising concerns about comparisons among publications. A simplified dichotomized judgment may be a more reproducible assessment when images are rated by the same observer(s) in randomized trials.

Neuroendovascular Fellowship Training: Self-Assessment of a Program Accredited by the Committee on Advanced Subspecialty Training.

The University at Buffalo's neuroendovascular fellowship is one of the longest running fellowship programs in North America. The burgeoning neurointerventional workforce and the rapid growth in the neurointerventional space on the heels of groundbreaking clinical trials prompted us to assess the fellowship's academic impact and its graduates' perceptions and productivity. An anonymized web-based survey was sent to all former neuroendovascular fellows with specific questions pertaining to current practice, research and funding, and perceptions about the fellowship's impact on their skills, competitiveness, and compensation. Additionally, the h-index was calculated to assess the academic productivity of each graduated fellow. Among 50 former fellows, 42 (84%) completed the survey. The fellows came from various countries, ethnic backgrounds, and specialties including neurosurgery (n = 39, 93%), neurology (n = 2, 5%), and neuroradiology (n = 1, 2%). Twenty (48%) respondents were currently chairs or directors of their practice. Most (n = 30, 71%) spent at least 10% of their time on research activities, with 27 (64%) receiving research funding. The median h-index of all 50 former fellows was 14. The biggest gains from the fellowship were reported to be improvement in endovascular skills (median = 10 on a scale of 0-10 [highest]) and increase in competitiveness for jobs in vascular neurosurgery (median = 10), followed by increase in academic productivity (median = 8), and knowledge of vascular disease (median = 8). In an era with open calls for moratoriums on endovascular fellowships, concerns over market saturation, and pleas to improve training, fellowship programs perhaps merit a more objective assessment. The effectiveness of a fellowship program may best be measured by the academic impact and leadership roles of former fellows.

Assessment of Competence in EVAR Procedures: A Novel Rating Scale Developed by the Delphi Technique.

OBJECTIVE/BACKGROUND: To develop a procedure specific global rating scale for assessment of operator competence in endovascular aortic repair (EVAR). METHODS: A Delphi approach was used to achieve expert consensus. A panel of 32 international experts (median 300 EVAR procedures, range 200-3000) from vascular surgery (n = 21) and radiology (n = 11) was established. The first Delphi round was based on a review of endovascular skills assessment papers, stent graft instructions for use, and structured interviews. It led to a primary pool of 83 items that were formulated as global rating scale items with tentative anchors. Iterative Delphi rounds were executed. The panellists rated the importance of each item on a 5 point Likert scale. Consensus was defined as 80% of the panel rating an item 4 or 5 in the primary round and 90% in subsequent rounds. Consensus on the final assessment tool was defined as Cronbach's alpha > .8 after a minimum of three rounds. RESULTS: Thirty-two of 35 invited experts participated. Three rounds of surveys were completed with a completion rate of 100% in the first two rounds and 91% in round three. The 83 primary assessment items were supplemented with five items suggested by the panel and reduced to seven pivotal assessment items that reached consensus, Cronbach's alpha = 0.82. The seven item rating scale covers key elements of competence in EVAR stent placement and deployment. Each item has well defined grades with explicit anchors at unacceptable, acceptable, and superior performance on a 5 point Likert scale. CONCLUSION: The Delphi methodology allowed for international consensus on a new procedure specific global rating scale for assessment of competence in EVAR. The resulting scale, EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE), represents key elements in the procedure. EVARATE constitutes an assessment tool for providing structured feedback to endovascular operators in training.

Better survival for African and Hispanic/Latino Americans after infrainguinal revascularization in the Society for Vascular Surgery Vascular Quality Initiative.

