Objective To choose the best procedure on preparation of acellularbovine pericardium (ABP) guided bone regeneration (GBR) material. Methods The BP was decellularized with 0.25% Trypsin+0.5% Triton X-100. The acellular bovine pericardiums (ABPs) were treated with phosphatebuffered saline(PBS) (group A), 95% glycerol (group B), EDAC (group C), and EDAC and 95% glycerol (group D) respectively. The treated ABPs were implanted subcutaneously in the back of SD rats respectively at random and no material was implanted as control. Seven rats were sacrificed at 2 weeks, twelve at 4 weeks, twelve at 8 weeks, seven at 16 weeks. Local reaction was studied grossly. The amount of antigen presenting cell (APC) and the percentage of ABP degeneration were reckoned by images analysis system. Results The ABPs were replaced by fibroblasts completely in group A at 8 weeks， in group C at 16 weeks, but only less than 50% till 16 weeks in groups B and D. In all groups, the depth of surrounding fibres attenuated timedependingly. The APC amount of the groups B and D was higher than that of the control group, and the ABP of the groups B and D degraded partly at 16 weeks. Conclusion The ABP treated with EDAC can be replaced by the surrounding tissues and has good biocompatibility.
Objective To compare the difference of effect while using homograft pericardium patch and Gore- tex patch in staged repair of tetralogy of Fallot（TOF） to enlarge the right ventricular outflow tract （RVOT）. Methods Twenty-eight patients with TOF who underwent the staged complete repair were divided into 2 groups according to the date of surgery. Gore-rex group, 13 cases, their RVOT were enlarged with Gore-tex patches. Cryopreserved homograft pericardium patch group, 15 cases, their RVOT were enlarged with cryopreserved homograft pericardium patches. Clinical results and follow-up results were compared. Results There were 1 operative death in Gore-tex patch group （7. 7%）, and 1 early postoperative death in cryopreserved homograft pericardium patch group （6. 7%）. Hemostasia time, the pericardial cavity drainage volume in cryopreserved homograft pericardium patch group were less than those in Gore-tex patch group （P〈0. 01）. All patients were followed-up for 0.8-4.5years. The residual obstruction rate at RVOT level in Gore-tex patch group was higher than that in cryopreserved homograft pericardium patch group by echocardiography （P〈0.01）. No calcification shadow was found on the chest X-ray. Conclusion Homograft pericardium is the tissue with high density and intensity, its elasticity and compliance are good. Using homograft pericardium patch may be helpful to decrease the residual obstruction of RVOT after operation. It can be adapted as a repairing material in heart surgery.
ObjectiveTo study the hemocompatibility of bioprosthetic heart valve materials respectively based on glutaraldehyde and non-glutaraldehyde treatment. MethodsFresh bovine pericardium was treated with glutaraldehyde or non-glutaraldehyde after adipose tissue was removed. To evaluate the hemocompatibility of the two bioprosthetic heart valve materials, hemolysis test, in vitro fibrinogen adsorption experiment, platelet adhesion experiment, thrombin-antithrombin complex (TAT) test, complement activation assay and ex vivo circulation experiment were performed. ResultsThe hemolysis test results demonstrated that both of the materials showed hemolytic rates lower than 5%. The results of TAT test and complement activation assay showed no statistical differences among the two materials and the blank control group. Compared to the bioprosthetic heart valve materials with glutaraldehyde-based treatment, the materials with non-glutaraldehyde-based treatment showed significantly decreased fibrinogen adsorption, platelet adhesion and thrombosis. ConclusionCompared to the bioprosthetic heart valve materials with glutaraldehyde-based treatment, the materials with non-glutaraldehyde-based treatment show better hemocompatibility.
