Reducing Catheter Dependency

ML0687.003 (08/2015)

Overview

• Introduction

• Product Overview

• Treatment Algorithm

• ESRD Toolkit & NKF Update

• Key Benefits

• Typical Operators

• Procedure Overview

• Fistula or Graft Salvage

• Clinical Outcomes

• HeRO Graft vs. Catheter

• Potential Candidates

• Case Reports

• Cost Benefits

• Packaging

HeRO (Hemodialysis Reliable Outflow) Graft is the ONLY fully subcutaneous AV access solution clinically proven to maintain long-term access for hemodialysis patients with central venous stenosis.

FDA Classification

HeRO Graft is classified by the FDA as a vascular graft prosthesis.

Introduction

Product Overview

• No venous anastomosis • Reinforced 48 braid nitinol: kink

& crush resistant • Removable and replaceable • Radiopaque band (at distal tip)

ePTFE Graft Silicone-Coated Nitinol Component

• Beading (3-4cm) for kink resistance • Orientation line on graft to guide

placement during tunneling • Titanium connector

6mm (ID) x 50cm

Connector

6mm - 5mm (ID)

5mm (ID), 6.3mm (OD), 19F (OD) x 40cm

(customizable length)

Venous Outflow Component Arterial Graft Component

Treatment Algorithm

Catheter HeRO

Graft Graft Fistula

Failing AVF or AVG due to central venous stenosis

Catheter-dependent patients

● Failing fistulas or grafts due to central venous stenosis

● Catheter-dependent or approaching catheter-dependency

HeRO Graft Candidates

HERO Graft in ESRD Network’s “Catheter Reduction Toolkit”

• HeRO Graft referenced in

Forum of ESRD Network’s

Medical Advisory Council

Catheter Reduction Toolkit1

1) The National Forum of ESRD Networks’ Medical Advisory Council, Catheter Reduction Toolkit 2009; revised 2011, page 24

HeRO Graft in Update from National Kidney Foundation (NKF)

1) NKF Supplement, 12-10-4487_KBB 2012.

• HeRO Graft is featured in

NKF’s “Clinical Update on An

Alternative Vascular Access

for the Catheter-Dependent

Hemodialysis Patient”1

Key Benefits • Fewer Infections: 69% reduced infection rate compared with catheters1

• Superior Dialysis Adequacy: 1.7 Kt/V, a 16% to 32% improvement compared with catheters1 • High Patency Rates: Up to 87% cumulative patency at 2 years1,2

• Cost Savings: A 23% average savings per year compared with catheters3

1) Katzman et al., J Vasc Surg 2009; IFU: Comparisons to catheters and AVGs are from literature review on file. 2) Gage et al., EJVES 2012. 3) Dageforde et al., JSR 2012.

Typical Operators

Vascular Surgeons with:

• Open surgical skills

• Endovascular skills

Note: If surgeon does not have endovascular skills, partner with an Interventionalist

Venous Outflow Component

Utilizing endovascular techniques, the Venous Outflow Component is placed in the central venous vasculature to the opening of the right atrium.1

Procedural Overview

1) HeRO Graft IFU

Connector

At the deltopectoral groove, the proprietary titanium connector on the ePTFE graft is joined with the Venous Outflow Component.1

Procedural Overview (continued)

1) HeRO Graft IFU

Procedural Overview (continued)

Arterial Graft Component

A standard arterial anastomosis is performed to attach the 6mm ePTFE graft to the target inflow artery (>3mm).1

1) HeRO Graft IFU

Temporary Catheter (during the bridging period if applicable)1

Cannulate ePTFE graft per your standard facility protocol1

Procedural Overview (continued)

1) HeRO Graft IFU

Fistula Salvage AVF to

HeRO Graft anastomosis

HeRO Graft Venous Outflow

Component HeRO Graft Arterial Graft Component

Stenosed & Ligated

AVF Venous Outflow Cannulation Area Immediately

After AVF Salvage*

Radiopaque Marker Band

AV Graft Salvage

Stenosed & Ligated AVG Venous Outflow

AVG to HeRO Graft anastomosis

Cannulation Area Immediately After AVG Salvage*

Radiopaque Marker Band

*If AVF is matured or AVG is incorporated. Follow your dialysis facility protocol for care and cannulation.

HeRO Graft Arterial Graft Component

HeRO Graft Venous Outflow

Component

for Fistula or Graft Salvage1

1) HeRO Graft IFU

Post-Implant View

Connector, (INCISION SITE)

VENOTOMY, (INCISION SITE)

ePTFE GRAFT, CANNULATION

AREA

VENOUS OUTFLOW COMPONENT

ARTERIAL ANASTOMOSIS, (INCISION SITE)

150+ Publications & Presentations

• A bibliography of HeRO Graft publications and presentations is available at www.herograft.com.

