Long-term performance of the Hancock porcine bioprosthesis in the tricuspid position. A review of forty-five patients with fourteen-year follow-up

Because little information is available regarding the clinical performance of the Hancock porcine bioprosthesis (Johnson & Johnson Cardiovascular, King of Prussia, Pa.) implanted in the tricuspid position, we reviewed the long-term follow-up of patients who had tricuspid valve replacement with this device. From March 1970 to December 1983, 45 patients had tricuspid valve replacement, either isolated (seven patients) or combined with replacement of other valves (38 patients) by means of a standard, glutaraldehyde-preserved Hancock porcine bioprosthesis. Follow-up ranged from 0.2 to 14.7 years (mean, 7.6 +/- 3.6 years) and was complete. The late mortality rate was 6.6% +/- 1.6%/pt-yr and the actuarial survival rate at 14 years was 23% +/- 9%. Reoperation because of structural deterioration of the tricuspid, the mitral, or both bioprostheses was performed in nine patients (3.7% +/- 1.2%/pt-yr) from 40 to 177 months (mean, 112 +/- 43 months) and resulted in no deaths. Actuarial freedom from structural deterioration of a Hancock tricuspid porcine bioprosthesis at 14 years is 68% +/- 13%. Morphologic examination of explanted porcine bioprostheses showed that those implanted in the tricuspid position had lower degrees of calcification and less severe structural changes than those simultaneously explanted from the mitral position. We conclude that the Hancock porcine bioprosthesis has an acceptable long-term durability and satisfactory performance after tricuspid valve replacement, and we continue to favor its use in the tricuspid position even in association with mechanical prostheses in the left side of the heart.     

Long-term durability of the Hancock II porcine bioprosthesis

BACKGROUND: Survival and prosthetic complications of patients receiving the Hancock II second-generation bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in the aortic, mitral, mitral-aortic, and tricuspid positions were analyzed at 15 years' follow-up. METHODS: Between May 1983 and December 1993, 212 patients (104 men and 108 women; mean age, 63 +/- 9 years; age range, 29-81 years) received 66 aortic, 114 mitral, 26 mitral-aortic, and 6 tricuspid Hancock II valves. Thirty-one percent of patients had previous valve operations, 15% had concomitant cardiac procedures, and 87% were in New York Heart Association class III or IV. Follow-up included 1704 patient-years and was 98% complete, with a median of 9 patient-years (range, 0.013-17.4 years). Forty-six patients were at risk at 14 to 15 years, and 30 were at risk after 15 years. RESULTS: One hundred twenty-two (57%) of 212 patients died, 20 of them perioperatively. Fifteen-year actuarial Kaplan-Meier survival was 35.2% +/- 3.8%, and freedom from valve-related mortality was 84% +/- 3.5%, with no difference on the basis of position or age (<65 or >or=65 years). Percentages for freedom from thromboembolism, anticoagulant-related hemorrhage, endocarditis, and paravalvular leak were, respectively, 78.2% +/- 4%, 83.5% +/- 3.6%, 95.7% +/- 2%, and 97.3% +/- 1.4%, with no significant difference between the aortic and mitral positions. Freedom from structural valve deterioration was 71.8% +/- 5.6%: 88.9% +/- 6.2% in the aortic position versus 59.5% +/- 3.9% in the mitral position (P =.01) and 64.3% +/- 3% in the mitral-aortic position. In patients younger than 65 years, actual freedom from structural valve deterioration was less than that seen in older patients (84.5% +/- 3.5% vs 95% +/- 3.0%) and was better in the aortic versus the mitral position (92% +/- 4.5% vs 82% +/- 4.2%). CONCLUSION: The Hancock II porcine valve showed excellent 15-year durability. We recommend its use in patients 65 years of age, as well as in younger patients undergoing aortic replacement.     

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-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.     

