More than ten years' follow-up of the Hancock porcine bioprosthesis in Japan.

From February 1975 through October 1981, 256 Hancock porcine bioprostheses (Johnson & Johnson Cardiovascular, King of Prussia, Pa.) (60 aortic, 169 mitral, and 27 pulmonary/tricuspid position) were implanted in 220 patients (104 male and 116 female, aged 9 to 67 years; mean 43.3) at Kyushu University Hospital in Japan. The procedures include 41 aortic valve replacements, 121 mitral valve replacements, 4 pulmonary valve replacements, 6 tricuspid valve replacements, and 48 combined valve replacements (31 aortic plus mitral, 13 mitral plus tricuspid, and 4 aortic plus mitral plus tricuspid). Hospital mortality was 6.4%. Follow-up was 98% during 8 to 14 (mean 10.5) years. Cumulative follow-up was 1836 patient-years and 2078 valve-years. At 10 years the overall actuarial survival rate, including hospital morality, was 70% +/- 3%, and freedom from valve-related mortality with sudden death was 87% +/- 3%. More than half of the current survivors required no anticoagulant therapy. Freedom from thromboembolism or anticoagulant-related hemorrhage (or both) and prosthetic valve endocarditis was common. Freedom from structural valve failure and reoperation declined more than 9 years after replacement of left-sided heart valves but not after replacement of right-sided heart valves. Sixty-seven patients underwent 68 repeat operations, and there were four deaths (5.9%). The rate of freedom from overall valve-related complications at 10 years was 62% +/- 8% for aortic valve replacement, 53% +/- 5% for mitral valve replacement, 80% +/- 13% for pulmonary/tricuspid valve replacement, and 42% +/- 9% for combined valve replacement. There was a significant difference between pulmonary/tricuspid valve replacement and combined valve replacement (p less than 0.05). The Hancock bioprosthesis is suitable for the replacement of valves in the right side of the heart but not for combined valve replacement.     

Long term results of cardiac valve replacement in patients aged 75 years and older.

From June 1978 to December 1989, 158 patients over 75 years of age (mean: 78 years; range 75 to 86 years) underwent 164 valve replacements: 134 in the aortic, 18 in the mitral and 6 in double mitral and aortic positions. One hundred and seven of these valves (66%) were bioprostheses, 93 aortic and 14 mitral and 57 valves (34%) were mechanical prostheses; 47 aortic and 10 mitral. Hospital mortality (less than or equal to 30 days) was 7% (11 patients, all in NYHA class III or IV) but was higher in patients who had undergone associated procedures (9.8%; 6/61 patients) or in patients who had mitral valve replacements (11%) and in double valve replacement (16.6%). Because of a minimal delay of one year, long term follow-up information (100%) was only obtained from the first 110 patients discharged from hospital. Late mortality has been 13.6% and actuarial survival at 11 years was 71.5% +/- 5. Therefore, despite a hospital mortality of more than twice that of patients operated upon under 75 years of age (3.3%), an actuarial survival at 11 years, similar to that of patients under 75 years (77 +/- 5%) and the functional improvement obtained (95% of survivors are NYHA class I or II) certainly justify surgery in these patients. Because of the incidence of anticoagulant related hemorrhages in these patients (1.7% patient year) and since, structural deterioration of the bioprostheses was non existent in this series, a bioprosthesis appears to be the best valvular substitute in patients over 75 years of age.     

Valve replacement in the young patient with rheumatic heart disease. Review of a twenty-year experience

During a 20-year period 303 young subjects between 9 and 20 years of age (mean, 16.2 +/- 2.72 years) with rapid and relentlessly progressive valvular disease from rheumatic fever underwent valve replacements. The Starr-Edwards ball valve prosthesis remains the device of choice, although other valves have been implanted. The overall hospital mortality rate was 9.6% in the mitral valve, 3.5% in the aortic valve, and 4.2% in the double valve replacement groups. Actuarial survival at 10, 15, and 20 years was 78.4% (+/- 3.3%), 70.0% (+/- 5.8%), and 59.3% (+/- 11.1%), respectively, for patients with mitral valve replacement. The rates for aortic valve replacement were 85.9% (+/- 4.6%) at 10 and 15 years and 72.7% (12.8%) at 20 years. In the double valve replacement group the survival rates after 5 and 10 years were 79.9% (+/- 5.1%). The incidence of thromboembolism was 0.41, 0.59, and 1.04 per 100 patient-years for the mitral, aortic, and double-valve prostheses, respectively. The prospect of childbearing seems promising in those young women who were subsequently married. Our favorable and gratifying experience in this review bears testimony to the physiologic advantages of the Starr-Edwards valve as the device of choice in the rehabilitation of patients with advanced and severe valvular disease after rheumatic fever.     

