Development of an ovine collagen-based composite biosynthetic vascular prosthesis

doi:10.1016/0267-6605(92)90102-Y

Clinical Materials

Volume 9, Issues 3–4, 1992, Pages 211-223

Clinical Materials

https://doi.org/10.1016/0267-6605(92)90102-Y Get rights and content

Abstract

The search for an ideal vascular prosthesis to bypass peripheral vascular obstructive lesions is necessary where autologous tissues are either unavailable or unsuitable.

This paper will outline the development and use of vascular conduits, principally of biological origin. The clinical benefits and limitations of these materials are discussed. The development of a composite biosynthetic prosthesis (Omniflow™) is described, together with the testing methods used to determine and predict its suitability for use as an arterial substitute.

The ovine biosynthetic prosthesis has significantly improved surface and mural properties over previous attempts at producing prostheses for vascular reconstruction. Immunohistological studies on samples recovered from dogs after 4 years show that the original ovine collagen is still present after 4 years, and it is further augmented by the deposition of new, host-derived connective tissue.

References (56)

J.E. Hasson et al.
Mural degeneration in glutaraldehyde-tanned umbilical vein graft: Incidence and implications
J. Vase. Surg.
(1986)
H. Dardik et al.
A decade of experience with the glutaraldehydetanned human umbilical cord vein graft for revascularization of the lower limb
J. Vase. Surg.
(1988)
W.S. Karkow et al.
Extended study of aneurysm formation in HUV grafts
J. Vase. Surg.
(1986)
P.N. Sawyer et al.
Ten year experience with the negatively charged glutaraldehyde-tanned vascular graft in peripheral vascular surgery. Initial multicenter trial
Am. J. Surg.
(1987)
S.R. Gundry et al.
A quantitative and qualitative comparison of fibrin glue, albumin and blood as agents to pretreat porous vascular grafts
J. Surg. Res.
(1987)
R.A. Jonas et al.
Biological sealants and knitted Dacron: Porosity and histological comparisons of vascular graft materials with and without collagen and fibrin glue pretreatments
Ann. Thorac. Surg.
(1986)
T.F. O'Donnell et al.
Correlation of operative findings with angiographic and noninvasive hemodynamic factors associated with failure of polytetrafluoroethylene grafts
J. Vase. Surg.
(1984)
C.H. Sparks
Autogenous grafts made to order
Ann. Thor. Surg.
(1969)
R.W. Hallin et al.
The Sparks' mandril graft. A seven year follow-up of mandril grafts placed by Charles H. Sparks and his associates
Am. J. Surg.
(1976)
B. Christie et al.
J. Surg. Res.
(1980)

G. Hamilton et al.

Prediction of aneurysm formation in vascular grafts of biological origin

J. Vase. Surg.

(1988)

A. Carrel et al.

Uniterminal and biterminal venous transplantations

Surg. Gynecol. Obstet.

(1906)

A. Carrel

Results of transplantation of blood vessels, organs and limbs

J.A.M.A.

(1908)

W.A. Dale

The beginnings of vascular surgery

Surgery

(1974)

J. Kunlin

Le traitement de I'arterite obliterante par la greffe veineuse

Arch. Mal. Coeur.

(1949)

R.P. Leather et al.

The saphenous vein as a graft and as an in situ arterial bypass

D.E. Szilagyi et al.

Autogenous vein grafting in femoropopliteal atherosclerosis : The limits of its effectiveness

Surgery

(1979)

L.K. LiCalzi et al.

Failure of autogenous reversed saphenous vein femoropopliteal grafting: Pathophysiology and prevention

Surgery

(1982)

R.E. Gross et al.

Methods for preservation and transplantation of arterial grafts Observations on arterial grafts in dogs. Report of transplantation of preserved arterial grafts in nine human cases

Surg. Gynecol. Obstet.

(1949)

D.E. Szilagyi et al.

Biological fate of human arterial homografts

Arch. Surg.

(1957)

J.L. Oschner et al.

Experience with fresh venous allografts as an arterial substitute

Ann. Surg.

(1971)

L.J. Perloff

Vascular allografts

H. Dardik et al.

Clinical experience with modified human umbilical cord vein for arterial bypass

Surgery

(1976)

H. Dardik et al.

Morphologic and biophysical assessment of long term human umbilical cord vein implants used as vascular conduits

Surg. Gynecol. Obstet.

(1982)

N. Rosenberg et al.

The use of segmental arterial implants prepared by enzymatic modification of heterologous blood vessels

Surg. Forum

(1956)

N. Rosenberg et al.

Tanned collagen arterial prosthesis of bovine carotid origin in man

Ann. Surg.

(1966)

K. Reddy et al.

A clinical experience with the NCGT graft

J. Biomed. Mater. Res.

(1981)

C. Hermansen et al.

Influence of porosity on the viability of the neointima

Eur. Surg. Res.

