Safety and Efficacy of Percutaneous Translumbar Inferior Vena Cava Catheters: A Systematic Review and Meta-Analysis.

PURPOSE: To examine the reported adverse events associated with inferior vena cava (IVC) catheterization and investigate the reasons for discrepancies between reports. MATERIALS AND METHODS: Cochrane Library trials register, PubMed, Embase, and Scopus databases were systematically searched for studies that included any terms of IVC and phrases related to catheters or central access. Of the 5,075 searched studies, 137 were included in the full-text evaluation. Of these, 37 studies were included in the systematic review, and the adverse events reported in 16 of these 37 identified studies were analyzed. An inverse-variance random-effects model was used to conduct the meta-analysis. Outcomes were summarized by the incidence rate (IR) and 95% CI. RESULTS: Compared with that of catheters <10 F in size (IR, 0.08; 95% CI, 0.03-0.12), the incidence of catheter-related infections per 100 catheter days was 0.2 more for catheters ≥10 F in size (IR, 0.28; 95% CI, 0.25-0.31). In addition, dual-lumen catheters showed 0.13 more malfunction per 100 catheter days (IR, 0.27; 95% CI, 0.16-0.37) than that shown by single-lumen catheters (IR, 0.14; 95% CI, 0.09-0.19). Both differences were statistically significant. Other adverse events were malposition (IR, 0.04; 95% CI, 0.04-0.05), fracture (IR, 0.01; 95% CI, 0.00-0.02), kinking (IR, 0.01; 95% CI, 0.00-0.01), replaced catheter (IR, 0.2; 95% CI, 0.1-0.31), removal (IR, 0.13; 95% CI, 0.1-0.16), IVC thrombosis (IR, 0.01; 95% CI, 0.00-0.03), and retroperitoneal hematoma (IR, 0.01; 95% CI, 0.00-0.01), all per 100 catheter days. CONCLUSIONS: Translumbar IVC access is an option for patients with exhausted central veins. Small-caliber catheters cause fewer catheter-related infections, and single-lumen catheters function longer.

Preoperative Depression is Associated with Worse Outcomes after The Lower Extremity Revascularization.

OBJECTIVE: This retrospective study sought to describe the association between preoperative diagnosis of depression and major adverse events after infrainguinal bypass surgery or peripheral vascular intervention (PVI). METHODS: We retrospectively analyzed a consecutive series of all patients undergoing PVI and/or infrainguinal bypass surgery at a single tertiary institution between 2010 and 2019. Propensity matching and Cox regression analysis were conducted to examine the impact of comorbid depression on the incidence of major adverse events (MAEs), defined as re-intervention, major amputation, or death, within 2 years of surgery. RESULTS: Of all patients (n = 512) undergoing intervention at our institution, 166 (32.4%) suffered an MAE and 169 (33.0%) patients had a preoperative diagnosis of depression. After propensity score matching, univariate (HR, 1.7; 95% CI, 1.1-2.7) and multivariable hazard analyses (aHR, 1.50; [1.1-2.2]) demonstrate that there is a statistically significant relationship between the diagnosis of depression and increased MAE. CONCLUSION: Over one-third of our lower extremity revascularization patients were noted to have a preoperative diagnosis of depression. After intervention, these patients had worse outcomes compared to patients without depression; this finding was more evident in patients who underwent PVI mainly due to high overall mortality rate. Prospective studies are necessary to better understand this association and to ascertain if early intervention can improve post-procedure vascular outcomes.

The Dynamic Platelet Transcriptome in Obesity and Weight Loss.

OBJECTIVE: Adiposity is associated with oxidative stress, inflammation, and glucose intolerance. Previous data suggest that platelet gene expression is associated with key cardiometabolic phenotypes, including body mass index but stable in healthy individuals over time. However, modulation of gene expression in platelets in response to metabolic shifts (eg, weight reduction) is unknown and may be important to defining mechanism. Approach and Results: Platelet RNA sequencing and aggregation were performed from 21 individuals with massive weight loss (>45 kg) following bariatric surgery. Based on RNA sequencing data, we measured the expression of 67 genes from isolated platelet RNA using high-throughput quantitative reverse transcription quantitative PCR in 1864 FHS (Framingham Heart Study) participants. Many transcripts not previously studied in platelets were differentially expressed with bariatric surgical weight loss, appeared specific to platelets (eg, not differentially expressed in leukocytes), and were enriched for a nonalcoholic fatty liver disease pathway. Platelet aggregation studies did not detect alteration in platelet function after significant weight loss. Linear regression models demonstrated several platelet genes modestly associated with cross-sectional cardiometabolic phenotypes, including body mass index. There were no associations between studied transcripts and incident diabetes or cardiovascular end points. CONCLUSIONS: In summary, while there is no change in platelet aggregation function after significant weight loss, the human platelet experiences a dramatic transcriptional shift that implicates pathways potentially relevant to improved cardiometabolic risk postweight loss (eg, nonalcoholic fatty liver disease). Further studies are needed to determine the mechanistic importance of these observations.

