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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.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.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.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.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.

Purpose to evaluate a novel eyelid warming and neuro-stimulating device, Hydro-Eye, that delivers heat via low-level infrared radiation on the eyelids of patients with meibomian gland dysfunction (MGD). Methods Prospective interventional study. Patients with MGD were recruited at a single medical center. Main outcome measures included changes in tear break-up time (TBUT), Schirmer’s test, and Ocular Surface Disease Index (OSDI), overall satisfaction, as well as 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 two-week treatment. Results A total of 10 patients were included, mean age was 67 ± 16 years, including six males (60%). Changes in pre- vs. post-treatment TBUT (5.0 to 6.11), OSDI (28.1 to 23.9), and Schirmer score (8.67 to 7.11) were not statistically significant. Over a course of 243 treatments, 131 (54%) demonstrated improvement in symptoms, 40% no change, and 6% worsening of symptoms. General satisfaction was observed overall in 80% of the patients. No adverse events were observed. Conclusion In this first study of a novel eyelid warming device, overall subjective satisfaction was reported in 80% of the patients, with no adverse events. Potential advantages of this user-friendly device include its ability to improve MGD and improving tear film stability, as well as symptomatic relief, while allowing the user to continue with normal daily functioning while undergoing treatment.

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.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.gov NCT02110901 and NCT02414841). The primary outcome was the rate of interventions at one 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 non-parametric bootstrapping.The cohort consisted of 914 patients; mean (SD) age was 57 (13) years and 22% were female. Median followup was 707 days (IQR 447-1066). The incidence of interventions per person-year (95% CI) was 1.04 (0.95-1.13) overall; 1.10 (0.98-1.21) before fistula use, and 0.96 (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 (e.g., 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 diameter3.0mm (vs. ≥4.0mm, 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).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 diameters3.0mm 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.

To compare the effectiveness and safety of a novel binocular eye-tracking-based-home-treatment (CureSight) to patching.Prospective, multi-center, randomized, masked, controlled non-inferiority pivotal trial.A total of 103 children aged 4 to ≤9 years with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia were enrolled at six clinical sites, randomized 1:1 to either CureSight treatment or patching.Binocular treatment group used the CureSight for 90 min/day, 5 days/week for 16 weeks (120 hours). The treatment combined anaglyph glasses and an eye tracker to induce dominant eye real-time blur around the fovea in dichoptic streamed video content. Patching group received 2-hour patching 7 days/week (224 hours). The pre-specified non-inferiority margin was 1 logMAR line.The primary outcome was the improvement in the amblyopic eye distance visual acuity (VA) from baseline at 16 weeks, modeled with a repeated measures ANCOVA. Secondary outcomes included stereoacuity, binocular VA, and treatment adherence rates, analyzed by a one-sample Wilcoxon-test within each group and a two-sample Wilcoxon-test comparing groups. Safety outcomes included the frequency and severity of study-related adverse events.Binocular treatment group VA improvement at 16 weeks was found to be not inferior to patching group improvement (0.28 logMAR (±0.13, p0.0001) and 0.23 logMAR (±0.14, p0.0001) in binocular treatment group and patching group (90% CI of difference [-0.008, 0.076]), respectively)), since the lower confidence bound of -0.008 falls within the non-inferiority margin of -0.1 logMAR. Stereoacuity improvement of 0.40 log-arcseconds (p0.0001) and improved binocular VA (0.13 logMAR, p0.0001) was observed in binocular treatment group, with similar improvements in patching group in stereoacuity (0.40 log-arcseconds, p0.0001) and binocular VA (0.09 logMAR, p0.0001), with no significant difference between improvements in the two groups for both stereoacuity (difference 0 95% CI[-0.27, -0.27]; p=0.76) and binocular VA (difference 0.041 95% CI[-0.002, 0.085]; p=0.07). A significantly higher adherence was observed in treatment compared with patching group (91% vs. 83%, difference 8% 95% CI[-4.0%-21%]; p=0.011). No serious adverse events were found.Binocular treatment was well tolerated, noninferior to patching in amblyopic children aged 4 to ≤9 years. High adherence may provide an alternative treatment option for amblyopia.

