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Ultrasound Preprocedure Assessment Vessel Mapping Guidance for Patient Desiring Endovascular (Dual Catheter System) Arteriovenous Fistula for Hemodialysis

©2021 All rights reserved Pfiedler Education, a Division of AORN 2170 S. Parker Rd., Ste. 400

Denver, CO80231 www.pfiedler.com Phone: 720-748-6144

OVERVIEW

This e-book is intended to supplement education and training of vascular vessel mapping protocols for creation of an endovascular arteriovenous fistula (endoAVF) utilizing the approach with dual magnetic catheters and application of radiofrequency energy to create an endoAVF (dual catheter system) anastomosis. Vessel mapping is an important step in identifying patients who can successfully receive an endoAVF (dual catheter system). Sonographers play a vital role in this process by accurately screening and communicating results to the physician to determine which patients are potential candidates.

LEARNING OBJECTIVES

After completing this continuing education activity, the participant should be able to: 1. Discuss the utilization and purpose of an arteriovenous fistula for hemodialysis. 2. Describe the percutaneous endovascular (dual catheter system) method alternative to traditional open surgical arteriovenous fistula approach for hemodialysis. 3. Explain vessel mapping requirements for endovascular arteriovenous fistula utilizing endovascular dual catheter system for arteriovenous fistula anastomosis creation. 4. Describe the patient selection and candidate screening components of endovascular (dual catheter system) arteriovenous fistula.

INTENDED AUDIENCE/EDUCATIONAL NEED

This continuing education activity is intended for a perioperative nurse, surgical technologist, radiologic technologist, or other healthcare professional who wants to learn more or needs to gain knowledge and skills related to endovascular (dual catheter system) arteriovenous fistula for hemodialysis management of chronic kidney disease.

TEACHING METHODOLOGIES

The eBook is a self-paced, independent learning activity. Course goals are presented, followed by corresponding content. Learners can evaluate attainment of objectives by completing the test questions and comparing with the answer key. References can be reviewed for additional information.

This continuing education activity is governed by principles of adult learning and consists of written content with illustrations to complement the narrative. Learner comprehension will be assessed through post-test questions following the content.

STEPS FOR SUCCESSFUL COURSE COMPLETION

To earn continuing education credit, the participant must complete the following steps: 1. Complete course content and review learner objectives. 2. Once you complete your review, the post-test will unlock in the menu. Answer questions correctly to access the evaluation. 3. Finish course evaluation to complete and receive credit for this activity. 4. Upon completion of the above requirements, a Certificate of Attendance is awarded. This Certificate is found in your MyLearning profile on the Pfiedler Education website.

Questions? Contact Pfiedler Education at 720-748-6144.

ACCREDITATION INFORMATION

California Board of Registered Nursing Association of periOperative Registered Nurses is provider-approved by the California Board of Registered Nursing, Provider Number CEP 13019 for 2.0 contact hours.

Obtaining full credit for this offering depends upon attendance, regardless of circumstances, from beginning to end. Licensees must provide their license numbers for record keeping purposes.

The certificate of course completion issued at the conclusion of this course must be retained in the participant’s records for at least four (4) years as proof of attendance.

NCCT The National Center for Competency Testing (NCCT) has approved this program for 2.0 contact hours.

American Society of Radiologic Technologists

EXPIRATION DATE

This continuing education activity was planned and provided in accordance with accreditation criteria. This material was produced in October 2021 and expires October 2023.

COMMERCIAL SUPPORT

Healthcare organizations engaged in continuing medical, nursing and allied health education have adopted standards to promote balanced and evidence-based content. This course is supported by funding provided by a commercial entity and complies with the intent of these standards. Pfiedler Education gratefully acknowledges educational funding provided by: BD.

DISCLAIMER

Pfiedler Education does not endorse or promote any commercial product that may be discussed in this activity.

DISCLOSURE

It is the policy of Pfiedler Education to identify and resolve conflicts of interest related to financial relationships with commercial entities for individuals in a position to control content for continuing education activities. Information regarding relevant financial relationships is provided to participants to determine if identified external interests or influences pose potential bias in content, recommendations, or conclusions. Disclosure includes relevant financial relationships with commercial inte rests related to the subject matter that may be presented in this continuing education activity. “Relevant financial relationships” are those in any amount, occurring within the past 12 months that create a conflict of interest. A commercial interest is any entity producing, marketing, reselling, or distributing healthcare goods or services consumed by, or used on, patients. For additional information regarding Pfiedler Education’s disclosure process, visit our website at: http://www.pfiedler.com/disclosure.