Twenty-year comparison of tissue and mechanical valve replacement

OBJECTIVE: We sought to compare outcomes with tissue and St Jude Medical mechanical valves over a 20-year period. METHODS: Valve-related events and overall survival were analyzed in 2533 patients 18 years of age or older undergoing initial aortic, mitral, or combined aortic and mitral (double) valve replacement with a tissue valve (Hancock, Carpentier-Edwards porcine, or Carpentier-Edwards pericardial) or a St Jude Medical mechanical valve. Total follow-up was 13,390 patient-years. There were 666 St Jude Medical aortic valve replacements, 723 tissue aortic valve replacements, 513 St Jude Medical mitral valve replacements, 402 tissue mitral valve replacements, 161 St Jude Medical double valve replacements, and 68 tissue double valve replacements. The mean age was 68 +/- 13.3 years (St Jude Medical valve, 64.5 +/- 12.9; tissue valve, 72.0 +/- 12.6). RESULTS: There were no overall differences in survival between tissue and mechanical valves. Multivariable analysis indicated that the type of valve did not affect survival. Analysis by age less than 65 years or 65 years or older and presence or absence of coronary disease revealed similar long-term survival in all subgroups. The risk of hemorrhage was lower in patients receiving tissue aortic valve replacements but was not significantly different in patients receiving mitral valve or double valve replacements. Thromboembolism rates were similar for tissue and mechanical valve recipients. However, reoperation rates were significantly higher in patients receiving both aortic and mitral tissue valves. The reoperation hazard increased progressively with time both in patients receiving aortic and in those receiving mitral tissue valves. Overall valve complications were initially higher with mechanical aortic valves but not with mechanical mitral valves. However, valve complication rates later crossed over, with higher rates in tissue valve recipients after 7 years in patients undergoing mitral valve replacement and 10 years in those undergoing aortic valve replacement. CONCLUSIONS: Tissue and mechanical valve recipients have similar survival over 20 years of follow-up. The primary tradeoff is an increased risk of hemorrhage in patients receiving mechanical aortic valve replacements and an increased risk of late reoperation in all patients receiving tissue valve replacements. The risk of tissue valve reoperation increases progressively with time.     

A five-year appraisal and hemodynamic evaluation of the Bj?rk-Shiley Monostrut valve

Two hundred forty-four Bj?rk-Shiley Monostrut valves were implanted in 225 consecutive patients from October 1983 to December 1988. Aortic valve replacement was performed in 90 patients, mitral valve replacement in 118, and double valve replacement in 16 patients. One patient had tricuspid valve replacement. There were 100 female patients and 125 male patients with a mean age of 54 years (range 2 to 71 years). Present data were completely available for all patients. The cumulative follow-up was 541 patient-years with a mean of 2 years, 5 months. The closing date for follow-up was July 1989, and the closing interval was 2 months. The early mortality rate was 3.1%, and the late mortality rate, 3.1%. The 5-year survival rate was 88% +/- 2.0%: 87% +/- 3.0% for aortic valve replacement, 91% +/- 3.3% for mitral valve replacement, and 75% +/- 9.6% for double valve replacement. The actuarial rates of freedom from thromboembolism at 5 years were 93% +/- 3.2% for aortic, 96% +/- 1.4% for mitral, and 94% +/- 6.1% for double valve replacement. There were no instances of structural valve deterioration. Actuarial rate of freedom from valve-related morbidity and mortality was 86% +/- 2.0% at 5 years: 86% +/- 9.5% for aortic, 87% +/- 3.3% for mitral, and 75% +/- 7.3% for double valve replacement. Effective valve areas (average) of 12 mitral and 12 aortic valve prostheses were calculated at rest and during bicycle exercise: 2.4 cm2 at rest and 2.8 cm2 during exercise in 27 mm aortic valves, 2.4 cm2 at rest and 3.0 cm2 during exercise in 25 mm aortic valves, 2.0 cm2 at rest and 2.4 cm2 during exercise in 27 mm mitral valves, and 2.6 cm2 at rest and 2.5 cm2 during exercise in 29 mm mitral valve. On the basis of our follow-up period of 5 years, we have judged the Bj?rk-Shiley Monostrut valve reliable, with a low incidence of valve-related morbidity and with acceptably satisfactory hemodynamic characteristics at rest and during exercise.     

