Evaluating the Effectiveness of Systemic Heparin During Arteriovenous Fistula Creation by Emulating a Target Trial.

Most of the 800,000 people living with end-stage kidney disease in the United States rely on a functioning vascular access to provide life-sustaining hemodialysis, yet one-third of arteriovenous fistulas experience early failures. Determining the safety and effectiveness of systemic heparin during fistula creation could improve the quality and quantity of life for these vulnerable patients. In this paper, a pragmatic randomized trial was emulated to assess the effect of systemic heparin administration (vs. none) during radiocephalic arteriovenous fistula creation on early bleeding and thrombosis using data from two international multicenter randomized trials performed between 2014 and 2019. Marginal risks were estimated using inverse probability weighted parametric survival analysis and confidence intervals were generated with bootstrapping. A total of 914 patients were enrolled and 61% received systemic heparin; median (IQR) age was 58 (49, 67) years and 45% were on hemodialysis at enrollment. No difference in the risk of bleeding events was observed, with a risk difference (95% CI) at 14 days of -0.1% (-1.6, 1.4). The risk of access thrombosis was lower in the heparin group, with a risk of 3.7% (2.6, 4.8) after heparin and 5.3% (3.4, 7.4) without heparin at 14 days (risk ratio 0.72, 95% CI 0.50, 0.98).

Real-World Vein Mapping Practice Patterns Before Endovascular Treatment of Limb Ischemia.

INTRODUCTION: The Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial results suggest that in patients with chronic limb-threatening ischemia (CLTI) and adequate single-segment great saphenous vein (SSGSV) by preoperative duplex ultrasonography, a surgical-first treatment strategy is superior to an endovascular-first strategy. However, the utilization of vein mapping prior to endovascular-first revascularization for CLTI in actual clinical practice is not known. METHODS: Data from a multicenter clinical data warehouse (2008-2019) were linked to Medicare claims data for patients undergoing endovascular-first treatment of infra-inguinal CLTI. Only patients who would have otherwise been eligible for enrollment in BEST-CLI were included. Adequate SSGSV was defined as healthy vein >3.0 mm in diameter from the groin through the knee. Logistic regression was used to estimate associations between preprocedure characteristics and vein mapping. Survival methods were used to estimate the risk of major adverse limb events and death. RESULTS: A total of 142 candidates for either surgical or endovascular treatment underwent endovascular-first management of CLTI. Ultrasound assessment for SSGSV was not performed in 76% of patients prior to endovascular-first revascularization. Of those who underwent preprocedure vein mapping, 44% had adequate SSGSV for bypass. Within one year postprocedure, 12.0% (95% confidence interval 7.4-18.0%) of patients underwent open surgical bypass and 54.7% (95% confidence interval 45.3-62.4%) experienced a major adverse limb event or death. CONCLUSIONS: In a real-world cohort of BEST-CLI-eligible patients undergoing endovascular-first intervention for infra-inguinal CLTI, three-quarters of patients had no preprocedure ultrasound assessment of great saphenous vein conduit. Practice patterns for vein conduit assessment in the real-world warrant reconsideration in the context of BEST-CLI trial results.

Descriptive Analysis of Amputation-Free Survival After First Time Infra-Inguinal Bypass Occlusion.

INTRODUCTION: Occlusion after infra-inguinal bypass surgery for peripheral artery disease is a major complication with potentially devastating consequences. In this descriptive analysis, we sought to describe the natural history and explore factors associated with long-term major amputation-free survival following occlusion of a first-time infra-inguinal bypass. METHODS: Using a prospective database from a tertiary care vascular center, we conducted a retrospective cohort study of all patients with peripheral artery disease who underwent a first-time infra-inguinal bypass and subsequently suffered a graft occlusion (1997-2021). The primary outcome was longitudinal rate of major amputation-free survival after bypass occlusion. Cox proportional hazard models were used to generate hazard ratios (HRs) and 95% confidence intervals (CIs) to explore predictors of outcomes. RESULTS: Of the 1318 first-time infra-inguinal bypass surgeries performed over the study period, 255 bypasses occluded and were included in our analysis. Mean age was 66.7 (12.6) years, 40.4% were female, and indication for index bypass was chronic limb threatening ischemia (CLTI) in 89.8% (n = 229). 48.2% (n = 123) of index bypass conduits used great saphenous vein, 29.0% (n = 74) prosthetic graft, and 22.8% (n = 58) an alternative conduit. Median (interquartile range) time to bypass occlusion was 6.8 (2.3-19.0) months, and patients were followed for median of 4.3 (1.7-8.1) years after bypass occlusion. Following occlusion, 38.04% underwent no revascularization, 32.94% graft salvage procedure, 25.1% new bypass, and 3.92% native artery recanalization. Major amputation-free survival following occlusion was 56.9% (50.6%-62.8%) at 1 y, 37.1% (31%-43.3%) at 5 y, and 17.2% (11.9%-23.2%) at 10 y. In multivariable analysis, factors associated with lower amputation-free survival were older age, female sex, advanced cardiorenal comorbidities, CLTI at index procedure, CLTI at time of occlusion, and distal index bypass outflow. Initial treatment after occlusion with both a new surgical bypass (HR 0.44, CI: 0.29-0.67) or a graft salvage procedure (HR 0.56, CI: 0.38-0.82) showed improved amputation-free survival. One-year rate of major amputation or death were 59.8% (50.0%-69.6%) for those who underwent no revascularization, 37.9% (28.7%-49.0%) for graft salvage, and 26.7% (17.6%-39.5%) for new bypass. CONCLUSIONS: Long-term major amputation-free survival is low after occlusion of a first-time infra-inguinal bypass. While several nonmodifiable risk factors were associated with lower amputation-free survival, treatment after graft occlusion with either a new bypass or a graft salvage procedure may improve longitudinal outcomes.

