Percutaneous Creation Research Articles

Abstract No. 10 Percutaneous creation of an extraluminal arterial bypass graft using a commercially available self-expanding stent graft: comparison to surgical arterial bypass graft in a swine model

Peripheral arterial disease (PAD) of the lower extremities is a prevalent disease that can result in claudication, rest pain, ulceration, gangrene, and loss of limb. Not all patients are candidates for surgical bypass grafting. In severe cases, endovascular recanalization of total occlusions of the femoropopliteal arteries may not be possible, and even when successful, severe arterial calcifications can significantly limit patency rates. The objective of this study was to compare the short-term patency of a percutaneous endovascular technique for arterial bypass versus the standard of care, a surgically created bypass using PTFE, in a swine model.

Non-invasive assessment of cardiac percutaneous occluders healing process using computed tomography imaging: a proof of concept study

Abstract Funding Acknowledgements Type of funding sources: Other. Main funding source(s): National Research Agency (ANR) French Federation of Cardiology : “Aide à la recherche par équipe 2018, Cardiopathies de l’enfant” Introduction After percutaneous implantation of an atrial septal defect (ASD) occluder device, a complex healing process leads to the device coverage within several months. However, an unexplained incomplete device coverage is at risk of complications such as thrombosis or infectious endocarditis. Purpose The aim of the study was to assess the device coverage process of ASD occluder devices in a chronic sheep model using micro-CT technology. Methods After percutaneous creation of an ASD by catheterization, 8 ewes (mean age 5.4 ± 0.7 yo and mean weight 55.6 ± 7.9 kg) were implanted with a 16-mm Nit-Occlud ASD-R occluder (PFM medical, Cologne, Germany) and were followed for 1 month (N = 3) and 3 months (N =5). After heart explantation, a iodine contrast agent was used to enhance the tissue signal. The device coverage was then assessed by micro-CT and the results were compared to histology, used as the gold standard for healing evaluation. The micro-CT image resolution was 41.7 µm. Reconstruction was performed in 2D and 3D with Amira® software, allowing to obtain images that were exploited by a code to measure the surface for each disk of the analyzed devices. Histological study was performed after resin embedding and Richardson blue staining was used. The pathologist was blinded to the duration of animals’ follow-up and micro-CT results. Results ASD creation and device closure was successful in 100% animals without complications. Following heart explantation, macroscopic assessment of devices showed that the coverage was complete for the left-side disk regardless of the duration of the follow-up and variable for the right-side disk, depending of the protrusion of this disk. 2D and 3D micro-CT analysis allowed an accurate evaluation of device coverage of each disk and was overall well correlated to histology slices (cf Figure). Surface calculation from micro-CT images showed that the median surface of coverage was 93 ± 8% for the left-side disk and 55 ± 31% for the right-side disk. Conclusion This preliminary study made the proof of concept that micro-CT is a reliable tool to assess the coverage of intra-cardiac occluders in vitro. The translation to clinical practice is challenging but would allow an individual follow-up, to avoid thrombotic or infective complications. Abstract Figure.

Non-invasive imaging of the healing process of atrial septal defect percutaneous occluders: A proof of concept study

After percutaneous implantation of an atrial septal defect (ASD) occluder, a complex healing process leads to the device coverage within several months. However, an unexplained incomplete device coverage increases the risk of device related complications such as thrombosis or infectious endocarditis. The aim of the study was to non-invasively assess the device coverage process of ASD occluders in a chronic sheep model using micro-CT technology. After percutaneous creation of an ASD, 8 ewes were implanted with a 16-mm Nit-Occlud ASD-R occluder (PFM medical, Germany) and were followed for 1 month ( N = 3) and 3 months ( N = 5) before sacrifice. The device coverage was then assessed using micro-CT and was compared to histological analysis (gold standard). The micro-CT image resolution was 41.7 μm, reconstruction was performed in 2D and 3D with Amira® software allowing measurement of the coverage thickness and surface for each disk of the analyzed devices, using a code. Histological study was performed following resin embedding and Richardson blue staining. ASD creation and device closure was successful in 100% animals without complications. Following sacrifice, macroscopic assessment of devices showed that the coverage was complete for the left-side disk regardless of the duration of the follow-up and variable for the right-side disk, depending of the protrusion of this disk. 2D and 3D micro-CT analysis allowed an accurate evaluation of device coverage of each disk and was overall well correlated to histology slices ( Fig. 1 ). Surface calculation from micro-CT images showed that the median surface of coverage was 93 ± 8% for the left-side disk and 55 ± 31% for the right-side disk. This preliminary study made the proof of concept that micro-CT is a reliable tool to assess the coverage of intra-cardiac occluders in vitro. The translation to clinical practice is challenging but would allow an individual follow-up.

