Clinical results with the xenograft cardiac valves were reviewed for 212 patients who underwent heart valve replacement from January 1981 to December 1987. One hundred and twenty-four Carpentier-Edwards k 88 Ionescu Shiley valves were used. Overall operative mortality was 11 out of 212[5.1%]: 5 out of 153[3.39o] for mitral valve replacement [MVR], 2 out of 34[5.9%] for aortic valve replacement [AVR], 0 out of 4[0%] for Tricuspid valve replacement [TVR], and 4 out of 21[19.1%] for double valve replacement [DVR;MVR+ AVR]. Two hundred and one operative survivors were followed up for a total of 824.3 patient-years [a mean 3.9*1.8 yrs], and the follow up was 78.1%. The linealized complication rates were 0.1% emboli / patient-year, 1.0% endocarditis/ patient-year and 2.2% overall valve failure / patient-year. A linealized rate of primary tissue failure was 0.7*/o/ patient-year. The actuarial survival rates including the operative mortality were 92*2.8% at 4 years and 85*4.3% at 7 years after surgery using the Xenograft cardiac valves. Probabilities of freedom from thromboembolism and overall valve failure were 73*11.0% and 69*2.4% at 7 years after surgery using the Xenograft cardiac valves respectively. The intrinsic durability of the Xenograft cardiac valves appears to be relatively well satisfactory over the long term [4 to 7 years] and the risk of failure appears well balanced by the advantages of a low incidence of thromboembolism and no mandatory anticoagulant therapy.
From June 1984 to February 1994, cardiac valve replacement was performed in 108 patients. The distribution of patients was ranged from 13 to 64 year-old age[mean 39.48 1.24] and 51 patients were male, 57 patients were female [male:female=1:1.1]. 64 patients had mitral valve replacement, 27 patients underwent aortic valve replacement and 17 patients were performed double[mitral & aortic] valve replacement. Total 125 artificial cardiac valves were used, mechanical valves were 51 valves and tissue valves were 74 valves. The duration of follow-up was 473.41 patient-year[mean 4.79 3.29 patient-year] and the information of follow-up was available for 99 patients[92%]. The actuarial survival rates including the operative mortality was 89.5% & 88.3 at postoperative fourth & ninth year. The probability of freedom from overall valve failure, thromboembolism and bacterial endocarditis were 77.5%, 89.2% and 95.6% at ninth year after cardiac valve replacement.
A total and consecutive 46 patients have undergone cardiac valvular surgery including 8 open mitral commissurotomy and 38 mitral, aortic, mitral-aortic, mitral-tricuspid, tricuspid valve replacements using 46 artificial valves in a period between September 1976 and July 1981. They were 19 males and 27 females with the age ranging from 16 to 50 (mean 32.6) years. Out of 46 valves replaced, 6 were prosthetic valves and 40 were tissue valves, and 33 were replaced in mitral, 9 in aortic and 3 In tricuspid position. Isolated replacements were 33 mitral valves, 6 aortic valves and 1 tricuspid valve; double valve replacements were 6 mitral-aortic valves and 2 mitral-tricuspid valves. . Early mortality within 30 days after operation was noted in 4 cases; 3 after MVR and 1 after open mitral commissurotomy. Causes of death were thrombus obstruction of Beall-Surgitool, Cerebral air embolism, acute renal shut down due to low output syndrome, and left upper pUlmonary vein rupture after open mitral commissurotomy (early mortality 8.7%). 3 late deaths were noted during the follow-up period from 2 to 59 months; 1 due to cerebral hemorrhage from warfarin overdose 3 months, 1 due to miliary tuberculosis 9 months, and another 1 due to cardiac failure after open mitral commissurotomy 42 months postoperatively. Total survival rate 59 months after valvular surgery was 84.8%; there were no early and late death in the group of AVR, TVR and double valve replacements. Preoperative NYHA Class III & IV were 35 cases (76%) out of total 46 cases, and 38 cases (94.8%) out of 39 survival cases were included In NYHA Class I & II during the follow-up period.
