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.     

Long-term performance of porcine heart valve bioprostheses

To assess the results after long-term implantation of porcine bioprosthetic heart valves, 320 patients with 381 valves were retrospectively reviewed. This group included all patients receiving one such xenograft in the mitral or aortic position (or both) in our institution between June 1974 and December 1976. The patients had a follow-up of 9-11.5 years. Actuarial patient survival rats (hospital mortality excluded) were 85%-90% at 6 years and 68%-79% at 11.5 years. Thromboembolic episodes did not show any significant clustering over the first weeks or months, in fact, they appeared at a constant rate. Actuarial rates of freedom from thromboembolism were greater than 90% for aortic patients at 11.5 years and greater than 80% for mitral and mitroaortic patients at 11.5 years. The linearized rate of anticoagulant-related haemorrhage for the whole group of patients was 0.4 events/100 patient years with a related mortality of 0.2 events/100 patient years. Prosthetic valve endocarditis and paravalvular leak appeared at linearized rates of 0.6 (0.1 of related mortality) and 0.4 (0.1 of related mortality) events/100 patient years. Primary tissue valve failure constituted the most prevalent complication (82 cases) in the long term but did not significantly worsen patient survival. Actuarial rates of freedom from primary tissue failure were 91% +/- 2% at 6, and 40% +/- 14% at 11.5 years for mitral valves, and 95% +/- 4% at 6 and 64% +/- 6% at 11.5 years for aortic valves.(ABSTRACT TRUNCATED AT 250 WORDS)     

Comparative analysis of long-term results with porcine-aortic, bovine pericardial and tilting disc valves

The three series with the first-generation valve prostheses were reviewed for long-term clinical evaluation in isolated aortic and mitral valve replacement. Hancock porcine xenograft was implanted in 71 patients from 1977 to 1979, ionescu-Shiley pericardial xenograft (standard model) in 271 patients from 1979 to 1983, and Bjork-Shiley tilting disc valve in 194 from 1978 to 1986. In aortic position, no any significant difference among three valve types could be demonstrated in the actuarial survival and freedom from thromboembolism and valve infection, while the actuarial freedom from valve dysfunction in lonescu-Shiley valve was significantly lower than that in other two valves. Bj?rk-Shiley valve in mitral position showed satisfactory clinical performance in terms of valve-related complications and survival in comparison with two types of bioprosthetic valves. In our conclusion at present time, Bj?rk-Shiley valve is suitable for the first choice of both aortic and mitral valve prostheses. In case of valve replacement with a bioprosthesis, however, porcine aortic valve is a better choice for aortic, and bovine pericardial valve likely for mitral replacement.     

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.     

The porcine bioprosthetic heart valve: experience at 15 years

The porcine bioprosthetic valve has been in use at Henry Ford Hospital since 1971. In this review, 980 patients with 1,081 porcine bioprosthetic valves were examined from 1 month to 16.4 years after implantation with a 99% complete follow-up. Patient survival was 59% +/- 2.2% (+/- standard error of the mean) at 10 years and 38% +/- 4.0% at 15 years. Factors associated with decreased survival after hospital discharge were age greater than 35 years and New York Heart Association functional class IV. Freedom from thromboembolism was 92% +/- 1.2% at 10 years and 89% +/- 3.2% at 15 years. Freedom from endocarditis was 93% +/- 1.2% at 10 years and 92% +/- 1.3% at 15 years. Freedom from structural valve degeneration for all valves was 71% +/- 2.6% at 10 years and 31% +/- 5.6% at 15 years. Factors associated with increased risk of structural valve degeneration were age younger than 35 years, female sex, and preoperative cardiac index greater than 2 L/min/m2. Among a total of 172 patients undergoing removal of a degenerated valve, mortality was 12.5%, and significant risk factors for death at reoperation were emergency operation and functional class IV. Experience with the porcine bioprosthetic valve after 15 years suggests that its use be confined to older patients or patients with a contraindication of anticoagulation.     

