• Journal of Chest Surgery
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• v.29 no.10
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• pp.1111-1117
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• 1996

Structural deterioration of the bioprosthetic xenograft valves due to primary tissue failure occurs in two modes: from fatigue lesions with tear and wear with or without calcification and from calcification with obstruction. Two groups of consecutive 56 patients with the Hancock porcine ortic valve(HM) and of 1 13 patients with the standard-profile onescu-Shiley bovine pericardial valve(ISM) explanted from mitral position at the time of re-replacement surgery for primary tissue failure at Seoul national University Hospital until 1994, were studied for clinical and pathological features. Their ages at primary implant were 31.9 $\pm$9.2 years In HM and 30.4$\pm$ 12.5 years in ISM. Hemodrnamic dysfunction of the failed mitral bloprostheses were predominantly insufficiency in HM(64.3%) and stenosis in ISM(51.3%)(p<0.001). Pathologic findings of the explanted mitral valves reflected these hemodynamic changes, revealing failure more often from tissue damage(tears and wears) in HM and more often from calcification in ISM(p< 0.001). Explant period(from primary implant to explant) was relatively short in ISM(8.7$\pm$2.6years), compared with the one in HM(10.4 $\pm$2.6 years)(p<0.001). In conclusion, both the Hancock and the lonescu-shiley valves would fail from calcification as well as issue damage. However, while the Hancock porcine valves in mitral position failed more frequently from tissue failure and insufficiency, the standard-profile lonescu-Shiley pericardial valves did from calcification and stenosis, especially in young pAtients . Although the possibility of less occurrence of valve failure from mechanical reasons may be expected with newer generation bloprostheses, it does not seem to Improve durability significantly unless further refinement in antimineralization is achieved. Therefore, clinical use of the glutaraldehyde-treated bioprosthetic valves is, at present, limited to the patients of advanced age groups.

• Journal of Chest Surgery
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• v.37 no.4
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• pp.328-334
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• 2004

There are only limited numbers of reports about long-term results of tricuspid valve replacement(TVR) with bioprosthetic and mechanical prostheses. We analyzed risk factors for tricuspid valve replacement and compared long-term clinical results of bioprosthetic and mechanical valves in tricuspid position. Material and Method: We reviewed 77 cases of TVR, which were performed between October 1978 and December 1996. Mean age was 38.8 15.9 years. Bioprostheses were implanted in 26 cases and mechanical prostheses were implanted in 51 cases. Result The operative mortality was 15.6% and late mortality was 12.3%. Survival for bioprosthetic and mechanical valve group at 5, 10 and 13 years was 81.3% vs. 100%, 66.1% vs. 100%, 60.6% vs. 100% (p=0.0175). Free from valve related re-operation for bioprosthetic and mechanical valve group at 5, 10 and 13 years was 100% vs. 93.9%, 100% vs. 93.9% and 58.3% vs. 93.9% (p=0.3274). Linealized incidences of valve related re-operation for bioprosthetic and mechanical valve group was 2.27 %/patient-years and 1.10 %/patient-years. Risk factor analysis showed that presence of preoperative ascites, hepatomegaly larger than 2 finger breaths, poor preoperative NYHA functional class and number of tricuspid valve replacement were risk factors for early mortality, and the use of bioprosthetic valve and number of open heart surgery were risk factors for late mortality. Conclusion: Long-term survival of mechanical valve was superior to bioprosthetic valve in tricuspid position. We recommend mechanical valve in tricuspid position if the patient can be closely followed up.

