Multi-Center Two-Year Patency Outcomes of Endovascular Arteriovenous Fistulas (endoAVF) Created with a 4 French System.

PURPOSE: To assess multicenter two-year patency outcomes of endovascular arteriovenous fistulas (endoAVF) created with the WavelinQ device. MATERIALS AND METHODS: Patients who had fistulas created at three centers from January 2018 to December 2020 were included in this retrospective study. In total, 112 patients underwent endoAVF creation [40 females, 72 males; mean age 60 years (range 18-88)]. Data collected included patient demographics, location of fistula creation, interventions performed, and brachial artery flows pre- and post-creation. Two-year cumulative patency, functional patency, and primary patency were assessed with Kaplan-Meier methodology. Factors affecting patency and maturation were examined using the Cox proportional hazards model. RESULTS: Technical success defined as angiographically successful endoAVF creation was 97.3% (109/112). In 11 patients the fistula did not mature for dialysis use. For 98 patients (87%) with endoAVF maturation, 12- and 24-month cumulative patency was 94.3% and 91.7%. Functional patency (two-needle cannulation) at 12 and 24 months was 95.7% and 92.7%, respectively. Median maturation time is 95 days (IQR 51-231 days). Male gender and brachial vein coiling at the time of endoAVF creation were predictive of maturation. There were 34 censored events (four patients undergoing renal transplantation; 30 patients deceased). Number of reinterventions per patient year was 0.73 where 43 were maturation procedures and 101 were maintenance procedures. One Grade 3 complication occurred of arterial access puncture site pseudoaneurysm. CONCLUSION: A high two-year functional and cumulative patency following endoAVF creation with the WavelinQ device was observed in this multicenter real-world experience Level of Evidence: 3 Level of Evidence III.

Arteriovenous Access for Hemodialysis: A Review.

Importance: Hemodialysis requires reliable vascular access to the patient's blood circulation, such as an arteriovenous access in the form of an autogenous arteriovenous fistula or nonautogenous arteriovenous graft. This Review addresses key issues associated with the construction and maintenance of hemodialysis arteriovenous access. Observations: All patients with kidney failure should have an individualized strategy (known as Patient Life-Plan, Access Needs, or PLAN) for kidney replacement therapy and dialysis access, including contingency plans for access failure. Patients should be referred for hemodialysis access when their estimated glomerular filtration rate progressively decreases to 15 to 20 mL/min, or when their peritoneal dialysis, kidney transplant, or current vascular access is failing. Patients with chronic kidney disease should limit or avoid vascular procedures that may complicate future arteriovenous access, such as antecubital venipuncture or peripheral insertion of central catheters. Autogenous arteriovenous fistulas require 3 to 6 months to mature, whereas standard arteriovenous grafts can be used 2 to 4 weeks after being established, and "early-cannulation" grafts can be used within 24 to 72 hours of creation. The prime pathologic lesion of flow-related complications of arteriovenous access is intimal hyperplasia within the arteriovenous access that can lead to stenosis, maturation failure (33%-62% at 6 months), or poor patency (60%-63% at 2 years) and suboptimal dialysis. Nonflow complications such as access-related hand ischemia ("steal syndrome"; 1%-8% of patients) and arteriovenous access infection require timely identification and treatment. An arteriovenous access at high risk of hemorrhaging is a surgical emergency. Conclusions and Relevance: The selection, creation, and maintenance of arteriovenous access for hemodialysis vascular access is critical for patients with kidney failure. Generalist clinicians play an important role in protecting current and future arteriovenous access; identifying arteriovenous access complications such as infection, steal syndrome, and high-output cardiac failure; and making timely referrals to facilitate arteriovenous access creation and treatment of arteriovenous access complications.

Two-Year Cumulative and Functional Patency after Creation of Endovascular Arteriovenous Hemodialysis Fistulae.