ACTIVITY PLANNING COMMITTEE

Terry Avitable, MSN, RN, CNOR Vice President, AORN Inc. Pfiedler Education, a Division of AORN Denver, CO No relevant financial relationships Bonnie G. Denholm, DNP, RN, CNOR(E) Director of CE Seminars and Online Programs Pfiedler Education, a Division of AORN Denver, CO No relevant financial relationships Anne Snyder, MSN, RN, CNOR Clinical Program Manager Pfiedler Education, a Division of AORN Denver, CO No relevant financial relationships Melinda T. Whalen, MSN, RN, CEN Director of Education and Live Events Pfiedler Education, a Division of AORN Denver, CO No relevant financial relationships

AUTHOR

Dondra Tolerson, BS, MA Medical Writer Woodstock, GA

No relevant financial relationships

HIPAA COMPLIANCE

Pfiedler Education makes every effort to comply with the Health Insurance Portability and Accountability Act (HIPAA). To protect patient privacy, faculty and participants have been requested to de-identify patient-related material.

INTRODUCTION

In recent decades, the healthcare industry has implemented programs to raise awareness of kidney disease as a significant public health problem. Current focus is on early disease management intended to slow the progression of chronic kidney disease (CKD) to end-stage kidney disease (ESKD), which requires hemodialysis or renal replacement therapy. As CKD advances to severe kidney damage, with low kidney function, treatment considerations include peritoneal dialysis, hemodialysis, and kidney transplant. As shown in Figure 1, more than 1 in 7, that is 15% of US adults or 37 million people, are estimated to have CKD. 1 As many as 9 in 10 adults with CKD do not know they have CKD. About 2 in 5 adults with severe CKD do not know they have CKD.

Figure 1 – United States Statistics for Adults with CKD

Source: Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States , 2021 Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention; 2021. https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html. Accessed October 13, 2021.

As of August 2021, two United States Food and Drug Administration (FDA) cleared catheter-based devices are designed to create endovascular arteriovenous fistula (AVF) for hemodialysis management of ESKD. 2 Both are designed around the vascular anatomy in the proximal forearm, which requires preoperative assessment of the upper extremity vasculature using ultrasound mapping. One system is a single-catheter thermal resistance device that uses heat and pressure to fuse the arterial and venous wall to construct a percutaneous AVF between the proximal radial artery and perforating vein of the proximal forearm. 3 The other is a dual catheter-based system that uses radiofrequency energy to produce an anastomosis between the ulnar artery and adjacent ulnar vein in the proximal forearm or the radial artery and adjacent radial vein in the proximal forearm. 3 This educational activity will focus on providing a deeper understanding of the dual catheter system and reinforce the importance of accurately screening patients to determine suitability for endovascular (dual catheter system) AVF creation with this device. Healthcare Expenditures for Persons with CKD In the 2020 Annual Report of the United States Renal Data System , Medicare fee-for-services (FFS) cost for patients with CKD (excluding ESRD) exceeded $81 billion in 2018 and represented 22.3% of Medicare FFS spending. 4 Additionally in 2018, Medicare spending for patients with CKD (excluding ESRD) aged 66 and over exceeded $70 billion, accounting for 23.8% of all spending in the age group. 4 In comparison over the past 20 years, expenditures for CKD patient has increased at a higher rate than that of the general public or for patients with diabetes mellitus or heart failure. 4 Hemodialysis Access A shared decision-making process between the patient and providers determines an individualized ESKD Life-Plan and vascular access options. In the United States, hemodialysis is the most broadly used modality of kidney replacement therapy. 5 Patients with CKD preparing to start hemodialysis, transitioning from another kidney replacement treatment, failing/failed kidney transplant, or currently on hemodialysis with a failing arteriovenous (AV) access or hemodialysis catheter should be considered for hemodialysis vascular access. 5 The Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines delineate the following key principles when considering vascular access locations and suitable vessels: 5 • Distal first to proximal next approach, • Always preserve the integrity of vessels for future vascular access options, and • Nondominant extremity is preferred to dominant, only if choices are equivalent.