Percutaneous Computed Tomography-Guided Radiofrequency Ablation of Spinal Trigeminal Tract and Nucleus Caudalis for Refractory Trigeminal Neuropathic Pain: 2-Dimensional Operative Video.

This is a surgical video of a computed tomography (CT)-guided percutaneous radiofrequency ablation of the spinal trigeminal tract and nucleus caudalis for refractory trigeminal neuropathic pain.1,2 Many have contributed historically, among them, Sjoqvist3 in 1938 first described destruction of the descending medullary trigeminal tractus via open craniotomy.3-6 In 1967 and 1968, Crue7 and Hitchcock8 independently developed a percutaneous tractotomy technique. Although Kanpolat9,10 first described the use of CT imaging for percutaneous creation of a single tractotomy/nucleotomy lesion resulting in satisfactory pain relief for 85% of patients. The spinal trigeminal tract is a descending fiber pathway containing central processes of first-order afferent neurons from cranial nerves V, VII, IX, and X. The spinal trigeminal nucleus is the terminal projection of the spinal trigeminal tract comprised of 3 subnuclei: oralis, interpolaris, and caudalis. The nucleus caudalis is the most caudal of the 3 subdivisions of the spinal trigeminal nucleus and houses the cell bodies of second-order afferent neurons critical in nociception of the face. Lesioning of the spinal trigeminal tract and nucleus caudalis can provide pain relief without affecting facial sensation or trigeminal motor function.9,11-13 Percutaneous radiofrequency ablation is performed using anatomical landmarks, serial CT scans, impedance monitoring, and functional confirmation to ensure appropriate insertion of the probe to the target of interest prior to lesioning. This procedure remains uncommon in current practices even among functional neurosurgery pain specialists but offers a low-risk, minimally invasive treatment option for refractory facial pain.14 This procedure was done under Institutional Review Board guidance (H-41228: retrospective chart review of patients undergoing spine surgery for pain). The risks and benefits were explained, and the patient consented to videography/procedure. Images in the video used with permission from the following: Carter HV. Anatomy of the Human Body. Wikimedia Commons [Public Domain]. https://commons.wikimedia.org/wiki/File:Gray698.png. Published 1918. Accessed June 30, 2019; Carter HV. Anatomy of the Human Body. Wikimedia Commons [Public Domain]. https://commons.wikimedia.org/wiki/File:Gray784.png. Published 1918. Accessed June 30, 2019; Reprinted from Kanpolat Y, Kahilogullari G, Ugur HC, Elhan AH, CT-guided percutaneous trigeminal tractotomy-nucleotomy, Neurosurgery, 2008, 63(1 Suppl 1), ONS147-53; discussion ONS153-5, by permission of the Congress of Neurological Surgeons; Madhero88. Onion Distribution of Pain and Temperature Sense by Trigeminal Nerve. Wikimedia Commons [Creative Commons BY 3.0 license]. https://en.wikipedia.org/wiki/File:Onionskinddistribution.svg#/media/File:Onionskinddistribution.svg. Accessed June 30, 2019.

Two-year results of the Ellipsys device in the creation of arteriovenous fistula: Technical recommendations and algorithm of maintenance

The aim of this study was to present our 2-year results of the percutaneous creation of arteriovenous fistula using the Ellipsys device, with technical recommendations and an algorithm of maintenance of the percutaneous arteriovenous fistula (AVFp).

Percutaneous creation of proximal radio-radial arteriovenous hemodialysis fistula before secondary brachial vein elevation.