PURPOSE: To assess 2-year cumulative and functional patency of endovascular arteriovenous fistulae (endoAVF) created with the WavelinQ device. MATERIALS AND METHODS: Patients who had fistulae created at a single center from December 2019 to December 2020 were included in this retrospective study. Forty-three patients underwent endoAVF creation (22 females, 21 males). Data collected included patient demographics, location of fistula creation, interventions performed, and brachial artery flow before and after creation. Two-year cumulative and functional patency rates were assessed with Kaplan-Meier method, and variables that affected patency and maturation were examined using Cox proportional hazards model. RESULTS: Technical success was 95% (41/43), and in 4 patients, the fistula did not mature for dialysis use (9.7%). For the remaining 37 patients with endoAVF maturation, 25 had ulnar-ulnar fistulae, 10 had radial-radial fistulae, and 2 had interosseous artery-vein fistulae. Mean maturity time was 73 days, and brachial artery flow of >886 mL/min was predictive of maturation. Mean tunneled dialysis catheter removal time was 133 days. Number of interventions per patient-year was 0.38, where 8 were maturation procedures (5 vein elevations/transpositions and 3 coil embolizations) and 21 were maintenance angioplasties. Two-year cumulative/secondary and functional patency rates were 89.4% and 92.1%, respectively, with a mean follow-up of 665.7 days. Examined variables did not impact cumulative or functional patency. One adverse event was migration of coil to the heart, which was successfully retrieved at time of procedure. CONCLUSIONS: Two-year patency of 89.4% and functional patency of 92.1% were observed after endoAVF creation with WavelinQ device.

Real-World Experience With the Angio-Seal Closure Device: Insights From Manufacturer and User Facility Device Experience Database.

PURPOSE: Angio-Seal (Terumo Medical Corporations, Somerset, New Jersey) device is indicated for femoral arteriotomy closure. Real-world published data on complications are limited. We present 1 year of safety events involving Angio-Seal from the US Food and Drug Administration's post-market surveillance database of Manufacturer and User Facility Device Experience (MAUDE). Steps for managing frequent device-related problems are discussed. MATERIALS AND METHODS: Angio-Seal MAUDE data from November 2019 to December 2020 was classified according to (1) mode of device failure, (2) complication, (3) treatment, and (4) Cardiovascular and Interventional Radiological Society of Europe (CIRSE) adverse event classification system. RESULTS: There were 715 safety events, involving Angio-Seal VIP (93.1%), Evolution (5.7%), STS Plus (1.1%), and sizes 6F (62.5%) and 8F (37.5%). Failure mode involved unrecognized use of a damaged device (43.4%), failed deployment (20.1%), failed arterial advancement (6.3%), detachment of device component (4.9%), failed retraction (3.6%), operator error (1.1%), and indeterminate (20.6%). Of total, 44.8% of events were associated with patient harm. Complications involved minor blood loss (34.1%), hematoma (5.6%), significant blood loss (1.4%), and pseudoaneurysm (1.4%). Of total, 43.3% of cases required manual compression (MC), whereas 8.8% required more advanced intervention. Interventions included surgical repair (49.2%), thrombin injection (9.5%), balloon tamponade (6.3%), covered stent (4.8%), and unspecified (30.2%). Majority of safety events were CIRSE grade 1 (92.0%), followed by grades 2 (3.1%), 3 (4.6%), and 6 (deaths, 0.3%). Minority of devices were returned for manufacturer analysis (27.8%). CONCLUSIONS: The majority of safety events were associated with minor blood loss or local hematoma and could be addressed with MC alone. Most events were attributed to damaged device; however, very few devices were returned to manufacturer for analysis. This should be encouraged to allow for root cause analysis in order to improve safety profile of devices. System-level strategies for addressing barriers to under-reporting of safety events may also be considered. CLINICAL IMPACT: Our study highlights important safety events encountered in real-world practice with Angio-Seal closure device. The MAUDE database captures real-world device malfunctions not typically appreciated in conventional clinical trials. Our study provides valuable insight for clinician-users on anticipating and managing the most common device malfunctions. Additionally, our data provide feedback for manufactures to optimize product design and direct manufacturer user training to improve safety. Finally, we hope that the study promotes system-level strategies that foster reporting of safety events and undertaking of root cause analysis.

