Article: A comparative study of bovine and porcine pericardium to highlight their potential advantages to manufacture percutaneous cardiovascular implants.Robert Gauvin, Georgi Marinov, Yayhe Mehri, Julianne Klein, Bin Li, Danielle Larouche, Randolph Guzman, Ze Zhang, Lucie Germain, Robert Guidoin[show abstract] [hide abstract]
ABSTRACT: Rationale: Prosthetic heart valves designed to be implanted percutaneously must be loaded within delivery catheters whose diameter can be as low as 18 F (6 mm). This mandatory crimping of the devices may result in deleterious damages to the tissues used for valve manufacturing. As bovine and porcine pericardial tissue are currently given preference because of their excellent availability and traceability, a preliminary comparative study was undertaken to highlight their potential advantages.Materials and methods: Bovine and pericardium patches were compared morphologically (light microscopy, scanning electron microscopy and transmission electron microscopy). The acute thrombogenicity of both materials was measured in term of platelet uptake and observed by scanning electron microscopy, porcine intact and injured arteries being used as controls. The pericardium specimens were also subjected to uniaxial tensile tests to compare their respective mechanical characteristics.Results: Both pericardiums showed a layered architecture of collagen bundles presenting some interstitial cells. They displayed wavy crimps typical of an unloaded collagenous tissue. The collagen bundles were not bound together and the fibrils were parallel with characteristic periodicity patterns of cross striations. The mesothelial cells found in vivo on the serous surface were no longer present due to tissue processing, but the adjacent structure was far more compacted when compared to the fibrous side. The fibrinocollagenous surfaces were found to be more thrombogenic for both bovine and porcine tissues and the serous side of the porcine pericardium retained more platelets when compared to the bovine samples, making the acute thrombogenicity more important in the porcine pericardium.Conclusion: Both bovine and porcine pericardium used in cardiovascular implantology can be selected to manufacture percutaneous heart valves. The selection of one pericardium preferably to the other should deserve additional testing regarding the innocuousness of crimping when loaded in delivery catheters and the long-term durability after percutaneous deployment.Journal of Biomaterials Applications 11/2012; · 2.08 Impact Factor
Article: Cuspal dehiscence at a post and along the stent cloth in a bovine pericardium heart valve implanted for seven years.Robert Guidoin, Taniela Marli Bes, Tomas Francisco Cianciulli, Julianne Klein, Bin Li, Robert Gauvin, Randolph Guzman, Olivier Rochette-Drouin, Lucie Germain, Ze Zhang[show abstract] [hide abstract]
ABSTRACT: A failing mitral valve prosthesis made from bovine pericardium was explanted from a 50-year-old patient. Preoperative transthoracic-echocardiography had confirmed severe mitral regurgitation due to structural failure of this HP Bio bovine pericardium heart valve prosthesis. The explanted device was examined macroscopically, by scanning electron microscopy (SEM), by light microscopy, and by transmission electron microscopy (TEM). Samples of unassembled patches of bovine pericardium were used as a pre-implantation control to better understand the changes that occurred in the structure of the pericardium following the 7 years of implantation. Examination confirmed complete dehiscence of a cusp along a valve post and the stent: This detached cusp was observed floating in the bloodstream at echocardiography. The fibrous pannus overgrowth was well developed along the stent and extended to the bottom of the cusps both on the inflow and the outflow sides. The fibrous panni were found to be poorly adhesive to the pericardium cusps and had become stiff, thus impairing the opening and closure of the valve. The structure of the pericardium cusps was severely deteriorated compared to the control bovine pericardium tissue samples. The collagen bundles were frequently broken and more stretched in the explanted device, lacking the wavy histological pattern of normal collagen fibers. However, the tissues were devoid of any calcification. In conclusion, the failure mode of this valve was the dehiscence of a cusp from a valve post and along the stent cloth in the absence calcification.Journal of Long-Term Effects of Medical Implants 01/2012; 22(2):95-111.