Outcomes of Infrainguinal Bypass in Patients with Cannabis vs Opioid Use Disorder.

BACKGROUND: Marijuana and opioids are commonly used illicit drugs in the United States and their use continues to rise. Cannabis use disorder (CUD) and Opioid use disorder (OUD) are associated with adverse effects on public health and postoperative outcomes. However, their impact on vascular surgery, specifically infrainguinal bypass repair (IIB). is not well described in the literature. Therefore, our study aimed to assess perioperative outcomes in patients with CUD and OUD who underwent IIB. METHODS: A retrospective analysis of the National Inpatient Sample database for the years 2005 to 2018 was performed. Using the International Classification of Diseases Clinical Modification, Ninth and Tenth revisions, patients who were diagnosed with peripheral artery disease and underwent IIB repair.were identified. Our primary outcome was the comparison of rates of in-hospital complications between the groups, and the secondary outcomes included analysis of total hospital charges and length of stay. A 1:1 propensity score matching (PSM) CUD and OUD patients to their control groups without the disease was conducted using the nearest-neighbor method. The matching was based on select patient demographics and comorbidities included in our analyses. RESULTS: A total of 190,794 patients were identified: 972 patients with CUD and 682 patients with OUD. In the matched cohorts, patients with a diagnosis of CUD had a higher incidence of in-hospital cardiac complications (adjusted Odds Ratio [aOR], 1.76; 95% Confidence Interval [CI], 0.99-3.12) and acute kidney injury (AKI) (aOR, 1.51; CI, 1.09-2.08). Additionally, total hospital charges and mean length of stay were higher in the CUD group (P < 0.001). Those with OUD had a higher incidence of postoperative respiratory complications (aOR, 1.92; CI, 1.23-2.99), sepsis (aOR, 2.39; CI, 1.32-4.34), infection (aOR, 3.55; CI, 1.16-10.84), AKI (aOR, 2.11; CI,1.47-3.04), major amputations (aOR, 1.69; CI, 1.07-2.69), along with higher total charges and mean length of stay (P < 0.001). CONCLUSIONS: Both CUD and OUD have increased incidence of postoperative complications following IIB. The OUD group had generally worse outcomes compared to patients with CUD. Both were associated with a substantial increase in total hospital charges and length of hospital stay. A further prospective study is warranted to provide better insight on the effects of substance use disorders on the procedure's short- and long-term outcomes.

A systematic review of the quality of cardiovascular surgery studies that extracted data from the MAUDE database.

OBJECTIVE: To investigate opportunities and limitations of using the Manufacturer and User Facility Device Experience (MAUDE) database for cardiovascular surgery research, we analyzed the quality of studies having ever used MAUDE, in the field of cardiovascular surgery. METHODS: We systematically searched the Cochrane Library, PubMed, EMBASE, and Google Scholar for randomized and nonrandomized studies, from inception to July 2019. Two authors evaluated the quality of the retrieved observational studies, according to the National Institutes of Health quality assessment tool for either case series or cross-sectional studies. These tools quantify the quality of case series and cohorts/cross-sectional studies, respectively, with nine and 14 queries. RESULTS: Fifty-eight studies were included in the final qualitative review. Of 58 identified studies, 32 were case series, 8 were abstracts of case series, and 13 were reviews or case discussion with an included series from MAUDE. Also, five articles were cross-sectional studies. Of the 32 formal case series, 26 (81%) were found to have poor quality. The most common reasons for a poor quality designation included a lack of consecutive participants, undetermined comparability of participants, and undetermined follow-up adequacy. Only one out of five cross-sectional studies had fair quality; four others were evaluated as poor quality studies. CONCLUSIONS: Cardiovascular surgery studies using the MAUDE database, whether case series or cross-sectional design, are mostly of poor quality. Their low quality is partly caused by poor study design, but mainly by intrinsic limitations to the MAUDE database: cases recruited are not consecutive; patient characteristics are not detailed enough to allow a meaningful comparison of patient characteristics between different patient entries; outcome measures are unclear; there is a limited follow-up; and time-to-event data are lacking. We conclude that the quality of cardiovascular surgery publications that rely on data from MAUDE could be improved if investigators were to extract all relevant data points from MAUDE entries, then apply standard quality assessment tools in compiling and reporting the data. MAUDE might be improved if it used medical case report standards during the process of reporting and indexing adverse events. To calculate the incidence rate of any adverse event, all event-free cases, as well as all adverse events in patients using a device, are required. Neither of these two variables is available in the MAUDE at the time of writing.

