Comparison of Ellipsys Percutaneous and Proximal Forearm Gracz-Type Surgical Arteriovenous Fistulas.

RATIONALE & OBJECTIVE: Percutaneous arteriovenous fistulas (AVF) are created by establishing a proximal forearm anastomosis and offer a safe and reliable vascular access. This study compares the Ellipsys percutaneous AVF with a proximal forearm Gracz-type surgical AVF, chosen for comparison as it is constructed at the same anatomical site. STUDY DESIGN: Retrospective study of prospectively collected clinical data. SETTING & PARTICIPANTS: All vascular access procedures conducted during a 34-month period were reviewed. The study groups comprised 89 percutaneous AVFs and 69 surgical AVFs. EXPOSURE: Percutaneous or surgical AVF placement. OUTCOME: AVF patency, function, and complications. ANALYTICAL APPROACH: Patency rates for each AVF group were evaluated by competing risk survival analysis using a cumulative incidence function. Association of primary, primary assisted, and secondary patency with the AVF groups was examined by Cox proportional hazard models. RESULTS: Technical success was 100% for both groups. Average procedure times were 14 minutes for percutaneous AVFs and 74 minutes for surgical AVFs (P < 0.001). Proximal radial artery (PRA) was used in all percutaneous AVF cases. Inflow for surgical AVFs included radial (30%), ulnar (12%), and brachial (58%) arteries. Outflow veins for both groups were the cephalic and/or basilic veins. Access flow volumes, times to maturation, and overall numbers of interventions per patient-year were not significantly different. Cumulative incidence of primary patency failure at 12 months was lower for surgical AVF (47% vs 64%, P = 0.1), but secondary patency failure was not different between groups (20% vs 12%, P = 0.3). PRA surgical AVFs had similar primary patency (65% vs 64%, P = 0.8) but higher secondary patency failure rates than percutaneous AVFs at 12 months (34% vs 12%, P = 0.04). LIMITATIONS: Retrospective study with a relatively short follow-up period, and not all patients required hemodialysis at the end of study. CONCLUSIONS: Both percutaneous and surgical AVFs demonstrated high rates of technical success and secondary patency. Percutaneous AVFs required shorter procedure times. The rate of intervention was similar. When a distal radial artery AVF is not feasible, percutaneous AVF might offer an appropriate procedure for creating a safe and functional access, maintaining further proximal forearm surgical AVF creation options.

Comparison of Outcomes of Percutaneous Arteriovenous Fistulae Creation by Ellipsys and WavelinQ Devices.

PURPOSE: The purpose of this study was to compare the clinical outcomes of Ellipsys with those of WavelinQ-4F percutaneous arteriovenous fistulae (pAVF) devices in a single center by a single operator. MATERIALS AND METHODS: A retrospective review was conducted in 100 patients who underwent pAVFs procedures (65 Ellipsys and 35 WavelinQ patients) and created between December 2017 and December 2019. A total of 69% were male and 37% were diabetic. Median age was 64.1 years (range: 28-86), and median body mass index was 27.2 (range: 15-45.1) kg/m2. A procedure sequence algorithm was followed for selecting all vascular accesses created. RESULTS: Ellipsys outcomes were compared to WavelinQ outcomes. Technical success was 100% versus 97%, respectively, and median procedure times were 14 versus 63 minutes, respectively (P < .001), with 183 (1-487) versus 185 (0-760) days follow-up, respectively. Maturation at 4 weeks was 68.3% versus 54.3%, respectively, and median times to cannulation were 60 (1-164) versus 90 (1-180) days, respectively. Successful pAVF dialysis was established in 31 of 39 patients (79.5%) versus 14 of 24 patients (58%), respectively (P = .071), dialysis patients with access-related adverse events observed in 4 individuals (1 Ellipsys versus 3 WavelinQ). Six patients (5 versus 1) with matured outflow from previous AVFs underwent first-day cannulations. Interventions were performed in 27.7% (33 Ellipsys) and 26.5% (15 WavelinQ) patients, and the number of interventions per patient-years was 0.96 versus 0.46, respectively. pAVF failure was seen in 15.4% versus 37.1% patients, respectively (P = .0137). Secondary patency at 12 months was significantly higher among patients who had an Ellipsys procedure (82%) than among those who underwent the WavelinQ procedure (60%). CONCLUSIONS: pAVFs were created with high technical success and low complications with both devices. Ellipsys pAVFs demonstrated significantly shorter procedure times without a need for radiation exposure and with superior secondary patency.

