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Percutaneous hemodialysis arteriovenous fistula

Percutaneous hemodialysis arteriovenous fistula
Literature review current through: Jan 2024.
This topic last updated: Apr 27, 2022.

INTRODUCTION — Percutaneous hemodialysis arteriovenous (AV) fistulas are created using endovascular techniques without the need for a surgical incision and are also termed endo-AV fistulas or endoAVFs.

The creation of permanent hemodialysis AV access in patients with end-stage kidney disease has historically been performed through the surgical creation of an AV fistula or AV graft. While these procedures are typically straightforward outpatient procedures, overall maturation-to-use rates remain low, with nearly 25 percent failing to mature despite high utilization of subsequent procedures to aid in maturation [1,2]. Over 50 percent of patients ultimately require reintervention to maintain patency of the AV access once maturation has occurred [1]. Other complications of traditional AV hemodialysis access include infection, steal syndrome, aneurysm formation, and pulmonary and venous hypertension [3]. As a result of complications or AV access failure, patients often require several different access procedures performed in multiple extremities. These issues along with surgical risks and the desire for a wider range of dialysis access creation sites have all driven the need for and rapid evolution of percutaneous hemodialysis AV fistulas.

In addition, in many areas there is a paucity of surgeons who are willing or able to create high-quality dialysis access. To enable more dialysis patients to have a permanent access, there have been efforts to make access creation techniques available to interventionalists outside of the traditional operating room.

The percutaneous approach to creation of permanent hemodialysis AV access is reviewed. A general overview of hemodialysis access, the surgical creation of vascular access and its failure rates and complications, and end-stage renal disease and its management are discussed elsewhere. (See "Approach to the adult patient needing vascular access for chronic hemodialysis" and "Arteriovenous fistula creation for hemodialysis and its complications" and "Primary failure of the hemodialysis arteriovenous fistula" and "Overview of the management of chronic kidney disease in adults".)

ANATOMIC CONSIDERATIONS

Upper extremity vascular anatomy — The primary blood supply to the arm, the brachial artery, typically divides into the radial and ulnar arteries laterally and medially, respectively, at the elbow. These arteries all have deep veins that correspond in name and course and that provide venous outflow from the arm. In addition to these deep veins (figure 1A-B), a system of superficial veins in the arm that includes the cephalic vein laterally and the basilic vein medially contribute to venous drainage. The presence of a perforating vein (ie, deep communicating vein) at the antecubital fossa provides a connection from the deep venous system to the superficial system and provides outflow from the ulnar, radial, or brachial veins to the superficial cephalic and basilic veins of the upper arm. This perforating vein is critical in the planned creation of a percutaneous AV fistula.

How the percutaneous arteriovenous fistula works — The available percutaneous hemodialysis AV fistula systems create a connection between a forearm artery (ulnar or radial artery) and a perforating vein or the named vein that corresponds to the artery (ulnar or radial vein). Once this connection is created, blood is shunted from the arterial system into the deep venous system and subsequently to the superficial venous system via the perforating vein. Once matured, the arterialized superficial veins can then be accessed for hemodialysis in a manner like surgically created AV fistulas using these superficial veins.

Since the perforating vein frequently drains to both the cephalic vein and basilic vein, both superficial veins may increase in size and have flow volumes adequate for dialysis, which may expand the options for dialysis access. The size of deep and superficial veins and the presence, size, and location of the perforating vein is variable, and as such, not all patients are candidates for percutaneous fistula creation. (See 'Preoperative evaluation' below.)

PREOPERATIVE EVALUATION

Vascular evaluation — Upper extremity vascular evaluation is necessary to determine if the patient is a candidate for creation of a distal surgical AV fistula (eg, radial-cephalic fistula at the wrist), and if not, whether they meet the anatomic criteria for creation of a more proximal antecubital fistula. Such "vascular mapping" allows determination of artery and vein sizes and suitability for both percutaneous and surgical fistulas. (See "Patient evaluation prior to placement of hemodialysis arteriovenous access".)

It must be ensured that the patient is not a candidate for a distal surgical AV fistula before a more proximal antecubital fistula (percutaneous or surgical) is created. This approach preserves more options if the initial access fails and serves to augment proximal venous flow and facilitate future options. (See "Approach to the adult patient needing vascular access for chronic hemodialysis", section on 'Initial access'.)

Preoperative imaging also confirms adequate triphasic flow to the hand through the artery that will not be used for the AV fistula, as well as an intact palmar arch using either arterial duplex or Doppler waveforms.