Fifteen-year clinical experience with the biocor porcine bioprostheses in the mitral position

BACKGROUND: Bioprosthetic valve use represents a crucial improvement in surgical treatment of mitral valve disease. The aim of this study is to determine the long-term durability of the Biocor porcine bioprosthetic mitral valve. METHODS: Between 1985 and 1989, a total of 158 Biocor porcine bioprosthetic valves were placed in the mitral position, and long-term results of these patients were investigated retrospectively in 1999. RESULTS: Thirty-day mortality was 4.4% (7 patients). Total follow-up was 1,499 patient-years. Actuarial survival was 83.66% +/- 3% at 5 years, 77.78% +/- 3.36% at 13 years (1.8% patient-year). Multivariate analysis demonstrated younger age, duration of implantation, congestive heart failure, and functional class to be significant predictors of late mortality. Actuarial freedom from valve-related mortality was 98.58% +/- 1% at 15 years (0.13% patient-year). Actuarial freedom from structural valve deterioration was 95.49% +/- 1.8% at 5 years, 70.2% +/- 4.12% at 10 years, and 64.82% +/- 5.34% at 13 years (2.6% patient-year). Actuarial freedom from structural valve deterioration-related reoperation was 98.43% +/- 1.1% at 5 years, 89.15% +/- 2.85% at 10 years, and 76.82% +/- 7.91% at 14 years. Multivariate analysis showed younger age and duration of implantation to be significant predictors of structural valve deterioration and its related reoperation. CONCLUSIONS: By studying a 15-year time period, it is seen that this new generation porcine bioprosthetic valve should be considered an alternative for mechanical valves in selected patients.     

Incidence of primary tissue valve failure in porcine bioprosthetic heart valves

This report provides retrospective follow-up data on 324 consecutive patients who received a Hancock-I porcine valve in the aortic or the mitral position, or in both positions, between June, 1974, and December, 1976. This analysis included 319 valves (193 mitral, 126 aortic) available for study of the incidence of primary tissue valve failure after 10 to 12.5 years of follow-up. Of the 319 prostheses at risk, 114 instances of primary tissue valve failure occurred. Seventy-three of the failed valves were in the mitral position, and 41 were in the aortic position. The calculated actuarial probability of freedom from primary tissue valve failure was 52 +/- 5% for the mitral and 58 +/- 6% for the aortic prostheses at 12.5 years of follow-up. For patients older than 40 years at the time of operation, the rate of freedom from primary failure was 68 +/- 8% and 55 +/- 6% for aortic and mitral prostheses, respectively, at 12.5 years. Comparison of both actuarial curves disclosed no meaningful difference. However, a tendency toward greater failure rate was observed in the mitral prosthesis group.     

Long-term results of porcine bioprosthetic heterograft; a 13-years' experience

One hundred and ninety-four patients underwent valve replacements with the glutaraldehyde-preserved porcine bioprostheses (133 Hancock valves, 39 Angell-Shiley valves, 22 Carpentier-Edwards valves and 3 other valves) from 1974 through 1979. There were 105 women and 89 men, whose age ranged 18 to 62 (mean 38.8) years. One hundred and eighty-two patients had mitral bioprosthetic valve replacement (BVR)s, of which 52 had combined aortic mechanical valve replacements, 8 had aortic BVR's, 3 had tricuspid BVR's and 3 had multi-BVR's. Operative mortality was 10.8%. Only one patient was lost to follow-up. Cumulative duration of follow-up is 1421 patient-years. Linearized rate of anticoagulant related hemorrhage, thromboembolism (TE), prosthetic valve endocarditis (PVE), primary tissue failure (PTF) and valve dysfunction (VD) were 0.07, 1.62, 0.49, 2.74 and 3.66% per patient-year. Actuarial freedom from TE, PVE, PTF and VD were 87.0 +/- 2.7%, 95.6 +/- 1.5%, 65.2 +/- 4.9% and 56.9 +/- 5.6% at 13 years. Actuarial survival rate was 67.4 +/- 4.0% at 13 years. Long term follow-up after valve replacement with porcine bioprosthetic valve confirms low thrombogenicity. But primary tissue failure was the chief cause of valve dysfunction and represent a major problem. At this time, we are going to use porcine bioprosthetic valve in the selected patients, that is in the situations in which anticoagulation is contraindicated.     