OBJECTIVE: Inferior survival outcomes have historically been reported for African Americans with cardiovascular disease, and poorer outcomes have been presumed for peripheral arterial disease (PAD) as well. The current study evaluates the effect of race and ethnicity on survival of patients undergoing open or endovascular interventions for lower extremity PAD. METHODS: Data of patients from the Society for Vascular Surgery Vascular Quality Initiative database were obtained for patients undergoing open infrainguinal (INFRA) or suprainguinal (SUPRA) bypass, peripheral vascular intervention (PVI), and amputation (AMP). Patients were further stratified as suprainguinal (SupraPVI) if any of the first three interventions listed included the aorta or iliac vessels or infrainguinal (InfraPVI) if not. The primary outcome was the patient's death (overall mortality) as recorded in the database or determined by cross-reference with the Social Security Death Index (SSDI). The secondary outcome consisted of perioperative mortality during the index hospitalization. Generalized linear modeling provided multivariate analysis, with entry of variables dependent on results of univariate analysis. RESULTS: From January 2003 through September 2015, a total of 24,241 INFRA bypass, 8028 SUPRA bypass, 48,048 InfraPVI, 21,196 SupraPVI, and 3423 AMP patients met criteria for analysis, with a median follow-up of 18 (interquartile range, 8-33) months. Combining all procedures, overall mortality was lower among African Americans than among white Americans (12.4% vs 14.2%; P < .0001) but not death in the periprocedural period (1.1% vs 1.2%; P = .26). To account for differences in length of follow-up, Cox proportional hazards analysis confirmed that the African American race was independently associated with a significantly lower occurrence of overall mortality after INFRA bypass (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.70-0.88; P < .0009), InfraPVI (HR, 0.72; 95% CI, 0.67-0.78; P < .0001), and SupraPVI (HR, 0.77; 95% CI, 0.66-0.90; P = .0009) interventions but not after SUPRA bypass or AMP. Similarly, by Cox proportional hazards, Hispanic/Latino ethnicity was also independently associated with lower overall mortality after INFRA bypass (HR, 0.75; 95% CI, 0.62-0.91; P = .0030), InfraPVI (HR, 0.69; 95% CI, 0.62-0.78; P < .0001), and SupraPVI (HR, 0.68; 95% CI, 0.52-0.89; P = .0045) but not after SUPRA bypass or AMP. CONCLUSIONS: Contrary to the published data for other forms of cardiovascular disease, African American patients as well as patients identified with Hispanic/Latino ethnicity with PAD included in the Society for Vascular Surgery Vascular Quality Initiative undergoing INFRA revascularization for lower extremity PAD experienced better overall survival compared with white Americans.

Content Validation and Evaluation of an Endovascular Teamwork Assessment Tool.

OBJECTIVE/BACKGROUND: To modify, content validate, and evaluate a teamwork assessment tool for use in endovascular surgery. METHODS: A multistage, multimethod study was conducted. Stage 1 included expert review and modification of the existing Observational Teamwork Assessment for Surgery (OTAS) tool. Stage 2 included identification of additional exemplar behaviours contributing to effective teamwork and enhanced patient safety in endovascular surgery (using real-time observation, focus groups, and semistructured interviews of multidisciplinary teams). Stage 3 included content validation of exemplar behaviours using expert consensus according to established psychometric recommendations and evaluation of structure, content, feasibility, and usability of the Endovascular Observational Teamwork Assessment Tool (Endo-OTAS) by an expert multidisciplinary panel. Stage 4 included final team expert review of exemplars. RESULTS: OTAS core team behaviours were maintained (communication, coordination, cooperation, leadership team monitoring). Of the 114 OTAS behavioural exemplars, 19 were modified, four removed, and 39 additional endovascular-specific behaviours identified. Content validation of these 153 exemplar behaviours showed that 113/153 (73.9%) reached the predetermined Item-Content Validity Index rating for teamwork and/or patient safety. After expert team review, 140/153 (91.5%) exemplars were deemed to warrant inclusion in the tool. More than 90% of the expert panel agreed that Endo-OTAS is an appropriate teamwork assessment tool with observable behaviours. Some concerns were noted about the time required to conduct observations and provide performance feedback. CONCLUSION: Endo-OTAS is a novel teamwork assessment tool, with evidence for content validity and relevance to endovascular teams. Endo-OTAS enables systematic objective assessment of the quality of team performance during endovascular procedures.

Trends in hospital treatments for peripheral arterial disease in the United States and association between payer status and quality of care/outcomes, 2007-2011.

OBJECTIVE: This study sought to identify the temporal trends of presenting diagnoses and vascular procedures performed for peripheral arterial disease (PAD) along with the rates of procedures and in-hospital outcomes by payer status. BACKGROUND: Previous studies suggest that patients with Medicare, Medicaid, or lack of insurance receive poorer quality of care leading to worse outcomes. METHODS: We analyzed 196,461,055 discharge records to identify all hospitalized patients with PAD records (n=1,687,724) from January 2007 through December 2011 in the Nationwide Inpatient Sample database. RESULTS: The annual frequency of vascular procedures remained unchanged during the study period. Patients with Medicaid were more likely to present with gangrenes, whereas patients with Medicare were more likely to present with ulcers. After adjustment, patients with Medicare and Medicaid were more likely to undergo amputations when compared with private insurance/HMO (OR=1.13, 95% CI=1.10-1.16 and OR=1.24, 95% CI=1.20-1.29, respectively). Patients with both Medicare and Medicaid were less likely to undergo bypass surgery (OR=0.82, 95% CI=0.81-0.84 and OR=0.87, 95% CI=0.85-0.90, respectively), but more likely to undergo endovascular procedures (OR=1.18, 95% CI=1.17-1.20 and OR=1.03, 95% CI=1.01-1.06, respectively). Medicare and Medicaid status versus private insurance/HMO was associated with worse adjusted odds of in-hospital outcomes, including mortality after amputations, endovascular procedures, and bypass surgeries. CONCLUSIONS: In this analysis, patients with Medicare and Medicaid had more comorbid conditions at baseline when compared with private insurance/HMO cohorts, were more likely to present with advanced stages of PAD, undergo amputations, and develop in-hospital complications. These data unveil a critical gap and an opportunity for quality improvement in the elderly and those with poor socioeconomic status.

