VasQ U.S. pivotal study demonstrates the safety and effectiveness of an external vascular support for arteriovenous fistula creation.

OBJECTIVE: Arteriovenous fistula (AVF) creation is a commonly performed vascular operation that reports 6-month functional success rates as low as 50%. Recently, a nitinol external vascular support device, VasQ, has shown potential in studies outside the United States (U.S.) to improve AVF outcomes when implanted at creation. Here, the pivotal study results of this novel technology in treating patients in the U.S. are described. METHODS: VasQ was implanted in 144 patients at 16 centers across the U.S. who were referred for creation of a new AVF and consented for enrollment in a 2-year, prospective, multicenter, single-arm, open-label study. Brachiocephalic (n = 129) and radiocephalic (n = 15) AVFs were analyzed. The primary endpoint was primary patency at 6 months compared against a performance goal of 55% derived from a systematic literature search. Safety endpoints included device-related events, ischemic steal, infection, aneurysm, and seroma at up to 6 months. Minimum arterial size was 2.0 mm; target veins were required to measure 2.5 to 6 mm. Key exclusion criteria were patients <18 or >80 years, those with known ipsilateral central venous occlusion, target cannulation zone venous depth greater than 8 mm, and New York Heart Association class 3 or 4. RESULTS: Patients were 61% male, 53% White, 35% African American, and 14% Hispanic. Mean age was 60 years, and median body mass index was 30.4. Of the patients, 69% were diabetic, 66% were on dialysis at the time of creation, and 70% had a prior access surgery. At 6 months, steal was observed in 2.1%, infection in 0.7%, and no aneurysms or seromas were seen. Primary patency at 6 months was 66% (P < .021 vs performance goal). Physiological maturation was achieved in 92.4% of patients. Successful two-needle cannulation for patients that entered the study on dialysis was achieved in 88% of VasQ AVFs at a median of 56 days. Pre-dialysis patients who initiated dialysis during the study achieved two-needle cannulation in 81.6% VasQ AVFs. Interventions were required at a rate of 1.07 per patient year over the entire study period. Two-year cumulative patency was 76.6% (95% confidence interval, 67.9%-83.4%) with no statistical difference between patients requiring interventions and those that did not. No patency differences were observed between brachiocephalic and radiocephalic AVFs. CONCLUSIONS: The U.S. pivotal study results demonstrated improved AVF outcomes and an excellent safety profile with VasQ use relative to traditional AVFs. Under the conditions of this trial, VasQ shows great promise in expeditiously and efficiently enhancing AVF functional success.

Early Intervention for Steal Syndrome in Patients on Hemodialysis.

Dialysis access-associated steal syndrome (DASS) is a serious, challenging complication related to diminished arterial blood flow to the hand. Patients may not be routinely assessed for this diagnosis, resulting in a delayed presentation with severe hand pain, nerve damage, and tissue loss. This pilot project examined the feasibility of implementing an assessment tool to routinely screen patients for steal syndrome. The tool was used for all patients in three participating dialysis centers. Positive patients had a streamlined referral to vascular surgery for assessment and possible treatment. This pilot project demonstrates that education and subsequent routine screening for DASS within the dialysis facility is feasible, and can be incorporated into the workflow for both the dialysis facility and the servicing vascular surgery office. Early recognition of DASS will prevent severe injuries and tissue loss.

Cost-effectiveness analysis of immediate access arteriovenous grafts versus standard grafts for hemodialysis.

