• Journal of Chest Surgery
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• v.37 no.7
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• pp.559-569
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• 2004

The CarboMedics mechanical valve has been reported to show acceptable valve-related complication rates. The aim of this study is to evaluate our clinical experience with the CarboMedics valve. Material and Method: Between August 1988 and September 1999, we implanted 1,144 CarboMedics valves in 850 patients (aortic 179; mitral 385; double-valve 234; tricuspid 52). The mean age was 44.5 $\pm$ 12.5 years. Follow-up was completed in 95.2% and median follow-up period was 7.9 years (6753 patient-years). Result: The overall hospital mortality rate was 3.4% and the mortality rate for each group was 1.7% for aortic group, 2.6% for mitral group, 4.7% for double-valve group, and 9.6% for tricuspid group, Tricuspid group showed significantly higher mortality rate than aortic and mitral group (p〈0.05). The actuarial survival at 10 years was 87.1 $\pm$ 2.6%, 88.9 $\pm$ 1.7%, 82.4 $\pm$ 2.9%, and 77.5 $\pm$ 7.0% for aortic, mitral, double, and tricuspid valve group, respectively. Age and tricuspid valve replacement were significant risk factors for long-term survival in multivariate analysis (p 〈 0.05). Freedom from valve thrombosis at 10 years was 99.4 $\pm$ 0.6%, 98.2 $\pm$ 0.8%, 99.2 $\pm$ 0.8%, and 87.6 $\pm$ 0.5% for aortic, mitral, double and tricuspid valve group. Tricuspid valve group showed significantly higher rate of valve thrombosis (p 〈 0.05). Conclusion: Long-term results of our experience demonstrated that CarboMedics valve showed acceptable incidence of valve-related complications. However, tricuspid valve replacement showed higher rate of early mortality and valve thrombosis than other valve replacement groups.

• Journal of Chest Surgery
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• v.29 no.9
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• pp.971-976
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• 1996

From March 1988 to October 1992, 201 CarboMedics cardiac valve prostheses (150 mitral, 50 aortic and 1 tricuspid) were implanted in 166 consecutive patients (mean age 38 years, male/female 66/100) by one surgical team operating on adult cardiac patients at Kyungpook University Hospital. Total follow up represen:toed 6646 patient-months (mean 40mon1hs) and follow up rate was 96%. One hundred and twenty-four patients (74.7 %) were in NYHA functional class 111 or tV preoperatively and 164 patients (98.7 %) were in class I or ll postoperatively. Hospital mortality was 4.2 % and late death was 4.2%. The actuarial survival at 78 months was 89.4%. The linearized incidence of valve related death, prosthetic valve thrombosis, anticoagulant related hemorrhage, non-structural dysfunction and reoperation was 0.72%/pt-yr, 0.18%/pt-yr, 0.18%trapt-yr, 0.18 %/pt-yr and 0. 36%/pt-yr respective y. The 78 month rates of freedom from valve related death, prosthetic valve thrombosis, anticoagulant related hemorrhage, non-structural dysfunction and reoperation were 94.9%, 99.4%, 99.4%, 98.6 % and 97.9 % respectivly. The 78 month rate of freedom from all valve related complications and deaths including hospital mortality was 90.9%. These fact suggest that the CarboMedics cardiac valve has execellent result, low incidence of valve-ie-lated complications and no structural deterioration, and long term follow up study is necessary.

• Journal of Chest Surgery
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• v.33 no.8
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• pp.643-647
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• 2000

From March 1988 to June 1994, 275 CarboMedics cardiac valve prostheses(199 mitral, 70 aortic and 3 tricuspid) were implanted in 226 consecutive patients(mean age 39 years, male/female 90/136) by one surgical team operating on adult cardiac patients at Kyungpook University Hospital. Total follow up represented 16,848 patient-months(mean 76 months) and follow up rate was 96%. One hundred and forty-nine patients(66%) wer in NYHA functional class III or IV preoperatively, and 204 patients(99.5%) were in class I or II postoperatively. Early mortality was 4.9% and late death was 9.3%. The actuarial survival at 81 months was 86.l2$\pm$3.1%. The linearized incidence of valve-related death, prosthetic valve thrombosis, anticoagulation-related hemorrhage, non-structural dysfunction and reoperation were 0.71%, 0.43%, 0.07%, 0.21%, and 0.14% respectively. The 81-month rate of freedom from all valve related complications and deaths including hospital mortality was 88.1$\pm$2.5%. Thee facts suggest that the CarboMedics cardiac valve has excellent result, low incidence of valve-related complications and no structureal deterioration.

