reducing catheter dependency - cryolife...6mm (id) x 50cm connector 6mm - 5mm (id) 5mm (id), 6.3mm...
TRANSCRIPT
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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