OBJECTIVE: Immediate-access arteriovenous grafts (IAAVGs), or early cannulation arteriovenous grafts (AVGs), are more expensive than standard grafts (sAVGs) but can be used immediately after placement, reducing the need for a tunneled dialysis catheter (TDC). We hypothesized that a decrease in TDC-related complications would make IAAVGs a cost-effective alternative to sAVGs. METHODS: We constructed a Markov state-transition model in which patients initially received either an IAAVG or an sAVG and a TDC until graft usability; patients were followed through multiple subsequent access procedures for a 60-month time horizon. The model simulated mortality and typical graft- and TDC-related complications, with parameter estimates including probabilities, costs, and utilities derived from previous literature. A key parameter was median time to TDC removal after graft placement, which was studied under both real-world (7 days for IAAVG and 70 days for sAVG) and ideal (no TDC placed with IAAVG and 1 month for sAVG) conditions. Costs were based on current Medicare reimbursement rates and reflect a payer perspective. Both microsimulation (10,000 trials) and probabilistic sensitivity analysis (10,000 samples) were performed. The willingness-to-pay threshold was set at $100,000 per quality-adjusted life-year (QALY). RESULTS: IAAVG placement is a dominant strategy under both real-world ($1201.16 less expensive and 0.03 QALY more effective) and ideal ($1457.97 less expensive and 0.03 QALY more effective) conditions. Under real-world parameters, the result was most sensitive to the time to TDC removal; IAAVGs are cost-effective if a TDC is maintained for ≥23 days after sAVG placement. The mean catheter time was lower with IAAVG (3.9 vs 8.7 months; P < .0001), as was the mean number of access-related infections (0.55 vs 0.74; P < .0001). Median survival in the model was 29 months. Overall mortality was similar between groups (76.3% vs 76.7% at 5 years; P = .33), but access-related mortality trended toward improvement with IAAVG (6.1% vs 6.8% at 5 years; P = .052). CONCLUSIONS: The Markov decision analysis model supported our hypothesis that IAAVGs come with added initial cost but are ultimately cost-saving and more effective. This apparent benefit is due to our prediction that a decreased number of catheter days per patient would lead to a decreased number of access-related infections.

Negative pressure wound therapy reduces surgical site infections.

OBJECTIVE: Surgical site infection (SSI) with lower extremity incisions represents a modifiable source of major morbidity. Our institutional bundled care protocol to decrease SSI includes optimization of perioperative risk factors, dedicated wound closure tray, and voluntary use of a closed surface negative pressure wound therapy (cNPWT) device applied over closed incisions in the operating room. This study examined the individual effect of cNPWT on SSI reduction and other perioperative outcomes. METHODS: All patients with lower extremity or infrainguinal incisions between January 2016 and December 2017 were prospectively identified and tracked for infectious complications. All patients were treated with the same perioperative care bundle to reduce SSI. cNPWT was applied over closed incisions at the discretion of the surgeon. The 90-day outcomes regarding SSI, return to operating room, death, and readmission were tracked. Univariate and multivariate analysis using binary logistic regression for factors associated with SSI was performed for patients with and without cNPWT devices, with P < .05 determined to be significant. RESULTS: There were 504 patients included, 225 with cNPWT and 279 with standard dressings. Between the groups, there were no major differences in mean age, mean body mass index, perioperative transfusions, use of prosthetic, reoperative field, dialysis status, and presence of diabetes. There were significantly more women (39.6% vs 27.2% female; P < .01) and active smokers (47.1% vs 30.2%; P < .01) in the cNPWT group along with increased mean operative times (238.3 vs 189.0 minutes; P < .01). Univariate analysis revealed significantly fewer SSIs with cNPWT (9.8% vs 19.0% in standard dressings; P < .01) along with decreased perioperative mortality (5.8% vs 11.2%; P = .04). There were no differences in return to operating room (27.6% cNPWT vs 27.7% standard; P = .97) or readmissions (29.8% cNPWT vs 26.5%; P = .43), but more returns to the operating room were for wound-related problems in the standard dressings group (48.3% vs 26.2%; P < .01). Binary logistic regression using an SSI end point demonstrated that female sex increases SSI (odds ratio, 2.43; confidence interval, 1.37-4.30; P < .01), whereas cNPWT reduces SSI (odds ratio, 0.32; confidence interval, 0.17-0.63; P < .01). CONCLUSIONS: The use of negative pressure wound therapy devices decreases the incidence of infrainguinal wound infections. This occurs as an independent factor as part of a patient care bundle targeting modifiable variables in perioperative care.

Deep Learning-Based Risk Model for Best Management of Closed Groin Incisions After Vascular Surgery.

BACKGROUND: Reduced surgical site infection (SSI) rates have been reported with use of closed incision negative pressure therapy (ciNPT) in high-risk patients. METHODS: A deep learning-based, risk-based prediction model was developed from a large national database of 72,435 patients who received infrainguinal vascular surgeries involving upper thigh/groin incisions. Patient demographics, histories, laboratory values, and other variables were inputs to the multilayered, adaptive model. The model was then retrospectively applied to a prospectively tracked single hospital data set of 370 similar patients undergoing vascular surgery, with ciNPT or control dressings applied over the closed incision at the surgeon's discretion. Objective predictive risk scores were generated for each patient and used to categorize patients as "high" or "low" predicted risk for SSI. RESULTS: Actual institutional cohort SSI rates were 10/148 (6.8%) and 28/134 (20.9%) for high-risk ciNPT versus control, respectively (P < 0.001), and 3/31 (9.7%) and 5/57 (8.8%) for low-risk ciNPT versus control, respectively (P = 0.99). Application of the model to the institutional cohort suggested that 205/370 (55.4%) patients were matched with their appropriate intervention over closed surgical incision (high risk with ciNPT or low risk with control), and 165/370 (44.6%) were inappropriately matched. With the model applied to the cohort, the predicted SSI rate with perfect utilization would be 27/370 (7.3%), versus 12.4% actual rate, with estimated cost savings of $231-$458 per patient. CONCLUSIONS: Compared with a subjective practice strategy, an objective risk-based strategy using prediction software may be associated with superior results in optimizing SSI rates and costs after vascular surgery.