Assessment of self-reported financial conflicts of interest in vascular surgery studies.

OBJECTIVE/BACKGROUND: With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COIs). This study aims to determine the accuracy of reporting of COIs among studies in major vascular surgery journals. METHODS: A literature search identified all comparative studies published from January 2018 through December 2018 from three major United States vascular surgery journals (Journal of Vascular Surgery, Vascular and Endovascular Surgery, and Annals of Vascular Surgery). Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior. RESULTS: A total of 239 studies (1642 authors) were identified. Two hundred twenty-one studies (92%) and 669 authors (63%) received undisclosed payments when utilizing a cut-off payment amount of $250. In 2018, 10,778 payments (totaling $22,174,578) were made by 145 companies. Food and beverage payments were the most commonly reported transaction (42%), but accounted for only 3% of total reported monetary values. Authors who accurately disclosed payments received significantly higher median general payments compared with authors who did not accurately disclose payments ($56,581 [interquartile range, $2441-$100,551] vs $2361 [interquartile range, $525-$9,699]; P < .001). When stratifying by dollar-amount discrepancy, the proportions of authors receiving undisclosed payments decreased with increasing payment thresholds. Multivariate analysis demonstrated that first and senior authors were both significantly more likely to have undisclosed payments (odds ratio, 2.0; 95% confidence interval, 1.1-3.6 and odds ratio, 2.9; 95% confidence interval, 1.6-5.2, respectively). CONCLUSIONS: There is a significant discordance between self-reported COI in vascular surgery studies compared with payments received in the Centers for Medicare and Medicaid Services Open Payments database. This study highlights the need for increased efforts to both improve definitions of what constitutes a relevant COI and encourage a standardized reporting process for vascular surgery studies.

Lessons learned during a 30-year experience with simultaneous carotid endarterectomy and coronary artery bypass grafting.

OBJECTIVE: A simultaneous operative approach to patients with significant carotid and coronary disease has been suggested as a safe, lower cost, and more convenient alternative to a staged approach. During the last three decades, spanning the career of our senior author, our group has pursued simultaneous coronary artery bypass grafting (CABG) and carotid endarterectomy (CEA) in limited circumstances. We previously reported on our results in series from 1984 to 1994 and 1994 to 1999. Based on these prior results and the current literature, we liberalized our inclusion criteria. We are now reporting on a contemporary cohort of 91 patients operated on from 2006 to 2018. METHODS: All patients who underwent combined CEA/CABG in 2006 to 2018 were entered into the Vascular Quality Initiative database. We compared the current series of 91 patients (group 3) with the 74 patients (group 2) from 1994 to 1999 and the 100 patients (group 1) from 1984 to 1994 who also underwent combined CEA/CABG. We examined demographic and comorbid factors, presence of cerebrovascular symptoms, degree of contralateral carotid stenosis, perioperative stroke, and death. Statistical comparison was made with χ2 analysis. RESULTS: The groups had similar demographics and comorbidities. Significant differences were noted in the preoperative diagnosis of hyperlipidemia (42%, 51%, 75%; P = .005) and the proportion of patients requiring urgent operations (24%, 47%, 56%; P = .002) during successive time periods. Patients in group 3 were much less likely to have preoperative symptoms from carotid stenosis before operation (55%, 31%, 4.4%; P < .001). Correspondingly, patients in group 3 were more likely to have asymptomatic unilateral carotid stenosis (20%, 55%, 78%; P < .001). The 30-day mortality rate remained stable compared with the first interval (8%, 3%, 2.2%; P = .11). Likewise, the overall stroke rate decreased in the later periods compared with the first series (9%, 1.4%, 2.2%; P = .016). Of the two perioperative strokes recorded for group 3, only one event was ipsilateral to the carotid artery operated on compared with the four ipsilateral strokes of nine total reported in group 1 and no ipsilateral stroke reported in group 2. CONCLUSIONS: Based on the favorable results of the previously reported series of CEA/CABG from our group, we continued to liberalize selection criteria for the combined procedure to essentially mirror the standard recommendations for CEA in patients without coronary disease. The current series using this treatment algorithm demonstrates the safety of this approach, with stroke and death rates equivalent to those of CABG alone. These excellent results were achieved in the face of increasingly urgent cardiac procedures. The fact that the majority of the perioperative strokes were contralateral to the carotid artery operated on reinforces the safety of our approach but underscores the significant burden of atherosclerosis in these patients.

