Mechanical valve replacement in children and teenagers

A previous study from this unit showed that only 19% of children with mitral bioprostheses were free from complications after 7 years and prompted us to review the performance of new-generation mechanical prostheses implanted in the same population group. In a 5-year period (1980-1985), 352 patients 20 years old and younger (mean age 15.3 +/- 4 years) with rheumatic valvular disease had 177 mitral, 62 aortic and 113 double (mitral + aortic) valve replacements with Medtronic-Hall or St. Jude prostheses. The overall early mortality was 6.3%. All survivors, followed up for a total of 1171 patient-years, received oral anticoagulation. The late mortality for mitral, aortic and double valve replacement was 4.1% per patient-year, 4.3% per patient-year and 8.0% per patient-year, respectively (P less than 0.05), and was valve-related in 46% of the cases. Twenty-nine patients, all but 2 in the mitral and double valve replacement groups, were reoperated upon (2.5% per patient-year), mainly for infective endocarditis (34%), for prosthetic thrombosis (33%) and for bland periprosthetic leak (31%). The incidence of thrombotic obstruction was 1.1% per patient-year: mitral valve replacement, 1.0% per patient-year; aortic valve replacement 0.5% per patient-year; and double valve replacement, 1.7% per patient-year; P less than 0.05) and was fatal in 33% of the cases. Major systemic thromboembolism occurred at the rate of 1.4% per patient-year, similar in the three groups. The incidence of prosthetic endocarditis was 0.9% per patient-year.(ABSTRACT TRUNCATED AT 250 WORDS)     

Twenty-year comparison of tissue and mechanical valve replacement

OBJECTIVE: We sought to compare outcomes with tissue and St Jude Medical mechanical valves over a 20-year period. METHODS: Valve-related events and overall survival were analyzed in 2533 patients 18 years of age or older undergoing initial aortic, mitral, or combined aortic and mitral (double) valve replacement with a tissue valve (Hancock, Carpentier-Edwards porcine, or Carpentier-Edwards pericardial) or a St Jude Medical mechanical valve. Total follow-up was 13,390 patient-years. There were 666 St Jude Medical aortic valve replacements, 723 tissue aortic valve replacements, 513 St Jude Medical mitral valve replacements, 402 tissue mitral valve replacements, 161 St Jude Medical double valve replacements, and 68 tissue double valve replacements. The mean age was 68 +/- 13.3 years (St Jude Medical valve, 64.5 +/- 12.9; tissue valve, 72.0 +/- 12.6). RESULTS: There were no overall differences in survival between tissue and mechanical valves. Multivariable analysis indicated that the type of valve did not affect survival. Analysis by age less than 65 years or 65 years or older and presence or absence of coronary disease revealed similar long-term survival in all subgroups. The risk of hemorrhage was lower in patients receiving tissue aortic valve replacements but was not significantly different in patients receiving mitral valve or double valve replacements. Thromboembolism rates were similar for tissue and mechanical valve recipients. However, reoperation rates were significantly higher in patients receiving both aortic and mitral tissue valves. The reoperation hazard increased progressively with time both in patients receiving aortic and in those receiving mitral tissue valves. Overall valve complications were initially higher with mechanical aortic valves but not with mechanical mitral valves. However, valve complication rates later crossed over, with higher rates in tissue valve recipients after 7 years in patients undergoing mitral valve replacement and 10 years in those undergoing aortic valve replacement. CONCLUSIONS: Tissue and mechanical valve recipients have similar survival over 20 years of follow-up. The primary tradeoff is an increased risk of hemorrhage in patients receiving mechanical aortic valve replacements and an increased risk of late reoperation in all patients receiving tissue valve replacements. The risk of tissue valve reoperation increases progressively with time.     

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.     

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.     

Tricuspid valve replacement with the St. Jude Medical valve

A study was conducted on 20 patients who underwent tricuspid valve replacement (TVR) with the St. Jude Medical (SJM) valve. Isolated TVR was performed on 9 patients, and additional mitral, or mitral and aortic valve replacements were performed on 11 patients. Four patients (20%) died in the early postoperative period, but there were no deaths related to the SJM valve in the tricuspid position. The mean follow-up period of the 16 survivors was 74.4 months, and there have been no deaths during the follow-up period. The postoperative actuarial survival rate was 80%, 10 years after surgery. Three patients, representing 0.25%/patient-months, developed valve thrombosis, the valve thrombosis-free rate being 72.8%, 10 years after surgery, while entrapment of a leaflet by endothelial pannus was found in one patient, representing 0.08%/patient-months. Thus, the incidence of all prosthetic valve-related complications was 0.34%/patient-months, and the postoperative complication-free rate was 65.3%, 10 years after surgery. The medium-term follow-up study of TVR with the SJM valve revealed no prosthetic valve-related deaths and a relatively low incidence of prosthetic valve-related complications. However, as with other mechanical valves, valve thrombosis was a major risk posed by the SJM valve in the tricuspid position.     

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.     

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.     

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.     

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

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

More than ten years' follow-up of the Hancock porcine bioprosthesis in Japan.