Treatment of Arm Swelling in Hemodialysis Patients with Ipsilateral Arteriovenous Access and Central Vein Stenosis: Conversion to the Hemodialysis Reliable Outflow Graft versus Stent Deployment.

PURPOSE: To compare outcomes after conversion of arteriovenous (AV) access to Hemodialysis Reliable Outflow (HeRO) graft vs stent deployment in patients with arm swelling owing to ipsilateral central vein stenosis. MATERIALS AND METHODS: This single-center retrospective study comprised 48 patients (19 men, mean age 58 y) with arm swelling ipsilateral to AV access and central vein stenosis over a 13-year period who had clinical follow-up and without prior central stents. Twenty-one patients underwent placement of a HeRO graft with anastomosis of the HeRO graft to the existing graft or fistula, and 27 patients underwent central venous stent deployment. Symptomatic improvement in arm swelling and access patency rates after intervention were ascertained from medical records. RESULTS: Improvement in swelling within 1 month after HeRO conversion and stent deployment was found in 95% and 89%, respectively (P = .62). Swelling eventually recurred in 16 patients (59%) treated with stents compared with 1 patient (5%) who underwent HeRO conversion (P < .001). Primary access patency was statistically significantly longer after HeRO conversions than stent deployments, with 6- and 12-month primary patency rates of 89% and 72% vs 47% and 11% (P < .001). HeRO conversions also resulted in longer 6- and 12-month secondary access patency rates (95% and 95% vs 79% and 58%, P = .006). Mean number of interventions per 1,000 access days to maintain secondary patency was 2.7 for the HeRO group vs 6.3 for the stent group. CONCLUSIONS: Although stent deployment and HeRO graft conversion are effective for alleviating arm swelling in the short term in patients receiving hemodialysis with clinically significant arm swelling and functioning AV access, the HeRO graft has more durable results.

A systematic review and meta-analysis of randomized controlled trials for the reduction of surgical site infection in closed incision management versus standard of care dressings over closed vascular groin incisions.

OBJECTIVE: Surgical site infection after groin incision is a common complication and a financial burden to patients and healthcare systems. Closed incision negative pressure therapy (ciNPT) has been associated with decreased surgical site infection rates in published literature. This meta-analysis examines the effect of ciNPT (PREVENA™ Incision Management System; KCI, San Antonio, TX) versus traditional postsurgical dressing use in reducing surgical site infection rates over closed groin incisions following vascular surgery. METHODS: A systematic literature search using PubMed, OVID, EMBASE, and QUOSA was performed on 3 January 2019, by two independent researchers and focused on publications between 1 January 2005 and 31 December 2018. The review conformed to the statement and reporting check list of the Preferred Reporting Items for Systematic Reviews and Meta Analyses. Inclusion criteria included abstract or manuscript written in English, published studies, conference abstracts, randomized controlled trials (RCTs), ciNPT usage over closed groin incisions in vascular surgery, comparison of ciNPT use and traditional dressings, study endpoint/outcome of surgical site infection, and study population of >10. Characteristics of study participants, surgical procedure, type of dressing used, duration of treatment, incidence of surgical site infection, and length of follow-up were extracted. Weighted odds ratios and 95% confidence intervals were calculated to pool study and control groups in each publication for analysis. Treatment effects were combined using Mantel-Haenszel risk ratios, and the Chi-Square test was used to assess heterogeneity. Overall, high-risk patients, normal-risk patients, and Szilagyi I, II, III outcomes were assessed between ciNPT and control groups. The Cochrane Collaboration tool was utilized to assess the risk of bias for all studies included in the analysis. RESULTS: A total of 615 articles were identified from the literature search. After removal of excluded studies and duplicates, six RCT studies were available for analysis. In these studies, a total of 362 patients received ciNPT, and 371 patients received traditional dressings (control). Surgical site infection events occurred in 41 ciNPT patients and 107 control patients. The heterogeneity test was nonsignificant (p > 0.05). The overall RCT meta-analysis showed a highly significant effect in favor of ciNPT (OR = 3.06, 95% CI [2.05, 4.58], p < 0.05). High-risk, normal-risk, Szilagyi I, and Szilagyi II meta-analyses were also statistically significant in favor of ciNPT use (p < 0.05). The varying RCT inclusion/exclusion criteria, such as differences in procedure types, and patient populations form the major limitations of this study. CONCLUSIONS: A statistically significant reduction in the incidence of surgical site infection was seen following ciNPT usage in patients undergoing vascular surgery with groin incisions.