Prospective, Multicenter, Observational Study to Evaluate a Cell-Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion within the Dialysis Outflow Circuit of an Arteriovenous (AV) Fistula or AV Graft (The WRAP Registry).

PURPOSE: Dysfunctional vascular access due to stenosis/occlusion within the arteriovenous fistula or graft (AVF/AVG) negatively affects the clinical management of patients undergoing hemodialysis. Results from the feasibility study of the WRAPSODY™ Cell-Impermeable Endoprosthesis demonstrated that the device can achieve high patency rates and maintain integrity of the dialysis outflow circuit. This study was designed to assess real-world evidence of safety and efficacy outcomes following device placement. MATERIALS AND METHODS: This is a prospective, multicenter, non-investigational, post-market observational study of 500 patients at up to 50 centers worldwide with a mature AVF/AVG dialysis access (≥ 1 hemodialysis session) who experience stenosis/occlusion of the outflow circuit prior to placement of WRAPSODY. Patients will be divided into the following two cohorts: peripheral or central thoracic. Primary outcome measures include target lesion primary patency (TLPP) at 6 months and procedure and/or device-related events through 30 days post-procedure. Secondary outcome measures include TLPP, safety events, and the number of interventions needed to maintain patency through the 24 month study period. Exploratory endpoints include time to access abandonment, resumption of successful dialysis, functional patency, and pending available imaging data, any incidence of stent fractures, migration, or edge stenosis. Study enrollment began in June 2022, the last patient visit is expected in 2026. DISCUSSION: It is expected that this study will provide real-world evidence regarding the performance of the WRAPSODY device in a diverse population of patients, which may encourage its use in the continuum of hemodialysis access management. TRIAL REGISTRATION: NCT05062291.

Objective Performance Goals Based on a Systematic Review and Meta-Analysis of Clinical Outcomes for Bare-Metal Stents and Percutaneous Transluminal Angioplasty for Hemodialysis-Related Central Venous Obstruction.

PURPOSE: To use safety and efficacy outcomes following treatment with percutaneous transluminal angioplasty (PTA) and/or stent placement for thoracic central venous obstruction in hemodialysis-dependent patients to establish objective performance goals (OPGs). METHODS: A systematic literature review and meta-analysis were conducted for articles published between January 1, 2000, and August 31, 2021. Efficacy outcomes included primary patency rates at 6 and 12 months, and safety outcomes included adverse events (AEs) categorized as access loss, procedure-related AEs, and serious AEs (SAEs). OPGs were derived from the upper and lower bounds of the 95% confidence intervals for primary patency and SAE rates. RESULTS: Of 66 articles reviewed, 17 met the inclusion criteria (PTA, n = 4; stent placement, n = 5; PTA/stent, n = 8). The 6- and 12-month primary patency rates for PTA were 50.9% and 36.7%, respectively. Based on these findings, the proposed 6- and 12-month primary patency OPGs identifying superiority against PTA were 66.5% and 52.6%, respectively, and those for noninferiority were 39.0% and 25.7%, respectively. For stent placement, the 6- and 12-month primary patency rates were 69.7% and 47.9%, respectively. The proposed 6- and 12-month primary patency OPGs identifying superiority were 82.1% and 64.1%, respectively, and those for noninferiority were 59.3% and 35.8%, respectively. SAE rates for PTA and stent placement were 3.8% and 8.1%, respectively. Proposed safety OPGs for noninferiority versus superiority for PTA and stent placement were 10.1% versus 1.4% and 13.6% versus 4.8%, respectively. CONCLUSION: The OPGs derived from real-world studies of PTA and stent placement may serve as a benchmark for future interventions indicated for this patient population.

Percutaneous Creation of Hemodialysis Fistulas.

Non-surgical, percutaneous, or endovascular hemodialysis arteriovenous creation represent an evolution of access creation away from traditional surgical fistulas. These fistulas are additional to surgical alternatives and published studies with the two commercially available devices suggest positive outcomes in terms of technical success, maturation, functionality, and patency. Relevant published studies are presented, and other considerations related to these new devices/procedures are also summarized.