Cardiac valve replacement in patients on dialysis: influence of prosthesis on survival

BACKGROUND: Mechanical valves have been recommended for patients on dialysis because of purported accelerated bioprosthesis degeneration. This study was undertaken to determine time-related outcomes in dialysis patients requiring cardiac valve replacement. METHODS: From 1986 to 1998, 42 patients on chronic preoperative dialysis underwent valve replacement; 17 received mechanical valves and 25 received bioprostheses. Age was similar in both groups: 54+/-18.5 years (mechanical) and 59+/-15.5 years (bioprosthetic, p = 0.4). Sites of valve replacement were aortic (27), mitral (11), and aortic and mitral (4). Follow-up was 100% complete. RESULTS: Survival at 3 and 5 years was 50% and 33% after mechanical valve replacement, and 36% and 27% after bioprosthetic valve replacement (p = 0.3). Four patients with bioprostheses required reoperation: 3 for allograft endocarditis and 1 at 10 months for mitral bioprosthesis degeneration. One patient who received a mechanical valve required reoperation. CONCLUSIONS: Prosthetic valve-related complications in patients on dialysis were similar for both mechanical and bioprosthetic valves. Because of the limited life expectancy of patients on dialysis, bioprosthesis degeneration will be uncommon. Therefore, surgeons should not hesitate to implant bioprosthetic valves in these patients.     

Ten-year experience with the porcine bioprosthetic valve: interrelationship of valve survival and patient survival in 1,050 valve replacements

The porcine bioprosthetic valve was used in 440 patients having isolated mitral valve replacement (MVR), 522 patients having isolated aortic valve replacement (AVR), and 88 patients having MVR + AVR between 1974 and 1981. Patients with associated surgical procedures were excluded. Mean follow-up was 8.3 years. At 10 years, there was no difference in patient survival between those having AVR and those having MVR. Reoperations were performed on 192 patients. Endocarditis was the reason for reoperation in 3.7% of patients who had MVR and 10.6% of those who had AVR. Structural valve degeneration was the reason for reoperation in 89.7% of MVR patients and 78.8% of AVR patients (p = 0.04). Hospital mortality among patients having valve reoperations was 4.7%. At 10 years, the freedom from valve reoperation for all causes and from structural valve degeneration was significantly better for the AVR group than the MVR group (74% +/- 3% versus 61% +/- 4%, p = 0.004; and 79% +/- 3% versus 63% +/- 4%, p = 0.0006, respectively). For patients in their 60s, the 10-year freedom from reoperation was 92% +/- 2% for AVR and 80% +/- 6% for MVR (p = not significant). At 10 years, freedom from cardiac-related death and valve reoperation was best for both MVR and AVR patients in their 60s. Patients 70 years old or older rarely had reoperation but died before valve failure occurred. The 10-year freedom from all major valve-related events (cardiac-related death, reoperation, thromboembolism, endocarditis, and anticoagulant-related bleeding) was practically the same for both MVR and AVR patients (48% +/- 3% versus 49% +/- 3%, respectively). The porcine bioprosthetic valve is the valve of choice only for patients 60 years old or older. Patients in their 70s have an extremely low rate of reoperation but a high rate of cardiac-related death and do not outlive the prostheses.     

Mechanical versus bioprosthetic valve replacement in middle-aged patients.

