Mitral and mitro-aortic valve replacement with Sorin Bicarbon valves compared with St. Jude Medical valves

OBJECTIVE: We assessed the clinical results of two bileaflet mechanical valves: the St. Jude Medical (SJM) and the Sorin Bicarbon (Sorin Bicarbon) used either in single mitral valve replacement (MVR) or in double, aortic and mitral, valve replacement (DVR). METHODS: Between September 1990 and November 1995, 217 patients received either a St. Jude Medical (n=134) or a Sorin Bicarbon (n=86): 136 mitral valve replacement with 83 St. Jude Medical and 53 Sorin Bicarbon and 84 double valve replacement with 51 St. Jude Medical and 33 Sorin Bicarbon. There was no difference between both St. Jude Medical and Sorin Bicarbon cohorts in respect of mitral valve physiopathology, etiology of valve disease, associated lesions, echocardiographic and hemodynamic data. The only significant preoperative difference was the age of patients within the double valve replacement group and the size of implanted valves within the mitral valve replacement group. Follow-up was 100% complete with a mean of 39+/-18 months, ranging between 6 and 68 months. The total follow-up was 657 patient-years (pt-y): 396 pt-y in the mitral valve replacement group and 274 pt-y in the double valve replacement group. RESULTS: Hospital mortality (St. Jude Medical: 2.2%; Sorin Bicarbon: 6.9%) and late mortality (St. Jude Medical: 8.4%; Sorin Bicarbon: 6.3%) were not significantly different. Ten deaths were considered valve-related (St. Jude Medical 6, Sorin Bicarbon 4). The estimated 4-yr overall survival, including hospital mortality, was for St. Jude Medical--mitral valve replacement: 89+/-4% and St. Jude Medical--double valve replacement: 93+/-4%, and for Sorin Bicarbon--mitral valve replacement: 87+/-5% and Sorin Bicarbon--double valve replacement: 91+/-5%. The linearized incidence (% per pt-y) of valve-related complications was 6.39 in the St. Jude Medical cohort and 9.2 in the Sorin Bicarbon cohort. The linearized incidence (% pt-y) of the prevalent complication, valve thromboembolism and bleeding, was for St. Jude Medical-mitral valve replacement: 3.41, St. Jude Medical--double valve replacement: 3.16 and for Sorin Bicarbon--mitral valve replacement: 2.17 and Sorin Bicarbon--double valve replacement: 3.67. The differences between each group of an estimated 4-yr freedom from combined thromboembolism and bleeding were not significant (St. Jude Medical--mitral valve replacement: 90+/-4%, St. Jude Medical--double valve replacement: 84+/-6%, and for Sorin Bicarbon--mitral valve replacement: 94+/-3% and Sorin Bicarbon--double valve replacement: 75+/-17%). CONCLUSIONS: In this clinical non-randomized study, there was no evidence of any significant difference between St. Jude Medical and Sorin Bicarbon valves over a 4-yr follow-up.     

Mitral valve replacement: randomized trial of St. Jude and Medtronic-Hall prostheses.

To better define the merits of the bileaflet and tilting-disc valves, we prospectively randomized 102 patients (mean age, 57 years; range, 11 to 85 years) to receive either the St. Jude (n = 55) or the Medtronic-Hall (n = 47) mitral valve prosthesis between September 1986 and May 1991. The two groups were not different with respect to preoperative New York Heart Association class, incidence of mitral stenosis and insufficiency, angina score, extent of coronary artery disease, ventricular function, completeness of revascularization, or cross-clamp or bypass time. The hospital mortality (14.5% versus 10.6%, St. Jude versus Medtronic-Hall) and late mortality (7.3% versus 2.1%) were not significantly different. Follow-up was complete in 84 of 89 hospital survivors (94%) with a mean of 26 months (range, 1 to 60 months). The linearized rates of valve-related events and the 3-year actuarial survival demonstrated no significant differences between both cohorts. Comparison of the clinical outcome and echocardiographic parameters obtained at the time of follow-up demonstrated no significant differences between the two prostheses. These data indicate that the Medtronic-Hall and St. Jude mitral prostheses are similar with respect to their rates of valve-related complications and hemodynamic profiles. This study suggests that there is no difference between the St. Jude and Medtronic-Hall prostheses with regard to early clinical performance or hemodynamic results and therefore does not support the preferential selection of either prosthesis.     