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.

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.

Manual measurements of strabismus are subjective, time consuming, difficult to perform in babies, toddlers, and young children, and rely on the examiner's skill and experience. An automated system, based on eye tracking and dedicated full occlusion glasses, was developed to provide a fast, objective, and easy-to-use alternative to the manual measurements of strabismus. This study tested the efficacy of the system in determining the presence of strabismus in children, as well as its type and the amount of deviation, in addition to differentiating between phorias and tropias.A prospective, masked, inter-rater reliability study.A prospective, masked, cross-sectional study included 69 children, 3-15 years of age. A cover-uncover test and a prism alternating cover test (PACT) for the primary gaze, at a distance of 50 cm, were performed by 2 independent, masked examiners and by the automated system.A high correlation was found between the automated and the manual test results (R = 0.9 and P 0.001 for the horizontal deviation, and R = 0.91 and P0.001 for the vertical deviations, with 100% correct identification of the type of deviation). The average automated test duration was 46 seconds. The Bland-Altman plot, used to compare the 2 measurement methods, showed a mean value of -2.9 prism diopters (PD) and a half-width of the 95% limit of agreement of ±11.4 PD.The automated system provides precise detection and measurements of ocular misalignment and differentiated between phorias and tropias. It can be used in participants from the ages of 3 years old and up.

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.

Editor’s PerspectiveWhat We Already Know about This TopicWhat This Article Tells Us That Is NewBackgroundPostoperative 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.MethodsThis 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.ResultsOne 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).ConclusionsDelirium 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.

Purpose Direct selective laser trabeculoplasty (DSLT) is a rapid, noncontact automated procedure performed directly through the limbus without gonioscopy. In this first nonrandomized clinical trial we assessed its safety and ability to reduce intraocular pressure (IOP). Methods Fifteen patients (15 eyes: 10 with open-angle glaucoma [OAG], 4 with ocular hypertension, and 1 with pseudoexfoliation glaucoma), naive or after medication washout, with an IOP ≥22 mm Hg, underwent DSLT by irradiation with 100 or 120 sequential noncontact 532-nm, Q-switched laser shots (0.8-1.4 mJ) automatically applied during 1.5 or 2.3 seconds on the limbus, guided by image analysis and eye tracking. Results were assessed at 1 and 3 hours, 1 day, 1 week, and 1, 3, and 6 months. Results The mean ± standard deviation baseline IOP (mm Hg) in all eyes was 26.7 ± 2.3. At 1, 3, and 6 months, this value was significantly reduced to 21.7 ± 4.2 (by 18.1%), to 20.8 ± 2.5 (by 21.4%), and to 21.5 ± 4.1 (by 18.8%), respectively. In six patients treated with 1.4 mJ/shot, the mean IOP at 6 months decreased from 26.7 ± 3.2 to 19.3 ± 2.0 (27.1%, P = 0.03). There was a significant reduction in hypotensive medications (from 1.6 ± 1.0 to 0.4 ± 0.7, P = 0.03). No serious adverse events occurred. Conclusions Automated DSLT appears to be an effective and safe noncontact, rapid modality for reducing IOP in patients with OAG. Higher energy usage led to better results. Translational relevance Studying laser transmission through sclera enabled laser irradiation of the trabeculum without gonioscopy.

