Image-based assessment of aortoiliac aneurysm anatomical characteristics in patients from the global iliac branch study.

OBJECTIVE: Endovascular repair is the preferred treatment for aortoiliac aneurysm, with preservation of at least one internal iliac artery recommended. This study aimed to assess pre-endovascular repair anatomical characteristics of aortoiliac aneurysm in patients from the Global Iliac Branch Study (GIBS, NCT05607277) to enhance selection criteria for iliac branch devices (IBD) and improve long-term outcomes. METHODS: Pre-treatment CT scans of 297 GIBS patients undergoing endovascular aneurysm repair were analyzed. Measurements included total iliac artery length, common iliac artery length, tortuosity index, common iliac artery splay angle, internal iliac artery stenosis, calcification score, and diameters in the device's landing zone. Statistical tests assessed differences in anatomical measurements and IBD-mediated internal iliac artery preservation. RESULTS: Left total iliac artery length was shorter than right (6.7 mm, P = .0019); right common iliac artery less tortuous (P = .0145). Males exhibited greater tortuosity in the left total iliac artery (P = .0475) and larger diameter in left internal iliac artery's landing zone (P = .0453). Preservation was more common on right (158 unilateral, 34 bilateral) than left (105 unilateral, 34 bilateral). There were 192 right-sided and 139 left-sided IBDs, with 318 IBDs in males and 13 in females. CONCLUSION: This study provides comprehensive pre-treatment iliac anatomy analysis in patients undergoing endovascular repair with IBDs, highlighting differences between sides and sexes. These findings could refine patient selection for IBD placement, potentially enhancing outcomes in aortoiliac aneurysm treatment. However, the limited number of females in the study underscores the need for further research to generalize findings across genders.

Costs of endovascular and open repair of thoracic aortic aneurysms.

BACKGROUND: Repair of thoracic aortic aneurysms with either endovascular repair (TEVAR) or open surgical repair (OSR) represents major surgery, is costly and associated with significant complications. The aim of this study was to establish accurate costs of delivering TEVAR and OSR in a cohort of UK NHS patients suitable for open and endovascular treatment for the whole treatment pathway from admission and to discharge and 12-month follow-up. METHODS: A prospective study of UK NHS patients from 30 NHS vascular/cardiothoracic units in England aged ≥18, with distal arch/descending thoracic aortic aneurysms (CTAA) was undertaken. A multicentre prospective cost analysis of patients (recruited March 2014-July 2018, follow-up until July 2019) undergoing TEVAR or OSR was performed. Patients deemed suitable for open or endovascular repair were included in this study. A micro-costing approach was adopted. RESULTS: Some 115 patients having undergone TEVAR and 35 patients with OSR were identified. The mean (s.d.) cost of a TEVAR procedure was higher £26 536 (£9877) versus OSR £17 239 (£8043). Postoperative costs until discharge were lower for TEVAR £7484 (£7848) versus OSR £28 636 (£23 083). Therefore, total NHS costs from admission to discharge were lower for TEVAR £34 020 (£14 301), versus OSR £45 875 (£43 023). However, mean NHS costs for 12 months following the procedure were slightly higher for the TEVAR £5206 (£11 585) versus OSR £5039 (£11 994). CONCLUSIONS: Surgical procedure costs were higher for TEVAR due to device costs. Total in-hospital costs were higher for OSR due to longer hospital and critical care stay. Follow-up costs over 12 months were slightly higher for TEVAR due to hospital readmissions.

Mixed reality for the assessment of aortoiliac anatomy in patients with abdominal aortic aneurysm prior to open and endovascular repair: Feasibility and interobserver agreement.

OBJECTIVES: The objective is to evaluate the feasibility and interobserver agreement of a Mixed Reality Viewer (MRV) in the assessment of aortoiliac vascular anatomy of abdominal aortic aneurysm (AAA) patients. METHODS: Fifty preoperative computed tomography angiographies (CTAs) of AAA patients were included. CTAs were assessed in a mixed reality (MR) environment with respect to aortoiliac anatomy according to a standardized protocol by two experienced observers (Mixed Reality Viewer, MRV, Brainlab AG, Germany). Additionally, all CTAs were independently assessed applying the same protocol by the same observers using a conventional DICOM viewer on a two-dimensional screen with multi-planar reconstructions (Conventional viewer, CV, GE Centricity PACS RA1000 Workstation, GE, United States). The protocol included four sets of items: calcification, dilatation, patency, and tortuosity as well as the number of lumbar and renal arteries. Interobserver agreement (IA, Cohen's Kappa, κ) was calculated for every item set. RESULTS: All CTAs could successfully be displayed in the MRV (100%). The MRV demonstrated equal or better IA in the assessment of anterior and posterior calcification (κMRV: 0.68 and 0.61, κCV: 0.33 and 0.45, respectively) as well as tortuosity (κMRV: 0.60, κCV: 0.48) and dilatation (κMRV: 0.68, κCV: 0.67). The CV demonstrated better IA in the assessment of patency (κMRV: 0.74, κCV: 0.93). The CV also identified significantly more lumbar arteries (CV: 379, MRV: 239, p < 0.01). CONCLUSIONS: The MRV is a feasible imaging viewing technology in clinical routine. Future efforts should aim at improving hologram quality and enabling accurate registration of the hologram with the physical patient.