Comparison of survival after mitral valve replacement with biologic and mechanical valves in 1139 patients

OBJECTIVE: We sought to compare 10-year survival in patients after mitral valve replacement with biologic or mechanical valve prostheses. METHODS: Retrospective survival analysis was performed on data from 1139 consecutive patients older than 18 years of age undergoing mitral valve replacement with Carpentier-Edwards (n = 495; Baxter Healthcare Corp, Irvine, Calif) or St Jude Medical (n = 644; St Jude Medical, Inc, St Paul, Minn) prostheses. RESULTS: The 10-year survival was not statistically different between the patients receiving Carpentier-Edwards valves and those receiving St Jude Medical valves (P =.16). Adjusted survival estimates at 2, 5, and 10 years were 82% +/- 2% (95% confidence intervals, 79%-85%), 69% +/- 2% (95% confidence intervals, 64%-73%), and 42% +/- 3% (95% confidence intervals, 37%-48%), respectively, for the Carpentier-Edwards group and 83% +/- 2% (95% confidence intervals, 80%-86%), 72% +/- 2% (95% confidence intervals, 69%-76%), and 51% +/- 3% (95% confidence intervals, 45%-58%), respectively, for the St Jude Medical group. Predictors of worse survival after mitral valve replacement are older age, lower ejection fraction, presence of class IV congestive heart failure, coronary artery disease, renal disease, smoking history, hypertension, concurrent other valve surgery, and redo heart surgery. CONCLUSION: Choice of biologic or mechanical prosthesis does not significantly affect long-term patient survival after mitral valve replacement.     

Clinical performance of St. Jude and Medtronic-Hall prostheses: a randomized comparative study

Newer and improved models of mechanical prostheses are regularly added to surgeons' armamentarium. This study was designed to compare the clinical performance of two of the most used current models of mechanical prostheses. From August 1983 through July 1985, 182 white patients were prospectively randomized to implantation of the St. Jude Medical (95 patients) or Medtronic-Hall (87 patients) prostheses. There were 84 mitral, 85 aortic, and 13 double (mitral and aortic) valve replacements. There were no differences between the two groups with regard to sex distribution, age, functional class, emergency operation, and site of implantation. Early mortality was 3.2% for patients with the St. Jude valve and 5.7% for those with the Medtronic-Hall (p = NS). The survivors were followed for 3 to 5 years (mean, 4.2 +/- 0.6 years; cumulative follow-up, 559 patient-years). Late mortality was 7.1%/patient-year for the St. Jude group and 3.2%/patient-year for the Medtronic-Hall group (p less than 0.05). However, the valve-related mortality was equal (1.4%/patient-year) for both groups. Noncardiac causes accounted for most of the difference between the St. Jude and Medtronic-Hall groups (2.5%/patient-year and 0.4%/patient-year, respectively). There were no cases of thrombotic obstruction, whereas serious systemic thromboembolism occurred at the rate of 1.8%/patient-year (5 episodes) for the St. Jude group and 2.5%/patient-year (7 episodes) for the Medtronic-Hall group (p = not significant); there were another nine episodes of systemic embolism that left no sequelae. Three patients (St. Jude, 2; Medtronic-Hall, 1), all of whom had aortic valve replacement, required reoperation (0.5%/patient-year) because of prosthetic endocarditis, with two deaths.(ABSTRACT TRUNCATED AT 250 WORDS)     

Late results after mitral valve replacement with bileaflet mechanical prosthesis in children: evaluation of prosthesis-patient mismatch