Vascular Closure Devices For Axillary Artery Access: A Systematic Review and Meta-Analysis.

PURPOSE: To evaluate the technical success and complication rates of vascular closure devices (VCDs) in the axillary artery. MATERIALS AND METHODS: MEDLINE and Embase were searched independently by two reviewers to identify observational studies from inception through October 2021. The following outcomes were meta-analyzed: technical success, hematoma, dissection, pseudoaneurysm, infection, and local neurological complications. Complications were also graded as mild, moderate, and severe. A logistic regression evaluating the influence of sheath size for the outcome of technical success rate was performed using individual patient-level data. RESULTS: Of 1496 unique records, 20 observational studies were included, totaling 915 unique arterial access sites. Pooled estimates were as follows: technical success 84.8% (95% confidence interval [CI]: 78%-89.7%, I2=60.4%), hematoma 7.9% (95% CI: 5.8%-10.6%, I2=0%), dissection 3.1% (95% CI: 1.3%-7.3%, I2=0%), pseudoaneurysm 2.7% (95% CI: 1.3%-5.7%, I2=0%), infection <1% (95% CI: 0%-5.7%, I2=20.5%), and local neurological complications 2.7% (95% CI: 1.7%-4.4%, I2=0%). There was a significant negative association between sheath size and technical success rate (odds ratio [OR]: 0.87 per 1 French (Fr) increase in sheath size, 95% CI: 0.80-0.94, p=0.0005). Larger sheath sizes were associated with a greater number of access-site complications (adjusted odds ratio [aOR]: 1.21 per 1 Fr increase sheath size, 95% CI: 1.04-1.40, p=0.013). CONCLUSIONS: Off-label use of VCDs in the axillary artery provides an 85% successful closure rate and variable complication rate, depending on the primary procedure and sheath size. Larger sheaths were associated with a lower technical success and greater rate of access-related complications. CLINICAL IMPACT: Safe arterial access is the foundation for arterial intervention. While the common femoral artery is a well established access site, alternative arterial access sites capable of larger sheath sizes are needed in the modern endovascular era. This article provides the largest synthesis to date on the use of vascular closure devices for percutaneous axillary artery access in endovascular intervention. It should serve clinicians with added confidence around this approach in terms of providing a reference for technical success and complications. Clinically, this data is relevant for patient consent purposes as well as for practice quality improvement in setting safety standards for this access site.

The Use of Vascular Closure Devices for Brachial Artery Access: A Systematic Review and Meta-Analysis.

PURPOSE: To estimate the rates of technical success and adverse events of vascular closure devices (VCDs) in the brachial artery and compare the rates of adverse events with manual compression. MATERIALS AND METHODS: MEDLINE and Embase were searched for observational studies examining VCDs in the brachial artery. Meta-analyses were performed using random effects for the following outcomes: (a) technical success, (b) hematoma at the access site, (c) pseudoaneurysm, (d) local neurological adverse events, and (e) total number of adverse events. A pairwise meta-analysis compared VCD with manual compression for the outcomes of hematoma and the total number of adverse events. RESULTS: Of 1,761 eligible records, 16 studies including 510 access sites were included. Primary procedures performed were peripheral arterial disease interventions, percutaneous coronary intervention, and endovascular thrombectomy for ischemic stroke. The technical success rate was 93% (95% CI, 87%-96%; I2 = 47%). Data on the following adverse events were obtained via meta-analysis: (a) hematoma, 9% (5%-15%; I2 = 54%); (b) stenosis or occlusion at access site, 3% (1%-14%; I2 = 51%); (c) infection, 0% (0%-5%; I2 = 0%); (d) pseudoaneurysm, 4% (1%-13%; I2 = 61%); (e) local neurological adverse events, 5% (2%-13%; I2 = 54%); and (f) total number of adverse events, 15% (10%-22%; I2 = 51%). Angio-Seal success rate was 96% (93%-98%; I2 = 0%), whereas the ExoSeal success rate was 93% (69%-99%; I2 = 61%). When comparing VCD and manual compression, there was no difference in hematoma formation (relative risk, 0.75; 95% CI, 0.35-1.63; I2 = 0%; P = .47) or the total number of adverse events (relative risk, 0.75; 95% CI, 0.35-1.58; I2 = 76%; P = .45). CONCLUSIONS: Despite being off-label, studies suggest that VCDs in the brachial artery have a high technical success rate. There was no significant difference in adverse events between VCDs and manual compression in the brachial artery.