First-in-human Clinical Trial of a Novel Eyelid warming Device in Meibomian Gland Dysfunction.

BACKGROUND: Meibomian gland dysfunction (MGD) causes significant patient morbidity as well as economic burden. OBJECTIVES: To evaluate a novel eyelid warming and a neuro-stimulating device that delivers heat via low-level infrared radiation to the eyelids of patients with MGD. METHODS: In this prospective interventional study, patients with MGD were recruited at a single medical center. The main outcome measures included changes in tear break-up time (TBUT), Schirmer's test, and Ocular Surface Disease Index (OSDI), overall satisfaction, and corneal signs of dry eye. Patients were instructed to use the device twice daily for 5 minutes on each eye for a total of 14 days. Follow-up assessments were performed after the 2-week treatment. RESULTS: A total of 10 patients were included; mean age was 67 ± 16 years; six males (60%). Changes in pre- vs. post-treatment TBUT (5.0-6.11), OSDI (28.1-23.9), and Schirmer score (8.67-7.11) were not statistically significant. Over a course of 243 treatments, 131 (54%) demonstrated improvement in symptoms, 40% found no change, and 6% experienced worsening of symptoms. General satisfaction was observed overall in 80% of the patients. No adverse events were observed. CONCLUSIONS: In this first study of a novel eyelid warming device, overall subjective satisfaction was reported in 80% of patients. Potential advantages of this user-friendly device include its ability to improve MGD and tear film stability, as well as symptomatic relief, while allowing the user to continue with normal daily functioning while undergoing treatment.

An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial.

PURPOSE: Comparing visual outcomes after use of a novel binocular eye-tracking-based home treatment (CureSight; NovaSight, Ltd) with patching. DESIGN: Prospective, multicenter, randomized, masked, controlled, noninferiority pivotal trial. PARTICIPANTS: One hundred three children 4 to < 9 years with anisometropic, small-angle strabismic or mixed-mechanism amblyopia were randomized 1:1 to either CureSight treatment or patching. METHODS: The CureSight treatment uses combined anaglyph glasses and an eye tracker to induce real-time blur around the fellow eye fovea in dichoptic streamed video content. Participants used the device for 90 minutes/day, 5 days/week for 16 weeks (120 hours). The patching group received 2 hours of patching 7 days/week (224 hours). The prespecified noninferiority margin was 1 line. MAIN OUTCOME MEASURES: The primary outcome was the improvement in the amblyopic eye visual acuity (VA), modeled with a repeated measures analysis of covariance. Secondary outcomes included stereoacuity, binocular VA, and treatment adherence rates, analyzed by a 1-sample Wilcoxon test within each group and a 2-sample Wilcoxon test comparing groups. Safety outcomes included the frequency and severity of study-related adverse events (AEs). RESULTS: CureSight group VA improvement was found to be noninferior to patching group improvement (0.28 ± 0.13 logarithm of the minimum angle of resolution [logMAR] [P < 0.0001] and 0.23 ± 0.14 logMAR [P < 0.0001], respectively; 90% confidence interval [CI] of difference, -0.008 to 0.076). Stereoacuity improvement of 0.40 log arcseconds (P < 0.0001) and improved binocular VA (0.13 logMAR; P < 0.0001) were observed in the binocular treatment group, with similar improvements in the patching group in stereoacuity (0.40 log arcseconds; P < 0.0001) and binocular VA (0.09 logMAR; P < 0.0001), with no significant difference between improvements in the 2 groups in either stereoacuity (difference, 0; 95% CI, -0.27 to -0.27; P = 0.76) or binocular VA (difference, 0.041; 95% CI, -0.002 to 0.085; P = 0.07). The binocular treatment group had a significantly higher adherence than the patching group (91% vs. 83%; 95% CI, -4.0% to 21%; P = 0.011). No serious AEs were found. CONCLUSIONS: Binocular treatment was well tolerated and noninferior to patching in amblyopic children 4 to < 9 years of age. High adherence may provide an alternative treatment option for amblyopia. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Evaluating national guideline concordance of recurrent interventions after radiocephalic arteriovenous fistula creation.