BACKGROUND: Mechanical prosthesis is the choice of valve at the mitral position in children, although re-replacement of prostheses because of prosthesis-patient mismatch is almost inevitable when prostheses were implanted in small children. The methods to predict prosthesis-patient mismatch as a result of patients' somatic growth or pannus formation in children by noninvasive methods have not been well established. METHODS: Thirty-two children underwent mitral valve replacement with 37 bileaflet mechanical prostheses (26 St. Jude Medical prosthetic valves, and 11 CarboMedics prosthetic valves) and were followed up a mean of 6.8 years (maximum 18.3 years) with a complete follow-up rate of 94%. RESULTS: There were no operative deaths and 5 late deaths. Re-replacement of mitral valve because of prosthesis-patient mismatch was required in 5 patients. Freedom from valve-related events and re-replacement of mitral valve at 15 years were 32% +/- 23% and 54% +/- 18%, respectively. Actuarial survival rate was 63% +/- 19% at 15 years. Prosthetic valve orifice area index (manufactured geometric prosthetic valve area divided by patient's body surface area) was well correlated with maximum transprosthesis flow velocity estimated by Doppler echocardiography during follow-up, whereas valve orifice area index had no significant correlation with pulmonary artery wedge pressure assessed by cardiac catheterization. Maximum transprosthesis flow velocity had a significant correlation with pulmonary artery wedge pressure. CONCLUSIONS: Valve orifice area index itself was not a reliable index to predict prosthesis-patient mismatch. Maximum transprosthesis flow velocity was a useful index to predict pulmonary artery wedge. Invasive cardiac catheterization to determine re-replacement of the prosthesis should be considered when maximum transprosthesis flow velocity exceeds 270 cm/s.     

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.     

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.     

Hemodynamic and hemolytic features of the St. Jude Medical valve prostheses

We performed valvular replacement in 86 cases (108 valves, 43 males, 43 females) from July 1978 to July 1981 with St. Jude Medical valves which utilize two discs made of pyrolytic carbon and employ a bileaflet central opening system. Ages ranged from 13 to 68 years (average 42.3). For all cases in this study, we performed anti-coagulant therapy. The incidence of thromboembolic complication was zero. With regard to postoperative clinical evaluation on valve function and chronic hemolysis, we compared the cases of St. Jude Medical valves with those of Starr-Edwards (S.E.) valves (aortic: Model 2320, mitral: Model 6400), Carpentier-Edwards (C.E.) valves and cases of open mitral commissurotomy. As for valve function such as left atrioventricular diastolic pressure gradient, mitral effective orifice area both at rest and on exercise, the St. Jude Medical valve yielded best results. Next was the C.E. and third was the S.E. The results of the St. Jude Medical valve group and those of the open mitral commissurotomy group were equivalent. In comparison with ball type cardiac valve prostheses and bioprostheses, the St. Jude Medical valve has excellent hemodynamic characteristic. Concerning hemolysis, the St. Jude Medical was below only the C.E., however the degree of hemolysis was so low that the St. Jude Medical valve holds great promise as central flow mechanical valve prostheses.     

Bileaflet mechanical valve (St. Jude Medical valve) replacement in long-term dialysis patients.

BACKGROUND: Few reports exist on the results of bileaflet mechanical valve (St. Jude Medical prosthesis; St. Jude Medical, Inc, St. Paul, MN) replacement in long-term dialysis patients. METHODS AND RESULTS: We retrospectively reviewed 12 patients, ranging in age from 50 to 86, undergoing long-term renal dialysis who had also undergone mechanical valve replacement at our institution. Operative procedures included aortic valve replacement, aortic and mitral valve replacement, aortic valve replacement and mitral annuloplasty, mitral valve replacement, and modified Bentall's operation. There was 1 hospital death (8.3%). During the mean follow-up period of 37.1 months (range: 5-87 months), there were 2 noncardiac late deaths. Bleeding from the esophageal varix and from a duodenal ulcer occurred in 1 patient with end-stage liver cirrhosis. There were no other major cases of bleeding or cerebrovascular accidents. There were no valve-related complications. All the survivors demonstrated excellent clinical improvement under the NYHA functional classification. CONCLUSIONS: Our study demonstrated good early and long-term results of mechanical valve replacement in patients undergoing long-term dialysis. These favorable results support the continued use of mechanical valves in dialysis patients.     

