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While cross-clamp site is a known risk factor for postoperative acute and chronic renal dysfunction following open abdominal aortic aneurysm surgery (AAA), the additive impact of patient demographic and clinical factors is lacking. In this study, we investigated the impact of body mass index (BMI), surgical duration and aneurysm diameter on the association between proximal cross-clamp location and postoperative renal dysfunction.In this study, we conducted a retrospective analysis of 4,197 patients undergoing open AAA surgery between 2011 and 2018 using data housed in the American College of Surgeons National Safety Quality Improvement Program (ACS-NSQIP) database. The primary outcome was renal dysfunction, which was defined as patients requiring dialysis within 30 days or patients with ≥2 mg/dL rise in creatinine from baseline. We assessed the incidence of renal dysfunction with regard to clamp location and subsequently used multivariable logistic regression to assess clinical and demographic factors associated with renal dysfunction. We used a regression model to plot the association of BMI, surgical duration, and aneurysm diameter with an adjusted probability of postoperative acute and chronic renal dysfunction for individual cross-clamp locations.Of the 4,197 patients analyzed, 405 patients (9.6%) developed renal dysfunction within 30 days with 287 patients requiring dialysis. Patients with supraceliac clamp location had the highest incidence of renal dysfunction (20.4%). Our data showed a significant association of renal dysfunction with higher BMI patients [OR 1.04 (1.02, 1.07), P = 0.001], longer operative times [OR1.01 (1.01, 1.02), P 0.001], clamp location between the superior mesenteric artery (SMA) and renal artery [OR 1.80 (1.17, 2.78), P = 0.007] and supraceliac clamp location [OR 2.47 (1.62, 3.76), P 0.001].The incidence of renal dysfunction increases with suprarenal clamps. Patients with higher BMI, longer operative times, and increasing aneurysm diameter, and a suprarenal clamp have a significantly increased risk of renal dysfunction compared to those who also had a suprarenal clamp but lower BMI, shorter operative times and smaller aneurysm diameter.

Traumatic brain injury (TBI) and blunt thoracic aortic injury (BTAI) are the top two leading causes of death after blunt force trauma. Patients presenting with concomitant BTAI and TBI pose a specific challenge with respect to management strategy, because the optimal hemodynamic parameters are conflicting between the two pathologies. Early thoracic endovascular aortic repair (TEVAR) is often performed, even for minimal aortic injuries, to allow for the higher blood pressure parameters required for TBI management. However, the optimal timing of TEVAR for the treatment of BTAI in patients with concomitant TBI remains an active matter of controversy.The Aortic Trauma Foundation international prospective multicenter registry was used to identify all patients who had undergone TEVAR for BTAI in the setting of TBI from 2015 to 2020. The primary outcomes included delayed ischemic or hemorrhagic stroke, in-hospital mortality, and aortic-related mortality. The outcomes were examined among patients who had undergone TEVAR at emergent (6 vs ≥6 hours) or urgent (24 vs ≥24 hours) intervals.A total of 100 patients (median age, 43 years; 79% men; median injury severity score, 41) with BTAI (Society for Vascular Surgery BTAI grade 1, 3%; grade 2, 10%; grade 3, 78%; grade 4, 9%) and concomitant TBI who had undergone TEVAR were identified. Emergent repair was performed for 51 patients (51%). Comparing emergent repair (6 hours) to urgent repair (≥6 hours), no difference was found in delayed cerebral ischemic events (2.0% vs 4.1%; P = .614), in-hospital mortality (15.7% vs 22.4%; P = .389), or aortic-related mortality (2.0% vs 2.0%; P = .996) and no patient had experienced delayed hemorrhagic stroke. Likewise, repairs conducted in an urgent (24 hours) setting showed no differences compared with those completed in an emergent (≥24 hours) setting regarding delayed ischemic stroke (2.6% vs 4.3%; P = .548), in-hospital mortality (18.2% vs 21.7%; P = .764), or aortic-related mortality (1.3% vs 4.3%; P = .654), and no patient had experienced delayed hemorrhagic stroke.In contrast to prior retrospective efforts, results from the Aortic Trauma Foundation international prospective multicenter registry have demonstrated that neither emergent nor urgent TEVAR for patients with concomitant BTAI and TBI was associated with delayed stroke, in-hospital mortality, or aortic-related mortality. In these patients, the timing of TEVAR did not have an effect on the outcomes. Therefore, the decision to intervene should be guided by individual patient factors rather than surgical timing.