Made available in DSpace on 2022-04-28T19:47:00Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-10-01 Introduction: Aortic graft infection remains a considerable clinical challenge, and it is unclear which variables are associated with adverse outcomes among patients undergoing partial resection. Methods: A retrospective, multi-institutional study of patients who underwent partial resection of infected aortic grafts from 2002 to 2014 was performed using a standard database. Baseline demographics, comorbidities, operative, and postoperative variables were recorded. The primary outcome was mortality. Descriptive statistics, Kaplan-Meier (KM) survival analysis, and Cox regression analysis were performed. Results: One hundred fourteen patients at 22 medical centers in 6 countries underwent partial resection of an infected aortic graft. Seventy percent were men with median age 70 years. Ninety-seven percent had a history of open aortic bypass graft: 88 (77%) patients had infected aortobifemoral bypass, 18 (16%) had infected aortobiiliac bypass, and 1 (0.8%) had an infected thoracic graft. Infection was diagnosed at a median 4.3 years post-implant. All patients underwent partial resection followed by either extra-anatomic (47%) or in situ (53%) vascular reconstruction. Median follow-up period was 17 months (IQR 1, 50 months). Thirty-day mortality was 17.5%. The KM-estimated median survival from time of partial resection was 3.6 years. There was no significant survival difference between those undergoing in situ reconstruction or extra-anatomic bypass (P = 0.6). During follow up, 72% of repairs remained patent and 11% of patients underwent major amputation. On univariate Cox regression analysis, Candida infection was associated with increased risk of mortality (HR 2.4; P = 0.01) as well as aortoenteric fistula (HR 1.9, P = 0.03). Resection of a single graft limb only to resection of abdominal (graft main body) infection was associated with decreased risk of mortality (HR 0.57, P = 0.04), as well as those with American Society of Anesthesiologists classification less than 3 (HR 0.35, P = 0.04). Multivariate analysis did not reveal any factors significantly associated with mortality. Persistent early infection was noted in 26% of patients within 30 days postoperatively, and 39% of patients were found to have any post-repair infection during the follow-up period. Two patients (1.8%) were found to have a late reinfection without early persistent postoperative infection. Patients with any post-repair infection were older (67 vs. 60 years, P = 0.01) and less likely to have patent repairs during follow up (59% vs. 32%, P = 0.01). Patients with aortoenteric fistula had a higher rate of any post-repair infection (63% vs. 29%, P < 0.01) Conclusion: This large multi-center study suggests that patients who have undergone partial resection of infected aortic grafts may be at high risk of death or post-repair infection, especially older patients with abdominal infection not isolated to a single graft limb, or with Candida infection or aortoenteric fistula. Late reinfection correlated strongly with early persistent postoperative infection, raising concern for occult retained infected graft material. University Hospitals Cleveland Medical Center Case Western Reserve University School of Medicine the Ronald Reagan UCLA Medical Center University of California Los Angeles SSM Healthcare Semmelweis University Keck School of Medicine University of Southern California University of North Carolina School of Medicine University of Arizona the Indiana University Health Physicians Vascular Surgery Michigan Medicine University of Michigan University Heart Center Hamburg University Medical Center Hamburg-Eppendorf Penn State Heart and Vascular Institute Milton S. Hershey Medical Center Johns Hopkins Hospital The Heart Hospital Baylor Plano the Cardiovascular Surgery Clinic University of Messina National & Kapodistrian University of Athens University of Patras Keio University University of Pennsylvania Vancouver General Hospital & University of British Columbia Mayo Clinic Christiana Health System University of Chicago Harborview Medical Center University of Washington Washington University Stanford University CHU de Poitiers Baylor College of Medicine MedStar Georgetown University Hospital SSM Health St. Louis University Faculdade de Medicina de Botucatu-Unesp Beth Israel Deaconness Medical Center Brigham and Women's Hospital St. Joseph's Hospital Massachusetts General Hospital Robert Wood Johnson Medical School Rutgers University Vita-Salute University School of Medicine San Raffaele Scientific Institute Kaiser Permanente University Heart Center Freiburg-Bad Krozingen Freiburg University of Virginia Medical Center University of Siena Kyung Hee University Gustave Dron Hospital Centro Hospitalar de Lisboa Norte Wexner Medical Center Ohio State University Uppsala University University Hospital of Trieste University Hospital of Verona University Hospital of Padova University of Alabama University of California Davis University of Florida Michael E. DeBakey Department of Surgery Baylor College of Medicine University Hospital University of Missouri Faculdade de Medicina de Botucatu-Unesp

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 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.