Anatomic suitability — Based on the venous and arterial parameters listed below, anatomic suitability for a percutaneous AV fistula has been assessed in several studies [4-7].

Anatomy amenable for creation of a percutaneous AV fistula is present in about 44 percent of patients for the WavelinQ procedure [5], and about 65 percent for the Ellipsys device [4,7,8]. Some studies report higher values; however, it is important to account for the baseline need for a perforating vein and suitable vessel diameters, which are not always reported. If these are not included, reported suitability rates may be falsely elevated.

In a review of 116 patients, eligibility based on the manufacturer's instructions for use (IFU) was 93 percent for the WavelinQ and 52 percent for the Ellipsys [6]. However, criteria for suitability didn't account for the requirement of a perforating vein, which was found in only 66 percent of patients. In another review, 67 percent were reported to be eligible for Ellipsys based on anatomic criteria that included the presence of the cubital veins, a perforating vein, and appropriate artery and vein diameters [4]. In the Novel Endovascular Access Trial (NEAT), 80 of 183 (44 percent) of the patients evaluated underwent endoAV fistula creation (two-catheter system) [5].

It should be noted that in these studies, 31 to 42 percent of patients met anatomic criteria for the surgical creation of a radial-cephalic fistula at the wrist, which in most cases would be preferred over the placement of a percutaneous AV fistula. These findings highlight that while a significant number of patients are candidates for distal surgical fistula first, use of the percutaneous AV fistula systems can broaden the availability of sites for hemodialysis AV access.

Specifically, anatomic requirements include the following:

The presence of the perforating vein (ie, deep communicating vein) of the proximal forearm is necessary since both the WavelinQ and the Ellipsys systems rely on this vein to divert flow into the superficial arm veins. A minimal diameter of 2 mm is required.

Similarly, the planned arterial inflow, as well as the primary superficial venous outflow arising from the communicating vein that is intended for use during hemodialysis (cephalic or basilic vein), should be at least 2 mm in diameter.

The distance between the inflow artery and its corresponding vein where the percutaneous AV fistula is created is important and differs slightly between the two approaches.

The WavelinQ system requires the distance between the ulnar or radial artery and corresponding vein to be ≤1 mm.

The Ellipsys system requires the distance between the perforating vein and the proximal radial artery to be <1.5 mm.

ENDOAVF DEVICES AND TECHNIQUES — The US Food and Drug Administration approved two percutaneous catheter-based dialysis creation systems in June 2018, and while they use different techniques to achieve the formation of an AV fistula, both have shown promising rates of maturation and subsequent use [9]. (See 'Outcomes' below.)

These approaches include the WavelinQ System, an angiography-based technique that uses radiofrequency energy to create a fistula between a superficial vein and deep artery, and the Ellipsis Vascular Access System, which achieves this same goal with an ultrasound-based technique that uses thermal energy.

These devices are placed using local anesthesia or regional anesthesia with or without sedation. Both devices are used exclusively in the upper extremities and require anatomy suitable for the procedure. (See 'Anatomic considerations' above.)

Radiofrequency endoarteriovenous fistula

WavelinQ device — The WavelinQ EndoAVF system is a two-catheter system consisting of a magnetic 4 Fr venous and 4 Fr arterial catheter and a radiofrequency generator. The arterial catheter contains orienting magnets and a ceramic backstop, while the venous catheter contains orienting magnets and the cutting electrode. Both catheters have rotational indicator windows that help guide the catheters into the correct orientation. The end goal of this device is to use radiofrequency energy to create a fistula between an artery and vein in the proximal forearm, most commonly the ulnar artery and the ulnar vein.

WavelinQ procedure — The first step in the WavelinQ procedure is to gain access to the arterial and deep venous systems. Either antegrade or retrograde access with respect to flow can be gained, and the orientation of the two catheters can be either parallel or antiparallel manner (image 1).

The location of access is determined by the size of the vessels, which must be >2 mm for the WavelinQ catheters. Furthermore, the distance between the target artery and vein must be 1 mm or less for the 4 Fr WavelinQ system. (See 'Anatomic suitability' above.)

Some thought needs to be given to the individual anatomy of the superficial venous outflow from the perforating vein. One common approach is to place the catheters in an antiparallel manner, with retrograde ulnar artery access at the wrist and brachial vein access in the proximal arm, although antegrade access to brachial artery and brachial vein both placed above the elbow can also be used.

