CENTRAL VENOUS RECANALIZATION AND ......7th Congress of Vascular Access Society Istanbul, Turkey --...

7th Congress of Vascular Access Society Istanbul, Turkey -- May 2011

CENTRAL VENOUS RECANALIZATION AND SUBSEQUENT IMPLANTATION OF THE HeRO® DEVICE

IN CATHETER DEPENDENT PATIENTS

Shawn M. Gage PA-C, P. Joshua O’Brien MD, Charles Y. Kim MD, and Jeffrey H. Lawson MD, PhD.

Section of Vascular Surgery and Division of Interventional Radiology

Duke University Medical Center Durham, North Carolina, United States of America

Disclosures

• Shawn M. Gage – Hemosphere, Inc. - consultant • P. Joshua O’Brien – none • Charles Y. Kim - none • Jeffrey H. Lawson – Hemosphere, Inc. - research funding - consultant

The Problem: Central venous occlusion

• Recurrent central venous instrumentation

• Central venous catheters • Balloon Angioplasty • Central venous stents • Shear stresses

• HD associated Inflammation • Aggressive venous intimal

hyperplasia

Current Options

• Lower extremity AV access - increased risk of infection - greater risk for LE steal

Current Options

Direct bypass to right atrium or CV reconstruction

• Requires sternotomy or thoracotomy

• High morbidity

• Sternal wounds

• Graft infections • Pleural or pericardial

effusions

Current Options

• “Destination” Dialysis Catheter - Increased infection risk - poorer dialysis adequacy - greater number of interventions - highest cost to healthcare system

Proposed Solution Central Venous Recanalization With Hemodialysis Reliable Outflow as adjunct

Recanalization Procedure

• Upper and lower extremity venous access

• Multi-projection imaging • Low profile catheters • Sharp recanalization • Through-and-through

guidewire access • Balloon angioplasty • Access place-holder

Right BCV & SVC Occlusion

Collateral veins

Occluded Left BCV stent

Axillary and Femoral vein access

• Low profile directional catheters

• Long rigid sheath • TIPS needle

Crossed occlusion

• Through and through venous access

• “body floss” • “trackability”

Balloon Angioplasty

• Dilate tract

Low profile catheter implanted as place-holder

A Brief Review ●HeRO™ Hemodialysis Reliable Outflow

●Hybrid vascular access device “graft-cath”

●2 primary components: ePTFE graft with Titanium connector 6mm ID, and radiopaque silicone outflow component with braided nitinol reinforcement 5mm ID

●Common access veins include: Subclavian and Internal Jugular

●End stage access device

●Indicated for catheter dependent patients with central venous stenosis and/or occlusion

Venous Outflow Component

ePTFE Graft Component

Cut down on catheter for access

Wire access to IVC

Peel-away sheath

Outflow component

Connect Outflow component to PTFE

Silicone outflow component

ePTFE graft

Tunnel graft and obtain inflow

Patients and Methods

• Single center retrospective review • 18 ESRD patients • All with total central venous occlusion • All dialysis catheter dependent (femoral or trans-hepatic)

Results

Demographics Age, mean (range) 50.1 (25-74)

Male, % (n/N) 46 (8/18)

Race, % (n/N)

Black/African American

White/Caucasian

78 (14/18)

22 (4/18)

BMI, mean (range) 32.6(16-48.2)

Results

CVR Specifics Successful CVR, % (n/N) 83.3 (15/18)

Thru & Thru access, % (n/N) 67 (10/15)

Catheter placed, % (n/N) 87 (13/15)

CVR to HeRO (days), mean (range) 32.5 (0-148)

Results

HeRO Implant Specifics Successful implants, % (n/N) 93.3% (14/15)

Side of body, % (n/N)

64 (9/14)

Insertion vein, % (n/N)

Subclavian

Internal Jug

External Jug

36 (5/14)

29 (4/14)

14 (2/14)

21 (3/14)

Patency Rates

Patency 6 months

12 months

Primary, % (n/N) 57% (4/7) 50% (2/4)

Secondary, % (n/N) 100% (7/7) 100% (4/4)

Results

• Intervention - Overall 71% FFI • Infection - 1 HeRO related infection - required interposition replacement of ePTFE • Death - 3 deaths (21%) - All unrelated to recanalization or HeRO implant

Conclusions

• Central venous recanalization is feasible • HeRO device allows for durable access • Maintain upper body access • Patency & intervention is acceptable • Reduced cost to healthcare system • Reduced morbidity and mortality

Shawn M. Gage, PA-C Section of Vascular Surgery

Duke University Medical Center

Thank You

CENTRAL VENOUS RECANALIZATION AND ......7th Congress of Vascular Access Society Istanbul, Turkey --...

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