Prospective Assessment of a Protocol Using Neuromonitoring, Early Limb Reperfusion, and Selective Temporary Aneurysm Sac Perfusion to Prevent Spinal Cord Injury During Fenestrated-branched Endovascular Aortic Repair.

OBJECTIVE: The aim of this study was to analyze the outcomes of a standardized protocol using routine CSFD, neuromonitoring, LL reperfusion, and selective TASP to prevent SCI during F-BEVAR. BACKGROUND: SCI is to be the most devastating complication for the patient, family, and surgeon, with impact on patient's quality of life and long-term prognosis. An optimal standardized protocol may be used to improve outcomes. METHODS: Patients enrolled in a prospective, nonrandomized single-center study between 2013 and 2018. A SCI prevention protocol was used for TAAAS or complex abdominal aneurysms with ≥5-cm supraceliac coverage including CSFD, neuromonitoring, LL reperfusion, and selective TASP. Endpoints included mortality and rates of SCI. RESULTS: SCI prevention protocol was used in 170 of 232 patients (73%) treated by F-BEVAR. Ninety-one patients (55%) had changes in neuromonitoring, which improved with maneuvers in all except for 9 patients (10%) who had TASP. There was one 30-day or in-hospital mortality (0.4%). Ten patients (4%) developed SCIs including in 1% (1/79) of patients with normal neuromonitoring and 10% (9/91) of those who had decline in neuromonitoring ( P = 0.02). Permanent paraplegia occurred in 2 patients (1%). Factors associated with SCI included total operating time (odds ratio 1.5, 95% confidence interval 1.1-2.2, P = 0.02) and persistent changes in neuromonitoring requiring TASP (odds ratio 15.7, 95% confidence interval 2.9-86.2, P = 0.001). CONCLUSION: This prospective nonrandomized study using a standardized strategy to prevent SCI was associated with low incidence of the SCI during F-BEVAR. Permanent paraplegia occurred in 1%.

Stent-graft placement for hepatic arterial bleeding: assessment of technical efficacy and clinical outcome in a tertiary care center.

BACKGROUND: To evaluate technical and clinical results of stent-graft (SG) placement for bleeding from the hepatic artery (HA). METHODS: All patients intended and treated with SG deployment for bleeding from the HA at single center from January 2012 to May 2020 were retrospectively identified, and procedural details, risk factors for rebleeding, SG occlusion and mortality were analyzed. RESULTS: Twenty-seven patients (mean age 68.8 ± 10.1) were identified, and 25 patients underwent 26 SG procedures. Twenty-four patients had recent surgery. The technical success rate was 92.8%. Three patients (3/25) had rebleeding (88% clinical success). Intensive-care need before the procedure (p = 0.013) and smaller stent-graft size (≤4 mm, p = 0.032) were related to clinical failure. Twenty-two patients had follow-up imaging. The SG maintained patency in 10 (45.4%) patients at the most recent imaging. Only placement of SG distal to the HA bifurcation (p = 0.012) was related to occlusion. The 30-day and in-hospital mortality rate after SG was 8% and 24%. In-hospital mortality was associated with the intraabdominal septic source (p = 0.010) and revision surgery (p = 0.001). CONCLUSION: Stent-grafts are effective in the emergent treatment of HA bleeding. Mortality is mainly related to the general condition of the patient, and stent-grafts offer time to treat underlying medical problems sufficiently.

Cause-specific mortality of type B aortic dissection and assessment of competing risks of mortality.