OBJECTIVE: The current trend towards decreasing the age for selection of a tissue over a mechanical prosthesis has led to a dilemma for patients aged 50-65 years. This cohort study examines the long-term outcomes of mechanical versus bioprosthetic valves in middle-aged patients. METHODS: Patients (N = 659) aged between 50 and 65 years who had first-time aortic valve replacement (AVR) and/or mitral valve replacement (MVR) with contemporary prostheses were followed prospectively after surgery. The total follow-up was 3,402 patient-years (mean 5.1 +/- 4.1 years; maximum 18.3 years). Outcomes were examined with multivariate actuarial methods. A composite outcome of major adverse prosthesis-related events (MAPE) was defined as the occurrence of reoperation, endocarditis, major bleeding, or thromboembolism. RESULTS: Ten-year survival was 73.2 +/- 4.2% after mechanical AVR, 75.1 +/- 12.6% after bioprosthetic AVR, 74.1 +/- 4.6% after mechanical MVR, and 77.9 +/- 7.4% after bioprosthetic MVR (P=NS). Ten-year reoperation rates were 35.4% and 21.3% with aortic and mitral bioprostheses, respectively. Major bleeding occurred more often following mechanical MVR (hazard ratio [HR]: 3.3; 95% confidence interval [CI] 1.2, 9.0; P = 0.022), and the incidence of any thromboembolic event was more common after mechanical MVR (HR: 4.7; CI 1.4, 13.3; P = 0.01). Overall freedom from MAPE at 10 years was 70.2 +/- 4.1% for mechanical AVR patients, 41.0+/-30.3% for bioprosthetic AVR patients, 53.3 +/- 8.8% for mechanical MVR patients, and 61.2 +/- 9.2% for bioprosthetic MVR patients. Although a trend existed towards more MAPE amongst middle-age patients with tissue valves, multivariate analysis did not identify the presence of a bioprosthesis as an independent risk factor for MAPE (HR: 1.3; CI 0.9, 2.0; P = 0.22). CONCLUSIONS: In middle-aged patients, MAPE may occur more often in patients with bioprosthetic valves, but definitive conclusions necessitate the accumulation of additional follow-up. At present, these data do not support lowering the usual cutoff for implantation of a tissue valve below the age of 65.     

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.     

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.     

Six- to ten-year follow-up of patients with the Hancock cardiac bioprosthesis. Incidence of primary tissue valve failure

From June, 1974, through June, 1978, 547 porcine xenografts (299 mitral, 239 aortic, eight tricuspid, and one pulmonary) were inserted in 459 selected patients who survived the operation and were considered at risk for primary tissue valve failure. Ninety-two instances of primary tissue valve degeneration occurred in 82 of the 459 patients. In patients operated on 10 years ago, 28% of the valves implanted in the mitral position (5/18) and 33% in the aortic position (4/12) failed. These percentages decreased to 24% (21/89) and 26% (15/57) for those implanted in 1975, 15% (13/85) and 16% (9/57) for those implanted in 1976, 13% (9/71) and 15% (12/82) for 1977, and 8% (3/36) and 3% (1/31) for 1978. None of the tricuspid or pulmonary valves have failed. The rate of valve survival without primary degeneration was 70% +/- 6% for the mitral and 69% +/- 7% for the aortic prostheses at 10 years of follow-up. Of the 10 valves implanted in patients younger than 20 years of age, 40% of the mitral and 60% of the aortic valves failed. This rate is 26% for mitral and 42% for aortic for the 21 to 30 year group, 20% and 19% for 31 to 40 years, 9% and 13% for 41 to 50 years, 20% and 6% for 51 to 60 years, and 11% and 0% for 61 to 70 years. The average interval between placement and explantation or death was 74 months (range 10 to 112) for valves in the mitral position and 78 months (range 13 to 117) for valves in the aortic position. We believe these current data should have some bearing of practical import not only when comparing different types of bioprostheses but especially when recommending the appropriate valve replacement for the individual patient.     

Durability of the Carpentier-Edwards porcine bioprosthesis in aortic or mitral positions. 10 years' results on 458 surgically treated cases

458 patients with a Carpentier-Edwards porcine bioprosthesis (aortic (Ao): 169, mitral (Mi): 289) operated between January 1975 and December 1981, were studied during the first trimester of 1987. Forty seven patients underwent an associated operation. The total follow-up was 3,001 patient-years with a maximum follow-up of 11.4 years and a mean follow-up of 6.5 years. Only 5.6% of patients were lost to follow-up. The patients were aged between 20 and 80 years. The actuarial 9-year survival rate was 69.2 +/- 6.3% for aortic prostheses and 79.6 +/- 3.9% for mitral prostheses. The principal cause of valve failure, appearing with a considerable frequency after 5 years, was primary tissue degeneration which alone represented 67.8% of the causes of valve failure. The rate of absence of valve failure, for all causes combined, was 77.8 +/- 5.9% for the aortic position and 74.9 +/- 4.9% for the mitral position. The actuarial rate of absence of primary tissue degeneration at 9 years was 79.7 +/- 4.1% for aortic prostheses and 75.2 +/- 4.4% for mitral prostheses. The frequency of tissue degeneration decreased with increasing age, representing 2.9%, 1.9% and 1.5% patient-years respectively for the age-groups: 20 to 39 years, 40 to 59 years and 60 to 80 years. However, this difference was not statistically significant. Tissue degeneration was the principal cause for reoperation (n = 59) with an operative mortality of 7.8%.     