We evaluate the creation of a percutaneous proximal radial artery-radial vein arteriovenous fistula with Ellipsys® instead of the usual first-stage brachial artery fistula prior to a second-stage brachial vein elevation, in patients with inadequate cephalic and basilic veins. Single center study of eight patients (six males, mean = 54 years) who underwent a two-stage brachial vein elevation procedure between May 2017 and October 2019. Inclusion criteria were life expectancy > 6 months, patent brachial and proximal radial artery (>2 mm in diameter) absent/inadequate cephalic and basilic veins, existence of a brachial vein >3 mm in diameter, and in continuity with a proximal radial vein > 2 mm in diameter. Technical success was 100%. Four patients required angioplasty of a juxta-anastomotic stenosis, accounting for a 6-month primary and secondary patency rates were 68% and 100%, respectively. Access flow averaged 982 mL/min (range 768-1586) at final follow-up evaluation. There were no significant adverse events related to the procedures. All fistulae were elevated at 4-12 (mean: 8) weeks post creation and were successfully cannulated with two needles after healing was completed (2-4 weeks after elevation). No patients developed hand ischemia or arm edema. Percutaneous creation of a proximal radial artery-radial vein fistula followed by brachial vein elevation is a safe and reliable option for autogenous access creation in patients with inadequate cephalic or basilic veins. Minimally invasive radial artery inflow and longer available length of the targeted brachial vein available for elevation are the main advantages in skilled hands.

Initial Experience and Lessons Learned with Percutaneous Creation of Arteriovenous Fistulae for Dialysis Access

In the United States, 800,000 people are currently being treated for end-stage kidney disease with 1600 per million on hemodialysis. Upcoming National Kidney Foundation guidelines endorse a "Patient Life-plan, Access Needs" approach, and new technologies are introducing percutaneous creation of arteriovenous fistulae for this population. Here, we describe our initial experience with percutaneous arteriovenous fistula (pAVF) creation. We reviewed prospectively collected data on our first 43 patients undergoing percutaneous creation of AVF using the Ellipsys Vascular Access System (Avenu Medical Inc, San Juan Capistrano, Calif). The procedure is an outpatient, single venous access, ultrasound guided creation of a pAVF between a deep perforating vein and the proximal radial artery. We examined the early global functional outcomes of pAVF creation. All cases were performed in an outpatient procedure center. Technical success was 88.3%. There were seven early occlusions requiring standard surgical AVF creation. Twenty-one required early fistulagrams/maturation procedures. Of these, eight have required more than one procedure. Intervention was performed most commonly from a radial arterial access. Five patients have required superficialization procedures (4 basilic, 1 cephalic). Two patients required basilic vein ligation. Eleven patients have clinically mature AVF but are not yet on dialysis. Fifteen patients are currently dialyzing. Overall primary-assisted patency is 79.1% for the entire cohort. The technical learning curve for pAVF creation is short, especially for those with endovascular experience and comfort with ultrasound-guided procedures. Where the learning curve exists is in the interpretation of the low-flow hemodynamics in these fistulas; when and where to access the mature pAVF; and how to effectively communicate strategy with dialysis centers. Early interrogation and intervention seem common in order to establish the fistula, but durability appears achievable with a coordinated effort.

Percutaneous Arteriovenous Fistula Creation With the Ellipsys Vascular Access System: The State of the Art

In this video, we present briefly the percutaneous creation of an arteriovenous fistula with the Ellipsys Vascular Access System under ultrasound guidance. The device allows the creation of a permanent anastomosis between the proximal radial artery and the deep communicating vein of the elbow that is immediately dilated with a 5-× 20-mm balloon in order to accelerate maturation. The video was created specifically for VAM 2020 and includes the most recent updates of the technique.

3D-Printed Coronary Implants Are Effective for Percutaneous Creation of Swine Models with Focal Coronary Stenosis.

Reliable, closed-chest methods for creating large animal models of acute myocardial hypoperfusion are limited. We demonstrated the feasibility and efficacy of using magnetic resonance (MR)-compatible 3D-printed coronary implants for establishing swine models of myocardial hypoperfusion. We designed, manufactured, and percutaneously deployed implants in 13 swine to selectively create focal coronary stenosis. To test the efficacy of the implants to cause hypoperfusion or ischemia in the perfused territory, we evaluated regional wall motion, myocardial perfusion, and infarction using MR imaging. The overall swine survival rate was 85% (11 of 13). The implant retrieval rate was 92% (12 of 13). Fluoroscopic angiography confirmed focal stenosis. Cine and perfusion MRI showed regional wall motion abnormalities and inducible ischemia, respectively. Late gadolinium enhancement and histopathology showed no myocardial infarction. Our minimally invasive technique has promising applications for validation of new diagnostic methods in cardiac MR. Graphical abstract Our new minimally invasive, percutaneous method for creating swine models of acute focal coronary stenosis can be used for magnetic resonance imaging studies of myocardial ischemia. Comparable to existing methods in its efficacy and reliability, this rapid prototyping technique will allow researchers to more easily conduct translational cardiac imaging studies of coronary artery disease in large animal models.

