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.

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.

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.

Hemodialysis Reliable Outflow (HeRO) graft creation in upper extremities abandoned due to stent obstruction via recanalization and HeRO outflow component insertion across stent interstices.

BACKGROUND: The purpose of this study was to assess the feasibility and outcomes of recanalization and subsequent HeRO graft outflow component insertion across stent interstices in patients with an otherwise abandoned upper extremity. METHODS: Over a 10-year period, 15 patients underwent central venous recanalization by interventional radiology across the interstices of one or more occluded stents for the purpose of subsequent HeRO graft creation. A tunneled central venous catheter was left across the stent and occlusions with tip in right atrium. On a later date, the catheter was used for rapid guidewire access for HeRO graft implantation in the OR by vascular surgery. Procedural and clinical outcomes were determined by retrospective review. Primary and secondary HeRO graft patency rates were estimated with the Kaplan-Meier technique. RESULTS: The technical success rates of recanalization across stent interstices was 100% (15/15). Between one and four overlapping stent walls were traversed. The technical success of the patients who underwent attempted HeRO graft implantation with outflow component traversing across stent interstices was 91% (11/12). No major complications were encountered with either recanalization or HeRO graft implantation. The primary and secondary HeRO patency rates at 12 months were 64% and 80%, respectively. CONCLUSION: HeRO graft insertion across stent interstices is feasible and can provide effective permanent AV access; thus, the presence of stents across the subclavian and brachiocephalic veins should not be considered a contraindication.

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.

Classification and treatment of endothermal heat-induced thrombosis: Recommendations from the American Venous Forum and the Society for Vascular Surgery.

The American Venous Forum (AVF) and the Society for Vascular Surgery set forth these guidelines for the management of endothermal heat-induced thrombosis (EHIT). The guidelines serve to compile the body of literature on EHIT and to put forth evidence-based recommendations. The guidelines are divided into the following categories: classification of EHIT, risk factors and prevention, and treatment of EHIT. One major feature is to standardize the reporting under one classification system. The Kabnick and Lawrence classification systems are now combined into the AVF EHIT classification system. The novel classification system affords standardization in reporting but also allows continued combined evaluation with the current body of literature. Recommendations codify the use of duplex ultrasound for the diagnosis of EHIT. Risk factor assessments and methods of prevention including mechanical prophylaxis, chemical prophylaxis, and ablation distance are discussed. Treatment guidelines are tailored to the AVF EHIT class (ie, I, II, III, IV). Reference is made to the use of surveillance, antiplatelet therapy, and anticoagulants as deemed indicated, and the recommendations incorporate the use of the novel direct oral anticoagulants. Last, EHIT management as it relates to the great and small saphenous veins is discussed.

Classification and treatment of endothermal heat-induced thrombosis: Recommendations from the American Venous Forum and the Society for Vascular Surgery This Practice Guidelines document has been co-published in Phlebology [DOI: 10.1177/0268355520953759] and Journal of Vascular Surgery: Venous and Lymphatic Disorders [DOI: 10.1016/j.jvsv.2020.06.008]. The publications are identical except for minor stylistic and spelling differences in keeping with each journal's style. The contribution has been published under a Attribution-Non Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0), (https://creativecommons.org/licenses/by-nc-nd/4.0/).

The American Venous Forum (AVF) and the Society for Vascular Surgery set forth these guidelines for the management of endothermal heat-induced thrombosis (EHIT). The guidelines serve to compile the body of literature on EHIT and to put forth evidence-based recommendations. The guidelines are divided into the following categories: classification of EHIT, risk factors and prevention, and treatment of EHIT.One major feature is to standardize the reporting under one classification system. The Kabnick and Lawrence classification systems are now combined into the AVF EHIT classification system. The novel classification system affords standardization in reporting but also allows continued combined evaluation with the current body of literature. Recommendations codify the use of duplex ultrasound for the diagnosis of EHIT. Risk factor assessments and methods of prevention including mechanical prophylaxis, chemical prophylaxis, and ablation distance are discussed.Treatment guidelines are tailored to the AVF EHIT class (ie, I, II, III, IV). Reference is made to the use of surveillance, antiplatelet therapy, and anticoagulants as deemed indicated, and the recommendations incorporate the use of the novel direct oral anticoagulants. Last, EHIT management as it relates to the great and small saphenous veins is discussed.

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.

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.

A systematic review of venous stents for iliac and venacaval occlusive disease.

