Case Report: Successful Treatment of Aberrant Left Subclavian Artery With a Right-Sided Aortic Arch.

Right sided aortic arches with concomitant aberrant left subclavian arteries are exceedingly rare anatomical variants. We present a case of a 45 year old male that presented with symptoms consistent with dysphagia and known right sided aortic arch with an aberrant left subclavian artery. Though previous reports of repair have indeed been reported, we confirm that a hybrid approach to these anatomic variants remain feasible and with symptom resolution for patients.

Predicting Transcarotid Artery Revascularization Adverse Outcomes by Imaging Characteristics.

BACKGROUND: Approximately 20-30% of ischemic strokes are caused by internal carotid artery stenosis. Stroke is the leading cause of disability and the second leading cause of death in the United States. Second generation transcarotid arterial revascularization (TCAR) stenting, using the ENROUTE flow reversal technology to prevent embolic stroke during the stenting process, has demonstrated stroke and death outcomes equivalent to carotid endarterectomy with reduced cranial nerve injury. However, at present, it is not known whether imaging characteristics obtained preoperatively can predict outcomes of TCAR procedures. METHODS: This retrospective cohort study included patients who underwent TCAR with flow reversal at three hospitals within a single hospital network who had computed tomography angiography, magnetic resonance imaging angiography, or preoperative diagnostic angiogram to determine whether carotid and lesion characteristics could predict patients who experienced major adverse critical events (MACE) versus those who did not. MACE was defined as myocardial infarction at 30 days, restenosis/persistent stenosis (peak systolic velocity within the stent >230 cm/sec by postoperative ultrasound), stroke within any time of follow-up, or death within 1 year of TCAR. Student's t-tests and Chi-squared tests were used to compare imaging characteristics, such as presence of pinpoint stenosis, calcification within the common carotid artery at the take-off from the aorta, and plaque length in millimeters. Binomial logistic regression was used to examine the likelihood that imaging characteristics were associated with MACE. RESULTS: Of 220 patients who underwent TCAR in our network, seven were excluded because flow reversal was not used or appropriate imaging had not been performed prior to TCAR. Of the 213 patients who were included in analysis, the median length of follow-up was 10.8 months (interquartile range: 3.4-33.1 months). Twelve percent (26/213) experienced MACE and a model based on imaging characteristics was statistically significant in predicting MACE with 68% accuracy (P = 0.005). The presence of pinpoint stenosis was highly predictive of MACE (hazards ratio: 3.34, confidence interval: 1.2 to 9.3, P = 0.021). A shorter clavicle to carotid bifurcation distance was associated with an increased likelihood of experiencing MACE (P = 0.009) but it was weakly predictive (hazards ratio: 1.03, confidence interval: 1.01 to 1.05). CONCLUSIONS: Preoperative imaging characteristics, such as pinpoint stenosis and clavicle to carotid bifurcation distance, can be used to predict adverse outcomes in TCAR placement.

Successful endovascular treatment of severe chronic mesenteric ischemia facilitated by intraoperative positioning system image guidance.

We report our initial experience using the intraoperative positioning system (IOPS), a novel endovascular navigation system that does not require contrast or radiation, in the treatment of chronic mesenteric ischemia (CMI). We used IOPS to help treat three of four consecutive patients with CMI. Technical problems prevented successful use in one patient. For the patients for whom IOPS was used effectively, catheterization of the mesenteric artery was accomplished more quickly than for the patient for whom IOPS was not effective. Our experience has shown that IOPS can be safely and effectively used for CMI and can reduce the contrast load and radiation dose.

Multifactorial dysphagia: Azygos vein aneurysm (AVA) and esophagogastric junction outflow obstruction (EGJOO).

INTRODUCTION: Vascular impingement of the esophagus is a rare cause of dysphagia, and is most commonly due to aortic arch anomalies such as arterial lusoria. Dysphagia resultant from venous compression is even further less likely. PRESENTATION OF CASE: We present a highly unusual case of dysphagia secondary to a large aneurysm of the azygous vein near its confluence with the superior vena cava, which was managed with endovascular modalities. Despite initial treatment success, patient reported some intermittent solid food dysphagia, and was also found to have esophagogastric junction outflow obstruction (EGJOO) on high resolution impedance manometry (HRIM) which was successfully managed with surgical myotomy and partial fundoplication. DISCUSSION: The azygos vein has an intimate anatomic relationship with the esophagus as it traverses the posterior mediastinum. Because of this anatomic association, the azygos vein may present a point of esophageal obstruction in the setting of significant pathology. CONCLUSION: This case highlights the possibility of multifactorial causes of dysphagia, and that HRIM is a key aspect of this workup. Additionally we discuss the pertinent anatomy, diagnosis, and treatments for azygos vein aneurysm and EGJOO.