Performance of bioprostheses and mechanical prostheses assessed by composites of valve-related complications to 15 years after mitral valve replacement

OBJECTIVE: Predominant concerns of patients undergoing valve replacement surgery are risks of death, stroke, antithrombotic bleeding, and reoperation related to the replacement prosthesis. The purpose of this study was to compare valve-related reoperation, morbidity (permanent impairment), and mortality between bioprostheses and mechanical prostheses for mitral valve replacement. METHODS: Between 1982 and 1998, a total of 959 bioprostheses were implanted in 943 patients, and a total of 961 mechanical prostheses were implanted in 839 patients. Total follow-ups were 5730 years for bioprostheses and 5271 years for mechanical prostheses. Eight variables were considered as predictors of risk for the composites of valve-related complications. RESULTS: The linearized occurrence rates for valve-related reoperation were 3.7 events/100 patient-years for bioprostheses and 0.5 events/100 patient-years for mechanical prostheses ( P < .001), with all age groups differentiated except older than 70 years. Valve-related morbidity was undifferentiated for bioprostheses and mechanical prostheses. Valve-related mortalities were 1.7 events/100 patient-years for bioprostheses and 0.7 events/100 patient-years for mechanical prostheses ( P < .001). Predictors of valve-related reoperation were age and valve type. The only predictor of valve-related morbidity was age, whereas age and valve type were predictors for valve-related mortality. Actual freedom from valve-related reoperation favored mechanical prostheses in all age groups except older than 70 years (91.7% +/- 2.0% for bioprostheses at 15 years and 96.7% +/- 1.5% at 12 years for mechanical prostheses). Actual freedom from valve-related morbidity was not different between bioprostheses and mechanical prostheses. Actual freedom from valve-related mortality favored mechanical prostheses in all groups except older than 70 years. CONCLUSION: Comparative evaluation gives high priority in mitral valve replacement for mechanical prostheses relative to bioprostheses for freedom from valve-related reoperation and valve-related mortality but not valve-related morbidity. Freedom from valve-related reoperation and valve-related mortality favors mechanical prostheses for all age groups except older than 70 years. Valve-related morbidity, due to neurologic or functional impairments, does not differentiate between bioprostheses and mechanical prostheses.     

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.     

Mitral valve replacement in ischemic mitral regurgitation. Preservation of both anterior and posterior mitral leaflets

BACKGROUND: The surgical risks associated with ischemic mitral regurgitation are thought to be greater than those for other forms of mitral regurgitation. We have performed mitral valve replacement using the St. Jude Medical bileaflet prostheses with preservation of both leaflets, along with all of the chordae tendineae and papillary muscles. The aim of this study was to retrospectively evaluate mitral valve replacement with preservation of both mitral valves with respect to long-term clinical results and left ventricular performance. METHODS: Between January 1, 1988 and February 29, 2000, 15 patients were operated on for ischemic mitral regurgitation. There were 7 males and 8 females, and the mean age was 69.7+/-8.1 years. The preoperative variables showed clinical deterioration of the state, such as emergency operation in 40% of the patients, more than NYHA functional III class in 93% of patients, cardiogenic shock in 47% of the patients, a mean left ventricular ejection fraction of 36.8%, and a mean left ventricular end-systolic volume index of 116.7 ml/m2. RESULTS: There were 5 (33.3%) hospital deaths during the follow-up period including 1 early death and 1 (10%) late death during the follow-up period. Thus, the actuarial survival rate after 5 years for the whole was 60%. However, the left ventricular dimensions and left ventricular fractional shortening, even if in patients with profound depressed left ventricular function preoperatively, showed maintenance of the cardiac function. CONCLUSIONS: These results suggested that mitral valve replacement using the St. Jude Medical prostheses with preservation of both leaflets and all chordae tendineae and papillary muscles might be a procedure of choice for ischemic mitral regurgitation.     