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The use of atherectomy during peripheral endovascular interventions (PVI) has increased dramatically, but data regarding its safety and effectiveness are lacking.This study sought to determine the long-term safety of atherectomy in contemporary practice.Medicare fee-for-service beneficiaries who underwent femoropopliteal artery PVI from 2015-2018 were identified in a 100% sample of inpatient, outpatient, and carrier file data using procedural claims codes. The primary exposure was the use of atherectomy. Inverse probability of treatment weighting was used to adjust for measured differences in patient populations. Kaplan-Meier methods and multivariable Cox proportional hazards regression were used to compare outcomes.Among 168,553 patients who underwent PVI, 59,142 (35.1%) underwent atherectomy. The mean patient age was 77.0±7.6 years, 44.9% were female, 81.9% were white, and 46.7% had chronic limb-threatening ischaemia. Over a median follow-up time of 993 days (interquartile range 319-1,377 days), atherectomy use was associated with no difference in the risk of either the composite endpoint of death and amputation (adjusted hazard ratio [aHR] 0.99, 95% confidence interval [CI]: 0.97-1.01; p=0.19) or of major adverse limb events (aHR 1.02, 95% CI: 0.99-1.05; p=0.26). Patients who underwent atherectomy had a modest reduction in the risk of subsequently undergoing amputation or surgical revascularisation (aHR 0.92, 95% CI: 0.90-0.94; p0.01) but an increase in the risk of undergoing a subsequent PVI (aHR 1.19, 95% CI: 1.16-1.21; p0.01).The use of atherectomy during femoropopliteal artery PVI was not associated with an increase in the risk of long-term adverse safety outcomes among patients with peripheral artery disease.

Spinal cord ischemia (SCI) is a rare but serious complication of Thoracic Endovascular Aortic Repair (TEVAR). Several measures including spinal drain (SD) placement have been proposed to reduce the risk of SCI in TEVARs performed for aneurysms. However, there are no specific large-scale data on potential benefits of SD placement in Stanford Type B aortic dissection (TBAD). We aimed to assess the impact of preoperative SD placement on preventing SCI during TEVARs performed for TBAD.We included all TEVAR cases performed for TBAD in Vascular Quality Initiative (VQI) from 2012 to 2021. Patients with connective tissue disease, open conversion, rupture, proximal disease zone 5, proximal landing zone2 or SCI on presentation were excluded. One-to-one propensity score matching was used to balance patients on 34 dimensions by the nearest neighbor principle to compare patients based on preoperative SD placement. The primary outcome was SCI. Secondary outcomes included 30-day and 90-day mortality, perioperative complications, and 90-day2intervention.A total of 2,683 TEVARs were performed for TBAD with 1,227 (45.7%) undergoing preoperative SD placement. Propensity matching produced 672 well-matched pairs. In the matched cohort, SD placement was not associated with significant reduction in temporary SCI (3.0% vs. 3.7%, P = 0.45). However, SD placement was associated with significant reduction of the risk of permanent SCI at discharge (1.3% vs. 3.4%, P = 0.012). SD was also associated with lower risk of 30-day mortality (3.7% vs 6.4%, P = 0.025) and shorter length of stay but not 90-day mortality or 90-day reintervention.Our study suggests that preoperative SD placement in patients undergoing TEVAR for TBAD is beneficial in reducing the risk of permanent SCI without increasing risks of perioperative complications. Further prospective studies are necessary to confirm these findings.

