UPDATE IN VASCULAR ACCESS Mercedeh Kiaii MD FRCPC Rick Luscombe RN BSN CNeph(C) Elizabeth Lee MD FRCPC

Background Endovascular AVF Outline Data from FLEX and NEAT study SPH data Clinical experience Cannulation Lessons learned

Guidelines Arteriovenous fistula (AVF) is the recommended VA. Target incidence 50% & prevalence 65% (80% if AVG included) International initiatives to increase fistula use Fistula first program Integrated vascular access program 2006 KDOQI guidelines

BC Prevalent data: AVF/AVG (target 80%) Vascular access in use for chronic HD pts AVF/AVG prevalence BC 10/16-03/17 04/16-09/16 10/13-03/14 59% (41-68%) (total n=2,104) 1,131 fistula 98 graft 103 combo with catheter 60% 63% BCPRA Vascular Access Report 2016/17

BC incidence rates: AVF/AVG incidence (target 50%) Vascular access in use for first HD among pts known to renal 6 mo AVF/AVG incidence BC Prior status CKD 29% (23-43%) 60/205 Prior status CKD, PD, Tx 10/16-03/17 04/16-09/16 10/13-03/14 25% (20-36%) 69/272 34% 59/171 27% 61/224 42% 33% BCPRA Vascular Access Reports 2016/17

ACCESS TO OR IS ONE OF THE MAJOR OBSTACLES TO TIMELY FISTULA PLACEMENT.

BC Surgical wait time Receipt of booking to OR Receipt of booking to OR (wks) BC 10/16-03/17 04/16-09/16 10/13-03/14 9.4 9.5 6.7 % above target time 52% (43-93%) 52% 49% BCPRA Vascular Access Reports 2016/17

Obstacles to meeting guidelines GFR at referral OR wait time Limited VA sites Suitability for AVF creation Patient refusal

IMPROVING TIMELY ACCESS TO AVF ENDOVASCULAR AVF CREATION

Endovascular fistula creation Fluoroscopy room, u/s machine; under local anesthetics; <2 hours EverlinQ system (TVA Medical Inc. Austin, Texas) 1. Arterial and venous catheters (magnetic) 2. Electrode delivering radiofrequency in the venous catheter 3. Power generator

Endo-AVF Side to side anastamosis of ulnar artery and vein 1. Brachial aa. & brachial vv. puncture under u/s guidance 2. Guidewire placement 3. Venogram 1. rule out central vein stenosis 2. Ideally, ulnar vv. 2mm 4. Magnets hold ulnar aa. & vv. together 5. Radiofrequency delivery 6. Brachial vv. Coiling

Procedure demonstration https://tvamedical.app.box.com/s/w11gy1zxejgmpp9ud34ep4ukmu2i52vg

Procedure demonstration https://tvamedical.app.box.com/s/xtv3moo0e5hifzx5c5g6y24kpjhqkfvy

No surgical incision Early vein dilation

100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Technical feasibility and safety of eavf creation FLEX study 97% 96% 96% Technical success @ 24 hrs AVF patency @6 months Usable for dialysis Clinical Endpoint AVF maturation time FLEX Study Result 58 days Interventions/patient-year 0.15** Thrombosis 4% (1/26) Stenosis 0% Access infection/patient-year 0% Serious device-related adverse events 3% (1/33)* Rajan et al.2015. JVIR

NEAT STUDY NOVEL ENDOVASCULAR ACCESS TRIAL AJKD.2017

NEAT: Prospective, single-arm, multi-center study 6 Canadian sites (1 BC, 3 ON, 1 QC, 1 NS) + 3 sites in Australia & New Zealand Operators (IR) had formal training and observed 5 procedures N=80 patients (60 full analysis, 20 roll-in), informed consent 34 pre-dialysis, 26 dialysis 1 yr follow-up post-creation Hypothesis 75% of eavfs would be physiologically suitable within 3 mo. of creation (fistula suitability benchmark 57.5%; study power 80%) AJKD.2017

Summary of NEAT findings 98% (59/60) of the study pts had successful creation of eavf 8% of the study pts (5/60) had procedure complications 87% of eavfs (52/60) were physiologically suitable within 3 mo of creation 64% of eavfs (28/44) were functional and used for dialysis in the first yr 75% of pre-hd pts started dialysis with eavf (avoiding catheter use) Primary and secondary AVF patency rates were 64% and 84% at 1 year AJKD. 2017

Technical safety Procedural complications 5/60 (8%) 2 closure device embolization 1 dissection of the brachial artery (repaired, no sequela) 1 pseudoaneurysm near endo-avf 1 pseudoaneurysm at access site 2 intraprocedural thrombus of brachial artery 1 intraprocedural thrombus at endo-avf site AJKD. 2017

