Comparison of noninvasive techniques in evaluation of the Bj?rk-Shiley and the St. Jude Medical valve prostheses in mitral position

Pressure gradients and left ventricular function were assessed by Doppler echocardiography in 50 patients with Bj?rk-Shiley mitral valve and 50 patients with St. Jude Medical valve prosthesis. There was correlation between pressure gradient and valve size, and between effective valve orifice area and valve size for St. Jude Medical valve. These correlations were not found in Bj?rk-Shiley valve. Clinical improvement and cardiac function were quite satisfactory in 20 patients with Bj?rk-Shiley valve and in 32 patients with St. Jude Medical valve whose pressure gradients were less than 10 mmHg. Twenty eight of 50 patients with Bj?rk-Shiley valve and 42 of 50 patients with St. Jude Medical valve showed good response to the exercise test. Eight patients underwent reoperation because of unacceptably high gradient caused by thrombus and pannus formation. The patients who show high pressure gradient across the valve prosthesis should be followed up cautiously.     

Valve replacement in narrow aortic roots: serial hemodynamics and long-term clinical outcome

No long-term data are available that correlate clinical outcome with serial hemodynamic studies for small-diameter (17-mm or 19-mm) aortic prostheses implanted without enlargement of the annulus. After insertion of these valves without annuloplasty, 52 patients underwent resting catheterization and were followed up at the Surgery Clinic of the National Heart, Lung, and Blood Institute for 295 patient-years (mean, 5.7 years per patient). At similar flow rates, peak systolic gradients across 17-mm Bj?rk-Shiley aortic prostheses (N = 6) tended to exceed those of the 19-mm Bj?rk-Shiley model (N = 38); these gradients averaged 30 +/- 6 mm Hg (mean +/- standard error of the mean) and 20 +/- 2 mm Hg, respectively (p = .053). Those patients with 19-mm Hancock (N = 4) and St. Jude Medical valves (N = 4) were studied, and the lowest prosthetic gradients were found with the St. Jude Medical prosthesis (mean, 3 +/- 2 mm Hg). Aortic gradient was independent of flow for 17-mm but not for 19-mm Bj?rk-Shiley valves. There was no difference in calculated effective orifice area with respect to valve size. Effective orifice area and prosthetic gradients were stable during intervals of 2 to 12 years in 10 patients who underwent additional catheterizations. No association was found between prosthetic gradients, flows, or calculated orifice areas and early or late functional class. Actuarial survival was 86 +/- 5% at 5 years, 83 +/- 5% at 8 years, 71 +/- 9% at 10 years, and 60 +/- 12% at 12 years of complete follow-up. It is concluded that small aortic prostheses provide acceptable palliation for long periods and that resting hemodynamic studies have a limited predictive value for long-term prognosis.     

Left ventricular outflow tract obstruction with mitral valve replacement in small ventricular cavities

The inference that mitral valve replacement (MVR) may produce left ventricular outflow tract (LVOT) obstruction has been made, but no comparative hemodynamic studies with various types of prostheses have been done. The purpose of the present study was to compare the gradients created across the LVOT with MVR in young sheep with small left ventricular cavities. Mitral valve replacement was accomplished using cardiopulmonary bypass and hypothermic cardioplegic arrest. Five animals were used for each of the following valves studied: 25-mm Ionescu-Shiley bovine pericardial valve, 25-mm Hancock porcine aortic valve, 2M-6120 28-mm Starr-Edwards ball-valve prosthesis, 25-mm Bj?rk-Shiley 60-degree flat tilting-disc prosthesis, and 25-mm St. Jude Medical hemidisc valve. Gradients across the LVOT were measured after MVR and then during infusion of isoproterenol hydrochloride (0.05 micrograms/kg/min). Following MVR, only the Starr-Edwards valve produced an LVOT gradient (32 +/- 23 mm Hg). Substantial gradients after MVR were seen, however, with isoproterenol administration with the Ionescu-Shiley (47 +/- 4 mm Hg), Hancock (13 +/- 8 mm Hg), and Starr-Edwards (65 +/- 30 mm Hg) valves but not with the low-profile valves (Bj?rk-Shiley and St. Jude Medical). The results of the present study demonstrate that MVR can produce LVOT obstruction. The greatest degree of obstruction was with the high-profile mechanical and bioprosthetic valves.     