Comparison of long-term results of Carpentier-Edwards and Hancock bioprosthetic valves

The long-term survival following valve replacement with Carpentier-Edwards or Hancock bioprostheses was compared between the two valve models and between the two groups totaling 407 patients who were discharged after valve replacement beginning in 1974. The two groups of patients were treated in a nonrandomized fashion. The actuarial survival for 299 patients with Carpentier-Edwards valves was 94 +/- 1.5% (+/- standard error) and 93 +/- 1.7% after 5 and 8 years of follow-up, respectively. Comparable figures for 108 patients undergoing valve replacement with Hancock valves were 89 +/- 3.0% and 83 +/- 3.7%, respectively (p = not significant [NS]). The probability of freedom from death and valve removal after 5 and 8 years of follow-up was 91 +/- 1.8% and 79 +/- 4.6%, respectively, with the Carpentier-Edwards valve and 84 +/- 3.5% and 75 +/- 4.3%, respectively, with the Hancock valve (p = NS). An accelerated rate of attrition for both valves was observed in the mitral position. There were no significant differences in actuarial survival between the two valves in the mitral or the aortic position or in the incidence of major valve-related complications.     

Excellent durability of the Hancock porcine bioprosthesis in the tricuspid position. A sixteen-year follow-up study.

From February 1975 to August 1981, 23 consecutive patients underwent tricuspid valve replacement, which was either isolated (six patients) or combined with the replacement of other valves (17) by means of a standard, glutaraldehyde-preserved Hancock porcine bioprostheses. Patients' ages ranged from 9 to 53 (mean 36.2) years. The follow-up period ranged from 0.2 to 16.5 years (mean 9.1) and was complete in 100% of all cases. Structural valve failure of the tricuspid Hancock valve was noticed in two patients, a 9-year-old boy and a 13-year-old girl 3.4 and 16.5 years after implantation, respectively. The actuarial freedom rate from structural valve failure at 10 years was 94 +/- 6%. There were six tricuspid prosthesis-related events: structural valve failure in two and valve thrombosis, anticoagulant-related bleeding, prosthetic valve endocarditis, and periprosthetic leak in one each, respectively. The actuarial freedom from these events at 10 years was 78 +/- 10%. Five pairs of aortic/mitral-tricuspid Hancock valves were explanted simultaneously from the same patients after 8.1 to 13.9 (mean 11.4) years postoperatively. A gross examination showed no valve dysfunction in the explants from the tricuspid position, but degenerative changes with valve dysfunction in those from the mitral and aortic position were observed (none of five versus five of seven; p < 0.03). We concluded that the selection of a Hancock bioprosthesis in the tricuspid position is acceptable because of the low incidence of prosthesis-related complications and the excellent durability of more than 10 years.     

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.     

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.     

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)     

Clinical assessment of prosthetic valve replacement of the right-sided cardiac valves: mechanical or bioprosthesis?

Clinical results with mechanical and bioprosthetic valve replacements for tricuspid and/or pulmonary positions were reviewed. Between February 1975 and December 1985, 34 bioprostheses (B) (22 Hancock, 9 Ionescu-Shiley and 3 Carpentier-Edwards pericardial) and 18 mechanical prostheses (M) (St. Jude Medical) were implanted in our institute excluding hospital death. Group with B included 29 tricuspid valve replacements and 5 pulmonary valve replacements. Group with M included 9 tricuspid valve replacements, 7 pulmonary valve replacements and 1 both valve replacements. The cumulative follow-up period was 207.2 patient-years (p-t) in group B and 55.0 p-y in group M. The incidence of valve failure was 0.48 +/- 0.48% per p-y in group B and 7.27 +/- 3.64% per p-y in group M (p less than 0.001). The incidence of valve-related events was 1.93 +/- 0.97% per p-y in group B and 9.09 +/- 4.07% per p-y in group M (p less than 0.001). At 3 years, the percent free of valve failure was 100 +/- 0% in group B and 76.8 +/- 10.2% in group M (p less than 0.05). Fourteen bioprosthetic valves (B') and 10 mechanical valves (M') were implanted at the right-sided cardiac valve position alone. The cumulative follow-up period was 94.2 p-y in group B' and 32.3 p-y in group M'. The incidence of valve-related events was 1.06 +/- 1.06% per p-y in group B' and 12.4 +/- 6.19% per p-y in group M' (p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)     

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.     