The choice of vascular access location (Figure 2) and type is complex and critical to hemodialysis functionality and patient quality of life. 6 The reliability and integrity of the access site determines the longevity and quality of hemodialysis treatment and should be suitable for the patient’s needs and lifestyle, to the extent possible. 5 Vascular access is also an important driver of clinical outcomes, especially related to infection, thromboses and associated resource utilization and costs. 7 Historically, the majority of patients begin hemodialysis with a catheter prior to converting to other access types, 4 with the advent of the Centers for Medicare & Medicaid Services National Vascular Access Improvement Initiative in 2004, Fistula First arteriovenous fistula (AVF) was recommended as a first-line optimal access 8 because it is associated with higher survival and fewer complications, hospitalizations, and costs. 9,10 The Kidney Disease Outcomes Quality Initiative (KDOQI) in 2019 advocated for the right access, in the right patient, at the right time, and for the right reasons. 5 According to the United States Renal Data System 2020 report, 65.7% prevalent hemodialysis patients dialyzed with an AVF as of December 2018. 4

Figure 2 – Vascular Access Locations for AV Fistula Creation

BD, the BD logo, and WavelinQ are trademarks of Becton, Dickinson and Company or its affiliates. © 2021 BD. All rights reserved. Illustration by Paul Schiffmacher. Copyright© 2021. All rights reserved. BD-31215.

Arteriovenous Fistula Creation Current options for creation of an AVF have expanded to include percutaneous access. A percutaneous arteriovenous fistula (also referred to as an endovascular arteriovenous fistula “endoAVF”) is a minimally invasive alternative to the surgical arteriovenous fistula (sAVF) method to create an AVF for hemodialysis. Both devices are cleared by the FDA to create an arteriovenous anastomosis. 3 Vascular vessels are not clamped, mobilized, dissected, or anastomosed with sutures. • AV anastomosis is located in the deep vascular system. • AV anastomosis is located in the proximal forearm, close to a perforating vein. • AV anastomosis is created with heat or radiofrequency energy (depending on device utilized) through an endovascular catheter system. • Respective systems are cleared to create AVFs in different forearm anatomy, each product’s instructions for use should be consulted. Vascular Access Planning The KDOQI guidelines recommend that vascular access planning and creation include a focused physical examination specific for vascular anatomy and selective vessel mapping. 5 Recommended elements of a focused physical exam should include character of peripheral pulses, Allen test, bilateral upper extremity blood pressure measurements, arm sizes, presence of edema, presence of collateral veins, identification of scars, or confirmed history of central/peripheral venous catheterization or arm, chest, surgery, and/or trauma. 5 In addition to a focused physical assessment, conducting a preprocedure ultrasound (US) mapping and vascular assessment is another essential component for patients undergoing evaluation for creation of an endoAVF. 5 The endoAVF technology for both systems are based on similar concepts: 11 •

Vessel Mapping Sonographers are vital in the AV access determination through accurately screening, documenting, and communicating results to the ordering physician to determine if patients are potential candidates for an endoAVF creation. Vessel mapping is a US procedure conducted by sonographers that gathers information about arterial and venous anatomy and is intended to provide critical preprocedure information to make a determination if the patient is an appropriate candidate for endoAVF. Vessel mapping consists of conducting a duplex ultrasound of patients’ veins and arteries i n the upper extremities. Duplex ultrasound allows the physician to select appropriate vessels for AV access based on luminal size and distensibility with manual occlusion of blood flow. 5 Depending on the physician’s order, sonographers can map the upper ex tremities entirely or perform a focused preprocedure mapping that concludes when vessels adequate for endoAVF creation are established. 12 Sonographers must take care with carrying out the procedure and be mindful of measurement errors due to skill competency, variance in interpretation, and patient factors (eg, patient temperature and/or hydration level may influence results). Candidate Screening and Patient Selection Individual and patient-centered endoAVF planning is essential and influenced by patient factors such as, medical status (ie, baseline health, stage of renal disease, life expectancy, comorbidities, mental health), anatomic considerations (eg, availability of suitable vessels), and history of hemodialysis using a different access method. Candidates for endoAVF must meet the standard screening for sAVF in addition to additional requirements for an endoAVF (dual catheter system) procedure (Table 1). Patients considered healthy enough to have a standard endovascular procedure and sAVF qualify for further assessment for endoAVF (dual catheter system). Candidates must also have a patent perforator that communicates between the superficial and deep veins. Lastly, candidates must have an adequate creation site with ulnar artery/vein or radial artery/ve in ≥2 mm in diameter. 13