Thoracic endovascular aortic repair is the method of choice in patients with complicated type B acute aortic dissection. However, thoracic endovascular aortic repair carries a risk of periprocedural neurological events including stroke and spinal cord ischemia. We aimed to look at procedure-related neurological complications within a large cohort of patients with type B acute aortic dissection treated by thoracic endovascular aortic repair.Between 1996 and 2021, the International Registry of Acute Aortic Dissection collected data on 3783 patients with type B acute aortic dissection. For this analysis, 648 patients with type B acute aortic dissection treated by thoracic endovascular aortic repair were included (69.4% male, mean age 62.7 ± 13.4 years). Patients were excluded who presented with a preexisting neurologic deficit or received adjunctive procedures. Demographics, clinical symptoms, and outcomes were analyzed. The primary end point was the periprocedural incidence of neurological events (defined as stroke, spinal cord ischemia, transient neurological deficit, or coma). Predictors for perioperative neurological events and follow-up outcomes were considered as secondary end points.Periprocedure neurological events were noted in 72 patients (11.1%) and included strokes (n = 29, 4.6%), spinal cord ischemias (n = 21, 3.3%), transient neurological deficits (n = 16, 2.6%), or coma (n = 6, 1.0%). The group with neurological events had a significantly higher in-hospital mortality (20.8% vs 4.3%, P .001). Patients with neurological events were more likely to be female (40.3% vs 29.3%, P = .077), and aortic rupture was more often cited as an indication for thoracic endovascular aortic repair (38.8% vs 16.5%, P .001). In patients with neurological events, more stent grafts were used (2 vs 1 stent graft, P = .002). Multivariable logistic regression analysis showed that aortic rupture (odds ratio, 3.12, 95% confidence interval, 1.44-6.78, P = .004) and female sex (odds ratio, 1.984, 95% confidence interval, 1.031-3.817, P = .040) were significantly associated with perioperative neurological events.In this highly selected group from dedicated aortic centers, more than 1 in 10 patients with type B acute aortic dissection treated by thoracic endovascular aortic repair had neurological events, in particular women. Further research is needed to identify the causes and presentation of these events after thoracic endovascular aortic repair, especially among women.

Cardiac implantable electronic device implantation rates have increased in recent decades. Venous obstruction of the subclavian, brachiocephalic, or superior vena cava veins represents an important complication of implanted leads. These forms of venous obstruction can result in significant symptoms as well as present a barrier to the implantation of additional device leads. The risk factors for the development of these complications remain poorly understood, and diagnosis relies on clinical recognition and cross-sectional imaging. Anticoagulation remains the mainstay of treatment, and thrombus debulking, lead extraction, venoplasty, and stenting are all important therapeutic interventions. This review provides a multidisciplinary-based approach to the evaluation and management of cardiac implantable electronic device lead-associated venous obstruction.

Existing surgical quality metrics have limited utility, are primarily used for high-mortality procedures, and often fail to account for differences in non-fatal outcomes. Our objective was to develop more comprehensive, novel surgical quality metrics, for patients undergoing abdominal aortic aneurysm (AAA) repair.Non-ruptured open and endovascular AAA repair (EVAR) from the Vascular Quality Initiative database were studied, 2016-2019. A win was defined as AAA repair without major complication (in-hospital) or mortality (in-hospital or within 30 days). Centers were divided into quality quartiles based on performance in two novel win-based metrics: (1) Wins Above Average (WAA) and (2) weighted Wins Above Average (wWAA). Patient-level and center-level analyses compared demographics and outcomes between "best" and "worst" quartiles, including wins, mortality, and failure to rescue (FTR) rates. Additional patient-level analyses were performed based on center stratification into volume quartiles. Correlation in surgical quality for open repair and EVAR was determined at centers performing both procedures.Overall, 3683 patients underwent open repair and 21,165 patients underwent EVAR. For open repair, crude rates of win, mortality, and FTR were 62.8%, 4.2%, and 10.3%, respectively. For EVAR, crude rates for win, mortality, and FTR were 94.4%, 1.1%, and 12.3%, respectively. When stratified by wWAA, patients undergoing open repair at "best" quartile centers had a higher win rate (72.0% vs 52.7%; risk ratio [RR], 1.37; 95% confidence interval [CI], 1.28-1.46) and lower mortality (3.1% vs 6.2%; RR, 0.50; 95% CI, 0.33-0.74) compared with "worst" quartile centers. Similarly, for EVAR, "best" quartile centers had a higher win rate (96.2% vs 92.1%; RR, 1.04; 95% CI, 1.03-1.05), lower mortality (0.4% vs 2.2%; RR, 0.19; 95% CI, 0.13-0.29), and a lower FTR rate (5.7% vs 17.9%; RR, 0.32; 95% CI, 0.18-0.56) compared with "worst" quartile centers. Stratification by volume showed that high-volume centers demonstrated improved wWAA for open repair (P = .04) but not for EVAR (P = .3) compared with low-volume centers. For centers that performed both open repair and EVAR, there was no correlation in quality as determined by wWAA (r = -0.056; P = .6).wWAA is a novel, risk-adjusted, complication-weighted surgical quality metric that also accounts for volume differences. wWAA successfully distinguishes high- and low-quality centers for both open AAA repair and EVAR. This methodology is potentially broadly applicable for measuring surgical quality.

ObjectiveTo evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data.DesignObservational surveillance study.Setting282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18).Participants20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models.Main outcome measuresReintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both.ResultsMedian age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017.ConclusionsThe linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions.