Fistula functional usability: cannulation Average vein length available for cannulation: 10.8cm Cannulating 2 separate veins can reduce risk of recirculation & vessel trauma AJKD. 2017

Comparison of endo-avf outcomes with surgical AVFs Fistula outcomes NEAT eavfs (n=60, Surgical AVFs in the literatures 1-3 full analysis cohort) Primary failure 13% 36% (USRDS) + 23-37% Forearm 28%, upper arm 20% Fistula patency (post creation) 1. Primary 69% at 1 yr 67% at 1 yr (primary failure excluded) 2. Secondary 84% at 1 yr 82% at 1 year (primary failure excluded) 3. Functional 64% 65% (USRDS) 66% (HD fistula maturation study) Thrombosis 7% (late) 14-26% Pseudo-aneurysm 3% 4.5-6.7% 1-3: MacRae et al. 2016. CJKHD; Al-Jaishi et al. 2014. AJKD; Beathard G et al. 2017. CJASN + The outcomes of surgical AVFs created in 2014 (n=43,473) in the 2015 USRDS report.

Intervention rate for NEAT eavf vs. surgical AVF 60 NEAT eavfs compared with 60 matching surgical AVFs in U.S (2011-13) 1:1 propensity score-matched, based on demographic and clinical info. eavf 0.59/PY vs. AVF 3.43/PY NEAT: 24 secondary interventions were performed in 19 pts 5 basilic vv. transpositions, 3 eavf ligations, 2 new AVF/AVG creation, 2 surgical aa. repairs, 2 angioplasties, 5 collateral vv. coiling, 2 thrombin injections, 2 thrombectomies, 1 thrombolysis Yang et al.2017. J Vasc Access

THE RESULTS OF THE LOCALLY CREATED eavfs

Study methods eavf attempted in 36 pts (Feb 2014-Jan 2017) 28 NEAT pts (78%) Routine vessel mapping (i.e. no pre-op consult) Inclusion criteria: ulnar vein 2mm (on u/s) Followed the NEAT protocol & SPH s access protocol Fistula vein diameter Brachial artery flow +/- stenosis, thrombosis

Study definitions & monitoring outcomes Fistula maturation Fistula vein 4mm Brachial artery flow 500 ml/min Fistula usability Achieves BPS of 300 ml/min using 2 needles 3 consecutive HD runs Fistula patency & intervention requirement Procedure complications

Study results: pt characteristics (n=36) Mean age 61 yr 28 male (78%) 21 diabetics (58%) Dialysis status at the time of eavf creation Pre-HD: 17 pts (47%) 2 pts (6%): failed RC AVF HD: 14 pts (39%) PD: 5 pts (14%)

Study results: pt characteristics (n=36) Vascular access at the time of eavf creation Catheter: 14 pts (39%) 6 pts (17%): failed RC AVF prior to catheter use Dysfunctional RC AVF: 1 pt (3%) Failed RC AVF: 3 pts (8%) 2 pts (6%): pre-dialysis 1 pt (3%): PD No HD access: 18 pts (50%)

(23%) 4/5 9/19 eavfs: ligated intervention-free 1 ulnar artery pseudo-aneurysm 1 central vein stenosis (likely missed) 2 steal syndrome (atypical) (14%) (9%)

Study results: procedure complications Minor discomfort from electrical stimulation 1 x brachial artery thrombosis during procedure Immediately treated & resolved (eavf still in use) 1 x ulnar artery pseudo-aneurysm (eavf ligated; discussed) 1 x failed creation likely related to arm movement

Study results eavf patency (total n=35) No intervention for 9 functioning eavfs (i.e. 26% of total) No diagnostic or therapeutic intervention post-creation 1 eavf was created 40 mo ago (Feb 2014)

Study results eavf patency (total n=35) Only 4/19 functioning eavfs (21%) required fistuloplasty No fistuloplasty in first yr of creation 3 eavf single fistuloplasty & 1 eavf repeat procedures FYI 40% of surgical AVFs fail or require 1 Tx by 1 yr 62% (1 0 patency) & 85% (2 0 patency) at 6 mo post-tx for stenosis 1 1. Beathard G et al. 2017. CJASN

Study results eavf patency (total n=35) 6/19 functioning eavfs (32%) had sig. Qa drop (i.e. >20%) No recirculation & no stenosis on fistulogram Qa subsequently restored back to baseline with BP only

Study results eavf/pt outcome (total n=35) Average Qa of 19 functioning eavfs: 523 ml/min Achieves BPS 300 ml/min using 2 needles 11 pts (31%) started HD with functioning eavf 6 HD pts (17%) replaced HD access with eavf 9 pts (26%) required surgery following failed eavf 8 pts (23%) required new surgical AVF 3 pts (9%) : eavf matured via basiic vein (discussed) 1 pt (3%) required revision of dysfunctional RC AVF