Mechanical valve replacement in children and teenagers

A previous study from this unit showed that only 19% of children with mitral bioprostheses were free from complications after 7 years and prompted us to review the performance of new-generation mechanical prostheses implanted in the same population group. In a 5-year period (1980-1985), 352 patients 20 years old and younger (mean age 15.3 +/- 4 years) with rheumatic valvular disease had 177 mitral, 62 aortic and 113 double (mitral + aortic) valve replacements with Medtronic-Hall or St. Jude prostheses. The overall early mortality was 6.3%. All survivors, followed up for a total of 1171 patient-years, received oral anticoagulation. The late mortality for mitral, aortic and double valve replacement was 4.1% per patient-year, 4.3% per patient-year and 8.0% per patient-year, respectively (P less than 0.05), and was valve-related in 46% of the cases. Twenty-nine patients, all but 2 in the mitral and double valve replacement groups, were reoperated upon (2.5% per patient-year), mainly for infective endocarditis (34%), for prosthetic thrombosis (33%) and for bland periprosthetic leak (31%). The incidence of thrombotic obstruction was 1.1% per patient-year: mitral valve replacement, 1.0% per patient-year; aortic valve replacement 0.5% per patient-year; and double valve replacement, 1.7% per patient-year; P less than 0.05) and was fatal in 33% of the cases. Major systemic thromboembolism occurred at the rate of 1.4% per patient-year, similar in the three groups. The incidence of prosthetic endocarditis was 0.9% per patient-year.(ABSTRACT TRUNCATED AT 250 WORDS)     

Clinical and hemodynamic results of cardiac valve replacement with the Monostrut Bj?rk-Shiley prosthesis

Between May 1983 and April 1986, 318 patients underwent cardiac valve replacement with the Monostrut Bj?rk-Shiley prosthesis. There were 136 aortic valve replacements, 128 mitral valve replacements, and 54 multiple replacements. A total of 373 valves were implanted. Associated procedures were done in 79 (25%) of the patients. Hospital (30-day) mortality rate was 5.6% (18 patients): 2.9% (n = 4) after aortic, 7.8% (n = 10) after mitrals and 7.4% (n = 4) after multiple valve replacement. Follow-up was obtained in all 300 operative survivors, for a total of 500 patient-years (mean 18 months). Actuarial survival rate, excluding operative deaths, at 4 years was 94.7% +/- 1.5% (mean +/- standard error of the mean). There were 16 thromboembolic episodes (3.2/100 patient-years). Freedom from all valve-related complications was 87% +/- 2.4% at 3 1/2 years. Neither valve thrombosis nor structural failure has been observed. Eighty percent of the patients are in New York Heart Association functional class I. Forty-two patients (26 with aortic and 16 with mitral valve replacement) underwent cardiac catheterization a mean of 6 1/2 months after the operation. In the aortic position, peak gradients were an average of 6.9 +/- 1.2 mm Hg. Mean systolic gradients were 12.4 +/- 6.3 mm Hg and did not increase with exercise. In the mitral position, end-diastolic gradients were an average of 2.1 +/- 2 mm Hg and mean gradients, 5.9 +/- 2 mm Hg. Discharge coefficient (estimated orifice area/geometric area) was 0.63 +/- 0.2 for the aortic and 0.53 +/- 0.2 for the mitral prostheses. Disc opening was maximal in most patients. These results indicate that the Monostrut prosthesis has a low rate of thromboembolic events, no structural failures or thrombotic obstructions and excellent hemodynamic performance, especially in the small aortic sizes (discharge coefficient for 19 and 21 mm valves, 0.77).     

Porcine versus pericardial bioprostheses: a comparison of late results in 1,593 patients

From 1976 to 1988, 1,593 patients underwent valve replacement with a porcine (878 patients) or a pericardial bioprosthesis (715 patients). There were 701 aortic, 678 mitral, and 214 multiple-valve replacements. Follow-up was obtained for 1,559 patients (98%). Early mortality was 9% (79 patients) in the porcine valve group and 5% (37 patients) among patients with a pericardial valve (p less than 0.01). Late survival after replacement with porcine valves was 80% +/- 1% and 62% +/- 3% at 5 and 10 years, respectively. With pericardial valves, 5-year survival was 79% +/- 2%. Among valve-related complications, rates of freedom from thromboembolism, endocarditis, and hemorrhage after 6 years were similar for both valve groups. Freedom from reoperation at 6 years was also similar after aortic (96% versus 91%) or multiple-valve replacement (95% versus 88%). However, for mitral valve replacement, freedom from reoperation was significantly better with porcine valves than with pericardial valves at 6 years (92% versus 68%; p less than 0.001). This difference was mainly due to the Ionescu-Shiley valve, which accounted for 83% of primary tissue failures among pericardial bioprostheses implanted in the mitral position (10/12 patients). After 6 years, freedom from primary tissue failure of mitral valves was 92% +/- 2% with porcine and 70% +/- 11% with pericardial bioprostheses (p less than 0.0001). The degree of clinical improvement among survivors was similar with both valve types. Thus, in the aortic position, pericardial valves compare with porcine valves up to 6 years, whereas in the mitral position, the durability of the former is significantly less, mainly because of the suboptimal performance of the Ionescu-Shiley pericardial bioprosthesis.     

