CryoVein® CryoArtery®
AV Access
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Overview
• Ideal Patients
• Clinical Outcomes
• Additional Benefits
• The CryoLife Difference
• Implanting Technique
• Available Allografts & Sizes
• Discussion
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Ideal Patients*
Patients with active infections due to either:
• Infected AV fistula
• Infected synthetic AV graft
Patients in whom an autologous AV fistula is not possible
Patients at risk of an AV access infection
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Patients with a limited number of AV access sites
NOTE: Transplantation of any allograft tissue can induce an anti-HLA antibody response in the recipient. The possibility that a patient may develop antibodies after allograft tissue transplantation should be considered for any patient who might be a future recipient of allograft tissue, organs, or cells.
*Based on current technology/understanding
Up to 35% of AV grafts become infected1
Estimated AV Access Graft Infection in U.S. is 13,0002
1Akoh J. J Vasc Access 2009;10:137-47. 2Calculated estimate based on forecasted procedures from iData Research Inc. Surgical Graft Procedure Numbers by Segment, U.S., 2006-2016.
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Ideal Patients: AV Access Infections
Allografts For Treating AV Graft Infections
CryoVein Femoral Vein
Patients Treated for AV Graft Infection
Re-infection Rates
Rate of Infection per
1,000 patient days
Follow Up
Lin et al.1 36 0% NR 1 Year
Matsuura et al.2 38 0% NR 1 Year
Matsuura et al.3 43 2.3% NR 2 Years
CryoLife Multicenter4 52 3% 0.099* 2 Years
1Lin P, et al. Am J Surg 2002;184:31-6. 2Matsuura J, et al. Ann Vasc Surg 2000;12:50-5. 3Matsuura J, et al. Cardiovasc Surg 2002. 10;6:561-65. 4CryoLife data on file (ML0101).
Clinical Outcomes: CryoVein Femoral Vein
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*This calculation is based on the subset of patients treated for an AVG infection, n=52 (20,017 cumulative patient days). The full series, n=148, rate of infection is 0.0062 per 1,000 patient days (48,223 cumulative patient days).
Clinical Outcomes: CryoVein Femoral Vein
CryoVein Femoral Vein Patients 1 Year
Cumulative Patency
2 Year Cumulative
Patency
Lin et al.1 38 68% -
Matsuura et al.2 44 75% -
Matsuura et al.3 43 68% 63%
CryoLife Multicenter4 148 80% 72%
1Lin P, et al. Am J Surg 2002;184:31-6. 2Matsuura J, et al. Ann Vasc Surg 2000;12:50-5. 3Matsuura J, et al. Cardiovasc Surg 2002. 10;6:561-65. 4CryoLife data on file (ML0101).
Allografts For AV Access: Cumulative Patency
Femoral Vein
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Clinical Outcomes: Cryopreserved Femoral Artery
Cryopreserved Femoral Artery*
Patients
1 Year Cumulative
Patency
2 Year Cumulative
Patency
Takamoto et al.1 5 100% 80%
1Takamoto S, et al. Trans Proceed 1998;30:3917-19.
Allografts For AV Access: Cumulative Patency
Femoral Artery
*non-CryoLife processed tissue
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Clinical Outcomes: Cryopreserved Saphenous Vein
Cryopreserved Saphenous Vein*
Patients 1 Year Cumulative
Patency
Baraldi et al.1 16 90%
1Baraldi A, et al. Trans Am Soc Artif Intern Organs 1989:196-9.
Allografts For AV Access: Cumulative Patency
Saphenous Vein
*non-CryoLife processed tissue
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Additional Benefits: Save the Site vs. Lose the Site
Allograft Method Single procedure: save the site1,2
Graft Excision Method Multiple procedures: lose the site1,2
1) Remove infected AV graft and implant allograft in the same infected site, saving potential future AV access sites
2) Insert a temporary dialysis catheter and begin IV antibiotic therapy
1) Remove infected AV graft
2) Insert a temporary dialysis catheter and begin IV antibiotic therapy
3) After the infection is cleared, perform another operation with a new AV graft in a different location, diminishing potential sites for future AV access
1Lin P, et al. Am J Surg 2002;184:31-6. 2Matsuura J. Contemp Dial & Neph 1999:30-2.