A Comparative Classification Analysis of Abdominal Aortic Aneurysms by Machine Learning Algorithms.

The objective of this work was to perform image-based classification of abdominal aortic aneurysms (AAA) based on their demographic, geometric, and biomechanical attributes. We retrospectively reviewed existing demographics and abdominal computed tomography angiography images of 100 asymptomatic and 50 symptomatic AAA patients who received an elective or emergent repair, respectively, within 1-6 months of their last follow up. An in-house script developed within the MATLAB computational platform was used to segment the clinical images, calculate 53 descriptors of AAA geometry, and generate volume meshes suitable for finite element analysis (FEA). Using a third party FEA solver, four biomechanical markers were calculated from the wall stress distributions. Eight machine learning algorithms (MLA) were used to develop classification models based on the discriminatory potential of the demographic, geometric, and biomechanical variables. The overall classification performance of the algorithms was assessed by the accuracy, area under the receiver operating characteristic curve (AUC), sensitivity, specificity, and precision of their predictions. The generalized additive model (GAM) was found to have the highest accuracy (87%), AUC (89%), and sensitivity (78%), and the third highest specificity (92%), in classifying the individual AAA as either asymptomatic or symptomatic. The k-nearest neighbor classifier yielded the highest specificity (96%). GAM used seven markers (six geometric and one biomechanical) to develop the classifier. The maximum transverse dimension, the average wall thickness at the maximum diameter, and the spatially averaged wall stress were found to be the most influential markers in the classification analysis. A second classification analysis revealed that using maximum diameter alone results in a lower accuracy (79%) than using GAM with seven geometric and biomechanical markers. We infer from these results that biomechanical and geometric measures by themselves are not sufficient to discriminate adequately between population samples of asymptomatic and symptomatic AAA, whereas MLA offer a statistical approach to stratification of rupture risk by combining demographic, geometric, and biomechanical attributes of patient-specific AAA.

A Comparative Study of Biomechanical and Geometrical Attributes of Abdominal Aortic Aneurysms in the Asian and Caucasian Populations.

In this work, we provide a quantitative assessment of the biomechanical and geometric features that characterize abdominal aortic aneurysm (AAA) models generated from 19 Asian and 19 Caucasian diameter-matched AAA patients. 3D patient-specific finite element models were generated and used to compute peak wall stress (PWS), 99th percentile wall stress (99th WS), and spatially averaged wall stress (AWS) for each AAA. In addition, 51 global geometric indices were calculated, which quantify the wall thickness, shape, and curvature of each AAA. The indices were correlated with 99th WS (the only biomechanical metric that exhibited significant association with geometric indices) using Spearman's correlation and subsequently with multivariate linear regression using backward elimination. For the Asian AAA group, 99th WS was highly correlated (R2 = 0.77) with three geometric indices, namely tortuosity, intraluminal thrombus volume, and area-averaged Gaussian curvature. Similarly, 99th WS in the Caucasian AAA group was highly correlated (R2 = 0.87) with six geometric indices, namely maximum AAA diameter, distal neck diameter, diameter-height ratio, minimum wall thickness variance, mode of the wall thickness variance, and area-averaged Gaussian curvature. Significant differences were found between the two groups for ten geometric indices; however, no differences were found for any of their respective biomechanical attributes. Assuming maximum AAA diameter as the most predictive metric for wall stress was found to be imprecise: 24% and 28% accuracy for the Asian and Caucasian groups, respectively. This investigation reveals that geometric indices other than maximum AAA diameter can serve as predictors of wall stress, and potentially for assessment of aneurysm rupture risk, in the Asian and Caucasian AAA populations.

Wall Stress and Geometry Measures in Electively Repaired Abdominal Aortic Aneurysms.