Angiography of Hemodialysis Fistulas and Grafts.

Angiography of the dialysis access is an important procedure in dealing with dialysis arteriovenous access (AVA) dysfunction. It is an integral part and the initiating procedure for all the interventional procedures performed for the management and salvage of dialysis AVA. The performance of this procedure and normal dialysis access-related anatomy including anatomical variants are discussed. In addition, pathology commonly encountered in association with the anatomy is reviewed.

We Refuse to Give up on Nonmaturing Fistulas.

The nonmaturing arteriovenous fistula (AVF) is a major problem and can lead to significant patient morbidity and mortality because the patient is exposed to the risk of dialysis with a central venous catheter (CVC). Access planning should include a strategy to decrease the incidence of AVF nonmaturation. All newly created AVFs should be evaluated for maturation at 4-6 weeks. If it is judged to not be usable at that time, it should be evaluated for salvage. However, if multiple procedures over a prolonged period of time are necessary for salvage, the decreasing chances of long-term success with the increasing risks of CVC-based dialysis must be considered. Giving up on the nonmaturing AVF may be in the best interest of the patient.

Subcutaneous implantable cardioverter defibrillator for dialysis patients: a strategy to reduce central vein stenoses and infections.

Central venous stenosis is a common complication of the transvenous leads associated with an implantable cardioverter defibrillator (ICD). Although epicardial leads have been reported to bypass this complication, their placement is much more invasive than the subcutaneous ICDs (SICDs) and requires the services of a cardiothoracic surgeon. Recent data have demonstrated successful defibrillation using an SICD. In this report, we present 4 long-term hemodialysis patients treated successfully with an SICD. 3 patients received the device for primary prevention of sudden cardiac death (cardiomyopathy with low ejection fraction). The patient in the fourth case had a prolonged QT interval and received the device for secondary prevention. 3 patients had an arteriovenous fistula, whereas 1 patient was dialyzing with a tunneled dialysis catheter. Insertion of an SICD is a minimally invasive procedure. By virtue of leaving the venous system untouched, this approach might offer the advantage of reduced risk of central venous stenosis and infection over an endocardial ICD with transvenous leads. SICD is not experimental; it has been approved by the US Food and Drug Administration and is currently being used in the United States and Europe.

Bacterial Colonization of Thrombosed Dialysis Arteriovenous Grafts.

In the absence of obvious infection, an abandoned arteriovenous graft (AVG) is generally left in place. This has been thought to be the best solution in view of the surgical procedure that would be required for its removal. However, there are reports of occult infection in these retained AVGs that can lead to significant infectious complications. In addition, there is evidence that abandoned, retained AVGs may contribute to the inflammatory state that exist in association with dialysis patients. This observational report of 100 cases of thrombosed AVG in which the thrombus was cultured at the time of thrombectomy demonstrated a significant degree of bacterial colonization in these cases without evidence of bacteremia. It is proposed that this could be the mechanism by which occult infection in an abandoned, retained AVGs occurs.

Chronically Occluded Arteriovenous Fistula Salvaged by Sharp Needle Recanalization.

Salvage of a failed arteriovenous access with occlusion of the venous outflow and no alternative for a secondary arteriovenous fistula that would provide for immediate dialysis is a difficult problem for which there is no ideal solution. The present report is such a patient. The patient had a radial-cephalic fistula represented by only a very short segment, inadequate for effective dialysis. Salvage was accomplished using the sharp needle revascularization technique in order to avoid a prolonged period of central venous catheter use.

Percutaneous thrombectomy of AVF: immediate success and long-term patency rates.

The purpose of this study was to report the results obtained in a cohort of 520 cases of thrombosed arteriovenous fistulas (AVF) treated by percutaneous intervention over a period of 8 years. The methods used varied according to the individual characteristics of the case. A clinical success rate of 91.1% was obtained with no significant difference being noted among radial-cephalic, brachial-cephalic, and brachial-basilic AVFs. The mean primary patency for this group was 227.3 ± 14.6 days, and the mean assisted primary patency was 677.2 ± 44.6 days. The lower arm AVFs had both a primary patency and an assisted primary patency that were significantly better than the upper arm cases (p = 0.006 and 0.002, respectively). The primary patency for radial-cephalic AVFs was significantly better than that for brachial-cephalic AVFs (p = 0.021), but not for brachial-basilic cases (p = 0.122). Assisted primary patency for radial-cephalic cases was significantly superior to the values for either patients with a brachial cephalic (p = 0.046) or a brachial-basilic (p = 0.004). Complications occurred in seven cases (1.3%), all of which were venous ruptures. Blood flow was affected in four cases. Only one of these was salvaged with angioplasty balloon tamponade. In the remaining three cases, the AVF was lost.