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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.
Additional Benefits: Cost Effectiveness
Treatment Methods Patients
Average hospital stay
(p=0.001)
Overall hospital cost
CryoVein Femoral Vein 20 2.3 days $13,843 ±
$6,007
Graft Excision 13 8.1 days $22,136 ± $12,665
Cost Comparison: CryoVein Femoral Vein vs. Graft Excision1
Conclusion: Cryopreserved femoral vein is a cost-effective means of treating infected AV grafts1
1Matsuura J, et al. Presented at the 10th Annual Winter Meeting of the Peripheral Vascular Surgery Society, Snowmass, CO. January 14, 2000.
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Additional Benefits: Natural Suturability
Looks, feels, and sutures like autologous tissue1
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1Martin et al. Ann Surg 1994 Jun;219(6):664-70.
Additional Benefits: Natural Pulsatile Flow
Flow dynamics of cryopreserved vascular allografts are comparable to that of autologous tissue1
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1Bia D et al. Artif Organs. 2007 Nov;31(11):809-18.
Benefit CryoLife
Safety & Clinical Validation
AATB Accreditation Yes
Clinical Data for AV Access 11 publications
Processing Standards Four stage microbiological testing
Quality
Donor Age Up to 55 years
Detailed Certificate of Assurance (e.g. diameter changes, ligations, leaks, etc.)
Yes
Packaging: Can it be submerged in Liquid Nitrogen?
Yes
The CryoLife Difference 13
Benefit CryoLife
Experience
Year Founded 1984
Service
Representatives Direct
Tissues Femoral Vein & Artery; Saphenous Vein
CryoFreezers for Hospitals Yes
Professional Education (wet labs) Yes
The CryoLife Difference 14
Implanting Technique
Remove infected AV graft and implant allograft in the same infected site, saving potential future AV access sites
Insert a temporary dialysis catheter and begin IV antibiotic therapy
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Implanting Technique 16
Alternative techniques:
CryoVein/CryoArtery as interpositional graft: ◦ Remove infected area of AVF or AVG
◦ Replace with CryoVein/CryoArtery in the same infected site
CryoVein/CryoArtery as jump graft for fistula salvage
Implanting Technique
To optimize flow, taper the arterial end of the CryoVein Femoral Vein using an angled cut of the allograft and oversewing the heel of the graft with 6-0 polypropylene suture to create a 4mm1, 5mm2, or 6mm diameter.3
For informational purposes only. Surgical technique is at the discretion of the surgeon.
1Lin P, et al. Am J Surg 2002;184:31-6. 2Matsuura J, et al. Ann Vasc Surg 2000;12:50-5. 3Matsuura J, et al. Cardiovasc Surg 2002. 10;6:561-65. Images from: Matsuura J, et al. Perspectives in Vascular Surgery 2000. 13(1):71-80.
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Access is possible 10 to 14 days after implantation1,2
The use of clamps post-dialysis should be restricted3
Rotating cannulation sites is recommended4
Buttonhole has been reported5
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Implanting Technique
1Matsuura J, et al. Ann Vasc Surg 2000;12:50-5. 2Matsuura J, et al. Cardiovasc Surg 2002. 10;6:561-65. 3www.fistulafirst.org. Clamp Usage Policy and Procedure. 4KDOQI Guidelines for AV Graft Cannulation, Guideline 3.3. 5Gallichio et al. Presented at VASA Meeting, May 2012.
Available Allografts & Sizes
Femoral Vein
Femoral Artery
Saphenous Vein
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Tissue Type Diameter Length Catalog #
Femoral Vein 6 mm – 15 mm 10 cm – 30+ cm V060
Saphenous Vein* 3 mm – 6 mm 20 cm – 80+ cm V010
CryoVein
Tissue Type Diameter Length Catalog #
Femoral Artery 4 mm – 5+ mm 10 cm – 30+ cm R020
CryoArtery
*Pressurized
Discussion 20 All trademarks are registered trademarks of CryoLife, Inc. © 2013 CryoLife, Inc. All rights reserved.
Image shown above is not intended to depict all possible access site locations.
Which sites do you typically choose?
Why?
How can CryoVein and CryoArtery fit into your treatment algorithm?
ML0671.000