After regional (axillary or supraclavicular block) or local anesthesia, arterial access is gained using ultrasound guidance and a micropuncture needle and sheath. To diminish arterial vasospasm, a mixture of nitroglycerin, verapamil, and heparin is frequently given directly through the sheath. Dosing varies by provider but is similar to that provided for percutaneous radial artery access procedures.

An angiogram is performed to better delineate the arterial anatomy, and a 0.014" wire is placed into the ulnar artery to serve as a landmark during venous catheterization. The brachial vein is accessed next. A proximal tourniquet is often used to distend the veins for easier cannulation. With retrograde venous access, patent valves may be encountered, which need to be carefully navigated with gentle pressure. Using 0.018" wire may provide more support than an 0.014" wire, although if used will have to be changed out for the 0.014" wire once the valves are crossed. A venogram is usually performed to better delineate the flow through the deep vein (radial or ulnar) through the perforating vein into the cephalic and basilic vein to guide the optimal location of the planned fistula.

The arterial and venous catheters are advanced with placement of the magnetic components in the planned location of the fistula. When placed in proximity, the magnets in the catheters will attract, coaptating the target artery and vein. The arterial catheter is advanced first until it is in the proper position at the site of the desired anastomosis. Care must be taken to ensure that the cutting electrode on the venous catheter is aligned with the ceramic backstop indentation in the arterial catheter and that the rotational indicator on the device appears as an open box (per the manufacturer's instructions for use). The venous catheter is advanced next, ensuring that it is rotated so the arc of the radiofrequency probe is facing the artery before it encounters the magnets of the arterial catheter. Proper placement will lead to a visual compression of the electrode.

Before the electrode is activated, the venous tourniquet is released, the guidewires are removed, and the patient's arm is restrained, since activation of the radiofrequency energy will cause an involuntary muscle contraction of the arm. When activated, the electrode should visibly advance and touch the arterial backstop. If this does not happen, the positions of the catheters should be confirmed; the device can be activated for a total of three attempts.

After creation of the fistula, the catheters are removed and a completion venogram is performed to confirm flow through the perforating vein into the superficial venous system. Prior to removal of the venous sheath, placement of an embolization coil into the accessed brachial vein more proximally in the arm can help drive more flow through the perforating vein into the superficial system and help in maturation of the fistula. This coil does not typically exclude flow completely through the vein but directs flow through the perforating vein and into the superficial veins. Care must be taken to properly size the coil to limit the possibility of pulmonary embolization.

Hemostasis is obtained per the usual institutional protocols with manual pressure of the arterial and venous puncture sites after sheath removal. (See "Percutaneous arterial access techniques for diagnostic or interventional procedures", section on 'Hemostasis at the access site'.)

Thermal endoarteriovenous fistula

Ellipsys device — The Ellipsys Vascular Access System is a single 6 Fr catheter device that uses thermal energy and pressure to create an AV fistula [9,10].

Ellipsys procedure — The Ellipsys procedure is performed under ultrasound guidance and does not require fluoroscopy or angiography, thus minimizing patient exposure to radiation and intravenous contrast. The procedure is generally quick, with an average time of 15 minutes (range 7 to 35 minutes) and is well tolerated by patients [11].

After either regional axillary or supraclavicular block or local anesthesia, the superficial vein (cephalic or basilic) that drains the perforating vein is accessed using ultrasound guidance proximal to the antecubital fossa. The needle is guided from the antecubital vein using ultrasonography through the perforating vein to the chosen site of fistula creation. The needle tip is advanced through the venous wall and into the proximal radial artery at this site, after which a guidewire is advanced into the radial artery.

A 6 Fr thin-walled sheath is placed over the wire and advanced into the radial artery, and the patient is systemically anticoagulated (typically heparin). A 0.014" wire is placed through the sheath over which the Ellipsys catheter is advanced and placed and positioned to have one portion of the open jaw in the radial artery and the other in the vein. The sheath is pulled back, and the jaws of the catheter are closed, compressing the arterial and venous walls together within the device.

Sensors in the device indicate when there is appropriate coaptation of tissue, at which point the device is activated, delivering thermal energy to the compressed area, completing the elliptical anastomosis. A 4 mm or 5 mm balloon catheter is placed over the wire, and balloon angioplasty of the anastomosis is performed. Increased flow through the brachial artery is confirmed by ultrasound.

The sheath is then removed, and pressure is applied to achieve hemostasis.