Late results after Starr-Edwards valve replacement in children

Selection of types of prosthetic heart valves for children remains controversial. The case histories of 50 children surviving valve replacement with Starr-Edwards prostheses between 1963 and 1978 were reviewed to evaluate the long-term performance of mechanical valves. The 31 boys and 19 girls ranged from 6 months to 18 years in age (mean 10.4 years); 19 patients had had aortic valve replacement, 24 patients had had mitral valve replacement, and one patient had had both. Among the six patients who had had tricuspid valve replacement, four had corrected transposition, so that the tricuspid valve was the systemic atrioventricular valve. Mean (+/- standard deviation) follow-up interval was 7.9 +/- 4.9 years (maximum 17 years). For all patients, the 5 year survival rate was 86% +/- 6%. At 10 years postoperatively, the survival rate (+/- standard error) was 90% +/- 7% after aortic valve replacement and 76% +/- 8% after systemic atrioventricular valve replacement. At follow-up, 39 patients were alive, and 38 were in New York Heart Association Class I or II. Of the 11 deaths, four were valve-related. Seven patients had major (requiring hospitalization) thromboembolic events, and five patients had minor transient neurological symptoms suggesting thromboembolism; 50% of these patients were not taking warfarin (Coumadin) at the time of the thromboembolic event. The incidence of late (greater than 30 days) thromboembolism was 5.3 per 100 patient-years after aortic and 2.0 per 100 patient-years after systemic atrioventricular valve replacement. At 10 years postoperatively, 66% +/- 15% of patients who had had aortic valve replacement and 91% +/- 6% of those who had had systemic atrioventricular valve replacement were free of thromboembolism. The excellent long-term survival, absence of mechanical failure, and relatively low rate of thromboembolism with this prosthesis contrast with our experience with biological valves, in which 41% of children required reoperation in 5 years. Currently, mechanical valves, such as the Starr-Edwards prostheses, are our preferred valves for pediatric patients.     

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.     

Long-term durability of the Hancock porcine bioprosthesis following combined mitral and aortic valve replacement: an 11-year experience

Long-term evaluation of patients undergoing combined mitral and aortic valve replacement (MVR + AVR) with a porcine bioprosthesis provides the opportunity for a direct comparison of the durability of the mitral versus the aortic porcine bioprosthesis in the same patient. From 1970 to 1983, 71 patients underwent MVR + AVR with Hancock porcine bioprostheses. There were 46 men an 25 women ranging in age from 21 to 64 years (mean, 47.5 +/- 5 years). Sixteen patients (22.5%) died at operation. The survivors were followed from 0.2 to 11.5 years (mean, 5.7 +/- 3 years). Duration of follow-up was 313 patient-years and was 100% complete. Overall late mortality was 6.7 +/- 1.4% per patient-year (linearized incidence), and actuarial survival was 54.2 +/- 8% at 11 years. Endocarditis occurred in 4 patients (linearized incidence of 1.3 +/- 0.6% per patient-year); thromboembolic events were sustained by 4 patients (linearized incidence of 1.3 +/- 0.6% per patient-year); the event was fatal in 1 patient. Actuarial freedom from thromboembolism was 90 +/- 4.8% at 11 years. Reoperation for primary tissue failure was performed in 11 patients (linearized incidence of 3.5 +/- 1% per patient-year) with no deaths; in 7 patients both bioprostheses were explanted, and in 4, only the mitral bioprosthesis was replaced. The durability of explanted aortic and mitral porcine bioprostheses was not significantly different, and the evaluation of seven pairs of explanted aortic and mitral bioprostheses showed similar amounts of calcification. Actuarial freedom from reoperation because of primary tissue failure was 44.6 +/- 13.7% at 11 years.(ABSTRACT TRUNCATED AT 250 WORDS)     

Heart valve replacement with the Sorin tilting-disc prosthesis. A 10-year experience.

