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.

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).

Binocular Home Treatment for Amblyopia: Gains Stable for One Year.

PURPOSE: To report the long-term outcomes of a noninferiority randomized controlled trial (RCT) with a binocular eye-tracking-based home treatment (CureSight; NovaSight, Ltd.) in patients with amblyopia. DESIGN: Prospective, multicenter, nonrandomized, long-term follow-up observational study of an RCT. METHODS: Forty-three children 4 to <9 years of age with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia were initially treated for 16 weeks (NCT05185076) with CureSight. In this planned observational follow-up study, 38 patients with no additional amblyopia treatment were evaluated at 12 weeks post-treatment, and 27 were evaluated at 1-year post-treatment. The main outcome measures were visual acuity (VA), stereoacuity, and amblyopia recurrence at 12- and 52-week post-treatment. RESULTS: At 12-week post-treatment, improvement in amblyopic eye VA was maintained vs baseline (0.27 ± 0.14 logMAR, P< .0001), with no change vs the end-of-treatment visit (P > .05). At 1 year there was a partial reduction in the amblyopic eye VA gain of 0.085±0.1 logMAR compared to end-of-treatment (P = .001), but the residual gain of 0.20±0.14 logMAR compared to baseline was statistically significant (P < .0001). Gains in stereoacuity and binocular VA were maintained vs baseline at both 12-weeks and 1-year post-treatment (P < .0001), with no change vs end-of-treatment (P > .05). Amblyopia recurrence (a worsening of ≥2 logMAR levels compared with end-of-treatment) occurred in 2/38 patients at 12-weeks post-treatment (5.3%), and in 5/27 patients at 1-year post-treatment (20.4%). CONCLUSIONS: VA and stereopsis gains following binocular treatment with CureSight were maintained at 1 year without additional treatment.

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.

A Proposal for the Use of a Fixed Low-Energy Selective Laser Trabeculoplasty for Open Angle Glaucoma.

Selective laser trabeculoplasty (SLT) has been in routine clinical use for over 20 years with millions of patients successfully treated and a low rate of clinically significant complications. The procedure requires the clinician to manually position the laser beam on the trabecular meshwork using a gonioscopy lens and to titrate the SLT laser energy based on the amount of pigmentation in the angle, as well as the observation of small bubbles produced by the laser effect. We propose that SLT energy titration is unnecessary either to achieve intraocular pressure (IOP) reduction or to minimize potential side effects. Ample evidence to support our proposal includes multiple clinical reports demonstrating comparable levels of IOP reduction resulting from different laser energies, a large variety of energy and other laser parameters used in commercially available SLT lasers, and the nature of the laser-induced changes in the trabecular meshwork tissue with respect to energy. Despite these variations in laser parameters, SLT consistently reduces IOP with a low complication rate. We propose that using low fixed energy for all patients will effectively and safely lower patients' IOP while reducing the complexity of the SLT procedure, potentially making SLT accessible to more patients.

Predicting recurrent interventions after radiocephalic arteriovenous fistula creation with machine learning and the PREDICT-AVF web app.

OBJECTIVE: Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines discourage ongoing access salvage attempts after two interventions prior to successful use or more than three interventions per year overall. The goal was to develop a tool for prediction of radiocephalic arteriovenous fistula (AVF) intervention requirements to help guide shared decision-making about access appropriateness. METHODS: Prospective cohort study of 914 adult patients in the United States and Canada undergoing radiocephalic AVF creation at one of the 39 centers participating in the PATENCY-1 or -2 trials. Clinical data, including demographics, comorbidities, access history, anatomic features, and post-operative ultrasound measurements at 4-6 and 12 weeks were used to predict recurrent interventions required at 1 year postoperatively. Cox proportional hazards, random survival forest, pooled logistic, and elastic net recurrent event survival prediction models were built using a combination of baseline characteristics and post-operative ultrasound measurements. A web application was created, which generates patient-specific predictions contextualized with the KDOQI guidelines. RESULTS: Patients underwent an estimated 1.04 (95% CI 0.94-1.13) interventions in the first year. Mean (SD) age was 57 (13) years; 22% were female. Radiocephalic AVFs were created at the snuffbox (2%), wrist (74%), or proximal forearm (24%). Using baseline characteristics, the random survival forest model performed best, with an area under the receiver operating characteristic curve (AUROC) of 0.75 (95% CI 0.67-0.82) at 1 year. The addition of ultrasound information to baseline characteristics did not substantially improve performance; however, Cox models using either 4-6- or 12-week post-operative ultrasound information alone had the best discrimination performance, with AUROCs of 0.77 (0.70-0.85) and 0.76 (0.70-0.83) at 1 year. The interactive web application is deployed at https://predict-avf.com. CONCLUSIONS: The PREDICT-AVF web application can guide patient counseling and guideline-concordant shared decision-making as part of a patient-centered end-stage kidney disease life plan.