An eight-year experience with porcine bioprosthetic cardiac valves

A total of 589 porcine bioprostheses were implanted in 509 patients from January, 1976, through December, 1983. Of the valves implanted, 390 were Hancock and 199 were Carpentier-Edwards. A total of 1,633 patient-years was accrued, with a mean follow-up of 38 months per patient. Two hundred eight patients had aortic valve replacement, 209 had mitral valve replacement, and 79 had multiple valve replacements, of which 46 were aortic and mitral replacements. The mortality for isolated aortic valve replacement was 5.8%; for isolated mitral replacement, 8.6%, and for all patients, 10.9%. Late mortality was 3.9% per patient-year. The actuarial survival rate at 5 years was 79% for aortic, 68% for mitral, and 76% for aortic-mitral valve replacement. There were 12 thromboembolic events (0.73% per patient-year). Two episodes occurred in patients with an aortic bioprosthesis, nine in patients with a porcine mitral valve, and one in a patient with mitral and tricuspid bioprosthetic valves. The probability of remaining free of thromboembolism at 5 years was 99% for the group having aortic valve replacement, 93% for those having mitral replacement, and 100% for the group having aortic-mitral valve replacements. Thirteen episodes of endocarditis occurred (0.8% per patient-year). Seven of the 13 patients died as a direct result of endocarditis. The probability of remaining free of prosthetic endocarditis at 5 years was 97% for the aortic valve replacement group, 95% for the mitral group, and 97% for the aortic-mitral group. There were 20 instances of xenograft failure (1.2% per patient-year). The probability of remaining free of valve failure at 5 years was 96% for the aortic valve replacement group, 93% for the mitral group, and 93% for the aortic-mitral replacement group. Primary tissue failure of a prosthesis occurred in seven patients, all with Hancock valves (0.43% per patient-year). As yet there has been no primary tissue failure of the Carpentier-Edwards prosthesis. There also appears to be a lower incidence of thromboembolism (Edwards, 0.3% per patient-year; Hancock, 0.8% per patient-year) and endocarditis (Edwards, 0.6% per patient-year; Hancock, 1.0% per patient-year). The low incidence of complications with the porcine bioprosthetic valve, especially the Carpentier-Edwards, encourages us to recommend its continued use, especially in situations in which anticoagulation is contraindicated.     

Thromboembolism in patients with pericardial valves in the absence of chronic anticoagulation: 12 years' experience.

Between January 1977 and January 1989, 465 pericardial bioprostheses were implanted in 424 patients. The mean age of patients was 59.1 years (range 16-81 y.) At the time of surgery, 68% of the patients suffered from chronic atrial fibrillation. Mitral valve replacement was performed in 167 patients, aortic valve replacement in 216, multiple replacement in 40 (36 mitral and aortic, 3 mitral and tricuspid, and 1 mitral, aortic and tricuspid), and 1 pulmonary valve replacement. The different types of pericardial valve used were: Ionescu-Shiley 408, Mitral Medical 23, Bioflo 30, and Hancock 4. Hospital mortality was 10.1% with an attrition rate of 1.8 episodes per 100 patients/year. The 12-year actuarial survival rate was 65.1%. No patient underwent long-term anticoagulant treatment. The first 144 patients undergoing mitral and multiple valve replacements received temporary anticoagulation for the first 8 weeks after surgery. There was no valve thrombosis observed. Altogether 19 thromboembolic events (6 early and 13 late) were clinically documented. One patient died after an embolic event. The linearized rates of thromboembolism were 1.64 episodes per 100 patients/year for mitral and multiple valve replacements and 0.33 episodes per 100 patients/year for aortic valve replacement, with an overall rate of 1.0 episodes per 100 patients/year. Excluding early thromboembolism, the linearized rate was 1.02 episodes per 100 patients/year overall. The actuarial freedom from embolism was 92.4% overall, 88.2% for the mitral and multiple valve replacement group, and 97.6% for the aortic valve replacement group at a maximum follow-up of 12 years.(ABSTRACT TRUNCATED AT 250 WORDS)     