Considerations in Access Cannulation: Traditional and Evolving Approaches.

Needle cannulation of hemodialysis access is the soft underbelly of hemodialysis access care that has remained unchanged for a long time. Cannulation error results in complications such as infiltration, hematoma, subsequent revision procedures, and potential loss of hard-earned access. The "best" cannulation method is contingent upon access type and characteristics along with local expertise. The rope ladder technique of cannulation, characterized by successive rotation of puncture sites with each hemodialysis session, permits sufficient time for healing of prior cannulation sites, and reduction in complications such as bleeding, infection, and aneurysm development. A steeper needle angle, higher blood flow rates, and deep needle tip can lead to wall stress on the posterior wall and up to 10cm from the needle cannulation site. Plastic cannulas provide a viable alternative to metallic needles; they have lower complications and a favorable cost-benefit ratio. There is lack of evidence to support an optimal arterial needle direction configuration. Needle injury may promote intimal thickening, but its effect on access outcomes is currently unknown. Percutaneous creation of arteriovenous fistula presents new challenges in dialysis access cannulation. Point-of-care ultrasound-guided cannulation will likely lead to a paradigm shift in access cannulation. Novel care delivery using cannulation stations is a promising development.

Percutaneous Extraanatomic Bypass for Treatment of Central Venous Occlusions in Patients Undergoing Hemodialysis.

OBJECTIVE. The pipeline technique has been described for percutaneous creation of a long extraanatomic bypass for a thrombosed hemodialysis vascular access in patients with outflow veins that cannot be recanalized. However, when we used the pipeline technique in nonthrombotic vascular access sites to create a bypass to treat central venous occlusion, we encountered two technical challenges not mentioned in previous reports: bleeding from the peripheral incision and difficulty in pushing the stent-graft catheter through the subcutaneous track. CONCLUSION. We report our solutions for these two technical challenges and the treatment outcomes of percutaneous extraanatomic bypass for central venous occlusion in patients undergoing hemodialysis with access-related upper limb swelling.

Abstract P158: Preeminent Role of the Cardiorenal Axis in the Antihypertensive Response to an Arteriovenous Fistula: An In Silico Analysis

Percutaneous creation of a small central arteriovenous (AV) fistula is currently being evaluated in clinical trials for the treatment of uncontrolled hypertension (HT). Although the mechanisms that contribute to the antihypertensive effects of the fistula are unclear, investigators have speculated that chronic blood pressure (BP) lowering may be due to: 1) reduced total peripheral resistance (TPR), 2) increased secretion of atrial natriuretic peptide (ANP), and 3) suppression of renal sympathetic nerve activity (RSNA). We used an established integrative mathematical model of human physiology to investigate these possibilities from baseline conditions that mimic sympathetic overactivity and impaired renal function in patients with resistant HT. After simulating a small fistula there were sustained increases in cardiac output, atrial pressures, and plasma ANP concentration (3-fold), without suppression of RSNA; at 8 weeks BP was reduced 14 mmHg along with a 32% fall in TPR. In contrast, when this simulation was repeated while clamping ANP at baseline BP decreased only 4 mmHg, despite a comparable fall in TPR. Further, when chronic resetting of atrial mechanoreceptors was prevented during the fistula RSNA decreased 7% and, along with the same 3-fold increase in ANP, BP fell 19 mmHg. This exaggerated fall in BP occurred with a similar decrease in TPR when compared to the above simulations. These findings suggest that ANP, but not TPR, is a key determinant of long-term BP lowering after an AV fistula and support a contribution of suppressed RSNA if resetting of the atrial-renal reflex is truly incomplete.

Preeminent role of the cardiorenal axis in the antihypertensive response to an arteriovenous fistula: an in silico analysis.