Abdominal aortic aneurysm (AAA) is a vascular disease characterized by the enlargement of the infrarenal segment of the aorta. A ruptured AAA can cause internal bleeding and carries a high mortality rate, which is why the clinical management of the disease is focused on preventing aneurysm rupture. AAA rupture risk is estimated by the change in maximum diameter over time (i.e., growth rate) or if the diameter reaches a prescribed threshold. The latter is typically 5.5 cm in most clinical centers, at which time surgical intervention is recommended. While a size-based criterion is suitable for most patients who are diagnosed at an early stage of the disease, it is well known that some small AAA rupture or patients become symptomatic prior to a maximum diameter of 5.5 cm. Consequently, the mechanical stress in the aortic wall can also be used as an integral component of a biomechanics-based rupture risk assessment strategy. In this work, we seek to identify geometric characteristics that correlate strongly with wall stress using a sample space of 100 asymptomatic, unruptured, electively repaired AAA models. The segmentation of the clinical images, volume meshing, and quantification of up to 45 geometric measures of each AAA were done using in-house Matlab scripts. Finite element analysis was performed to compute the first principal stress distributions from which three global biomechanical parameters were calculated: peak wall stress, 99th percentile wall stress and spatially averaged wall stress. Following a feature reduction approach consisting of Pearson's correlation matrices with Bonferroni correction and linear regressions, a multivariate stepwise regression analysis was conducted to find the geometric measures most highly correlated with each of the biomechanical parameters. Our findings indicate that wall stress can be predicted by geometric indices with an accuracy of up to 94% when AAA models are generated with uniform wall thickness and up to 67% for patient specific, non-uniform wall thickness AAA. These geometric predictors of wall stress could be used in lieu of complex finite element models as part of a geometry-based protocol for rupture risk assessment.

A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery.

OBJECTIVE: New formulations and applications of hemostatic adjuncts such as fibrin sealant (FS) to support local hemostasis and sutures continue to be developed. In a pivotal, confirmatory, controlled, prospective, single-blinded, randomized, multicenter phase III clinical trial, the efficacy and safety of FS Grifols during vascular surgeries were evaluated. METHODS: Patients undergoing a nonemergency, open, peripheral vascular surgical procedure with moderate arterial bleeding were recruited. In an initial preliminary part of the study, all patients were treated with FS Grifols. In a subsequent primary part, patients were randomized (2:1) to FS Grifols or manual compression (MC). The primary efficacy end point was the proportion of the primary part patients achieving hemostasis by 4 minutes after the start of treatment. Cumulative proportion and time to hemostasis were secondary efficacy end points. Safety end points (in pooled preliminary and primary parts) included adverse events (AEs), vital signs, physical assessments, clinical laboratory tests, viral markers, and immunogenicity. RESULTS: The primary efficacy end point was met by 76.1% of patients (83/109) for the FS Grifols group versus 22.8% of patients (13/57) for the MC group (P < .001). The cumulative proportion of patients at 5, 7, and 10 minutes was 80.7%, 84.4%, and 88.1%, respectively, in the FS Grifols treatment group, and 28.1%, 35.1%, and 45.6% in the MC treatment group (P < .001). The median time to hemostasis was shorter in the FS Grifols group (4 minutes vs ≥10 minutes in the MC group; P < .001). The nature of AEs reported were those expected in the study patient profile. The percentage of patients experiencing treatment-emergent AEs were similar in both the FS Grifols (pooled n = 59 + 109) and MC groups (81.0% and 77.2%, respectively), most recurrent being procedural pain (34.5% and 36.8%, respectively) and pyrexia (11.3% and 10.5%, respectively). CONCLUSIONS: FS Grifols was superior in efficacy and similar in safety to MC as an adjunct local hemostatic agent in patients undergoing open vascular surgeries.

Correction to: Decision Tree Based Classification of Abdominal Aortic Aneurysms Using Geometry Quantification Measures.

This erratum is to correct the variable name on the left hand side of Eq. (2). The correct variable name is "Diameter" rather than the stated "Area."

Decision Tree Based Classification of Abdominal Aortic Aneurysms Using Geometry Quantification Measures.

