Strategies to Reduce Catheter Use in 2014



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Strategies to Reduce Catheter Use in 2014 Timothy A. Pflederer, MD Chair, Network 10 MRB (I have no commercial affiliations or conflicts of interest to report)

Fibrin Sheathing

Central Venous Stenosis

Arm Edema

Infection

Fistula First Catheter Last

Catheter Reduction Strategies Catheter avoidance Timely placement of the best access Urgent start PD Early cannulation grafts Atrium Flixene TM Gore Acuseal TM Catheter removal Timely removal of the worst access HeRO graft

Decision points Fistula First (unless a graft is better) Are we early enough to mature an avf? Will the patient live long enough to benefit from an avf? Disciplined follow-up Intervene when failing to mature (6-8wks) Decide when enough is enough Remove catheter after 3 successful cannulations

Timeline (Best case scenarios) AVF matures without assistance (40%) Placement Use (2 months) AVF matures with assistance (60%) Placement Proc1 Use (3 months) Placement Proc1 Proc2 Use (4 months) AVF fails after salvage attempts (20%) Placement Proc1 Proc2 Fail Avg Use 8wks 4 4 4 3 (6 months) AVG Placement Use (3 weeks)

Urgent Start PD Useful for patients who crash into dialysis without prior access planning (80%?) Place PD catheter instead of TDC Initiate low volume/supine PD in hospital Continue this in home dialysis unit Educate on treatment options Continue PD (complete training) Change to HD (avf/avg then transfer to in-center)

Benefits of urgent start PD TDC avoidance Lower infection, hospitalization, mortality Immediate Medicare enrollment Payment Hospital, access surgeon, dialysis facility, nephrologist PD training payment Effective way to grow home therapies

Early Cannulation Graft Patients with urgent dialysis need No fistula option (or graft is felt to be best) Very borderline upper arm fistula option Patients with failing fistula or graft Graft options/details

FLIXENE Vascular Graft (Atrium product) Durable Cannulation Zone: Wall Construction Tri-laminate (3 layers) 100% PTFE (no additional material added or needed) Shown To Reduce Common Graft Related Complications Reduce Pseudoaneurysms 1 Reduce Seromas 1 Higher Rate of Complication Free Patients compared to standard PTFE group 4 1. Schild AF, Schuman ES, Noicely K, et al. Early cannulation prosthetic graft (Flixene ) for arteriovenous access. J Vasc Access. 2011 Jul-Sep;12(3):248-52 2. Schild AF. et al. New Graft fro Low Friction Tunneling in Vascular Access Surgery, Journal of Vasc Access 2004 3. Scarritt T, Paragone C, O Gorman R, Kyriazis D, Maltese C, Rostas J. Traditional vs. Early Access Grafts for Hemodialysis Access: A Single Institution Comparative Study.. The American Surgeon, February 2014. pp. 155-158. 4. Chiang, N, Ria Hulme K, Haggart P, Vasudevan. Comparison of FLIXENE and Standard PTFE Arteriovenous Graft For Early Hemodialysis Journal of Vascular Access, 2014

FLIXENE Vascular Graft (Atrium product) Key Features and Benefits: Durable Cannulation Zone: Reduce Pseudoaneurysms 1 (?) Reduce Seromas 1 Is Safe to Cannulate Within 24-72 hrs 1 Shown to Reduce Catheter Rates compared to standard PTFE 3 No Additional Steps Required for Early or Standard Cannulation Follow KDOQI guidelines 1. Schild AF, Schuman ES, Noicely K, et al. Early cannulation prosthetic graft (Flixene ) for arteriovenous access. J Vasc Access. 2011 Jul-Sep;12(3):248-52 2. Schild AF. et al. New Graft fro Low Friction Tunneling in Vascular Access Surgery, Journal of Vasc Access 2004 3. Scarritt T, Paragone C, O Gorman R, Kyriazis D, Maltese C, Rostas J. Traditional vs. Early Access Grafts for Hemodialysis Access: A Single Institution Comparative Study.. The American Surgeon, February 2014. pp. 155-158.

Acuseal TM Vascular Graft (Gore Product) Outer Graft Layer Expanded polytetrafluoroethylene Middle Graft Layer Elastomeric membrane Inner Graft Layer Expanded polytetrafluoroethylene CBAS Heparin Surface Tri-Layer Design

Hinders Cannulation Needle Hole Bleeding Low Bleed versus Bleed 16 gauge cannulation needle hole through GORE ACUSEAL Vascular Graft luminal surface (left) Standard eptfe graft luminal surface (right)

Summary ACUSEAL Vascular Graft Clinical Study* Primary Efficacy Endpoint: Cumulative Patency No difference in hematoma, infections or steal syndrome from standard PTFE graft Within 28 days of graft implantation, 75.6% of the implanted grafts had been successfully cannulated 3 consecutive times allowing the potential for the CVC to be removed * Data on file

Early Cannulation Grafts Safe to use within 24 hours of placement Similar patency to typical PTFE grafts No difference in complications Infection, hematoma, pseudoaneurysm*, steal Useful for Avoiding catheter in urgent situations Faster removal of catheters Revising failing graft/fistula * Might be improved?