Hand ischemia associated with dialysis vascular access: an individualized access flow-based approach to therapy.

With the rise in the median age of hemodialysis patients, the increasing numbers of patients with multiple risk factors for vascular disease, and the efforts being made to increase the creation of autogenous arteriovenous fistulas (AVFs), dialysis access-related steal syndrome (DASS) has become a growing problem. This syndrome, caused by arterial insufficiency distal to the arteriovenous access due to diversion of blood into the access, is a potentially devastating complication. It is crucial that physicians who manage hemodialysis patients and perform vascular access procedures have a comprehensive understanding of the pathophysiology, symptoms, diagnostic maneuvers, and treatment options for DASS. The goals of management must be twofold-relieve the ischemia and preserve the access. The choice of any intervention, if such is necessary, should be based upon the clinical features presented by that individual patient; the clinical condition and prognosis of the patient, stage of the disease, location of the arterial anastomosis, and the level of blood flow within the access. This review presents information that supports an individualized, physiologic approach to this condition.

Radiation dose associated with dialysis vascular access interventional procedures in the interventional nephrology facility.

The number of dialysis access procedures performed by interventional nephrologists using a mobile C-arm fluoroscopy machine in freestanding centers continues to rise. With this activity comes the risk of radiation exposure to patients being treated and staff. This study was conducted to assess the levels of radiation dosage involved with these procedures. Dosimetry information including kerma area product (KAP), reference point air kerma (RPAK) and fluoroscopy time (FT) was collected prospectively. Radiation dosage data were collected from 24 centers in various parts of the United States and reflected cases managed by 69 different interventional nephrologists. The data were tabulated separately for eight procedures - fistula angioplasty and thrombectomy, graft angioplasty and thrombectomy, tunneled catheter placement and exchange, vein mapping and cases in which only angiographic evaluation was performed. The range for all of the measured parameters was large. Additionally there was considerable inter-operator variability. The dosage levels noted in this series were well below the threshold for deterministic effects. FT for AVF procedures was higher than for other types of access. The highest values were observed for thrombectomies. The highest KAP values were recorded for venous mapping. Thrombectomy procedures were associated with the highest RPAK levels. All dosage metrics were considerably lower than those previously reported.

Clinical and economic value of performing dialysis vascular access procedures in a freestanding office-based center as compared with the hospital outpatient department among Medicare ESRD beneficiaries.

Dialysis vascular access (DVA) care is being increasingly provided in freestanding office-based centers (FOC). Small-scale studies have suggested that DVA care in a FOC results in favorable patient outcomes and lower costs. To further evaluate this issue, data were drawn from incident and prevalent ESRD patients within a 4-year sample (2006-2009) of Medicare claims (USRDS) on cases who receive at least 80% of their DVA care in a FOC or a hospital outpatient department (HOPD). Using propensity score matching techniques, cases with a similar clinical and demographic profile from these two sites of service were matched. Medicare utilization, payments, and patient outcomes were compared across the matched cohorts (n = 27,613). Patients treated in the FOC had significantly better outcomes (p < 0.001), including fewer related or unrelated hospitalizations (3.8 vs. 4.4), vascular access-related infections (0.18 vs. 0.29), and septicemia-related hospitalizations (0.15 vs. 0.18). Mortality rate was lower (47.9% vs. 53.5%) as were PMPM payments ($4,982 vs. $5,566). This study shows that DVA management provided in a FOC has multiple advantages over that provided in a HOPD.

ASDIN white paper: Management of cephalic arch stenosis endorsed by the American Society of Diagnostic and Interventional Nephrology.

