• Journal of Chest Surgery
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• v.16 no.4
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• pp.602-614
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• 1983

Six hundred fourteen consecutive cases of bioprosthetic cardiac valve replacement performed during the period from March 1976 through December 1982 were reviewed. A total of 748 tissue valves [534 Ionescu-Shiley valves, 144 Hancock valves, 46 Angell-Shiley, and 24 Carpentier-Edwards] were implanted in 610 patients. Of these, 477 had single valve replacements [403 mitral, 60 aortic, and 14 tricuspid] including three REDO MVR and one REDO AVR. The remaining 129 had double valve replacements [95 AVR and MVR and 34 MVR and TVR] and 8 had triple valve replacement.592 cases were evaluated. Overall early mortality rate [within 30 days of operation] was 7.1% [6.2% in single valve replacement, 10.2% in double valve replacement, and 16.7% in triple valve replacement]. Leading causes of mortality were low cardiac output or myocardial failure and ventricular arrhythmias. The follow-up period was from one month to 7 years with a cumulative follow-up of 906.6 patient-years [mean 1.53 years]. The late mortality was 1.6%, 3.9%, 0%, 2.6%, 6.6% and 2.0% per patient-year for MVR, AVR, TVR or triple valve replacement, AVR+MVR, MVR+TVR and total, respectively. Actuarial analysis of late results including early mortalities indicates an expected survival rate of 87.6+1.8% at 3 years and 85.92.4% at 7 years for all cases. We also analyzed actuarial survival rate between groups of each valve replacement [AVR, TVR, Double valve, and Triple valve] and the tissue valve groups in MVR. We experienced 7 cases [0.77% per patient-year] of confirmed endocarditis, two of which were fatal. Valve failure-free rates calculated according to the confirmed cases were 97.5% at 4 years, 87.5% at 7 years, and 88.3% at 6 years for Ionescu-Shiley, Hancock and Angell-Shiley valves, respectively. The occurrence rate of thromboembolism was 2.0% per patient-year in total cases, although almost all the patients were given anticoagulant therapy for one year. The occurring rate in MVR was 1.5% and 2.7% per patient-year for Ionescu-Shiley and Hancock valve groups, respectively. The difference in actuarial rate free from thromboemboli between Ionescu-Shiley and Hancock groups was statistically significant [P value less than 0.001]. Thromboembolic events beyond the period of anticoagulation therapy mainly occurred in patients with atrial fibrillation. The actuarial thromboemboli free survival was 95.71.4% at 3 years and 80.17.3% at 7 years. The incidence of hemorrhagic complications was 1.2% per patient-year [fatality 0.55% per patient-year] for anticoagulated patients. Although our clinical data favorably compares with results from other reports, our results suggest that anticoagulant therapy be given on a short-term basis or not at all to hemodynamically stable patients. Long-term therapy with antiplatelet drugs is probably inevitable with patients who have thromboembolic risk factors [such as atrial fibrillation].

• Journal of Chest Surgery
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• v.41 no.6
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• pp.695-702
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• 2008

Background: The choice between a bioprosthetic and a mechanical valve is an important decision in cardiac valve surgery, and the durability of the tissue valve is a major decision factor. We retrospectively evaluated the midterm results of bioprosthetic valve replacement in the mitral position. Material and Method: The subjects were all patients who had undergone mitral bioprosthesis replacement between July 1989 and August 200.7. Among the 216 patients, there were 236 surgical cases. The mean age was $63{\pm}15$ years, and the male to female ratio was 1 : 3. We retrospectively analyzed hospital and outpatient records such that the total follow-up duration amounted to 760.2 patient-years, and the mean follow-up duration was $41.9{\pm}40.7$ months (range $0{\sim}212$ months). Result: Early death occurred in 18 patients (8.3%), and 13 of these underwent concomitant cardiac procedures. The survival rate after 5 years was $79.9{\pm}3.5%$, and the survival rate after 8 years was $65.5{\pm}5.5%$, while freedom from structural valve deterioration (SVD) was $96.2{\pm}2.2%$ at 5 years and $85.9{\pm}5.3%$ at 8 years. Freedom from reoperation was $90.6{\pm}1.7%$ at 5 years and $90.4{\pm}4.2%$ at 8 years, while freedom from reoperation for SVD was $98.1{\pm}1.2%$ at 5 years and $92.3{\pm}4.1%$ at 8 years. On multivariate analysis of preoperative risk factors, small valve size (between 25mm and 27mm) was a significant risk factor for reoperation, and low LV ejection fraction (<40%) was a significant risk factor for SVD and mortality. Conclusion: Survival and freedom from reoperation for SVD in mitral bioprosthesis replacement had acceptable midterm results, but freedom from SVD Was relatively low. In particular, since SVD increased sharply at the eighth postoperative year, frequent follow-up and echocardiograms around that time will be helpful for the early detection of SVD. It will be necessary to conduct further studies involving long-term follow-up and more patients.