• Journal of Chest Surgery
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• v.37 no.4
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• pp.307-312
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• 2004

With the development of cardiac surgical technique, we need more prosthetic materials for repairing the intra- and extracardiac defects. Although bovine pericardial bioprosthesis treated with glutaraldehyde (GA) solution is one of the most popular materials, it has a drawback of later calcific degeneration. The purpose of this study is to investigate the effectiveness of several materials and methods in reducing the calcific degeneration of bovine pericardium. Material and Method: Forty square-shaped pieces of bovine pericardia were fixed in 0.625% GA solution with 4 g/L MgCl$_2$ㆍ6$H_2O$ as a control group (group 1). Other 40 pieces pre-treated with 1 % SDS(group 2) and 40 pieces post-treated with 8% glutamate (group 3) and 2% chitosan (group 4) were also fixed in the same GA solution. Other 40 pieces pre-treated with 1% SDS and post-treated with 8% glutamate and 40 pieces post-treated with 2% chitosan were also fixed in the same GA solution (group 5, 6). The pericardial pieces were implanted into the belly of 40 Fisher 344 rats subdermally and were extracted 1 month, 2 months, 3 months, and 6 months after the implantation. With an atomic absorption spectrophotometry, we measured the calcium amount deposited and examined the tissue with microscope. Result: The calcium deposition in 1 month was less in group 2, 5, 6 than that in group 1 (p＜0.05). It was most prominent in group 5 (p＜0.01). This finding continued in 2 month. In 3 month, the calcium deposition was less in group 3 and 4 as well as group 2, 5, and 6 than in group 1. In 6 month, the calcium deposition in group 2, 3, 4, 5, and 6 was less than that in group 1 and the difference was more than that of 1, 2, and 6 month. The microscopic calcium deposition was also less in group 2 and 5. Calcium deposition developed in the whole layer of pericardium, beginning with the surrounding the collagen fiber and progressing inwardly. Conclusion: Pre-treatment with SDS, post-treatment with glutamate or chitosan, and SDS pre-treatment and post-treatment with glutamate or chitosan were effective in reducing the calcium deposition in bovine pericardium. Moreover, the combined method of SDS pre-treatment and glutamate post-treatment was more effective than other methods.

• Journal of Chest Surgery
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• v.31 no.5
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• pp.451-455
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• 1998

Bovine pericardial bioprosthesis treated with glutaraldehyde is one of the most popular prosthetic materials, but late calcific degeneration must be solved. According to the alleged hypothesis of this calcification mechanism the free aldehyde groups on the surface of the tissue treated with glutaraldehyde bind to the circulating free calcium and induce mineralization. For mitigating the calcific degeneration, I added MgCl2 into the 0.625% glutaraldehyde solution to compete with calcium for binding to free aldehyde from the glutaraldehyde. I prepared 60 pieces of square shaped bovine pericardia and fixed in the 0.625% glutaraldehyde solution as control group(group 1), and the other 60 pieces in the same glutaraldehyde solution with 4g/L MgCl2 6H2O as the other group(group 2). After fixation for 1 month these were implanted into the bellies of 60 Sprague-Dawley rats subdermally and extracted on 1 month, 2 months, 3 months and 6 months later. With atomic absorption spectophotometry I measured the deposited calcium amount with the following results; 1 month and 2 months after implantation I could not find any differences between two groups, but in the 3rd month calcium was 1.738 mg/g in group 1 and 0.786 mg/g in group 2 and in the 6th month calcium had risen to 3.102 mg/g in group 1 and 1.623 mg/g in group 2, which has statistical significance(p<0.05). This means magnesium shows meaningful calcium mitigation effects on subcutaneously implanted bovine pericardium in the rat models.

• Journal of Chest Surgery
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• v.57 no.3
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• pp.242-251
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• 2024