Comparative analysis of mechanical and bioprosthetic valves after aortic valve replacement

Comparative long-term performance characteristics of Bj?rk-Shiley mechanical and bioprosthetic valves were analyzed for patients undergoing aortic valve replacement between 1976 and 1981. A total of 419 patients received either a standard Bj?rk-Shiley (n = 266) or bioprosthetic (porcine, n = 126, or pericardial, n = 27) aortic valve. Cumulative patient follow-up was 1,705 patient-years; the average patient follow-up was 4.1 +/- 2.7 years. Survival data were obtained for all but 11 patients (97% complete follow-up) up to 9 years after operation. Survival at 5 years was 81% +/- 4% (+/- standard error) for Bj?rk-Shiley and for bioprosthetic valve recipients. Valve failure in the Bj?rk-Shiley group was predominantly due to valve-related mortality and did not result from structural failure. Patients with bioprosthetic valves experienced valve failure as a result of prosthetic valve endocarditis and intrinsic valve degeneration. Although patients with bioprostheses experienced a lower incidence of valve-related morbidity than Bj?rk-Shiley valve recipients (p less than 0.03), no difference could be demonstrated in the incidence of valve-related mortality or valve failure at 5 years between bioprosthetic and Bj?rk-Shiley valves. Mortality rate from valve failure was higher for Bj?rk-Shiley (86%, 12/14) than bioprosthetic valves (36%, 5/14) (p less than 0.01).     

Comparative study of the hydrodynamic function of the CarboMedics valve

The hydrodynamic function of each size of the CarboMedics valve was assessed in a pulsatile flow simulator. The mean pressure difference with respect to forward flow, regurgitant volumes, and total energy loss across each valve were analyzed. The results for the 23-mm aortic and 29-mm mitral CarboMedics valves were compared with those for the St. Jude Medical and Bj?rk-Shiley Monostrut valves. Results showed good hydrodynamic function for each CarboMedics valve, although the pressure difference and total energy loss across the 19-mm aortic valve was high. The hydrodynamic function of the CarboMedics valve was comparable with that of the St. Jude Medical valve. Both valves showed similar leakage volumes, which were significantly larger than that for the Bj?rk-Shiley Monostrut valve. On account of this the total energy loss in the Bj?rk-Shiley valve was significantly less than that for the bileaflet valves in the aortic position. Concern remains for the continuing presence of high closed-valve regurgitation in the bileaflet valves.     

Long-term comparative analysis of the Bj?rk-Shiley and Hancock valves implanted in 1975

The long-term results in all patients undergoing isolated mitral, aortic, or double mitral-aortic heart valve replacement operated upon in 1975 has been retrospectively analyzed. A total of 153 patients received the standard Bj?rk-Shiley (flat pyrolytic disc) mechanical prostheses and 150 patients received the noncomposite Hancock porcine xenograft. Overall operative mortality was not significantly different between groups. All patients receiving a Bj?rk-Shiley prosthesis, but none in the Hancock group, received long-term anticoagulant therapy. Medium and long-term actuarial survival rates (5 and 10 years postoperatively) were comparable for the two groups (88% for Bj?rk-Shiley and 84% for Hancock [NS] at 5 years; 86% for Bj?rk-Shiley and 80% for Hancock at 10 years [NS]). The incidence of systemic embolism was similar in the two groups (1.6% +/- 0.4% per patient-year for the Bj?rk-Shiley group and 1.3% +/- 0.3% per patient-year for the Hancock group [NS]). Also the incidence of endocarditis was similar (0.6% +/- 0.2% per patient-year for the Bj?rk-Shiley group and 0.8% +/- 0.3% per patient-year for the Hancock group [NS]). In the Hancock group the overall incidence of reoperations was significantly higher than in the Bj?rk-Shiley group (4.2% +/- 0.6% per patient-year versus 0.9% +/- 0.3% per patient-year (p = 0.001). The major cause for reoperation in the Hancock group was primary tissue failure (3% +/- 0.5% per patient-year). In the Bj?rk-Shiley group the major cause of reoperation was valve thrombosis (0.5% +/- 0.2% per patient-year). Therefore, accepting the fact that other bioprostheses may behave differently from the Hancock noncomposite xenograft, we currently restrict our indications for valve replacement with bioprostheses.     