Article: Can marine mammals be a reliable source for the manufacture of prosthetic heart valves for percutaneous surgery?Robert Guidoin, Robert R Reed, Antoine Lagaude, Taniela Marli Bes, Bin Li, Julianne Klein, Robert Gauvin, Randolph Guzman, Lucie Germain, Ze Zhang[show abstract] [hide abstract]
ABSTRACT: Marine mammals experience unique physiological conditions when diving. Myocardial function is sustained despite a 90% reduction of the blood flow in the coronaries. Therefore, their heart valves and pericardium could serve as a unique source of tissue for the manufacture of prosthetic heart valves. The pericardium of a stillborn pup sea lion was investigated to determine its morphology using gross observation, scanning electron microscopy (SEM), light microscopy, and transmission electron microscopy (TEM). Depending upon the site of sampling, the structure of the pericardium varied significantly. The atrial sample was well structured with wavy bundles of collagen fibers. The thickness in the atrial sample was regular with a smooth serous surface. The fibrous side of the pericardium of the auricular sample was irregular and incorporated microcapillaries. Both the sternoperitoneal ligament and the phrenoperitoneal ligament section were irregular and incorporated various amounts of adipocytes. Because of the increased amount of adipocytes, the fibrils of the collagen fibers were also observed to be occasionally agglutinated. Practically, the harvesting of pericardium would have to be restricted to the atrial surface. The presence of adipocytes in the pericardium wall makes the selection of this tissue a poor choice compared to alternative existing tissue sources.Journal of Long-Term Effects of Medical Implants 01/2012; 22(2):113-26.
Article: Detailed analysis of a series of explanted Talent AAA stent-grafts: biofunctionality assessment.Mark Nutley, Robert Guidoin, Tieying Yin, Yvan Douville, Ze Zhang, Georgi R Marinov, Dangheng Wei, Jing Lin, Benedikt Weber, Lu Wang, Bin Li, Gregory Samisb, Yahye Merhi, Robert McGregor, Guy Dionne, Nathalie Gilbert[show abstract] [hide abstract]
ABSTRACT: Six Talent stent-grafts were harvested at reoperations (N=5) and autopsy (N=1). The explants were observed nondestructively, including gross morphology, X-rays, CT scans and closed pressure system analysis. The Nitinol frames in three devices harvested at reoperations and another harvested at autopsy were intact. One had a stent fracture of the proximal bare stent, and one had a wire fracture of a thin proximal external supporting stent as well as a hole in the fabric just above the bifurcation. For the three devices structurally intact, reoperations were performed for a type 1A endoleak (one patient) and aorto-enteric fistulas (two patients). The healing characteristics were poor or absent. The fabric in the main body of the grafts harvested after aorto-enteric fistula was devoid of biological deposits. Two of the grafts harvested at reoperation demonstrated fabric holes of up to 4 mm 2. The device obtained at autopsy showed an almost continuous internal capsule with variable thickness. The luminal surface was smooth, but the capsule detached easily. The devices explanted at reoperations showed various levels of impaired biofunctionality associated with adverse outcomes. The stent-graft retrieved from autopsy was intact.Journal of Long-Term Effects of Medical Implants 01/2011; 21(4):299-319.
Article: Intra-operative fenestration of stent grafts: a note of caution based upon preliminary in vitro observations.[show abstract] [hide abstract]
ABSTRACT: Intra-operative fenestrations of stent grafts make more frail and elderly patients amenable to endovascular surgery but require further assessment of the viability of currently used experimental techniques. Four types of polyester fabrics currently employed in stent grafts were exposed in vitro to various protocols of fenestration: cutting, trocaring, and cantering. The resulting fenestrations were examined by gross observation, light microscopy, and scanning electron microscopy. Blunt fenestration by scissors and sharp penetration led to unpredictable apertures, impairment of the integrity of the grafts, and damage to the filaments. The fenestrations were more likely to extend in the woven fabrics, whereas the knitted fabrics were more resistant to fraying. The use of the electric cautery demonstrated the ability to create a fenestration by simultaneously perforating/cutting and edge sealing. Any safe fenestration requires a perforating method that ensures the sealing of the edge of the graft material with a well-controlled diameter. A preoperative fenestration can be tolerated, but there are risks of damage to the stent grafts when reloading the device. More elegant methods of preoperative fenestration, particularly in situ retrograde laser fenestration, are in development and deserve clinical validation.Journal of Long-Term Effects of Medical Implants 01/2011; 21(3):251-60.