Background: This study compared the outcomes of surgical aortic valve replacement (AVR) in patients aged 50 to 70 years based on the type of prosthetic valve used. Methods: We compared patients who underwent mechanical AVR to those who underwent bioprosthetic AVR at our institution between January 2000 and March 2019. Competing risk analysis and the inverse probability of treatment weighting (IPTW) method based on propensity score were employed for comparisons. Results: A total of 1,580 patients (984 patients with mechanical AVR; 596 patients with bioprosthetic AVR) were enrolled. There was no significant difference in early mortality between the mechanical AVR and bioprosthetic AVR groups (0.9% vs. 1.7%, p=0.177). After IPTW adjustment, the risk of all-cause mortality was significantly higher in the bioprosthetic AVR group than in the mechanical AVR group (hazard ratio [HR], 1.39; 95% confidence interval [CI], 1.07-1.80; p=0.014). Competing risk analysis revealed lower risks of stroke (sub-distributional hazard ratio [sHR], 0.44; 95% CI, 0.28-0.67; p<0.001) and anticoagulation-related bleeding (sHR, 0.35; 95% CI, 0.23-0.53; p<0.001) in the bioprosthetic AVR group. Conversely, the risk of aortic valve (AV) reintervention was higher in the bioprosthetic AVR group (sHR, 6.14; 95% CI, 3.17-11.93; p<0.001). Conclusion: Among patients aged 50 to 70 years who underwent surgical AVR, those receiving mechanical valves showed better survival than those with bioprosthetic valves. The mechanical AVR group exhibited a higher risk of stroke and anticoagulation-related bleeding, while the bioprosthetic AVR group showed a higher risk of AV reintervention.

• Journal of Chest Surgery
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• v.12 no.4
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• pp.383-394
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• 1979

Treatment of valvular heart disease with valve replacement has been one of the most popular procedures in cardiac surgery recently. Although, first effort was directed toward the prosthetic valve, it soon became popular that bioprosthesis, the valvular xenograft, was prefered in the majority cases. Valvular xenograft has some superiority to the artificial prosthetic valve in some points of thromboembolism and hemolytic anemia, and it also has some inferiority of durability, immunologic reaction and resistance to Infection. Tremendous efforts were made to cover the inferiority with several methods of collection, preservation, and valve mounting of the porcine valve or pericardium of the calf, and also with surgical technique of the valvular xenograft replacement. Auther has collected 320 porcine aortic valves immediately after slaughter, and aortic cusps were coapted with cotton balls in the Valsalva sinuses to protect valve deformity after immersion in the Hanks' solution, and oxidation, cross-linking and reduction procedures were completed after the proposal of Carpentier in 1972. Well preserved aortic valves were suture mounted in the hand-made tissue valve frame of 19, 21, and 23 mm J.d., and also in the prosthetic vascular segment of 19 mm Ld. with 4-0 nylon sutures after careful trimming of the aortic valves. Completed valves were evaluated with bacteriologic culture, pressure tolerance test with tolerane gauge, valve durability test in the saline glycerine mixed solution with tolerance test machine in the speed of 300 rpm, and again with pathologic changes to obtain following results: 1. Bacteriologic culture of the valve tissue in five different preservation method for two weeks revealed excellent and satisfactory result in view of sterilization including 0.65% glutaraldehyde preservation group for one week bacteriologic culture except one tissue with Citobacter freundii in 75% ethanol preserved group. 2. Pressure tolerance test was done with an apparatus composed of V-connected manometer and pressure applicator. Tolerable limit of pressure was recorded when central leaking jet of saline was observed. Average pressure tolerated in each group was 168 mmHg in glutaraldehyde, 128 mmHg in formaldehyde, 92 mmHg in Dakin's solution, 48 mmHg in ethylene oxide gas, and 26 mmHg in ethanol preserved group in relation to the control group of Ringer's 90 mmHg respectively. 3. Prolonged durability test was performed in the group of frame mounted xenograft tissue valve with 300 up-and-down motion tolerance test machine/min. There were no specific valve deformity or wearing in both 19, 21, and 23 mm valves at the end of 3 months (actually 15 months), and another 3 months durability test revealed minimal valve leakage during pressure tolerance test due to contraction deformity of the non-coronary cusp at the end of 6 months (actually 30 months) in the largest 23 mm group. 4. Histopathologic observation was focussed in three view points, endothelial cell lining, collagen and elastic fiber destructions in each preservation methods and long durable valvular tolerance test group. Endothel ial cell lining and collagen fiber were well preserved in the glutaraldehyde and formaldehyde treated group with minimal destruction of elastic fiber. In long durable tolerance test group revealed complete destruction of the endothelial cell lining with minimal destruction of the collagen and elastic fiber in 3 month and 6 month group in relation to the time and severity. In conclusion, porcine xenograft treated after the proposal of Carpentier in 1972 and preserved in the glutaraldehyde solution was the best method of collection, preservation and valve mounting. Pressure tolerance and valve motion tolerance test, also, revealed most satisfactory results in the glutaraldehyde preserved group.