The study objective was to evaluate the safety and effectiveness of the second-generation, low-profile RelayPro (Terumo Aortic) thoracic endograft for the treatment of descending thoracic aortic aneurysm or penetrating atherosclerotic ulcer.A prospective, international, nonblinded, nonrandomized, pivotal trial analyzed a primary safety end point of major adverse events at 30 days (death, myocardial infarction, stroke, renal/respiratory failure, paralysis, bowel ischemia, procedural blood loss) and a primary effectiveness end point of treatment success at 1 year (technical success, patency, absence of aneurysm rupture, type I/III endoleaks, stent fractures, reinterventions, aneurysm expansion, and migration) compared with performance goals from the previous generation Relay pivotal study. The study was conducted in 36 centers in the United States and Japan and enrolled participants between 2017 and 2019.The study population of 110 patients had a median (interquartile range) age of 76 (70-81) years, 69 (62.7%) were male, and 43 (39.1%) were Asian. Patients were treated for 76 fusiform aneurysms (69%), 24 saccular aneurysms (22%), and 10 penetrating atherosclerotic ulcers (9%). Most patients (82.7%) were treated with a non-bare stent configuration. Technical success was 100%. The median (interquartile range) procedure time was 91 (64-131) minutes, and the deployment time was 16 (10-25) minutes. A total of 50 patients (73.5%) in the US cohort had percutaneous access, whereas centers in Japan used only surgical cutdown. The 30-day composite major adverse events rate was 6.4% (95% upper confidence interval, 11.6%; P = .0002): 2 strokes, 2 procedural blood losses greater than 1000 mL requiring transfusion, 2 paralysis events, and 1 renal failure. Primary effectiveness was 89.2% (lower 95% confidence interval, 81.8%; P = .0185). Nine subjects experienced 11 events (1 aneurysm expansion, 6 secondary interventions, and 4 type I endoleaks). There was no loss of stent-graft patency, no rupture, no fractures, and no migration.The low-profile RelayPro thoracic endograft met the study primary end points and demonstrated satisfactory 30-day safety and 1-year effectiveness for the treatment of patients with aneurysms of the descending thoracic aorta or penetrating atherosclerotic ulcers. Follow-up is ongoing to evaluate longer-term outcomes and durability.

The proportion of open aneurysm repairs requiring at least a suprarenal clamp has increased in the past few decades, partly owing to preferred endovascular approaches for most patients with infrarenal aneurysms, suggesting that the management of aortic clamp placement has become even more relevant. This study evaluated the association between the proximal clamp site and intraoperative ischemia times with postoperative renal dysfunction and mortality.We used the Vascular Quality Initiative to identify all patients undergoing open repairs of elective or symptomatic juxtarenal AAAs from 2004 to 2018 and compared outcomes by clamp site: above one renal artery, above both renal arteries (suprarenal), or above the celiac trunk (supraceliac). Outcomes evaluated included acute kidney injury (AKI), new-onset renal failure requiring renal replacement therapy (RRT), 30-day mortality, and 1-year mortality. We used multilevel logistic regressions and Cox proportional hazards models, clustered at the hospital level, to adjust for confounding.We identified 3976 patients (median age, 71 years; 70% male; 8.2% non-Caucasian), with a median aneurysm diameter of 5.9cm (interquartile range [IQR], 5.4-6.8 cm). Proximal clamp sites were above one renal artery (31%), suprarenal (52%), or supraceliac (17%). The rates of unadjusted outcomes were 20.5% for AKI, 4.1% for new-onset RRT, 4.9% for 30-day mortality, and 8.3% for 1-year mortality. On adjusted analyses, independent of ischemia time, suprarenal clamping relative to clamping above a single renal artery had higher odds of postoperative AKI (adjusted odds ratio [aOR], 1.50; 95% confidence interval; 95% CI, CI, 1.28-1.75), but similar odds for new-onset RRT (aOR, 1.27; 95% CI, 0.79-2.06) and 30-day mortality (aOR, 1.12; 95% CI, 0.79-1.58) and hazards for 1-year mortality (adjusted hazard ratio, 1.12; 95% CI, 0.86-1.45). However, every 10 minutes of prolonged intraoperative ischemia time was associated with an increase in odds or hazards ratio of postoperative AKI by 7% (IQR, 3%-11%), new-onset RRT by 11% (IQR, 4%-17%), 30-day mortality by 11% (IQR, 6%-17%), and 1-year mortality by 7% (IQR, 2%-13%). Patients with more than 40 minutes of ischemia time had notably higher rates of all four outcomes.Suprarenal clamping relative to clamping above a single renal artery was associated with AKI, but not new-onset RRT or 30-day mortality. However, the intraoperative renal ischemia time was independently associated with all four postoperative outcomes. Although further studies are warranted, our findings suggest that an expeditious proximal anastomosis creation is more important than trying to maintain clamp position below one renal artery, suggesting that suprarenal clamping may be the best strategy for open AAA repair when needed to efficiently perform the proximal anastomosis.