Abdominal aortic aneurysm (AAA) is an asymptomatic aortic disease with a survival rate of 20% after rupture. It is a vascular degenerative condition different from occlusive arterial diseases. The size of the aneurysm is the most important determining factor in its clinical management. However, other measures of the AAA geometry that are currently not used clinically may also influence its rupture risk. With this in mind, the objectives of this work are to develop an algorithm to calculate the AAA wall thickness and abdominal aortic diameter at planes orthogonal to the vessel centerline, and to quantify the effect of geometric indices derived from this algorithm on the overall classification accuracy of AAA based on whether they were electively or emergently repaired. Such quantification was performed based on a retrospective review of existing medical records of 150 AAA patients (75 electively repaired and 75 emergently repaired). Using an algorithm implemented within the MATLAB computing environment, 10 diameter- and wall thickness-related indices had a significant difference in their means when calculated relative to the AAA centerline compared to calculating them relative to the medial axis. Of these 10 indices, nine were wall thickness-related while the remaining one was the maximum diameter (Dmax). Dmax calculated with respect to the medial axis is over-estimated for both electively and emergently repaired AAA compared to its counterpart with respect to the centerline. C5.0 decision trees, a machine learning classification algorithm implemented in the R environment, were used to construct a statistical classifier. The decision trees were built by splitting the data into 70% for training and 30% for testing, and the properties of the classifier were estimated based on 1000 random combinations of the 70/30 data split. The ensuing model had average and maximum classification accuracies of 81.0 and 95.6%, respectively, and revealed that the three most significant indices in classifying AAA are, in order of importance: AAA centerline length, L2-norm of the Gaussian curvature, and AAA wall surface area. Therefore, we infer that the aforementioned three geometric indices could be used in a clinical setting to assess the risk of AAA rupture by means of a decision tree classifier. This work provides support for calculating cross-sectional diameters and wall thicknesses relative to the AAA centerline and using size and surface curvature based indices in classification studies of AAA.

Geometric surrogates of abdominal aortic aneurysm wall mechanics.

The maximum diameter criterion is the most important factor in the clinical management of abdominal aortic aneurysms (AAA). Consequently, interventional repair is recommended when an aneurysm reaches a critical diameter, typically 5.0 cm in the United States. Nevertheless, biomechanical measures of the aneurysmal abdominal aorta have long been implicated in AAA risk of rupture. The purpose of this study is to assess whether other geometric characteristics, in addition to maximum diameter, may be highly correlated with the AAA peak wall stress (PWS). Using in-house segmentation and meshing algorithms, 30 patient-specific AAA models were generated for finite element analysis using an isotropic constitutive material for the AAA wall. PWS, evaluated as the spatial maximum of the first principal stress, was calculated at a systolic pressure of 120 mmHg. The models were also used to calculate 47 geometric indices characteristic of the aneurysm geometry. Statistical analyses were conducted using a feature reduction algorithm in which the 47 indices were reduced to 11 based on their statistical significance in differentiating the models in the population (p < 0.05). A subsequent discriminant analysis was performed and 7 of these indices were identified as having no error in discriminating the AAA models with a significant nonlinear regression correlation with PWS. These indices were: Dmax (maximum diameter), T (tortuosity), DDr (maximum diameter to neck diameter ratio), S (wall surface area), Kmedian (median of the Gaussian surface curvature), Cmax (maximum lumen compactness), and Mmode (mode of the Mean surface curvature). Therefore, these characteristics of an individual AAA geometry are the highest correlated with the most clinically relevant biomechanical parameter for rupture risk assessment. We conclude that the indices can serve as surrogates of PWS in lieu of a finite element modeling approach for AAA biomechanical evaluation.

Malpractice litigation in the endovascular era.