HeRO Graft

Gage, et al. EJVES1

HeRO Graft

Nassar, et al. Semin Dial2

HeRO Graft

Katzman, et al. JVS3

Catheter Literature

AV Graft Literature

Bacteremia Rates (Infections/1,000 days)

0.14 0.13 0.70 2.311,3,4 0.112,4

Adequacy of Dialysis (mean Kt/V)

NA 1.6 1.7 1.29 - 1.464 1.37 - 1.622-4

Cumulative Patency at 1 Year

91% 68% 72%^ 37%1,3,4 65%1-4

Intervention Rate (per year)

1.5 2.2 2.5 5.81,3 1.6 - 2.41,3

Note: Every 0.1 decrease in Kt/V increases the mortality rate by 7%5 and is significantly (P<0.05) associated with 11% more hospitalizations, 12% more hospital days, and a $940 increase in Medicare inpatient expenditures.6

^8.6months

1) Gage et al., EJVES 2012. 2) Nassar et al., Semin Dial 2014. 3) Katzman et al., J Vasc Surg 2009. 4) Data on file. 5) Dhingra et al., Kidney Int 2001. 6) 2006 NKF KDOQI, Guideline 4.

Clinical Outcomes

Catheter Vs.

Key Features Device Yes No

HeRO Graft

Catheter

HeRO Graft

Catheter

HeRO Graft

Catheter

Infection rates comparable

to access grafts1

Dialysis adequacy (Kt/V)

comparable to access

grafts1

Patency rates comparable

to access grafts1

1) Katzman et al., J Vasc Surg 2009; IFU: Comparisons to catheters and AVGs are from literature review on file.

Identifying a HeRO Graft Candidate

If YES is checked for any box above, consider referring patient for a surgical assessment.

● Is the patient currently catheter-dependent or approaching catheter- dependency?

● Is the patient failing a fistula or AV graft?

● Does the patient have a record of central venous stenosis?

● Does the patient have swollen arms and/or distended collateral veins?

● Has the patient had multiple interventions (e.g. angioplasty)?

● Is the measured Kt/V less than 1.4?

● Has the flow rate dropped >20%?

YES

YES

YES

YES

NO

NO

NO

NO

YES NO

YES NO

YES NO

Case Report: Virginia AV Graft Salvage with HeRO Graft

• A 55 year old obese African-American female.

• Multiple medical co-morbidities including: ESRD, hypertension, diabetes, obesity, hyperparathyroidism, anemia.

• Multiple bilateral upper extremity arteriovenous access placed by another surgeon.

• Presented to Vascular Interventional Radiology (VIR) for aneurysms of right upper extremity (RUE) AV graft and prolonged bleeding at decannulation.

• Angiogram revealed two pseudoaneurysms and degeneration of RUE AV graft (AVG) and occlusion of right brachiocephalic vein (BCV). Treated with angioplasty and stenting of right BCV.

Case Report: Virginia (part 2) AV Graft Salvage with HeRO Graft

• Recurrence of stenosis (in-stent) 3 months later. Received angioplasty again in VIR.

• 1 month following VIR procedure, presents to our surgical clinic with poor access flow and prolonged bleeding at decannulation from RUE AVG.

• Bilateral UE venogram for pre-operative planning revealed complete occlusion of left subclavian/axillary vein and recurrence of right BCV in-stent high-grade stenosis.

• Angioplasties were performed to treat the in-stent and central venous stenosis

Above: Fluoroscopic image of in-stent stenosis

In-stent restenosis

Above: Fluoroscopic image of multiple angioplasties of the in-stent and venous stenosis

Case Report: Virginia (part 3) AV Graft Salvage with HeRO Graft

• RUE HeRO Graft was placed (images to right) via percutaneous access to treat recurrent BCV in-stent stenosis and to salvage the failing AVG access.

• The use of the previous RUE AVG inflow was chosen to treat the previous AVG pseudoaneurysms and graft degeneration (image below).

HeRO Graft Titanium Connector HeRO Graft

ePTFE, Cannulation Area

Anastomosis previous failing AVG (with good inflow)

Inflow of previous failing AVG

HeRO Graft ePTFE, Cannulation Area

HeRO Graft Venous Outflow Component

HeRO Graft Titanium Connector

HeRO Graft ePTFE, Cannulation Area

HeRO Graft Venous Outflow Component

Anastomosis previous failing AVG (with good inflow)

Above: Fluoroscopic image of HeRO Graft Above: Image of the ePTFE of the HeRO Graft being anastomosed to the inflow site of the previous failing AVG

Above: Image of map of HeRO Graft post-implant

Case Report: Riley 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.