The increasing number of replacement of the substitute cardiac valves were seen in these 2 years. Out of a total 1,408 patients with cardiac valve replacement, 54 required replacement of the substitute valves. Fifty-nine substitute valves replaced were 43 in mitral, 14 in aortic and 2 in tricuspid positions; and they were 36 Ionescu-Shiley, 15 Hancock and 3 Angell-Shiley bioprosthetic valves and 3 St. Jude Medical and 2 Bjork-Shiley prosthetic valves. Primary tissue failure was the most frequent reason of replacement[38 patients] followed by paravalvular leak[9 patients], prosthetic valve endocarditis[6 patients] and valve thrombosis[1 patient] in order. The most pronounced pathology of the failed xenograft valves seen in the primary tissue failure group was calcification and fixation of the cusps with or without tear and defect of the cuspal tissue. The operative mortality rate was 7.4%. Fifty early survivors were followed up for a total of 82.6 patient-years and there was no late death. Actuarial survival rate was 92.3*3.8% at 6 years after surgery. Although the definite tendency toward early and accelerated degeneration of the xenograft valves has been seen in patients younger than 20 to 25 years of age, no strict age limit from where the tissue failure slows down could be determined. The requirement of the ideal substitute valves would be the durability of the recently developed mechanical prostheses armed with the low thrombogenicity of the bioprostheses. At the present time, the need of compromise in selection between less thrombogenic bioprosthetic and more durable mechanical valves should be stressed. The difficulty in choice is yet important in patients of middle age and children where the use of homograft valves may be one of the solution despite of certain limitations from sociomedical reasons.
It has been over 20 years since successful operations of Cardiac valves at the Department of Thoracic and Cardiovascular surgery, college of medicine, Yonsei University. About six hundreds of patients with severely symptomatic valvular heart disease have had valve operations with complete loss or sharp decrease in their cardiac symptoms since 1956. As the number of cardiac patient increases, reoperation on valves assumes greater importance. To define the group of patients undergoing reoperations on valves and the factors influencing their survival, we have reviewed our experiences of the reoperation on valves at the Yonsei University, Severance Hospital. This is a report of 29 cases which was undergone secondary or more surgery for valvular heart disease from 1966 to 1983. The primary operations includes 159 cases of open heart surgery from 1966 to 1975 and 476 cases from 1976 to march, 1983. The secondary operations are classified into groups of secondary valvuloplasty or valvotomy [8 cases], prosthetic valve replacement following valvuloplasty or valvotomy [14 cases] and prosthetic valve rereplacement [2 case] for such as calcification, degeneration and perforation of the cusps and paravalvular leakage, of the bioprosthetic valves. The leading indication for reoperation of mitral valve was restenosis or stenoinsufficiency, The indications of aortic valve replacement was active bacterial endocarditis, medically uncontrollable prosthetic endocarditis or paravalvular leakage. Overall death rate of the reoperation was 17.4% [5 death among the 29 patients] and the leading causes of death were myocardial failure, arrhythmia, cerebral embolism, acute renal failure due to low output syndrome. And it was followed by sepsis associated with active prosthetic endocarditis. The death rate of reoperation was 4.3% in the elective cases except urgent cases and the death rate of overall cardiac valve except reoperation cases was 4.1% in the last two years. Although the general mortality of reoperation was high, both mortality rates were comparable except emergency cases due to urgent preoperative patient’s condition.
Mitral and aortic valve replacement with tricuspid annuloplasty was undertaken in 5 patients out of 38 valvular surgery between the period from Jan. 1977 to May 1979 in the Dept. of Thoracic and Cardiovascular Surgery in Korea University Hospital. All were male patients with age ranging from 18 to 42 years, and preoperative evaluation revealed one case in Class IV, and four cases in Class III according to the classification of NYHA. Preoperative diagnosis was confirmed by routine cardiac study including retrograde aorto- and left ventriculography, and there were two cases with MSi+ASi+Ti, two cases with MSi+Ai+Ti, and one case with Mi+Ai+Ti. Double valve replacement was performed under the hypothermic cardiopulmonary bypass with total pump time of 247 min. in average ranging from 206 min. to 268 min. During aortic valve replacement, left coronary perfusion was done in the first two cases, and cardiac arrest with cardioplegic solution proposed by Bretschneider was applied in the remained three cases. Starr-Edwards, Bjork-Shiley prosthetic valves and Carpentier-Edwards tissue valve were replaced in the aortic area, and Carpentier-Edwards and Angell-Shiley tissue valves were replaced in the mitral area with each individual combination [three prosthetic and two tissue valves in the aortic, and five tissue valves in the mitral area respectively]. Postoperative recovery was uneventful in all cases except one case with hemopericardium, which was managed with pericardiectomy on the postoperative 10th day in good result. Follow-up after double valve replacement of the all five cases for the period from 6 months to 33 months revealed satisfactory adaptation in social activity and occupation with cardiac function of Class I according to the classification of NYHA In all five cases.