Hemodialysis Arteriovenous Access Cosmesis Scale (AVACS): A new measure for vascular access.

RATIONALE AND OBJECTIVE: This study aimed to develop a cosmesis scale to evaluate the cosmetic appearance of hemodialysis (HD) arteriovenous (AV) accesses from the perspective of the patient and clinician, which could be incorporated into clinical trials. STUDY DESIGN: Using a modified Delphi process, two AV access cosmesis scale (AVACS) components were developed in a four-round Delphi panel consisting of two surveys and two consensus meetings with two rounds of patient consultation. SETTING AND PARTICIPANTS: The Delphi panel consisted of 15 voting members including five interventional or general nephrologists, five vascular surgeons, three interventional radiologists, and two vascular access nurse coordinators. Four patients experienced with vascular access were involved in patient question development. ANALYTICAL APPROACH: For a component to be included in the AVACS, it had to meet the prespecified panel consensus agreement of ⩾70%. RESULTS: The clinician component of the AVACS includes nine questions on the following AV access features: scarring, skin discoloration, aneurysm/pseudoaneurysms and megafistula appearance. The patient component includes six questions about future vascular access decisions, interference with work or leisure activities, clothing choices, self-consciousness or attractiveness, emotional impact, and overall appearance. LIMITATIONS: Delphi panel methods are subjective by design, but with expert clinical opinion are used to develop classification systems and outcome measures. The developed scale requires further validation testing but is available for clinical trial use. CONCLUSIONS: While safety and efficacy are the primary concerns when evaluating AV access for HD, cosmesis is an important component of the ESKD patient experience. The AVACS has been designed to assess this important domain; it can be used to facilitate patient care and education about vascular access choice and maintenance. AVACS can also be used to inform future research on developing new techniques for AV access creation and maintenance, particularly as relates to AV access cosmesis.

Outcomes of Wrist-Access Deep Venous Embolization Following Percutaneous Fistula Creation: A Two-Year Single Center Experience.

PURPOSE: During percutaneous arteriovenous (pAVF) fistula creation, deep venous embolization is recommended to encourage superficial venous flow development. The safety of crossing adjacent to the newly formed fistula from wrist venous access has not been established. The purpose of this study was to evaluate the safety and efficacy of antegrade deep venous embolization after creation of the pAVF. MATERIALS: A retrospective analysis was performed of all procedural data related to pAVF creation using the Wavelinq device from October 2019 to November 2021. Patient data from the hospital information systems were collected where the venous access for fistula creation was from the wrist-access (ulnar or radial vein) and where deep venous embolization was performed after forming the fistula and crossing adjacent to the anastomosis. Thirty-nine patients were identified. RESULTS: Twenty pAVFs were created from wrist ulnar vein access and 19 from radial vein access. The accessed veins were used for embolization of the brachial veins central to the newly created anastomosis. No pAVFs were lost by crossing adjacent to the anastomotic area to perform deep venous embolization at time of creation. There were no major complications, specifically bleeding, infection, pseudoaneurysm formation. Rates of minor complications consisted of two coil migrations to the right atrium requiring uneventful retrieval (5%). Follow-up ultrasound data showed no evidence of delayed complications. CONCLUSION: In this single center experience crossing alongside the anastomosis of a newly formed percutaneous fistula from an antegrade venous approach was safe with no risk of loss of the pAVF.

Percutaneous Hemodialysis Fistula Creation.