Blunt thoracic aortic injury (BTAI) is the second leading cause of death from blunt trauma. In the present study, we aimed to determine the outcomes of medical management (MM) for BTAI. We hypothesized from the results of several previously reported studies, that patients with a minimal aortic injury (BTAI grades 1 and 2) could safely be treated with definitive MM alone.The Aortic Trauma Foundation international prospective multicenter registry was used to examine the demographics, injury characteristics, management, and outcomes of patients with BTAI. We analyzed a subset of patients for whom MM was initiated as definitive therapy.From November 2016 to April 2020, 432 patients (median age, 41 years; 76% male; median injury severity score, 34) with BTAI (Society for Vascular Surgery grade 1, 23.6%; grade 2, 14.4%; grade 3, 51.2%; grade 4, 10.9%) were evaluated. Of the 432 patients, 245 (57%) had received MM in the initial period and 114 (26.4%) had received MM as the planned definitive therapy (grade 1, 59.6%; grade 2, 23.7%; grade 3, 15.8%; grade 4, 0.9%). The most common mechanism of BTAI was a motor vehicle collision (60.4%). Hypotension was present on arrival in 74 patients (17.2%). Continuous titratable infusion of antihypertensive medication was used for 49.1%, followed by intermittent bolus administration (29.8%), with beta-blockers (74.6%) the most common agent used. Treatments were targeted to a goal systolic blood pressure for 83.3%, most often to a target goal systolic blood pressure120 mm Hg (66.3%). The MM goals based on blood pressure control were attained in 64.0% (73 of 114). Twelve patients (10.5%; grade 1, 1; grade 2, 0; grade 3, 10; grade 4, 1) had required subsequent intervention after MM. Eleven patients (9.6%) had undergone thoracic endovascular aortic repair and one (0.9%) had required open repair for a grade 4 injury. The overall in-hospital mortality for patients selected for definitive MM was 7.9%. No aortic-related deaths had occurred in the patients receiving definitive MM.Approximately one in four patients with BTAI will receive MM as definitive therapy. The variation in the pharmacologic therapies used is considerable. MM for patients with minimal aortic injury (BTAI grades 1 and 2) is safe and effective, with a low overall intervention rate and no aortic-related deaths. These findings support the use of definitive MM for grade 2 BTAI.

Background Wound complications after open infrainguinal revascularization are a frequent cause of patient morbidity, resulting in increased healthcare costs. The purpose of the present study was to assess the effects of closed incision negative pressure therapy (ciNPT) on groin wound complications after infrainguinal bypass and femoral endarterectomy. Methods A total of 242 patients who had undergone infrainguinal bypass (n = 124) or femoral endarterectomy (n = 118) at five academic medical centers in New England from April 2015 to August 2019 were randomized to ciNPT (PREVENA; 3M KCI, St Paul, Minn; n = 118) or standard gauze (n = 124). The primary outcome measure was a composite endpoint of groin wound complications, including surgical site infections (SSIs), major noninfectious wound complications, or graft infections within 30 days after surgery. The secondary outcome measures included 30-day SSIs, 30-day noninfectious wound complications, readmission for wound complications, significant adverse events, and health-related quality of life using the EuroQoL 5D-3L survey. Results The ciNPT and control groups had similar demographics (age, 67 vs 67 years, P = .98; male gender, 71% vs 70%, P = .86; white race, 93% vs 93%, P = .97), comorbidities (previous or current smoking, 93% vs 94%, P = .46; diabetes, 41% vs 48%, P = .20; renal insufficiency, 4% vs 7%, P = .31), and operative characteristics, including procedure type, autogenous conduit, and operative time. No differences were found in the primary composite outcome at 30 days between the two groups (ciNPT vs control: 31% vs 28%; P = .55). The incidence of SSI at 30 days was similar between the two groups (ciNPT vs control: 11% vs 12%; P = .58). Infectious (13.9% vs 12.6%; P = .77) and noninfectious (20.9% vs 17.6%; P = .53) wound complications at 30 days were also similar for the ciNPT and control groups. Wound complications requiring readmission also similar between the two groups (ciNPT vs control: 9% vs 7%; P = .54). The significant adverse event rates were not different between the two groups (ciNPT vs control: 13% vs 16%; P = .53). The mean length of the initial hospitalization was the same for the ciNPT and control groups (5.2 vs 5.7 days; P = .63). The overall health-related quality of life was similar at baseline and at 14 and 30 days postoperatively for the two groups. Although not powered for stratification, we found no differences among the subgroups in gender, obesity, diabetes, smoking, claudication, chronic limb threatening ischemia, bypass, or endarterectomy. On multivariable analysis, no differences were found in wound complications at 30 days for the ciNPT vs gauze groups (odds ratio, 1.4; 95% confidence interval, 0.8-2.6; P = .234). Conclusions In contrast to other randomized studies, our multicenter trial of infrainguinal revascularization found no differences in the 30-day groin wound complications for patients treated with ciNPT vs standard gauze dressings. However, the SSI rate was lower in the control group than reported in other studies, suggesting other practice patterns and processes of care might have reduced the rate of groin infections. Further study might identify the subsets of high-risk patients that could benefit from ciNPT.