Bivalvular mechanical mitral-aortic valve replacement in 254 patients: long-term results--a 22-year follow-up

BACKGROUND: We have retrospectively studied 254 patients who underwent a bivalvular mechanical mitral-aortic replacement in the cardiovascular and thoracic surgery unit of Nantes from 1979 to 1989. The follow-up was 22 years (1979 to 2001). The last patient was operated on 12 years before the end of the follow-up. METHODS: All mitral prostheses were St. Jude Medical (SJM) bileaflet valves, and the aortic prostheses were 124 monodisc Bj?rk-Shiley valves, 3 Sorin prostheses, and 127 St. Jude Medical bileaflet prostheses. The mean age was 56.8 +/- 8.5 years with a sex ratio equal to 1. Rheumatism as the etiology predominated with 79.5%. Ninety-seven percent of the patients were followed for a total of 2,779 patient-years and a mean of 11.7 years. RESULTS: Operative mortality was 7.08%. Freedom from overall mortality and valve-related mortality at 22 years were 45.7% +/- 3.6% and 73.1% +/- 3%, respectively. The linearized rates of thromboembolic and hemorrhagic events were 1.07% and 0.9% per patient-year, respectively. Multivariate analysis showed age (p < 0.002), sex (p < 0.01), and degenerative etiology (p = 0.04) as independent factors of late mortality, and age, sex, degenerative disease, and tricuspid pathology were related to valve-related mortality. CONCLUSIONS: This study shows good results after mechanical mitral-aortic replacement in terms of survival rate and quality of life in surviving patients, and outlines the factors influencing long-term results as compared with isolated mitral valve replacement.     

Thromboembolic and bleeding complications after mitral valve replacement

One thousand six hundred and sixty-eight consecutive patients who underwent isolated mitral valve replacement (MVR) from 1963 to 1984 were evaluated retrospectively. Thromboembolism occurred with a linearised rate of 2.5% +/- 0.2%/patient-year (PY) for Starr-Edwards disc prosthesis Model 6520, 2.4% +/- 0.3%/PY for Bj?rk-Shiley plane prosthesis, 3.0% +/- 0.8%/PY for Bj?rk-Shiley convexo-concave 60 degrees prosthesis, 3.0% +/- 0.8%/PY for St. Jude Medical prosthesis and 3.4% +/- 0.5%/PY for Carpentier-Edwards tissue valve without the differences reaching significance. In the SJM group, the incidence of thromboembolism was significantly higher (P less than 0.025) in smaller sizes (less than M29) probably due to a more turbulent flow. The linearised rate for major haemorrhage was 1.6% +/- 0.1%/PY. Twenty-three percent of the thromboembolic and 18% of the bleeding events were fatal. Sixty-eight percent of the emboli involved the central nervous system and bleeding apart from fatalities was predominantly non-cerebral (81%). Whereas thromboembolism was a time-related event with more than twice as high a risk in the first postoperative year (4.2% +/- 0.5% vs. 1.7% +/- 0.8%, P less than 0.01), bleeding occurred with a constant rate over time (0.9% +/- 0.4%). Adequacy of anticoagulation was an important risk factor for postoperative embolism with the prothrombin time (PT) exceeding the therapeutic range in 65% of all events. A preoperative history of embolism was the only additional patient-related risk factor for postoperative embolism (18.3% vs. 9.6%, P less than 0.001). In 30% of all haemorrhage, the PT was below 15%.(ABSTRACT TRUNCATED AT 250 WORDS)     

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.     

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.     

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.     

Outcome following isolated tricuspid valve replacement.