• Journal of Chest Surgery
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• v.42 no.2
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• pp.157-164
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• 2009

Background: Various studies and experimental trials have been done to develop bioprosthetic devices to treat complex congenital heart disease due to the limited usage of homograft tissue. The purpose of the present study was to evaluate the effect of diamine bridges with using L-lysine, as compared with using ethanol. Material and Method: Porcine pericardium was fixed at 0.625% GA (commercial fixation). An interim step of ethanol (80%; 1 day at room temperature) or L-lysine (0.1 M; 2 days at $37^{\circ}C$) was followed by completion of the GA fixation (2 days at $4^{\circ}C$ and 7 days at room temperature). The tensile strength and thickness of the porcine percardium were measured, respectively. The treated pericardiums were implanted subcutaneously into three-week old Long-Evans rats for 8 weeks. The calcium content of the implants was assessed by atomic absorption spectroscopy and the histology. Result: Ethanol pretreatment ($13.6{\pm}10.0ug/mg$, p=0.008), L-lysine pretreatment ($15.3{\pm}1.0 ug/mg$, p=0.002), and both treatment ($16.1{\pm}11.1ug/mg$, p=0.012) significantly inhibited calcification, as compared with the controls $(51.2{\pm}8.5ug/mg)$. L-lysine pretreatment ($0.18{\pm}0.02mm,\;1.20{\pm}0.30kg$ f/5 mm) significantly increased the thickness and tensile strength, as compared with ethanol pretreatment ($0.13{\pm}0.03mm,\;0.85{\pm}0.36$ 1.0 kg f/5 mm) (p<0.01, p=0.035). Conclusion: The diamine bridges using L-lysine seemed to decrease the calcification of porcine pericardium fixed with glutaraldehyde, and this was comparable with Ethanol. Additionally, it seemed to enhance the thickness and tensile strength.

• Journal of Chest Surgery
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• v.42 no.2
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• pp.165-174
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• 2009

Background: With the advances of cardiac surgery, the demand for an artificial prosthesis has increased, and this has led to the development and utilization of diverse alternative materials. We conducted this research to improve an artificial prosthesis by examining the changes of the physical qualities, the pressure related tensile strength, the change in elasticity and the thermostability of a xenograft valve (porcine) and pericardium (bovine, porcine) based on the type of fixation liquid we used. Material and Method: The xenograft valves and pericardium were assigned into three groups: the untreated group, the fixed with glutaraldehyde (GA) group and the glutaraldehyde with GA+solvent such as ethanol etc. group. The surgeons carried out each group's physical activities. Each group's uniaxial tension and elasticity was measured and compared. Thermostability testing was conducted and compared between the bovine and porcine pericardium fixed with GA group and the GA+solvent group. Result: On the physical activity test in the surgeon's hand, no significant difference between the groups was sensed on palpation. For suture and tension, the GA+solvent group was slightly firmer than the low GA concentration group. In general, the circumferential uniaxial tension and elasticity of the porcine aortic and pulmonary valves were better in the fixed groups than that in the untreated group. There was no significant difference between the GA and GA+solvent groups (p>0.05). Bovine and porcine pericardium also showed no significant difference between the GA group and the GA+solvent group (p>0.05). When comparing between the groups for each experiment, the elasticity tended to be stronger in most of the higher GA concentration group (porcine pulmonary valve, porcine pericardium). On the thermostability testing of the bovine and porcine pericardium, the GA group and the G+solvent group both had a sudden shrinking point at $80^{\circ}C$ that showed no difference (bovine pericardium: p=0.057, porcine pericardium: p=0.227). Conclusion: When fixing xenograft prosthetic devices with GA, adding a solvent did not cause a loss in pressure-tension, tension-elasticity and thermostability. In addition, more functional solvents or cleansers should be developed for developing better xenografts.