Pericardial tamponade (PT) is a dangerous complication of surgeries requiring dissection of the pericardium, including Acute Type A Aortic Dissection (TAAAD) repair. However, there are few studies on the predictors and/or outcomes associated with PT development post-surgery for TAAAD. We evaluated

Purpose: The majority of patients undergoing EVAR do not require blood transfusion, yet blood type and screen (T&S) is routinely performed. Identifying patients in whom T&S can be avoided presents a substantial cost saving opportunity. Hypothesis: We hypothesized that intraoperative blood transfusions can be predicted preoperatively. Methods: Using the Vascular Study Group of New England database from 2003-2014, we performed a retrospective review of 4700 patients who underwent EVAR. The cohort was split randomly into a training (60%) and validation (40%) set. A backwards logistic regression analysis was performed to identify predictors of intraoperative blood transfusion in the training set. The model was then tested in the validation set to estimate the receiver operating curves (ROC) and goodness of fit. Results: Preoperative hemoglobin, urgency (elective, symptomatic, or ruptured), age, maximal anterior-posterior AAA diameter, female gender, and history of CHF (asymptomatic, mild, moderate, or severe) were all significant predictors of intraoperative blood transfusions. The c-statistic for our model was .82 in the training set and .84 in the validation set, and the Hosmer-Lemenshow goodness-of-fit statistic was 0.99. Conclusions: Intraoperative blood transfusions can be routinely predicted preoperatively. Avoidance of T&S in low risk populations provides a substantial cost-saving opportunity.

Despite improvements in endovascular therapy for lower extremity arterial disease, open surgical revascularization is still required when the disease is extensive. Although autogenous vein is the conduit of choice for open femoropopliteal bypass, prosthetic grafts can be an acceptable alternative when adequate vein is not available. The FUSION BIOLINE heparin-coated vascular graft (Maquet Endovascular, Wayne, NJ) was developed to improve the patency rate associated with standard prosthetic grafts. The current study, the FINEST Trial (Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE), was designed to assess the clinical outcome of heparin-coated and standard vascular grafts in a prospective, randomized, controlled, multicenter trial.During a 25-month period ending in June 2012, 209 eligible patients scheduled to undergo elective prosthetic femoral to above-knee or below-knee popliteal bypass were randomized to receive a standard expanded polytetrafluoroethylene (ePTFE) graft or the heparin-coated FUSION BIOLINE vascular graft. Among 203 patients in the efficacy analysis, claudication was the presenting symptom in 147 (72.4%), and the site of the distal anastomosis was at the above-knee level in 174 (85.7%). Grafts were assessed by duplex ultrasound imaging and ankle-brachial indices performed postoperatively at discharge and at 30 days, 6 months, and 12 months. The primary efficacy end point was primary patency of the study graft. The primary safety end point was the composite of major adverse events and periprocedural death. Secondary end points included the time to hemostasis of bleeding at the anastomotic suture hole and primary assisted and secondary patency.The primary patency rates at 6 months were 86.4% for the FUSION BIOLINE heparin-coated vascular graft group compared with 70.0% for the standard ePTFE group, a difference of 16.4% (95% confidence interval, 2.7%-29.9%; P = .006), and the respective rates at 12 months were 76.5% and 67.0% (95% confidence interval, -4.8% to 23.0%; P = .05). The mean time to hemostasis of bleeding at the suture hole was 3.5 minutes in the FUSION BIOLINE group and 11.0 minutes in the standard ePTFE group (P.0001). Major adverse events were significantly lower in the FUSION BIOLINE group, occurring in 17.1%, compared with 30.7% in the standard ePTFE group (P = .033), principally a result of a lower rate of major graft reinterventions through 12 months in the FUSION BIOLINE group (16.2% vs 30.7%).Data from this randomized multicenter study demonstrated improved midterm patency, less bleeding at the suture hole, and lower major adverse events with the FUSION BIOLINE heparin-coated vascular graft compared with standard ePTFE grafts. Although the ultimate long-term benefit of the graft cannot be ascertained with the data currently available, the utility of the FUSION BIOLINE vascular graft appears promising.