OBJECTIVE: The standard of care in the treatment of vascular disease continues to evolve as endovascular therapies develop. Currently, it is unclear how medical malpractice litigation has adapted to the "endovascular era." This retrospective case review is the most comprehensive analysis to date of malpractice actions involving endovascular procedures performed by vascular surgeons (VSs), interventional radiologists (IRs), interventional cardiologists (ICs), and cardiothoracic surgeons (CTSs). METHODS: The legal databases LexisNexis and Westlaw were searched for all published legal cases in the United States involving endovascular procedures. The search was limited to state and federal cases up to and including the year 2016. Keywords included "malpractice," "vascular," "endovascular," "catheter," "catheterization," "stent," "angiogram," "angiography," and "surgery." Cases involving tax revenue, insurance disputes, Social Security Disability, and hospital employment contract disputes were excluded. Data were analyzed using χ2 test. RESULTS: There were 2115 initial search results identified, and 369 cases were included in final analysis. The rate of endovascular procedure-related lawsuits (per 1000 active physicians in the specialty) was highest for ICs (105.56), whereas rates for VSs and IRs were comparable (18.47 and 16.85, respectively); 93% of the IC cases were related to coronary interventions. Overall, 55% (148/271 classifiable cases) of actions were related to elective procedures. For VSs specifically, 46% (25/54) of cases arose from diagnostic angiography and inferior vena cava filter placement, two relatively minor procedure types. Overall, 83% (176/211 finalized cases) of verdicts favored defendants, with no significant differences across the specialties; 43% (157/368) of total cases involved death of the patient. Among the four specialties, there was a significant (P = .0004) difference in the primary allegation (informed consent, preprocedure negligence, intraprocedure complications, or postprocedure complications) underlying the litigation. For CTSs and VSs, there was a predominance of informed consent and preprocedure negligence allegations (70% [7/10] and 52% [28/54], respectively). Intraprocedure negligence was the most common allegation for IRs (59% [23/39]), whereas allegations were more evenly distributed among ICs. CONCLUSIONS: Key issues were identified regarding malpractice litigation involving the specialties that commonly perform endovascular procedures. Despite the increasing number of ICs doing peripheral interventions, a large majority of IC cases were related to coronary treatments. A surprisingly large percentage of VS cases were related to seemingly minor cases. There were significant interspecialty differences in the primary underlying allegations. As the scope of endovascular procedures broadens and deepens, it is important for clinicians to be aware of legal considerations relevant to their practice.

The Association Between Geometry and Wall Stress in Emergently Repaired Abdominal Aortic Aneurysms.

Abdominal aortic aneurysm (AAA) is a prevalent cardiovascular disease characterized by the focal dilation of the aorta, which supplies blood to all the organs and tissues in the systemic circulation. With the AAA increasing in diameter over time, the risk of aneurysm rupture is generally associated with the size of the aneurysm. If diagnosed on time, intervention is recommended to prevent AAA rupture. The criterion to decide on surgical intervention is determined by measuring the maximum diameter of the aneurysm relative to the critical value of 5.5 cm. However, a more reliable approach could be based on understanding the biomechanical behavior of the aneurysmal wall. In addition, geometric features that are proven to be significant predictors of the AAA wall mechanics could be used as surrogates of the AAA biomechanical behavior and, subsequently, of the aneurysm's risk of rupture. The aim of this work is to identify those geometric indices that have a high correlation with AAA wall stress in the population of patients who received an emergent repair of their aneurysm. In-house segmentation and meshing algorithms were used to model 75 AAAs followed by estimation of the spatially distributed wall stress by performing finite element analysis. Fifty-two shape and size geometric indices were calculated for the same models using MATLAB scripting. Hypotheses testing were carried out to identify the indices significantly correlated with wall stress by constructing a Pearson's correlation coefficient matrix. The analyses revealed that 12 indices displayed high correlation with the wall stress, amongst which wall thickness and curvature-based indices exhibited the highest correlations. Stepwise regression analysis of these correlated indices indicated that wall stress can be predicted by the following four indices with an accuracy of 76%: maximum aneurysm diameter, aneurysm sac length, average wall thickness at the maximum diameter cross-section, and the median of the wall thickness variance. The primary outcome of this work emphasizes the use of global measures of size and wall thickness as geometric surrogates of wall stress for emergently repaired AAAs.

The importance of patient-specific regionally varying wall thickness in abdominal aortic aneurysm biomechanics.