• Journal of Chest Surgery
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• v.39 no.6 s.263
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• pp.427-433
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• 2006

Background: Current vascular prostheses are considered still inadequate for reconstruction of small-diameter vessels. To evaluate the potential use of xenograft vessels as small diameter arterial grafts, we implanted porcine vessels in goats. The grafts were treated with two different processes, freezing and acellularization, before implantation, and gross inspection as well as microscopic examination followed after a predetermined period. Material and Method: Bilateral porcine carotid arteries were harvested and immediately stored at $-70^{\circ}C$ within tissue preservation solution. One of them was designated as frozen xenograft vessel. The other one was put on acellularization process using NaCl-SDS solution and stored frozen until further use. Grafts were implanted in the place of carotid arteries of the same goat. The grafts have remained implanted for 1, 3, and 6 months in three animals, respectively. Periodic ultrasonographic examinations were performed during the observation period. After explantation, the grafts were analyzed grossly and histologically under light microscope. Result: All animals survived the experimental procedure without problems. Ultrasonographic examinations showed excellent patency of all the grafts during the observation period. Gross examination revealed nonthrombotic, patent lumens with smooth surfaces. Microscopic examinations of the explanted grafts showed cellular reconstruction at the 6-month stage in both grafts. Although more inflammatory responses were observed in the early phase of frozen xenografts, there was no evidence of significant rejection. Conclusion: These findings suggest that porcine xenograft vessels, regardless of pre-implantation processes of acelluarization or freezing, can be acceptably implanted in goats, although short duration of observation in a small number of animals may limit this study.

• Journal of Chest Surgery
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• v.35 no.2
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• pp.94-101
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• 2002

All kinds of tissue valves must be pretreated for the inactivation of immunologic properties and the strengthening of tissue before implantation. However, the tissue valves are gradually denatured with the calcification process and they eventually lose their functions. Recent reports have shown the existence of specific calcium binding non collagenous proteins in the calcified area of implanted biomaterials. This experiment was intended to confirm the effect of pretreatment with RGDS(Arg-Gly-Asp-Ser) tetrapeptide on the calcification of subcutaneously implanted bovine pericardium in rats. RGDS tetrapeptide has the same amino acid sequence of attachment site of specific calcium binding non collagenous proteins. Material and Method: All bovine pericardial pieces were fixed with 0.6% glutaraldehyde. The pretreatments were done using 5 different methods, groupI, with normal saline for 60 minutes, groupII, with 0.5% GRSD(Gly-Arg-Scr-Asp) tetrapeptide solution for 60 minutes, group III : with 0.5% RGDS(Arg-Gly-Asp-Ser) tctrapeptide for 30 minutes, group IV ; with 0.5% RGDS for 60 minutes, and group V : with 0.5% RGDS for 120 minutes. The pretreated bovine pericardial pieces were implanted subcutaneously at the abdominal sites of rats. 30 days after the implantation, the implanted bovine pericardial tissue were examined radiologically, biochemically, and histologically to measure the severity of calcification. Result: On the radiological examination, group I ; 68.42$\pm$3.06, group II , 64.25$\pm$5.58 showed significant difference with group III: 48.00$\pm$3.57, group IV; 43.67$\pm$2.31, and group V ; 2.58$\pm$2.47(p<0.05). There was no difference between group I and II(p=0.105). On the biochemical examination, the amount of calcium in group I was , 33.09$\pm$6.59 mg, in group II ; 28.12$\pm$5.50mg, in group III ; 25.42$\pm$7.67mg, in group Ⅵ ; 20.51$\pm$5.11mg, and in group V : 15.43$\pm$4.25mg.