FOLLOW-UP — As with any hemodialysis AV access, success depends upon close follow-up and subsequent interventions to assist maturation. Flow within the fistula as well as inflow artery should be measured soon after the procedure is completed and ideally at the end of the procedure itself. Patients with flow volumes within the fistula <400 mL/min may need follow-up within a week for balloon angioplasty of the anastomosis. For flow volumes >400 mL/min, generally the patient can be seen a month after the procedure, and the patient can be cleared to use their fistula soon thereafter [9].

If arterial flow volumes are sufficient but flow through the cannulation zone remains <500 mL/min, outflow veins may need to be coiled or ligated. Like surgically created fistulas, percutaneous AV fistulas may also require transposition or superficialization if they are too deep.

CANNULATION OF THE MULTI-OUTFLOW FISTULA — The multi-outflow AV fistula created with a percutaneous approach presents opportunities and challenges for hemodialysis access cannulation. Possible options for cannulation include forearm veins, both median cephalic or median basilic veins, and more commonly, the upper arm cephalic or basilic veins.

In patients a multi-outflow fistula, manually obstructing a vein for cannulation provides less augmentation in the targeted vein when compared with a single-outflow fistula because flow will divert to the noncompressed outflow vein. Using a tourniquet rather than manual compression can assist cannulation because it will augment flow in all the superficial veins.

Ultrasound guidance during early cannulation and use of plastic cannulas can be helpful to evaluate and make use of any of the potential cannulation sites. Alternatively, flow can be directed toward a single outflow vein with banding or ligation of competitive outflow to convert the multi-outflow fistula into a single-outflow fistula to obtain the look, feel, and flow of the more traditional surgical AV fistula.

OUTCOMES — A variety of published studies have evaluated outcomes of both percutaneous AV fistula devices, generally noting favorable short- and long-term results. Studies include a mixture of clinical trials and small and large observational series of "real world" experience.

Clinical trials — In the pivotal Ellipsys Trial, among 107 patients deemed eligible for the procedure, successful creation of an endoAV fistula was achieved in 102 patients (95 percent). Subsequent maturation procedures were required in 99 patients (97 percent). This included anastomotic balloon dilation in 72 percent, brachial vein embolization in 32 percent, cubital vein ligation in 31 percent, and surgical transposition in 26 percent. The average time to reintervention was 35 days, and the average number of maturation procedures per patient was 2.1 [12]. Cumulative patency at one year and two years was 93.9 and 92.7 percent, respectively [13].

WavelinQ clinical trials include the Flex trial [14], the EASE trial [15], and the NEAT trial [5], with the NEAT trial being the largest of the three (n = 60). Ninety-eight percent of patients in the NEAT trial successfully had a percutaneous AV fistula created, and 87 percent of these ended up being suitable for dialysis. Fifty-two percent of the percutaneous AV fistulas were functional without any intervention, and the rate of interventions was 0.46 per patient per year. At 12 months, the primary patency was 69 percent, and cumulative patency was 84 percent.

The largest series evaluated midterm outcomes using the Ellipsys system from procedures performed between 2017 and 2019 in 234 patients [11]. Technical success was 99 percent, average procedure time was 15 minutes, and the primary, primary assisted, and secondary patency at one year was 54, 85, and 96 percent, respectively. The most common postmaturation intervention was angioplasty of the anastomosis and perforating vein, which was required in 35 percent of patients. Twenty-four of the patients (11 percent) required superficialization of veins that were too deeply situated and difficult cannulation, but only 3 patients (1 percent) required a conversion to a surgical AV fistula. Other smaller series have confirmed the findings of the pivotal Ellipsys trial and reported that 41 to 67 percent of patients require subsequent procedures to facilitate maturation [8,16].

Comparative studies

Radiofrequency versus thermal endoAV fistula – Other studies have specifically looked at whether there were any differences between the WavelinQ and Ellipsys systems. In one review, the primary patency rate was similar at 33 and 32 percent, respectively, and the secondary patency rate was 60 percent for the WavelinQ and 82 percent for the Ellipsys at one year [7]. Based on a Kaplan-Meir analysis, the difference was not significant between the two devices at one year; however, there was a significantly higher secondary patency for the Ellipsys compared with WavelinQ group (hazard ratio 0.42, 95% CI 0.19-0.97). It should be noted, though, that these results are difficult to generalize, since the protocol gave preference to WavelinQ if a patient was a candidate for both devices [7].