Immediate-access grafts provide comparable patency to standard grafts, with fewer reinterventions and catheter-related complications.

BACKGROUND: No independent comparisons, with midterm follow-up, of standard arteriovenous grafts (SAVGs) and immediate-access arteriovenous grafts (IAAVGs) exist. The goal of this study was to compare "real-world" performance of SAVGs and IAAVGs. METHODS: Consecutive patients who underwent placement of a hemodialysis graft between November 2014 and April 2016 were retrospectively identified from the electronic medical record and Vascular Quality Initiative database at two tertiary centers. Only primary graft placements were included for analysis. Patients were divided into two groups based on the type of graft implanted. Patients' comorbidities, graft configuration, operative characteristics, and follow-up were collected and analyzed with respect to primary and secondary patency. Additional outcomes included graft-related complications, time to first cannulation, time to tunneled catheter removal, catheter-related complications, and overall survival. Patency was determined from the time of the index procedure; χ2, Kaplan-Meier, and Cox regression analyses were used, with the P value set as significant at < .05. RESULTS: There were 210 grafts identified, 148 SAVGs and 62 IAAVGs. At baseline, the patients' characteristics were similar between groups, except for a greater prevalence of preoperative central venous occlusions in the IAAVG group (16.3% vs 6.8%; P < .04). Of the IAAVG group, 50 were Acuseal (W. L. Gore & Associates, Flagstaff, Ariz) and 12 were Flixene (Atrium Medical Corporation, Hudson, NH). Primary patency was similar at both 1 year (SAVG, 39.4%; IAAVG, 56.7%; P = .4) and 18 months (SAVG, 29.0%; IAAVG, 43.7%; P = .4). Secondary patency was similar at 1 year (SAVG, 50.7%; IAAVG, 52.1%; P = .73) and 18 months (SAVG, 42.3%; IAAVG, 46.3%; P = .73). Overall survival was 48% at 24 months. IAAVG patients required fewer overall additional procedures to maintain patency (mean number of procedures, 0.99 for SAVGs vs 0.61 for IAAVGs; P = .025). There was no difference in occurrence of steal syndrome (SAVG, 6.8%; IAAVG, 8.1%; P = .74) or graft infection (SAVG, 19.0%; IAAVG, 12.0%; P = .276). Seventy-five percent of all grafts were successfully cannulated, with shorter median time to first cannulation in the IAAVG group (6 days; interquartile range [IQR], 1-19 days) compared with the SAVG group (31 days; IQR, 26-47 days; P < .01). Of all pre-existing catheters, 65.75% were removed, with a shorter median time until catheter removal in the IAAVG cohort at 34 days (IQR, 22-50 days) vs 49 days (IQR, 39-67 days) in the SAVG group (P < .01). Catheter-related complications occurred less frequently in the IAAVG group (16.4% vs 2.9%; P < .045). CONCLUSIONS: IAAVGs allow earlier cannulation and tunneled catheter removal, thereby significantly decreasing catheter-related complications. Patency and infection rates were similar between SAVGs and IAAVGs, but fewer secondary procedures were performed in IAAVGs.

Current Experience and Midterm Follow-up of Immediate-Access Arteriovenous Grafts.