OBJECTIVE: Radiocephalic arteriovenous fistulas have been historically perceived as requiring multiple follow-up procedural interventions to achieve maturation and maintain patency. Recent clinical practice guidelines from the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) emphasize a patient-centered hemodialysis access strategy with new maximum targets for intervention rates, potentially conflicting with concomitant recommendations to prioritize autogenous forearm hemodialysis access creation. The present descriptive study seeks to assess whether radiocephalic fistulas can meet the KDOQI guideline benchmarks for interventions following access creation, and to elucidate clinical and anatomic characteristics associated with the timing and frequency of interventions following radiocephalic arteriovenous fistula creation. METHODS: Prospective patient-level data from the multicenter PATENCY-1 and PATENCY-2 randomized trials, which enrolled patients undergoing new radiocephalic arteriovenous fistula creation, was analyzed (ClinicalTrials.govNCT02110901 and NCT02414841). The primary outcome was the rate of interventions at 1 year postoperatively. Incidence rates were calculated, and time to surgical or endovascular intervention following fistula creation was modeled using recurrent event extensions of the Cox proportional hazards model. Confidence intervals at the 95% level were calculated using nonparametric bootstrapping. RESULTS: The cohort consisted of 914 patients; mean age was 57 years (standard deviation, 13 years), and 22% were female. Median follow-up was 707 days (interquartile range, 447-1066 days). The incidence of interventions per person-year was 1.04 (95% confidence interval [CI], 0.95-1.13) overall; 1.10 (95% CI, 0.98-1.21) before fistula use, and 0.96 (95% CI, 0.82-1.11) after fistula use. The most common interventions overall were balloon angioplasty (54.9% of all interventions), venous side-branch ligation (16.4%), and open revisions (eg, proximalization from snuffbox to wrist, 16.4%). The locations requiring balloon angioplasty included the juxta-anastomotic segment (51.7% of angioplasties), the outflow vein (29.2%), the inflow artery (14.8%), the central veins (3.8%), and the cephalic arch (0.5%). Common indications were to restore or maintain patency (75.6% of all interventions), assist maturation (14.9%), improve depth (4.4%), or improve augmentation (3.0%). In the multivariable regression analysis, female sex (adjusted hazard ratio [HR], 1.21; 95% CI, 1.05-1.45), diabetes (HR, 1.21; 95% CI, 1.01-1.46), and intraoperative vein diameter <3.0 mm (vs ≥4.0 mm: HR, 1.33; 95% CI, 1.02-1.66) were associated with earlier and more frequent interventions. Patients not on hemodialysis at the time of fistula creation underwent less frequent interventions (HR, 0.69; 95% CI, 0.59-0.81). CONCLUSIONS: Patients with radiocephalic arteriovenous fistulas can expect to undergo one intervention, on average, in the first year after creation, which aligns with current KDOQI guidelines. Patients already requiring hemodialysis, female patients, patients with diabetes, and patients with intraoperative vein diameters <3.0 mm were at increased risk for repeated intervention. No subgroup exceeded guideline-suggested maximum thresholds for recurrent interventions. Overall, the results demonstrate that creation of radiocephalic arteriovenous fistula remains a guideline-concordant strategy when part of an end-stage kidney disease life-plan in appropriately selected patients.

Staged autogenous to prosthetic hemodialysis access creation strategy to maximize forearm options.

OBJECTIVE: When an adequate cephalic vein is not available for fistula construction, surgeons often turn to basilic vein or prosthetic constructions. Single-stage forearm prosthetic hemodialysis accesses are associated with poor durability, and upper arm non-autogenous access options are often limited by axillary outflow failure, which inevitably drives transition to the contralateral arm or lower extremity. We hypothesized that initial creation of a modest flow proximal forearm arterial-venous anastomosis to dilate ("develop") inflow and outflow vessels, followed by a planned second-stage procedure to create a cannulation zone with a prosthetic graft in the forearm, would result in reliable and durable hemodialysis access in patients with limited options. METHODS: We performed an institutional cohort study from 2017 to 2021 using a prospectively maintained database supplemented with adjudicated chart review. Patients without traditional autogenous hemodialysis access options in the forearm underwent an initial non-wrist arterial-venous anastomosis creation in the forearm as a first stage, followed by a second-stage interposition graft sewn to the existing inflow and venous outflow segments to create a useable cannulation zone in the forearm while leveraging vascular development. Outcomes included time from second-stage access creation to loss of primary and secondary patency, frequency of subsequent interventions, and perioperative complications. RESULTS: The cohort included 23 patients; first-stage radial artery-based (74%) configurations were more common than brachial artery-based (26%). Mean age was 63 years (standard deviation, 14 years), and 65% were female. Median follow-up was 340 days (interquartile range [IQR], 169-701 days). Median time to cannulation from second-stage procedure was 28 days (IQR, 18-53 days). Primary, primary assisted, and secondary patency at 1 year was 16.7% (95% confidence interval [CI], 5.3%-45.8%), 34.6% (95% CI, 15.2%-66.2%), and 95.7% (95% CI, 81.3%-99.7%), respectively. Subsequent interventions occurred at a rate of 3.02 (IQR, 1.0-4.97) per person-year, with endovascular thrombectomy with or without angioplasty/stenting (70.9%) being the most common. There were no cases of steal syndrome. Infection occurred in two cases and were managed with antibiotics alone. CONCLUSIONS: For patients without adequate distal autogenous access options, staged prosthetic graft placement in the forearm offers few short-term complications and excellent durability with active surveillance while strategically preserving the upper arm for future constructions.

Comparative analysis of open abdominal aortic aneurysm repair outcomes across national registries.