OBJECTIVE: Natural history studies of type B aortic dissection (TBAD) commonly report all-cause mortality. Our aim was to determine cause-specific mortality in TBAD and to evaluate the clinical characteristics associated with aorta-related and nonaorta-related mortality. METHODS: Clinical and administrative records were reviewed for patients with acute TBAD between 1995 and 2017. Demographics, comorbidities, presentation, and initial imaging findings were abstracted. Cause of death was ascertained through a multimodality approach using electronic health records, obituaries, social media, Social Security Death Index, and state mortality records. Causes of death were classified as aorta related, nonaorta related, or unknown. A Fine-Gray multivariate competing risk regression model for subdistribution hazard ratio was employed to analyze the association of clinical characteristics with aorta-related and nonaorta-related mortality. RESULTS: A total of 275 individuals met inclusion criteria (61.1 ± 13.7 years, 70.9% male, 68% white). Mean survival after discharge was 6.3 ± 4.7 years. Completeness of follow-up Clark C index was 0.87. All-cause mortality was 50.2% (n = 138; mean age, 70.1 ± 14.6 years) including an in-hospital mortality of 8.4%. Cause-specific mortality was aorta related, nonaorta related, and unknown in 51%, 43%, and 6%, respectively. Compared with patients with nonaorta-related mortality, patients with aorta-related mortality were younger at acute TBAD (69.5 ± 11.2 years vs 61.6 ± 15.5 years; P = .001), underwent more descending thoracic aortic repairs (19.4% vs 45.8%; P = .002), and had a shorter survival duration (5.7 ± 3.9 vs 3.4 ± 4.5 years; P = .002). There was clear variation in cause of death by each decade of life, with higher aorta-related mortality among those younger than 50 years and older than 70 years and a stepwise increase in nonaorta-related mortality with each increasing decade (P < .001). All-cause mortality at 1 year, 3 years, and 10 years was 15%, 24%, and 57%, respectively. After accounting for competing risks, the cumulative incidence of aorta-related mortality at 1 year, 3 years, and 10 years was 8.9%, 16.5%, and 27.2%, respectively, and that of nonaorta-related mortality was 2.7%, 7.2%, and 29%, respectively. A maximum descending thoracic aortic diameter >4 cm was associated with an increase in hazard of aorta-related mortality by 84% (subdistribution hazard ratio, 1.84; 95% confidence interval, 1.03-3.28) on multivariate competing risk regression analysis. CONCLUSIONS: TBAD is associated with high 10-year mortality. Those at risk for aorta-related mortality have a clinical phenotype different from that of individuals at risk for nonaorta-related mortality. This information is important for building risk prediction models that account for competing mortality risks and to direct optimal and individualized surgical and medical management of TBAD.

Editor's Choice - A Systemic Evaluation of the Costs of Elective EVAR and Open Abdominal Aortic Aneurysm Repair Implies Cost Equivalence.

OBJECTIVE: The suggested high costs of endovascular aneurysm repair (EVAR) hamper the choice of insurance companies and financial regulators for EVAR as the primary option for elective abdominal aortic aneurysm (AAA) repair. However, arguments used in this debate are impeded by time related aspects such as effect modification and the introduction of confounding by indication, and by asymmetric evaluation of outcomes. Therefore, a re-evaluation minimising the impact of these interferences was considered. METHODS: A comparative analysis was performed evaluating a period of exclusive open repair (OR; 1998-2000) and a period of established EVAR (2010-2012). Data from four hospitals in The Netherlands were collected to estimate resource use. Actual costs were estimated by benchmark cost prices and a literature review. Costs are reported at 2019 prices. A break even approach, defining the costs for an endovascular device at which cost equivalence for EVAR and OR is achieved, was applied to cope with the large variation in endovascular device costs. RESULTS: One hundred and eighty-six patients who underwent elective AAA repair between 1998 and 2000 (OR period) and 195 patients between 2010 and 2012 (EVAR period) were compared. Cost equivalence for OR and EVAR was reached at a break even price for an endovascular device of €13 190. The main cost difference reflected the longer duration of hospital stay (ward and Intensive Care Unit) of OR (€11 644). Re-intervention rates were similar for OR (24.2%) and EVAR (24.6%) (p = .92). CONCLUSION: Cost equivalence for EVAR and OR occurs at a device cost of €13 000 for EVAR. Hence, for most routine repairs, EVAR is not costlier than OR until at least the five year follow up.

Volume Change after Endovascular Treatment of Common Iliac Arteries ≥ 17 mm Diameter: Assessment of Type 1b Endoleak Risk Factors.

