• Journal of Chest Surgery
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• v.19 no.1
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• pp.92-100
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• 1986

Results of reoperation for tissue valve failure were presented with review of current knowledge. Through January 1986, 19 patients required reoperation: 18 had undergone mitral, 2 aortic, and 1 tricuspid valve. Primary tissue failure was the main cause of tissue valve failure: it occurred in 18 valves [15 mitral, 2 aortic, and 1 tricuspid] at a mean postoperative interval of 54-25 months [range 29-120]. During the same period, 2 patients required reoperation for prosthetic valve endocarditis, 1 for paravalvular leakage. The types of valves failed were 12 lonescu-Shiley valves, 5 Hancock valves, and 1 Carpentier-Edwards valve. All 6 patients younger than 15 years of age at first operation had been implanted with lonescu-Shiley valves and failed after a mean interval of 35 months. In contrast, 11 patients older than 15 years had been implanted with 5 Hancock, 6 lonescu-Shiley, and 1 Carpentier-Edwards valve initially, and eventually failed after mean intervals of 81, 53, 47 months each other. The kinds of valves used at reoperation were 8 lonescu-Shiley, 4 Bjork-Shiley, and 6 St. Jude Medical valves for primary tissue failure cases and 3 lonescu-Shiley valves for the other 3 cases. Overall mortality at reoperation was 10%: 5.6% for primary tissue failure, 50% for prosthetic valve endocarditis. In 15 cases [all mitral] primary tissue failure were caused by calcification associated with or without leaflet destruction or fibrous ingrowth, and in 2 cases [all aortic] caused by cusp perforation and tearing without any evidence of calcification. In conclusion: 1 primary tissue failure is the main cause of reoperation in patients with tissue valve failure; 2. the majority of the failed valves is in mitral position; 3. leaflet calcification is the leading pathology of primary tissue failure; 4, reoperation for tissue valve failure may be a major concern, although the mortality is low; 5. the limited durability of tissue valve suggests its use be restricted to selected cases.

• Journal of Chest Surgery
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• v.22 no.2
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• pp.246-255
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• 1989

A total and consecutive 291 patients of isolated single mitral valve replacement using the Ionescu-Shiley bovine pericardial xenograft valve operated on between October 1978 and June 1983 were retrospectively studied for the durability of the substitute valves based on the structural degeneration of primary tissue failure which had been proved on their re-replacement surgery. The mean age at the initial surgery was 32.4*12.5 years, and the operative mortality rate was 5.2 %. The early survivors of 276 patients were followed up for a total 1148.3 patient-years[mean\ulcornerD, 4.16*2.57 years]at the follow-up end of June 1988. They experienced 4 major late complications: 1.045 % thromboembolism/patient-year [pt-yr]; 0.871 % bleeding/pt-yr; 0.610% endocarditis/pt-yr; and 3.309% overall valve failure/pt-yr or 1.655% primary tissue failure/pt-yr. The actuarial survival rates were 89.4*2.2% and 87.7*2.5% at 5 and 10 years after initial surgery respectively. The probabilities of freedom from thromboembolism were 95.1*1.6% and 93.2*2.0% at 5 and 10 years after surgery. Nineteen patients underwent re-replacement of the Ionescu-Shiley valve because of primary tissue failure, and there was no operative mortality. The incidence of primary tissue failure was highest for the patients less than 15 years of age occurring in 9 out of 27 patients [33.3 %] or 8.68 %/pt-yr, while it was 4.0 % or 0.96 %/pt-yr for the rest of patients older than this age. The probabilities of freedom from primary tissue failure were 96.7*1.4 % and 84.2*3.8% at 5 and 9 years after surgery. The freedom from tissue failure increased as the age limits of cumulative younger patients were increased while it decreased as the age limits of cumulative older patients were decreased. Although it is clear that the Ionescu-Shiley valve would degenerate prematurely in young patients, the definite age limit could not be identified when the risk of early failure was significantly high.

• Journal of Chest Surgery
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• v.19 no.4
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• pp.584-594
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• 1986

Despite the multivariate improvements in tissue treatment, material, and design of prosthetic heart valves in recent years, numerous complications that may lead to valve dysfunction remain a constant threat after valve replacement. Most common indications for prosthetic valve failure are primary valve failure, infective endocarditis, paravalvular leakage, and thromboembolism. From 1977 to 1986, 15 patients underwent reoperation for prosthetic valve failure in 278 cases of valve surgery. The etiology of prosthetic valve failure were primary valve failure in 12 patients [80 %], infective endocarditis in 2 patients [13.3 %], and a paravalvular leakage [6.7 %]. The average durations of implantation were 45.5 months; 53.9 months in primary valve failure, 16 months in infective endocarditis, and 4 months in paravalvular leakage. The rate of valve failure was high under age of 30 [11/15]. Calcifications and collagen disruption of prosthesis were main cause of primary valve failure in macro- & micropathology. Prosthesis used in reoperation were 5 tissue valves and 10 mechanical valves. Operative mortality were 13.3 % [2/15], due to intractable endocarditis and ventricular arrhythmia.