OBJECTIVE: Endovascular stenting of the deep venous system is increasingly used to treat stenotic and occluded veins. This article reviews the efficacy and safety of venous stenting for lower extremity occlusive disease. METHODS: The Ovid portal was used to search the MEDLINE database for English-language randomized controlled trials and case series published between January 1, 2005, and December 31, 2018, involving venous stenting for lower extremity and inferior venacaval occlusive and compressive disease. Studies were eligible for inclusion if they contained at least 30 patients with at least 6 months of follow-up. Clinical outcomes, long-term patency, complications, and postoperative anticoagulation regimens were reviewed. Also included are nationally presented trial results of dedicated venous stents that may not have been formally published yet. RESULTS: Relevant studies were too heterogeneous for a formal meta-analysis to be performed. We analyzed 3812 stented limbs from 23 published studies and two national presentations. Dedicated venous stents were used in 740 patients, and standard stents were used in 3072 patients. The overall major complication rate was <1%. Median symptomatic improvement and ulcer healing were seen in 79% and 71% of the standard stented limbs, respectively. For standard stents, the median primary, assisted primary, and secondary patency rates were 71%, 89%, and 91%, respectively, with a median study follow-up of 23.5 months. Dedicated venous stents had an overall primary patency of 78.8% at 12 months, with lower patency (73%) seen in post-thrombotic vs compressive (96%) disease. CONCLUSIONS: Whereas the quality of evidence remains weak, iliocaval venous stenting appears to be a safe and effective treatment of chronic venous disease. In early results, dedicated venous stents appear safe and demonstrate results that are as good as or better than those of historically used devices.

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.

Standardized care protocol and modifications to electronic medical records to facilitate venous ulcer healing.

BACKGROUND: Venous ulcers are painful, recurrent, and difficult to heal. Electronic medical records (EMRs) are often not optimized to track wounds. Specialized wound care programs may not interface with office-based records, creating a need to standardize the process of venous ulcer measurement and dressing documentation within existing systems. This work describes the creation of an EMR protocol to track venous ulcer size, to standardize dressings, to address related health issues, and to improve education of the patient. We hypothesized that the institution of an EMR protocol to track clinical features of venous ulcer patients, including wound size and health status, would facilitate wound healing. METHODS: We performed a retrospective review of a prospective database from September 2014 to May 2017. Modifications to the EMR included the formation of a venous ulcer patient list, a dressing tracker, calculation of total ulcer area, graphing of ulcer size over time, and images of the wound area. Patient education materials were created through the EMR and loaded into an automatic end-visit printout that emphasized smoking cessation, weight loss, and consultation with specialty services as necessary. Quarterly meetings with the supervising physician were established to review each patient's wound progress and to target areas of improvement. RESULTS: During the study period, 204 patients with chronic C5 and C6 disease were observed. Before the start of the project, the healing rate was 53.3%. Wound healing rates improved from 59.5% (quarter 1) to 77.94% (quarter 8). In the quarter before the project started, there were no patients who had quit or cut down on smoking or smokeless tobacco, no patients who were referred for weight loss consultation, and nine who were already patients of bariatric surgery. During the study period, 29% of patients quit smoking, 19% decreased smoking, and 20% cut down smokeless tobacco use. There were 54 patients who underwent advanced arterial evaluation; 175 patients underwent sclerotherapy and 137 patients had endovenous thermal ablation to treat axial reflux in the affected limb. The EMR modification project took 13 months to craft and to implement, with approximately 8 hours of meeting time from the surgical team. CONCLUSIONS: A comprehensive care model for venous ulcer patients through EMR modification improved overall patient care, increased communication between providers, and facilitated ulcer healing. EMR modification can be introduced with an acceptable time investment on the part of both the provider and the institutional information technology team.

Thermal and Nonthermal Endovenous Ablation Options for Treatment of Superficial Venous Insufficiency.

Open saphenous removal, phlebectomy, and venous ligation were historic mainstays of surgical treatment of venous disease. Duplex ultrasound has become standard to diagnose venous insufficiency. Percutaneous modalities have allowed treatments to include thermal and nonthermal endovenous ablation. These treatments vary in preoperative planning, procedural steps, and postprocedural care, but all are safe and effective. An individualized approach should be taken in determining which modality is offered to each patient. Endovenous options, which often are minimally invasive and safely performed in an outpatient setting, allow access to effective treatments with low risk and discomfort.

The evaluation of the implementation of the vascular preventative bundle and development of suggested interventions for improvement and sustainability.

Postoperative infections can complicate patient care and increase health care costs. A vascular preventative bundle was implemented at a large teaching/research intensive hospital to decrease surgical site infections (SSIs) with vascular surgery patients. The aim of this study was to measure fidelity to the bundle and determine if implementation of the vascular SSI bundle reduced the rate of SSIs. Three periods of data were collected, and they are identified as preimplementation (period 1), early implementation (period 2), and postimplementation (period 3). There were 711 patients for all three periods, approximately equally distributed in the periods. The use of preoperative hair clippings, chlorhexidine (CHG) wipes, and appropriate antibiotics showed the greatest improvement from preimplementation to early implementation. All three measures showed significant improvements in fidelity. For appropriate antibiotics, the fidelity was the highest and showed the largest improvement compared to the other measures. The performance of clippings preoperatively and using CHG wipes improved significantly. Evidence-based interventions have been recommended to support the implementation and sustainability of the bundle. The infection rate between preop and postperiod was not statistically different.