DESCRIPTION
Chronic kidney disease (CKD)) can often lead to end stage renal disease (ESRD) and in most cases requires dialysis. Vascular access to the bloodstream is preferred to administer dialysis. Traditionally, surgery is used to place an arteriovenous fistula (AVF) creating a direct connection between the vein and artery in an individual’s arm and providing adequate blood flow for dialysis through a closed circuit. Over 50% of individuals will require reintervention to maintain patency of the AV access once maturation has occurred.
Percutaneous arteriovenous fistula systems (e.g., Ellipsys®, WavelinQ™) are now being proposed for hemodialysis by creating a connection between the forearm artery (ulnar or radial) and a perforating vein or the named vein that corresponds with the artery (ulnar or radial vein) using ultrasound or fluoroscopy guidance. Once connected and matured, blood is then shunted from the arterial system to the deep venous system and finally the superficial venous system through the perforating vein. The atrialized superficial veins can then be accessed for hemodialysis in a manner like surgically created AV fistulas by using superficial veins.
POLICY
Endovascular percutaneous devices (e.g., Ellipsys®System; WavelinQ™System) for the creation of an arteriovenous fistula for hemodialysis access is considered investigational.
IMPORTANT REMINDERS
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ADDITIONAL INFORMATION
This technology is new, and though early experience is promising, both the number of individuals and the length of follow-up are limited.
SOURCES
Berland, T., Clement, J., Inston, N., Kreienberg, P., & Ouriel, K. (2022). Percutaneous arteriovenous fistula creation with the 4F wavelinQ endoAVF system. Journal of Vascular Surgery, 75 (3), 1038-1046. (Level 5 evidence)
Bontinis, A., Bontinis, V., Koutsoumpelis, A., Wilmink, T., Giannopoulos, A., Rafailidis, V., & et al. (2022). A systematic review aggregated data and individual participant data meta-analysis of percutaneous endovascular arteriovenous fistula. Journal of Vascular Surgery, 77 (4), 1252-1261. (Level 2 evidence)
European Society for Vascular Surgery. (2018). Editor’s choice - vascular access: 2018 clinical practice guidelines of the european society for vascular surgery (ESVS). Retrieved May 12, 2023 from https://www.ejves.com/article/S1078-5884(18)30080-7/pdf.
Harika, G., Mallios, A., Allouache, M., Costanzo, A., de Blic, R., Boura, B & et al. (2021). Comparison of surgical versus percutaneously created arteriovenous hemodialysis fistulas. Journal of Vascular Surgery, 74 (1) 209-216. (Level 4 evidence)
Inston, N., Khawaja, A., Tullett, K., & Jones, R. (2019). WavelinQ created arteriovenous fistulas versus surgical radiocephalic arteriovenous fistulas? A single-centre observational study. Journal of Vascular Surgery, 21 (5), 646-651. (Level 5 evidence)
Kitrou, P.M., Balta, L., Papachristou, E., Papachristou, M., Katsanos, K., Theofanis, M., Papadoulas, S., et al. (2021). Percutaneous arteriovenous fistula creation with the wavelinQ 4 - french endoAVF system: A single-center retrospective analysis of 30 patients. Journal of Vascular and Interventional Radiology, 33 (1), 33-40. (Level 5 evidence)
Malik, M H., Mohammed, M., Kallmes, D F., & Misra, S. (2021). Endovacular versus surgical arteriovenous fistulas: A systematic review and meta-analysis. Kidney Medicine, 4 (3), 100406. doi: 10.1016/j.xkme.2021.100406. (Level 2 evidence)
Mallios, A., Malik, J., & Jennings, W.C. (2022). Endovascular arteriovenous fistula creation – review of current experience. Diagnostics, 12 (10), 2447.doi:10.3390/diagnostics 12102447. (Level 5 evidence)
Mordhorst, A., Clement, J., Kiaii, M., Faulds, J., Hsiang, Y., & Misskey, J. (2022). A comparison of outcomes between open and endovascular arteriovenous access creation for hemodialysis. Journal of Vascular Surgery, 75 (1), 238-247. (Level 4 evidence)
National Institute for Health and Care Excellence (NICE). (2021, October). Percutaneous endovascular forearm arteriovenous fistula creation for haemodialysis access. RetrievedMay 12, 2023 rom http://www.nice.org.uk.
National Kidney Foundation. (2020, April). KDOQI clinical practice guideline for vascular access: 2019 update. Retrieved May 12, 2023 from https://www.ajkd.org/article/S0272-6386(19)31137-0/fulltext.
Osofsky, R., Byrd, D., Reagor, J., Das Gupta, J., Clark, R., Argyropoulos, C., & et al. (2021). Initial outcomes following introduction of percutaneous arteriovenous fistula program with comparison to historical surgically created fistulas. Annals of Vascular Surgery, 74, 271-280. Abstract retrieved June 21, 2023 from PubMed Database.
Popli, K., Dittman, J M., Amendola, M F., Plum, J., & Newton, D H. (2020). Anatomic suitability for commercially available percutaneous arteriovenous fistula creation systems. Journal of Vascular Surgery, doi:https://doi.org/10.1016/j.jvs.2020.09.021. (Level 4 evidence)
Repko, B M., & Rajan, D K. (2022). Outcomes of wrist-access deep venous embolization following percutaneous fistula creation: A two-year single center experience. Cardiovascular and Interventional Radiology, 45 (11), 1742-1746. (Level 4 evidence)
Shahverdyan, R., Beathard, G., Mushtaq, N., Litchfield, T F., Vartanian, S., Lonner, L., & et al. Comparison of ellipsys percutaneous and proximal forearm gracz-type surgical arteriovenous fistulas. (2021). American Journal of Kidney Diseases: The Official Journal of the National Kidney Foundation, 78 (4), 520-529. (Level 4 evidence)
Sun, J-B., Liu, C-C., Shen, X., Chen, Q., Xu, C-L., & Cui, T-L. (2022). Percutaneous endovascular arteriovenous fistula: A systematic review and meta-analysis. Frontiers in Cardiovascular Medicine, 9:978285. doi: 10.3389/fcvm.2022.978285. (Level 1 evidence)
U.S. Food and Drug Administration. (2019, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K182796. Retrieved May 12, 2023 from http://www.fda.gov/cdrh/pdf4/k182796.pdf.
U.S. Food and Drug Administration. (2019, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K192239. Retrieved May 12, 2023 from http://www.fda.gov/cdrh/pdf4/k192239.pdf.
Wee, I J Y., Yap, H Y., Tang, T Y., & Chong, T T. (2019). A systematic review, meta-analysis, and meta-regression of the efficacy and safety of endovascular arteriovenous fistula creation. Journal of Vascular Surgery, 71 (1), 309-317. (Level 2 evidence)
Winifred S. Hayes, Inc. Evolving Evidence Review. (2021, July; last update search March 2023). WavelinQ (formerly everlinQ) endoAVF system. Retrieved May 10, 2023 from www.Hayesinc.com/subscribers. (15 articles and/or guidelines reviewed)
Zemela, M S., Minami, H R., Alvarez, A C., & Smeds, M R. (2020). Real-world usage of the wavelinQ endoAVF system. Annals of Vascular Surgery, 70, 116-122. (Level 5 evidence)
ORIGINAL EFFECTIVE DATE: 9/30/2023
MOST RECENT REVIEW DATE: 9/30/2023
ID_BT
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