• Journal of Chest Surgery
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• v.20 no.4
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• pp.673-682
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• 1987

The principal feature of bioprosthetic valve which remains to be completely defined is long-term durability, especially, with regard to the impact of patient age. This report provides extended data regarding valve durability derived from a data base of 515 patients who received lonescu-Shiley bioprosthetic valve between 1978 and 1985; cumulative duration of follow-up was 1562.3 patient-years, with a maximum follow-up duration of 8.7 years. The results of this survey showed as follows: 1] The actuarial freedom from valve failure at 6 years were 43*7% for 0-19 year-old group, 70*1% for 20-39 year-old group and 75*1% for over 40 year-old group separately. 2] Of the causes of valve failure, only the primary tissue failure was markedly influenced by patient`s age [p<0.001], but the prosthetic valve endocarditis was not [p>0.1]. 3] The linealized incidences of primary tissue failure were 7.31% per patient-year in 0-19 year-old group and 0.12% in 20-39 year-old group. 4] The primary tissue failure rate in 0-19 year-old group was 6.36% during first 4 years, but then increased upto 10.95% at postoperative 5 year. Thus we find that in bioprosthetic valve the primary tissue failure is apt to occur when patient is young [especially less than 20 years old] and the postreplacement time passes [especially over 5 years]. The rate of bioprosthesis failure among children and adolescents is clearly higher than that observed in adult patients; however, conclusive quantification of time-related risk for young patient is not yet possible on the basis of existing data. Therefore, the advisability of bioprosthesis implantation in children remains to be determined.

• Journal of Chest Surgery
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• v.21 no.5
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• pp.893-898
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• 1988

A number of centers have recorded a significant incidence of primary tissue valve failure with the Ionescu-Shiley pericardial valve. Clinically, Endothelialization and host tissue ingrowth on the cloth and the leaflets at the edge of the frame greatly reduced the amounts of abrasion and the incidence of tissue failure. In most cases severe regurgitation was caused by leaflet tears adjacent to the edge of the cloth-covered stent. We report a case of spontaneous disruption of one cusp on the Ionescu-Shiley pericardial xenograft in mitral position at 6years and its successful management.

• 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.24 no.7
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• pp.656-662
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• 1991

endocarditis, 1.475% /pt-yr, overall valve failure, 3.319% /pt-yr; and primary tissue failure, 1.475% /pt-yr. The actuarial probability of survival was 94.3$\pm$3.6% and the probability of freedom from thromboembolism 90.6$\pm$4.6% at 11 years after surgery respectively. And, the probability of freedom from primary tissue failure was 60.4$\pm$16.9% also at 11 years The evidence of possible premature and accelerated failure of the pericardial valve in the aortic position among the young population was not clear on the age-related analysis of the structural failure, and no suggestion could be made to indicate age limit when the use of the pericardial valve would better be avoided.

• Journal of Chest Surgery
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• v.29 no.2
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• pp.164-170
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• 1996

From January 1986 to June 1993, 12 patients Aad required reoperation: 9 had undergone mitral and 3 aortic valve replacement. Five were male and 7 female, and ages ranged from 29 to 61 years. Replacement of the prosthetic heart valve was performed at a mean interval of 98 $\pm$ 1 months after the Hrst operation. In aortic valve replacement patients the mean interval was 115 $\pm$ 2 months and in mitral valve replacement patients 98 $\pm$ 4 months. Primary tissue failure was the most frequent reason of replacement (10 patients) followed by valve thrombosis (1 patient) and prophylactic replacement (1 patient) in order. The most pronounced pathology of the failed prosthetic heart valves seen in the primary tissue failure group was calcification, perforation, shrinkage and tearing of the cusps. There was one early operative death (8.3%) due to intractable low cardiac output and acute renal failure. Eleven early survivors had successful operative results and there was no late death.

• 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.26 no.9
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• pp.667-676
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• 1993

Boprosthetic cardiac valves fail from biological and metabolic as well as mechanical reasons, and the limited durability is the main factor of marked withdrawal in their clinical use. Starting the use of bioprosthetic valves in 1976, up to the end of 1992, the consecutive 178 patients have undergone re-replacement of glutaraldehyde-treated xenograft valves for primary tissue failure [PTF]among the patients who had initial valve replacement at Seoul national University Hospital. The explanted valves were 69 porcine aortic [51 Hancock, 12 Angell-Shiley and 6 Carentier-Edwards] and 141 bovine pericardial [129 standard-profile and 12 low-profile ionescu-Shiley] valwes, with an overall incidence of PTF of 15.2%. The operative mortality rate of re-replacement was 5.1%. Calcific degeneration and tissue damage in relation to calcification were the most frequent modes of PTF on gross examinatin of the explanted valves resulting hemodynamically in valvular regurgitation. The number of Hancocg porcine and the standard-profile Ionescu-Shiley valves in valves in mitral position failed more often from tissue damage [tears, holes, and loss or destruction of cuspal tissue] than calcification [68.3% vs. 39.0%, p<0.01] with resultant regurgitation in 61%, the Ionescu-Shiley valves in the same position in 53%. The tendency of more calcification than tissue damage[71.3% vs. 33.3%, p<0.001]with stenosis in 53%. The tendency of more calcification and immobility of cusps in the latter group was partly explainable by the inclusion of patients of pediatric age. Observation made in this study suggest : many of bioprosthetic valves would fail from calcification and tissue damage : some fail prematurely because of mechanical stress probably owing to the valve design in construction ; andeven those valves escaped early damage would be subject to calcify in the prolonged follow-up period. In conclusion, at the present time, the clinical use of bioprostheticxenograft valves seems to be quite limited until further improvement in biocompatibility and refinement in valve design in manufacture are achieved.