OBJECTIVE: In a recent analysis, we discovered lower mortality after open abdominal aortic aneurysm repair (OAAA) in the Society for Vascular Surgery Vascular Quality Initiative (VQI) database when compared with previously published reports of other national registries. Understanding differentials in these registries is essential for their utility because such datasets increasingly inform clinical guidelines and health policy. METHODS: The VQI, American College of Surgeons National Surgical Quality Improvement Program (NSQIP), and National Inpatient Sample (NIS) databases were queried to identify patients who had undergone elective OAAA between 2013 and 2016. χ2 tests were used for frequencies and analysis of variance for continuous variables. RESULTS: In total, data from 8775 patients were analyzed. Significant differences were seen across the baseline characteristics included. Additionally, the availability of patient and procedural data varied across datasets, with VQI including a number of procedure-specific variables and NIS with the most limited clinical data. Length of stay, primary insurer, and discharge destination differed significantly. Unadjusted in-hospital mortality also varied significantly between datasets: NIS, 5.5%; NSQIP, 5.2%; and VQI, 3.3%; P < .001. Similarly, 30-day mortality was found to be 3.5% in VQI and 5.9% in NSQIP (P < .001). CONCLUSIONS: There are fundamental important differences in patient demographic/comorbidity profiles, payer mix, and outcomes after OAAA across widely used national registries. This may represent differences in outcomes between institutions that elect to participate in the VQI and NSQIP compared with patient sampling in the NIS. In addition to avoiding direct comparison of information derived from these databases, it is critical these differences are considered when making policy decisions and guidelines based on these "real-world" data repositories.

Contemporary indications for open abdominal aortic aneurysm repair in the endovascular era.

OBJECTIVE: Despite the emergence of endovascular aneurysm repair (EVAR) as the most common approach to abdominal aortic aneurysm repair, open aneurysm repair (OAR) remains an important option. This study seeks to define the indications for OAR in the EVAR era and how these indicatioxns effect outcomes. METHODS: A retrospective cohort study was performed of all OAR at a single institution from 2004 to 2019. Preoperative computed tomography scans and operative records were assessed to determine the indication for OAR. These reasons were categorized into anatomical contraindications, systemic factors (connective tissue disorders, contraindication to contrast dye), and patient or surgeon preference (patients who were candidates for both EVAR and OAR). Perioperative and long-term outcomes were compared between the groups. RESULTS: We included 370 patients in the analysis; 71.6% (265/370) had at least one anatomic contraindication to EVAR and 36% had two or more contraindications. The most common anatomic contraindications were short aortic neck length (51.6%), inadequate distal seal zone (19.2%), and inadequate access vessels (15.7%). The major perioperative complication rate was 18.1% and the 30-day mortality was 3.0%. No single anatomic factor was identified as a predictor of perioperative complications. Sixty-one patients (16.5%) underwent OAR based on patient or surgeon preference; these patients were younger, had lower incidences of coronary artery disease and chronic obstructive pulmonary disease, and were less likely to require suprarenal cross-clamping compared with patients who had anatomic and/or systemic contraindications to EVAR. The patient or surgeon preference group had a lower incidence of perioperative major complications (8.2% vs 20.1%; P = .034), shorter length of stay (6 days vs 8 days; P < .001) and no 30-day mortalities. The multivariable adjusted risk for 15-year mortality was lower for patient or surgeon preference patients (adjusted hazard ratio, 0.44; 95% confidence interval, 0.24-0.80; P = .007) compared with those anatomic or systemic contraindications. CONCLUSIONS: Within a population of patients who did not meet instruction for use criteria for EVAR, no single anatomic contraindication was a marker for worse outcomes with OAR. Patients who were candidates for both aortic repair approaches but elected to undergo OAR owing to patient or surgeon preference have very low 30-day mortality and morbidity, and superior long-term survival rates compared with those patients who underwent OAR owing to anatomic and/or systemic contraindications to EVAR.

In-situ bypass is associated with superior infection-free survival compared with extra-anatomic bypass for the management of secondary aortic graft infections without enteric involvement.

OBJECTIVE: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI. METHODS: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed. RESULTS: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02). CONCLUSIONS: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective.

Contemporary outcomes of a "snuffbox first" hemodialysis access approach in the United States.

OBJECTIVE: The Society for Vascular Surgery guidelines for permanent hemodialysis (HD) access creation recommend prioritizing the most distal possible autogenous access to minimize complications and preserve more proximal options. The "snuffbox" arteriovenous fistula (AVF) is the most distal radial artery-cephalic vein AVF. Despite the theoretical benefits of the snuffbox approach, recent trends have been toward upper arm access. Our study sought to investigate the feasibility of a snuffbox-first strategy for HD access in all anatomically appropriate candidates. METHODS: From January 2016 to August 2019, all patients with end-stage renal disease (ESRD) or pre-ESRD under consideration for HD access were evaluated for a snuffbox-first approach by a team of vascular surgeons and nephrologists at a single, urban academic medical center in the United States. Data were collected prospectively and supplemented by medical record review. A survival analysis was performed to evaluate primary unassisted and secondary patency and clinical and functional maturation. Patients were censored if they had received a kidney transplant or had died. Cox proportional hazards regression was used to determine the risk factors for prolonged clinical maturation and functional maturation. RESULTS: A total of 55 snuffbox AVFs were created. The median patient age was 60 years (interquartile range [IQR], 52-70 years), and 52.7% of the patients were men. The median follow-up was 369 days (IQR, 166-509 days). The median survival for primary unassisted patency was 90 days (95% confidence interval [CI], 79-111). Secondary patency at 1 year was 92.3% (95% CI, 85.3%-99.9%). The clinical maturation rate at 1 year was 83.7% (n = 55; 95% CI, 66.8%-91.9%), and the functional maturation rate at 1 year was 85.6% (n = 40; 95% CI, 63.3%-94.4%). Of the patients who were pre-ESRD at AVF creation and had initiated HD during the study period, 87.5% had successfully received incident HD with their snuffbox AVF. Twenty-four patients were receiving HD via a catheter at snuffbox creation. Of those patients, the functional maturation rate at 1 year was 82.5% (95% CI, 44.8%-94.4%). The patients had undergone a median of two interventions (IQR, zero to seven interventions) in the first year. Of these, 46.9% were percutaneous angioplasty and 31.2% were side-branch ligation. Diabetes was associated with slower AVF clinical maturation (multivariate hazard ratio, 0.35; 95% CI, 0.15-0.82; P = .016). A larger artery diameter was associated with earlier AVF clinical maturation (multivariate hazard ratio, 6.64; 95% CI, 2.11-20.9). CONCLUSIONS: A snuffbox-first approach to HD access is a viable option for distal access creation in a cohort of patients requiring HD in the United States. Subsequent ancillary interventions to facilitate access maturation were required for most patients.