ObjectiveTo assess clinical results of aortic cusps replacement with bovine pericardium for bicuspid aortic valve (BAV) and severe aortic regurgitation (AR). MethodsClinical data of 79 patients with BAV and severe AR who underwent aortic cusps replacement with bovine pericardium in Wuhan Asia Heart Hospital from June 2008 to December 2013 were retrospectively analyzed. There were 60 male and 19 female patients with their age of 38±14 years (ranged 12-78 years). All the patients were in NYHA class Ⅱ. There were 26 patients with ascending aorta and sinotubular expanding. ResultsNo early death or major complication was recorded. Intraoperative transesophageal echocardiography showed successful repair with normal coaptation of the aortic leaflets in all the patients. AR grade was less than mild in all the patients with peak aortic valve pressure gradients of 14.2±2.8 mm Hg. All the patients were discharged from the hospital within 15 postoperative days without any adverse symptom, and were followed up for 50±16 months (ranged 9-64 months). During follow-up, all the patients were in NYHA classⅠ. There were 57 patients without AR, 16 patients with mild AR, 5 patients with moderate AR and 1 patients with severe AR. The peak of aortic valve pressure gradient was 12.4±3.2 mm Hg. The average diameter of ascending aorta was 2.7 cm in the patients with ascending aorta and sinotubular expanding. The shape of sinotubular kept normal. The height of coaptation of aortic valve was 0.58 cm by echocadiography. None of the patients died or required reoperation. The structural valve degeneration was not observed during the follow-up. ConclusionThree aortic cusps replacement with bovine pericardium can produce good hemodynamics and midterm results for patients with BAV and severe AR. The ascending aorta and sinotubular should be reduced and fixed in the patients with ascending aorta and sinotubular expanding.
ObjectiveTo study the biocompatibility of bioprosthetic heart valve material with a non-glutaraldehyde-based treatment, and to provide the safety data for the clinical application. MethodsAll the tests were conducted according to GB/T16886 standards. The in vitro cytotoxicity was determined by methyl thiazolyl tetrazolium assay. Fifteen guinea pigs were divided into a test group (n=10) and a control group (n=5) in the skin sensitization test. Three New Zealand white rabbits were used in the intradermal reactivity test. Five sites on both sides of the rabbit back were set as test sites and control sites, respectively. In the acute systemic toxicity test, a total of 20 ICR mice were randomly assigned to 4 groups: a test group (polar medium), a control group (polar medium), a test group (non-polar medium) and a control group (non-polar medium), 5 in each group. Forty SD rats were divided into a test group (n=20) and a control group (n=20) in the subchronic systemic toxicity test. ResultsThe viability of the 100% extracts of the bioprosthetic heart valve material with a non-glutaraldehyde-based treatment was 75.2%. The rate of positive reaction was 0.0%. The total intradermal reactivity test score was 0. There was no statistical difference in the body weight between the test group and control group in the acute systemic toxicity test. There was no statistical difference in the body weight, organ weight, organ weight/body weight ratio, blood routine test or blood biochemistry between the test group and control group in the subchronic systemic toxicity test. ConclusionThe bioprosthetic heart valve material with a non-glutaraldehyde-based treatment has satisfying biocompatibility, which conforms to relevant national standards. The material might be a promising material for application in valve replacement.
Currently, as the key raw material of artificial biological heart valve, bovine pericardium is mainly depend on import and has become a “bottleneck” challenge, greatly limiting the development of domestic biological heart valve. Therefore, the localization of bovine pericardium is extremely urgent. In this study, the pericardium of Sichuan yak was compared with that of Australian cattle in terms of fundamental properties and anti-calcification performance. The results demonstrated that the appearance and thickness of yak pericardium were more advantageous than the Australian one. Sichuan yak pericardium and Australian cattle pericardium had comparable performance in shrinkage temperature, mechanical test and anti-calcification test. This study preliminarily verifies the feasibility of substitution of Australian cattle pericardium by Sichuan yak pericardium and promotes the progression of bovine pericardium localization with data support.