Abdominal aortic aneurysm (AAA) is a vascular condition where the use of a biomechanics-based assessment for patient-specific risk assessment is a promising approach for clinical management of the disease. Among various factors that affect such assessment, AAA wall thickness is expected to be an important factor. However, regionally varying patient-specific wall thickness has not been incorporated as a modeling feature in AAA biomechanics. To the best our knowledge, the present work is the first to incorporate patient-specific variable wall thickness without an underlying empirical assumption on its distribution for AAA wall mechanics estimation. In this work, we present a novel method for incorporating regionally varying wall thickness (the "PSNUT" modeling strategy) in AAA finite element modeling and the application of this method to a diameter-matched cohort of 28 AAA geometries to assess differences in wall mechanics originating from the conventional assumption of a uniform wall thickness. For the latter, we used both a literature-derived population average wall thickness (1.5 mm; the "UT" strategy) as well as the spatial average of our patient-specific variable wall thickness (the "PSUT" strategy). For the three different wall thickness modeling strategies, wall mechanics were assessed by four biomechanical parameters: the spatial maxima of the first principal stress, strain, strain-energy density, and displacement. A statistical analysis was performed to address the hypothesis that the use of any uniform wall thickness model resulted in significantly different biomechanical parameters compared to a patient-specific regionally varying wall thickness model. Statistically significant differences were obtained with the UT modeling strategy compared to the PSNUT strategy for the spatial maxima of the first principal stress (p = 0.002), strain (p = 0.0005), and strain-energy density (p = 7.83 e-5) but not for displacement (p = 0.773). Likewise, significant differences were obtained comparing the PSUT modeling strategy with the PSNUT strategy for the spatial maxima of the first principal stress (p = 9.68 e-7), strain (p = 1.03 e-8), strain-energy density (p = 9.94 e-8), and displacement (p = 0.0059). No significant differences were obtained comparing the UT and PSUT strategies for the spatial maxima of the first principal stress (p = 0.285), strain (p = 0.152), strain-energy density (p = 0.222), and displacement (p = 0.0981). This work strongly recommends the use of patient-specific regionally varying wall thickness derived from the segmentation of abdominal computed tomography (CT) scans if the AAA finite element analysis is focused on estimating peak biomechanical parameters, such as stress, strain, and strain-energy density.

Fluid-structure interaction modeling of abdominal aortic aneurysms: the impact of patient-specific inflow conditions and fluid/solid coupling.

Rupture risk assessment of abdominal aortic aneurysms (AAA) by means of biomechanical analysis is a viable alternative to the traditional clinical practice of using a critical diameter for recommending elective repair. However, an accurate prediction of biomechanical parameters, such as mechanical stress, strain, and shear stress, is possible if the AAA models and boundary conditions are truly patient specific. In this work, we present a complete fluid-structure interaction (FSI) framework for patient-specific AAA passive mechanics assessment that utilizes individualized inflow and outflow boundary conditions. The purpose of the study is two-fold: (1) to develop a novel semiautomated methodology that derives velocity components from phase-contrast magnetic resonance images (PC-MRI) in the infrarenal aorta and successfully apply it as an inflow boundary condition for a patient-specific fully coupled FSI analysis and (2) to apply a one-way-coupled FSI analysis and test its efficiency compared to transient computational solid stress and fully coupled FSI analyses for the estimation of AAA biomechanical parameters. For a fully coupled FSI simulation, our results indicate that an inlet velocity profile modeled with three patient-specific velocity components and a velocity profile modeled with only the axial velocity component yield nearly identical maximum principal stress (σ1), maximum principal strain (ε1), and wall shear stress (WSS) distributions. An inlet Womersley velocity profile leads to a 5% difference in peak σ1, 3% in peak ε1, and 14% in peak WSS compared to the three-component inlet velocity profile in the fully coupled FSI analysis. The peak wall stress and strain were found to be in phase with the systolic inlet flow rate, therefore indicating the necessity to capture the patient-specific hemodynamics by means of FSI modeling. The proposed one-way-coupled FSI approach showed potential for reasonably accurate biomechanical assessment with less computational effort, leading to differences in peak σ1, ε1, and WSS of 14%, 4%, and 18%, respectively, compared to the axial component inlet velocity profile in the fully coupled FSI analysis. The transient computational solid stress approach yielded significantly higher differences in these parameters and is not recommended for accurate assessment of AAA wall passive mechanics. This work demonstrates the influence of the flow dynamics resulting from patient-specific inflow boundary conditions on AAA biomechanical assessment and describes methods to evaluate it through fully coupled and one-way-coupled fluid-structure interaction analysis.