A systematic review and meta-analysis of predilation and postdilation in transfemoral carotid artery stenting.

OBJECTIVE: In this review, we evaluate the short-term impact of different ballooning combinations on hemodynamic instability neurologic events, and mortality associated with carotid artery stenting. METHODS: We used a search strategy to identify studies in the Cochrane Library trials register, PubMed, EMBASE, Google Scholar, and the US National Library of Medicine clinical trial databases up to May 2019. Studies reporting either hemodynamic instability, neurologic events, or mortality were included according to the recommendations of the Preferred Reporting Items for Systematic reviews and Meta-analysis. Fixed and random models were used to summarize the effects. RESULTS: Of seven included cohort studies for qualitative review, six were selected for meta-analysis. Patients without postdilation had significantly less hemodynamic instability in the random effects model (risk ratio, 0.53; 95% confidence interval, 0.37-0.77; P = .001). Regardless of the dilation type, the overall summary effect in the fixed model showed a significant decrease in the risk of developing short-term neurologic events (risk ratio, 0.67; 95% confidence interval, 0.47-0.97; P = .03). Last, the exclusion of either of the two dilation techniques had no significant effect on mortality. CONCLUSIONS: Avoiding postdilation reduces perioperative hemodynamic instability and this benefit lasts at least up to 30 days. Regardless of the type, fewer dilations during carotid artery stenting possibly decreases the neurologic events during and 30 days after the procedure. The data also suggest that the residual stenoses above current practiced standard may provide a safer threshold to prompt postdilation. Statements about the long-term effects of dilation techniques requires more study.

Proteins Altered by Surgical Weight Loss Highlight Biomarkers of Insulin Resistance in the Community.

Objective- Mechanisms of early and late improvements in cardiovascular risk after bariatric surgery and applicability to larger, at-risk populations remain unclear. We aimed to identify proteins altered after bariatric surgery and their relations to metabolic syndrome and diabetes mellitus. Approach and Results- We identified 19 proteins altered in 32 nonfasting plasma samples from a study of patients undergoing bariatric surgery who were evaluated preoperatively (visit 1) versus both early (visit 2; ≈3 months) and late (visit 3; ≈12 months) postoperative follow-up using predefined protein panels (Olink). Using in silico methods and publicly available gene expression repositories, we found that genes encoding 8 out of 19 proteins had highest expression in liver relative to other assayed tissues, with the top biological and disease processes, including major obesity-related vascular diseases. Of 19 candidate proteins in the surgical cohort, 6 were previously measured in >3000 FHS (Framingham Heart Study) participants (IGFBP [insulin-like growth factor binding protein]-1, IGFBP-2, P-selectin, CD163, LDL (low-density lipoprotein)-receptor, and PAI [plasminogen activator inhibitor]-1). A higher concentration of IGFBP-2 at baseline was associated with a lower risk of incident metabolic syndrome (odds ratio per log-normal unit, 0.45; 95% CI, 0.32-0.64; P=7.7×10-6) and diabetes mellitus (odds ratio, 0.63; 95% CI, 0.49-0.79; P=0.0001) after multivariable adjustment. Conclusions- Using a directed protein quantification platform (Olink), we identified known and novel proteins altered after surgical weight loss, including IGFBP-2. Future efforts in well-defined obesity intervention settings may further define and validate novel targets for the prevention of vascular disease in obesity.

Histology and Biaxial Mechanical Behavior of Abdominal Aortic Aneurysm Tissue Samples.

Abdominal aortic aneurysms (AAAs) represent permanent, localized dilations of the abdominal aorta that can be life-threatening if progressing to rupture. Evaluation of risk of rupture depends on understanding the mechanical behavior of patient AAA walls. In this project, a series of patient AAA wall tissue samples have been evaluated through a combined anamnestic, mechanical, and histopathologic approach. Mechanical properties of the samples have been characterized using a novel, strain-controlled, planar biaxial testing protocol emulating the in vivo deformation of the aorta. Histologically, the tissue ultrastructure was highly disrupted. All samples showed pronounced mechanical stiffening with stretch and were notably anisotropic, with greater stiffness in the circumferential than the axial direction. However, there were significant intrapatient variations in wall stiffness and stress. In biaxial tests in which the longitudinal stretch was held constant at 1.1 as the circumferential stretch was extended to 1.1, the maximum average circumferential stress was 330 ± 70 kPa, while the maximum average axial stress was 190 ± 30 kPa. A constitutive model considering the wall as anisotropic with two preferred directions fit the measured data well. No statistically significant differences in tissue mechanical properties were found based on patient gender, age, maximum bulge diameter, height, weight, body mass index, or smoking history. Although a larger patient cohort is merited to confirm these conclusions, the project provides new insight into the relationships between patient natural history, histopathology, and mechanical behavior that may be useful in the development of accurate methods for rupture risk evaluation.