Percutaneous versus surgical AV fistulas – Another area of interest is the patency of percutaneous compared with surgical AV fistulas. In one comparative study, maturation rates at six weeks were higher for the Ellipsys system compared with surgical AV fistulas (65 versus 50 percent), but primary and secondary patency rates were similar at two years (52 versus 55 percent and 88 versus 91 percent, respectively) [17]. A study comparing WavelinQ to radial-cephalic AV fistulas reported similar primary and secondary patency rates (56.5 versus 44 percent and 69.5 versus 57.6 percent, respectively) at 12 months [18]. When looking specifically at the Gracz-type surgical fistula compared with Ellipsys at one year, primary patency was 36 and 35 percent and secondary patency was 66 versus 88 percent, respectively. Due to small sample sizes, the differences were not statistically significant between the two groups [19].

Complications — Percutaneous AV fistula creation has low rates of complications. This includes a small risk of hematoma/bleeding or aneurysm at the puncture site occurring in between 1.5 and 9.3 percent of patients [7,16,20]. In the pivotal trial for the Ellipsys device, there were no major device complications including vessel perforation, vessel dissection, electric shock, or distal embolization [12].

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Hemodialysis vascular access".)

SUMMARY AND RECOMMENDATIONS

Percutaneous hemodialysis arteriovenous fistulas – Percutaneous hemodialysis arteriovenous (AV) fistulas, which are also termed endo-AV fistulas or endoAVFs, are created using endovascular techniques without the need for a surgical incision. In the absence of anatomy acceptable for distal surgical AV fistula (eg, radial-cephalic fistula), an endoAVF is an option for AV fistula creation. (See 'Introduction' above and 'How the percutaneous arteriovenous fistula works' above.)

Devices – The available percutaneous AV fistula systems create a connection between a proximal forearm artery (ulnar or radial artery) and its corresponding vein (ulnar or radial vein). The presence of a perforating vein (ie, deep communicating vein) at the antecubital fossa is necessary in the creation of a percutaneous AV fistula. The AV fistula is created using local anesthesia or regional anesthesia with or without sedation. (See 'How the percutaneous arteriovenous fistula works' above and 'EndoAVF devices and techniques' above.)

The WavelinQ System is an angiography-based technique that uses radiofrequency energy to create the AV fistula. (See 'WavelinQ device' above.)

The Ellipsis Vascular Access System is an ultrasound-based technique that uses thermal energy to create the AV fistula. (See 'Ellipsys device' above.)

Vascular evaluation – Upper extremity vascular evaluation is necessary to determine if the patient is a candidate for a creation of a distal surgical AV fistula (eg, radial-cephalic AV fistula at the wrist, which should always be attempted first), and if not, whether they meet the anatomic criteria for creation of a more proximal antecubital fistula AV fistula using a percutaneous approach. (See 'Vascular evaluation' above and 'Anatomic suitability' above.)

The size of the deep and superficial veins (figure 1A-B) and the presence, size, and location of the perforating vein (ie, deep communicating vein) are variable. Thus, not all patients are candidates for percutaneous AV fistula creation.

Preoperative vascular imaging is also important to ensure adequate blood flow to the hand.

Anatomic requirements – Anatomic requirements for percutaneous AV fistula creation include the following (see 'Anatomic suitability' above):

A minimal perforating vein diameter of 2 mm or larger.

Inflow artery diameter of 2 mm or larger.

Superficial venous outflow diameter (eg, cephalic vein, basilic vein) 2 mm or larger.

Adequate distance between the inflow artery and corresponding vein in which the percutaneous AV fistula will be created. This distance differs slightly between the two devices.

-WavelinQ requires the distance between the ulnar or radial artery and corresponding vein to be ≤1 mm.

-Ellipsys requires the distance between the perforating vein and the proximal radial artery to be <1.5 mm.

Follow-up and reintervention – After creation of a percutaneous AV fistula, the arterialized superficial veins are followed for maturation. Reinterventions are frequently needed to assist maturation similar to surgically created AV fistulas. Either or both of the cephalic and basilic veins may increase in diameter, resulting in a multi-outflow fistula with flow volumes adequate for hemodialysis since the perforating vein frequently drains to both. Once matured, the superficial veins are accessed for hemodialysis like a surgically created AV fistulas; however, there are some special considerations when accessing a multi-outflow fistula. (See 'Follow-up' above and 'Cannulation of the multi-outflow fistula' above.)

Outcomes – A variety of studies have evaluated outcomes percutaneous AV fistulas, with generally favorable short-term results. Percutaneous AV fistulas have high initial technical success rates and reasonable maturation rates. No clinically important differences have been proven when comparing the available percutaneous AV fistula systems. Compared with surgical AV fistulas, patency rates appear similar out to two years. (See 'Outcomes' above.)

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