Valve replacement in the elderly. Is the mechanical valve a good alternative?

The controversy surrounding the choice of a prosthesis for valve replacement in the elderly patient prompted me to review the performance of mechanical (Medtronic Hall [Medtronic, Inc., Minneapolis, Minn.] and St. Jude Medical [St. Jude Medical, Inc., St. Paul, Minn.]) valves implanted in 213 patients 65 years and older (mean 70.4 years) from 1980 to 1985. There were 63 mitral, 131 aortic, and 19 double (aortic and mitral) valve replacements. Most patients undergoing aortic valve replacement had stenotic lesions, but half of the patients in the mitral valve replacement group had regurgitation with or without stenosis. Early mortality rates for mitral, aortic, and double valve replacement were 4.8%, 6.1%, and 21.1%, respectively (p less than 0.01). The mortality rate for patients 65 to 74 years old was 6.5% and that for those older than 75 years was 9.1%. The cumulative follow-up for the survivors was 850 patient-years. The late mortality rate was 8.1% per patient-year but was valve-related in only 1.3% per patient-year. Noncardiac causes accounted for 43.5% of the late deaths. The late mortality rate was significantly higher in patients who had regurgitant lesions than in those who had stenotic or mixed disease. It was also higher in the older patients (10.3% per patient-year) than in the younger group (7.6% per patient-year; p less than 0.05). Reoperation was required in only six patients (0.7% per patient-year). Thrombotic obstruction of the prosthesis and systemic thromboembolism occurred at linearized rates of 0.6% per patient-year and 2.5% per patient year, respectively, and significant anticoagulant-related hemorrhage at a rate of 0.6% per patient-year. With the exception of late mortality, the incidence of all late complications was similar to that of patients younger than 65 years operated on during the same period. Actuarially, global survival (58% +/- 4%) and freedom from reoperation (95% +/- 2%), from thrombotic obstruction (96% +/- 1%), from thromboembolism (92% +/- 2%), from all valve-related mortality and morbidity (82% +/- 3%), and from valve failure (93% +/- 2%) were also similar to those of the younger patients. Mechanical prostheses perform well in elderly patients. I could not confirm an increase in thromboembolic or hemorrhagic episodes, and the respective mortality and morbidity indexes were similar to those observed in younger patients.     

Acute mechanical valve thrombosis of the St. Jude medical prosthesis

From 1986 to 1996, 2585 patients underwent valve replacement with the St. Jude medical prosthesis. Sixty experienced mechanical valve thrombosis. Seventeen of 60 patients (28.3%) had isolated aortic valve replacements, 33 had isolated mitral valve replacements (55%), and 10 had double valve replacements (16.7%) (aortic and mitral valve replacement). All patients who underwent reoperation for mechanical valve thrombosis were functional Class III or IV. Against medical advice, systemic anticoagulation with warfarin sodium had been discontinued or used only intermittently. Thus, anticoagulant activity was not adequate. The diagnosis of thrombosis was made by clinical examination, laboratory findings, and echocardiography and cineradiography. Of the 60 patients, 9 patients died early after surgery or before discharge. Most of the deaths were attributed to low cardiac output. The overall hospital mortality was 15%. The overall 10-year actuarial survival rate was 82.8+/-1.6%. In our study, reoperation for thrombosed mechanical prosthesis was not an independent parameter determining mortality. Age was the only statistically important hospital mortality predictor. Of this group, 90% suffered mechanical valve obstruction within the first 5 years after operation. These results suggest that valve re-replacement appears to be a suitable surgical treatment for thrombosis of mechanical prosthetic valves, especially in the young. In these patients subsequent anticoagulation management is necessary.     