• Journal of Chest Surgery
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• v.24 no.11
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• pp.1074-1080
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• 1991

A total and consecutive 62 patients between 13 and 58 years of age receiving biological prosthetic heart valves at the Korea University Hospital from January 1978 through October 1983 were analyzed. Out of 71 valves replaced, 64 were Carpentier-Edwards valves, 4 were Ionescu-Shiley valves, 2 were Angell-Shiley valves, 1 was Hancock valve. Early mortality within 30 days after operation was noted in 4 cases[6.4%]. There were no cases of valve-related early death. The 58 early survivors were followed-up for a total 387 patient-year over a period of 3 years to 12 years[Mean$\pm$S.D: 6.37$\pm$2.51 years] at the follow-up end of April 1991. During follow-up, seven patients died and late mortality rate was 12%. There were two major late complications: the one is thromboembolism[1.6% /patient-year], the other is primary tissue failure[2.76% /patient-year]. Ten patients underwent re-replacement of 13 tissue valves because of primary tissue failure[nine Carpentier-Edwards, two Ionescu-Shiley, two Angell-Shiley]. There was operative mortality. The probabilities of freedom from primary tissue failure were 95.4% and 75.3% at 5 and 10 years after operation respectively, The actuarial survival rates were 86.2% and 81.8% at 5 and 10 years after initial surgery respectively.

• Journal of Chest Surgery
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• v.16 no.2
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• pp.139-146
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• 1983

Between 1974 and 1982, 31 patients from 7 to 15 years of age have undergone valve replacement for their acuqired cardiac valvular diseases at Seoul National University Hospital. Furteen patients (45.2%) had a definite history of rheumatic fever and only 4 patients (12.9%) had atrial fibrillation on their preoperative electrocardiograms. Characteristically, the valvular lesions were ones of insufficiency with or without associated stenosis in all patients except only one whose mitral valve was tightly stenotic. Thrity-seven valves were replaced in 31 patietns including a case of successful replacement of his failed xenogragt mitral valve : 4 mechanical valves were used in 3 patients and 33 xenograft valves were used in the remaining 28 patients. The size of the valves were not the major problem at the time of opertion because most of the patients had a dilated heart from disease. There were 3 diaths within 30 days of surgery (9.7% operative mortality rate) and 3 late deaths (9.7% late mortality rate) with an overall mortality rate of 19.4%. Twenty-eight early survivors were followed up for a total of 488 patient-months. Thromboembolic complications occurred in 5 patients with 2 deaths: cmbolic rate of 17.9% or the actuarial embolic incidence of 12.29%/patients-year. four xenograft tissue valves in 4 patients had failed during the period from 19 to 41 months of surgery with an overall valve failure rate of xenograft of 14.3% or the actuarial incidence of 9.84% failure/patient-year. One of these 4 patients had required replacement of his failed mitral xenograft valve which had severe calcification and tissue disruption with primary tissue failure rate of 3.6% or the actuarial incidence of 3.13% failure/patient-year. The actuarial survial including the operative morality was 50.0% at 5 years of surgery. /the actuarial incidence free from thromboembolism in bioprosthetic group was 85.4% at 42 months, while it was 33.4% in mechanicial group at 60 months after operation. The actuarial incidence free from overall valve failur of 100.0% until 18 months after surgery was followed by a rapid decrease during the next 2-year period, and it was only 17.8% at the follow-up end of 42 months after surgery. It was suggested that the major advantage of low thrombogenecity with xenograft valve should be balanced against the high incidence of accelerated valve failure when it is used in children whose age is younger than 15 years old. The possible role of recurrent rheumatic attacks to the early failure of xenograft tissue valve was also discussed.

