Our Summary

This research paper looks at two new devices, the Ellipsys and WavelinQ, that were approved in 2018 by the US Food and Drug Administration for creating an arteriovenous fistula. This is a connection between an artery and a vein, usually in the arm, that is commonly used for patients who need regular hemodialysis, a type of treatment for kidney failure. Early results from studies suggest that these devices could provide benefits and possibly improved results for patients who have the right type of anatomy for the procedure.

The paper discusses the key elements of the body’s blood vessels that these systems interact with, noting that they differ in their design, the type of energy they use, the imaging techniques required, how long the procedure takes, the types of catheters used, where the procedure is performed on the body, and the techniques used.

The authors review these two devices, including how to choose the right patient for the procedure, how to assess the patient after the operation, what interventions may be needed, what outcomes can be expected, potential complications, and issues that may arise during the process of inserting a needle into the fistula (known as cannulation).

FAQs

  1. What are the two arteriovenous fistula systems approved by the US Food and Drug Administration?
  2. What are some benefits and potential improved outcomes of using catheter-based devices for arteriovenous fistula creation?
  3. What are the key differences between the Ellipsys and WavelinQ arteriovenous fistula devices?

Doctor’s Tip

One helpful tip a doctor might tell a patient about AV fistula creation is to closely follow postoperative care instructions, including keeping the access site clean and dry, avoiding heavy lifting or strenuous activities with the arm where the fistula was created, and regularly monitoring for any signs of infection or complications. It is important to communicate any concerns or changes in symptoms to your healthcare provider promptly. Additionally, proper cannulation techniques for dialysis access should be followed to prevent complications and maximize the lifespan of the AV fistula.

Suitable For

Patients who are typically recommended for AV fistula creation using percutaneous systems like the Ellipsys and WavelinQ devices include those with end-stage renal disease who require hemodialysis. These devices may be particularly beneficial for patients with appropriate anatomy, such as a suitable deep communicating vein in the cubital fossa and a proximal radial artery or proximal ulnar artery that can be accessed for the procedure. Patients who are not good candidates for traditional surgical AV fistula creation or who may benefit from a less invasive approach may also be recommended for percutaneous AV fistula creation.

Timeline

Before AV fistula creation:

  • Patient is diagnosed with end-stage renal disease and requires hemodialysis
  • Patient undergoes evaluation to determine suitability for AV fistula creation, including vascular mapping
  • Patient may need to undergo preoperative imaging studies to assess the anatomy of the vasculature
  • Patient may need to have a preoperative discussion with their healthcare team about the risks and benefits of AV fistula creation

After AV fistula creation:

  • Patient undergoes the percutaneous procedure to create the AV fistula using devices such as the Ellipsys or WavelinQ
  • Postoperative evaluation is performed to assess the success of the procedure and ensure proper healing
  • Patient may need to have follow-up appointments with their healthcare team to monitor the function of the AV fistula and address any issues that may arise
  • Patient may need to undergo interventions to address any complications that may occur, such as stenosis or thrombosis of the AV fistula
  • Once the AV fistula is properly healed and functioning, the patient can begin hemodialysis treatments using the newly created access site.

What to Ask Your Doctor

  1. What are the benefits of using a percutaneous arteriovenous fistula device compared to traditional surgical methods?

  2. How do I know if I am a suitable candidate for a percutaneous AV fistula creation?

  3. What are the potential complications associated with the percutaneous AV fistula creation procedure?

  4. How long does the percutaneous AV fistula creation procedure typically take?

  5. What is the expected recovery time after a percutaneous AV fistula creation procedure?

  6. How often will I need to have follow-up appointments or evaluations after the procedure?

  7. What are the success rates of percutaneous AV fistula creation compared to traditional surgical methods?

  8. How soon after the procedure can I start using the AV fistula for hemodialysis?

  9. Are there any specific restrictions or lifestyle changes I need to make after the procedure?

  10. What should I do if I experience any issues or complications with the AV fistula after the procedure?

Reference

Authors: Nelson PR, Mallios A, Randel M, Jennings WC. Journal: Semin Vasc Surg. 2021 Dec;34(4):195-204. doi: 10.1053/j.semvascsurg.2021.10.010. Epub 2021 Oct 30. PMID: 34911625