Ten-year follow-up after valve replacement with the St. Jude Medical prosthesis in children

Since 1979, 50 children, 4 months to 15 years of age, have successfully undergone cardiac valve replacement with the St. Jude Medical prosthesis (St. Jude Medical, Inc., St. Paul, Minn.). There were 24 boys and 26 girls. The valve replaced was mitral in 28 children, aortic in 15, mitral and aortic in 1, and mitral and tricuspid in 1. A left-sided tricuspid valve was replaced in 3 children. Anticoagulant therapy was maintained in all children; 40 children were treated with warfarin, whereas 10 children who underwent aortic or mitral valve replacement were on a regimen of aspirin combined with dipyridamole. The follow-up period, comprising 224 patient-years, ranged from 1 to 10 years. There were four valve-related complications: one from thromboembolism, two from valve thrombosis, and the other one from prosthetic valve endocarditis. Actuarial rate free from all valve-related complications at 10 years was 84.7%. There were four late deaths: one from valve thrombosis and the others from non-valve-related complications. Actuarial survival rate at 10 years was 90.8%. All surviving children are in functional class I, and no child so far has needed replacement of a prosthesis because of somatic growth. These results indicate that the St. Jude Medical prosthesis is a cardiac valve substitute of choice for valve replacement in children.     

Long-term outcome after biologic versus mechanical aortic valve replacement in 841 patients

OBJECTIVE: The purpose of this study was to optimize selection criteria of biologic versus mechanical valve prostheses for aortic valve replacement. METHODS: Retrospective analysis was performed for 841 patients undergoing isolated, first-time aortic valve replacement with Carpentier-Edwards (n = 429) or St Jude Medical (n = 412) prostheses. RESULTS: Patients with Carpentier-Edwards and St Jude Medical valves had similar characteristics. Ten-year survival was similar in each group (Carpentier-Edwards 54% 3% versus St Jude Medical 50% 6%; P =.4). Independent predictors of worse survival were older age, renal or lung disease, ejection fraction less than 40%, diabetes, and coronary disease. Carpentier-Edwards versus St Jude Medical prostheses did not affect survival (P =.4). Independent predictors of aortic valve reoperation were younger age and Carpentier-Edwards prosthesis. The linearized rates of thromboembolism were similar, but the linearized rate of hemorrhage was lower with Carpentier-Edwards prostheses (P <.01). Perivalvular leak within 6 months of operation was more likely with St Jude Medical than with Carpentier-Edwards prostheses (P =.02). Estimated 10-year survival free from valve-related morbidity was better for the St Jude Medical valve in patients aged less than 65 years and was better for the Carpentier-Edwards valve in patients aged more than 65 years. Patients with renal disease, lung disease (in patients more than age 60 years), ejection fraction less than 40%, or coronary disease had a life expectancy of less than 10 years. CONCLUSIONS: For first-time, isolated aortic valve replacement, mechanical prostheses should be considered in patients under age 65 years with a life expectancy of at least 10 years. Bioprostheses should be considered in patients over age 65 years or with lung disease (in patients over age 60 years), renal disease, coronary disease, ejection fraction less than 40%, or a life expectancy less than 10 years.     

Simultaneous implantation of St. Jude Medical aortic and mitral prostheses

Since January 1980, 92 consecutive patients received St. Jude Medical aortic and mitral prostheses simultaneously. Mean age was 57.6 years (standard deviation 12.4); 14 were 70 years or older. Twenty-three had a previous cardiac operation and 22 had additional procedures performed at the time of double valve replacement. Before the operation 62% of the patients were in New York Heart Association functional class III and 29% were in class IV or required emergency operation. There were six (6.5%) deaths within 30 days. None of the hospital deaths were valve related; all occurred in patients who had additional risk concerns. Follow-up is 100% complete and ranges from 2 to 80 months, totaling 242 patient-years (mean 33.8 months). All except four hospital survivors reached class I or II and 40 patients (47%) remain asymptomatic. The actuarial survival rates are 82% at 1 year, 70% at 3 years, and 60% at 5 years. Causes of late death include heart failure (10), sudden, unexplained death (five), reoperation for coronary artery disease (one), noncardiac (four), and valve related (five). The linearized rate of fatal valve-related events is 2.1% pt-yr. A total of 22 valve-related complications (including five fatal) occurred is 18 patients, for a linearized rate or incidence of 9.1%/pt-yr. Eleven thromboembolic episodes (rate 4.6%/pt-yr) occurred in nine patients; three of these (1.2%/pt-yr) were fatal. Thromboembolic and bleeding complications represented 64% of all valve-related complications. Four patients had six episodes of prosthetic valve endocarditis (incidence 2.5%/pt-yr), of which one (incidence 0.4%/pt-yr) was fatal. Paravalvular leak contributed to the fifth valve-related death. At 5 years, 83% of patients were free of thromboembolic complications; 94% were free of anticoagulant-related hemorrhage; and 71% were free of all valve-related complications. There are few comparable data for patients who have had simultaneous replacement of aortic and mitral valves with other mechanical prostheses. The total incidence of valve-related complications for patients with bioprostheses ranges between 3.9%/pt-yr and 10.4%/pt-yr and is similar to the 9.1%/pt-yr observed in the present series. The type of valve-related complication (thromboemboli and bleeding versus valve deterioration) is the principal difference between St. Jude Medical and bioprosthetic valves in patients who require simultaneous replacement of aortic and mitral valves.     