In 1968, Carpentier and his associates introduced glutaraldehyde as a compound for preparing cardiac tissue valve, and this technique has provided a considerably more suitable and durable tissue valve substitute. To increase further durability of valve tissue, Reis and his colleagues designed a flexible stent to reduce the stress on the heterogeneous tissue valve mounted. However with the advent of more innovative mechanical valve currently, many bioprosthetic valves are being substituted by mechanical valves at our department of cardiothoracic surgery because of bioprosthetic valve failure. Main cause of bioprosthetic valves failure were calcification or/and tear of tissue valves. The purpose of this retrospective study is to clarify the relationship between the patients clinical profile during implantation of tissue valves and pathologic features of the failed bioprosthetic valve. From March, 1982 through June, 1988, 53 bioprosthetic heart valves that had been ex-planted from 45 patients at the department of cardiac surgery of Yonsei University Hospital were subjected to this study. The patients were 10 to 65 year-old [mean age: 30.3 yr] with 17 males and 28 females. Re-replacements of prosthetic valves were carried out twenty nine in mitral position, eight in aortic position and eight in both aortic and mitral position simultaneously. The grading and location for calcification of valves were verified by radiograms. The calcification of the explanted valves leaflets was graded from 0 to 4 plus according to Cipriano and associates method. The types of tear and perforation of leaflet were classified into four types as Ishihara has adopted initially in 1981. In younger age group under thirty three years, explanted tissue valves were significantly more affected in terms of grades of severity of valve calcification as compared with older age group [p < 0.035]. Valve calcification appeared more severe in male as compared to female [p< 0.002]. Ionescu-Shiley bovine pericardial bioprosthetic valves showed more severe calcification than Hancock porcine tissue valves [p< 0.035]. Calcium deposit was found very prevalent at the area of commissural attachment [86 % of all]. Type I of valve rupture was shown to be related with simultaneous calcification. However, the relation of explanted valve position, duration of implanted prosthetic valve, atrial fibrillation and anticoagulant therapy to the severity of bioprosthetic valve calcification were not significantly clear statistically [p > 0.05].
A total and consecutive 156 patients have undergone cardiac valve surgery including 13 closed mitral commissurotomy, 13 open mitral commissurotomy, one mitral annuloplasty, 75 mitral valve replacement, one aortic annuloplasty, 24 aortic valve replacement, 3 tricuspid valve replacement, 25 double valve replacement and one triple valve replacement. 155 prosthetic valves were replaced in a period between September 1976 and August 1985. There were 68 males and 88 females with age range from 8 to 69 yrs [mean 36.5 yr]. Out of replaced valves, 61 was tissue valve including 54 Carpentier-Edwards, and 4 was mechanical valves including 74 St. Jude Medical, and the position replaced was 101 valves for mitral, 46 for aortic and 8 for tricuspid. Single valve replacement in 102 cases, double valve replacement in 25 cases [17 for AVR+MVR, and 8 for MVR+TVR], and only one case was noted in the triple valve replacement. Early mortality within 30 days after operation was noted in 11 cases [7%]; 7 after MVR, 2 after DVR, and each one after open mitral commissurotomy and mitral annuloplasty. Cause of death was valve thrombus, cerebral air embolism, low output syndrome, uncontrollable arrhythmia, parapneumonic sepsis, acute cardiac tamponade and left atrial rupture. 7 late deaths were noted during the follow-up period from 1 to 104 months [average 48 month]; three due to valve and left atrial thrombus formation, two due to CVA from overdose of warfarin, and each one due to congestive heart failure and chronic constrictive pericarditis, Anticoagulants after prosthetic valve replacement were maintained with warfarin, dipyridamole and aspirin to the level of around 50% of normal prothrombin time in 79 cases, and Ticlopidine with aspirin in 47 cases to compare the result of each group. There were 11 major thromboembolic episodes including 3 deaths in the warfarin group. Two cases of CVA due to overdose of warfarin was noted in the warfarin group. In the ticlopidine group, there was only one left atrial thrombus confirmed at the time of autopsy. Among the survived 138 cases, nearly all cases[136 cases] were included in NYHA functional class I and II during the follow-up period. In conclusion, surgical treatment of the cardiac valve disease in 156 clinical cases revealed excellent result with acceptable operative risk and late mortality. Prevention of thrombus formation with anti-platelet aggregator Ticlopidine has better result than warfarin group presently with no specific side effect such as bleeding or gastrointestinal trouble.