OBJECTIVE: The aim of this study was to assess the post-operative volumetric evolution of common iliac arteries (CIA) ≥ 17 mm diameter with respect to the type of endovascular technique performed and to assess type 1b endoleak risk factors. METHODS: All consecutive patients presenting with aneurysmal disease with CIA ≥17 mm treated endovascularly from 2008 to 2016 were included. Patients were divided into two groups dependent upon the type of endovascular technique performed: bell bottom technique (BBT group), vs. other techniques (non-BBT group). Volumetric evolution of the CIA was assessed for each patient by computed tomography angiographic reconstructions performed pre-operatively, at six months, one year, and two years. Multivariable analysis was performed to identify risk factors for type 1b endoleak. RESULTS: From 2008 to 2016, 74 patients with 110 CIA ≥17 mm were treated (BBT group: n = 58; non-BBT group: n = 52). Mean follow up was 48.1 months (median 39.0, IQR 38.1). Mean volumetric evolution significantly differed in the BBT group +14.2% (median 19.9%, IQR 24.6) compared with the non-BBT group: -20.9% (median -20.1%, IQR -26.0), p < .001. The five year type 1b endoleak related re-intervention rate was 16.1% and 7.7% in the BBT and non-BBT groups, respectively (p = .04), mean time to type 1b endoleak was 24.8 months and 54.3 months, respectively. The BBT appeared as a risk factor for type 1b endoleak (OR: 7.13; 95% CI: 1.58-3.04; p < .001). CONCLUSION: The BBT is associated with an increase in CIA volume post-operatively and consequently can be considered a risk factor for type 1b endoleak. It might be avoided if an iliac branched endograft is possible.

GRADE-Based Recommendations for Surgical Repair of Nonruptured Abdominal Aortic Aneurysm.

The objective of this study was to provide evidence-based recommendations for endovascular aneurysm repair (EVAR) versus open surgical repair (OSR) for patients with a nonruptured abdominal aortic aneurysm (AAA). We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement and adhered to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Both low- and high surgical risk patients treated with EVAR showed decreased 30-day mortality, but the low-risk group had no differences in 4-year mortality. Compared with friendly anatomy, patients with hostile anatomy had an increased risk of type I endoleak. Young patients may prefer OSR. Endovascular aneurysm repair was not cost-effective in Europe. Four conditional recommendations were formulated: (1) OSR for low-risk patients up to 80 years old, (2) EVAR for low-risk patients older than 80 years, (3) EVAR for high-risk patients as long as is anatomically feasible, and (4) OSR in patients in whom it is not anatomically feasible to perform EVAR. Based on GRADE criteria, either OSR or EVAR can be suggested to patients with nonruptured AAA taking into account their surgical risk, hostile anatomy, and age. Given the weakness of the recommendations, personal preferences are determinant.

Editor's Choice - Hospital Incidence, Treatment, and In Hospital Mortality Following Open and Endovascular Surgery for Thoraco-abdominal Aortic Aneurysms in Germany from 2005 to 2014: Secondary Data Analysis of the Nationwide German DRG Microdata.

OBJECTIVE: Hospital incidence, treatment modality, and in hospital mortality after surgery are reported for thoraco-abdominal aortic aneurysms (TAAAs) treated by endovascular or open means in Germany from 2005 to 2014. METHODS: Data were extracted from diagnosis related group statistics from the German Federal Statistical Office. All inpatient cases with a diagnosis of ruptured and non-ruptured TAAA (ICD-10 I71.5 and I71.6) and procedure codes for fenestrated or branched endovascular aortic repair (f/bEVAR 5-38a.7x and 5-38a.8x), open aortic repair (OAR 5-384.4), or hybrid procedure (5-384.b/c, 5-38a.a/b/8/80) were included. To adjust for sex, age, medical risk (Elixhauser comorbidity score), type of procedure, and type of admission, a multilevel multivariable regression model with robust error variance was applied. The primary outcome was in hospital mortality; secondary outcomes were organ complications. The relationship between annual hospital volume and outcome was analysed. RESULTS: A total of 2607 cases (406 rTAAA, 2201 nrTAAA) were included. f/bEVAR was performed in 856 cases (32.8%), OAR in 1422 cases (54.5%), and hybrid repair in 354 cases (13.6%). Endovascular repair became more frequent over time (6% in 2005 vs. 76% in 2014 for nrTAAA). Hypertension (75.2%), peripheral artery disease (including abdominal aortic aneurysm, 49.5%), other heart diseases (44.6%), coronary heart disease (30.6%), and renal failure (28.7%) were the most frequently coded comorbidities. The number of hospitals treating TAAAs almost tripled within 9 years. The in hospital mortality was 46.1% for rTAAA and 15.9% for nrTAAA. f/bEVAR (RR 0.35, 0.24-0.51) and high hospital volume (p < .001) were significantly associated with decreased in hospital mortality. Aortic rupture, increasing age, and comorbidity were significantly associated with higher mortality (RR 3.17, 2.45-4.09; 1.52, 1.32-1.76, and 1.05, 1.04-1.06). CONCLUSIONS: Seventy-six percent of all TAAAs were treated endovascularly in 2014 with increasing frequency over a decade. In hospital mortality is lower with endovascular repair and in high volume centres. Aortic rupture, age, and severe comorbidities are associated with worse outcomes.