Twenty-year experience with the St Jude Medical mechanical valve prosthesis

BACKGROUND: We have prospectively followed all adult St Jude Medical mechanical valve recipients at the Medical University of South Carolina since the initial implant in January 1979 and now present our 20-year experience. METHODS: We prospectively followed 837 valve recipients (aortic valve replacement; n = 478; mitral valve replacement; n = 359) from January 1979 to December 2000 at 12-month intervals. RESULTS: Ages ranged from 19 to 84 years. Follow-up averaged (mean +/- standard deviation) 7 +/- 5 years (98% complete). Patients were in New York Heart Association class III or IV in 77% (aortic valve replacement) and 89% (mitral valve replacement) preoperatively. A 19-mm valve was implanted in 15.5% of aortic valve replacement patients. Coronary bypass was required in 31% of aortic valve replacements and 20% of mitral valve replacements. Operative mortality was 17/478 (3.6%) in aortic valve replacement and 19/359 (5.3%) in mitral valve replacement, and multivariable predictors were 19-mm valve size, 3 or more coronary bypass grafts, and New York Heart Association class IV for aortic valve replacement and New York Heart Association class IV and age for mitral valve replacement. Actuarial survivorship at 10 and 20 years was 57% +/- 3% and 26% +/- 5% for aortic valve replacement and 61% +/- 3% and 39% +/- 4% for mitral valve replacement. Multivariable predictors of late death were African-American ethnicity, New York Heart Association class III or IV, coronary bypass, and age for aortic valve replacement and New York Heart Association class III or IV, coronary bypass, and age for mitral valve replacement. For aortic valve replacement, effective orifice area was univariately (P =.002) but not multivariately (P =.378) predictive of late death. Structural valve deterioration was not observed. For aortic valve replacement, actuarial freedom (at 10 and 20 years) from reoperation was 93% +/- 1% and 90% +/- 2%; thromboembolism, 82% +/- 3% and 68% +/- 8%; bleeding events, 77% +/- 3% and 66% +/- 6%; prosthetic valve endocarditis, 94% +/- 1% and 94% +/- 1%; valve-related mortality, 94% +/- 2% and 86% +/- 4%; and valve-related mortality or morbidity, 58% +/- 3% and 32% +/- 8%. For mitral valve replacement, actuarial freedom (at 10 and 20 years) from reoperation was 96% +/- 1% and 90% +/- 3%; thromboembolism, 77% +/- 3% and 59% +/- 7%; bleeding events, 86% +/- 2% and 65% +/- 8%; prosthetic valve endocarditis, 98% +/- 1% and 96% +/- 2%; valve-related mortality, 89% +/- 0.2% and 74% +/- 8%; and valve-related mortality or morbidity, 63% +/- 3% and 29% +/- 7%. CONCLUSIONS: After 2 decades of observation with close follow-up, the St Jude Medical mechanical valve continues to be a reliable prosthesis.     

Failure of Hancock xenograft valve: importance of valve position (4- to 9-year follow-up)