Comparative effectiveness of bovine carotid artery xenograft and polytetrafluoroethylene in hemodialysis access revision.

BACKGROUND: When hemodialysis arteriovenous accesses fail, autogenous options are often limited. Non-autogenous conduit choices include bovine carotid artery xenografts (BCAG) and expanded polytetrafluoroethylene (PTFE), yet their comparative effectiveness in hemodialysis access revision remains largely unknown. METHODS: A cohort study was performed from a prospectively collected institutional database from August 2010 to July 2021. All patients undergoing an arteriovenous access revision with either BCAG or PTFE were followed for up to 3 years from their index access revision. Revision was defined as graft placement to address a specific problem of an existing arteriovenous access while maintaining one or more of the key components of the original access (e.g. inflow, outflow, and cannulation zone). Outcomes were measured starting at the date of the index revision procedure. The primary outcome was loss of secondary patency at 3 years. Secondary outcomes included loss of post-intervention primary patency, rates of recurrent interventions, and 30-day complications. Pooled logistic regression was used to estimate inverse probability weighted marginal structural models for the time-to-event outcomes of interest. RESULTS: A total of 159 patients were included in the study, and 58% received access revision with BCAG. Common indications for revision included worn out cannulation zones (32%), thrombosis (18%), outflow augmentation (16%), and inflow augmentation (13%). Estimated risk of secondary patency loss at 3 years was lower in the BCAG group (8.6%, 3.9-15.1) compared to the PTFE group (24.8%, 12.4-38.7). Patients receiving BCAG experienced a 60% decreased relative risk of secondary patency loss at 3 years (risk ratio 0.40, 0.14-0.86). Recurrent interventions occurred at similar rates in the BCAG and PTFE groups, with 1.86 (1.31-2.43) and 1.60 (1.07-2.14) interventions at 1 year, respectively (hazard ratio 1.22, 0.74-1.96). CONCLUSIONS: Under the conditions of this contemporary cohort study, use of BCAG in upper extremity hemodialysis access revision decreased access abandonment when compared to PTFE.

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.

Contemporary outcomes of precision banding for high flow hemodialysis access.

OBJECTIVE: High-flow hemodialysis accesses are a well-recognized source of patient morbidity. Among available management strategies inflow constriction based on real-time physiologic flow monitoring offers a technically straightforward data-driven approach with potentially low morbidity. Despite the benefits offered by this approach, large contemporary series are lacking. METHODS: A retrospective review of a prospectively maintained clinical database was undertaken to capture patients undergoing precision banding within a signal tertiary care institution between 2010 and 2019. Multivariable logistic regression modeling of thrombosis within 30 days and re-banding within 1 year were performed. RESULTS: In total, 297 patients underwent banding during the study period for a total number of 398 encounters. Median [IQR] follow-up was 157 [52-373] days. Most accesses were upper arm with brachial artery inflow (84%) and half of the banding procedures were performed for flow imbalance based on exam, duplex, or fistulogram. Median flow rate reduction was 58%. The 30-day thrombosis rate after banding was 15 of 397 (3.8%) with a median time to event of 5.5 days (2-102). The re-banding rate within a year was 54 of 398 (14%) with a median time to re-banding of 134 days [56-224]. Multivariate logistic regression analysis using a univariate screen did not identify any predictors of 30-day thrombosis. Having a forearm radial-cephalic AVF compared to all other access types was protective against need for rebanding at 1 year (OR 0.12 95% CI 0.02-0.92, p = 0.04), as was flow imbalance as the indication for banding (OR 0.43 95% 0.23-0.79, p = 0.006). CONCLUSIONS: Precision banding offers an effective, low-morbidity approach for high-flow hemodialysis accesses. Early thrombosis is a rare event after precision banding, although in the long term, one in four patients will require re-banding to maintain control of flow volumes.

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.

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.

Radiocephalic Arteriovenous Fistula Patency and Use: A Post Hoc Analysis of Multicenter Randomized Clinical Trials.