Valve replacement in the elderly: a long term appraisal

From July 1972 through July 1983, 360 consecutive patients 70 years of age and older (mean age 74.1; range 70-88 years) underwent 362 valve replacement procedures. There were 122 isolated aortic valve replacements (33.7%; Group I); 70 isolated mitral valve replacements (19.3%; Group II); and 170 patients had combined procedures (47.0%; Group III), which included the replacement of at least one valve. Eighteen patients (5.0%) had previous cardiac surgery. Thirty-two patients (8.8%) were operated as emergencies. Three hundred and thirty-two (86.5%) of all valves implanted were porcine heterografts. Pre-operatively, over one-half (53.6%) of the patients were in New York Heart Association Functional Class IV. The overall hospital mortality was 13.8% (50 patients). The aortic valve mortality was 11.5%, the mitral valve mortality was 15.7%, and the combined procedures 14.7%. The follow-up period for hospital survivors (312 patients) extended from 2 weeks to 127.2 months, with a mean of 38.7 months or a total of 1,006 patient-years. The long term survival computed up to six years shows a 65 +/- 3.8% (standard error of the mean) for the entire group. The aortic valve group survival was 71 +/- 5.6%; the mitral valve group 60 +/- 8.2%; and the combined procedures group was 64 +/- 5.3%. Postoperative functional improvement was significant with 71.8% of the survivors in Class I and 19.6% in Class II. Based on these results, advanced age can no longer be considered a deterrant to cardiac surgery. The porcine heterograft appears to be the valve substitute of choice for this age group.(ABSTRACT TRUNCATED AT 250 WORDS)     

The porcine bioprosthetic valve. Twelve years later

The porcine bioprosthetic heart valve has been commercially available since 1970 and has been the prosthetic heart valve of choice in our institution since 1971. Since that time 817 patients with 951 porcine valves have been discharged from the hospital and were available for long-term follow-up. Patient survival rates, with operative mortality excluded, were 80% +/- 1.7% (standard error) at 5 years and 68% +/- 2.7% at 10 years. Survival rates for patients with aortic valve prostheses were 78% +/- 2.8% at 5 years and 57% +/- 5.4% at 10 years; for patients with mitral valve prostheses, survival rates were 80% +/- 2.2% at 5 years and 69% +/- 3.2% at 10 years. Freedom from thromboembolism for aortic valves was 93% +/- 1.4% at 5 years and 88% +/- 2.6% at 10 years; for mitral valves the freedom from degeneration or primary tissue failure for aortic valves was 97% +/- 1.3% at 5 years and 71% +/- 7.6% at 10 years; for mitral valves these figures were 96% +/- 1.2% at 5 years and 71% +/- 4.1% at 10 years. Valves in patients 35 years of age and below had a significantly greater rate of degeneration (p less than 0.001). After 12 years' experience the porcine bioprosthetic valve has performed well with regard to patient survival and low rate of thromboembolism. For patients older than 35 years the freedom from primary tissue failure is 80% at 10 years.     

Use of the Carpentier-Edwards porcine bioprosthesis: assessment of a patient selection policy.

The Carpentier-Edwards bioprosthesis was implanted in 369 patients (414 valves) between May 1977 and December 1987 (age 67.2 +/- 0.5 years); 242 had aortic valve replacement, 80 had mitral valve replacement, 44 had multiple valve replacement, of which 41 were aortic and mitral valve replacement, 2 had isolated tricuspid valve replacement, and 1 had a pulmonary valve replacement. The selection criteria were the following: shorter life expectancy (253 patients) or contraindications to anticoagulants for organic (113 patients) or psychologic (38 patients) reasons, or both. The early mortality rate was 11.1% (aortic valve replacement, 9.1%; mitral valve replacement, 12.4%; aortic and mitral valve replacement, 23.1%). Total cumulative follow-up was 1456 pt-yr (mean 4.4 years, range 1 to 148 months), and the patient evaluation was 99.5% complete. Late mortality was 4.9%/pt-yr. Five-year survival was 70.4% +/- 2.7% overall, 74.3% +/- 3.2% after aortic valve replacement, 60.9% +/- 6.2% after mitral valve replacement (p < 0.03), and 60.7% +/- 8.1% after aortic and mitral valve replacement. Eight patients were reoperated on for primary tissue failure, and freedom from reoperation for structural valve deterioration was 97.5% +/- 1.2% at 5 years and 95.6% +/- 1.8% at 8 years. Failing aortic bioprostheses were explanted in four patients (0.4%/pt-yr) and mitral bioprostheses in seven (1.6%/pt-yr). No patient whose valve was inserted after the age of 70 had to be reoperated on for structural valve dysfunction. The probability of freedom from thromboembolism after 5 and 8 years of follow-up was 93.1% +/- 1.6% and 92.2% +/- 1.8%, respectively. The prevalence of anticoagulant-related hemorrhage was 0.8%/pt-yr (major 0.6%, minor 0.2%). Anticoagulants had to be maintained in 16.3% of the patients: 5.9% after aortic valve replacement, 35.7% after mitral valve replacement, and 45.8% after aortic and mitral valve replacement, while 80.0% were on a regimen of antiplatelet drug therapy. Prosthetic valve endocarditis happened in five patients (0.3%/pt-yr). Freedom from all valve-related morbidity and mortality, including hospital deaths, was 71.0% +/- 2.7% at 5 years and 58.6% +/- 4.6% at 8 years and was significantly better in the aortic valve replacement group (61.3% +/- 6.6% at 8 years) compared with the mitral valve replacement group (54.4% +/- 7.7% at 8 years; p = 0.04). This study confirms the satisfactory performance of the Carpentier-Edwards valve after aortic valve replacement in elderly patients.(ABSTRACT TRUNCATED AT 400 WORDS)     

