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.     

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.     

Valve replacement in the right side of the heart in children: long-term follow-up

Twenty-five patients (16 male, 9 female) underwent right-sided valve replacement (10 pulmonary valve replacement, 14 tricuspid valve replacement, 3 tricuspid plus pulmonary valve replacement, and 2 replacements of a single atrioventricular valve) at the University of Nebraska Medical Center from June 1977 to December 1986. Twenty-one patients (84%) are long-term survivors with 2,035 months follow-up (range, 41 to 143 months; mean, 96.9 months). Twenty-three Carpentier-Edwards bioprosthetic valves, one Ionescu-Shiley bioprosthetic valve, and nine St. Jude Medical valves were inserted. Follow-up of 17 patients with a Carpentier-Edwards valve ranged from 5 years 9 months to 11 years 9 months (mean, 8 years 11 months). To date there has been one reoperation after 3 years 4 months in this group. One patient who received an Ionescu-Shiley bioprosthesis required re-replacement at 20 months after operation. Three of 4 patients who received St. Jude mechanical valves and are long-term survivors have required replacement after 36 to 56 months. We conclude that the Carpentier-Edwards bioprosthetic valve is a viable option in the right side of the heart in the young age group when annular size is adequate to accommodate an appropriate bioprosthesis.     

Surgical treatment of the prosthetic valves in reoperation

Surgical treatment and problems in patients required reoperation for malfunctioning prosthetic valves are reviewed in our institute. The cinefluoroscopy and pulse doppler echocardiography were helpful for diagnosis of artificial valve dysfunction. In recent two decades valve replacement were performed in 382 cases and number of re-implanted valve were 469. Among them the cases of reoperation were 21 and reimplanted valves were 25 (5.6%); 4.7% in aortic, 5.0% in mitral, 6.7% in tricuspid position. Three cases of those patients had three operations. Main causes of reoperation were primary tissue failure in Carpentier-Edwards porcine xenograft (6 cases, 23%) and cloth wear in Starr-Edwards ball valve (9 cases, 38%) and thrombosis in St. Jude Medical bi-leaflet valve (3 cases, 15%). In most cases St. Jude Medical valve were chosen for the alternative prosthetic valve in reoperation. We applied IABP support to seven patients for severe low cardiac output syndrome after the operation and overall mortality was 24% in reoperation. It concluded that St. Jude Medical valve may be most reliable because of low incidence of postoperative complication in our institute.     

Acute mechanical valve thrombosis of the St. Jude medical prosthesis

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

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.     

A 5 1/2 year experience with the St. Jude Medical cardiac valve prosthesis. Early and late results of 737 valve replacements in 671 patients

Between June 12, 1978, and June 12, 1983, 737 St. Jude Medical valves were implanted in 671 patients (431 males, 240 females) ranging in age from 9 months to 82 years (mean 55 years); 16 of these patients (2.3%) were less than or equal to 15 years and 82 (12.2%) were greater than or equal to 70 years. Associated procedures were performed in 28.2% of the 500 aortic valve replacements, 13.3% of the 105 mitral valve replacements, and 10.6% of the 66 double mitral and aortic valve replacements. Hospital mortality (less than or equal to 30 days) was 3.6% (18/500 patients) for aortic, 4.7% (5/105 patients) for mitral, and 0% for double valve replacement. Only one of these 23 hospital deaths was possibly valve-related. Complete follow-up was achieved during December, 1983, and January, 1984, to provide a minimum follow-up of 6 months. Follow-up has been 100% for a total of 1,619 patient-years, with a mean follow-up of 2 1/2 years. There were 41 late deaths (6.1%): 30 in the aortic group, eight in the mitral group, and three in the double valve replacement group. Fourteen (34.2%) of these late deaths have been considered valve-related. At 5 1/2 years, the actuarial survival rate, hospital mortality excluded, is 91% for aortic, 90% for mitral, and 95% for double valve replacement. Functional improvement of these patients is quite satisfactory: Preoperatively, 60.3% were in Class III or IV of the New York Heart Association, whereas postoperatively, 99.5% of the patients are in Class I or II. As 78 patients (65 aortic, 10 mitral, and three double valve replacement) did not receive anticoagulation therapy for a total period of 84 patient-years, the incidence of valve thrombosis, systemic embolism, and sudden or suspicious deaths in this group was compared with that in a group of 630 patients (including 60 patients from the first group who were given anticoagulants afterwards) subjected to long-term anticoagulation for a total period of 1,535 patient-years. A significantly higher incidence of valve thrombosis and systemic embolism was observed in the absence of anticoagulation. Anticoagulant-related complications occurred in 10 patients, with an incidence of 0.65/100 patient-years. On the basis of this 5 1/2 years of experience, the St. Jude Medical valve appears to be an excellent mechanical prosthesis for cardiac valve replacement, in terms of hemodynamic performance and low thrombogenicity, in patients receiving anticoagulants.     