Table 1 – Standard and Endovascular (Dual Catheter System) AVF Screening Standards

EndoAVF Screening (Dual Catheter System)

Screening Criteria

Standard AVF Screening

Good Inflow – Brachial artery >2 mm in diameter

Good Outflow – Superficial cephalic and basilic veins >2.5 mm in diameter without a flow limiting central venous stenosis

Does not have flow limiting central venous stenosis

Does not have upper extremity venous occlusion on same side as planned AVF creation

Adequate Target Creation Vessels – Ensure diameter of ulnar or radial artery and at least one ulnar or radial vein is ≥2 mm in diameter Presence of a Perforator – Perforator adequately communicates between deep and superficial veins Procedure Access – Ensure diameter of brachial artery and one vein (Ulnar, Radial, and/or Brachial) is ≥2 mm

Standard surgical AVF screening includes assessing for good blood inflow with the brachial artery measuring at least 2 mm in diameter. Good blood outflow should be present with the superficial basilic and/or superficial cephalic vein measuring 2.5 mm in diameter or greater and without a flow limiting central venous stenosis. 13 EndoAVF systems have established additional anatomical options for AV fistula creation; however, patients without a perforator, with known central venous stenosis, or upper extremity venous occlusion on the side of the anticipated AVF are not suitable candidates. Additionally, the procedure is contraindicated for patients with target creation vessels less than 2 mm in diameter. 13 Venous Outflow Vessel mapping begins with assessing venous outflow. Prior to vessel mapping, sonographers place a tourniquet on the patient’s arm ( see Figure 3).

Figure 3 – Placing the Tourniquet

Video provided by BD

The goal is to assess, measure, and document superficial cephalic and basilic veins diameter and depth (Table 2).

Table 2 – Upper Arm Cephalic and Basilic Vein Measurement

Source: BD, Bard. WavelinQ™ 4F Vessel Mapping Sheet. BD-12525v2. https://wavelinq.bd.com/wordpress/wp-content/uploads/2020/03/BD-12525v2-WavelinQ-4F- Vessel-Mapping-Sheet.pdf. Accessed October 10, 2021.

The sonographer should position the ultrasound probe proximally and proceed to measure proximal, mid, and distal locations in the upper arm and evaluate for flow limiting central venous stenosis (see Figure 4 and Figure 5).

Figure 4 – Assess and Measure Superficial Cephalic Vein

Video provided by BD

Figure 5 – Assess and Measure Superficial Basilic Vein

Video provided by BD

In order for a patient to meet the minimum candidacy requirements for endoAVF (dual catheter system), the cephalic vein and/or the basilic vein must be ≥2.5 mm in diameter (see Figure 6). 13

Figure 6 – Examples of Upper Arm Cephalic and Basilic Vein Measurements

Video provided by BD

After confirming the patient has adequate venous outflow and diameters measuring ≥2.5 mm, the sonographer should proceed to confirm and assess for presence of perforator(s).

Perforator Follow the cephalic or basilic vein distally to where it meets the median cubital as shown in Figure 7.

Figure 7 – Perforator Measurement

Video provided by BD

The sonographer should assess for a perforating vein that communicates between the deep and superficial veins, while paying close attention to carefully measure the perforator longitudinally to assess and confirm it is ≥2 mm in diameter and is not tortuous (Figure 8).

Figure 8 – Assessing for a Perforating Vein That Communicates, Meets Criteria for Size, and Is Not Tortuous

Video provided by BD

If the perforator diameter is confirmed to be ≥2 mm, document findings per facility requirements (Table 3) and continue screening to identify if the patient meets the additional qualifications for dual catheter system endoAVF. 15

Table 3 – Perforator Measurement

Source: BD, Bard. WavelinQ™ 4F Vessel Mapping Sheet. BD-12525v2. https://wavelinq.bd.com/wordpress/wp-content/uploads/2020/03/BD-12525v2-WavelinQ-4F- Vessel-Mapping-Sheet.pdf. Accessed October 10, 2021.

A tortuous, or incompetent, perforator has a C-shape curve. Patients with this type of complex perforator may not be ideal candidates for dual catheter system endoAVF.