Objective To compare the effect of guiding boneregeneration between l-ethyl-3(3-diaminopropyol)-carbodiimide(EDAC)crosslinked acellular bovine pericardium (ABP) and medical collagen membrane (CM). Methods Defects of 7 mm×7 mm×5 mm were created in both mandibles of 24 rabbits, which weighted 2.6～3.5 kg. One side defect was covered with EDAC-crosslinked ABP(EDAC-crosslinked ABP group), the other side defect with medical CM as control(CM group). The ability of bone defect repair and change ofboth membrane materials were evaluated by gross observation, histological study and computer graphic analysis in the 4th, 8th, 16th and 24th weeks after operation. Results The surface of bone defects was even, consistent with adjacent normal bonein EDACcrosslinked ABP group, while that of bone defects was of no evenness in CM group in the 16th and the 24th weeks. The histological observation showed that bone trabecula formed in the EDAC-crosslinked ABP group and fibrous connective tissue was seen in CM group in the 16th and the 24th weeks. There were no significant differences in new bone percentage of bone defects between 2 groups inthe 4th and the 8th weeks(P＞0.05). In the 16th week new bone percentage of bone defects was 81.99%±3.92% in EDAC-crosslinked ABP group and 76.35%±4.29% in CM group, showing significant difference (Plt;0.05). The average percentage of absorption in EDAC-crosslinked ABP group was 16.57%, 27.94%, 65.61% and85.72% in the 4th, 8th, 16th and 24th weeks respectively, while that in CM group was more than 50% in the 4th week and completely degraded at the end of 8 weeks. Conclusion EDAC-crosslinked ABP has a better effect on guiding bone regeneration than CM in the repair of bone defects.
Objective To assess clinical results of three different conduit materials （Gore-Tex synthetic graft，bovinejugular vein and autologous pericardium）for palliative right ventricle-to-pulmonary artery （RV-PA） shunt，and explore the correlation between suitable conduit size and patients’ body weight and McGoon ratio. Methods We retrospectively analyzed clinical data of 24 patients with congenital heart diseases who underwent palliative RV-PA shunt in Department of Pediatric Cardiovascular Surgery of Fu Wai Cardiovascular Hospital from July 2010 to July 2012. There were 11 males and 13 females with their age ranging from 60 days to 6 years and body weight of 10.22±7.41 kg. There were 22 patients with pulmonary atresia and ventricular septal defect （PAVSD），1 patient with tetralogy of Fallot （TOF） and 1 patient with doubleoutlet right ventricle （DORV）. Among different conduit materials，autologous pericardium was used for 17 patients，Gore-Texsynthetic graft was used for 5 patients，and bovine jugular vein was used for 2 patients. Conduit size and children’s body weight were analyzed with linear regression，then the equation was corrected with McGoon ratio. Results There was no perioperative death. Postoperative percutaneous saturation （SpO2）of the 24 children was 20.37%±28.33% higher than preoperative SpO2 . Electrocardiogram showed sinus rhythm in all the patients. Twenty-three patients were NYHA classⅡ，and 1 patient was NYHA classⅢ. Postoperative mechanical ventilation time of patients with autologous pericardium were significantly shorter than those of patients with other 2 materials （P=0.017）. Sixteen patients were followed up from 10 months to 2 years after discharge，including 12 patients with autologous pericardium，3 patients with Gore-Tex synthetic graft and 1 patient with bovine jugular vein. During follow-up，McGoon ratio of patients with autologous pericardium，Gore-Tex synthetic graft and bovine jugular vein were 1.98±0.46，1.83±0.33 and 1.68 respectively，all of which weresignificantly higher than preoperative McGoon ratio （P＜0.05）. Six patients underwent radical corrective surgery，including5 patients with autologous pericardium and 1 patient with Gore-Tex synthetic graft. There was no complication directly related to surgery during follow-up. Linear regression was performed to form an equation between suitable conduit size and patients’ body weight：conduit diameter （mm）=0.327×body weight （kg）＋4.599. McGoon ratio，conduit size and equationresult were compared to find a practical choice of conduit size. If McGoon ratio＜0.8，the first integer greater than the equation result could be chosen. If McGoon ratio＞1.2，the first integer less than the equation result could be chosen. If 1.2＞McGoon ratio＞0.8，the first integer either less or greater than the equation result could be chosen. Group analysis showed that patients who recovered better postoperatively were those whose conduit sizes were closer to equation results as well as equation results corrected with McGoon ratio. Conclusion All the 3 materials can be conventionally chosen for RV-PA shunt. Appropriate conduit size can be decided upon patients’ body weight and McGoon ratio for RV-PA shunt.