To evaluate long-term durability of Hancock valves, we reviewed our results in 107 hospital survivors (120 valves) who were operated on during 1974 through mid-1979. Mitral valve replacement was done in 63 patients, aortic valve replacement in 20, and mitral valve replacement combined with other procedures in 24. The 7-year survival was 84 +/- 4% (standard error of the mean) for 91 patients and 97 valves. During a follow-up of 590 patient-years, 15 (12 mitral and 3 aortic) of 120 valves at risk (87 mitral, 32 aortic, 1 tricuspid) were removed from 14 patients. Six valves (3 mitral and 3 aortic) were removed because of bacterial endocarditis. One mitral valve was removed because of thromboembolism. Eight mitral valves were removed because of valve structural failure, which occurred at a mean follow-up of 42 months. These valves showed extensive calcification, leaflet perforation, or cusp tear. Structural failure was unrelated to valve size, year of implantation, or valve shelf-life. Structural failure was not seen after aortic valve replacement. Results show that structural failure of the Hancock xenograft valve in the mitral position is related primarily to valve position. After aortic valve replacement, valve failure is predominantly due to endocarditis. Although medium-term (mean, 6-year) durability of this xenograft valve compares satisfactorily with prosthetic valves, its high failure rate in the mitral position indicates the necessity for improvement in valve mounting, design, and preservation.     

Determinants of survival and valve failure after mitral valve replacement

A prospective evaluation of 333 consecutive patients undergoing isolated mitral valve replacement between 1982 and 1985 was performed to identify the predictors of survival and valve failure. Follow-up between 2 and 6 years postoperatively (mean, 32 +/- 17 months) was 98% complete. Four prostheses were inserted to permit a prospective evaluation of alternative valves: Bj?rk-Shiley mechanical (n = 118), Ionescu-Shiley pericardial (n = 146), Carpentier-Edwards porcine (n = 38), and Hancock pericardial (n = 31). Hospital mortality was 6%, and actuarial survival at 5 years was 74% +/- 5%. Multivariate Cox regression analysis identified advancing age (less than 40 years, 88% +/- 7%; greater than 70 years, 50% +/- 14%) and poor left ventricular function (ejection fraction less than 0.20, 62% +/- 17%; ejection fraction greater than 0.60, 80% +/- 7%) as independent predictors of postoperative survival. Freedom from structural valve dysfunction, prosthetic valve endocarditis, reoperation, and valve-related mortality and morbidity were 86% +/- 4%, 91% +/- 4%, 81% +/- 4%, and 72% +/- 5%, respectively, at 5 years. The actuarial incidence of valve failure was inordinately high with the Hancock pericardial valve (p less than 0.05). Freedom from thromboembolic events (78% +/- 8% at 5 years) was significantly lower in patients with poor ventricular function (ejection fraction (less than 0.20, 54% +/- 20%; ejection fraction greater than 0.60, 73% +/- 11%; p less than 0.05). Survival after mitral valve replacement was determined by age and left ventricular function. Premature failure of the Hancock pericardial valve resulted in an unacceptable rate of valve-related complications.     

Late incidence and predictors of persistent or recurrent heart failure in patients with mitral prosthetic valves

OBJECTIVE: The study's objective was to examine factors associated with persistent or recurrent congestive heart failure after mitral valve replacement. METHODS: Patients who underwent mitral valve replacement with contemporary prostheses (N = 708) were followed with annual clinical assessment and echocardiography. Cox proportional hazard models were developed to evaluate the impact of demographic, comorbid, and valve-related variables on the occurrence of congestive heart failure after mitral valve replacement, defined as the composite outcome of New York Heart Association class III or IV symptoms or death caused by congestive heart failure postoperatively. Factors associated with all-cause mortality were also examined. Models were bootstrapped 1000 times. RESULTS: The total follow-up was 3376 patient-years (mean 4.8 +/- 3.7 years, range 60 days to 17.1 years). Freedom from New York Heart Association III or IV symptoms or death caused by congestive heart failure was 96.1% +/- 0.8%, 82.7% +/- 1.7%, 66.4% +/- 3.0%, and 38.8% +/- 6.9% at 1, 5, 10, and 15 years, respectively. Preoperative New York Heart Association class, left ventricular grade, atrial fibrillation, coronary artery disease, smoking, persistent tricuspid regurgitation, and redo status predicted congestive heart failure postoperatively (all P <.05). Patients who underwent mitral valve replacement for pure mitral stenosis had less congestive heart failure events after surgery than those with regurgitation or mixed disease. Prosthesis size and elevated transprosthesis gradients were not predictive of freedom from congestive heart failure after mitral valve replacement. Atrial fibrillation, persistent tricuspid regurgitation, and surgical referral for mitral valve replacement at an advanced functional stage were also risk factors for all-cause mortality. CONCLUSIONS: This study identifies the incidence of and risk factors for congestive heart failure and death late after mitral valve replacement. Although prosthesis size has no effect, other potentially modifiable factors such as atrial fibrillation, persistent tricuspid regurgitation, and late surgical referral have a negative impact on freedom from congestive heart failure and overall survival after mitral valve replacement.     