Matrix- and plasma-derived peptides promote tissue-specific injury responses and wound healing in diabetic swine.

BACKGROUND: Non-healing wounds are a major global health concern and account for the majority of non-traumatic limb amputations worldwide. However, compared to standard care practices, few advanced therapeutics effectively resolve these injuries stemming from cardiovascular disease, aging, and diabetes-related vasculopathies. While matrix turnover is disrupted in these injuries, debriding enzymes may promote healing by releasing matrix fragments that induce cell migration, proliferation, and morphogenesis, and plasma products may also stimulate these processes. Thus, we created matrix- and plasma-derived peptides, Comb1 and UN3, which induce cellular injury responses in vitro, and accelerate healing in rodent models of non-healing wounds. However, the effects of these peptides in non-healing wounds in diabetes are not known. Here, we interrogated whether these peptides stimulate healing in a diabetic porcine model highly reminiscent of human healing impairments in type 1 and type 2-diabetes. METHODS: After 3-6 weeks of streptozotocin-induced diabetes, full-thickness wounds were surgically created on the backs of adult female Yorkshire swine under general anesthesia. Comb1 and UN3 peptides or sterile saline (negative control) were administered to wounds daily for 3-7 days. Following sacrifice, wound tissues were harvested, and quantitative histological and immunohistochemical analyses were performed for wound closure, angiogenesis and granulation tissue deposition, along with quantitative molecular analyses of factors critical for angiogenesis, epithelialization, and dermal matrix remodeling. RESULTS: Comb1 and UN3 significantly increase re-epithelialization and angiogenesis in diabetic porcine wounds, compared to saline-treated controls. Additionally, fluorescein-conjugated Comb1 labels keratinocytes, fibroblasts, and vascular endothelial cells in porcine wounds, and Far western blotting reveals these cell populations express multiple fluorescein-Comb1-interacting proteins in vitro. Further, peptide treatment increases mRNA expression of several pro-angiogenic, epithelializing, and matrix-remodeling factors, importantly including balanced inductions in matrix metalloproteinase-2, -9, and tissue inhibitor of metalloproteinases-1, lending further insight into their mechanisms. CONCLUSIONS: Comb1 and UN3 stimulate wound resolution in diabetic Yorkshire swine through upregulation of multiple reparative growth factors and cytokines, especially matrix metalloproteinases and inhibitors that may aid in reversing the proteolytic imbalance characteristic of chronically inflamed non-healing wounds. Together, these peptides should have great therapeutic potential for all patients in need of healing, regardless of injury etiology.

Twenty-year analysis of trends in the incidence and in-hospital mortality for lower-extremity arterial thromboembolism.

BACKGROUND: Epidemiology data for lower-extremity arterial thromboembolism (LET) are limited and may result from either acute limb ischemia or an acute exacerbation of critical limb ischemia. Given marked changes in both diagnosis and therapy over the last 2 decades, we hypothesized that this time period would have witnessed reductions in both the incidence and in-hospital mortality of LET. METHODS AND RESULTS: Data from 1988 through 2007 from the National Hospital Discharge Survey were analyzed. All admissions for patients with LET were extracted, and the respective International Classification of Diseases, Ninth Revision, Clinical Modification codes were internally validated for both LET and acute limb ischemia. Descriptive statistics were used. The validity of the codes was good for identifying LET cases but poor for identifying acute limb ischemia cases because many of these acute presentations were attributable to critical limb ischemia. Over the 20-year span, there were 1.76 million cases of LET. The incidence of LET decreased significantly from 42.4 per 100 000 persons between 1988 and 1997 to 23.3 per 100 000 persons between 1998 and 2007. The in-hospital mortality for LET decreased significantly from 8.28% between 1988 and 1997 to 6.34% between 1998 and 2007, and male patients achieved greater mortality reduction compared with female patients. Treatments for acute limb ischemia showed decreasing use of surgical bypass and amputation and increasing rates of catheter-based thrombolysis. CONCLUSIONS: Over the 20-year study period, there have been significant reductions in both LET incidence and in-hospital mortality. Unfortunately, LET admissions extracted from an administrative database comprise a diverse group of individuals, including those with acute and chronic forms of limb ischemia and iatrogenic arterial injury, limiting the true assessment of ALI incidence.

