Coverage Policy Manual
Policy #: 2021029
Category: Surgery
Initiated: June 2021
Last Review: June 2022
  Percutaneous Arteriovenous Fistula (pAVF)

Description:
The choice for long term hemodialysis access is an important decision in the care of patients with chronic renal failure. Choices include A-V fistula, A-V graft, and tunneled catheters. Each has advantages and disadvantages. In the early 2000’s the Fistula First Initiative came about as a quality improvement project with the goal of promoting the use of A-V fistulas as the access for hemodialysis for the majority of dialysis patients.
 
Recently, minimally invasive interventional radiology techniques have become available for creating autologous A-V fistulas. The first endovascular technique employs arterial and venous catheters.  Magnets in the catheters hold the artery and associated vein in apposition. A radiofrequency electrode is then used to fuse the vessel walls and create a lumen between the vessels resulting in an A-V fistula.
 
Another technique uses a single catheter placed in a cephalic vein or basilic vein. The tip of the catheter is positioned to engage the proximal radial artery.  A side-to-side elliptical anastomosis is then formed using thermal energy.
 
This technique is new, and though early experience is promising, both the number of patients and the length of follow-up are limited.
 
Regulatory Status
 
On June 22, 2018, the FDA granted a De Novo classification order for 2 systems (Ellipsys™ and everlinQ®) intended to create an AVF via a percutaneous approach.
 
The WavelinQ™ 4F EndoAVF System (BD Bard, Tempe, AZ) [previously everlinQ® endoAVF, TVA Medical, Austin TX] was granted De Novo classification (DEN160006) on June 22, 2018. The system consists of a pair of over-the-wire catheters with magnets and a spring-loaded radiofrequency (RF) electrode and is indicated for, ”the creation of an arteriovenous fistula (AVF) using the ulnar artery and ulnar vein in patients with minimum artery and vein diameters of 2.0 mm and less than 2.0 mm separation between the artery and vein at the fistula creation site who have chronic kidney disease and need HD.” A newer generation WAVELINQ™ obtained 510(k) clearance (K182796) on February 6, 2019, based on its substantial equivalence to the predicate device (FDA, 2018 and 2019). In early 2019, safety issues related to magnet malfunction were reported in the FDA, and  on 04/12/2019, the manufacturer issued a recall (#84946) for Lot Number S0053 of the 4FEndoAVF System due to risk of “experiencing a magnetic deficiency between the venous and arterial magnetic catheters, which may result in the magnets failing to attract to one another.” (FDA, 2019).
 
The Ellipsys™ Vascular Access System (Avenu Medical, San Juan Capistrano, CA) is an image guided, single catheter system used to percutaneously create an AVF for HD access. The Ellipsys™ System (original De Novo classification number DEN170004 granted on June 22, 2018) utilizes an access cannula, guidewire, and vessel capture construct that creates a connection of the vein to the artery using thermal energy. A modification to the Ellipsys™ System received 510(k) clearance (K181725) on October 5, 2018, based on its substantial equivalence to the predicate device for the indication of, “creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis” (FDA, 2018).
 
Product Code PQK (percutaneous catheter for creation of an AVF for HD).
 
Coding
 
The following HCPCS codes may be billed for pAVF creation:
 
G2170 (Ellipsys System) - Percutaneous arteriovenous fistula creation (avf), direct, any site, by tissue approximation using thermal resistance energy, and secondary procedures to redirect blood flow (e.g., transluminal balloon angioplasty, coil embolization) when performed, and includes all imaging and radiologic guidance, supervision and interpretation, when performed
 
G2171 (WavelinQ System)- Percutaneous arteriovenous fistula creation (avf), direct, any site, using magnetic guided arterial and venous catheters and radiofrequency energy, including flow directing procedures (e.g., vascular coil embolization with radiologic supervision and interpretation, when performed) and fistulogram(s), angiography, enography, and/or ultrasound, with radiologic supervision and interpretation, when performed
 
37799 - Unlisted procedure, vascular surgery

Policy/
Coverage:
Effective June 2021
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of an endovascular percutaneous device for the creation of an arteriovenous fistula (AVF) for hemodialysis (HD) access does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, the use of an endovascular percutaneous device for the creation of an arteriovenous fistula (AVF) for hemodialysis (HD) access is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:
Ellipsys™ System (Avenu Medical, San Juan Capistrano, CA)
 