• Proceedings of the KOSOMBE Conference
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• v.1994 no.12
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• pp.161-164
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• 1994

• Biotechnology and Bioprocess Engineering:BBE
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• v.10 no.3
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• pp.218-224
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• 2005

Surface modification of glutaraldehyde fixed bovine pericardium (GFBP) was success­fully carried out with hyaluronic acid (HA) derivatives. At first, HA was chemically modified with adipic dihydrazide (ADH) to introduce hydrazide functional group into the carboxyl group of HA backbone. Then, GFBP was surface modified by grafting HA-ADH to the free aldehyde groups on the tissue and the subsequent HA-ADH hydrogel coating. HA-ADH hydrogels could be prepared through selective crosslinking at low pH between hydrazide groups of HA-ADH and crosslinkers containing succinimmidyl moieties with minimized protein denaturation. When HA­ADH hydrogels were prepared at low pH of 4.8 in the presence of erythropoietin (EPO) as a model protein, EPO release was continued up to $85\%$ of total amount of loaded EPO for 4 days. To the contrary, only $30\%$ of EPO was released from HA-ADH hydrogels prepared at pH=7.4, which might be due to the denaturation of EPO during the crosslinking reaction. Because the carboxyl groups on the glucuronic acid residues are recognition sites for HA degradation by hyaluronidase, the HA-ADH hydrogels degraded more slowly than HA hydrogels prepared by the crosslinking reaction of divinyl sulfone with hydroxyl groups of HA. Following a two-week subcutaneous implantation in osteopontin-null mice, clinically significant levels of calcification were observed for the positive controls without any surface modification. However, the calcification of surface modified GFBP with HA-ADH and HA-ADH hydrogels was drastically reduced by more than $85\%$ of the positive controls. The anti-calcification effect of HA surface modification was also confirmed by microscopic analysis of explanted tissue after staining with Alizarin Red S for calcium, which followed the trend as observed with calcium quantification.

• Journal of Chest Surgery
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• v.31 no.12
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• pp.1165-1171
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• 1998

Background: All currently available mechanical and bioprosthetic valves are associated with various types of deterioration leading to dysfunction and/or valvular complications. Reoperation on prosthetic heart valves is increasingly under consideration for both clinical and prophylactic indications. This review was conducted to determine the factors affecting the risk of reoperation for prosthetic valve replacement. Material and method: From January 1985 to July 1996, 124 patients underwent reoperation on prosthetic heart valves, and 3 patients had a second valve reoperation. The causes of reoperation were prosthetic valve failure(96 cases, 77.4%), prosthetic valve thrombosis(16 cases, 12.9%), prosthetic valve endocarditis(7 cases, 5.6%) and paravalvular leak(5 cases, 4.1%). This article is based on the analysis of the experience with particular emphasis on the preoperative risks affecting the outcome of the reoperation. Result: Overall hospital mortality rate was 8.9%(11/124). Low cardiac output was the most common cause of death(70.6%). Left ventricular systolic dimension(p=0.001), New York Heart Association functional class IV(p=0.003) and serum creatinine level(p=0.007) were the independent risk factors, but age, sex and cardiothoracic ratio did not have any influence on the operative mortality. Follow-up period was ranged from 3 to 141 months (mean, 50.6 months). A late mortality rate was 1.8%. Conclusion: The surgical risk of reoperation on heart valve prostheses in the advanced NYHA class patients is higher, therefore reoperation is recommended before the hemodynamic impairment become severe.

• Korean Circulation Journal
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• v.54 no.1
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• pp.43-56
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• 2024

Background and Objectives: The therapeutic strategy for inflammation and degenerative calcification is of utmost importance for bioprosthetic heart valve (BHV) implanted patients. The purpose of this study was to compare the anti-inflammatory and anti-calcification effects of Entelon150^® (grape seed extract), losartan, and rosuvastatin, in a rabbit model of intravascular BHV leaflet implantation in bovine pericardium. Methods: A total of 28 rabbits were implanted with BHV leaflet in the external jugular veins. The Entelon150^® group was administered 7.7 mg/kg Entelon150^® twice daily for 6 weeks after surgery. The losartan and rosuvastatin groups received 5.14 mg/kg and 1 mg/kg, respectively, once per day. The control group received 1 ml of saline once daily. And then, calcium concentration was measured in the implanted BHV, and histological and molecular analyses were performed on the surrounding tissues. Results: The calcium content of the implanted tissue in the Entelon150^® group (0.013±0.004 mg/g) was lower than that in the control group (0.066±0.039 mg/g) (p=0.008). The losartan (0.024±0.016 mg/g, p=0.032) and rosuvastatin (0.022±0.011 mg/g, p=0.032) groups had lower calcium content than the control group, and higher tendency than the Entelon150^® group. Immunohistochemistry revealed that the expressions of bone morphogenic protein 2 (BMP2), S-100, and angiotensin II type 1 receptor in the Entelon150^® group showed lower tendency than those in the control group. The protein expression levels of BMP2 were reduced in the Entelon150^® group compared with those in the control group. Conclusions: Entelon150^® exhibited a significant effect, similar to other drugs, in reducing calcification and inflammation in the intravascular bovine pericardium.