• Journal of Chest Surgery
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• v.33 no.1
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• pp.45-50
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• 2000

Background: The CarboMedics prosthetic heart valve was produced in an attempt to improve the existing valve designs and was especially concerned with easily the implantation and further reduction of turbulence. Precise positioning of the valve in situ was achieved by the abilityof the valve to rotate relative to the sewing ring. Improved monitoring is possible due to increased radiopacity and the dacron sewing ring is coated with carbon to reduce pannus overgrowth. The leaflets have an opening angle of 78 degrees that apparently allows a rapid synchronous closure The aim of this study was to analyze the clinical performance of the CarboMedics valve prostheses(45 mitral 13 aortic and 7 double aortic-mitral valve replacement) were implanted in 65 patients(mean age 48.75$\pm$9.74 years) Result: The operative mortality was 3.1%(2/65) causes of death were low cardiac output syndrome. Total follow up was 1831 patient-months and mean follow up was 29.06$\pm$10.97 months/patient. No structural failure hemorrhage valve thrombosis and late death have been observed. Embolism occurred at a rate of 0.65%/Patient-year. Actuarial survival and thrombo-mbolism free rate at 36 months were 96.9% and 98.4% respectively. Consclusions: The CarboMedics valve stands for low valve related complicatons.

• Journal of Chest Surgery
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• v.26 no.10
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• pp.753-760
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• 1993

The CarboMedics valve is a bileaflet prosthesis with excellent hemodynamic characteristics, but the long term surgical experience with this valve, its durability and its biocompatibility are unknown. During a 5 year period from october 1988 to July 1993, 748 prostheses [402 mitral, 261 aortic, 58 tricuspid, 27 pulmonic] were inserted in 552 patients [mean age 40.2 years]. The operative mortality was 6.6% [37/560, 13.2% in age group below 15 years and 5.7% above 15 years]. and the main causes of death were complex congenital malformation and left ventricular failure. Follow up was totaled 1182 patient- years and mean follow up was 28.3 months/patient. No structural failure has been observed. Hemorrhage was the most frequent valve related complication[1.78% / Patient-year]. Embolism occurred at a rate of 0.93% / Patient-year. There were 5 cases of valve thrombosis [0.42% / Patient-year, two fatal]. There occurred 11 late deaths[6 valve related] and 42 valve related complications. Actuarial survival at 5 years is 97.18 0.94% and actuarial complication free survival at 5 years is 89.07 1.54%. In summary, the CarboMedics valve stands for a durable valve substitute, with low valve related complications.

• Journal of Chest Surgery
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• v.31 no.8
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• pp.781-786
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• 1998

Materials and methods: Between 1984 to 1994, 136 patients underwent primary and isolated aortic valve replacement with 79 Carbomedics and 57 St. Jude prostheses. Results: Age ranged from 16 to 67 year(mean : 44.5${\pm}$12.7 years). Statistically significant differences in preoperative clinical characteristics between two groups were not found. There was one early death in the St. Jude group and none in the Carbomedics group. Early prosthetic valve-related complications including death were not significantly different between the two groups(p value= 0.572). One hundred thirty five early survivors were followed for a total of 354.2 patient-years(mean=31.5${\pm}$16 months). In the CarboMedics group, actuarial survial rate at 5 years was 97.1${\pm}$1.9%, and in the St. Jude group, it was 95.9${\pm}$2.8%. In the CarboMedics group, actuarial free rate from all valve-related events at 5 years was 92.1${\pm}$3.1%, and in St. Jude group, it was 89.8${\pm}$5.0%. Conclusion: We conclude that early and late results after performing isolated aortic valve replacement with CarboMedics and St. Jude valve are not significantlly different.

• Proceedings of the KTCVS Conference
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• 1998.10a
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• pp.151-151
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• 1998

• Journal of Chest Surgery
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• v.25 no.6
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• pp.661-671
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• 1992