Patient comprehension necessary for informed consent for vascular procedures is poor and related to frailty.

OBJECTIVE: Informed consent is an essential principle of high-quality health care. A core component of surgical informed consent is patient comprehension of basic information such as the diagnosis, risks, benefits, and alternatives of the proposed surgery. We sought to assess informed consent among vascular surgery patients and the association between frailty, education, decisional conflict, and patient comprehension. METHODS: We tested patient comprehension of basic information required for informed consent with a procedure-specific questionnaire in 102 consecutive patients undergoing selected vascular surgery procedures. Two patients who underwent open aortic aneurysm repair were excluded because of small sample size. All patients underwent assessment using the decisional conflict scale and the Frail/Nondisabled questionnaire. Analyses were performed to determine relationships between being informed and frailty, education level, and decisional conflict score. Patients included in this cohort had a median age of 71 years, and 25%, 14%, 28%, and 33% underwent carotid endarterectomy, endovascular aortic aneurysm repair, dialysis access creation, and percutaneous lower extremity procedures. RESULTS: Overall, 14% of patients were classified as "informed" and correctly answered all questions. Procedure type (P = .001), consent obtained by the attending surgeon vs a trainee (P = .04), and frailty score (P = .005) were all associated with whether a patient was informed or not. However, after multivariable adjustment, only frailty score was independently associated with being informed (odds ratio, 0.54; 95% confidence interval, 0.30-0.95; P = .03). The median decisional conflict scale score was 7.8, suggesting that patients feel well informed and supported in spite of poor understanding of procedural indications, risks, benefits, and alternatives. CONCLUSIONS: As a group, patients have a poor comprehension of basic information related to surgical informed consent. These findings have potential ethical and clinical implications, and additional work is required to best determine causes of poor comprehension and strategies to mitigate the same.

Association and interplay of surgeon and hospital volume with mortality after open abdominal aortic aneurysm repair in the modern era.

OBJECTIVE: Operative volume has been used as a marker of quality. Research from previous decades has suggested minimum open abdominal aortic aneurysm (AAA) repair volume requirements for surgeons of 9 to 13 open AAA repairs annually and for hospitals of 18 open AAA repairs annually to purportedly achieve acceptable results. Given concerns regarding the decreased frequency of open repairs in the endovascular era, we examined the association of surgeon and hospital volume with the 30- and 90-day mortality in the Vascular Quality Initiative (VQI) registry. METHODS: Patients who had undergone elective open AAA repair from 2013 to 2018 were identified in the VQI registry. We performed a cross-sectional evaluation of the association between the average hospital and surgeon volume and 30-day postoperative mortality using a hierarchical Bayesian model. Cross-level interactions were permitted, and random surgeon- and hospital-level intercepts were used to account for clustering. The mortality results were adjusted by standardizing to the observed distribution of relevant covariates in the overall cohort. The outcomes were compared to the Society for Vascular Surgery guidelines recommended criteria of <5% perioperative mortality. RESULTS: A total of 3078 patients had undergone elective open AAA repair by 520 surgeons at 128 hospitals. The 30- and 90-day risks of postoperative mortality were 4.1% (n = 126) and 5.4% (n = 166), respectively. The mean surgeon volume and hospital volume both correlated inversely with the 30-day mortality. Averaged across all patients and hospitals, we found a 96% probability that surgeons who performed an average of four or more repairs per year achieved <5% 30-day mortality. Substantial interplay was present between surgeon volume and hospital volume. For example, at lower volume hospitals performing an average of five repairs annually, <5% 30-day mortality would be expected 69% of the time for surgeons performing an average of three operations annually. In contrast, at higher volume hospitals performing an average of 40 repairs annually, a <5% 30-day mortality would be expected 96% of the time for surgeons performing an average of three operations annually. As hospital volume increased, a diminishing difference occurred in 30-day mortality between lower and higher volume surgeons. Likewise, as surgeon volume increased, a diminishing difference was found in 30-day mortality between the lower and higher volume hospitals. CONCLUSIONS: Surgeons and hospitals in the VQI registry achieved mortality outcomes of <5% (Society for Vascular Surgery guidelines), with an average surgeon volume that was substantially lower compared with previous reports. Furthermore, when considering the development of minimal surgeon volume guidelines, it is important to contextualize the outcomes within the hospital volumes.

In situ bypass and extra-anatomic bypass procedures result in similar survival in patients with secondary aortoenteric fistulas.