Lower extremity arterial disease affects more than 200 × 10e6 people worldwide causing Critical Limb Ischemia (CLI), also referred to as chronic limb-threatening ischemia (CLTI) a life-threatening disease and the major cause of ischemic amputation. For nonrevascularizable patients, the outlook is bleak and novel therapies are needed. This chapter discusses new approaches including gene therapy and stem/progenitor cell (SPC)-based therapies, including autologous bone marrow-derived cells (BM), MB-mononuclear cells (BM-MNC), mesenchymal stem cells (MSC), mobilized bone marrow cell (PB-MNC), allogeneic cells and ex vivo expanded or activated/differentiated cell products. A preliminary first-in-human trial of a novel treatment is presented that combines immune cell therapy and a stepwise activation and differentiation of SPC. Cells from a standard blood draw (with no pretreatment or mobilization) are transformed, within a day, into a therapeutic product (BGC101) composed of endothelial progenitor cells (EPCs), SPCs, dendritic cells (DCs), and T helper cells. BGC101 was found safe and effective in stabilizing and reversing the course of CLI. Controlled studies on a larger population are planned to evaluate this new concept.

During the past quarter century, the rate of glaucoma-related publication in general ophthalmology journals increased due to higher representation in "experimentally oriented" journals. The rate of glaucoma randomized controlled clinical trial (RCT) articles decreased during the same time period.To evaluate trends in rate of glaucoma publications in leading general ophthalmology journals over the past quarter century.Q1 ophthalmology journals Web sites were reviewed. Only journals not limited to certain subspecialty were considered "general" and included in the analysis. In addition we categorized journals orientation as either "clinical" or "experimental." The PubMed search engine was used to collect publications from the selected journals between January 1, 1995 to December 31, 2019. Publications captured by "glaucoma" or "ocular hypertension" filters were considered glaucoma related. The fraction of glaucoma articles out of total number of articles within each year for each journal was calculated. A linear mixed effects model was applied to detect trends in glaucoma publication rates during the study period.Eight journals were included: 4 "clinically oriented" and 4 "experimentally oriented." The PubMed search yielded 72,750 publications, of which 9329 (12.8%) considered "glaucoma related." Percentage of glaucoma publications remained stable within "clinically oriented" journals, and significantly increased within "experimentally oriented" journals (annual change of 0.3%, P0.001). The number of glaucoma-related RCTs decreased significantly in each (annual change of -0.21% and -0.13%, respectively, P0.05).There has been a significant rise in the rates of glaucoma publications in "experimentally oriented" journals, while their representation in "clinically oriented" journals remained stable over the past quarter century. This change might be due to the increasing efforts to develop more advanced methods for evaluation and treatment in glaucoma, although still unable to address clinical demands. The decrease in glaucoma-related RCT articles might indicate reduced funding for such research.

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.

The substantial burden of heart disease promotes an interest in new ways of screening for early disease diagnosis, especially by means of noninvasive imaging. Increasing evidence for association between retinal microvascular signs and heart disease prompted us to systematically investigate the relevant current literature on the subject. We scrutinized the current literature by searching PubMed and Embase databases from 2000 to 2020 for clinical studies of the association between retinal microvascular signs and prevalent or incident heart disease in humans. Following exclusions, we extracted the relevant data from 42 publications (comprising 14 prospective, 26 cross-sectional, and 2 retrospective studies). Our search yielded significant associations between retinal vascular changes, including diameter, tortuosity, and branching, and various cardiac diseases, including acute coronary syndrome, coronary artery disease, heart failure, and conduction abnormalities. The findings of our research suggest that the retinal microvasculature can provide essential data about concurrent cardiac disease status and predict future risk of cardiac-related events.