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.     

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.     

Mechanical valve thrombosis in the tricuspid position--reoperative management of 2 cases

Because valve thrombosis occurred after the tricuspid valve replacement with the mechanical valve, we performed replacement of the mechanical valve with the bovine pericardial valve in two cases. Case 1: The patient, at 13 years old, received open-heart surgery to correct infundibular stenosis. At 23 years of age, decortication and tricuspid valve replacement (TVR) with a phi 31 mm Bj?rk-Shiley valve were performed due to constrictive pericarditis and tricuspid regurgitation developed after the initial operation. Thrombosis of the mechanical valve occurred after the TVR. Treatment with urokinase for the thrombolytic therapy failed to improve the valve opening. Finally 12 years after the TVR, replacement of the mechanical valve with a phi 27 mm Carpentier-Edwards bovine pericardial valve was performed. Case 2: The patient, at 21 years old, received open-heart surgery to close an atrial septal defect. At 40 years of age, mitral and tricuspid valve replacements were performed because regurgitation developed in both valves. The mitral and tricuspid valves were replaced with phi 27 mm and 31 mm St. Jude Medical valves, respectively. Thrombosis of the mechanical valve used for the TVR occurred 2 months after the replacement. The mechanical valve was replaced with a phi 27 mm Carpentier-Edwards bovine pericardial valve. In both cases, subjective symptoms improved and prosthetic valve complications did not occur after re-replacement with the bovine pericardial valve. These cases suggested that for TVR a bovine pericardial valve of sufficient size would be better to select than a mechanical valve.     

Carpentier-Edwards pericardial aortic valve in middle-aged patients comparison with the St. Jude medical valve

Objective The objective of the present study was to compare long-term results of single aortic valve replacement (AVR) with mechanical (St. Jude Medical valves: standard) and biologic (the Carpentier-Edwards pericardial) prostheses. Method: Between 1995 and 2002, 95 patients who underwent single AVR with mechanical (n=46) or biologic (n=49) prostheses were enrolled in this study. The mean age at the operation was 54.0±9.6 years (range: 20 to 69 years) with the mechanical and 68.8±7.1 years (range: 44 to 85 years) with the biologic prosthesis. Results: The 9-year actuarial survival rate, which was calculated by taking perioperative mortality into account, was 90.3±4.6% for patients with mechanical valves and 87.6 ±4.8% for patients with bioprostheses, with no difference between the two groups (p=0.342). The 9-year freedom rate from thromboembolism, reoperation, endocarditis was 94.8+3.6%, 100% and 97.8 ±2.2% for patients with mechanical valves and 98.0 ±2.0%, 97.5 ±3.4% and 95.0 ±3.4% for those with bioprostheses, respectively. After 9 years, freedom from cardiac death averaged 97.8% in the group with mechanical valves compared with 95.3% in those with bioprostheses (p=0.541). Conclusion: We conclude that the mid-term durability of the Carpentier-Edwards pericardial valve in the aortic position for the elderly is excellent. Nevertheless, the risk of tissue valve reoperation progressively increases with time, and a longer follow-up may be necessary to provide its value compared with the mechanical valves in a country like Japan with a high life expectancy. (Jpn J Thorac Cardiovasc Surg 2005; 53:465-469)     

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.     

Biological versus mechanical valves. Analysis of 1,116 valves inserted in 1,012 adult patients with a 4,818 patient-year and a 5,327 valve-year follow-up

All surviving patients between 18 and 88 years of age receiving biological or mechanical prosthetic heart valves at the Yale-New Haven Hospital from January 1974 through January 1985 were analyzed for thromboembolism, anticoagulation-related hemorrhage, endocarditis, perivalvular leak, valve failure, need for reoperation, late cardiac death, and valve-related death. The rates of these events were analyzed in linear and actuarial terms over the 11 year period. A total of 533 patients received 606 biological valves (328 aortic, 252 mitral, 24 tricuspid, and two pulmonary, consisting of 482 Carpentier-Edwards, 108 Hancock, 15 Ionescu-Shiley, and one other), with a mean follow-up of 2,571 patient-years and 2,935 valve-years. They were compared with 479 patients with 510 mechanical valves (330 aortic, 175 mitral, and five tricuspid, consisting of 178 Starr-Edwards, 166 St. Jude Medical, 164 Bj?rk-Shiley, and two others), which were implanted for 2,247 patient-years and 2,392 valve-years. We found a significantly increased incidence of thromboembolism (p less than 0.001) and reoperation for perivalvular leak (p less than 0.05) in the mechanical valves compared with the biological valves, but a significantly increased rate of valve failure (p less than 0.001) in the biological valves compared with the mechanical valves. The overall analysis comparing total morbidity and valve-related mortality significantly (p less than 0.01) favored the biological valves in the first 5 years of the study and the mechanical valves (p less than 0.001) in the second 5 years of the study. However, the net 10 year results showed no significant difference between the two types of valves. In summary, we found little direct evidence to strongly support the generalized use of one type of valve over another.     