ObjectiveTo investigate the effects of modification of acellular bovine pericardium with 1-ethyl-3-(3-dinethylami-nopropyl) carbodimide (EDC)/N-hydroxysuccininide (NHS) or genipin and find out the best crosslinking reagent. MethodsThe cellular components of the bovine pericardiums were removed. The effects of decellularization were tested by HE staining. The acellular bovine pericardiums were crosslinked with EDC/NHS (EDC/NHS group) or genipin (genipin group). The properties of the crosslinked acellular matrix were evaluated by scanning electron microscope (SEM), matrix thickness, crosslinking index, mechanical property, denaturation temperature, enzymatic degradation, and cytotoxicity test before and after the crosslinking. Acellular bovine pericardium (ABP group) or normal bovine pericardium (control group) were harvested as controls. ResultsSEM showed that collagen fibers were reticulated in bovine pericardial tissues after crosslinked by EDC/NHS or genipin, and relative aperture of the collagen fiber was from 10 to 20 μm. The thickness and denaturation temperature of the scaffolds were increased significantly after crosslinking with EDC/NHS or genipin (P<0.05), while there was no significant difference between EDC/NHS group and genipin group (P>0.05). The difference had no statistical significance in crosslinking index between EDC/NHS group and genipin group (t=0.205, P=0.218). The degradation rate in EDC/NHS group and genipin group was significantly lower than that in ABP group and control group (P<0.05). Elastic modulus and fracture stress in EDC/NHS group and genipin group were significantly lower than those in ABP group (P<0.05), but there was no significant difference among EDC/NHS group, genipin group, and control group (P>0.05). The break elongation in EDC/NHS group and genipin group were significantly increased than those in ABP group and control group (P<0.05). The difference had no statistical significance in stability and mechanical properties between EDC/NHS group and genipin group (P>0.05). Cytotoxicity of genipin crosslinked tissue (grade 1) were much lower than that of EDC/NHS (grade 2) at 5 days. ConclusionAcellular bovine pericardium crosslinked with genipin has better biocompatibility than EDC/NHS.
Abstract： Objective To evaluate clinical outcomes of tricuspid annuloplasty using a C-type ring made of autologous pericardium for the treatment of functional tricuspid regurgitation （TR）. Methods Eleven patients underwent tricuspid annuloplasty in Guizhou Provincial People’s Hospital between March 2009 and January 2011， including 5 male patients and 6 female patients with their age of 32-57 （43.80±12.20） years. There were 3 patients with mild TR， 7 patients with moderate TR， and 1 patient with severe TR. Concomitant procedures included mitral valve replacement and/or aortic valve replacement and/or left atrial thrombectomy. The C-type ring was created using a strip of pericardium after 0.8% glutaraldehyde fixation for 15 minutes. Interrupted horizontal mattress suture was used to secure the C-type ring to the tricuspid annulus. Hear function and echocardiography were examined during follow-up. Results There was no in-hospital death， and the hospital stay was 15-28 （21.10±3.80） days. All the patients were followed up for 8-28 （18.50±7.00）months. There was no death or reoperation because of TR or tricuspid stenosis during follow-up. Ten patients had TR during follow-up， including 9 patients with mild TR and 1 patient with mild to moderate TR， but there was no patient with severe TR. The degree of TR during follow-up was significantly reduced than preoperative degree （Z =-2.81，P＜0.05）. Preoperative and postoperative right ventricular dimension （19.95±5.11 mm vs. 21.57±12.81 mm，P=0.705） and right atrial dimension（37.55±6.79 mm vs. 35.55±5.22 mm，P=0.317）were not statistically different. Conclusion Tricuspid annuloplasty using a C-type ring made of autologous pericardium has satisfactory clinical outcomes for patients with functional TR.