Figure 9 – Example of a Tortuous Perforator

Video provided by BD

If a tortuous perforator is observed, the sonographer should document the assessment and discuss it with the physician. 14 If during screening of the cephalic or basilic vein to the proximal arm a perforator is not observed, it means that there is no communication between the deep and superficial veins at the site where a fistula would be created. This is an indication the patient is not a candidate for endoAVF procedure utilizing the dual catheter system. 14 If the perforator is not evident during screening of the cephalic or basilic vein to the proximal arm, the patient is not a candidate for endoAVF procedure utilizing the dual catheter system (see Figure 10). 14

Figure 10 – Example of Perforator that Does Not Meet Criteria for endoAVF Utilizing Dual Catheter System

Video provided by BD

Identifying Flow Dominance Flow dominance is important information for the physician to know when considering endoAVF. To assess flow dominance, rotate the ultrasound probe to the axis on the proximal arm where the perforator is identified (see Figure 11). Blood flow predominantly travels to the larger outflow vein in line with the perforator configuration.

Figure 11 – Flow Dominance

Video provided by BD

Arterial Inflow Arterial inflow is assessed just above the crease of the elbow. The sonographer should use the ultrasound probe to locate and measure the brachial artery, which must measure ≥2 mm in diameter for the patient to be a candidate for endoAVF (dual catheter system); and also measure the paired brachial veins as these can also be potential access points (see Figure 12).

Figure 12 – Locate and Measure the Brachial Artery

Video provided by BD

Only the brachial artery should be used for arterial access for dual catheter system endoAVF creation. In the event that the patien t has a brachial artery that measures ≥2 mm in diameter, document result per facility requirements (Table 4) and continue screening otherwise they cannot qualify for an endoAVF procedure utilizing the dual catheter system. 15

Table 4 – Brachial Measurements

Source: BD, Bard. WavelinQ™ 4F Vessel Mapping Sheet. BD-12525v2. https://wavelinq.bd.com/wordpress/wp-content/uploads/2020/03/BD-12525v2-WavelinQ-4F- Vessel-Mapping-Sheet.pdf. Accessed October 10, 2021.

Creation Site Selecting the optimal vascular access type requires careful consideration of individual patient characteristics and clinical factors. For patients to be qualified candidates for endoAVF, they must have adequately sized arteries and veins at the intended creation site. The radial artery assessment should be taken immediately after the perforator and not too distal down the arm. The sonographer should measure the radial artery and paired radial veins not too distal down the extremity (Figure 13). Next, assess the common ulnar trunk, which are each typically located between the radial and interosseous take-off. Also verify triphasic flow and assess for the presence of calcium.

Figure 13 – Measuring the Radial Artery and Paired Radial Veins

Video provided by BD

The sonographer should move the probe more proximal to obtain the measurement of the ulnar artery and ulnar veins, then verify triphasic flow and assess for the presence of calcium (Figure 14).

Figure 14 – Measure the Ulnar Artery, Assess Flow, and Assess for Calcium

Video provided by BD

In order to continue endoAVF (dual catheter system) screening at this time, the patient must have a radial artery and at least one radial vein that are each ≥2 mm in diameter or the ulnar artery and at least one ulnar vein that are each ≥2 mm in diameter. 14 Document findings including diameter and doppler waveform (Table 5) and proceed to screen access options.

Table 5 – Radial and Ulnar EndoAVF Creation Site Measurements

Source: BD, Bard. WavelinQ™ 4F Vessel Mapping Sheet. BD-12525v2. https://wavelinq.bd.com/wordpress/wp-content/uploads/2020/03/BD-12525v2-WavelinQ-4F- Vessel-Mapping-Sheet.pdf. Accessed October 10, 2021.

Access Options Assess the brachial artery for arterial access, which is the only artery that should be used for dual catheter system endoAVF creation. 14 At this point, the brachial artery would have already been assessed for the appropriate diameter of ≥2 mm in diameter so that it can accommodate the endoAVF (dual catheter system) devic e and provide sufficient blood flow. There are multiple venous access options. Note the size of the brachial veins just above the elbow and assess as a potential access point. Also, measure the radial and ulnar veins within 3 inches from the wrist — the upper arm brachial or ulnar or radial must be ≥2 mm in diameter to accommodate procedural components of the dual catheter system (Figure 15) and document findings (Table 6). The physician will decide which option is best for access and if they are a candidate for dual catheter system endoAVF procedure. 14

Figure 15 – EndoAVF (Dual Catheter System) Creation Site Measurements

Video provided by BD

Table 6 – Radial and Ulnar Measurements

Source: BD, Bard. WavelinQ™ 4F Vessel Mapping Sheet. BD-12525v2. https://wavelinq.bd.com/wordpress/wp-content/uploads/2020/03/BD-12525v2-WavelinQ-4F- Vessel-Mapping-Sheet.pdf. Accessed October 10, 2021.