Assessing the impact of distal protection filter design characteristics on 30-day outcomes of carotid artery stenting procedures.

OBJECTIVE: This study aims to review retrospectively the records of patients treated with carotid artery stenting (CAS) to investigate the potential correlations between clinical variables, distal protection filter (DPF) type and characteristics, and 30-day peri-/postprocedural outcomes. METHODS: This is a multicenter, single-arm, nonrandomized retrospective study of patients who underwent filter-protected CAS in the Pittsburgh, Pennsylvania, region between July 2000 and May 2011. Analysis of peri-/postprocedural complications included myocardial infarction, transient ischemic attacks (TIA), stroke, death, and a composition of all adverse events (AEs). Filter characteristics for Accunet (Abbott Vascular, Santa Clara, Calif; n = 429 [58.8%]), Angioguard (Cordis Endovascular, Miami Lakes, Fla; n = 114 [15.6%]), FilterWire (Boston Scientific, Natick, Mass; n = 113 [15.5%]), Spider (ev3 Endovascular, Plymouth, Minn; n = 45 [6.2%]), and Emboshield (Abbott Vascular; n = 24 [3.3%]) were previously determined in vitro and were used to find correlations with CAS procedural outcomes. Both univariate and multivariate analyses were performed, as well as goodness-of-fit tests to find multivariate correlations with procedural outcomes. RESULTS: In total, 731 CAS procedures using six different DPFs were analyzed. Peri-/postprocedural AEs included 19 TIAs (2.6%), 38 strokes (5.2%), one myocardial infarction (0.1%), 19 deaths (3.6%), and a total of 61 patients with complications (8.3%). Univariate analysis for filter design characteristics showed that the composite of AE was negatively associated with both vascular resistance (P = .01) and eccentricity (P = .02) and was positively associated with porosity (P = .0007), number of pores (P = .005), and pore density (P = .001). Multivariate analysis and the goodness-of-fit test revealed that patients with a history of congestive heart failure, stroke, and TIA (each with odds ratio >1) led to a good-fit model P value of .72 for peri-/postprocedural AEs. Multivariate analysis was inconclusive for all filter design characteristics. CONCLUSIONS: The following filter design characteristics are independently significant for minimizing peri-/postprocedural AEs: higher vascular resistance, concentric in shape, greater capture efficiency, lower porosity, lower number of pores, and lower pore density. Lower porosity and smaller wall apposition were also found to be independently significant for minimization of peri-/postprocedural TIAs. This information can be used when considering the desirable design characteristics of future DPFs.).

Surface curvature as a classifier of abdominal aortic aneurysms: a comparative analysis.

An abdominal aortic aneurysm (AAA) carries one of the highest mortality rates among vascular diseases when it ruptures. To predict the role of surface curvature in rupture risk assessment, a discriminatory analysis of aneurysm geometry characterization was conducted. Data was obtained from 205 patient-specific computed tomography image sets corresponding to three AAA population subgroups: patients under surveillance, those that underwent elective repair of the aneurysm, and those with an emergent repair. Each AAA was reconstructed and their surface curvatures estimated using the biquintic Hermite finite element method. Local surface curvatures were processed into ten global curvature indices. Statistical analysis of the data revealed that the L2-norm of the Gaussian and Mean surface curvatures can be utilized as classifiers of the three AAA population subgroups. The application of statistical machine learning on the curvature features yielded 85.5% accuracy in classifying electively and emergent repaired AAAs, compared to a 68.9% accuracy obtained by using maximum aneurysm diameter alone. Such combination of non-invasive geometric quantification and statistical machine learning methods can be used in a clinical setting to assess the risk of rupture of aneurysms during regular patient follow-ups.

A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts.