Tunneled Dialysis Catheter

Central Venous Stent

Central Venous Occlusion

Fluoroscopic image of central venous occlusion, a central venous stent, and a TDC

Case Report: Riley (part 3) From Catheter to HeRO Graft

• The patient was referred by an interventional nephrologist to a vascular surgeon.

• The patient used the hemodialysis catheter until a HeRO Graft was placed via the existing TDC.

• He is now using the HeRO Graft without difficulty, and his bridging femoral TDC was removed.

HeRO Graft Venous Outflow Component Tip

HeRO Graft Titanium Connector and ePTFE graft

HeRO Graft ePTFE, Cannulation Area

HeRO Graft Venous Outflow Component

HeRO Graft Titanium Connector

Central Venous Stent

Above: Image of HeRO Graft after implantation

Above: Fluoroscopic image of HeRO Graft implanted through a stent

Case Report: Sadie From Catheter to HeRO Graft

• 58 year old African-American female with renal failure, diabetes, stroke, and bilateral central vein occlusion, and deemed “catheter dependent.”

• She has been on hemodialysis for over 10 years and had failed multiple AV access both in bilateral upper extremities and lower extremities.

• She had numerous tunneled dialysis catheters (TDCs) in the chest and femoral areas (bilaterally) over the years for dysfunctional AV access.

• As a result of those multiple TDCs and multiple bilateral pacemakers (that had since become infected and removed), she developed total central venous occlusion both in the chest and pelvis which is why she was dialyzing via a transhepatic TDC.

Transhepatic Tunneled Dialysis Catheter

Central Venous Occlusion

Fluoroscopic image of central venous occlusion and a transhepatic TDC

Case Report: Sadie (part 2) From Catheter to HeRO Graft

• An interventional radiologist was able to recanalize her central venous occlusion via "body floss" technique (upper and lower body percutaneous venous access), and balloon angioplasty.

• The brachiocephalic vein and SVC were treated with angioplasty, and a low profile temporary Hickman® catheter was implanted across the occlusion as a place holder for staged HeRO Graft implant 1 week later by a vascular surgeon.

• She is now using the HeRO Graft for hemodialysis and the bridging transhepatic TDC has been removed.

HeRO Graft ePTFE, Cannulation Area

HeRO Graft Venous Outflow Component HeRO Graft

Titanium Connector

HeRO Graft Venous Outflow Component

HeRO Graft Titanium Connector

Above: Image of plan before HeRO Graft implanted

Above: (left) “Body floss” technique with upper and lower percutaneous guidewire access. (right) Fluoroscopic image

of HeRO Graft implanted

Wire access

Wire access

HeRO Graft Patients’ Feedback

With the HeRO Graft, I no longer have catheter tubes exposed outside my body that are a constant risk and worry of infection. - Kaaren

“Consider the HeRO Graft! Yes, there are needles involved, but the risk of infection is far less than a catheter and that is worth it to me.” - Kay

“It gave me another chance at life.” - Stewart

Cost Benefits: Hospital

•23% average savings per year with the HeRO Graft compared with catheters1

•Reduces catheter-related infections and hospital admissions projected at $23k to $56k per stay2,3

• Lowers interventions and associated costs by more than 50% compared to catheters4,5

1) Dageforde et al., JSR 2012. 2) Ramanathan et al., Infect Control Hosp Epidemiol 2007. 3) O’Grady et al., The Centers for Disease Control 2002. 4) Katzman et al., J Vasc Surg 2009; IFU: Comparisons to catheters and AVGs are from literature review on file. 5) Gage et al., EJVES 2012.

Cost Benefits: Dialysis Center

1) Yost and Dinwiddie, American Society of Nephrology (ASN), Nov 2010.

Impact of HeRO Graft in the Era of Dialysis Provider Bundling1

Cost savings of over $3,100 (per patient/year) to the dialysis center when converting catheter-dependent patients to the HeRO Graft1

Three Separate Packages

Venous Outflow Component (HERO 1001)

Arterial Graft Component (HERO 1002)

Accessory Component Kit (HERO 1003)

Learn more at: www.herograft.com

Surgical technique is at the discretion of the surgeon. Variations in technique and practices will inevitably and appropriately occur when clinicians take into account the needs of the individual patients, available resources, and limitations unique to an institution or type of practice.

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