Background: Each of the embolic protection devices used in carotid artery stenting (CAS) has advantages and disadvantages. The prospective, multicenter, single-arm EMPiRE Clinical Study investigated a proximally placed device (GORE Flow Reversal System) that provides distal neuroprotection during CAS by reversing blood flow in the internal carotid artery, thereby directing emboli away from the brain. Methods: The study evaluated 30-day outcomes in 245 pivotal high-surgical-risk patients (mean age, 70 years; 32% symptomatic; 16% ≥80-years old) with carotid stenosis who underwent CAS using the flow reversal system. The primary endpoint was a major adverse event (MAE; stroke, death, myocardial infarction, or transient ischemic attack) within 30 days of CAS. The MAE rate was compared with an objective performance criterion (OPC) derived from CAS studies that included embolic protection. Results: The MAE rate was 4.5% (11 patients; P = 0.002 compared with the OPC). The stroke and death rate was 2.9%. No patient had a major ischemic stroke. Six patients (2.4%) had intolerance to flow reversal. The death and stroke rates in the symptomatic, asymptomatic, and octogenarian subgroups were 2.6, 3, and 2.6%, respectively, meeting American Heart Association guidelines for carotid endarterectomy. Conclusion: The stroke and death rate in this study was among the lowest in CAS trials. The results indicate that the flow reversal system is safe and effective when used for neuroprotection during CAS and that it provides benefits in a broad patient population. © 2010 Wiley-Liss, Inc.

Objective There is abundant evidence linking hostile proximal aortic neck anatomy to poor outcome after endovascular aortic aneurysm repair (EVAR), yet the definition of hostile anatomy varies from study to study. This current analysis was undertaken to identify anatomic criteria that are most predictive of success or failure at the aortic neck after EVAR. Methods The study group comprised 221 patients in the Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry (ANCHOR) clinical trial, a population enriched with patients with challenging aortic neck anatomy and failure of sealing. Imaging protocols were not protocol specified but were performed according to the institution's standard of care. Core laboratory analysis assessed the three-dimensional centerline-reformatted computed tomography scans. Failure at the aortic neck was defined by type Ia endoleak occurring at the time of the initial endograft implantation or during follow-up. Receiver operating characteristic curve analysis was used to assess the value of each anatomic measure in the classification of aortic neck success and failure and to identify optimal thresholds of discrimination. Binary logistic regression was performed after excluding highly intercorrelated variables, creating a final model with significant predictors of outcome after EVAR. Results Among the 221 patients, 121 (54.8%) remained free of type Ia endoleak and 100 (45.2%) did not. Type Ia endoleaks presented immediately after endograft deployment in 58 (58.0%) or during follow-up in 42 (42.0%). Receiver operating characteristic curve analysis identified 12 variables where the classification of patients with type Ia endoleak was significantly more accurate than chance alone. Increased aortic neck diameter at the lowest renal artery (P = .013) and at 5 mm (P = .008), 10 mm (P = .008), and 15 mm (P = .010) distally; aneurysm sac diameter (P = .001), common iliac artery diameters (right, P = .012; left, P = .032), and a conical (P = .049) neck configuration were predictive of endoleak. By contrast, increased aortic neck length (P = .050), a funnel-shaped aortic neck (P = .036), and neck mural thrombus content, as measured by average thickness (P = .044) or degrees of circumferential coverage (P = .029), were protective against endoleak. Binary logistic regression identified three variables independently predictive of type Ia endoleak. Neck diameter at the lowest renal artery (P = .002, cutpoint 26 mm) and neck length (P = .017, cutpoint 17 mm) were associated with endoleak, whereas some mural neck thrombus content was protective (P = .001, cutpoint 11° of circumferential coverage). Conclusions A limited number of independent anatomic variables are predictive of type Ia endoleak after EVAR, including aortic neck diameter and aortic neck length, whereas mural thrombus in the neck is protective. This study suggests that anatomic measures with identifiable threshold cutpoints should be considered when defining the hostile aortic neck and assessing the risk of complications after EVAR.