Two devices have been recently introduced to the European Union and North American clinical practice that allow for percutaneous creation of autogenous hemodialysis fistulae (percutaneous arteriovenous fistulae [pAVFs]). Although there are many similarities between the devices, there are several important differences. The adoption of either or both technologies by an interventionalist may be determined by the individual's familiarity and preferences. Current and future outcomes will shape the acceptance and use of this technology. This review focuses on the similarities and differences between the devices, procedures, published outcomes to date, and their interpretation and other clinical considerations toward the initiation of a successful pAVF program.

Uterine Artery Embolization for Pedunculated Subserosal Fibroids: A Systematic Review and Meta-Analysis.

PURPOSE: To provide a comprehensive overview of the literature assessing the safety and efficacy of uterine artery embolization (UAE) for patients with pedunculated subserosal fibroids. MATERIALS AND METHODS: MEDLINE and Embase databases were searched without language or publication type restrictions for observational studies to estimate safety (adverse events) and efficacy (devascularization, fibroid volume reduction, and uterine volume reduction) outcomes. Case reports were included to qualitatively report adverse events. Meta-analysis was performed for single proportions and mean changes with random-effects modeling. RESULTS: Of 98 eligible articles, 11 studies were included in the final analysis. Of the adverse events detailed in these cases, 5 events were mild, 2 were moderate (torsion of pedunculated fibroid requiring laparoscopic myomectomy and persistent bleeding after embolization requiring hysterectomy), and 1 was severe (fibroid necrosis causing bowel obstruction requiring bowel resection and hysterectomy). There were no deaths reported in the literature. The pooled risk of adverse events was 1.7% (95% confidence interval [CI], 0.29%-9.2%; 4 of 181; I2 = 0%). The pooled devascularization rate was 75.9% (95% CI, 62.4%-85.6%; 140 of 189; I2 = 75%) at 3.91 months of follow-up. The percent volume reduction of the dominant pedunculated fibroid was 38.6% (95% CI, 33.0%-44.2%; I2 = 0%) at 4.3 months of follow-up. The percent uterine volume reduction was 36.7% (95% CI, 30.3%-43.0%; I2 = 47%) at 3.5 months of follow-up. CONCLUSIONS: UAE for pedunculated subserosal fibroids has a low risk of adverse events and effectively reduces fibroid and uterine size.

KDOQI 2019 Vascular Access Guidelines: What Is New.

The new Kidney Disease Outcomes Quality Initiative (KDOQI) Vascular Access Guidelines have a patient focus for comprehensive vascular access management. The patient's unique circumstances and individualized needs are the foundation of their dialysis access strategy, which is interlinked with the patient's End Stage Kidney Disease (ESKD) Life-Plan. The ESKD Life-Plan is an individualized and comprehensive map for dialysis modalities and vascular access for the lifetime of the patient. New targets are introduced that align with this patient-centered approach. They are less detail prescriptive than prior vascular access guidelines, giving opportunity for vascular access management at the clinician's discretion, partly in consideration of constraints of local resources and available expertise; however, the guidelines also emphasize the importance of high-quality standards with defined targets for achieving the guideline's overarching goal for vascular access care. The guidelines made significant changes relevant to the interventionalist, including selective use of vessel mapping in planning for vascular access, choice of vascular access that allows for considering endovascular access creations, and endovascular treatment (e.g., angioplasty, stent graft insertions) based on clinical indicators found on routine clinical monitoring. To that end, preemptive angioplasty of fistulas and grafts with stenosis, not associated with clinical indicators, is not recommended. New content in these guidelines also includes the use of stent grafts and management of central venous stenosis. The new KDOQI Vascular Access Guidelines 2019 represent a rigorous review of the evidence; however, the available evidence to guide vascular access practice remains limited. There is a significant need and opportunity for new and ongoing high-quality research to inform best practice.

Endovascular community response to mortality data in use of paclitaxel devices for peripheral vascular disease.