Percutaneous creation of a small central arteriovenous (AV) fistula is currently being evaluated for the treatment of uncontrolled hypertension (HT). Although the mechanisms that contribute to the antihypertensive effects of the fistula are unclear, investigators have speculated that chronic blood pressure (BP) lowering may be due to 1) reduced total peripheral resistance (TPR), 2) increased secretion of atrial natriuretic peptide (ANP), and/or 3) suppression of renal sympathetic nerve activity (RSNA). We used an established integrative mathematical model of human physiology to investigate these possibilities from baseline conditions that mimic sympathetic overactivity and impaired renal function in patients with resistant HT. After a small fistula was stimulated, there were sustained increases in cardiac output, atrial pressures, and plasma ANP concentration (3-fold), without suppression of RSNA; at 8 wk, BP was reduced 14 mmHg along with a 32% fall in TPR. In contrast, when this simulation was repeated while clamping ANP at baseline BP decreased only 4 mmHg, despite a comparable fall in TPR. Furthermore, when chronic resetting of atrial mechanoreceptors was prevented during the fistula, RSNA decreased 7%, and along with the same threefold increase in ANP, BP fell 19 mmHg. This exaggerated fall in BP occurred with a similar decrease in TPR when compared with the above simulations. These findings suggest that ANP, but not TPR, is a key determinant of long-term BP lowering after the creation of an AV fistula and support a contribution of suppressed RSNA if resetting of the atrial-renal reflex is truly incomplete.NEW & NOTEWORTHY The mechanisms that contribute to the antihypertensive effects of a small arteriovenous (AV) fistula comparable to the size used by the ROX coupler currently in clinical trials are unclear and not readily testable in clinical or experimental studies. The integrative mathematical model of human physiology used in the current study provides a tool for understanding key causal relationships that account for blood pressure (BP) lowering and for testing competing hypotheses. The findings from the simulations suggest that after creation of a small AV fistula increased ANP secretion plays a critical role in mediating long-term reductions in BP. Measurement of natriuretic peptide levels in hypertensive patients implanted with the ROX coupler would provide one critical test of this hypothesis.

CCI clinical practice guidelines: management of TIPS for portal hypertension (2019 edition)

Portal hypertension(PH) is one of the main complications of cirrhosis.Transjugular intrahepatic portosystemic shunt(TIPS) is the percutaneous creation of a conduit from the hepatic vein to the portal vein that is used to manage consequences of PH (i.e., variceal bleeding and refractory ascites) and used as a bridging therapy to liver transplant for decompensated cirrhosis. The following Clinical Practice Guidelines (CPGs) presents profession associational recommendations of the Chinese College of Interventionalists(CCI) on TIPS for PH. The CPGs was written by more than 30 experts in the field of TIPS in China (including interventional radiologists, liver surgeons, hepatologists and gastroenterologist, et al.). The panel of experts, produced these CPGs using evidence from PubMed and Cochrane database searches and combined with relevant expert consensuses and high quality clinical researches in China providing up to date guidance on TIPS for PH with the only purpose of improving clinical practice.

Percutaneous deep venous arterialization in patients with critical limb ischemia.

Critical limb ischemia (CLI) is the presentation of end stage peripheral arterial disease and typically presents with rest pain, ulceration and gangrene. The outcome of conservative treatment is poor and often leads to amputations. Arterial revascularization plays an important role in amputation prevention. Unfortunately, a significant percentage of CLI patients cannot be revascularized and subsequently end up with a palliative amputation. This has led to the need and exploration of new treatment options in this no option subgroup of CLI. Deep venous arterialization (DVA) is one of them and has been reported as a save and feasible novel and promising alternative to amputation. The goal of DVA is to provide arterialized blood in significant volumes and pressure to the plantar venous arch and ischemic tissue to enable wound healing. Selecting the right patients is critical for successful DVA and requires that extra attention is paid to the wounds as well as arterial and venous vascular status. The procedure was previously described in our initial experience in the first-in-man study performed on 7 patients with NOP-CLI. The angiographic goal of the procedure is to deliver arterialized blood to the plantar venous arch in significant volumes and pressure, circumventing the numerous valves in the process. The clinical goal is to achieve wound healing. Technical success was achieved in all patients. Flow in the plantar arch was achieved in 5 of the 7 patients. One patient with chronic rest pain became pain free within 48 hours after the procedure. Complete wound healing was achieved at 12 months in 5 of the 7 patients. Reinterventions were performed in 5 of 7 patients to maintain patency. Of the 7 study patients, five underwent minor amputation of one or more toes, and two underwent major amputations within 12 months (limb salvage, 71%). The LimFlow system is currently the only registered device a total percutaneous DVA can be performed with. In addition to the percutaneous creation of an arteriovenous fistula (AVF), it also allows disruption of the veins with a dedicated valvulotome.

Endovascular bypass for salvage of vascular access in hemodialysis catheter-consigned patients.