Brachiocephalic arteriovenous fistulas (AVF) makeup approximately one third of prevalent dialysis vascular accesses. The most common cause of malfunction with this access is cephalic arch stenosis (CAS). The accepted requirement for treatment of a venous stenosis lesion is ⩾50% stenosis associated with hemodynamically abnormalities. However, the correlation between percentage stenosis and a clinically significant decrease in access blood flow (Qa) is low. The critical parameter is the absolute minimal luminal diameter (MLD) of the lesion. This is the parameter that exerts the key restrictive effect on Qa and results in hemodynamic and functional implications for the access. CAS is the result of low wall shear stress (WSS) resulting from the effects of increased blood flow and the unique anatomical configuration of the CAS. Decrease in WSS has a linear relationship to increased blood flow velocity and neointimal hyperplasia exhibits an inverse relationship with WSS. The result is a stenotic lesion. The presence of downstream venous stenosis causes an inflow-outflow mismatch resulting in increased pressure within the access. Qa in this situation may be decreased, increased, or within a normal range. Over time, the increased intraluminal pressure can result in marked aneurysmal changes within the AVF, difficulties with cannulation and the dialysis treatment, and ultimately, increasing risk of access thrombosis. Complete characterization of the lesion both hemodynamically and anatomically should be the first step in developing a strategy for management. This requires both access flow measurement and angiographic imaging. Patients with CAS present a relatively broad spectrum as relates to both of these parameters. These data should be used to determine whether primary treatment of CAS should be directed toward the anatomical lesion (small MLD and low Qa) or the pathophysiology (large MLD and high Qa).

High brachial artery bifurcation: clinical considerations and practical implications for an arteriovenous access.

High brachial artery bifurcation (HiBAB) is not a rare occurrence. Recent data have emphasized that HiBAB can have major clinical implications including high failure rate and decreased functional patency of an arteriovenous (AV) fistula. In this retrospective study, we investigated the incidence of HiBAB. Patients with advanced chronic kidney disease and end-stage renal disease on chronic hemodialysis undergoing preoperative vascular mapping for the creation of an AV access were included in this analysis. Ultrasound examination was used to map the arteries of the upper extremities. Four hundred and eighty-one arms in 340 patients were examined (right arm = 181, left arm = 300). Sixty-nine of the 481 (12.3%) demonstrated HiBAB. The internal diameter of the radial and ulnar arteries measured at the elbow region was found to be 2.9 ± 0.8 and 3.6 ± 1.0 mm, respectively (p = 0.0001). There were no statistically significant differences in terms of race, gender, and right versus left arms regarding the incidence of HiBAB. As HiBAB can be present in a significant number of patients and have an impact on the AV access, its presence should be evaluated during vascular mapping prior to an AV access creation.

Fistula first breakthrough initiative: targeting catheter last in fistula first.

An arteriovenous fistula (AVF) is the optimal vascular access for hemodialysis (HD), because it is associated with prolonged survival, fewer infections, lower hospitalization rates, and reduced costs. The AVF First breakthrough initiative (FFBI) has made dramatic progress, effectively promoting the increase in the national AVF prevalence since the program's inception from 32% in May 2003 to nearly 60% in 2011. Central venous catheter (CVC) use has stabilized and recently decreased slightly for prevalent patients (treated more than 90 days), while CVC usage in the first 90 days remains unacceptably high at nearly 80%. This high prevalence of CVC utilization suggests important specific improvement goals for FFBI. In addition to the current 66% AVF goal, the initiative should include specific CVC usage target(s), based on the KDOQI goal of less than 10% in patients undergoing HD for more than 90 days, and a substantially improved initial target from the current CVC proportion. These specific CVC targets would be disseminated through the ESRD networks to individual dialysis facilities, further emphasizing CVC avoidance in the transition from advanced CKD to chronic kidney failure, while continuing to decrease CVC by prompt conversion of CVC-based hemodialysis patients to permanent vascular access, utilizing an AVF whenever feasible.

The risk of sedation/analgesia in hemodialysis patients undergoing interventional procedures.

Data derived from a large cohort of hemodialysis patients (12,896) undergoing dialysis access maintenance procedures being performed by interventional nephrologists were analyzed to determine the safety of sedation/analgesia (S/A) in a freestanding facility. Data collected included patient demographics, procedures performed, time of procedures, drugs used, doses used, and complications that occurred. Four high-risk groups were identified based upon age, pulmonary status, and over all physical status. These were compared to the total cohort. Midazolam, fentanyl, or a combination of the two were used. Within the total cohort of patients, midazolam alone was used most commonly (94.7%). The total mean dose of midazolam when used alone was 3.4 mg. The dosages used in the high-risk groups tended to be only slightly lower (3-3.2 mg). This setting appears to be safe for hemodialysis patients, even those in high-risk subgroups having these types of procedures. The types of drugs and the dosages that are commonly used do not appear to be associated with an unacceptable risk to the hemodialysis patient. A nephrologist that is not specialty trained in anesthesia is able to provide S/A safely in a freestanding facility.