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.

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.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.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.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.

Background: The substantial burden of kidney disease fosters interest in new ways of screening for early disease diagnosis, especially by non-invasive imaging. Increasing evidence for an association between retinal microvascular signs and kidney disease prompted us to investigate the relevant current literature on such an association systematically by performing a meta-analysis of our findings. Methods: We scrutinized the current literature by searching PubMed and Embase databases from for clinical studies of the association between retinal microvascular signs and prevalent or incident kidney disease. After excluding cases that did not meet our criteria, we extracted relevant data from 42 published studies (9 prospective, 32 cross-sectional, and 1 retrospective). Results: Our investigation yielded significant associations between retinal vascular changes (including retinopathy and retinal vascular diameter) and kidney dysfunction (including chronic kidney disease (CKD), end-stage renal disease (ESRD), albuminuria, and estimated glomerular filtration rate (eGFR) decline). According to our meta-analysis, retinopathy was associated with ESRD (hazard ratio (HR) 2.12 (95% confidence interval CI; 1.39–3.22)) and with CKD prevalence in the general population (odds ratio (OR) 1.31 (95% CI; 1.14–1.50)), and specifically in type 2 diabetic patients (OR 1.68 (95% CI; 1.68–2.16)). CRAE was associated with prevalent CKD (OR 1.41 (95% CI; 1.09–1.82)). Conclusions: Our findings suggest that the retinal microvasculature can provide essential data about concurrent kidney disease status and predict future risk for kidney disease development and progression.

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.

Brachial-cephalic arteriovenous fistulas (BCFs) are associated with high-flow volumes, leading to potential risks such as arm swelling, steal syndrome, pseudoaneurysm (due to a pressurized access), and cephalic arch stenosis. We hypothesized that a proximal radial-cephalic fistula (prRCF) configuration mitigates these risks because a lower flow state is created. Furthermore, we also hypothesized that despite these lower flows, patencies (primary, primary assisted, secondary) are sustained.Leveraging a prospectively collected database supplemented with detailed medical record data, analyses of patients undergoing BCF and prRCF were completed (November 2008 through March 2016). Preoperative clinical and imaging characteristics, operative variables, and postoperative complications were reviewed. The primary end point was a composite of arm swelling, steal, and pseudoaneurysm at 2 years. Fistulograms and interventions (surgical revision, thrombectomy, endovascular treatment of cephalic arch stenosis) censored at 2 years were compared between configurations. Patencies were plotted using Kaplan-Meier techniques and compared using Cox proportional hazards.During the study period, 345 arteriovenous fistulas and 72 prosthetic grafts were primarily placed; 56 patients underwent BCF and 50 patients underwent prRCF with a mean follow-up of 1.8 ± 1.7 (standard deviation) years. Except for prRCF patients being older, there was no difference between the groups with regard to preoperative characteristics. The artery diameter used for anastomosis was significantly larger in the BCF group (4.0 ± 1.1 mm vs 2.6 ± 0.8 mm; P .001), with higher flow volumes at 6-week ultrasound examination (1060 ± 587 mL/min vs 735 ± 344 mL/min; P .001). Complications (arm swelling, steal, pseudoaneurysm) were significantly more common in the BCF group (P = .02). There was a trend, albeit statistically insignificant, for the BCF group to require more cephalic arch stenosis interventions. Of those patients needing dialysis within 1 year, both BCF and prRCF were successfully used in the majority of patients (n = 27 [66%] vs n = 25 [63%]; P = 1.0). Unadjusted and adjusted primary, primary assisted, and secondary patency rates were similar between the groups.prRCFs have fewer complications yet similar midterm durability compared with BCFs. When it is anatomically feasible, prRCFs should be constructed over BCFs because of their superior physiology and clinical outcomes.