Lymphoscintigraphy is frequently recommended but seldom used in a "real world setting".

OBJECTIVE: Lymphedema (LED) lacks a standard, simple, guiding noninvasive diagnostic test, unlike the two other circulatory disorders-arterial or venous disease. Lymphoscintigraphy (LSG) has been recommended by several guidelines as the diagnostic test of choice for LED. Several recent expert panels, however, have suggested from anecdotal experience that LSG was used infrequently, and that the diagnosis of LED is usually based on clinical examination. METHODS: To determine the use of LSG in a large real-world LED population, the International Business Machines MarketScan Research Database was examined from April 2012 to March 2020 for patients with a new diagnosis of LED (the index date). Use of LSG (LSG+) was ascertained during the period beginning 12 months prior to the initial coding of a LED diagnosis and ending 12 months after the index date based on the corresponding Current Procedural Terminology code; LSG use for sentinel node mapping at the time of oncologic surgery was excluded. Demographic profiles, comorbidities, and causes of LED among patients with and without evidence of LSG were characterized. RESULTS: We identified 57,674 patients, aged ≥18 years, who had a new diagnosis of LED and health care coverage for ≥12 months before and after this index date. Only a small number (1429; 2.5%) of these patients underwent LSG during the study period. The LSG + cohort was younger (53.7 vs 60.7 years), had a higher proportion of women (91.3% vs 73.4%), but a lower percentage of diabetes (12.8% vs 27.5%), heart failure (2.2% vs 8.7%), hypertension (32.4% vs 51.0%), and obesity (15.1% vs 22.2%) compared with the LED population who did not undergo LSG (all P < .001). Most importantly, the use of LSG for diagnosis varied with the etiology of LED (LSG was most frequently utilized among patients with melanoma-LED (9.5%) and patients with breast cancer-LED (6.7%), in contrast to patients with advanced venous disease-related LED (1.1%; P < .05 for both comparisons). CONCLUSIONS: Despite four guidelines recommending LSG, including the Guidelines of the American Venous Forum (Handbook of Venous and Lymphatic Disease-4th edition), which recommended LSG "for the initial evaluation of patients with LED" with a 1B recommendation, LSG plays a minor role in establishing the diagnosis of LED in the United States. This underlines the need for a better, simple diagnostic test for LED to complement clinical examination.

Characterization of the plasma metabolome and lipidome in response to sleeve gastrectomy and gastric bypass surgeries reveals molecular patterns of surgical weight loss.

OBJECTIVES: Bariatric surgery improves metabolic health, but the underlying mechanisms are not fully understood. We analyzed the effects of two types of bariatric surgery, sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB), on the plasma metabolome and lipidome. METHODS: We characterized the plasma metabolome (1268 metabolites) and lipidome (953 lipids) pre-operatively and at 3 and 12 months post-operatively in 104 obese adults who were previously recruited to a prospective cohort of bariatric surgery. The metabolomic and lipidomic responses to bariatric surgery over time were analyzed using multivariable linear mixed-effects models. RESULTS: There were significant changes in multiple metabolites and lipids, including rapid early changes in amino acid and peptide metabolites, including decreases in branched-chain amino acids (BCAAs), aromatic AAs, alanine and aspartate, and increases in glycine, serine, arginine and citrulline. There were also significant decreases in many triglyceride species, with increases in phosphatidylcholines and phosphatidylethanolamines. There were significant changes in metabolites related to energy metabolism that were apparent only after 12 months. We observed differences by bariatric surgery type in the changes in a small number of primary and secondary bile acids, including glycohyocholate and glyco-beta-muricholate. CONCLUSIONS: Our findings highlight the comprehensive changes in metabolites and lipids that occur over the 12 months following bariatric surgery. While both SG and RYGB caused profound changes in the metabolome and lipidome, RYGB was characterized by greater increases in bile acids following surgery.

Guidelines for management of actual or suspected inadvertent intra-arterial injection of sclerosants.