• Journal of Chest Surgery
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• v.22 no.6
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• pp.980-989
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• 1989

The Hancock porcine xenograft valves had been used in Seoul National University Hospital, mainly because of their antithrombogenicity despite of the predicted failure, from March 1976 to April 1984, and a total and consecutive 163 patients were retrospectively studied for late results with the special stress on the structural failure. The hospital mortality rate [within 30 days] was 6.1 %, and the 153 early survivors were followed up for a total of 822.9 patient-years [p-y][Mean * SD 5.38 * 3.02 years]. The linealized late mortality was 1.823%/p-y. Four major complications related to the Hancock valve were: 1.822% thromboembolism/p-y; 0.729 % bleeding/p-y; 0.972% endocarditis/p-y; 3.646% overall valve failure/p-y and 2.187 % primary tissue failure [PTF]/p-y. The actuarial survival rates at 5 and 10 years were 94.90 * 1.89% and 80.58 * 5.21 %; and the probabilities of freedom from thromboembolism at 5 and 10 years were 90.93 * 2.63% and 83.35 * 7.64 9o respectively. The probabilities from PTF at 5, 10 and 12 years were 98.02 * 1.39%, 60.62 * 8.89% and 49.60 * 12.34 %. One hundred-eighteen patients [72.4%] had single MVR [age, 34.0 * 10.9 years] with the operative mortality rate of 4.2%; and 113 early survivors were followed up for a total 616.4 patient-years[5.46 * 2.96 years]. The late mortality rate was 1.460 %/p-y. The major complications were: 1.622 % thromboembolism /p-y; 0.487% bleeding/p-y; 0.649 % endocarditis/p-y; 2.920% primary valve failure/p y and 1.785% PTF/p-y. The actuarial survival rates were 97.08 * 1.67%[at 5 years] and 81.27 * 6.64%[at 10 years], and the probabilities of freedom from thromboembolism 92.44 * 2.76 %[at 5 years] and 80.89 * 11.08%[at 10 years]. The probabilities of freedom from PTF at 5 and 10 years were 98 70 * 1.29% and 65.59 * 9.78% respectively. The mean age of 11 patients of PTF was 25.7 * 8.8 years and the valve extraction period 7.16 * 1.45 years. Failure of bioprosthetic xenograft valves are reportedly known to occur earlier in young patients in an accelerated fashion. The study with two groups divided into the cumulative younger and the cumulative older patients according to the age limits of 5-year interval strongly suggested these tendency. Although PTF began to occur past postoperative 5 years and the probabilities of freedom from PTF increased as the age limits raised and the number of patients increased in the cumulative younger patients while they decreased as the age limits lowered and the number of patients increased in the cumulative older patients, the definite age limits from which the Hancock valve can be safely recommended could not be obtained. From the results, the Hancock valves are contraindicated in patients younger than 20 to 25 years and may be safely recommended in patients older than 45 years as a tentative conclusion. Further longitudinal study may define these age factors.

• Journal of Chest Surgery
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• v.32 no.11
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• pp.1023-1030
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• 1999

This is a retrospective study of 42 pregnancies from 33 women with prosthetic heart valves who were on anticoagulation regimen prior to or during their pregnancy. Material and Method: Of the 17 women with bioprosthesis, 15 had 21 pregnancies following cessation of the anticoagulation therapy which resulted in the delivery of 20 healthy babies and 1 abortion. Remaining 2 had 3 pregnancies maintained with heparin, resulting in 2 healthy babies and 1 spontaneous abortion. Result: Among 16 women with mechanical heart valves, there were 7 pregnancies during which warfarin was used and this was associated with 4 fetal wastages(2 therapeutic abortion, 1 spontaneous abortion and 1 stillbirth with cerebral hemorrhage). However, in pregnancies where heparin was used, there was no fetal wastage. A patient who did not take anticoagulant for the first trimester and took warfarin for the remaining period and a patient who did not take anticoagulant during pregnancy delivered normal babies. There was an other fetal wastage in a patient on anti-platelet therapy for the first trimester and warfarin therapy for the remaining periods. There was 1 minor petechial complication in a heparin administered group. Conclusion: The study indicates that woman with bioprosthetic heart valves can go through pregnancy without undue risks or complications. On the other hand, the use of warfarin during pregnancy in women with mechanical heart valves, was shown to be associated with unacceptable high risk for the fetus. However, in the same group of women, judicious use of heparin during pregnancy was accompanied by a much reduced risk. The safety and adequate therapeutic range of heparin usage under such circumstances are subject to further studies.