The FDA marketing authorization for the Ellipsys™ System was based primarily on data from a pivotal trial the purpose of which was to demonstrate the safety and effectiveness of the Ellipsys™ Vascular Access System in creating a native AV fistula via percutaneous access to support future hemodialysis. (Hull, 2018).  The study was a non-randomized, prospective multi-center study conducted in the United States, in which a total of 107 subjects from 5 sites were enrolled to undergo creation of an AV fistula using the Ellipsys™ Vascular Access System. Patients who met the inclusion criteria and had suitable vascular anatomy, as confirmed by pre-procedure ultrasound vascular mapping, were enrolled in the study. Follow-up visits were scheduled at 24 hours, 1 week, 4 weeks, 90 days, 6 months and 1 year using the following standard of care assessments: vital signs, upper extremity vessel dimensions by ultrasound, post-procedure patency and flow rates, and adverse events.
 
Of the 107 participants, 102 (95%) were technically successful (i.e., an AVF was created), and 92 patients (89.3%) met the criteria for a usable AV fistula within three months. Almost all patients (97%) required an additional maturation or maintenance procedure (balloon angioplasty, brachial vein embolization, vein transposition, accessory vein ligation, valvulotomy, stent) in the first 12 months to achieve a one-year cumulative patency of 86.7%. No device related serious adverse events (SAEs) were reported. All pivotal trial authors own stock in Avenu Medical, and the principal investigator has an associated patent.
 
Beathard et al published the report of a two-year retrospective analysis of a mix of 105 patients (mean age 56.2 years; range, 30-80 years) (i.e., not exactly the original pivotal trial cohort) and cited a one and two-year cumulative patency of 92.8% and 91.6%, respectively (Beathard, 2019).
 
Franco et al published the results of a study of 100 consecutive patients (mean age 61 years, range 21-87 years) assessed for first AVF creation, found that sixty-three patients (63%) and a total of 100 limbs (50%) were a candidate for pAVF by imaging criteria according to device instructions for use (IFU) (Absence of superficial antecubital veins and anatomical variations of the proximal radial artery were the most common limiting factors (Franco, 2020). A surgical distal sAVF was feasible (based on current standards) in 91 limbs (45%) but dropped to 17% in patients older than 70 years. Among the 100 limbs eligible for a pAVF, only 30 (30%) were eligible for a distal sAVF. According to the authors, this “indicates that the two techniques are complementary, especially for the older and sicker patients.” However, they provided no comparable stratification of pAVF eligibility by age.
 
Mallios et al published a small retrospective data review of 60 pAVF patients found 14 (mean age 58 years; range 26-80 years) in whom early cannulation (within 14 days of access creation) had been attempted to either avoid or replace catheter dialysis (Mallios, 2019). This goal was achieved in 13/14 (92%), suggesting that pAVF could potentially allow avoidance of a catheter for immediate dialysis use in select patients, though the authors caution a larger study is needed to confirm.
 
WAVELINQ™ 4F EndoAVF System (Becton Dickinson, Franklin Lakes, NJ)
 
WAVELINQ™ 4F EndoAVF System (Becton Dickinson, Franklin Lakes, NJ) [previously everlinQ® ] received FDA approval based on the "Novel Endovascular Access Trial" (NEAT Pivotal Study)  the purpose of which was to evaluate the safety and effectiveness of the everlinQ endoAVF System among subjects undergoing endoAVF creation (Lok, 2017). The NEAT study was a prospective, single-arm, multi-center study that enrolled 60 “study cohort” subjects and 20 “roll-in” subjects at 9 sites in Canada, Australia, and New Zealand. Candidates for this study were subjects with chronic kidney disease (CKD) who required a hemodialysis vascular access. In the full-analysis-set cohort (all 60 patients), technical success was achieved in 98%, 13% suffered primary failure, and 86.7% met the criteria for a usable AV fistula within three months after the procedure. A separate ‘evaluable cohort’ was also analyzed consisting of patients who were excluded due to circumstances not related to the device and technical success was achieved in 91%. Twenty eight percent of patients required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula, giving a secondary procedure per patient-year (ppy) rate of only 0.5. Cumulative 1-year patency was 84%. Eight device SAEs occurred in 5 (8%) participants. The 6F catheter used in this study was superseded by a 4F version in 2019.  There was also supporting data from three other studies (Berland, 2019; Rajan, 2015; Yang, 2017).  
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2022. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
37799Unlisted procedure, vascular surgery
G2170Percutaneous arteriovenous fistula creation (avf), direct, any site, by tissue approximation using thermal resistance energy, and secondary procedures to redirect blood flow (e.g., transluminal balloon angioplasty, coil embolization) when performed, and includes all imaging and radiologic guidance, supervision and interpretation, when performed
G2171Percutaneous arteriovenous fistula creation (avf), direct, any site, using magnetic guided arterial and venous catheters and radiofrequency energy, including flow directing procedures (e.g., vascular coil embolization with radiologic supervision and interpretation, wen performed) and fistulogram(s), angiography, enography, and/or ultrasound, with radiologic supervision and interpretation, when performed