OBJECTIVES: The clinical outcome of isolated tricuspid valve replacement is not well defined because this procedure is usually performed concomitantly with other valve surgery. METHODS: We retrospectively studied the short and long-term outcome of 15 consecutive patients (six men and nine women, aged 61+/-3 years) undergoing isolated tricuspid valve replacement from 1984 to 1996. The cause of valve dysfunction was rheumatic heart disease in 12 patients, healed endocarditis in two patients, and sarcoidosis in one patient. The tricuspid valve was stenotic in one patient, regurgitant in eight patients, and both stenotic and regurgitant in six patients. A St. Jude Medical prosthesis was placed in eight patients, Carpentier-Edwards in five patients, and Bj?rk-Shiley and Starr-Edwards in one patient each. RESULTS: The median survival was only 1.2 years. Three patients (20%) died < or =30 days after the surgery or before discharge, and six other patients (40%) died within 3 years of surgery. Anasarca was the only predictor of short-term mortality (P=0.03), while the predictors of long-term mortality were anemia (P=0.01), rheumatic heart disease (P=0.04), previous stroke (P=0.04), and previous mitral valve surgery (P=0.04). CONCLUSIONS: Isolated tricuspid valve replacement is characterized by a poor short and long-term outcome.     

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.     

Operative results of tricuspid valve replacement with St. Jude Medical prosthesis

Since 1974, 14 patients underwent tricuspid valve replacement (TVR) with prosthetic heart valves. Hardy's operation was undergone in 2 patients with Ebstein's anomaly and mitral valve surgery or multiple valve surgery were undergone in 9 patients with rheumatic valvular disease, concomitantly. Four types of prosthetic heart valves were used in the tricuspid position, i.e. 2 Starr-Edwards prostheses, 1 Hancock xenograft, 1 Bj?rk-Shiley prosthesis and 12 st. Jude Medical prostheses. The operative mortality rate was 14.3% (2/14) and 2 hospital deaths were due to low cardiac output syndrome. Twelve survivors have been followed with a maximum follow-up of 13 years and the mean of 4.7 years. There were 3 late deaths due to congestive heart failure and prosthetic valve endocarditis (PVE) of the aortic Bj?rk-Shiley prosthesis. There was 1 PVE of the tricuspid Starr-Edwards prosthesis and 1 thrombosis of the tricuspid Bj?rk-Shiley prosthesis, but no thrombosis and no other valve-related complications of SJM prostheses in the tricuspid position. The post-operative NYHA function class improved satisfactorily in 9 survivors. Judging from our relatively satisfactory post-operative results in TVR cases using SJM prostheses, SJM prosthesis in the tricuspid position is one of advisable prosthesis to get satisfactory hemodynamic improvement post-operatively.     

Comparative clinical results with Omniscience (STM1), Medtronic-Hall, and Bj?rk-Shiley convexo-concave (70 degrees) prostheses in mitral valve replacement

The intermediate clinical results of 289 patients undergoing isolated mitral valve replacement with three different low-profile mechanical prostheses have been retrospectively analyzed and compared. Between June, 1980, and September, 1983, 70 patients received the Omniscience prosthesis, 159 patients the Medtronic-Hall valve, and 60 patients the convexo-concave 70 degree Bj?rk-Shiley prosthesis. Hospital mortality was 15% for the Bj?rk-Shiley group, 4.4% for the Medtronic-Hall group, and 7.1% for the Omniscience group. Cumulative follow-up was 88 years (mean 1.7 years) for the Bj?rk-Shiley, 229 years (mean 1.5 years) for the Medtronic-Hall, and 223 years (mean 3.3 years) for the Omniscience group. All patients were placed on a program of anticoagulant therapy (dicumarol) postoperatively. Actuarial survival rates (+/-SE) 2 years postoperatively were comparable for the three groups: Bj?rk-Shiley, 90% +/- 4.7%; Medtronic-Hall, 93% +/- 2.2%; and Omniscience, 88% +/- 4.1% (p = NS). Late mortality, expressed at linearized rates (percent patient-year +/-SE), was 3.4% +/- 1.9% for the Bj?rk-Shiley group, 1.7% +/- 0.8% for the Medtronic-Hall group, and 3.6% +/- 1.2% for the Omniscience group (p = NS). Actuarially determined rates of freedom from thromboembolic complications (systemic embolism and valvular thrombosis) 2 years postoperatively were 97% +/- 2.2% for the Bj?rk-Shiley group, 94% +/- 2.1% for the Medtronic-Hall, and 84% +/- 4.7% for the Omniscience group (p = 0.05, Omniscience versus Medtronic-Hall; p = 0.02, Omniscience versus Bj?rk-Shiley) The actuarial probability of being free from reoperation 2 years postoperatively was 92 +/- 3.5 for the Bj?rk-Shiley group, 92 +/- 2.9 for the Medtronic-Hall group, and 82 +/- 3.9 for the Omniscience group (p = 0.04). The major cause for reoperation in the Omniscience group was valve thrombosis (seven patients), yielding a linearized incidence (+/-SE) of 3.1 +/- 1.1 (p = 0.01). No statistically significant differences were obtained regarding the incidence of prosthetic infective endocarditis or perivalvular leak. Overall rates of anticoagulant-related hemorrhage were comparable for the three groups.     