ObjectiveProximal attachment site complications continue to occur after endovascular repair of abdominal aortic aneurysms (EVAR), specifically type Ia endoleak and endograft migration. EndoAnchors (Aptus Endosystems, Sunnyvale, Calif) were designed to enhance endograft proximal fixation and sealing, and the current study was undertaken to evaluate the potential benefit of this treatment.MethodsDuring the 23-month period ending in December 2013, 319 subjects were enrolled at 43 sites in the United States and Europe. EndoAnchors were implanted in 242 patients (75.9%) at the time of an initial EVAR procedure (primary arm) and in 77 patients with an existing endograft and proximal aortic neck complications (revision arm). Technical success was defined as deployment of the desired number of EndoAnchors, adequate penetration of the vessel wall, and absence of EndoAnchor fracture. Procedural success was defined as technical success without a type Ia endoleak at completion angiography. Values are expressed as mean ± standard deviation and interquartile range.ResultsThe 238 male (74.6%) and 81 female (25.4%) subjects had a mean age of 74.1 ± 8.2 years. Aneurysms averaged 58 ± 13 (51-63) mm in diameter at the time of EndoAnchor implantation (core laboratory measurements). The proximal aortic neck averaged 16 ± 13 (7-23) mm in length (42.7%

Objective The proximal aortic neck remains one of the challenges of endovascular aneurysm repair (EVAR), and the risk of type Ia endoleak and endograft migration is increased in patients with short, large-diameter, or highly angulated necks. EndoAnchors have been used as an adjunct to EVAR in such patients, and the aim of this study was to assess their benefit analyzed by indication for use. Methods During a 2-year period, 319 patients were enrolled at 43 sites in the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) study. This prospective, multinational, real-world analysis of EndoAnchors comprised two groups of patients, those undergoing first-time EVAR (primary arm, 242) and those with proximal neck complications remote from the time of an initial endograft implantation (revision arm, 77). The primary arm was further subdivided into patients undergoing prophylactic EndoAnchor use for hostile proximal neck anatomy (178), with a type Ia endoleak evident during initial endograft deployment (60), and in conjunction with extender cuffs after unsatisfactory endograft deployment distally in the neck (four). The revision arm was subdivided into patients presenting with a type Ia endoleak alone (45), endograft migration alone (11), and migration with endoleak (21). Technical success was site reported as satisfactory deployment of the desired number of EndoAnchors without fracture or loss of integrity. Procedural success was defined as technical success without type Ia endoleak at completion arteriography. Core laboratory analysis was performed on 249 baseline and 192 follow-up computed tomographic studies, 66 of which were available within the 1-year window. Results Technical and procedural success rates were highest in the prophylactically treated subset (172 of 178; 96.6%). Whereas the technical success of EndoAnchor deployment was also high in the other subsets, residual type Ia endoleaks were more frequent at completion angiography when the indication for EndoAnchor use was type Ia endoleak, both in the primary arm (17 of 60; 28%) and in the revision arm (9 of 45; 20%). During a median imaging follow-up of 7 months, 183 of 202 patients (90.1%) remained free of type Ia endoleaks. Primary prophylactic patients were free from type Ia endoleak in 110 of 114 cases (96.5%). The most challenging subset was revision patients treated for type Ia endoleak; type Ia endoleaks were evident during follow-up in 10 of 29 of the cases (34%). Sac regression >5 mm in patients with 1-year imaging was observed in 26 of 66 patients (39%) and was highest in the primary prophylaxis subset (20 of 43; 47%). Conclusions EndoAnchor implantation can be a useful adjunct to EVAR as prophylaxis against proximal attachment site complications in patients with hostile aortic neck anatomy, as treatment for early and late type Ia endoleaks, or, in conjunction with aortic extension cuffs, for endograft migration. Whereas the most challenging patients are those who present with type Ia endoleaks remote from initial EVAR, EndoAnchors are still effective in treating the majority of these cases.