OBJECTIVE: We examined the endovascular community response to data demonstrating increased mortality in paclitaxel devices for the treatment of peripheral arterial disease in femoropopliteal lesions. METHODS: A retrospective observational study using the Vascular Quality Initiative Peripheral Vascular Intervention registry dataset was performed to examine paclitaxel device use for peripheral arterial disease in femoropopliteal arteries treated from 2017 to 2019. A total of 41,707 patients and 52,208 procedures were analyzed during the study period. A post hoc analysis was performed to examine paclitaxel device use during selected periods in 2019. RESULTS: The total number of femoropopliteal procedures in 2017, 2018, and 2019 were 17,458, 21,140, and 21,322, respectively. Paclitaxel devices were used for 8852 arteries in 2017, 10,691 in 2018, and 6732 in 2019, which was significantly reduced in 2019 compared with 2017 or 2018 (P < .0001) and 2019 compared with the 2018 and 2017 volumes combined (P < .0001). Post hoc analysis of selected periods in 2019 demonstrated variable use throughout 2019. CONCLUSIONS: After the report of data with concerns of mortality associated with paclitaxel device use in 2018, a rapid reduction in overall paclitaxel device use was observed in 2019.

Hepatic Arterial Blood Flow Modulation in Patients with Hepatocellular Carcinoma: A Pilot Study of the Influence of Intraarterial Norepinephrine Assessed with CT Perfusion.

PURPOSE: This pilot study aims to evaluate the effect of hepatic intraarterial norepinephrine injection in vasculature modulation for hepatocellular carcinoma (HCC) tumors. MATERIALS AND METHODS: This is a single-center prospective study of patients with HCC with proven single-lobe tumors > 3 cm. Eight patients were included, with a mean age of 63 y ± 8. All patients had Barcelona Clinic Liver Cancer stage B HCC and an Eastern Cooperative Oncology Group performance status of 0. Mean tumor size was 6.1 cm ± 1.8; all tumors were hypervascular. Patients underwent CT hepatic perfusion before and after injection of 24 µg of norepinephrine intraarterially (4 µg/mL; total 6 mL injected at a rate of 1 mL/s). Color-coded perfusion maps were used to assess the effects of local therapy on hepatic perfusion values. Tumor-to-liver ratio (TLR) was calculated from the ratio of tumor perfusion to background liver perfusion value. RESULTS: Seven of 8 patents had significant (P = .04) absolute increase in tumor perfusion vs background liver, varying from incremental (-2 mL/min/100 mL) to 290 mL/min/100 mL. There was a nonsignificant increase in TLR from 2.7 ± 1.3 to 2.9 ± 1.4 after norepinephrine injection (P = .8). Mean peak time to maximal increase in tumor perfusion after injection was 6.1 s (range, 4.5-9.1 s). Norepinephrine injection was well tolerated without major adverse events. CONCLUSIONS: Norepinephrine causes increased blood flow toward HCC tumors, but with a corresponding smaller increase in blood flow to noncancerous liver tissue, with no observed systemic side effects.

A Single-Center Experience With Percutaneous Interventional Management of Refractory Chylous Ascites.

PURPOSE: Management of chylous ascites is poorly understood with no management guidelines. We retrospectively reviewed patients treated for chylous ascites at our institution to evaluate efficacy and safety of lipiodol lymphangiography and embolization. MATERIALS AND METHODS: Seven patients underwent percutaneous interventional management of chylous ascites (average age 52.5 years, 3 female, 6 post-surgical, 1 pancreatitis) from 2012. All patients underwent lipiodol inguinal lymph node injection. Adjunctive glue embolization was performed if a leak was identified. Data were collected on the cause of chylous ascites, conservative management strategies, procedural details, and success. RESULTS: All patients had chylous ascites refractory to conservative management. Preprocedure lymphoscintigraphy identified a retroperitoneal leak in 6 patients. Seven patients underwent 12 lymphangiogram procedures; 8 were performed at our institution. Lymphangiography identified a leak in 5 patients (71%). Success was achieved in 2 patients (28%) treated at our institution after glue embolization following cannulation of the leaking lymphatic channels and 1 patient (14%) after lymphangiography alone for an overall success rate of 43% (3/7). Two patients (29%) were successfully treated after one procedure. Two patients (29%) unsuccessfully treated at our institution were referred to a specialized center in the United States. No 30 day post procedural complications. CONCLUSIONS: In our experience, lymphangiography and embolization was a safe, relatively effective and minimally invasive method for treating medically refractory chylous ascites. Complex cases required referral to a specialized institution with resources unavailable at our tertiary care center.