Prospective, randomized trial of bioresorbable scaffolds vs. everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction: the Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial.

Aims: Bioresorbable scaffolds (BRS) provide short-term coronary artery scaffolding and drug delivery. Although prior trials showed a higher rate of device failure compared with conventional drug-eluting stents (DES), only a single trial investigated patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI). We aimed to compare outcomes with BRS vs. DES in patients undergoing PCI for MI. Methods and results: We did a prospective, randomized, multicentre, non-inferiority, clinical trial of everolimus-eluting BRS vs. durable polymer everolimus-eluting stents (EES) in patients with acute MI. Patients were eligible for enrolment if they presented with ST-elevation MI, or non-ST-elevation MI with thrombosis visual at angiography and were randomly allocated to treatment with BRS or EES in 2:1 proportion. Angiographic follow-up was scheduled at 6-8 months and clinical follow-up was done at 12 months. The primary endpoint was percentage diameter stenosis in-segment at follow-up. A total of 262 patients were enrolled and were allocated to BRS (n = 173) or EES (n = 89). Angiographic follow-up was available for 213 (81.3%) patients. Mean diameter stenosis was 24.6 ± 12.2% with BRS vs. 27.3 ± 11.7% with EES (mean difference -2.7%, upper limit of one-sided 97.5% confidence limit 0.7%, pre-specified margin of non-inferiority 5%, Pnon-inferiority <0.001). The rate of the device-oriented composite of cardiac death/target vessel MI/target lesion revascularization [BRS: 12 (7.0%) vs. EES: 6 (6.7%), hazard ratio (HR) 1.04, 95% confidence interval (CI) 0.39-2.78] and definite/probable stent thrombosis [3 (1.7%) vs. 2 (2.3%), HR 0.76, 95% CI 0.13-4.56] were comparable in both groups. Conclusion: In patients undergoing PCI for acute MI BRS were non-inferior to EES for percentage diameter stenosis at angiographic follow-up. Rates of clinical events were comparable between the treatment groups, although the study was not powered to detect differences in clinical outcomes. Clinical trial registration: The trial was registered at www.clinicaltrials.gov (NCT01942070).

Assessment of geometrical remodelling of the aortic arch after hybrid treatment.

OBJECTIVES: The aim of this study was to measure the morphological remodelling of the ascending aorta, aortic arch and thoracic aorta after aortic arch hybrid treatment including debranching and stent graft implantation. METHODS: Preoperative, 1-month and 1-year follow-up of computed tomography angiography scans of 22 patients were analysed to compute the lumen centreline from the aortic root to the coeliac trunk, and the following measurements were derived: the total centreline length, distance from the aortic root to the left subclavian artery, distance from the left subclavian artery to the distal landing zone. For both pre- and postoperative centrelines, the pointwise curvature was measured at the proximal and the distal landing zones. The mean curvature values of the whole aortic segment and the endografting region of the ascending and the descending aorta were measured. Surface outerline was computed as well, and curvature values at the endograft landing points were extracted. RESULTS: At the 1-month follow-up, centreline length were already significantly increased (382.66 ± 48.69 to 388.1 ± 50.75 mm; P = 0.01). Centreline pointwise curvature increased in the proximal (+29%, P = 0.011) and the distal zones (+63%, P = 0.004). Similarly, pointwise curvature of the outerline significantly increased in the proximal (+77%, P = 0.01) and the distal landing zones (+100%, P = 0.04). The centreline mean curvature increased in the ascending aorta (+7%, P = 0.02) and decreased in the endografting region (-3.3%, P = 0.004). No evidence of a relationship of such a remodelling with the type of endograft and the type of pathology was observed. This remodelling trend was confirmed by the analysis of 1-year computed tomography angiographies. CONCLUSIONS: Hybrid arch repair was associated with a significant elongation of the vessel and a significant increase in the curvature on the ascending aorta and the descending aorta and on the endograft proximal and the distal landing zones.

Racial Comparisons of the Outcomes of Transcatheter and Surgical Aortic Valve Implantation Using the Medicare Database.