Ten-year experience with the St. Jude Medical valve for primary valve replacement

The St. Jude Medical valve is a bileaflet prosthesis with excellent hemodynamic characteristics, but the long-term surgical experience with this valve, its durability, and its biocompatibility are unknown. During a 10-year period from March 1978 to 1988, 690 prostheses (290 aortic, 252 mitral, and 74 double aortic-mitral) were inserted as the initial valve replacement substitute in 616 patients (mean age 63 years). Coronary atherosclerosis was present in 58%. Follow-up totaled 2031 patient-years (mean 3.3 years) and was 95% complete (32 lost). Early (30-day) mortality rates were 5.2%, 11.9%, and 8.1% after aortic, mitral, and double valve replacement; 5- and 9-year actuarial survival rates were 71% +/- 3% and 51% +/- 8%, 59% +/- 4% and 41% +/- 6%, and 69% +/- 6% and 47% +/- 15%, respectively. Deaths were associated with extensive coronary atherosclerosis (p less than 0.001), older age (p less than 0.001), advanced preoperative New York Heart Association functional class (p less than 0.05), and malignant ventricular arrhythmias (p less than 0.05). No structural failures have been observed. Embolism (40 events) occurred at a rate of 2.0%/pt-yr (2.3% aortic, 1.6% mitral, 2.0% double). There were six cases of valve thrombosis (0.3%/pt-yr; one fatal). Hemorrhage was the most frequent complication (2.6%/pt-yr); 13 (25%) of 52 events were fatal, accounting for 62% of all valve-related deaths. After the target prothrombin time ratio was lowered, the rate of hemorrhage decreased by 44% (2.7% to 1.5%/pt-yr), while the combined rate of embolism and valve thrombosis increased slightly (2.2% to 2.5%/pt-yr, a 14% change). In summary, the St. Jude Medical valve remains a durable valve substitute. Survival was strongly related to the presence of associated coronary atherosclerosis. The most common complication has been hemorrhage; a less intensive warfarin regimen may reduce hemorrhagic risk while maintaining thromboembolic protection.     

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.     

Clinical outcome in patients with 19-mm and 21-mm St. Jude aortic prostheses: comparison at long-term follow-up