Documentation Complete documentation is crucial and there should be a permanent record of the ultrasound examination, interpretation, and images of appropriate anatomy (normal and abnormal). 12 Any variations from normal size anatomy observed should be accompanied by measurements. Images should be labeled with the patient and facility identification, examination date and location of the anatomy imaged. An official interpretation in the form of a final report should be included in the patient’s medical record and retained according to legal, federal , and facility requirements. 12 Post Maturation Protocol Recommendations After the endoAVF (dual catheter system) procedure is completed, the patient post-procedure follow-up appointment occurs between 2-6 weeks per standard of care protocols. 14 Vessel mapping protocols post-fistula creation include measuring the brachial artery flow rate which should be ≥ 500 ml/min, determining which superficial outfl ow vein is dominant (cephalic or basilic) and that it measures at least 4 mm in diameter. 16 A brachial artery flowrate of ≥ to 500 ml/min and a superficial outflow vein of at least 4 mm in diameter is considered matured sufficiently to begin hemodialysis. 16

SUMMARY

This educational activity has focused on two key points. The first key point is that AVF as a recommended option for first- line optimal access, which can be provided via an endovascular (dual catheter system) approach that applies radiofrequency energy to create an arteriovenous anastomosis. The second key point is the importance of accurately screening patients to determine suitability for endoAVF (dual catheter system) creation. Vascular access location and type is critical to hemodialysis functionality, longevity, clinical outcomes, and quality of life. Preprocedure vessel mapping is an essential first step to correctly identify patients who may qualify for an endoAVF (dual catheter system). If the patient is considered healthy enough to have a surgical-AVF, the additional requirements for the endovascular (dual catheter system) procedure can be verified through vessel mapping and meeting all of the other criteria set out in the product labeling, including that which has been discussed here.

GLOSSARY

Anastomosis

A communication between an artery and a vein by surgical or endovascular techniques.

Arteriovenous Fistula

An arteriovenous fistula (AVF) creates a direct connection between a vein and an artery in the arm. This results in a closed circuit that provides adequate blood flow for hemodialysis. Blood can be withdrawn, cleaned through the dialysis machine, and returned to the body.

AV Access

The connection of an artery and vein for the purposes of establishing hemodialysis access.

AV Access Creation

The connection of an artery and vein for the purposes of establishing hemodialysis access.

Catheter

A thin flexible tube that is inserted into a blood vessel through which devices can be introduced or contrast dye or appropriate solutions can be injected.

Chronic Kidney Disease (CKD)

Slow and progressive deterioration of kidney function; an abnormality in the kidneys that is present for more than 3 months, and is graded stages 1, 2, 3a, 3b, 4, and 5 for minor to severe kidney disease.

Dialysis Access Usability

A dialysis access that can reliably and safely provide prescribed dialysis, per definition of mature fistula or graft.

Duplex Doppler Ultrasound

Combines Doppler and B-mode (grayscale) imaging to provide quantitative color velocity assessment (AV access flow) as well as anatomic visualization of stenosis/abnormality.

End Stage Renal Disease (ESRD)

The stage of renal impairment that appears irreversible, permanent, and requires a regular course of dialysis or kidney transplantation to maintain life.

Endovascular Arteriovenous Fistula (endoAVF)

An autologous fistula created by endovascular techniques, originally described by anastomosis of the proximal ulnar artery and proximal ulnar vein.

Fistula

Autologous arteriovenous fistula, also referred to as native fistula.

Fistula Maturation

The process by which a fistula becomes suitable for providing prescribed dialysis.

Flow

The amount of blood flowing through a system.

Insertion Site

The location at which the catheter enters the vein.

Incidence

A measure of a disease that allows determination of a person's probability of being diagnosed with a disease during a given period of time. Therefore, incidence is the number of newly diagnosed cases of a disease.

Magnetic Resonance Angiography (MRA)

A technique to visualize the arterial and venous systems using a radiologic contrast material, usually gadolinium, as the imaging agent.