References: Al-Jaishi AA, Oliver MJU, Thomas SM, Lok CE, et al.(2013) Patency rates of the arteriovenous fistula for hemodialysis: A systematic review and meta-analysis. Am J Kidney Dis 2014; 63:464–478. doi: 10.1053/j.ajkd.2013.08.023

Almasri J, Alsawas M, Mainou M, Mustafa R, et al.(2016) Outcomes of vascular access for hemodialysis: A systematic review and meta-analysis. J Vasc Surg 2016; 64:236–243. doi: 10.1016/j. jvs.2016.01.053

Beathard GA, Litchfield T, Jennings WC.(2019) Two-year cumulative patency of endovascular arteriovenous fistula. The Journal of Vascular Access. 2019.

Berland TL, Clement J, Griffin J, Westin GG, Ebner A.(2019) Endovascular Creation of Arteriovenous Fistulae for Hemodialysis Access with a 4 Fr Device: Clinical Experience from the EASE Study. Ann Vasc Surg. 2019;60:182-192. 29.

FDA(2021) FDA 510(k): WavelinQ 4F EndoAVF System. FDA 510(k): WavelinQ 4F EndoAVF System. https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182796.pdf.

FDA(2021) FDA Approval-Ellipsys. FDA Approval-Ellipsys. https://www.accessdata.fda.gov/cdrh_docs/pdf17/DEN170004.pdf.24.

FDA(2021) FDA- MAUDE - Manufacturer and User Facility Device Experience. FDA- MAUDE - Manufacturer and User Facility Device Experience. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/results.cfm?start_search=1&productcode=PQK&productproblem=&devicename=&modelNumber=&reportNumber=&manufacturer=&brandname=&eventtype=&reportdatefrom=05%2F01%2F2018&reportdateto=04%2F30%2F2019&pagenum=10.

Franco G, Mallios A, Bourquelot P, Hebibi H, et al.(2020) Feasibility for arteriovenous fistula creation with Ellipsys(®). J Vasc Access. 2020:1129729819900114

Hicks CW, Cannerjk, Arhuidese I, Zarkowsky DS, et al.(2015) Mortality benefits of different hemodialysis access types are age dependent. J Vasc Surg 2015; 61:449–456. doi: 10.1016/j.jvs.2014.07.091

Hull JE, Jennings WC, Cooper RI, Waheed U, et al.(2018) The Pivotal Multicenter Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation for Hemodialysis Access. J Vasc Interv Radiol. 2018;29(2):149-158 e145

Lee T, Qian JZ, Zhang Y, Thamer M, et al.(2019) Long-term outcomes of arteriovenous fistulas with unassisted versus assisted maturation: A retrospective national hemodialysis cohort study. J Am Soc Nephrol 2019; 30:2209–2218. doi: 10.1681/ASN.2019030318

Leermakers JJ, Bode AS, Vaidya A, vander Sande, FM, et al.(2013) Cost-effectiveness of vascular access for haemodialysis: arteriovenous fistulas versus arteriovenous grafts. Eur J Vasc Endovasc Surg 2013; 45:84–92. doi: 10.1016/j.ejvs.2012.10.012

Lok CE, Rajan DK, Clement J, et al.(2017) Endovascular Proximal Forearm Arteriovenous Fistula for Hemodialysis Access: Results of the Prospective, Multicenter Novel Endovascular Access Trial (NEAT). Am J Kidney Dis. 2017;70(4):486-497.

Mallios A, Beathard GA, Jennings WC.(2019) Early cannulation of percutaneously created arteriovenous hemodialysis fistulae. J Vasc Access. 2019:1129729819892796

Rajan DK, Ebner A, Desai SB, Rios JM, Cohn WE.(2015) Percutaneous creation of an arteriovenous fistula for hemodialysis access. J Vasc Interv Radiol. 2015;26(4):484-490.

Yang S, Lok C, Arnold R, Rajan D, Glickman M.(2017) Comparison of post-creation procedures and costs between surgical and an endovascular approach to arteriovenous fistula creation. J Vasc Access. 2017;18(Suppl. 2):814.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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