This study was performed to retrospectively assess the efficacy of percutaneous creation of an intervascular bypass with or without stent graft deployment (endovascular bypass) for salvage of abandoned vascular access sites in hemodialysis catheter-consigned patients. Salvage of abandoned vascular access sites was attempted in 16 patients with hemodialysis catheters. These vascular access sites were salvaged using endovascular bypass techniques to redirect the access flow to a nonarterialized vein as a new outflow conduit or cannulation segment. The postintervention primary, assisted primary, and secondary patency rates of the access site and bypass were calculated using the Kaplan-Meier method. The procedural and clinical success rates were both 100%. The postintervention primary patency rate of the bypass and access site at 360 days was 75.7 ± 12.5% and 56.8 ± 14.9%, respectively. The mean follow-up period was 461.9 days (range: 121-900 days). No major complications were observed. One bare bypass tunnel rupture and one pseudoaneurysm were noted during the procedure. Salvage of abandoned vascular access sites for hemodialysis catheter-consigned patients can be technically feasible and clinically successful using endovascular bypass techniques in selected patients when surgical revision is not considered or is not possible.

Percutaneous Creation of a Central Iliac Arteriovenous Anastomosis for the Treatment of Arterial Hypertension.

Provision of a summary on the physiologic effects of arteriovenous fistula creation and description of previously published human data on the efficacy of a percutaneously implanted device creating an arteriovenous fistula. Though antihypertensive therapy is effective, some patient's blood pressure remains poorly controlled despite adherence to optimal medical therapy. Moreover, some patients are not compliant with recommended medical therapy due to side effects or personal decision. This has prompted exploration of alternative, device-based antihypertensive therapies including, among others, the percutaneous creation of an arteriovenous fistula. An arteriovenous fistula is accompanied by a number of favorable physiologic changes that may lower blood pressure. These physiologic changes, conduction of the procedure, and previously published human experience are summarized in this review article. The results of a recently published trial comparing arteriovenous fistula creation and standard antihypertensive therapy versus standard antihypertensive therapy alone are summarized. Creation of an arteriovenous fistula is accompanied by a significant blood pressure reduction likely related to a reduction in total arterial resistance, perhaps blood volume reduction, inhibition of the baroreceptor reflex, and release of natriuretic peptides. These findings foster further interest in studying the impact of an arteriovenous fistula and arterial blood pressure. The design of a large randomized trial comparing arteriovenous fistula creation to sham control is outlined.

Correction to: Percutaneous Creation of a Central Iliac Arteriovenous Anastomosis for the Treatment of Arterial Hypertension

In the March 2018 issue of Current Hypertension Reports, the second author's name Nathan A. Sobotka was inadvertently left out of the byline. Also, the author names were changed from initials to spelled out. The corrected author list is given above. The original article has been corrected.

Percutaneous creation of an arteriovenous fistula (pAVF) for hemodialysis access

Percutaneous creation of an arteriovenous fistula (pAVF) for hemodialysis access

Thermal Resistance Anastomosis Device for the Percutaneous Creation of Arteriovenous Fistulae for Hemodialysis

PurposeTo evaluate the safety and efficacy of arteriovenous fistula (AVF) creation with a thermal resistance anastomosis device (TRAD). Materials and MethodsFrom January 2014 to March 2015, 26 patients underwent ultrasound (US)-guided percutaneous creation of proximal radial artery–to–perforating vein AVFs with a TRAD that uses heat and pressure to create a fused anastomosis. Primary endpoints were fistula creation, patent fistula by Doppler US, two-needle dialysis at the prescribed rate, and device-related complications. ResultsTechnical success rate of fistula creation was 88% (23 of 26). Procedure time averaged 18.4 minutes (range, 5–34 min), and 96% of anastomoses (22 of 23) were fused. At 6 weeks, 87% of AVFs (20 of 23) were patent, 61% (14 of 23) had 400-mL/min brachial artery flow, 1 patient was receiving dialysis, 2 fistulae had thrombosed, and 1 patient had died unrelated to the procedure. Eighty percent (16 of 20), 70% (14 of 20), and 60% (12 of 20) of patients were receiving dialysis at 3, 6, and 12 months; 4 patients died, 3 fistulae failed, and one patient was lost to follow-up. Overall, 87% of AVFs (20 of 23) had an additional procedure at a mean of 56 days (range, 0–239 d), including balloon dilation in 43% (n = 10), brachial vein embolization in 26% (n = 6), basilic vein ligation in 17% (n = 4), venous transposition in 30% (n = 7), and valvulotomy in 4% (n = 1). There were no major complications related to the device. ConclusionsPercutaneous AVFs created with a TRAD met the safety endpoints of this study. Midterm follow-up demonstrated intact anastomoses and fistulae suitable for dialysis.