Fourteen years' experience with the Bj?rk-Shiley tilting disc prosthesis

Between 1970 and 1984, 1,574 Bj?rk-Shiley valve prostheses have been implanted in 1,171 patients in Glasgow. Between 1970 and 1980, 1,023 standard disc prostheses were implanted in 729 patients: 184 had aortic valve replacement, 323 mitral, and 222 multiple valve replacement. Between 1980 and 1984, 551 convexo-concave valves were implanted in 442 patients: 125 had aortic, 228 mitral, and 89 multiple valve replacement. Concomitant coronary artery bypass grafting was performed in 9.2% of the latter group as compared with 2.7% of the earlier group. The overall hospital (30 day) mortality for the group with the standard disc prosthesis was 10.4% and for patients with the convexo-concave prosthesis, 7.0%. Cumulative follow-up extends to 4,125 patient-years--standard disc group 3,378 patients-years, range 4 to 14 years (mean 5.2 years); convexo-concave group 747 patient-years, range 1.5 to 5.3 years (mean 1.9 years). The late mortality is 3.8% per patient-year--standard disc group 2.9% per patient-year and convexo-concave group 4.3% per patient year (no significant difference). Actuarial survival rate at 12 years for the whole group, excluding operative deaths, is 69.4% +/- 6.3%. The freedom from all valve-related complications at 12 years is 65.9% +/- 6.5%. there is no significant difference in the incidence of most major complications between the standard disc and convexo-concave prostheses apart from the occurrence of mitral valve thrombosis (p less than 0.05) in the standard disc group and outlet strut fracture (p less than 0.005) in the convexo-concave group. These results confirm the excellent long-term performance of the Bj?rk-Shiley tilting disc prosthesis.     

Mid-term follow-up in patients with Biocor porcine bioprostheses

BACKGROUND: Prosthetic cardiac valves have increased life expectancy of patients (pts) with valvular heart disease. Bioprosthetic complications required devices replacements within 10 years of implantation; structural valve deterioration (SVD) has emerged as the major cause of reoperation. We reviewed survival and prosthetic complications of Biocor porcine bioprostheses implanted in mitral, aortic and mitro-aortic position. METHODS: Between January 1991 and January 2001 446 pts (192 males; 254 females; mean age 73.4+/-6.7 year, range 40-91) received 258 aortic, 138 mitral and 50 mitro-aortic Biocor porcine valves; of these 83 pts have previous different types of prosthetic devices (15 aortic, 53 mitral and 15 double). Concomitant cardiac procedures, namely myocardial revascularization, were performed in 91/446 pts (20.5%). All explanted bioprostheses (BPS) were available for pathologic investigation. Follow-up included 1319 pt.-years and was 98% complete with a median time of 36 pt.-months. RESULTS: Perioperative mortality was 6.8% (30/446 pts; 12 aortic, 17 mitral and 1 double) and was mostly related to reoperations. At the end of follow-up 18.5% of pts died (77/416), 12 deaths were valve-related with freedom from valve related mortality of 94% at 9 years. Survival was 54% at 9 years. It was 63%, 41% and 62% for aortic, mitral and double valve replacement, respectively. At follow-up 87% of pts. were in NYHA I-II class and 13% were in III-IV class; 55% were in sinus rhythm, 36% in atrial fibrillation and 9% had a pace-maker. Eighty-five percent of pts were anticoagulated. There were 6 thromboembolic and 5 anticoagulant-related haemorrhagic episodes with no significant difference between aortic and mitral position (p=0.7). The event freedom was respectively 92% and 98.5% at 9 years. Prosthetic valve endocarditis (PVE) and non-SVD freedom were 96% and 93% at 9 years. SVD due to tissue degeneration, calcification and cusp's tears affected 2 pts with 94% freedom at 9 years. Overall freedom from all valve-related complications was 80% at 9 years and freedom from reoperation was 92% at 9 years. CONCLUSIONS: (1) Our intermediate-term follow-up of the Biocor porcine valve (BPS) showed excellent durability in all positions. (2) The aortic patients and especially the oldest group had better results than the mitral patients (41% vs. 63% 9 years survival, p=0.0004). (3) Higher mitral risk was related to higher prevalence of reoperations. (4) The incidence of anticoagulation-related complications is low in both aortic and mitral position without significant difference (p=0.7). 4) A longer follow-up is required to get more information about SVD timing.     

