what’s on the horizon in dialysis access? materials and...central venous catheter useat enrollment...

What’s on the Horizon in Dialysis Access?

Libby Watch, MD, FACS

Miami Cardiac & Vascular Institute

Disclosures

• No relevant disclosures

• Employee Advanced Access Care

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

What is new?

• Access creation

• Access salvage

• Access restoration

1. Roy-Chaudhury et al. JASN 2006;17:1112-27

From Bharat et al. JVS 2012;55(1):274-80

• 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 failure1

• Disruption of vasa vasorum

• Mobilization

• Torsion

• Stretching

Importance of Surgical Technique

Why do surgical AVFs Fail to Mature?

• 43% to 65% reported incidence2

• Described as an inflammatory response to surgical trauma2

• Endothelial cells migrate inward, constricting flow3

1. Beathard ACKD 2009;16(5):339-51.2. Beathard et al. Kidney Int 2003;64:1487-94.3. Proteon Therapuetics

Flow limiting lesions often at the site of surgery1

TVA everlinQ System

Magnets align cathetersFlexible spacers6 Fr over the wire

and RX system

Radiofrequency electrode

creates fistula

Venous catheter

Arterial catheter

RF Generator

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.

Study Overview

• Single center, prospective design

• Paraguay

• 33 patients, 4 cohorts

• 6 month follow-up

• Study endpoints:

• Technical success

• Patency

• Safety

• Study completed Q1 2014

Patient Demographics+

Gender male 61%Age (years) 51.0+11.4BMI 24.3+3.8BMI > 25 30.3%Race

Hispanic 100%Predialysis at enrollment 6.1%Previous AVF 12.1%Diabetes 58%

J Vasc Interv Radiol 2015; 26:484–490.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.

Clinical Results: FLEX Study

97% 96% 96%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Technicalsuccess @ 24

hrs

AVF patency@6 months

Usable fordialysis

Clinical Endpoint FLEX Study

Result

AVF maturation time 58 days

Interventions/patient-year 0.15**

Thrombosis 4% (1/26)

Stenosis 0%

Access infection/patient-year 0%

Serious device-related

adverse events3% (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.

Data reported per-protocol, not intent to treat.

+

N = 33 N = 26 N = 28


J Vasc Interv Radiol 2015; 26:484–490.

Clinical Results: FLEX 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 Q3 2016

Patient Demographics+

Gender male 65.0%

Age (years) 59.9 ± 13.6

BMI 28.0 ± 6.1

BMI > 25 64.4%

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 use at enrollment

41.7%

+ n=60, updated December 2015DISCLAIMER: 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.

Clinical Experience: NEAT Study

everlinQ endoAVF demonstrated reproducible procedure success,

low complication rate and a high suitability for dialysis

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

Based on NEAT 3m results

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


Clinical Results: NEAT Study

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


• 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 acellularvessel (HAV)

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

Access Salvage

Radiofrequency wire technology

Generator:

RF energy = vaporizes channel through occlusion but minimal damage to surrounding tissues

Grounding Pad

Activated by a pedal or pushing the yellow button

Pad: patien’s leg

JVIR August, 2012

Results

• 42 patients/43 occlusions

• 42/42 successful recanalization

• One complication• Cardiac tamponade

• 40/42 (95.2%) patients patent at 6 and 9 months

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

Groin

Access to

SVC

AP Oblique

Power wire

advanced and

snared

Final

S/P 14mm

PTA

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

Right basilic fistulaOccluded right brachiocephalic veinPatent left internal jugularLeft arm multiple grafts

HERO graft crossing from right arm to left internal jugular vein

HERO Hemodialysis Reliable Outflow

• 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

Restoring Lost Access

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

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