BACKGROUND: No independent reviews, with midterm follow-up, of current experience with immediate-access arteriovenous grafts (IAAVGs) exist. The goal of this project was to assess the real-world performance of 2 different IAAVGs over a 2-year period at a large tertiary referral center. METHODS: Between January 2014 and April 2016, all consecutive patients who underwent placement of Acuseal (Gore) or Flixine (Maquet) IAAVGs were identified for retrospective analysis from the electronic medical record and Vascular Quality Initiative database. Primary, primary-assisted and secondary patency rates, time to first cannulation, time to tunneled catheter removal, and overall survival were recorded. RESULTS: Forty-three patients were identified to have undergone placement of IAAVG, 31 Acuseal (72%), and 12 Flixine (28%). Of the Acuseal cohort, 7 were implanted with outflow through a HeRO catheter system (Merit Medical). Mean follow-up time was 8.4 months. Overall survival was 57.4% at 18 months. Overall primary, primary assisted, and secondary patency at 18 months were 33.36%, 34.31%, and 51.03%, respectively. Eighty three percent of grafts were successfully cannulated, and 78% of preexisting catheters were removed. Mean time to successful graft cannulation and catheter removal were 14.85 and 32.26 days, respectively. CONCLUSIONS: Real-world experience with novel arteriovenous access grafts is consistent with results from industry-sponsored studies. Early cannulation of immediate-access grafts can be successfully performed in a wide variety of patients. However, prolonged catheter dwell times persist despite increased rates of successful early-graft cannulation. Further study of methods for promoting catheter removal in this patient population is warranted.

Patients started on hemodialysis with tunneled dialysis catheter have similar survival after arteriovenous fistula and arteriovenous graft creation.

OBJECTIVE: Current guidelines suggest that arteriovenous fistula (AVF) is associated with survival advantage over arteriovenous graft (AVG). However, AVFs often require months to become functional, increasing tunneled dialysis catheter (TDC) use, which can erode the benefit of an AVF. We sought to compare survival in patients with end-stage renal disease after creation of an AVF or AVG in patients starting hemodialysis (HD) with a TDC and to identify patient populations that may benefit from preferential use of AVG over AVF. METHODS: Using U.S. Renal Data System databases, we identified incident HD patients in 2005 through 2008 and observed them through 2008. Initial access type and clinical variables including albumin levels were assessed using U.S. Renal Data System data collection forms. Attempts at AVF and AVG creation in patients who started HD through a TDC were identified by Current Procedural Terminology codes. We accounted for the effect of changes in access type by truncating follow-up when an additional AVF or AVG was performed. Survival curves were then constructed, and log-rank tests were used for pairwise survival comparisons, stratified by age. Multivariate analysis was performed with Cox proportional hazards regressions; variables were chosen using stepwise elimination. An interaction of access type and albumin level was detected, and Cox models using differing thresholds for albumin level were constructed. The primary outcome was survival. RESULTS: Among the 138,245 patients who started with a TDC and had complete records amenable for analysis, 22.8% underwent AVF creation (mean age ± standard deviation, 68.9 ± 12.5 years; 27.8% mortality at 1 year) and 7.6% underwent AVG placement (70.2 ± 12.0 years; 28.2% mortality) within 3 months of HD initiation; 69.6% remained with a TDC (63.2 ± 15.4 years; 33.8% mortality). In adjusted Cox proportional hazards regression, AVF creation is equivalent to AVG placement in terms of survival (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.93-1.02; P = .349). AVG placement is superior to continued TDC use (HR, 1.54; 95% CI, 1.48-1.61; P < .001). In patients older than 80 years with albumin levels >4.0 g/dL, AVF creation is associated with higher mortality hazard compared with AVG creation (HR, 1.22; 95% CI, 1.04-1.43; P = .013). CONCLUSIONS: For patients who start HD through a TDC, placement of an AVF and AVG is associated with similar mortality hazard. Further study is necessary to determine the ideal access for patients in whom the survival advantage of an AVF over an AVG is uncertain.

Management and outcomes of dialysis access-associated steal syndrome.