Mature Fistula

Per Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, “ a mature fistula is one that can provide prescribed dialysis consistently with 2 needles for more than two thirds of dialysis sessions within 4 consecutive weeks.” A duration of time measuring intra-access patency that starts from the date of vascular access creation (AV access) or insertion (central venous catheter) to the date of vascular access abandonment.

Patency (Cumulative)

Physical Examination (of Vascular Access)

Inspection, palpation, and auscultation of the vascular access.

Prevalence

Prevalence is a measure of a disease permits determination a person's likelihood of having a disease. Therefore, the number of prevalent cases is the total number of cases of disease existing in a population.

Stenosis

A constriction or narrowing of a duct or passage; a stricture.

Ultrasound

The use of ultrasonic waves for diagnostic or therapeutic purposes, specifically to image an internal body structure.

Venogram

An x-ray examination that uses an injection of contrast material to show how blood flows through the veins.

REFERENCES

1. Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2021 . US Department of Health and Human Services. Updated March 4, 2021. https://www.cdc.gov/kidneydisease/publications- resources/ckd-national-facts.html. Accessed October 14, 2021. 2. Food and Drug Administration. FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients. Published June 22, 2018. https://www.fda.gov/news-events/press- announcements/fda-permits-marketing-first-catheter-based-systems-used-create-vascular-access-hemodialysis- patients. Accessed October 11, 2021. 3. Wasse H. Place of percutaneous fistula devices in contemporary management of vascular access. Clin J Am Soc Nephrol . 2019;14(6):938-40. doi: 10.2215/cjn.00980119. 4. Johansen KL, Chertow GM, Foley RN, et al. US Renal Data System 2020 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. Am J Kidney Dis . 2021;77(4 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2021.01.002. 5. Lok CE, Huber TS, Lee T, et al. KDOQI clinical practice guideline for vascular access: 2019 update. AJKD . 2020;75(4):S1-64. doi: 10.1053/j.ajkd.2019.12.001. 6. Almasri J, Alsawas M, Mainou M, et al. Outcomes of vascular access for hemodialysis: a systematic review and meta-analysis. J Vasc Surg . 2016;64(1):236-43. doi: 10.1016/j.jvs.2016.01.053. 7. Nordyke RJ, Reichert H, Bylsma LC, et al. Costs attributable to arteriovenous fistula and arteriovenous graft placements in hemodialysis patients with Medicare coverage. Am J Nephrol . 2019;50(4):320-8. doi: 10.1159/000502507. 8. Centers for Medicare and Medicaid Ser vices. CMS launches “fistula first” initiative to improve care and quality of life for hemodialysis patients. https://www.cms.gov/newsroom/press-releases/cms-launches-fistula-first-initiative- improve-care-and-quality-life-hemodialysis-patients. Published April 14, 2004. Accessed October 11, 2021. 9. Vassalotti JA, Jennings WC, Beathard GA, et al. Fistula First Breakthrough Initiative Community Education Committee. Fistula first breakthrough initiative: targeting catheter last in fistula first. InSemin Dial . 2012;25(3):303-310. Oxford, UK: Blackwell Publishing Ltd. doi: 10.1111/j.1525-139X.2012.01069.x. 10. Yan Y, Ye D, Yang L, et al. A meta-analysis of the association between diabetic patients and AVF failure in dialysis. Ren Fail . 2018;40(1):379-83. doi: 10.1080/0886022X.2018.1456464. 11. Steinke T, Rieck J, Nuth L. Endovascular arteriovenous fistula for hemodialysis access. Gefässchirurgie . 2019;24(1):25-31. doi: 10.1007/s00772-018-0500-y. 12. American Institute of Ultrasound in Medicine. AIUM Practice Parameter for the Performance of Ultrasound Vascular Mapping for Preoperative Planning of Dialysis Access. Published 2016. https://www.aium.org/resources/guidelines/predialysisaccess.pdf. Accessed October 28, 2021. 13. BD, Bard. WavelinQ™ 4F V essel Mapping Sheet. BD-12525v2. https://wavelinq.bd.com/wordpress/wp- content/uploads/2020/03/BD-12525v2-WavelinQ-4F-Vessel-Mapping-Sheet.pdf. Accessed October 10, 2021. 14. BD. 190716-NJAFLM1_S001_S001_T006.mp4. https://www.youtube.com/watch?v=EMQp0Uf0wHs&t=24s. Accessed October 28, 2021. 15. BD WavelinQ™ EndoAVF System BAW1491700 Rev 1. December 2019. Instructions for Use. https://wavelinq.bd.com/clinical-and-educational-resources/. Accessed October 11, 2021. 16. Lok, C E, Rajan, DK, Clement J, et al. 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. doi: 10.1053/j.ajkd.2017.03.026.

