CENTRAL VENOUS RECANALIZATION AND SUBSEQUENT IMPLANTATION OF THE HeRO DEVICE IN CATHETER DEPENDENT PATIENTS
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1 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 7 th Congress of Vascular Access Society Istanbul, Turkey -- May 2011
2 Disclosures Shawn M. Gage Hemosphere, Inc. - consultant P. Joshua O Brien none Charles Y. Kim - none Jeffrey H. Lawson Hemosphere, Inc. - research funding - consultant
3 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
4 Current Options Lower extremity AV access - increased risk of infection - greater risk for LE steal
5 Current Options Direct bypass to right atrium or CV reconstruction Requires sternotomy or thoracotomy High morbidity Sternal wounds Graft infections Pleural or pericardial effusions
6 Current Options Destination Dialysis Catheter - Increased infection risk - poorer dialysis adequacy - greater number of interventions - highest cost to healthcare system
7 Proposed Solution Central Venous Recanalization With Hemodialysis Reliable Outflow as adjunct
8 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
9 Right BCV & SVC Occlusion Collateral veins Occluded Left BCV stent
10 Axillary and Femoral vein access Low profile directional catheters Long rigid sheath TIPS needle
11 Crossed occlusion Through and through venous access body floss trackability
12 Balloon Angioplasty Dilate tract
13 Low profile catheter implanted as place-holder
14 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 eptfe Graft Component Venous Outflow Component
15 Cut down on catheter for access
16 Wire access to IVC
17 Peel-away sheath
18 Outflow component
19 Connect Outflow component to PTFE eptfe graft Silicone outflow component
20 Tunnel graft and obtain inflow
21 Patients and Methods Single center retrospective review 18 ESRD patients All with total central venous occlusion All dialysis catheter dependent (femoral or trans-hepatic)
22 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( )
23 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)
24 Results HeRO Implant Specifics Successful implants, % (n/n) 93.3% (14/15) Side of body, % (n/n) Right 64 (9/14) Insertion vein, % (n/n) Subclavian Internal Jug External Jug Other 36 (5/14) 29 (4/14) 14 (2/14) 21 (3/14)
25 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)
26 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
27 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
28 Thank You Shawn M. Gage, PA-C Section of Vascular Surgery Duke University Medical Center
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