OBJECTIVE: Dialysis access-associated steal syndrome (DASS) complicates arteriovenous access surgery. We describe a 10-year experience with the surgical management of DASS. METHODS: DASS operations were retrospectively reviewed from July 2003 to July 2013 from a single academic institution. Demographics, symptoms, surgical details, and outcomes were collected. RESULTS: A total of 201 patients had 218 episodes of DASS. Mean age was 65 years, and 62% were women. DASS was caused by 175 arteriovenous fistulas (80%), 41 upper extremity prosthetic grafts (19%), and two thigh grafts (1%); 87% were brachial artery based. A portion (22%) were referred for DASS from outside practices. All patients had grade 2 (48%) or grade 3 (52%) DASS; 92% (185) were available for follow-up, with a median time to first follow-up of 23 days. Surgical procedures included ligation (73), distal revascularization with interval ligation (DRIL) (59), revision using distal inflow (RUDI) (21), banding (38), proximalization of arterial inflow (12), and distal radial artery ligation (13). There were no differences in preoperative comorbidities between treatment groups. The 30-day complications included continued steal, thrombosis, bleeding, infection, and mortality. Ligation and DRIL were performed most often for grade 3 steal. Ligation and banding were performed most acutely (median time to intervention after access creation of 39 and 24 days vs DRIL and RUDI at 97 and 100 days). Fistula preservation was 0% for ligation, 100% for DRIL, 95% for RUDI, and 89% for banding (P < .01). Improvement of symptoms ranged from 75% (banding) to 98% (DRIL) (P = .005). Women were less likely to have DRIL but more likely to have ligation (P = .001). Complications were highest in the banding (49%) and RUDI (37%) groups. Average mortality was 3.5%, with no significant differences among groups. During the study period, 3287 access procedures were performed, and access volume steadily increased (2003-2008, 1312 access creations; 2008-2013, 1975). Percentage of fistulas (79% vs 86%), incidence of steal (4% vs 6%), and percentage of DRILs (25% vs 28%) were consistent across the two study periods. CONCLUSIONS: DRIL and ligation were performed in patients with the most severe symptoms. Compared with ligation, DRIL has equal symptom resolution, no increase in complications, and fistula preservation. Compared with banding, DRIL resulted in superior fistula preservation and fewer complications. DRIL should be considered the preferred procedure for management of DASS in patients with a functioning autologous fistula who can tolerate a major operation.

Arteriovenous grafts are associated with earlier catheter removal and fewer catheter days in the United States Renal Data System population.

OBJECTIVE: Arteriovenous fistulas (AVFs) are associated with improved long-term outcomes but longer maturation times and higher primary failure rates compared with arteriovenous grafts (AVGs). The Fistula First Breakthrough Initiative has recently emphasized tunneled dialysis catheter (TDC) avoidance. We sought to characterize the relationship of AVFs and AVGs to the use of TDCs as well as secondary procedures. METHODS: Using the United States Renal Data System (USRDS) database, we identified incident hemodialysis (HD) patients in 2005 that started HD with a TDC and survived at least 1 year. We then monitored them through 2008. Access creation, TDC removal, TDC placement, and secondary procedures were identified by Current Procedural Terminology codes (American Medical Association, Chicago, Ill). Multivariate logistic regression was used to identify risk factors for the primary end points. RESULTS: In 2005, HD was initiated in 56,495 patients, 74% with a TDC. Of these, 6286 had an access procedure ≤3 months and 1 year of follow-up (AVF, 4634; AVG, 1652). Mean age was 67.7 years (AVF, 67.3; AVG, 68.7 years; P < .001), 53.3% were men (AVF, 58.1%; AVG, 40.5%; P < .001), and 33.8% were obese (AVF, 33.6%; AVG, 34.4%; P = not significant). AVG placement was associated with a higher TDC removal at 1 (7.9% vs 3.1%; P < .001), 3 (47.8% vs 17.8%; P < .001), and 6 (60.6% vs 47.2%; P < .001) months. There was no difference at 9 months (AVG, 64.9% vs AVF, 62.3%; P = .06). The median time to TDC removal was lower in the AVG group (70 days vs 155 days; P < .001). Multivariable model found AVFs were associated with decreased odds of TDC removal at 3 (odds ratio, 0.22; P < .001) and 6 months (odds ratio, 0.54; P < .001). AVGs required more secondary procedures than AVFs at all time points up to 1 year and specifically had increased thrombectomy procedures (39.8% vs 11.5%; P < .001). CONCLUSIONS: In patients starting dialysis with a TDC, AVGs are associated with increased TDC removal and fewer catheter days compared with AVFs at up to 6 months. However, AVGs require more secondary procedures at all time points up to 1 year.

Gender-specific 30-day outcomes after carotid endarterectomy and carotid artery stenting in the Society for Vascular Surgery Vascular Registry.

OBJECTIVE: Although the optimal treatment of carotid stenosis remains unclear, available data suggest that women have higher risk of adverse events after carotid revascularization. We used data from the Society for Vascular Surgery Vascular Registry to determine the effect of gender on outcomes after carotid endarterectomy (CEA) and carotid artery stenting (CAS). METHODS: There were 9865 patients (40.6% women) who underwent CEA (n = 6492) and CAS (n = 3373). The primary end point was a composite of death, stroke, and myocardial infarction at 30 days. RESULTS: There was no difference in age and ethnicity between genders, but men were more likely to be symptomatic (41.6% vs 38.6%; P < .003). There was a higher prevalence of hypertension and chronic obstructive pulmonary disease in women, whereas men had a higher prevalence of coronary artery disease, history of myocardial infarction, and smoking history. For disease etiology in CAS, restenosis was more common in women (28.7% vs 19.7%; P < .0001), and radiation was higher in men (6.2% vs 2.6%; P < .0001). Comparing by gender, there were no statistically significant differences in the primary end point for CEA (women, 4.07%; men, 4.06%) or CAS (women, 6.69%; men, 6.80%). There remains no difference after stratification by symptomatology and multivariate risk adjustment. CONCLUSIONS: In this large, real-world analysis, women and men demonstrated similar results after CEA or CAS. These data suggest that, contrary to previous reports, women do not have a higher risk of adverse events after carotid revascularization.