(1980)

Cited by (19)

Contemporary results with the biosynthetic glutaraldehyde denatured ovine collagen graft (Omniflow II) in femoropopliteal position
2020, Journal of Vascular Surgery
Citation Excerpt :
Therefore, besides the currently available synthetic grafts, biologic material may be considered for bypass graft in case of absent autologous vein. The OCP was introduced for clinical use in peripheral bypass almost three decades ago, but there is still a lack of information about its long-term clinical outcome.9-12 Good incorporation of the denatured OCP conduit into the host tissue by deposition of type III and type IV collagen was described.17
The objective of this study was to analyze the outcome of a contemporary series of femoropopliteal bypass operations with the glutaraldehyde denatured polyester mesh-reinforced ovine collagen prosthesis (OCP; Omniflow II [LeMaitre Vascular, Inc, Burlington, Mass]). The experience of two tertiary centers regarding long-term graft function, secondary reinterventions, and biodegeneration of the OCP prosthesis is presented.
Between January 2006 and January 2014, a series of 205 consecutive operations with the OCP in the femoropopliteal position (54 above knee and 151 below knee) were performed in 194 patients in 202 limbs for disabling claudication (72), chronic critical ischemia (105), acute ischemia (18), popliteal artery aneurysm (4), degeneration of a venous or prosthetic graft (5), and infection of a synthetic bypass graft (1). Grafts were observed with duplex ultrasound scan supplemented by additional angiography in case of recurrent ischemia with prospective documentation of follow-up data in a computerized vascular database. Retrospective analysis of graft patency, limb salvage, and diagnosis of aneurysmal graft degeneration was performed.
The 30-day mortality was 3.9%. Early thrombotic bypass occlusion occurred in 8.2% of cases. Four early graft infections could be successfully managed by local treatment with graft preservation. After a mean (median) follow-up of 56 (55) months (range, 1-135 months), primary patency, primary assisted patency, secondary patency, and limb salvage were 71%, 78%, 78%, and 91% for above-knee bypass and 40%, 50%, 63%, and 87% for below-knee bypass at 5 years. Biodegeneration in the form of graft aneurysm or graft stenosis was detected in 26 grafts (12.6%), resulting in secondary open or endovascular procedures in 16 cases.
The OCP provides satisfactory medium- and long-term patency and limb salvage in the femoropopliteal position. Aneurysmal degeneration or graft stenosis may develop over time, demanding lifelong duplex ultrasound surveillance and secondary intervention if needed. Its possible infection-resistant behavior in a contaminated field combined with an acceptable graft patency and limb salvage justifies the use of this graft in the absence of autologous vein.
Elastomers in vascular tissue engineering
2016, Current Opinion in Biotechnology
Citation Excerpt :
Collagen-based cardiac patches derived from bovine pericardium (CardioCel) [35] have allowed for the delivery of mesenchymal stem cells (MSC) in human patients for cardiac repair [36]. The omniflow vascular prosthesis (OVP), created by preimplanting a silicone rod within sheep before removing and stabilizing the deposited collagen has been used as a graft for femoral artery repair and peripheral bypass with around 20,000 implants since 1990 [37]. These outperform ePTFE materials by resisting neointimal hyperplasia, however only limited endothelialization is observed in clinical explants [38].
Elastomers are popular in vascular engineering applications, as they offer the ability to design implants that match the compliance of native tissue. By mimicking the natural tissue environment, elastic materials are able to integrate within the body to promote repair and avoid the adverse physiological responses seen in rigid alternatives that often disrupt tissue function. The design of elastomers has continued to evolve, moving from a focus on long term implants to temporary resorbable implants that support tissue regeneration. This has been achieved through designing chemistries and processing methodologies that control material behavior and bioactivity, while maintaining biocompatibility in vivo. Here we review the latest developments in synthetic and natural elastomers and their application in cardiovascular treatments.
Tissue-Engineered Vascular Grafts: Autologous Off-the-Shelf Vascular Access?
2012, Seminars in Nephrology
Citation Excerpt :
A technique to avoid the incubation period, xenogenic tissue could be used, and a xenogenic bioreactor-grown TEVG currently is available outside of the United States. Glutaraldehyde-tanned ovine collagen tubes grown around polyester (Dacron) mesh templates in sheep (Omniflow II; Bio Nova, North Melbourne, Australia) currently have been approved for use in dialysis access in Australia, Germany, and Canada, and are undergoing clinical trials in Europe.35,36 The first version of this product, Omniflow I, had a low patency rate of only 30% at 4 years with occlusive complications, so changes were made to the culture technique and mesh composition.
Dialysis grafts have provided reliable access for millions of patients in need of renal replacement therapy. However, regardless of the material used for artificial dialysis grafts their mean patency remains generally poor and infection rates are greater than native arteriovenous fistulas. The need for superior alternatives to conventional synthetic materials used for vascular access has been an area of investigation for more than 25 years and recently there has been a great deal of progress in the field of tissue-engineered vascular grafts. Many of these technologies are either commercially available or are now entering early phases of clinical trials. This review briefly covers the history, potential advantages, and disadvantages of these technologies, which are likely to create an impact in the field of vascular access surgery.
Animal models for the assessment of novel vascular conduits
2010, Journal of Vascular Surgery
Citation Excerpt :
Assessment of the structural durability of tissue-engineered vessels is complicated by fibroblast migration and collagen deposition at the external surface of the vessel, potentially masking graft wall remodeling and weakening that would otherwise lead to aneurysm or rupture. This encapsulation is a feature of ruminants and is also seen in swine, but is more uncommon in primate models.3,123 Implantation of acellular conduit scaffolds for subsequent population through invasion of host tissues represents a promising approach for the development of an off-the-shelf commercial product able to achieve the ideal tissue-engineered autologous arterial graft.177
The development of an ideal small-diameter conduit for use in vascular bypass surgery has yet to be achieved. The ongoing innovation in biomaterial design generates novel conduits that require preclinical assessment in vivo, and a number of animal models have been used for this purpose. This article examines the rationale behind animal models used in the assessment of small-diameter vascular conduits encompassing the commonly used species: baboons, sheep, pigs, dogs, rabbits, and rodents. Studies on the comparative hematology for these species relative to humans are summarized, and the hydrodynamic values for common implant locations are also compared. The large- and small-animal models are then explored, highlighting the characteristics of each that determine their relative utility in the assessment of vascular conduits. Where possible, the performance of expanded polytetrafluoroethylene is given in each animal and in each location to allow direct comparisons between species. New challenges in animal modeling are outlined for the assessment of tissue-engineered graft designs. Finally, recommendations are given for the selection of animal models for the assessment of future vascular conduits.
Structural analysis of a collagen-polyester composite vascular prosthesis
1993, Clinical Materials
The Omniflow Vascular Prosthesis is a collagen-polyester composite which has been used successfully for peripheral vascular replacement. In this study, we have examined the distribution of the various connective tissue components and the ultrastructural organisation of these in order to understand and allow improvement of its functional properties. Using immunohistology with specific monoclonal antibodies, types I and III collagens were found to be the major components throughout the prosthesis. Type VI collagen was also present but was mainly associated with cells, particularly around the polyester mesh and silicone interfaces. While elastin was absent, two elastic tissue microfibrillar proteins were present uniformly throughout the structure. Ultrastructurally, clear differences existed between the local environments of the inner surface, which had formed around the silicone mandrel, the polyester mesh within the prosthesis, and the outer collagenous tissue which formed the central wall. At the inner surface, the amount of collagen was less and the orientation of these fibres was not well defined. The collagen fibrils in the polyester region were smaller than those of the main wall, which were well ordered and orientated along the axis of the device.
Ovine Biosynthetic Grafts for Aortoiliac Reconstructions in Nonsterile Operative Fields
2022, Thoracic and Cardiovascular Surgeon