Racial disparities in the outcomes after intervention for aortic valve disease remain understudied. We stratified patients by race who underwent surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) in the Medicare database. The TAVI cohort consisted of 17,973 patients (3.9% were black and 1.0% were Hispanic). The SAVR cohort consisted of 95,078 patients, (4.8% were black and 1.3% were Hispanic). Most comorbidities were more common in blacks. After TAVI, 30-day mortality was not significantly different in races with both unadjusted and adjusted data. There were no significant racial differences in readmission rates or discharge to home after TAVI. After SAVR, black patients had worse unadjusted 30-day and 1-year mortality than whites or Hispanics (30-day mortality, 4.7% vs 6.2% vs 4.7% for whites, blacks, and Hispanics, respectively, p = 0.0001; 1-year mortality 11.7% vs 16.1% vs 12.5%, respectively, p = 0.0001); however, after adjustment, there were no differences in mortality. Black patients had higher 30-day readmission rates after SAVR (20.1% vs 25.2% vs 21.7% for whites, blacks, and Hispanics, respectively, p = 0.0001), which persisted after adjustment for comorbidities. Minorities were underrepresented in both SAVR and TAVI relative to what would be predicted by population prevalence. In conclusion, while blacks have worse outcomes in SAVR compared with whites or Hispanics, race did not impact mortality, readmission, or discharge to home in TAVI. Both blacks and Hispanics were underrepresented compared with what would be predicted by population prevalence.

Assessment of EVAR Competence: Validity of a Novel Rating Scale (EVARATE) in a Simulated Setting.

OBJECTIVES: The aims of this study were to investigate the validity evidence for a novel procedure specific assessment tool of competence in endovascular aortic repair (EVAR) and to establish a pass/fail level for the assessment. METHODS: Computed tomography angiography data of a 55 mm in diameter infrarenal aortic aneurysm was implemented into an endovascular simulator. Twenty-three physicians with varying EVAR experiences were video-recorded when performing a standard EVAR procedure on the simulator. Two experienced EVAR operators assessed the participants using the novel rating scale, "EndoVascular Aortic Repair Assessment of Technical Expertise" (EVARATE). Validity was studied according to the framework endorsed by the American Educational Research Association. RESULTS: The EVARATE scale had a high internal consistency (Cronbach's alpha = .90). The inter-rater reliability was acceptable (Intraclass Correlation Coefficient = .68, p = .005). Specific EVAR experience correlated significantly with the EVARATE score (Spearman's rho = .62, p = .002), but general endovascular experience did not. Consequence analysis showed that the EVARATE assessment could distinguish novices from intermediates (p < .01) and from experts (p < .001). A pass/fail score was determined using the contrasting groups' method. CONCLUSION: This paper presents the initial validity evidence for a novel procedure specific assessment tool, EVARATE, for operator competence in endovascular aortic repair investigated in a simulated setting. The assessment tool can be used to provide structured formative feedback to trainees.

National trends in open surgical, endovascular, and branched-fenestrated endovascular aortic aneurysm repair in Medicare patients.

BACKGROUND: Open repair effectively prevents rupture for patients with abdominal aortic aneurysm (AAA) and is commonly studied as a metric reflecting hospital and surgeon expertise in cardiovascular care. However, given recent advances in endovascular aneurysm repair (EVAR), such as branched-fenestrated EVAR, it is unknown how commonly open surgical repair is still used in everyday practice. METHODS: We analyzed trends in open AAA repair, EVAR, and branched-fenestrated EVAR for AAA in Medicare beneficiaries from 2003 to 2013. We used Medicare Part B claims to ascertain counts of these repair types annually during the study period. We assessed regional and national trends in characteristics of the patients and procedure volume. RESULTS: Between 2003 and 2013, the total number of AAA repairs performed in fee-for-service Medicare patients declined by 26% from 31,582 to 23,421 (P < .001), after a peak number of 32,540 was performed in 2005 (28% decline since 2005). The number of open AAA repairs steadily declined by a total of 76%, from 20,533 in 2003 to 4916 in 2013 (P < .001). Whereas the number of EVARs increased from 11,049 in 2003 to 19,247 in 2011 (P < .001), it has since declined a total of 15% to only 16,362 repairs in 2013 (P < .001). After its introduction in 2011, the number of branched-fenestrated EVAR cases continuously rose from 335 procedures in 2011 to 2143 procedures in 2013 (P < .001). By 2013, virtually all hospital referral regions in the United States had rates of open AAA repair that would have been in the lowest quintile of volume in 2003. CONCLUSIONS: The number of open AAA repairs fell by nearly 80% during the last decade, whereas traditional EVAR declined slightly and branched-fenestrated EVAR rapidly disseminated into national practice. These results suggest that open AAA repair is now performed too infrequently to be used as a metric in the assessment of hospital and surgeon quality in cardiovascular care. Furthermore, surgical training paradigms will need to reflect the changing dynamics necessary to ensure that surgeons and interventionists can safely perform these high-risk surgical procedures.