OBJECTIVE: The optimal revascularization modality in secondary aortoenteric fistula (SAEF) remains unclear in the literature. The purpose of this investigation was to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients with SAEF. METHODS: A retrospective, multi-institutional study of SAEF from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and operative and postoperative variables were recorded. The primary outcome was long-term mortality. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariate analyses were performed. RESULTS: During the study period, 182 patients at 34 institutions from 11 countries presented with SAEF (median age, 72 years; 79% male). The initial aortic procedures that resulted in SAEF were 138 surgical grafts (76%) and 42 endografts (23%), with 2 unknown; 102 of the SAEFs (56%) underwent complete excision of infected aortic graft material, followed by in situ (in-line) bypass (ISB), including antibiotic-soaked prosthetic graft (53), autogenous femoral vein (neoaortoiliac surgery; 17), cryopreserved allograft (28), and untreated prosthetic grafts (4). There were 80 patients (44%) who underwent extra-anatomic bypass (EAB) with infected graft excision. Overall median Kaplan-Meier estimated survival was 319 days (interquartile range, 20-2410 days). Stratified by EAB vs ISB, there was no significant difference in Kaplan-Meier estimated survival (P = .82). In comparing EAB vs ISB, EAB patients were older (74 vs 70 years; P = .01), had less operative hemorrhage (1200 mL vs 2000 mL; P = .04), were more likely to initiate dialysis within 30 days postoperatively (15% vs 5%; P = .02), and were less likely to experience aorta-related hemorrhage within 30 days postoperatively (3% aortic stump dehiscence vs 11% anastomotic rupture; P = .03). There were otherwise no significant differences in presentation, comorbidities, and intraoperative or postoperative variables. Multivariable Cox regression showed that the duration of antibiotic use (hazard ratio, 0.92; 95% confidence interval, 0.86-0.98; P = .01) and rifampin use at time of discharge (hazard ratio, 0.20; 95% confidence interval, 0.05-0.86; P = .03) independently decreased mortality. CONCLUSIONS: These data suggest that ISB does not offer a survival advantage compared with EAB and does not decrease the risk of postoperative aorta-related hemorrhage. After repair, <50% of SAEF patients survive 10 months. Each week of antibiotic use decreases mortality by 8%. Further study with risk modeling is imperative for this population.

Aberrant subclavian artery division and revascularization by a supraclavicular approach for definitive or staged treatment of dysphagia lusoria.

OBJECTIVE: There is no consensus on the optimal approach to treatment of dysphagia lusoria (DL), especially in the absence of a Kommerell diverticulum (KD). We leveraged our institutional experience to clarify the safety and efficacy of aberrant subclavian artery (aSA) division with revascularization by a supraclavicular approach alone in patients with DL. METHODS: We identified 10 consecutive patients who underwent surgery for DL at our institution between January 2007 and March 2019. Clinical and radiographic characteristics for all patients were collected. The primary outcome was improvement in dysphagia symptoms. Secondary outcomes included need for second-stage operation, postoperative complications, and long-term radiologic changes in the aSA remnant. RESULTS: Seven patients underwent initial division of the aSA followed by revascularization through a supraclavicular exposure, and three had simultaneous supraclavicular and transthoracic intervention. Median follow-up was 52 (range, 1-143) months. In the four patients without a KD, a supraclavicular approach alone resulted in improvement in dysphagia symptoms. Conversely, the three patients who had a KD did not have durable relief of dysphagia and required a second-stage transthoracic procedure. Postoperatively, one developed a pulmonary embolism after supraclavicular approach alone and two patients developed complications after transthoracic intervention: left recurrent laryngeal nerve neurapraxia and pleural effusion requiring thoracentesis in one, and thoracic duct injury requiring reoperation in the second. Among those who underwent a single-stage procedure by a supraclavicular approach alone, no patients had aneurysm progression, rupture, or dissection after median follow-up of 60 (range, 1-100) months. CONCLUSIONS: Division and revascularization of the aSA through a supraclavicular exposure in patients with DL result in durable symptomatic improvement in the majority of patients, particularly those without a concomitant KD. Patients with a KD may require a second-stage procedure to address the KD, but it appears safe to trial staged intervention rather than simultaneous operations to divide the aSA and to address the KD.

Dementia is associated with increased mortality and poor patient-centered outcomes after vascular surgery.

OBJECTIVE: Dementia has been associated with increased complications and mortality in orthopedics and other surgical specialties, but has received limited attention in vascular surgery. Therefore, we evaluated the association of dementia with surgical outcomes for elderly patients with Medicare who underwent a variety of open and percutaneous vascular surgery procedures. METHODS: We reviewed claims data from the Centers for Medicare and Medicaid Services for beneficiaries enrolled in Medicare Part A fee-for-service insurance from January 1, 2011, to December 31, 2011, who underwent inpatient vascular surgery. Only the first surgery during the first admission was considered for analysis. Traditional outcomes (30- and 90-day mortality, intensive care admission, complications, length of stay) and patient-centered outcomes (discharge to home, extended skilled nursing facility [SNF] stay, time at home) were adjusted for patient and procedure characteristics using multilevel linear or logistic regression as appropriate. All analyses were performed using SAS (v9.4, SAS Institute Inc, Cary, NC). RESULTS: Our study included 210,918 patients undergoing vascular surgery, of whom 27,920 carried a diagnosis of dementia. The average age of the entire cohort was 75.74 years, and 55.43% were male. Patients with dementia were older and had higher rates of comorbidities compared with patients without a dementia diagnosis. The three most common defined classes of intervention excluding miscellaneous ones were cerebrovascular, peripheral arterial, and aortic cases, which jointly accounted for 53.15% of cases. Among all cases, 56.62% were open. Emergent/urgent cases were more frequent amongst those with dementia (60.66% vs 37.93%; P < .001). After adjustment, patients with dementia had increased odds of 30-day mortality (odds ratio [OR], 1.21; P < .0001) and 90-day mortality (OR, 1.63; P < .0001), extended SNF stay (OR, 3.47; P < .0001), and longer hospital length of stay (8.29 days vs 5.41 days; P < .001). They were less likely to be discharged home (OR, 0.31; P < .0001) and spent a lower fraction of time at home after discharge (63.29% vs 86.91%; P < .001). Intensive care admission and inpatient complications were similar between the two groups. CONCLUSIONS: Dementia is associated with poor traditional outcomes, including increased 30- and 90-day mortality and longer hospital lengths of stay in this large national patient sample. It is also associated with worse patient-centered outcomes, including substantially lower discharge rates to home, less time spent at home after discharge, and higher rates of extended stay in a SNF. These data should be used to counsel patients facing vascular surgery to provide goal-concordant care, particularly to patients with dementia.