View all citing articles on Scopus

View full text

Development of an ovine collagen-based composite biosynthetic vascular prosthesis

Abstract

J. Vase. Surg.

J. Vase. Surg.

J. Vase. Surg.

Am. J. Surg.

J. Surg. Res.

Ann. Thorac. Surg.

J. Vase. Surg.

Ann. Thor. Surg.

Am. J. Surg.

J. Surg. Res.

J. Vase. Surg.

Uniterminal and biterminal venous transplantations

Surg. Gynecol. Obstet.

Results of transplantation of blood vessels, organs and limbs

J.A.M.A.

The beginnings of vascular surgery

Surgery

Le traitement de I'arterite obliterante par la greffe veineuse

Arch. Mal. Coeur.

The saphenous vein as a graft and as an in situ arterial bypass

Autogenous vein grafting in femoropopliteal atherosclerosis : The limits of its effectiveness

Surgery

Failure of autogenous reversed saphenous vein femoropopliteal grafting: Pathophysiology and prevention

Surgery

Methods for preservation and transplantation of arterial grafts Observations on arterial grafts in dogs. Report of transplantation of preserved arterial grafts in nine human cases

Surg. Gynecol. Obstet.

Biological fate of human arterial homografts

Arch. Surg.

Experience with fresh venous allografts as an arterial substitute

Ann. Surg.

Vascular allografts

Clinical experience with modified human umbilical cord vein for arterial bypass

Surgery

Morphologic and biophysical assessment of long term human umbilical cord vein implants used as vascular conduits

Surg. Gynecol. Obstet.

The use of segmental arterial implants prepared by enzymatic modification of heterologous blood vessels

Surg. Forum

Tanned collagen arterial prosthesis of bovine carotid origin in man

Ann. Surg.

A clinical experience with the NCGT graft

J. Biomed. Mater. Res.

Influence of porosity on the viability of the neointima

Eur. Surg. Res.