The role of surgery for assisted maturation after endovascular and percutaneous arteriovenous fistula creation.

Even in the best of circumstances, a significant number of patients will require adjunctive endovascular and/or surgical revision prior to achieving functional patency after endovascular or percutaneous AVF creation, at least within the United States. This rate appears to be higher after percutaneous AVF than after endovascular AVF, although because published reports of the former are mostly derived from American experience and those of the latter derived from experience outside the United States, it is unclear whether these differences are due to the technique itself or cultural and/or anatomic differences in dialysis access practices and patient populations. If arterial inflow is poor, this should be corrected first. When flow is adequate (perhaps 900 cc/min) but no single vein is cannulatable, a dominant suitable vein can be superficialized or transposed. If no suitable vein is dominant (most accurately assessed by using an intraoperative flowmeter), the best vein can be used, with or without occlusion of the other veins or reimplantation into the brachial artery. Finally, if the original anastomosis remains the sole supply to the cannulated vein, the original fistula has achieved assisted primary maturation (and assisted primary patency continues), while if a new arteriovenous anastomosis has been constructed, the original fistula has failed. We point out that for this reason as well as to best utilize the upper arm for later access, endovascular and percutaneous AVFs should be constructed and maintained within an atmosphere where both surgeons and non-surgeons work together on the overall access plan.

Complication rates associated with antegrade use of vascular closure devices: a systematic review and pooled analysis.

BACKGROUND: Vascular closure devices (VCDs) have become a mainstay in endovascular interventions in recent years. On-label use only allows for retrograde interventions originating at the common femoral artery (CFA). However, off-label use in antegrade and/or superficial femoral artery (SFA) access has become more common in the treatment of peripheral arterial disease. Despite this, there is a paucity of comparative literature assessing individual VCD safety profiles and relative complication risks of CFA vs SFA applications. METHODS: MEDLINE and EMBASE systematic searches were performed from inception to October 2019 to identify studies assessing VCD use in antegrade CFA and SFA interventions. Abstract selection and data extraction were performed by two independent reviewers. Primary outcomes included bleeding-related complications, vessel occlusion or stenosis, embolization, pseudoaneurysm formation, or arteriovenous fistula formation. RESULTS: Twenty-four unique studies with 4124 vascular closure events via six unique VCDs were included (Angioseal, Exoseal, Femoseal, Glubran 2, Mynx, Starclose; 3698 CFA, 426 SFA). Pooled occurrence of all complications across closure devices used in the CFA and SFA ranged from 0.9% (Mynx) to 7.4% (Starclose) and 0% (Perclose) to 10.1% (Starclose), respectively, depending on VCD type. Clinically meaningful differences were identified between devices with a trend toward significance (P = .08 CFA, P = .07 SFA). Individual devices demonstrated a range of bleeding complication rates from 0.4% (Mynx) to 7.2% (Femoseal) for the CFA site and from 0% (Perclose) to 6.4% (Starclose) for the SFA site (P = .01 and P = .03, respectively). Significant heterogeneity between studies precludes definitive characterization of the device as cause for variations in bleeding complication rates. Pooled complication rates did not differ between the CFA and SFA arms (4.6% vs 5.8%, P = .56). Bleeding complication rates also did not differ between the CFA and SFA arms (3.6% vs 3.6%, P = .98). CONCLUSIONS: Clinically meaningful differences in overall pooled complications were identified between VCDs with a trend toward significance. Significant differences between VCDs exist with respect to bleeding risk. However, this must be interpreted with caution as these differences could be secondary to interstudy heterogeneity. Finally, no difference was identified between antegrade SFA and CFA VCD use with respect to overall complication and bleeding risks.