The choice of anticoagulation in pediatric patients with the St. Jude Medical valve prostheses

Between February 1982 and January 1984 27 St. Jude Medical cardiac valve prostheses were implanted in 24 children ranging in age from 5 to 20 years (mean 12.38 years). There were 10 isolated aortic valve replacements, 14 isolated mitral valve replacements and one triple valve replacement (aortic, mitral and tricuspid). There was one operative and four late deaths. All patients were maintained on Aspirin and Dipyridamole from the early postoperative period. There were six documented thromboembolic events occurring in five patients. There were 0.68 thromboembolic events per patient year in the aortic valve group and 0.19 events in the mitral valve group. Because of the significant incidence of thromboembolic events in our patients, we now recommend universal anticoagulation with Coumadin in all pediatric age patients in whom the St. Jude Medical prosthesis is implanted.     

Impact of small prosthetic valve size on operative mortality in elderly patients after aortic valve replacement for aortic stenosis: does gender matter?

OBJECTIVE: Ideal management of the elderly patient with a small aortic root remains controversial. This retrospective analysis was performed to determine whether small prosthetic valve size is related to outcome in patients 70 years of age or older undergoing aortic valve replacement for aortic stenosis. METHODS: Between December 1991 and July 1998, 366 patients 70 years of age or older (median age 77 years, range 73-81 years, 49% male) underwent isolated aortic valve replacement or aortic valve replacement with coronary bypass grafting with standard Carpentier-Edwards bovine pericardial valves (Baxter Healthcare Corp, Edwards Division, Santa Ana, Calif) (n = 277; 76%) or St Jude Medical mechanical valves (St Jude Medical, Inc, St Paul, Minn) (n = 89; 24%). Propensity scoring and multivariable regression models were used to evaluate the risks associated with implantation of 19-mm valves. RESULTS: Operative mortality was 16.7% (17/102) in patients who received 19-mm valves and 3% (8/264) among those receiving >/=21-mm valves (P /=21-mm valves was 6.4 (95% CI 2.7, 15.4; P 相似文献   

Long-term results of valve replacement in the right side of the heart in congenital heart disease--comparative study of bioprosthetic valve and mechanical valve

Valve replacements in the right side of the heart (TVR and PVR) were done on 16 patients with congenital heart disease, mainly tetralogy of Fallot and Ebstein anomaly. Including reoperations, 19 operations were performed on them and 20 artificial valves were inserted. Ten mechanical valves (7 St. Jude Medical valves, 3 Starr-Edwards valves) and 10 bioprosthetic valves (7 Carpentier-Edwards valves, 3 Ionescu-Shiley valves) were used. Age at valve replacement ranged from 9 to 52 years (mean 23.0 years), and the follow-up period was 1.28-19.8 years (mean 5.7 years). Including 2 sudden deaths, late death occurred in 4 patients, on all of whom mechanical valve replacements were done at the primary operation. Five-year survival rate of all patients was 76.4 +/- 12.1%, and 10-year survival rate was 63.6 +/- 15.4%. All the patients who received bioprosthesis at the primary operation survived at the time of this follow-up study. On the contrary, long-term results of mechanical valve was unsatisfactory with the 5-year survival of 62.5 +/- 17.1%. In spite of anti-coagulation therapy with warfarin, three patients with mechanical valve complicated thrombotic valves, which necessitated re-operations. Calcified bioprosthetic valve occurred in one patient with I-S valve 8.5 years after the implantation. Five-year complication-free rate was 87.5 +/- 11.7% for bioprosthesis, whereas it was 50.0 +/- 15.8% for mechanical valve (p less than 0.056). It is concluded that the bioprosthesis is the first choice for the valve replacement in the right side of the heart in congenital heart disease.     

Severe haemolysis with the St. Jude Medical prosthesis

The St. Jude Medical prosthesis has become one of the most widely used mechanical heart valves because of its excellent haemodynamic function. Although subclinical haemolysis has been described with this prosthesis, there has only been a single report of frank haemolysis in the absence of a paravalvular leak. We report the occurrence of severe haemolysis in five patients following St Jude Medical prosthesis implantation, four of whom had combined aortic and mitral valve replacements. In no patient could the haemolysis be attributed either to a paravalvular leak or an obvious valve malfunction.     

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.     

Thirty-year experience with a bileaflet mechanical valve prosthesis

Background

The objective was to evaluate the long-term outcomes of the St Jude Medical (Saint Paul, Minn) mechanical valve prosthesis implantation.

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.