The impact of combined iliac occlusive disease and aortic aneurysm on open surgical repair.

OBJECTIVE: Severe aortoiliac occlusive disease is a relative contraindication for endovascular aneurysm repair, owing to an association with high stent graft-related complication and reintervention rates in this population. Open AAA repair requiring aortofemoral bypass (AFB), however, may represent a unique population with differing outcomes from standard open repair. We sought to compare the demographic and procedural characteristics, as well as outcomes of patients undergoing standard intra-abdominal repairs (STD) versus those requiring AFB. METHODS: Using a prospectively maintained database, we retrospectively identified patients who underwent open AAA repair from 1994 to 2017. A total of 1087 consecutive cases were performed consisting of 981 STD (681 tube graft, 300 aortoiliac) and 106 AFB cases. Demographics, procedural data, postoperative complications, and long-term survival were analyzed. RESULTS: The AFB cohort had more women (39.0 vs 22.8%; P = .001) and higher rates of hypertension (81.1 vs 69.8%; P = .015), chronic obstructive pulmonary disease (28.3 vs 17.4%; P = .006), and smoking (50.9 vs 36%; P = .002). The AFB group had smaller mean aortic (5.22 vs 5.77 cm; P = .001) and graft (17.08 vs 18.2 mm; P = .001) diameters. Proximal clamp position and blood loss were equivalent, although total anesthesia time was longer (295 vs 234 minutes; P = .001) in the AFB cohort. Overall 30-day postoperative morbidity (38.7 vs 24.8%; P = .002) was higher in the AFB group. Specifically, postoperative renal insufficiency (8.2 vs 3.4%; P = .032), wound infection (5.7 vs 1.2%; P = .005), and hematoma/seroma (5.7 vs 1.2%; P = .003) were more likely. Hospital length of stay was longer for AFB (11.9 vs 9.9 days; P = .007). The 30-day mortality (0.9% AFB vs 1.8% STD; P = .50) and major morbidity (17 vs 11.5%; P = .10) did not differ. Reintervention rate within 30 days of the initial surgery (12.3 vs 4.6; P = .001) and overall (33 vs 18.9%; P = .001) was higher in the AFB group. Long-term survival was lower in the AFB group (5-year survival: 63.1% AFB vs 71.9% STD; hazard ratio 0.76, log-rank P = .047). Multivariate regression analysis identified age, comorbid conditions, and aneurysm characteristics-rather than repair type-as independent predictors of 30-day reintervention and mortality at 5 years. CONCLUSIONS: Patients requiring AFB for AAA owing to associated iliac occlusive disease have more preoperative comorbidities, postoperative complications, a longer length of stay, reintervention rates and shorter 5-year survival. Patient and aneurysm characteristics rather than surgical repair type appear to be responsible for these differences. Nevertheless, 30-day mortality and major morbidity were comparable, making AFB an attractive alternative to endovascular aneurysm repair in patients with advanced iliac occlusive disease.

Emergency intraoperative vascular surgery consultations at a tertiary academic center.

OBJECTIVE: Vascular surgeons are frequently called on to provide emergency assistance to surgical colleagues. Whereas previous studies have included elective preoperative vascular consultations, we sought to characterize the breadth of assistance provided during unplanned intraoperative consultations at a single tertiary academic center. METHODS: We queried our institutional billing department during a 15-year period and reviewed the records (January 1, 2002-December 31, 2016) and identified unanticipated unplanned vascular surgery intraoperative consultations from all surgical services. Patients' demographics and comorbidities were recorded along with the consulting services, type of index operation, reasons for vascular consultation, regions of anatomic interventions, type of vascular interventions performed, and outcomes achieved. RESULTS: There were 419 emergency intraoperative consultations identified. Patients were 51% male, with an average age of 57 years and body mass index of 28.3 kg/m2. The most frequently consulting subspecialties included surgical oncology (n = 139 [33.2%]), cardiac surgery (n = 82 [19.6%]), and orthopedics (n = 44 [10.5%]). Index cases were elective/nonurgent (n = 324 [77.3%]), urgent (n = 27 [6.4%]), and emergent (n = 68 [16.2%]), with a majority involving tumor resection (n = 240 [57.3%]). The primary reasons for vascular consultation were revascularization (n = 213 [50.8%]), control of bleeding (n = 132 [31.5%]), assistance with dissection or exposure (n = 46 [11%]), embolic protection (n = 24 [5.7%]), and other (n = 4 [1.1%]). The primary blood vessel and anatomic field of intervention were categorized. Most cases (n = 264 [63%]) included preservation of blood flow, including primary arterial repair (n = 181 [43.2%]), patch angioplasty (n = 83 [19.8%]), bypass (n = 63 [15%]), and thrombectomy (n = 38 [9.1%]). Postoperative mean length of stay was 15 days, with 30-day and 1-year mortality of 7.2% and 26.5%. CONCLUSIONS: Vascular surgeons are called on to provide unplanned open surgical consultations for a wide variety of specialties over wide-ranging anatomic regions, employing a variety of skills and techniques. This study testifies to the essential services supplied to hospitals and our surgical colleagues along with the broad skills and training necessary for modern vascular surgeons.