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).     

Survival and valve failure after aortic valve replacement.

A prospective evaluation of 412 consecutive patients undergoing isolated aortic valve replacement between January 1982 and December 1985 was performed in an attempt to identify the determinants of survival and valve failure. A variety of valves were inserted to permit a prospective evaluation of alternative valves including: Bj?rk-Shiley mechanical (n = 37), Ionescu-Shiley pericardial (n = 261), Hancock pericardial (n = 78), and Carpentier-Edwards porcine (n = 36). Thirteen patients died in the hospital (3.2%) and 47 patients died in the follow-up period producing an actuarial survival of 81% +/- 3% at 48 months. Survival was independently predicted by advancing age, preoperative New York Heart Association functional class, and the presence of endocarditis (p less than 0.05 by Cox regression analysis). The majority of patients were symptomatically improved (New York Heart Association class I or II: 21% preoperative, 88% postoperative). Freedom from structural valve dysfunction, prosthetic valve endocarditis, and reoperation for valve-related complications were 95% +/- 2%, 95% +/- 2%, and 92% +/- 2% at 48 months, respectively. These valve-related complications occurred more frequently in younger patients and in those with a Hancock pericardial valve (freedom from structural valve dysfunction, 89% +/- 5%; prosthetic valve endocarditis, 84% +/- 9%; reoperation, 78% +/- 10%; p less than 0.05 by Cox regression). Freedom from thromboembolism was 88% +/- 2% at 48 months; it was significantly lower in patients with a preoperative thromboembolic event and was not influenced by the type of prosthesis inserted. Freedom from anticoagulant-related hemorrhage was 85% +/- 8% at 48 months and was not influenced by any preoperative factors.(ABSTRACT TRUNCATED AT 250 WORDS)     

Clinical evaluation of the Bj?rk-Shiley disc valve in the tricuspid position. Long-term results

Between 1971 and 1981, 1210 Bj?rk-Shiley prostheses were implanted. Of these, 79 were in the tricuspid position, comprising 30 triple valve replacements, 46 mitral plus tricuspid, and 3 isolated tricuspid replacements. The ages ranged from 10-55 years (mean 45 years). Sixty-three patients (80%) were in NYHA grades III or IV preoperatively. Thirteen patients died in hospital after surgery (16.5%). The 66 survivors have been followed for up to 16 years (mean 7.5 years). There have been 37 late deaths (7.5 per patient year). Twelve were valve-related: 4 tricuspid complications, 4 mitral complications, 2 prosthetic endocarditis, 1 aortic leak and 1 anticoagulant-related bleed. Twenty-one late deaths were not valve-related, and 4 causes of death are unknown. Expressed actuarially, survival at 5 years was 68%, and at 10 years, 49.4% +/- 12%. Freedom from valve-related death at 10 years was 80.7% +/- 7%. At last follow-up, 90% of the survivors were in NYHA class 1 or 2 with only modest signs of venous hypertension. The commonest life-threatening complication was obstruction of the tricuspid prosthesis by tissue ingrowth. This occurred in 7 patients (1.4% per patient year) 4 were re-operated upon and survived, 3 died. Doppler echocardiography has been carried out on 27 survivors of whom 5 had abnormal pressure-half times but only 3 of these were symptomatic. This series shows that function of the standard disc Bj?rk-Shiley prosthesis in the tricuspid position compares favourably with other prostheses. The problem of tissue ingrowth can be diagnosed by echo Doppler and reoperation successfully carried out.