Early cannulation guidelines (When used in first 2 weeks) Strict aseptic technique Mask, sterile gloves, prep Small needles 17g Lower blood flow rate 200-300ml/min Hold pressure 10-15 minutes Lower or no heparin if immediately postop

Differences in clinical use Physical exam Markedly reduced thrill Difficult to hear bruit Cannulation Firmer feel so greater pressure required at entry Enhanced pop into graft

Catheter Reduction Strategies Catheter avoidance Timely placement of the best access Urgent start PD Early cannulation grafts Gore accuseal Atrium Flixene Catheter removal Timely removal of the worst access HeRO graft

Removing Catheters - Three - Successful Infection Replacement - Treatments Removed within 1 week of referral

HeRO TM Graft Hemodialysis Reliable Outflow

Treatment Algorithm Failing AVF or AVG due to central venous stenosis Fistula Graft Not for patients with low cardiac output/low BP HeRO Graft Catheter-dependent patients Catheter HeRO Graft Candidates Failing fistulas or grafts due to central venous stenosis Catheter-dependent or approaching catheter-dependency

for Fistula or Graft Salvage 1 AVF to HeRO Graft anastomosis Fistula Salvage Cannulation Area Immediately After AVF Salvage* HeRO Graft Arterial Graft Component Stenosed & Ligated AVF Venous Outflow HeRO Graft Venous Outflow Component Radiopaque Marker Band AVG to HeRO Graft anastomosis AV Graft Salvage Stenosed & Ligated AVG Venous Outflow Cannulation Area Immediately After AVG Salvage* HeRO Graft Arterial Graft Component HeRO Graft Venous Outflow Component Radiopaque Marker Band *If AVF is matured or AVG is incorporated. Follow your dialysis facility protocol for care and cannulation. 1) HeRO Graft IFU, L7163

Clinical Outcomes HeRO Graft Gage, et al. EJVES 1 HeRO Graft Patency Study 2 HeRO Graft Katzman, et al. JVS 2 Catheter Literature 2 AV Graft Literature 2 Bacteremia Rates (Infections/1,000 days) 0.14 0.18 0.70 2.3 0.11 Adequacy of Dialysis (mean Kt/V) NA NA 1.7 1.29-1.46 1.37-1.62 Cumulative Patency at 1 Year Intervention Rate (per year) 91% 88% 72% 37% 65% 1.5 1.7 2.5 5.8 1.6-2.4 1) Gage et al., EJVES 2012. 2) Katzman et al., J Vasc Surg 2009; IFU: Comparisons to catheters and AVGs are from literature review on file. 3) Dhingra et al., Kidney Int 2001. 4) 2006 NKF KDOQI, Guideline 4.

Case Report From Catheter to HeRO Graft A 50 year old African-American male with HIV and renal failure, and deemed catheter-dependent. He has been on hemodialysis for over 10 years, and has had 3 failed fistulas and 3 failed AV grafts. Both arms have been deemed exhausted for use. He had 4 tunneled dialysis catheters (TDCs) total (2 on each side).

Case Report: Riley (part 2) From Catheter to HeRO Graft His central venous system had occluded bilaterally. A left-sided brachiocephalic vein stent was placed 2 years ago to try to salvage a poorly functioning left upper extremity AVG. When that access failed, a TDC was placed through the stenotic stent. Central Venous Occlusion Central Venous Stent Tunneled Dialysis Catheter Fluoroscopic image of central venous occlusion, a central venous stent, and a TDC

Case Report: Riley (part 3) From Catheter to HeRO Graft A HeRO Graft was placed via the existing TDC. Central Venous Stent HeRO Graft Titanium Connector and eptfe graft He is now using the HeRO Graft without difficulty, and his bridging femoral TDC was removed. HeRO Graft Venous Outflow Component HeRO Graft Venous Outflow Component Tip Above: Fluoroscopic image of HeRO Graft implanted through a stent HeRO Graft Titanium Connector HeRO Graft eptfe, Cannulation Area Above: Image of HeRO Graft after implantation

Summary Catheter use can be reduced drastically by utilizing several old and new strategies Early referral for avf Individualized selection of preferred access type Efficient processes for following new accesses and removing catheters Considering PD first Utilizing early cannulation grafts, and HeRO graft when indicated