Factors that influence perforator thrombosis and predict healing with perforator sclerotherapy for venous ulceration without axial reflux.

OBJECTIVE: Refluxing perforators contribute to venous ulceration. We sought to describe patient characteristics and procedural factors that (1) impact rates of incompetent perforator vein (IPV) thrombosis with ultrasound-guided sclerotherapy (UGS) and (2) impact the healing of venous ulcers (CEAP 6) without axial reflux. METHODS: A retrospective review of UGS of IPV injections from January 2010 to November 2012 identified 73 treated venous ulcers in 62 patients. Patients had no other superficial or axial reflux and were treated with standard wound care and compression. Ultrasound imaging was used to screen for refluxing perforators near ulcer(s). These were injected with sodium tetradecyl sulfate or polidocanol foam and assessed for thrombosis at 2 weeks. Demographic data, comorbidities, treatment details, and outcomes were analyzed. Univariate and multivariable modeling was performed to determine covariates predicting IPV thrombosis and ulcer healing. RESULTS: There were 62 patients (55% male; average age, 57.1 years) with active ulcers for an average of 28 months with compression therapy before perforator treatment, and 36% had a history of deep venous thrombosis and 30% had deep venous reflux. At a mean follow-up of 30.2 months, ulcers healed in 32 patients (52%) and did not heal in 30 patients (48%). Ulcers were treated with 189 injections, with an average thrombosis rate of 54%. Of 73 ulcers, 43 ulcers (59%) healed, and 30 (41%) did not heal. The IPV thrombosis rate was 69% in patients whose ulcers healed vs 38% in patients whose ulcers did not heal (P < .001). Multivariate models demonstrated male gender (P = .03) and warfarin use (P = .01) negatively predicted thrombosis of IPVs. A multivariate model for ulcer healing found complete IPV thrombosis was a positive predictor (P = .02), whereas a large initial ulcer area was a negative predictor (P = .08). Increased age was associated with fewer ulcer recurrences (P = .05). Predictors of increased ulcer recurrences were hypertension (P = .04) and increased follow-up time (P = .02). Calf vein thrombosis occurred after 3% (six of 189) of injections. CONCLUSIONS: Thrombosis of IPVs with UGS increases venous ulcer healing in a difficult patient population. Complete closure of all IPVs in an ulcerated limb was the only predictor of ulcer healing. Men and patients taking warfarin have decreased rates of IPV thrombosis with UGS.

Report on the Hemodialysis Reliable Outflow (HeRO) experience in dialysis patients with central venous occlusions.

OBJECTIVE: The Hemodialysis Reliable Outflow (HeRO) graft (Hemosphere/CryoLife Inc, Eden Prairie, Minn) has provided an innovative means to obtain hemodialysis access for patients with severe central venous occlusive disease. The outcomes of this novel treatment modality in a difficult population have yet to be clearly established. METHODS: A retrospective review of HeRO graft placement from June 2010 to January 2012 was performed. Patient hemodialysis access history, clinical complexity, complications, and outcomes were analyzed. Categoric data were described with counts and proportions, and continuous data with means, ranges and, when appropriate, standard deviations. Patency rates were analyzed using life-table analysis, and patency rate comparisons were made with a two-group proportion comparison calculator. RESULTS: HeRO graft placement was attempted 21 times in 19 patients (52% women), with 18 of 21 (86%) placed successfully. All but one was placed in the upper extremity. Mean follow-up after successful placement has been 7 months (range, 0-23 months). The primary indication for all HeRO graft placements except one was central vein occlusion(s) and need for arteriovenous access. Patients averaged 2.0 previous (failed) accesses and multiple catheters. Four HeRO grafts (24%), all in women, required ligation and removal for severe steal symptoms in the immediate postoperative period (P < .01 vs men). Three HeROs were placed above fistulas for rescue. All thrombosed <4 months, although the fistulas remained open. An infection rate of 0.5 bacteremic events per 1000 HeRO-days was observed. At a mean follow-up of 7 months, primary patency was 28% and secondary patency was 44%. The observed 12-month primary and secondary patency rates were 11% and 32%, respectively. Secondary patency was maintained in four patients for a mean duration of 10 months (range, 6-18 months), with an average of 4.0 ± 2.2 thrombectomies per catheter. CONCLUSIONS: HeRO graft placement, when used as a last-resort measure, has been able to provide upper extremity access in patients who otherwise would not have this option. There is a high complication rate, however, including a very high incidence of steal in women. HeRO grafts should continue to be used as a last resort.