Clinical results with the Mechanical cardiac valves were reviewed for 261 patients who underwent cardiac valve replacement from September, 1985 to July, 1990. of the Mechanical valves used, 156 were Carbomedics, 109 Duromedics, 52 St. Jude and 11 Bjork-Shiley. Overall hospital mortality was 14 out of 261[5,36%]: 9 out of 159[5.66%] for MVR, 1 out of 35[2.86%] for AVR and 4 out of 67[5.96%] for DVR[AVR+MVR]. Two hundred and forty seven operative survivors were followed up for a total 466.8 patient-years, ranged from 1 month to 4.9 years [a mean 1.8 years] and the follow up was 96.0%. There were 12 valve-related complications: three from thromboembolism, three from valve thrombosis, three from prosthetic valve endocarditis, two from paravalvular leak and the other one from hemorrhage. Actuarial rate free from all valve-related complication at 4.9 years was 96$\pm$1.3%. There were 11 late deaths: two from thromboembolism, one from valve thrombosis, one from prosthetic valve endocarditis, one from hemorrhage and the others 6 from non-valve-related complications. Actuarial survival rate at 4.9 years was 94$\pm$2.0%. 96$\pm$3.0% for MVR, 94$\pm$4.2% for AVR and 91$\pm$3.7% for DVR[AVR+MVR]. And there are 7 reoperations: three from paraprosthetic leak, two from prosthetic valve endocarditis and two from valve thrombosis. Actuarial rate free from reoperation at 9 years was 96$\pm$2.9%. On the basis of this 4.9 years of experience, the pyrolytic carbon mechanical valves appears to be an excellent mechanical prosthesis for cardiac valve replacement, in terms of hemodynamic performance, low mortality and low thrombogenecity.
A total of 1,239 patients had cardiac valve replacement using 1,514 substitute valves at Seoul National University Hospital from 1968 to 1986. Of the total substitute vales, 84.9% were the glutaraldehyde-treated xenograft valves. Six hundred ninety-four patients who had 820 bioprosthetic tissue valves were studied for their clinical characteristics. They were a total and consecutive cases to the end of the study. Four hundred sixty-four patients had the lonescu-Shiley pericardial valves: MVR 291, AVR 66 and MVR+AVR 107; 163 had the Hancock porcine valves; 46 had the Angell-Shiley porcine valves; and 21 had the Carpentier-Edwards porcine valves. Five hundred forty patients underwent single valve replacement: MVR 460, AVR 76 and TVR 4; 154 had multiple valve replacement: MVR+AVR 141, MVR+TVR 12 and one triple valve replacement. Additional surgery was necessary in 22.3% of the cases. Operative mortality rate within 30 days of surgery was 6.77% for the total patients: 5.2% and 4.2% with MVR, 13.6% and 12.5% with AVR, and 7.5% and 7.4% with MVR+AVR using the lonescu and the Hancock valves respectively. A linealized annual late mortality rate was 2.56%/patient-year. Six hundred forty-three operative survivors were followed up for a total of 1482.7 patient-years [a mean 27.7 months], and the follow-up rate was 67.7%. The Idealized complication rates were: 2.02% emboli/patient-year, 0.94% bleeding/patient-year, 1.21% endocarditis/patient-year, and 3.84% overall valve failure/patient-year. A linealized rate of primary tissue failure was 0.87%/patient-year. Actuarial survival rates including the operative mortality were: 87.8*2.6%, 82.3*4.9% and 82.2*4.7% with MVR, AVR and MVR+AVR using the lonescu valves at 4 years after surgery respectively; and they were 88.0*4.1% with MVR at 8 years, 82.3*4.9% with AVR at 4 years and 84.9*7.0% with MVR+AVR at 6 years after surgery using the Hancock valves respectively. Probabilities of freedom from thromboembolism were 89.8*6.3% with MVR using the lonescu valves at postoperative 5 years and 89.2*3.8% with MVR using the Hancock valves at postoperative 7 years, and 93.3*3.9% with AVR using the lonescu valves at postoperative 5 years. None had embolic complication after AVR using the Hancock valves. Probabilities of freedom from valve failure [according to the Stanford criteria] were 81.0*7.1% with MVR using the lonescu valves at postoperative 4 years and 57.4*12.5% with MVR using the Hancock valves at postoperative 9 years. These clinical results prove the excellent antithrombogenicity of the glutaraldehyde-treated xenograft substitute valves and confirm the previously speculated rate of tissue failure. At the present situation, it may be concluded that there is a room for the further development of more durable bioprosthetic valves.
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