Postoperative initial 2-day blood pressure management facilitates the shrinkage of abdominal aortic aneurysm after endovascular aneurysm repair by reducing the incidence of type II endoleak.

OBJECTIVE: The aim of this study was to evaluate the effect of initial 2-day blood pressure management (BPM) after endovascular aneurysm repair (EVAR) for the incidence of subsequent type II endoleak (T2E) and shrinkage of abdominal aortic aneurysm (AAA) sac diameter. METHODS: We reviewed 136 patients who underwent EVAR for atherosclerotic AAA between July 2008 and July 2014 with one of three stent grafts (Excluder [W. L. Gore & Associates, Flagstaff, Ariz], Powerlink [Endologix Inc, Irvine, Calif], and Endurant [Medtronic Vascular, Santa Rosa, Calif]). Starting from 2013, the mean blood pressure of 76 participating patients (treatment group) was maintained at 75 to 90 mm Hg for the initial 48 hours after EVAR. The incidence of T2E at 7 days and AAA sac diameter 12 months after EVAR were evaluated using computed tomography scanning. The results so obtained were then compared with those of the control group composed of 60 consecutive patients who underwent EVAR before 2013. RESULTS: The incidence of T2E at 7 days was significantly lower in patients who received treatment (treatment group, 19.7%; control group, 40.0%; P = .013), and AAA sac diameter at 12 months in the treatment group had a mean decrease of 5.1 mm compared with the mean 2.2 mm in the control group (P = .004). In multivariate regression analysis, BPM was significantly related to the reduction of incidence of T2E at 7 days (odds ratio, 0.31; P = .007) and a decrease in AAA sac diameter at 12 months (P = .005). In addition, although the use of Endurant had less effect, the use of Excluder under controlled blood pressure conditions improved the incidence of T2E from 80% to 23% compared with those under normal postoperative management (P = .001). CONCLUSIONS: The initial 2-day postoperative BPM might have positive effects, such as lower incidence of T2E and facilitation of AAA sac shrinkage.

Overstenting the hypogastric artery during endovascular aneurysm repair with and without prior coil embolization: A comparative analysis from the ENGAGE Registry.

BACKGROUND: Endovascular aneurysm repair of aortoiliac or iliac aneurysms is often performed with stent graft coverage of the origin of the hypogastric artery (HA) to ensure adequate distal seal. It is considered common practice to perform adjunctive coiling of the HA to prevent a type II endoleak. Our objective was to question the necessity of pre-emptive coiling by comparing the outcomes of HA coverage with and without prior coil embolization. METHODS: Data from the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE), which prospectively enrolled 1263 endovascular aneurysm repair patients between March 2009 and April 2011 from multiple centers worldwide, were used for this study. We identified patients in whom the Endurant stent graft (Medtronic Vascular, Santa Rosa, Calif) covered one or both HAs and grouped them into cases in which prior HA embolization-coils or plugs-was performed (CE) and cases in which HA embolization was not performed (NE). The occurrence of covered HA-related endoleak and secondary interventions were compared between groups. RESULTS: In 197 patients, 225 HAs were covered. Ninety-one HAs were covered after coil embolization (CE group), and 134 HAs were covered without prior coil embolization (NE group). Both groups were similar at baseline and had comparable length of follow-up to last image (665.2 ± 321.7 days for CE patients; 641.6 ± 327.6 days for NE patients; P = .464). Importantly, both groups showed equivalent iliac morphology concerning common iliac artery proximal, mid, and distal dimensions and tortuosity, making them suitable for comparative analysis. During follow-up, HA-related endoleaks were sparse and occurred equally often in both groups (CE 5.5% vs NE 3.0%; P = .346). Secondary intervention to resolve an HA-related endoleak was performed twice in the CE group and three times in the NE group. Late non-HA-related endoleaks occurred more often in the CE group compared with the NE group, (25.0% vs 15.0%; P = .080). Secondary interventions for other reasons than HA-related endoleaks occurred in 7.5% of NE cases and 15.4% of CE cases (P = .057), mostly for occlusions in the ipsilateral iliac limb. During follow-up, 19 NE patients and 9 CE patients died, which is not significantly different (P = .225), and no deaths were related directly or indirectly to HA coverage. Also, no reports of gluteal necrosis and bowel ischemia were made. CONCLUSIONS: This study shows that HA coverage with the Endurant endograft without prior coil embolization does not increase the incidence of endoleak or related secondary interventions. These findings together with the already available evidence suggest that omission of coil embolization may be a more resource-effective strategy whenever HA coverage is required.