From 1978 to 1988, 697 patients with a mean age of 48 +/- 11 years (range 5 to 75 years) received a Sorin tilting-disc prosthesis; 358 had had aortic valve replacement, 247 mitral valve replacement, and 92 mitral and aortic valve replacement. Operative mortality rates were 7.8%, 11.3%, and 10.8%, respectively, in the three groups. Cumulative duration of follow-up is 1650 patient-years for aortic valve replacement (maximum follow-up 11.4 years), 963 patient-years for mitral valve replacement (maximum follow-up 9.9 years) and 328 patient-years for mitral and aortic valve replacement (maximum follow-up 9.4 years). Actuarial survival at 9 years is 72% +/- 4% after mitral valve replacement, 70% +/- 3% after aortic valve replacement, and 50% +/- 12% after mitral and aortic valve replacement, and actuarial freedom from valve-related deaths is 97% +/- 2% after mitral valve replacement, 92% +/- 2% after aortic valve replacement, and 62% +/- 15% after mitral and aortic valve replacement. Thromboembolic events occurred in 21 patients with aortic valve replacement (1.3% +/- 0.2%/pt-yr), in 12 with mitral valve replacement (1.2% +/- 0.3% pt-yr), and in seven with mitral and aortic valve replacement (2.1% +/- 0.8%), with one case of prosthetic thrombosis in each group; actuarial freedom from thromboembolism at 9 years is 92% +/- 3% after mitral valve replacement, 91% +/- 3% after aortic valve replacement, and 74% +/- 16% after mitral and aortic valve replacement. Anticoagulant-related hemorrhage was observed in 15 patients after aortic valve replacement (0.9% +/- 0.2%/pt-yr), in 9 after mitral valve replacement (0.9% +/- 0.3%/pt-yr), and in 6 with mitral and aortic valve replacement (0.9% +/- 0.5%/pt-yr); actuarial freedom from this complication at 9 years is 94% +/- 2% after aortic valve replacement, 91% +/- 4% after mitral valve replacement, and 68% +/- 16% after mitral and aortic valve replacement. Actuarial freedom from reoperation at 9 years is 97% +/- 2% after mitral and aortic valve replacement, 92% +/- 4% after mitral valve replacement, and 89% +/- 3% after aortic valve replacement, with no cases of mechanical fracture. The Sorin valve has shown a satisfactory long-term overall performance, comparable with other mechanical prostheses, and an excellent durability that renders it a reliable heart valve substitute for the mitral and aortic positions.     

Long-term clinical results with the Ionescu-Shiley pericardial xenograft

From 1977 to 1987, 829 Ionescu-Shiley pericardial valves (Shiley, Inc., Irvine, Calif.) were implanted in 766 patients at the University of Ottawa Heart Institute. There were 476 patients who had aortic valve replacement, 234 who had mitral valve replacement, and 44 who had double valve replacement. The standard-profile design was used in 508 patients and the low-profile design in 321 patients. Follow-up was obtained for 97% of patients, with calculation of event-free probabilities. At 10 years the overall probability of freedom from structural failure was 48% +/- 7% after aortic valve replacement, 44% +/- 15% after mitral valve replacement, and 79% +/- 11% after double valve replacement. Although at 5 years the probability of failure was statistically lower with the low-profile design, this favorability was lost by 6 years. Freedom from structural failure was only 47% +/- 7% for the standard-profile valve at 10 years. Thus the probability of freedom from reoperation was only 46% +/- 7% after aortic valve replacement, 39% +/- 6% after mitral valve replacement, and 65% +/- 20% after double valve replacement at 10 years. Thromboembolism occurred in 69 patients, for a predicted freedom from this complication at 10 years of 79% +/- 3% after aortic, 73% +/- 7% after mitral, and 96% +/- 4% after double valve replacement. There were 31 cases of endocarditis. The 10-year predicted freedom from endocarditis, therefore, was 86% +/- 3% after aortic, 98% +/- 1% after mitral, and 97% +/- 1% after double valve replacement. A total of 221 operative and late deaths were recorded in this series. Prosthetic valve failure accounted for 27% of late deaths. The 10-year survival rates were estimated to be 56% +/- 5% (aortic valve replacement), 54% +/- 6% (mitral valve replacement), and 51% +/- 8% (double valve replacement). We concluded that the Ionescu-Shiley pericardial xenograft provides less than optimal clinical performance and its use has been discontinued.