Wa velinQ™ EndoAVF System

Indications : The WavelinQ™ EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

Contraindications : Target vessels < 2mm in diameter.

Warnings : The WavelinQ™ EndoAVF System is only to be used with the approved compo nents specified in the instructions for use (IFU). Do not attempt to substitute non-approved devices or use any component of this system with any other medical device system. Use of the system with other components may interfere with proper functioning of the device. 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 serious injury or death. The WavelinQ™ EndoAVF System should not be used in patients who have known central venous stenosis or upper extremity venous occlusion on the same side as the planned AVF creation. The WavelinQ™ EndoAVF System should not be used in patients who have a known allergy or reaction to any drugs/fluids used in this procedure. The WavelinQ™ EndoAVF System should not be used in patients who have known adverse reactions to moderate sedation and/or anesthesia. The safety and performance of the device via arterial wrist access has not been fully established. The incidence of vessel stenosis or occlusion that occurs in the radial and ulnar arteries after arterial wrist access has not been evaluated. Do not use the device to create an EndoAVF using arterial access via the radial or ulnar artery. The EndoAVF should only be created using brachial artery access. Use caution when performing electrosurgery in the presence of pacemakers or implantable cardioverter defibrillators. Improper use could damage insulation that may result in injury to the patient or operating room personnel. Do not plug device into the electrosurgical pencil with ESU powered on. Consult the ESU User Guide on its proper operation prior to use. Do not use closure devices not indicated to close the artery use d for access. Ensure the patient’s arm is restrained to minimize movement during device activation; potential hazards of patient arm movement during activation are hematoma or pseudoaneurysm near the fistula site. The puncture site should be closed and hemostasis should be achieved by manual compression per the instructions in the IFU. Use of closure devices with the WavelinQ™ EndoAVF System may be associated with an increased risk of access site complications. The WavelinQ™ EndoAVF System has only been eva luated for the creation of an AVF between the ulnar artery and concomitant ulnar vein and between the radial artery and concomitant radial vein in the clinical studies described in the IFU. Refer to the latest National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI) guidelines for recommendations and considerations for AV access creation in patients on or requiring hemodialysis. For patients expected to have prolonged durations on hemodialysis, a distal to proximal approach to AVF creation provides the best opportunity to preserve vessels for future vascular access sites following the individual patient ESKD Life-Plan. This device is coated with a hydrophilic coating at the distal end of the device for a length of 26.4 cm (10.4 in). Please refer to the AVF Creation section in the IFU for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating. Cautions : Only physicians trained and experienced in endovascular techniques, who have received appropriate training with the device, should use the device. Endovascular technique training and experience should include ultrasound vessel access in the arm, guidewire navigation, radiographic imaging, placement of vascular embolization devices (including embolization coils), and access hemostasis. Adhere to universal precautions when utilizing the device.

Precautions : 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. 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. Some patients who have veins deeper than 6mm may require superficialization. Pre-planned vessel superficialization is acceptable and not considered an additional intervention for fistula maturation, per KDOQI Clinical Practice Guideline for Vascular Access: 2018. Ensure the patient has adequate collateral blood flow to the hand before use of the device. Prior to the procedure, ensure that the access location, access vessels, and target AVF location are of appropriate size to account for the devices during use. Oversizing the device to the access vessel may increase risk of vessel injury, which may result in stenosis and/or occlusion. Vessel injury may impact future dialysis access options and/or the ability to perform future endovascular procedures from the target access vessels. Users should consider the potential risk of distal arterial stenosis and/or occlusion on end stage renal disease patients when selecting vascular access sites for the procedure. Adjunctive procedures are expected to be required at the time of the index procedure to increase and direct blood flow into the AVF target outflow vein to assist maturation. Care should be taken to proactively plan for any adjunctive procedures, such as embolization coil placement, when using the device. 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.

Please consult product labels and instructions for use for all indications, contraindications, hazards, warnings, and precautions.

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