BACKGROUND: Inadvertent intra-arterial injection of sclerosants is an uncommon adverse event of both ultrasound-guided and direct vision sclerotherapy. This complication can result in significant tissue or limb loss and significant long-term morbidity. OBJECTIVES: To provide recommendations for diagnosis and immediate management of an unintentional intra-arterial injection of sclerosing agents. METHODS: An international and multidisciplinary expert panel representing the endorsing societies and relevant specialities reviewed the published biomedical, scientific and legal literature and developed the consensus-based recommendations. RESULTS: Actual and suspected cases of an intra-arterial sclerosant injection should be immediately transferred to a facility with a vascular/interventional unit. Digital Subtraction Angiography (DSA) is the key investigation to confirm the diagnosis and help select the appropriate intra-arterial therapy for tissue ischaemia. Emergency endovascular intervention will be required to manage the risk of major limb ischaemia. This includes intra-arterial administration of vasodilators to reduce vasospasm, and anticoagulants and thrombolytic agents to mitigate thrombosis. Mechanical thrombectomy, other endovascular interventions and even open surgery may be required. Lumbar sympathetic block may be considered but has a high risk of bleeding. Systemic anti-inflammatory agents, anticoagulants, and platelet inhibitors and modifiers would complement the intra-arterial endovascular procedures. For risk of minor ischaemia, systemic oral anti-inflammatory agents, anticoagulants, vasodilators and antiplatelet treatments are recommended. CONCLUSION: Inadvertent intra-arterial injection is an adverse event of both ultrasound-guided and direct vision sclerotherapy. Medical practitioners performing sclerotherapy must ensure completion of a course of formal training (specialty or subspecialty training, or equivalent recognition) in the management of venous and lymphatic disorders (phlebology), and be personally proficient in the use of duplex ultrasound in vascular (both arterial and venous) applications, to diagnose and provide image guidance to venous procedure. Expertise in diagnosis and immediate management of an intra-arterial injection is essential for all practitioners performing sclerotherapy.

Defining the radiation "scatter cloud" in the interventional suite.

OBJECTIVE: We hypothesized that fluoroscopic imaging creates radiation fields that are unevenly scattered throughout the endovascular suite. We sought to quantify the radiation dose spectrum at various locations during imaging procedures and to represent this in a clinically useful manner. METHODS: Digital subtraction imaging (Innova 4100; GE Healthcare, Waukesha, Wisc) of the abdomen and pelvis was performed on a cadaver in anteroposterior, left lateral, and right anterior oblique 45° projections. Radiation exposure was monitored in real time with DoseAware dosimeters (Phillips, Houston, Tex) in eight radial projections at distances of 2, 4, and 6 ft from the center of the imaged field, each at 5-ft heights from the floor. Three to five consecutive data points were collected for each location. RESULTS: At most positions around the angiographic table, radiation exposure decreased as the distance from the source emitter increased; however, the intensity of the exposure varied dramatically around the axis of imaging. With anteroposterior imaging, the radiation fields have symmetric dumbbell shapes, with maximal exposure perpendicular to the table at the level of the gantry. Peak levels at 4 and 6 ft from the source emitter were 2.4 times and 3.4 times higher, respectively, than predicted based on the inverse square law. Maximal radiation exposure was measured in the typical operator position 2 ft away and perpendicular to the table (4.99 mSv/h). When the gantry was rotated 45° and 90°, the radiation fields shifted, becoming more asymmetric, with increasing radiation doses to 10.9 and 69 mSv/h, respectively, on the side of the emitter. Minimal exposure is experienced along the axis of the table, decreasing with distance from the source (<0.77 mSv/h). CONCLUSIONS: Quantifiable and reproducible radiation scatter is created during interventional procedures. Radiation doses vary widely around the perimeter of the angiography table and change according to imaging angles. These data are easily visualized using contour plots and scatter three-dimensional mesh plots. Rather than the concentric circles predicted by the inverse square law, these data more closely resemble a "scatter cloud." Knowledge of the actual exposure levels within the endovascular environment may help in mitigating these risks to health care providers.

Endovascular treatment of stenoses in a pediatric patient with incomplete aortic duplication, mesenteric ischemia, and renovascular hypertension.

Variations in abdominal aortic anatomy may have significant implications in various surgical procedures. We report here a pediatric patient with symptoms of chronic mesenteric ischemia, labile hypertension, and lower extremity claudication. Angiography revealed a partially duplicated aorta with the anterior aorta containing the splanchnic and renal arteries and the posterior segment perfusing the lower extremities. She was successfully treated with balloon angioplasty of two focal stenoses and is normotensive without abdominal symptoms at 1-year follow-up. To our knowledge, this is the first report of a successful endovascular intervention in a partially duplicated aorta.

Impact of lymphedema in the management of venous leg ulcers.