Select early type IA endoleaks after endovascular aneurysm repair will resolve without secondary intervention.

OBJECTIVE: Although it is traditionally considered ominous, the natural history of early proximal attachment site endoleaks (IA) after endovascular aneurysm repair (EVAR) is not well known. Our aim was to identify risk factors for persistent type IA endoleaks and to determine their effect on long-term outcomes after EVAR. METHODS: All patients who underwent infrarenal EVAR at a single institution between 1998 and 2015 were identified. Preoperative axial imaging and intraoperative arteriograms were reviewed, and those patients with a type IA endoleak were further studied. Aneurysm features were characterized by two reviewers and were studied for predictors of persistent endoleaks at the conclusion of the case. Patient records and the Social Security Death Index were used to record 1-year and overall survival. RESULTS: We identified 1484 EVARs, 122 (8%) of which were complicated by a type IA endoleak on arteriography after graft deployment, with a median follow-up of 4 years. The majority of patients underwent additional ballooning of the proximal site (52 [43%]) or placement of an aortic cuff (47 [39%]); 30 patients (25%) received a Palmaz stent, and four patients were treated with coils or anchors. At case end, only 43 (35%) of the type IA endoleaks remained; at 1 month, only 16 endoleaks persisted (13%), and only six persisted at 1 year (6%). In multivariable analysis, the only independent predictor of persistence of type IA endoleak at the conclusion of the case was the presence of extensive neck calcifications (odds ratio [OR], 9.9; 95% confidence interval [CI], 1.4-67.9; P = .02). Thirteen patients (11%) underwent reintervention for type IA endoleaks, with a time frame ranging from 3 days postoperatively to 11 years. There were three patients (2.4%) who experienced aneurysm rupture. Postoperative type IA endoleak was associated with lower survival at 1 year (79% vs 91%; relative risk, 2.5; 95% CI, 1.1-5.4; P = .02), but it did not affect long-term survival (log-rank, P = .45). Both an increase in aneurysm sac size and failure of the endoleak to resolve by case end were independent predictors of a need for reintervention (growth: OR, 8.3; 95% CI, 2.2-31.6; P < .01; persistent endoleak: OR, 7.6; 95% CI, 1.8-31.5; P < .01). A persistent type IA endoleak was not independently associated with an increase in sac size on surveillance imaging (P = .28). CONCLUSIONS: Aneurysm rupture secondary to persistent type IA endoleak is rare, and most will resolve within 1 year. Extensive neck calcification is the only independent predictor of persistent type IA endoleak, and an increase in sac size warrants reintervention. These data suggest that select early persistent type IA endoleaks can be safely observed.

Cost-utility analysis comparing laparoscopic vs open aortobifemoral bypass surgery.

OBJECTIVES: Laparoscopic aortobifemoral bypass has become an established treatment option for symptomatic aortoiliac obstructive disease at dedicated centers. Minimally invasive surgical techniques like laparoscopic surgery have often been shown to reduce expenses and increase patients' health-related quality of life. The main objective of our study was to measure quality-adjusted life years (QALYs) and costs after totally laparoscopic and open aortobifemoral bypass. PATIENTS AND METHODS: This was a within trial analysis in a larger ongoing randomized controlled prospective multicenter trial, Norwegian Laparoscopic Aortic Surgery Trial. Fifty consecutive patients suffering from symptomatic aortoiliac occlusive disease suitable for aortobifemoral bypass surgery were randomized to either totally laparoscopic (n=25) or open surgical procedure (n=25). One patient dropped out of the study before surgery. We measured health-related quality of life using the EuroQol (EQ-5D-5L) questionnaire at 4 different time points, before surgery and for 6 months during follow-up. We calculated the QALYs gained by using the area under the curve for both groups. Costs were calculated based on prices for surgical equipment, vascular prosthesis and hospital stay. RESULTS: We found a significantly higher increase in QALYs after laparoscopic vs open aortobifemoral bypass surgery, with a difference of 0.07 QALYs, (p=0.001) in favor of laparoscopic aortobifemoral bypass. The total cost of surgery, equipment and hospital stay after laparoscopic surgery (9,953 €) was less than open surgery (17,260 €), (p=0.001). CONCLUSION: Laparoscopic aortobifemoral bypass seems to be cost-effective compared with open surgery, due to an increase in QALYs and lower procedure-related costs.