Coding of procedures in interventional nephrology: overview of changes in the 2010 revision.

A new educational document titled "Coding Procedures in Interventional Nephrology 2010" has been published by ASDIN for 2010. The purpose of this communication is to present a review of these new regulations issued by CMS to take effect January 1, 2010, and how they will affect the coding of interventional procedures used in vascular access maintenance.

Interventional Nephrology: Opportunities and Challenges.

The nephrologist has a pivotal role as the leader of multidisciplinary teams to optimize vascular access care of the patient on dialysis and to promote multidisciplinary collaboration in research, training, and education. The continued success of interventional nephrology as an independent discipline depends on harnessing these efforts to advance knowledge and encourage innovation. A comprehensive curriculum that encompasses research from bench to bedside coupled with standardized clinical training protocols are fundamental to this expansion. As we find ourselves on the threshold of a much-awaited revolution in nephrology, there is great opportunity but also formidable challenges in the field - it is up to us to work together to realize the enormous potential of our discipline.

Exploring correlations between anatomic characteristics of dialysis arteriovenous fistula stenosis and arteriovenous fistula blood flow rate (Qa).

BACKGROUND: Radiologic justification for endovascular treatment of a dialysis arteriovenous fistula circuit stenosis is currently based on ⩾50% severity. However, the clinical significance of any given stenosis is not always clear. The minimum luminal diameter of any stenotic lesion in the arteriovenous fistula circuit might exert a more predictive effect on the arteriovenous fistula blood flow rate (Qa). METHODS: To investigate relationships between anatomic parameters of stenosis and Qa, this study was conducted in a cohort of patients with a variety of arteriovenous fistula stenotic lesions. The goals were to determine (1) the degree of correlation between arteriovenous fistula stenosis estimated during the procedure, and that which is measured, and (2) the correlations between two anatomic stenosis parameters (percent stenosis and stenosis minimum luminal diameter) and Qa. RESULTS: The cohort comprised 113 patients. Only a moderate correlation between estimated and measured stenosis was seen. A correlation between measured stenosis and Qa for the whole cohort was not seen, but a weak correlation between estimated stenosis and Qa was seen. Correlations between stenosis minimum luminal diameter and Qa were superior. The superiority of stenosis minimum luminal diameter to percent stenosis in correlating with a Qa of <500 mL/h was also demonstrated by receiver operating characteristics curve analysis. Stenosis minimum luminal diameter cutoffs of ⩽2.5 mm or >4 mm seemed to have a good predictive value of Qa. CONCLUSIONS: Percent stenosis determination is fraught with uncertainty and exhibits a weak correlation with Qa. Compared with percent stenosis, the minimum luminal diameter of the stenosis demonstrates a superior correlation with Qa.

Early cannulation of percutaneously created arteriovenous hemodialysis fistulae.

INTRODUCTION: The optimal vascular access for most dialysis patients is an arteriovenous fistula and the recognized appropriate process of care for the chronic kidney disease patient is to have the access in place ready for use when renal replacement therapy is required. Unfortunately, as a result of multiple barriers, most patients start dialysis with a catheter and many experience multiple interventions. The recent advent of the percutaneous arteriovenous fistula may offer at least a partial solution to these problems. The purpose of this study was to report of the results of early cannulation of the percutaneous arteriovenous fistula. MATERIALS AND METHODS: Early cannulation, less than 14 days post creation, was performed in 14 cases in order to avoid an initial catheter or continued use of a problematic catheter for dialysis. Immediately post access creation, blood flow ranged from 491 to 1169 mL/min (mean = 790 mL/min). Ultrasound was used to map potential cannulation sites prior to use. Cannulation was performed using plastic fistula cannulas. RESULTS: Early cannulation was successful in this cohort of cases except for one cannulation complication. Dialysis treatments were otherwise uncomplicated. Primary patency at 3, 6, and 12 months was 76%, 76%, and 66%, respectively. Assisted primary patency for the same intervals was 100%, 100%, and 91%, respectively. Cumulative patency was 100% at all three-time intervals. CONCLUSION: The results of this study suggest that the possibility of successful early cannulation with a percutaneous arteriovenous fistula can be considered as an additional factor in making this access a reasonable alternative for a surgically created arteriovenous fistula in appropriate patients.