Postoperative Surveillance and Long-term Outcomes After Endovascular Aneurysm Repair Among Medicare Beneficiaries.

IMPORTANCE: The Society for Vascular Surgery recommends annual surveillance with computed tomography (CT) or ultrasonography after endovascular aortic aneurysm repair (EVAR) for abdominal aortic aneurysms. However, such lifelong surveillance may be unnecessary for most patients, thereby contributing to overuse of imaging services. OBJECTIVE: To investigate whether nonadherence to Society for Vascular Surgery-recommended surveillance guidelines worsens long-term outcomes after EVAR among Medicare beneficiaries. DESIGN, SETTING, AND PARTICIPANTS: We collected data from Medicare claims from January 1, 2002, through December 31, 2011. A total of 9503 patients covered by fee-for-service Medicare who underwent EVAR from January 1, 2002, through December 31, 2005, were categorized as receiving complete or incomplete surveillance. We performed logistic regressions controlling for patient demographic and hospital characteristics. Patients were then matched by propensity score with adjusting for all demographic variables, including age, sex, race, Medicaid eligibility, residential status, hospital volume, ruptured abdominal aortic aneurysms, and all preexisting comorbidities. We then calculated differences in long-term outcomes after EVAR between adjusted groups. Data analysis was performed from January 1, 2002, through December 31, 2011. MAIN OUTCOMES AND MEASURES: Post-EVAR imaging modality, aneurysm-related mortality, late rupture, and complications. RESULTS: Median follow-up duration was 6.1 years. Incomplete surveillance was observed in 5526 of 9695 patients (57.0%) who survived the initial hospital stay at a mean (SD) of 5.2 (2.9) years after EVAR. After propensity matching, our cohort consisted of 7888 patients, among whom 3944 (50.0%) had incomplete surveillance. For those in the matched cohort, patients with incomplete surveillance had a lower incidence of late ruptures (26 of 3944 [0.7%] vs 57 of 3944 [1.4%]; P = .001) and major or minor reinterventions (46 of 3944 [1.2%] vs 246 of 3944 [6.2%]; P < .001) in unadjusted analysis. Aneurysm-related mortality was not statistically different between groups (13 of 3944 [0.3%] vs 24 of 3944 [0.6%]; P = .07). In adjusted analysis of postoperative outcomes controlling for all patient and hospital factors by the tenth postoperative year, patients in the incomplete surveillance group experienced lower rates of total complications (2.1% vs 14.0%; P < .001), late rupture (1.1% vs 5.3%; P < .001), major or minor reinterventions (1.4% vs 10.0%; P < .001), aneurysm-related mortality (0.4% vs 1.3%; P < .001), and all-cause mortality (30.9% vs 68.8%, P < .001). CONCLUSIONS AND RELEVANCE: Nonadherence to the Society for Vascular Surgery guidelines for post-EVAR imaging was not associated with poor outcomes, suggesting that, in many patients, less frequent surveillance is not associated with worse outcomes. Improved criteria for defining optimal surveillance will achieve higher value in aneurysm care.

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.

Quality assessment of elective abdominal aortic aneurysm repair from referral to surgery.

BACKGROUND: The risk of rupture for a large (≥ 55 mm) abdominal aortic aneurysm(AAA) is significant and therefore operative treatment should take place before possible aneurysm rupture. Timing of elective AAA surgery has rarely been investigated previously. The aim of this study is to evaluate success in the elective treatment process of large AAAs from referral to surgery in Helsinki University Central Hospital. PATIENTS AND METHODS: We retrospectively analyzed all 361 patients who were assigned for elective treatment of AAA during 2005 - 2010. We divided the patients into subgroups according to size of the aneurysm: <60 mm, 61 - 70 mm and >70 mm. The main focus was set on the preoperative period and on potential factors causing delay. End points indicating failure in the treatment process were aneurysm ruptures and deaths before surgery. RESULTS: The median time from referral to surgery for the three subgroups was 112, 91 and 45 days respectively (p < 0,001). There were no significant differences between the treatment methods: open repair (OR) with 103 days and endovascular aortic repair (EVAR) with 113 days until surgery. Twenty three (6.4 %) patients were operated on emergency basis while waiting for the operation, six of them for ruptured aneurysm. There were an additional five patients with aneurysm ruptures who all died, as did four out the six operated ones. CONCLUSIONS: The whole treatment process starting from the referral should be considered in order for elective AAA treatment to succeed. Recommendations should be established for the preoperative period to guarantee rapid preoperative evaluation.