INTRODUCTION: Lymphedema (LED) in patients with venous leg ulcers (VLU) [VLU+LED] can impair ulcer healing and predispose to cellulitis. There is little data, however, demonstrating how lymphatic dysfunction may impact the clinical course, treatment, and healthcare expenditures for VLU+LED versus VLU-LED patients. OBJECTIVE: To determine how lymphatic dysfunction might influence treatment and expenditures among VLU patients in a large deidentified healthcare claims database. METHODS: A retrospective cohort design and data from the IBM MarketScan Database (April 2013 to March 2019) were employed. Study population comprised VLU patients, and was stratified into two subgroups: VLU+LED (index date = date of first LED diagnosis) and VLU-LED (index dates randomly assigned to match distribution of index dates for VLU+LED). Within each subgroup, patients with <1 year of healthcare claims information before and after their index dates were excluded. Demographics, comorbidities, procedures/treatments, as well as all-cause post-index medical resource utilization and expenditures ($/patient/year) of the two groups were compared. Stabilized inverse probability treatment weights (IPTWs) were employed to adjust for differences between groups in baseline characteristics. RESULTS: A total of 5466 VLU patients were identified (VLU+LED: N = 299; VLU-LED: N = 5167). Overall ambulatory encounters (AMB ENC) and their components were higher in VLU+LED, which were reflected in increased expenditures for this group (Table 1). Treatment with endovenous ablation (EVA) or stenting for venous hypertension as well as for specific measures for LED were higher in the 1-year post-index period for VLU+LED. The use of LED specific therapy was low for both groups, but a greater percentage of VLU+LED patients received therapy, which was predominantly manual lymphatic drainage (17.4%) rather than pneumatic compression (10.7%). CONCLUSIONS: The clinical presence of LED in patients with VLU is a marker for a more complex disease process with more episodes of cellulitis and expenditures, but a surprisingly low specific treatment for LED.

A systematic review of routine post operative screening duplex ultrasound after thermal and non-thermal endovenous ablation.

OBJECTIVE: The Society of Vascular Surgery and the American Venous Forum recommend duplex ultrasound (DUS) following endovenous ablation. However, this screening may not be cost-effective or clinically indicated. The most common abnormal finding, endovenous heat-induced thrombosis (EHIT level 1-2), represents extension of thrombus from the saphenous <50% across the femoral or popliteal vein, which is thought to have a benign course regardless of intervention. The likelihood of venous thromboembolism (VTE) after thermal and non-thermal ablations was explored to determine the utility of routine postoperative DUS. METHODS: This is an updated and expanded systematic review including data from randomized trials and large observational studies (≥150 patients) of thermal and non-thermal ablations, examining the incidence of VTE. Using PubMed and EMBASE, 4584 publications were screened from 2000 through 2020. After applying inclusion and exclusion criteria, 72 studies were included. Random effects DerSimonian-Laird method was conducted to obtain the pooled incidence. We calculated the number of tests needed to detect one VTE, and the cost was derived from Center for Medicare Services tables. RESULTS: A total of 31,663 patients were included. The pooled incidence of EHIT II-IV, deep venous thrombosis (DVT), and pulmonary embolism (PE) was 1.32% (95% confidence interval [CI], 0.75%-2.02%); DVT (excluding EHIT), 0.20% (95% CI, 0.0%-0.2%); EHIT (I-IV), 2.51% (95% CI, 1.54%-3.68%); and EHIT (II-IV), 1.00% (95% CI, 0.51%-1.61%). There was no mortality. There was a lower DVT rate in thermal vs non-thermal ablations (0.23% vs 0.43%; P = .02); however, for all VTE (EHIT I-IV + DVT + PE), thermal techniques had more thrombosis (2.5% vs 0.5%; P <.001). When clinical significance is defined as DVT + EHIT (II-IV), 175 studies are needed to identify one VTE, costing $21,813 per "significant VTE." Patients receiving pharmacological prophylaxis had less EHIT I-IV compared with those who did not (3.04% vs 1.63%; P < .001); those who received DUS during the first post-op week had three times higher EHIT incidence compared with those whose first DUS was >7 days postoperative (6.6% vs 2.4%; P < .001). CONCLUSIONS: For thermal and non-thermal endovenous ablations, the incidence of VTE diagnosed with routine DUS is small and without clear clinical significance but caries a high cost. The Society of Vascular Surgery and the American Venous Forum recommendation to perform DUS within 72 hours is not justified by these data. We recommend a more targeted post-ablation scanning protocol including symptomatic patients and those at high risk.