Strategies and outcomes for aortic endograft explantation.

BACKGROUND: Failure of endovascular aneurysm repairs (EVARs) requiring open conversion remains a major challenge. We analyzed indications for repair, operative strategies, and outcomes with a focus on iliac artery degeneration after endograft removal. METHODS: A prospective, institutional database was reviewed to identify patients who underwent explantation of a failed EVAR device. Demographics, reason for failure, operative details including extent of endograft removal, and complications/survival were examined. Postexplantation computed tomography imaging was evaluated for iliac artery degeneration. RESULTS: There were 32 patients who underwent explantation from 2002 to 2017. Six patients were treated emergently for rupture. The majority were elderly (average age, 76 ± 8.5 years), white (100%) men (91%) who had their EVAR graft inserted 45.5 months (range, 0.3-86 months) before open conversion, usually at an outside institution (75%). Explanted endografts included nine AneuRx (Medtronic, Minneapolis, Minn), nine Excluder (W. L. Gore & Associates, Flagstaff, Ariz), four Endurant (Medtronic), three Zenith (Cook Medical, Bloomington, Ind), three Powerlink/AFX (Endologix, Irvine, Calif), one Aorfix (Lombard Medical, Oxfordshire, United Kingdom), one Talent (Medtronic), and two unknown. Failure was due to endoleak in 91% (type I, 38%; type II, 28%; type III, 13%; type V, 13%), infection in 6%, and occlusion/kinking in 3%. A previous attempt at endovascular salvage of EVAR occurred in 12 (37.5%) patients. Operative approach was transabdominal in 69% and retroperitoneal in 31%. Initial aortic clamp position was supraceliac in 31%, suprarenal in 31%, and infrarenal in 38%. Most patients had complete removal of their endograft (n = 19 [59%]), with 22 (69%) having at least the iliac limbs removed. Grafts with suprarenal fixation were more likely to have the upper main body left in situ (67% vs 17%; P = .029). The 30-day mortality was 6.3% (3.8% elective, 16.7% ruptured), and 31% had a major complication. Of the 23 patients who had follow-up imaging, there was a trend for more iliac degeneration (>5 mm in growth) in those who had the iliac limbs removed (29.4% vs 0%; P = .184). Three patients with iliac limb removal required subsequent iliac endovascular intervention (two for rupture). Patients who presented with a rupture had a decreased 5-year overall survival (33%) compared with those who were converted electively (59%). CONCLUSIONS: Both complete and partial endograft explantation, although morbid procedures, can be performed safely. Postoperative imaging surveillance is important, especially if the endograft has been removed from the iliac arteries, as degeneration can occur.

Postoperative Delirium and Postoperative Cognitive Dysfunction: Overlap and Divergence.

BACKGROUND: Postoperative delirium and postoperative cognitive dysfunction share risk factors and may co-occur, but their relationship is not well established. The primary goals of this study were to describe the prevalence of postoperative cognitive dysfunction and to investigate its association with in-hospital delirium. The authors hypothesized that delirium would be a significant risk factor for postoperative cognitive dysfunction during follow-up. METHODS: This study used data from an observational study of cognitive outcomes after major noncardiac surgery, the Successful Aging after Elective Surgery study. Postoperative delirium was evaluated each hospital day with confusion assessment method-based interviews supplemented by chart reviews. Postoperative cognitive dysfunction was determined using methods adapted from the International Study of Postoperative Cognitive Dysfunction. Associations between delirium and postoperative cognitive dysfunction were examined at 1, 2, and 6 months. RESULTS: One hundred thirty-four of 560 participants (24%) developed delirium during hospitalization. Slightly fewer than half (47%, 256 of 548) met the International Study of Postoperative Cognitive Dysfunction-defined threshold for postoperative cognitive dysfunction at 1 month, but this proportion decreased at 2 months (23%, 123 of 536) and 6 months (16%, 85 of 528). At each follow-up, the level of agreement between delirium and postoperative cognitive dysfunction was poor (kappa less than .08) and correlations were small (r less than .16). The relative risk of postoperative cognitive dysfunction was significantly elevated for patients with a history of postoperative delirium at 1 month (relative risk = 1.34; 95% CI, 1.07-1.67), but not 2 months (relative risk = 1.08; 95% CI, 0.72-1.64), or 6 months (relative risk = 1.21; 95% CI, 0.71-2.09). CONCLUSIONS: Delirium significantly increased the risk of postoperative cognitive dysfunction in the first postoperative month; this relationship did not hold in longer-term follow-up. At each evaluation, postoperative cognitive dysfunction was more common among patients without delirium. Postoperative delirium and postoperative cognitive dysfunction may be distinct manifestations of perioperative neurocognitive deficits.