We sought to confirm and extend the understanding of clinical outcomes following creation of a common distal autogenous access, the radiocephalic arteriovenous fistula (RCAVF). Background: Interdisciplinary guidelines recommend distal autogenous arteriovenous fistulae as the preferred hemodialysis (HD) access, yet uncertainty about durability and function present barriers to adoption. Methods: Pooled data from the 2014-2019 multicenter randomized-controlled PATENCY-1 and PATENCY-2 trials were analyzed. New RC-AVFs were created in 914 patients, and outcomes were tracked prospectively for 3-years. Cox proportional hazards and Fine-Gray regression models were constructed to explore patient, anatomic, and procedural associations with access patency and use. Results: Mean (SD) age was 57 (13) years; 45% were on dialysis at baseline. Kaplan-Meier estimates of 3-year primary, primary-assisted, and secondary patency were 27.6%, 56.4%, and 66.6%, respectively. Cause-specific 1-year cumulative incidence estimates of unassisted and overall RC-AVF use were 46.8% and 66.9%, respectively. Patients with larger baseline cephalic vein diameters had improved primary (per mm, hazard ratio [HR] 0.89, 95% confidence intervals 0.81-0.99), primary-assisted (HR 0.75, 0.64-0.87), and secondary (HR 0.67, 0.57-0.80) patency; and higher rates of unassisted (subdistribution hazard ratio 1.21, 95% confidence intervals 1.02-1.44) and overall RCAVF use (subdistribution hazard ratio 1.26, 1.11-1.45). Similarly, patients not requiring HD at the time of RCAVF creation had better primary, primary-assisted, and secondary patency. Successful RCAVF use occurred at increased rates when accesses were created using regional anesthesia and at higher volume centers. Conclusions: These insights can inform patient counseling and guide shared decision-making regarding HD access options when developing an individualized end-stage kidney disease life-plan.

Predicting radiocephalic arteriovenous fistula success with machine learning.

After creation of a new arteriovenous fistula (AVF), assessment of readiness for use is an important clinical task. Accurate prediction of successful use is challenging, and augmentation of the physical exam with ultrasound has become routine. Herein, we propose a point-of-care tool based on machine learning to enhance prediction of successful unassisted radiocephalic arteriovenous fistula (AVF) use. Our analysis includes pooled patient-level data from 704 patients undergoing new radiocephalic AVF creation, eligible for hemodialysis, and enrolled in the 2014-2019 international multicenter PATENCY-1 or PATENCY-2 randomized controlled trials. The primary outcome being predicted is successful unassisted AVF use within 1-year, defined as 2-needle cannulation for hemodialysis for ≥90 days without preceding intervention. Logistic, penalized logistic (lasso and elastic net), decision tree, random forest, and boosted tree classification models were built with a training, tuning, and testing paradigm using a combination of baseline clinical characteristics and 4-6 week ultrasound parameters. Performance assessment includes receiver operating characteristic curves, precision-recall curves, calibration plots, and decision curves. All modeling approaches except the decision tree have similar discrimination performance and comparable net-benefit (area under the ROC curve 0.78-0.81, accuracy 69.1-73.6%). Model performance is superior to Kidney Disease Outcome Quality Initiative and University of Alabama at Birmingham ultrasound threshold criteria. The lasso model is presented as the final model due to its parsimony, retaining only 3 covariates: larger outflow vein diameter, higher flow volume, and absence of >50% luminal stenosis. A point-of-care online calculator is deployed to facilitate AVF assessment in the clinic.

Energy Dose-Response in Selective Laser Trabeculoplasty: A Review.

PRCIS: A literature review of selective laser trabeculoplasty (SLT) energy dose-response found no definitive relationship between intraocular pressure (IOP) reduction with respect to total or pulse energy, race, pigmentation, or application pattern. PURPOSE: SLT is a safe and effective treatment for lowering IOP. Although evidence is mounting for the advantage of its use as a first-line treatment for IOP reduction, the SLT procedures in use vary widely. The purpose of this literature review was to investigate whether there were any relationships between SLT energy and efficacy for lowering IOP in the published literature. METHODS: A literature review was undertaken that included studies in which energy levels required for successful SLT treatment were investigated: in general, with respect to angle pigmentation, race or ethnicity, and treatment arc extent. RESULTS: There was no indication that higher (or lower) energy used in the treatment leads to greater (or less) IOP reduction. Similar results were obtained regarding the level of trabecular meshwork pigmentation. Race was not found to be associated with altered dose response in SLT. There were indications that treating the full 360 degrees, as opposed to smaller arcs, could be beneficial for more IOP reduction. IOP reduction from SLT was found to be similar to that provided by topical medications. CONCLUSIONS: The optimal energy level of SLT needed for IOP reduction has not yet been definitively established, with all reported pulse energies resulting in similar IOP reduction. Furthermore, similar lack of conclusive findings exists regarding optimal SLT energy dosage for use in different races and degrees of trabecular meshwork pigmentation. This parameter and each of the abovementioned factors requires further research.

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 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.

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.