The Monostrut Bj?rk-Shiley valve. Seven years' experience.

The results of cardiac valve replacement with the Monostrut Bj?rk-Shiley prosthesis (Shiley, Inc., Irvine, Calif.) during a 7-year period are presented. A total of 984 valves were implanted in 820 patients from May 1983 to April 1990. Aortic valve replacement was performed in 378 patients, mitral replacement in 294, and multiple replacement in 148. In addition, 180 patients (22%) underwent associated procedures. Mean age was 52.6 +/- 11 years. Operative (30 days) mortality was 5.9% (49 patients): 3.9% (15 patients) for aortic, 7.8% (23 patients) for mitral, and 7.4% (11 patients) for multiple valve replacement. All patients were given long-term anticoagulation therapy. Follow-up was 99% complete (eight patients were lost to follow-up), with a closing interval of 3 months, and totaled 2422 patient-years. Valve-related complications, expressed as percentage event-free (+/- standard error) at seven years were as follows: structural deterioration, 100%; nonstructural dysfunction, 98.3% +/- 0.6%; thromboembolism, 90.2% +/- 1.7%; anticoagulant-related hemorrhage, 88.7% +/- 2.8%; and prosthetic valve endocarditis, 98.1% +/- 0.8%. There were no cases of valve thrombosis. Actuarial survival (free from operative, valve-related, and sudden death) was 88.4% +/- 1.2% at 7 years. Freedom from reoperation was 96.8% +/- 0.1%. Probability of being free from all valve-related morbidity and mortality was 70% +/- 3%, and 708 (93%) of the survivors were in New York Heart Association class I or II. Serial Doppler echocardiograms were done prospectively in 243 patients (with 154 aortic and 120 mitral prostheses), both postoperatively and at regular intervals up to 3 years. Mean prosthetic gradients ranged from an average of 20.9 to 7 mm Hg in the aortic prostheses (21 to 29 mm) and from 6.1 to 4.8 mm Hg in the mitral prostheses (25 to 31 mm). The gradients in each patient did not change significantly during the follow-up period. Our 7 year's experience with the Monostrut valve shows a low rate of valve-related complications, a durable design, and good hemodynamic and functional results.     

Redo valve surgery with on-pump beating heart technique

AIM: Reoperations have become of increasing frequency in the last four decades. Redo surgery is more complex than primary surgery and is associated with higher mortality and morbidity. We present our immediate and mid-term results of mitral and aortic prosthetic valve replacement undertaken with beating heart technique. METHODS: The prospective study included 26 consecutive redo valve surgery patients who underwent valve re-replacement. The operation was carried out on a beating heart using normothermic bypass without cross-clamping the aorta for mitral valve surgery and retrograde coronary sinus normothermic noncardioplegic blood perfusion during cross-clamping the aorta for aortic valve procedures. RESULTS: Twenty-six patients (mean age 50+/-15 years) underwent reoperation with beating heart technique. Twenty (76.9%) mitral prosthetic replacements, 4 (15.4%) aortic prosthetic replacements, and 2 (7.7%) double valve replacements were achieved. Fourteen patients (53.8%) were operated for prosthetic valve dysfunction. Eighteen patients (69.2%) were in NYHA class III or IV preoperatively. Mean bypass time was 85+/-30 min. Mean duration of ventilation was 13.6+/-6 h, mean intensive unit stay was 2.8+/-6.4 days, and mean hospital stay was 8.3+/-7.2 days. Two (7.7%) patients required high dose inotropic support and in one patient (3.8%) intra-aortic balloon support was required. Pulmonary complication occurred in 1 patient (3.8%), low cardiac output in 1 patient (3.8%), and re-exploration for bleeding in 2 patients (7.7%). Operative mortality was not observed. CONCLUSION: Normothermic on-pump beating heart valve replacement offers a safe alternative to cardioplegic arrest in high-risk group. Complication rates are low and perioperative mortality is lower than with conventional surgery. Beating heart technique has the advantage of maintaining physiologic condition of the heart throughout the procedure.     