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.     

Mechanical heart valve prostheses: sound level and related complaints.

In a randomised study, we investigated the sound production of mechanical heart valve prostheses and the complaints related to this sound. The CarboMedics, Bj?rk-Shiley monostrut and StJude Medical prostheses were compared. A-weighted levels of the pulse-like sound produced by the prosthesis were measured in 25 patients after aortic valve replacement. Additionally, 141 patients, 117 after aortic valve replacement, 20 after mitral valve replacement and 4 after double valve replacement were interviewed. The average sound pulse pressure levels were 46.0 +/- 2.9 dB(A) in the Carbomedics group, 55.4 +/- 1.2 dB(A) in the Bj?rk-Shiley monostrut group and 44.1 +/- 4.4 dB(A) in the StJude Medical group, measured at a distance of 1 cm from the chest. The Bj?rk-Shiley monostrut was louder than the other two prostheses (p less than 0.0005). Twenty (14.2%) of all patients had complaints related to the valve sound such as sleeping disturbances, irritation, nervousness or fear. Significantly more patients with a Bj?rk-Shiley monostrut could hear their valve or had complaints when compared to the other two prostheses. Younger patients and patients with a mitral valve prosthesis could hear their valve more often than older patients or patients after aortic valve replacement. We conclude that sound characteristics and related complaints differ considerably among heart valve prostheses.     

Rest and exercise hemodynamics of 20 to 23 mm allograft, Medtronic Intact (porcine), and St. Jude Medical valves in the aortic position

Doppler echocardiography was used to measure gradients and valve areas at rest and after supine bicycle exercise in 35 patients with valve replacements 20 to 23 mm in size. Thirteen patients with a St. Jude Medical valve (St. Jude Medical, Inc., St. Paul, Minn.) were matched to 13 patients with an allograft valve, and seven patients with a Medtronic Intact (porcine) valve (Medtronic, Inc., Minneapolis, Minn.) to seven patients with an allograft valve. Patients were matched for age, sex, valve size, body surface area, and left ventricular systolic function. There was no statistically significant difference between the matched groups for body surface areas, resting cardiac output, exercise heart rate, or workload achieved. Mean pressure gradient was higher for St. Jude Medical than for allograft groups, both at rest (11.8 +/- 6.67 mm Hg for St. Jude Medical versus 6.67 +/- 2.98 mm Hg for allografts) and after exercise (16.4 +/- 8.47 mm Hg versus 9.7 +/- 3.94 mm Hg), but the differences were of borderline significance (p = 0.016 and 0.027, respectively). Valve area at rest was similar for both devices (1.4 +/- 0.45 cm2 for St. Jude Medical versus 1.8 +/- 0.56 cm2 for allograft; p greater than 0.1). There were highly significant differences between patients with Intact and those with allograft valves for resting mean pressure gradient (19.3 +/- 4.23 mm Hg for Intact versus 5.9 +/- 3.68 mm Hg for allograft; p less than 0.001) and for exercise mean pressure gradient (27.8 +/- 8.63 mm Hg versus 8.1 +/- 8.43 mm Hg; p less than 0.001). The differences between the valve areas at rest also were significant (1.1 +/- 0.12 cm2 versus 2.2 +/- 0.62 cm2; p less than 0.01). It is concluded that when a tissue valve is indicated in patients with a small aortic root, the freehand allograft aortic valve is an ideal device from the hemodynamic perspective and is superior to the Intact valve. It is also probably superior in this respect to the St. Jude Medical valve, although the analysis may be biased slightly in favor of the allograft valve.     