Study results: eavf usage as of July 2017 eavf/pt outcomes # (total n=35) Comments eavf in current use 7 (20%) 5 eavfs at least 3 yrs old eavf not in use although functioning 2 (6%) Needle phobia (1 pt HHD) eavf not in use although mature 1 (3%) Pre-dialysis eavf thrombosis 1 (3%) Late thrombosis Transplant (eavf used) 6 (17%) Death (eavf used) 3 (9%) Death (eavf never used) 2 (6%) Clinically unusable 5 (14%) Failure to mature 8 (23%)

Study results: patient feedback Happy with avoiding Long surgical wait Surgical incision/scar Potential surgical complications e.g. slow wound healing Didn t not report hand numbness/tingling Commonly reported in 24-72 hrs post fistula surgery

Study results Cannulation & RN feedback Assessments of an Arteriovenous Fistula Look Feel Listen

Look No scar Complications What is the predominate flow pathway? Cannulation sites Endovascular AVFs

Feel Thrill below antecubital fossa Basilic vein Cephalic vein Diameter Depth Determine points of cannulation

Listen Bruit Anastomosis Cephalic outflow Basilic outflow Biphasic Stenotic

Considerations for Cannulation Maturation 6-8 weeks (facility policy) Antecubital fossa Flows patterns Cephalic vein vs. Basilic vein Types of needle (Angio or steel) Are they available? Diverting flow Do you need to? Skill level of nursing staff Novice to advance cannulation skills

Tips for Cannulation Use a tourniquet Needle placement may vary from typical cannulation patterns May not dilate like a traditional AVF

Ultrasound for vessel location Is ultrasound necessary? (facility practice and policy) Proximity of vessels (Basilic system) Vein (compressed) Artery

Recommendations for Cannulation BC Provincial Renal Agency (BCPRA) (2015) Unit specific policies and procedures

Cannulation 90% of cannulations Cephalic vein

Cannulation 9%

Cannulation As of July 2017, only one pt is self cannulating using the basilic vein

400mL/min is achievable

One year later

Nursing Comfort level Challenges Recognizing own limitations Challenges with the new and unfamiliar Experienced nurses more reservations than novice nurses Two years later, no significant issues

To Date Pts have been transferred to Different Health Authorities Community Units Pts have travelled to US Philippines No issues with cannulating

LESSONS LEARNED & MOVING FORWARD

Lessons Learned: measured vs. actual Qa Assessment of vessels and flow patterns Qa 400-550mL/min Target BPS being achieved Flow is multi-directional Sensitive to pt s BP Low risk of steal syndrome

Lessons Learned: procedures Strapping fistula arm down to prevent Procedure failure Pseudo-aneurysm formation Accessing the brachial artery during diagnostic fistulogram To help locate & better visualize anastomosis

eavf doesn t preclude upper arm fistula Failed or failing RC AVF (bridging therapy to upper arm AVF) Not a candidate for surgical AVF e.g. Failed eavf in 59M on HD (catheter for VA) Previously poor candidate for AVF due to small vessels eavf likely dilated native veins-> BC AVF created later Pts who refuse to go for surgery Pts who need urgent access creation (avoiding catheter use)

Moving forward 200 eavfs being created in U.K & Germany (study in progress) eavf creation using other anatomic sites being evaluated The device has been approved for use in Canada Need enough buy-ins (Renal, IR, Surg, Admin) Procedure cost vs. procedure benefits

Conclusions Surgical anastomosis has been the only way to create AVF Access to OR is one of the major obstacles to AVF placement eavf may be a viable option to improve access to AVF creation eavf provides a new site of anastomosis (4 th site) Current technology (e.g. magnetic catheters) is reliable & safe eavfs are comparable to (may be better than) surgical AVFs Need RCT comparing eavf with surgical AVF

Thank for your attention today! Acknowledgement Questions & Answers period

EXTRA SLIDES

eavfs eavfs created 12 mo ago (total n=31) Initially mature (n=23) Initially usable (n=16) eavfs created 36 mo ago (total n=10; initially mature n=9; initially usable n=7) Patent at 1 yr after creation (# of eavfs) 12/31=39% Procedure-free=10/31 Fistuloplasty=0/31 Diag fistulogram=2/31 12/23=52% Procedure-free=10/23 Fistuloplasty=0/23 Diag fistulogram=2/23 12/16=75% Procedure-free=10/16 Fistuloplasty=0/16 Diag fistulogram=2/16 5/10=50% Procedure-free=4/10 Fistuloplasty=0/10 Diag fistulogram=1/10 Patent at 2 yrs after creation (# of eavfs) 5/10=50% Procedure-free=1/10 Fistuloplasty=2/10 Diag fistulogram=2/10 Patent at 3 yrs after creation (# of eavfs) 5/10=50% Procedure-free=1/10 Fistuloplasty=2/10 Diag fistulogram=2/10