What s on the Horizon in Dialysis Access? Libby Watch, MD, FACS Miami Cardiac & Vascular Institute

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1 What s on the Horizon in Dialysis Access? Libby Watch, MD, FACS Miami Cardiac & Vascular Institute

2 Disclosures No relevant disclosures Employee Advanced Access Care

3 Dialysis Work 5 operating surgeons 3 Hospitals 820 AVF/ AVG creation/ insertion 336 Access revision procedures 1 Outpatient Center 475 Interventions (fistulagrams, catheter management, declots) ~1600 dialysis access cases/ year

4 What is new? Access creation Access salvage Access restoration

5 Importance of Surgical Technique Surgical skill is often cited as the limiting factor in AVF creation Require delicate manipulation and suturing of the vessels to minimize trauma Physical manipulation of the vein is associated with fistula failure 1 Disruption of vasa vasorum Mobilization Torsion Stretching From Bharat et al. JVS 2012;55(1): Roy-Chaudhury et al. JASN 2006;17:

6 Why do surgical AVFs Fail to Mature? Flow limiting lesions often at the site of surgery 1 43% to 65% reported incidence 2 Described as an inflammatory response to surgical trauma 2 Endothelial cells migrate inward, constricting flow 3 1. Beathard ACKD 2009;16(5): Beathard et al. Kidney Int 2003;64: Proteon Therapuetics

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8 TVA everlinq System Venous catheter Arterial catheter RF Generator Radiofrequency electrode creates fistula 6 Fr over the wire and RX system Magnets align catheters Flexible spacers DISCLAIMER: everlinq endoavf System is not available for sale in the United States. everlinq endoavf System has received European CE Mark and Health Canada Medical Device License have been issued for the creation of an arteriovenous fistula for hemodialysis.

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10 Clinical Results: FLEX Study Study Overview Single center, prospective design Paraguay 33 patients, 4 cohorts 6 month follow-up Study endpoints: Technical success Patency Safety Patient Demographics + Gender male 61% Age (years) BMI BMI > % Race Hispanic 100% Predialysis at enrollment 6.1% Previous AVF 12.1% Diabetes 58% Study completed Q DISCLAIMER: everlinq endoavf System is not available for sale in the United States. everlinq endoavf System has received European CE Mark and Health Canada Medical Device License have been issued for the creation of an arteriovenous fistula for hemodialysis. J Vasc Interv Radiol 2015; 26:

11 Clinical Results: FLEX Study 100% 90% 97% 96% 96% Clinical Endpoint FLEX Study Result 80% AVF maturation time 58 days 70% 60% 50% 40% 30% 20% 10% 0% Technical 24 hrs AVF months+ Usable for dialysis N = 33 N = 26 N = 28 Interventions/patient-year 0.15** Thrombosis 4% (1/26) Stenosis 0% Access infection/patient-year 0% Serious device-related adverse events Data reported per-protocol, not intent to treat. 3% (1/33)* + 1 patient developed venous hypertension at 37 days from a central vein stenosis. Patient received balloon angioplasty. EndoAVF occluded at 106 days. *1 patient developed pseudoaneurysm during procedure due to arm motion from neuromuscular stimulation. Pseudoaneurysm was resolved with thrombin injection. A procedure modification to limit arm motion mitigated this risk in subsequent cases. ** Interventions for Groups C & D (coil embolization performed at index procedure). 1 intervention in 14 patients, median follow-up time 177 days. Rate reported per patient-year. DISCLAIMER: everlinq endoavf System is not available for sale in the United States. everlinq endoavf System has received European CE Mark and Health Canada Medical Device License have been issued for the creation of an arteriovenous fistula for hemodialysis. J Vasc Interv Radiol 2015; 26:

12 Clinical Experience: NEAT Study Study Overview Multicenter, prospective design Canada, Australia, New Zealand 80 patients, single arm 3, 6, & 12 month follow-up Study endpoints: Fistula Usability Patency Safety Study completion Q Patient Demographics + Gender male 65.0% Age (years) 59.9 ± 13.6 BMI 28.0 ± 6.1 BMI > % Caucasian 60.0% Predialysis at enrollment 56.7% Previous AVF 31.7% Diabetes 65.0% Hypertension 91.7% CAD 21.7% Prior renal transplant 13.3% Prior PD 30.0% Central venous catheter 41.7% use at enrollment + n=60, updated December 2015 DISCLAIMER: everlinq endoavf System is not available for sale in the United States. everlinq endoavf System has received European CE Mark and Health Canada Medical Device License have been issued for the creation of an arteriovenous fistula for hemodialysis.

13 Clinical Results: NEAT Study Procedural Results: 98.3% success at creating endoavf Average time 62.0 ± 38.5 minutes Safety Results: 1.7% serious device-related events 3.3% endoavf thrombosis 1.7% steal 0% procedure-related infections N=57 Maturation: endoavf that is free of stenosis or thrombosis, with brachial artery flow of > 500 ml/min and > 4mm vein diameter (duplex US) OR patient dialyzed with 2 needles everlinq endoavf demonstrated reproducible procedure success, low complication rate and a high suitability for dialysis Based on NEAT 3m results DISCLAIMER: everlinq endoavf System is not available for sale in the United States. everlinq endoavf System has received European CE Mark and Health Canada Medical Device License have been issued for the creation of an arteriovenous fistula for hemodialysis.

14 The endoavf Post-Creation 24 hours post procedure No incision and minimal vessel trauma Early dilation of veins 1 month post procedure Ready for cannulation Multiple cannulation zones DISCLAIMER: everlinq endoavf System is not available for sale in the United States. everlinq endoavf System has received European CE Mark and Health Canada Medical Device License have been issued for the creation of an arteriovenous fistula for hemodialysis.

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16 Vascular cells isolated from human donors and cultured Degradable scaffold shaped like an artery Bathed in nutrients and stretched 8 weeks to produce a human acellular vessel (HAV)

17 Results 60 patients Mean follow-up 16 months 1 infection in 82 patient years of follow-up 6 months 63% primary patency 97% secondary patency 12 months 28% primary patency 89% secondary patency

18 Access Salvage

19 Radiofrequency wire technology Generator: RF energy = vaporizes channel through occlusion but minimal damage to surrounding tissues Grounding Pad Pad: patien s leg Activated by a pedal or pushing the yellow button

20 JVIR August, 2012

21 Results 42 patients/43 occlusions 42/42 successful recanalization One complication Cardiac tamponade 40/42 (95.2%) patients patent at 6 and 9 months

22 Access salvage #1 45 year old male with ESRD On hemodialysis for 13 years Numerous previous catheters Currently with right upper extremity fistula Chronic SVC syndrome 4 previous attempts at recanalization

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25 Groin Access to SVC

26 AP Oblique

27 Power wire advanced and snared

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29 Final S/P 14mm PTA

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32 Access salvage #2 34 year old female with ESRD secondary to SLE Left arm AVF lasted average 24 months Left arm graft failure Right brachial basilic AVF 2 stage procedure

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35 Right basilic fistula Occluded right brachiocephalic vein Patent left internal jugular Left arm multiple grafts

36 HERO graft crossing from right arm to left internal jugular vein

37 HERO Hemodialysis Reliable Outflow

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39 Results at 8.6 months 38.9% primary patency 86.1% assisted primary patency 72.2% secondary patency 69% reduction in bacteremia compared to tunneled catheter

40 Restoring Lost Access

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47 Give skill to my hand, clear vision to my mind, kindness and sympathy to my heart. Give me singleness of purpose, and the strength to relieve at least a part of the burden of my patients. Physicians Prayer