OBJECTIVE: The ideal hemostatic agent for treatment of suture-line bleeding at vascular anastomoses has not yet been established. This study evaluated whether the use of a fibrin sealant containing 500 IU/mL thrombin and synthetic aprotinin (FS; marketed in the United States under the name TISSEEL) is beneficial for treatment of challenging suture-line bleeding at vascular anastomoses of expanded polytetrafluoroethylene (ePTFE) grafts, including those further complicated by concomitant antiplatelet therapies. METHODS: Over a 1-year period ending in 2010, ePTFE graft prostheses, including arterio-arterial bypasses and arteriovenous shunts, were placed in 140 patients who experienced suture-line bleeding that required treatment after completion of anastomotic suturing. Across 24 US study sites, 70 patients were randomized and treated with FS and 70 with manual compression (control). The primary end point was the proportion of patients who achieved hemostasis at the study suture line at 4 minutes after start of application of FS or positioning of surgical gauze pads onto the study suture line. RESULTS: There was a statistically significant difference in the comparison of hemostasis rates at the study suture line at 4 minutes between FS (62.9%) and control (31.4%) patients (P < .0001), which was the primary end point. Similarly, hemostasis rates in the subgroup of patients on antiplatelet therapies were 64.7% (FS group) and 28.2% (control group). When analyzed by bleeding severity, the hemostatic advantage of FS over control at 4 minutes was similar (27.8% absolute improvement for moderate bleeding vs 32.8% for severe bleeding). Logistic regression analysis (accounting for gender, age, intervention type, bleeding severity, blood pressure, heparin coating of ePTFE graft, and antiplatelet therapies) found a statistically significant treatment effect in the odds ratio (OR) of meeting the primary end point between treatment groups (OR, 6.73; P < .0001), as well as statistically significant effects for intervention type (OR, 0.25; P = .0055) and bleeding severity (OR, 2.59; P = .0209). The safety profile of FS was excellent as indicated by the lack of any related serious adverse events. CONCLUSIONS: The findings from this phase 3 study confirmed that FS is safe and its efficacy is superior to manual compression for hemostasis in patients with peripheral vascular ePTFE grafts. The data also suggest that FS promotes hemostasis independently of the patient's own coagulation system, as shown in a representative population of patients with vascular disease under single- or dual-antiplatelet therapies.

The kissing-stent technique for treatment of distal aortic stenosis and protection of the inferior mesenteric artery orifice.

Focal infrarenal aortic stenosis is relatively rare. Traditionally, aortic endarterectomy and aortic bypass surgery have been used to treat these lesions. However, percutaneous transluminal angioplasty and stenting have become well-defined alternatives. A 62-year-old woman presented with bilateral ischemic rest pain. Angiography revealed a mid-infrarenal aortic stenosis adjacent to an enlarged, patent inferior mesenteric artery. Celiac artery and superior mesenteric artery stenoses were also present. The kissing-stent technique is a viable option for ensuring inferior mesenteric artery patency when treating distal aortic lesions by endovascular means in patients with asymptomatic multivessel mesenteric artery disease.

Results of staged carotid endarterectomy and coronary artery bypass graft in patients with severe carotid and coronary disease.

BACKGROUND: To evaluate our experience with staged carotid endarterectomy (CEA) followed by coronary artery bypass grafting (CABG) within the perioperative period for patients with severe carotid and coronary artery disease. METHODS: From 1998 to August of 2010, 40 patients who were referred for isolated coronary surgery were found to have significant carotid disease. All patients underwent CEA followed by subsequent CABG within 30 days of the CEA. Severe carotid stenosis was defined as >70%. RESULTS: Average patient age was 65.5 ± 10.6 years and 32 (80%) were male. Severe carotid stenosis was unilateral in 37 of the patients, bilateral in 3, and asymptomatic in 37. Patients underwent CEA with either patch angioplasty or eversion technique. General anesthesia with selective shunting was used in all cases. There were zero deaths, zero strokes, and one myocardial infarction (MI) (2.5%) immediately after CEA. After CEA, CABG was performed within 30 days. The average interval between procedures was 6.87 days. There were two (5.0%) deaths, one from MI and the other from multisystem organ failure. There were two strokes (5.0%), with one having permanent effects. The perioperative mortality, stroke, and MI rates after both operations were 5.0%, 5.0%, and 5.0%, respectively. CONCLUSIONS: Staging of CEA followed by CABG in the immediate perioperative period may be an acceptable approach to patients with severe carotid and coronary disease. Despite the presence of known severe coronary disease, the performance of CEA under general anesthesia as the initial procedure was well tolerated. We propose that this strategy may be a possible option for patients who present with severe disease in both coronary and carotid distributions. The results of our study, though based on a limited cohort, suggest that this approach of staged CEA-CABG within the perioperative period <30 days is reasonable.