From March 1988 to May 1991, 140 CarboMedics cardiac valve prostheses[75 mitral, 9 aortic and 28 double aortic-mitral] were implanted in 112 consecutive patients[mean age 36.7$\pm$11.6 years, male/female 48/76] by one surgical team operating on adult cardiac patients at Kyoungpook University Hospital Associated Surgical procedures were performed in 19 patients[16.9%]. Total follow up represented 2,345 patient-months[mean 22.4 months] and was 100% complete. Eighty-two patients[73%] were in NYHA functional class IIIor IV preoperatively and 102 patients [95%] were in class I or II postoperatively. Hospital[30 day] mortality was 4.4%, [3/75 mitral, 1/9 aortic, 1/28 double valve replacement] and late death was 1.7%. [1 /74 mitral, 1 /28 double valve replacement] The actuarial survival at 36 months was 94.0% after mitral, 80% after aortic, 92% after double valve replacement, and 93.2% for the total group. The linearized incidence of valve relater death, prosthetic valve thrombosis, anticoagulant related hemorrhage, and reoperation was 1.00%/pt-yr, 0.51%/pt/yr, 0.51%/pt-yr, and 0.51%/pt-yr respectively. The 36 month rates of freedom from valve replated death, thromboembolism, endocarditis, anti-coagulant related hemorrages, and reoperation were 98.75%, 99.08%, 100%, 99.04%, and 99.08% respectively. The 36 month rate of freedom from all valve related complications and deaths including hospital mortality was 90.2%. These fact suggest that the CarboMedics heart valve has excellent short-term result, low incidence of valve-related complications and valve dysfunction, and additional long term follow up study is necessary.

• Journal of Chest Surgery
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• v.27 no.12
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• pp.995-1001
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• 1994

The CarboMedics valve prosthesis is a relatively new. low profile bileaflet prosthesis. During a 6 year period from Aug. 1988 to July 1994. 158 patients had CarboMedics prostheses implanted in the mitral [n=94], aortic [n=25], or aortic and mitral [n=39] in National Medical Center. Hospital mortality was 9.4% and the main cause of death was low output syndrome. Follow up was 96% complete, with 365.4 patient-years and a mean follow up of 30 months [ range 1 to 72 months ] . The overall actuarial 6 year survival rate was 91.61 3.47% and actuarial 6year freedom from all valve related complications was 73.9 7.67%. The linearized incidence of vavle related complications was as follows: thromboembolism 1.37%/patient-year ; valve thrombosis 0.82%/ patient-year ; anticoagulant related hemorrhage 0.85%/patient-year ; perivalvular leakage 0.55%/paitent-year: prosthetic valve endocarditis 0.82%/patient-year ; reoperation 1.37%/patient-year. There were no instances of structural failure. We conclude that the Carbomedics valve has a low rate of complications that further improves the quality of life in patients with heart valve prostheses.

• Journal of Chest Surgery
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• v.31 no.12
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• pp.1183-1194
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• 1998

Background: From Sept. 1985 to Sept. 1997, 2,000 cases of open heart surgery(OHS) were performed in the Department of Thoracic & Cardiovascular Surgery, Pusan Paik Hospital, College of Medicine, Inje University. Material and Method: Among the total of 2,000 cases of OHS, 1532 cases were congenital heart disease(CHD) and 468 cases were acquired heart disease(AHD). The age distribution was 9 days(4.0kg) to 68 years in CHD and 11 to 66 years in AHD. In 1532 cases of CHD, there were 1403 acyanotic cases and 129 cyanotic cases. Result: The CHD cases consisted of 940 ventricular septal defects(61.4%), 324 atrial septal defects(21.1%), 112 tetralogy of Fallot(7.3%), 46 pulmonary stenosis(3%), 38 endocardial cushion defects(2.5%), 15 valsalva sinus ruptures(1%), 4 transposition of great arteries (0.3%), 4 double outlet right ventricles(0.3%), and etc. Corrective operations were applied for congenital heart disease with a result of 3.1% hospital mortality. Of 468 AHD, 381 cases were valvular heart diseases, 48 ischemic heart diseases, 12 cardiac tumors, 8 annuloaortic ectasias, 16 dissecting aortic aneurysms and etc. In the 381 valvular heart diseases, there were 226 single valve replacements(36 aortic valve replacements(AVR), 188 mitral valve replacements(MVR), and 2 tricuspid valve replacements(TVR), among these were 71 cases of double valve replacements(AVR & MVR), 54 cases of MVR with tricuspid valve annuloplasty(TVA), and 18 cases of AVR, MVR with TVA. The total implanted prosthetic valves were 466. In MVR, 123 St. Jude Medical valves, 90 Carpentier-Edwards valves, 65 CarboMedics valves, 42 Sorin valves and 16 other valves were used. In AVR, 68 St. Jude Medical valves, 36 CarboMedics valves, 14 Carpentier-Edwards valves and 9 other valves were used. Coronary Artery Bypass Surgery(CABG) were performed in 48 cases. The patterns of bypass graft were 14 patients of single vessel graft, 21 patients of two vessels graft, 10 patients of three vessels graft and 3 patients of four vessels graft. Conclusion: The hospital operation mortality rate of congenital acyanotic, cyanotic and acquired heart diseases were 2.0%, 15.5%, and 5.1% respectively. The overall mortality rate was 3.6%(72/2,000).