Valve-related complications with the Hancock I porcine bioprosthesis. A twelve- to fourteen-year follow-up study

Valve-related morbidity and mortality after heart valve replacement with the Hancock I porcine bioprosthesis has been retrospectively analyzed. From June 1974 through December 1976, 253 Hancock I bioprostheses (150 mitral and 103 aortic) were inserted in 220 selected patients who survived the operation and had follow-up until June 1989 (mean follow-up 13.5 years, with an accumulative follow-up of 2956.4 patient-years). One hundred seventeen patients had mitral valve replacement, 70 had aortic valve replacement, and 33 had combined mitral and aortic valve replacement. There were 27 thromboembolic events. The probability of being free from thromboembolism at 14 years was 81.0% +/- 7.4% for the mitral valve replacement group, 85.4% +/- 6.7% for the aortic group, and 67.1% +/- 18.4% for the mitral-aortic group. Fifteen episodes of prosthetic valve endocarditis occurred. There were 10 instances of nonstructural dysfunction (paravalvular leaks) in seven mitral valves (4.6%) and in three aortic valves (2.9%). One hundred twenty-two bioprostheses in 106 patients resulted in structural deterioration. The probability of freedom from structural deterioration at 14 years was 37.2% +/- 3.9% for the mitral group, 43.9% +/- 7.1% for the aortic group, and 30.1% +/- 8.9% for the mitral-aortic group. The logistic regression analysis between age at the time of operation and bioprosthetic life (structural deterioration-free period) demonstrates a linear regression curve (r = 0.53). There were 56 late deaths (27 patients died at reoperation). The actuarial survival rate (including hospital mortality) at 14 years was 57.2% +/- 5.4% for the entire series, with no statistically significant difference between groups. The probability of remaining free from valve-related morbidity and mortality at 14 years was 16.7% +/- 4.8% for the mitral group, 20.8% +/- 6.2% for the aortic group, and 14.0% +/- 7.0% for the mitral-aortic group. The long-term results of this series show that the clinical performance of the Hancock I porcine valve appears satisfactory during the first 6 years. The behavior of this bioprosthesis at 14 years' follow-up changes drastically, because only a minor group of patients is free from valve-related complications, justifying the restriction of its use for selected patients.     

复杂性感染性心内膜炎的外科治疗

目的评价瓣周脓肿、心肌脓肿以及瓣膜严重毁损等复杂性感染性心内膜炎手术治疗的近、远期疗效.方法回顾性分析1988年12月至2002年6月手术治疗的复杂性心内膜炎患者57例临床资料,均为原发性心内膜炎,其中感染侵犯主动脉瓣25例、二尖瓣16例、二尖瓣和主动脉瓣16例.术中发现瓣叶严重毁损32例、主动脉瓣周脓肿19例、主动脉根部环形脓肿导致左心室-主动脉连接破坏4例、二尖瓣后瓣环脓肿11例、心肌脓肿6例、瓣膜赘生物形成55例.脓肿清除后遗留残腔采用间断褥式缝合6例、自体心包片修补19例、牛心包片修补6例、聚四氟乙烯膨体补片修补4例;施行以带瓣管道作升主动脉根部替换和左、右冠状动脉移植术4例,主动脉瓣替换术21例,二尖瓣替换术16例,主动脉瓣及二尖瓣双瓣替换术16例.结果早期死亡6例(11%),死亡主要原因为低心输出量综合征、人造心脏瓣膜性心内膜炎和多脏器功能衰竭.随访4个月至14年,平均(5.93±0.20)年.晚期死亡5例,晚期主要并发症为人造瓣膜性心内膜炎.术后1年心功能恢复NYHA分组Ⅰ～Ⅱ级占96%(44/46);5年再手术免除率为(84±3)%,5年实际生存率为(61±9)%.结论复杂性心内膜炎局部组织破坏较多,应限期手术或急症手术,清创后残腔的处理是影响手术本身能否成功以及术后近、远期效果的关键.     

Eight year experience with the CarboMedics bileaflet valvular prosthesis.

Two hundred and two patients (97 female and 105 male; mean age: 45. 5+/-9 years) received CarboMedics bileaflet valves during a period of eight years. Ninety-one patients received mitral, 72 aortic and 39 aortic+mitral valve prosthesis. Tricuspid plasty and coronary artery bypass surgery were the concomitant operations in 17 and 12 patients, respectively. The mean follow-up period was 24.7 months and the ratio was 91%. Overall operative mortality was 3.96% (8 patients); 2.78% for aortic valve replacement (AVR), 3.29% for mitral valve replacement (MVR) and 7.7% for double valve replacement (DVR). The late mortality rate was 2.89% for AVR, 2.2% for MVR and 8. 3% for DVR. The main cause of mortality was low cardiac output. The overall survival rate was 91.5% in 2 years. The actuarial freedom from thromboembolism in 2 years was 97% for AVR, 95% for MVR and 84% for DVR. No mortality due to heamorrhagic events was observed. CarboMedics prosthetic heart valves may be used satisfactorily with a low incidence of valve-related morbidity and mortality.