Ellipsys Fistula Creation

Ellipsys fistula creation is a minimally invasive nonsurgical procedure performed to create a percutaneous arteriovenous fistula using the Ellipsys Vascular Access System. 

The creation of an AV fistula increases pressure and blood flow through the vein, which makes the vein grow larger and stronger. The enlarged vein provides easy and reliable vascular access for life-saving hemodialysis treatments.

Indications for Ellipsys Fistula Creation

An Ellipsys fistula creation is usually indicated for patients with chronic kidney disease, a condition characterized by progressive loss of the kidney’s ability to filter and purify the blood, necessitating hemodialysis treatment.

The creation of the AV fistula connects the proximal radial artery and perforating vein to allow safe and effective purification of the blood by passing it through a dialysis machine connected to the body through the AV fistula.

Preparation for an Ellipsys Fistula Creation

In preparation for an AV fistula creation, a Doppler ultrasound procedure will be performed to map the radial artery. The diameter of the radial artery should be at least 2 mm and the distance between the artery and adjacent vein should be no more than 1.5 mm.

You will have to inform your doctor about any allergies and medications you take regularly as certain medications such as blood-thinners may need to be stopped temporarily about a week before the procedure. 

You may be asked to avoid eating and drinking after midnight on the day prior to surgery.

Ellipsys Fistula Creation Procedure

An Ellipsys fistula creation involves the following steps:

• The skin over the AV fistula site is cleaned with an antiseptic solution and a local anesthesia is administered to numb the area.
• With local anesthesia, you remain awake and may feel some pressure at the site, but no pain.
• Under ultrasound guidance, a micro puncture needle is used to access the vein in the elbow.
• The needle is then advanced into the radial artery and a guidewire is passed through the needle into the artery.
• The Ellipsys catheter is passed over the guidewire into the radial artery and slight tension is applied to ensure the catheter tip is against the radial artery wall.
• The catheter is activated to produce thermal energy that fuses the walls of the blood vessel producing a permanent anastomosis or connection between the artery and vein.

The catheter is then removed, and a bandage is placed over the puncture site. The entire procedure takes about 30 minutes.

Recovery and Post Procedure Care

AV fistula creation can be performed in an outpatient setting and most patients can expect to be discharged after being monitored for 60 to 90 minutes in the recovery room. There may be slight bruising, swelling, and pain at the needle puncture site which will all resolve on their own. For the first 24 hours after the procedure, you should avoid any strenuous activity, driving, operating heavy machinery, drinking alcohol, or wearing any clothing that presses against the puncture site. You can return to routine activities a day after the procedure.

You will be given medication for any postoperative pain and advised to keep the arm elevated to reduce swelling. Specific instructions will be given on how to care for the fistula access site.  It takes about 2 to 3 months before the fistula is developed and mature enough to be used for hemodialysis.

To protect the access site, you should take the following precautions:

• Wash the vascular access site every day and keep it clean and dry.
• Ensure that your doctor checks the access site before each hemodialysis treatment.
• Use the access site only for dialysis.
• Be careful not to bump or injure the access site.
• Check for thrill (a rhythmic vibration) over the access site, which indicates the AV fistula is healthy.
• Do not put a blood pressure cuff, tight clothing, or jewelry over the access site.
• Do not lift heavy objects with the access arm.
• Avoid sleeping with the access arm under your head or body.
• Report any signs of infection such as redness, swelling, or pus drainage to your doctor as soon as possible.

Risks and Complications 

Ellipsys fistula creation is a safe, minimally invasive procedure; however, there are some risks and complications involved that may include:

• Hematoma formation (a pooling of blood under the skin)
• Infection
• Swelling
• Pain
• Formation of clots that may slow down or block blood flow through the AV fistula
• Failure to achieve fistula maturation

Benefits of the Ellipsys Vascular Access System

The main benefits of the Ellipsys Vascular Access System are:

• Nonsurgical alternative for fistula creation
• Utilizes patented tissue fusion technology
• Enables venous access using a single catheter
• No foreign material is implanted into the body
• No sutures are used
• Can be done under local anesthesia
• Can be performed in an outpatient setting
• Ensures a fast recovery and return to routine activities.