Prospective randomized comparison of CarboMedics and St Jude Medical bileaflet mechanical heart valve prostheses: an interim report.

OBJECTIVE: This is a midterm report of a study comparing the clinical performance of CarboMedics and St Jude Medical heart valve prostheses through a projected 10-year period. METHODS: Between 1992 and 1996, a total of 485 patients undergoing mechanical valve replacement were prospectively randomly assigned to receive either CarboMedics (n = 234) or St Jude Medical (n = 251) prostheses for aortic (n = 288), mitral (n = 160), or double (n = 37) valve replacements and were followed up annually. RESULTS: Baseline and operative characteristics were similar between the two groups with respect to major demographic characteristics, preoperative clinical status, and operative data. Mean follow-up was 50 +/- 22 months for the CarboMedics group (97% complete) and 47 +/- 20 months for the St Jude Medical group (96% complete), yielding a total of 1959 patient-years. The 30-day mortality, and 5-year actuarial survival, and linearized survival were 6.0%, 82.4% +/- 2.6%, and 4.3% per patient-year in the CarboMedics group and 4.4%, 79.9% +/- 2.8%, and 4.7% per patient-year in the St Jude Medical group (log-rank P =.7). Freedom at 5 years from valve-related mortality, major thromboembolism, hemorrhage, and other nonstructural valve dysfunction was, respectively, 96.7% +/- 1.4% (0.7% per patient-year), 90.9% +/- 2.1% (2.2% per patient-year), 87.3% +/- 2.5% (3.6% per patient-year), and 96.1% +/- 1.4% (0.7% per patient-year) in the CarboMedics group and 95.9% +/- 1.5% (1.0% per patient-year), 92.5% +/- 1.8% (2.0% per patient-year), 82.6% +/- 2.8% (4.3% per patient-year), and 96.0% +/- 1.3% (0.6% per patient-year) in the St Jude Medical group, with no overall intergroup differences. No statistically significant intergroup differences in international normalized ratio values were detected during the study period. CONCLUSIONS: This study shows no significant differences in the early and midterm clinical outcomes between patients who received CarboMedics valve prostheses and those who received St Jude Medical mechanical prostheses. Choices with respect to valve type can be based on considerations other than patient outcome.     

Comparison of reoperation findings of the Carpentier-Edwards (standard) bioprosthesis and the St Jude bioimplant (formerly Liotta) in the mitral position

Between 1986 and 1996, 50 patients with Carpentier-Edwards porcine bioprostheses and 211 with a St Jude bioprosthesis underwent reoperation because of structural valve deterioration. Structural valve deterioration was defined as an intrinsic abnormality of the prosthesis (leaflet disruption, calcification, leaflet thickening, etc.) that caused stenosis or regurgitation found on physical examination and echocardiography. Fifteen of the Carpentier-Edwards bioprosthesis group were male and 35 were female. Eighty-two of the St Jude group were male and 129 female. The mean age at reoperation was 33.88 +/- 10.31 years (range 19-70) for the Carpentier-Edwards group and 39.03 +/- 9.97 years (range 20-70) for the St Jude group. The average duration was 94.32 +/- 3.83 months for the Carpentier-Edwards group and 73.76 +/- 1.44 months for the St Jude group (P < 0.001). The mean aortic cross-clamp time was 67.4 min (minimum 32, maximum 210) for the St Jude group and 63.21 min (minimum 36, maximum 230) for the Carpentier-Edwards group. Reoperative hospital mortality was 10% (5/50) in the Carpentier-Edwards group and 7.1% (15/211) in the St Jude group (P > 0.05). Late failure modes of the bioprostheses were defined for the purposes of this study as calcification, stenosis and torn leaflets. Of the Carpentier-Edwards group, seven patients (14%) developed calcification, six patients (12%) developed stenosis and 13 patients (26%) developed leaflet tears. Of the St Jude group, the incidences were 22 patients (10%), 67 patients (31.8%) and 87 patients (41%), respectively. This study indicates that the Carpentier-Edwards bioprosthesis is more durable than the St Jude. The St Jude bioprosthesis tended to develop leaflet tears and linear calcification in female patients, and nodular calcification in male patients.