Short neck length, and angulated infrarenal aortic necks, are historically associated with sac expansion following endovascular abdominal aortic aneurysm repair. Aorfix (Lombard Medical, Inc, Irvine, Calif), a conformable stent graft US Food and Drug Administration approved for highly angulated necks, was investigated in the US Pythagoras Trial. We investigated the incidence of, and factors related to, sac regression and expansion following implantation of the Aorfix device.Pythagoras trial data was assessed with mutivariable modeling for factors associated with sac regression or expansion (defined as change in maximum aneurysm diameter of ≥5 mm on annual follow-up computed tomography compared with last preoperative scan). All anatomic measurements were performed per protocol by a core laboratory (M2S; West Lebanon, NH).A total of 218 patients were enrolled; neck angle was ≥60° in 151 (69.3%), 60° in 67 (30.7%). Follow-up, including computed tomography imaging, was available at 1 year (n = 165), 2 years (n = 142), 3 years (n = 106), and 4 years (n = 70). Sac size decreased or was unchanged in 98.8% (1 year), 95.1% (2 years), 94.3% (3 years), and 92.9% (4 years). Mean neck length for the entire cohort was 22.3 mm; mean proximal neck angle was 71.4°. Maximum aneurysm diameter was 57.5 mm. Sac regression or expansion was not statistically associated with neck length, neck diameter, maximal aneurysm diameter, or patient sex (or 19 other demographic and medical history variables). Neck angle was not statistically associated with sac regression or expansion.In this study cohort, there is a low incidence of sac expansion with the Aorfix device. We were unable to demonstrate an association between neck length/angulation and sac expansion.

Early and midterm outcomes of the Prospective Aneurysm Trial: High Angle Aorfix Bifurcated Stent Graft (PYTHAGORAS) trial in patients with highly angulated aortic necks (≥60 degrees) have already been published and shown comparable outcomes to other endografts in normal anatomy. Herein, we present the long-term outcomes of the PYTHAGORAS trial of Aorfix (Lombard Medical, Irvine, Calif) for patients with highly angulated aortic neck anatomy.The Aorfix endograft is a highly conformable nitinol/polyester device designed for transrenal fixation. The U.S. trial enrolled 218 patients and observed all patients at 1 month, 6 months, and 12 months and then annually for a total of 5 years. Endovascular aneurysm repair (EVAR)-specific complications were compared between the standard-angle (60 degrees) and highly angulated (≥60 degrees) neck groups at 5 years using standard statistical methods. Kaplan-Meier analysis was performed to evaluate the overall 5-year survival and freedom from aneurysm rupture, aneurysm-related mortality, and reintervention.Of the 218 patients enrolled in the trial, there were 67 patients in the standard-angle neck group (I) and 151 patients in the highly angulated neck group (II). Mean proximal neck angle was 45 degrees in group I vs 83 degrees in group II (P .001). At 5 years, 87% of surviving patients were followed up. The 5-year EVAR-specific results showed no type I or type III endoleak in either group, 4% migration in group I vs 3% in group II, and 4% sac expansion in group I vs 15.0% in group II (P ≥ .27). The 5-year freedom from all-cause mortality was 69% (73% in group I vs 68% in group II; P = .43); from aneurysm-related mortality, 96% (99% vs 95%; P = .44); from aneurysm rupture, 99% (99% vs 99%; P = 1.0); and from device-related secondary intervention, 83% (88% vs 80%; P = .18). None of these differed between groups.The U.S. PYTHAGORAS trial of the Aorfix endograft is the first EVAR clinical trial to include a majority of highly angulated (≥60 degrees) infrarenal aortic necks and is the first to produce evidence after 5 years of implantation. Despite predictors of worse short- and long-term outcomes, pertinent outcomes were better than or similar to those of trials with less severe anatomy. These results support the use of this "on-label" endovascular option, particularly in patients with highly angulated aortic neck anatomy.