The impact of Centers for Medicare and Medicaid Services high-risk criteria on outcome after carotid endarterectomy and carotid artery stenting in the SVS Vascular Registry.

OBJECTIVE: The Centers for Medicare and Medicaid Services (CMS) require high-risk (HR) criteria for carotid artery stenting (CAS) reimbursement. The impact of these criteria on outcomes after carotid endarterectomy (CEA) and CAS remains uncertain. Additionally, if these HR criteria are associated with more adverse events after CAS, then existing comparative effectiveness analysis of CEA vs CAS may be biased. We sought to elucidate this using data from the SVS Vascular Registry. METHODS: We analyzed 10,107 patients undergoing CEA (6370) and CAS (3737), stratified by CMS HR criteria. The primary endpoint was composite death, stroke, and myocardial infarction (MI) (major adverse cardiovascular event [MACE]) at 30 days. We compared baseline characteristics and outcomes using univariate and multivariable analyses. RESULTS: CAS patients were more likely to have preoperative stroke (26% vs 21%) or transient ischemic attack (23% vs 19%) than CEA. Although age ≥ 80 years was similar, CAS patients were more likely to have all other HR criteria. For CEA, HR patients had higher MACEs than normal risk in both symptomatic (7.3% vs 4.6%; P < .01) and asymptomatic patients (5% vs 2.2%; P < .0001). For CAS, HR status was not associated with a significant increase in MACE for symptomatic (9.1% vs 6.2%; P = .24) or asymptomatic patients (5.4% vs 4.2%; P = .61). All CAS patients had MACE rates similar to HR CEA. After multivariable risk adjustment, CAS had higher rates than CEA for MACE (odds ratio [OR], 1.2; 95% confidence interval [CI], 1.0-1.5), death (OR, 1.5; 95% CI, 1.0-2.2), and stroke (OR, 1.3; 95% CI,1.0-1.7), whereas there was no difference in MI (OR, 0.8; 95% CI, 0.6-1.3). Among CEA patients, age ≥ 80 (OR, 1.4; 95% CI, 1.02-1.8), congestive heart failure (OR, 1.7; 95% CI, 1.03-2.8), EF <30% (OR, 3.5; 95% CI, 1.6-7.7), angina (OR, 3.9; 95% CI, 1.6-9.9), contralateral occlusion (OR, 3.2; 95% CI, 2.1-4.7), and high anatomic lesion (OR, 2.7; 95% CI, 1.33-5.6) predicted MACE. Among CAS patients, recent MI (OR, 3.2; 95% CI, 1.5-7.0) was predictive, and radiation (OR, 0.6; 95% CI, 0.4-0.8) and restenosis (OR, 0.5; 95% CI, 0.3-0.96) were protective for MACE. CONCLUSIONS: Although CMS HR criteria can successfully discriminate a group of patients at HR for adverse events after CEA, certain CMS HR criteria are more important than others. However, CEA appears safer for the majority of patients with carotid disease. Among patients undergoing CAS, non-HR status may be limited to restenosis and radiation.

ACR Appropriateness Criteria® Dialysis Fistula Malfunction.

The creation and maintenance of a dialysis access is vital for the reduction of morbidity, mortality, and cost of treatment for end stage renal disease patients. One's longevity on dialysis is directly dependent upon the quality of dialysis. This quality hinges on the integrity and reliability of the access to the patient's vascular system. All methods of dialysis access will eventually result in dialysis dysfunction and failure. Arteriovenous access dysfunction includes 3 distinct classes of events, namely thrombotic flow-related complications or dysfunction, nonthrombotic flow-related complications or dysfunction, and infectious complications. The restoration of any form of arteriovenous access dysfunction may be supported by diagnostic imaging, clinical consultation, percutaneous interventional procedures, surgical management, or a combination of these methods. This document provides a rigorous evaluation of how variants of each form of dysfunction may be appraised and approached systematically. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where peer reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

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.