Cannulation

WavelinQ™ EndoAVF System creates an AV fistula without open surgery. An endovascular AV fistula (EndoAVF) does not have a surgical scar to identify the location of the AV fistula. Recognizing and accessing an endoAVF is not complicated, but it is a little different than surgical AVF cannulation. View the resources below for tips on how to successfully cannulate a WavelinQ™ EndoAVF System.

What’s different about EndoAVF?

Non-surgical AVFs will not have a visible scar identifying the AVF creation site (anastomosis).
Surgical AVFs typically will have a single outflow vein, whereas non-surgical AVFs may have multiple outflow veins available for cannulation.

Identification

With a non-surgical AVF, there will not be a surgical scar to identify where the anastomosis was created. EndoAVFs avoid surgical scarring and minimize arm disfigurement associated with open surgery. Palpation can be used to help identify the creation site.

VISUALLY EXPLAINED

Avoids scars and minimizes arm disfigurement associated with open surgery

Illustration 1

EndoAVF Creation Site

Illustration 2

At first cannulation

Illustration 3

At ~1 Year Post Op

Illustration 4

At ~2.5 Year Post Op

Individual patient outcomes can and do vary based on the condition of the patient, severity of disease, extent of surgery, and response to treatment.

Opportunities for Cannulation

Non-surgical AVFs can result in in split or multiple outflow vessels to be used for cannulation.

Cannulation Overview

1. Assess the AV fistula. The EndoAVF will not look like a typical surgically-created AV fistula. It may be less pronounced with no surgical scar, which can be important to patients, but it may make identifying the AV fistula a little tricky at first. You will be able feel the AV fistula’s thrill and hear the bruit, even though the thrill will most likely be a little softer and the bruit will be a little quieter than what you are used to.

2. Find the patient’s cannulation sites. Apply a tourniquet to make this easier. EndoAVFs often have multiple cannulation sites from the elbow to the upper arm. Refer to the AV fistula creation specialist’s recommendations for needle placement.

3. Follow your clinic’s protocols when selecting the needle gauge and consider a shorter needle for more superficial cannulation zones and certain body habitus.

4. Once you are ready to cannulate the endoAVF, consider inserting the needle at a shallow angle in order to accommodate more superficial veins and to ensure that you don’t backwall or sidewall the vessel. Being gentle is key. Flashback will occur, but it may be less rapid.

Cannulation Resources

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Indications

The WavelinQ™ EndoAVF System is intended for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an arteriovenous fistula used for hemodialysis.

Contraindications

Known central venous stenosis or upper extremity venous occlusion on the same side as the planned AVF creation. procedure. procedure.

Known allergy or reaction to any drugs/fluids used in this procedure.

Known adverse effets tomoderatesedation and/or anesthesia.

Distance between target artery and wein > 1.5mm.

Target wessels 2mm in diameter.

Warnings, Cautions, and Precautions

Warnings

The WavelinQ™ EndoAVF System is only to be used with the approved commercially available devices specified above. Do not attempt to substitute non-approved devices or use any component of this system with any other medical device system.

The WavelinQ™ catheters are single use devices. DO NOT re-sterilize or re-use either catheter. Potential hazards of reuse include infection, device mechanical failure, or electrical failure, potentially resulting in serioys injury or death.

Use caution when performing electrosurgery in the presence of pacemakers.

Improper use could damage insulation that may result in injury to the patient or operating room personnel.

Do not plug devie into the electrosurgical pencil with ESU on.

Keep active accessories away frompatientwhen not in use.

Do not permit cable to be parallel to and/or in close proximity to leads of other devices.

Do not warp cable around handles or metallic objects such as hemostats.

Consult the ESU User's Guide on its proper operation prior to use.

Do not use closure devices not indicated to close the artery used for access.

Cautions

Only physicians trained and experienced in endovascular techniques should use the device.

Adhere to universal precautions when utilizing the device..

Do not kink, pinch, cut, bend, twist, or pull excessively or with excessive force on any portion of the devices. Damage to the catheter body may cause the device to become inoperable.

Avoid sharp bends. This may cause the device to become inoperable.

Do not pinch or grasp the catheter with excessive force or with other instruments

Do not bend the rigid portion of the catheter near the electrode or backstop.

Do not touch or handle the active electrode. Electrode dislodgement may occur.

Always use the hemostasis valve crosser to assist insertion of the venous catheter through the introducer sheath. Insertion into introducer sheath without hemostasis valve crosser may damage electrode.

Do not attempt to remove the hemostasis valve crosser located on the venous device. Device damage or fracture may occur.

Precautions

Care should be taken to avoid the presence of fluid on the ESU.

Care should be taken during handling of the arterial and venous catheters in patients with implantable cardiac defibrillators or cardiac pacemakers to keep the distal 3 inches of the catheters at least 2 inches from the implanted defibrillator or pacemaker.

Care should be taken to avoid attempting fistula creation in a heavily calcified location of a vessel as fistula may not be adequately formed.

The safety and performance of this device has not been established for pediatric patients.

If the device does not perform properly during the creation of the endovascular fistula it is possible that a fistula will not be created or there may be some vessel injury.

Keep magnetic ends of catheters away from other metallic objects which may become attracted and collide with devices.

Potential Adverse Events

The known potential risks related to the WavelinQ™ EndoAVF System and procedure, a standard AVF, and endovascular procedures may include, but are not limited to: aborted or longer procedure; additional procedures; bleeding, hematoma or hemorrhage; bruising; burns; death; electrocution; embolism; failure to mature; fever; increased risk of congestive heart failure; infection; numbness, tingling, and/or coolness; occlusion/stenosis; problem due to sedation or anesthesia; pseudoaneurysm; aneurysm; sepsis; steal syndrome or ischemia; swelling, irritation, or pain; thrombosis; toxic or allergic reaction; venous hypertension (arm swelling); vessel, nerve, or AVF damage or rupture; wound problem.

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