BACKGROUND: Small-sized prostheses for aortic valve replacement may result in residual left ventricular outflow tract obstruction. Aim of the study was to verify whether implantation of 19-mm versus 21-mm St. Jude Medical standard prostheses (St. Jude Medical, Inc, St. Paul, MN) influences long-term clinical outcome. METHODS: Two hundred twenty-nine patients who underwent aortic valve replacement with 19 mm (group 1, 53 patients) or 21-mm St. Jude Medical standard prostheses (group 2, 176 patients) were included in the study. Mean follow-up of current survivors was 10+/-4 years. RESULTS: Operative mortality was 7.5% in group 1 and 8.5% in group 2. At discharge, an important patient-prosthesis mismatch (effective orifice area index < or = 0.60 cm2/m2) was present in 18% of group 1 versus 5% in group 2 (p = 0.004). Among patients with body surface area less than 1.70 m2, such mismatch was present in 15% of group 1 versus 2% of group 2 (p = 0.008). At last follow-up New York Heart Association (NYHA) functional class (p < 0.001), left ventricular mass reduction (p = 0.02), mean (p = 0.002) and peak transprosthetic gradients (p < 0.001), and effective orifice area index (p = 0.005) were significantly better in group 2. Freedom from sudden death (92%+/-5% vs 99%+/-1%, p = 0.01), valve-related death (84%+/-6% vs 90%+/-5%, p = 0.02), and cardiac events (56%+/-13% vs 86%+/-4%, p = 0.008), were significantly lower in group 1. Effective orifice area index was an independent predictor of late cardiac events. CONCLUSIONS: Although long-term results after aortic valve replacement with small-sized St. Jude Medical standard prostheses are satisfactory, 19-mm valve recipients show a high prevalence of important patient-prosthesis mismatch with less evident functional improvement and higher rate of cardiac events, suggesting a very cautious use of this prosthesis.     

A retrospective comparative study of aortic valve replacement with St. Jude medical and medtronic-hall prostheses: a 20-year follow-up study

OBJECTIVE: To compare the long-term clinical outcome of patients who underwent aortic valve replacement with St. Jude Medical and Medtronic-Hall mechanical prostheses. DESIGN: From June 1978 to June 1982, 43 Medtronic-Hall and 48 St. Jude Medical mechanical valves were implanted in 90 consecutive patients with aortic valve disease, and their clinical outcome was retrospectively assessed. RESULTS: At 20 years in the St. Jude Medical group and in the Medtronic-Hall group the actuarial rates of overall survival were 50 and 49% (p = NS), of cardiovascular survival 66 and 63% (p = NS), of valve-related survival 95 and 91% (p = NS), of freedom from major valve-related complications 83 and 45% (p = 0.005), from major cerebrovascular events 93 and 71% (p =0.06), from valve thrombosis 97 and 89% (p = NS), from aortic valve reoperation 93 and 88% (p = NS), from major bleeding 96 and 82% (p = 0.04), and from endocarditis 93 and 82% (p = NS), respectively. The linearized rate of overall major aortic valve prosthesis-related complications was 3.47%/year in the Medtronic-Hall valve group and 1.53%/year in the St. Jude Medical valve group (p = 0.003). Multivariate analysis showed that the type of prosthesis was predictive of freedom from valve-related complications (p = 0.01; 2.849; C.I. 95%: 1.246-6.516). CONCLUSION: The aortic St. Jude Medical mechanical valve seems to be associated with a slightly lower rate of long-term valve-related morbidity than the aortic Medtronic-Hall mechanical valve. Because of the small patient population and the retrospective nature of the study, the choice between these two prostheses should not be made only on the basis of these findings. However, these results suggest a reappraisal for further comparative studies with such an extended follow-up.     

40 Years experience in mitral valve replacement using Starr-Edwards, St. Jude Medical and ATS valves.

BACKGROUND: We have used the Starr-Edwards ball (S-E) valve since 1963, the St. Jude Medical (SJM) valve since 1978, and the ATS valve, since 1993 as the first choice of mechanical valve. In this study, the results with each valve during the 40 years were investigated in single mitral valve replacement (MVR) cases. PATIENTS AND METHODS: The mean age for S-E valves was 32.8+/-11.1 years old (y.o.), for SJM it was 47.2+/-12.6 y.o. and for ATS it was 56.3+/-11.4 y.o., indicating the aging of patients over time. The operative mortality decreased over the same time from 10.3% to 5.2% then 1.4% respectively. A significant difference was observed among the 3 groups with regards to the valve-related complication-free rate and cardiac event-free rate. However, there was no significant difference among the 3 groups with the other complications. CONCLUSION: Although there are many cases of valve-related complications with S-E valves, they have a role as an initial stage mechanical valve. In view of the long-term results extending over 20 years, the SJM valves is considered as the most reliable valve. The ATS valve is expected to achieve favorable results in the future because it may improve the quality of life (QOL) of patients and produce fewer valve-related complications.