From February 1975 through October 1981, 256 Hancock porcine bioprostheses (Johnson & Johnson Cardiovascular, King of Prussia, Pa.) (60 aortic, 169 mitral, and 27 pulmonary/tricuspid position) were implanted in 220 patients (104 male and 116 female, aged 9 to 67 years; mean 43.3) at Kyushu University Hospital in Japan. The procedures include 41 aortic valve replacements, 121 mitral valve replacements, 4 pulmonary valve replacements, 6 tricuspid valve replacements, and 48 combined valve replacements (31 aortic plus mitral, 13 mitral plus tricuspid, and 4 aortic plus mitral plus tricuspid). Hospital mortality was 6.4%. Follow-up was 98% during 8 to 14 (mean 10.5) years. Cumulative follow-up was 1836 patient-years and 2078 valve-years. At 10 years the overall actuarial survival rate, including hospital morality, was 70% +/- 3%, and freedom from valve-related mortality with sudden death was 87% +/- 3%. More than half of the current survivors required no anticoagulant therapy. Freedom from thromboembolism or anticoagulant-related hemorrhage (or both) and prosthetic valve endocarditis was common. Freedom from structural valve failure and reoperation declined more than 9 years after replacement of left-sided heart valves but not after replacement of right-sided heart valves. Sixty-seven patients underwent 68 repeat operations, and there were four deaths (5.9%). The rate of freedom from overall valve-related complications at 10 years was 62% +/- 8% for aortic valve replacement, 53% +/- 5% for mitral valve replacement, 80% +/- 13% for pulmonary/tricuspid valve replacement, and 42% +/- 9% for combined valve replacement. There was a significant difference between pulmonary/tricuspid valve replacement and combined valve replacement (p less than 0.05). The Hancock bioprosthesis is suitable for the replacement of valves in the right side of the heart but not for combined valve replacement.     

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)     

The Medtronic-Hall cardiac valve: 7 1/2 years' clinical experience

Clinical information on the Medtronic-Hall valve prosthesis was obtained by reviewing the records of 379 patients, 164 of whom had aortic valve replacement (AVR), 163 of whom had mitral valve replacement (MVR), and 52 of whom had double valve replacement over 90 months (1,225 patient-years) (mean follow-up, 42.01 +/- 1.3 months [+/- standard error]). Mean age was 53.8 +/- 12 years. One hundred ninety-three patients (50.9%) had some type of concomitant operation, such as tricuspid annuloplasty, coronary artery bypass grafting, or resection of ascending aortic aneurysm. Ninety-one percent were in New York Heart Association (NYHA) Functional Class III or IV preoperatively. Early mortality and late mortality were 7.7% (29 patients) and 13.5% (51 patients), respectively. The actuarial survival at 7 1/2 years was 74.1 +/- 2.7% for the total group and 69.0 +/- 4.5% for those having AVR, 81.0 +/- 3.2% for those having MVR, and 67.0 +/- 8.9% for those having double valve replacement. All patients but 2 were maintained on a regimen of chronic anticoagulation with warfarin sodium. Twenty-six thromboembolic episodes occurred (2.1/100 patient-years): 13 after MVR (2.3/100 patient-years), 11 after AVR (2.1/100 patient-years), and 2 after double valve replacement (1.4/100 patient-years). Four thromboembolic episodes were fatal; no valve thrombosis occurred. There were no structural failures. Of the 350 late survivors, 92% were in NYHA Functional Classes I and II. Total valve-related complications have been minimal.(ABSTRACT TRUNCATED AT 250 WORDS)     

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 clinical experience with the CarboMedics heart valve implants

We reviewed the histories of 144 patients who underwent heart valve replacement with the CarboMedics prosthesis from 1990 to 2000. There were 74 males and 70 females, with a mean age of 52 years, including 69 aortic valve replacements, 48 mitral valve replacements, and 27 double (aortic and mitral) valve replacements. The mean duration of follow-up was 6.5 years. Early mortality was 7.6% (11 patients). Late deaths occurred in 14 patients, including cardiac-related late deaths in 9 and valve-related deaths in 3. The survival rate including early deaths was 84.7 +/- 3.2% at 5 years and 78 +/- 4.1% at 10 years. Preoperative New York Heart Association Class IV (p = 0.0001) was found to be a significant predictor of cardiac-related late death. Freedom rate from complications at 10 years were embolism 84.7 +/- 4.2% (linearized rate 1.8% per patient year), valve thrombosis 92.7 +/- 2.7% (linearized rate 0.8% per patient year), bleeding 95.6 +/- 2.6% (linearized rate 0.4% per patient year), reoperation 85.9 +/- 4% (linearized rate 1.5% per patient year), valve endocarditis 98.7 +/- 1.3% (linearized rate 0.1% per patient year), and nonstructural dysfunction 90 +/- 3.5% (linearized rate 1% per patient year). There was no structural deterioration. The early and long-term results with the CarboMedics heart valve implantation were acceptable, but valve thrombosis remains a concern in the present study. Further investigation for optimal anticoagulation therapy is necessary to reduce the incidence of valve thrombosis as well as embolic and bleeding complications.     

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.     

Clinical and hemodynamic results of cardiac valve replacement with the Monostrut Bj?rk-Shiley prosthesis

Between May 1983 and April 1986, 318 patients underwent cardiac valve replacement with the Monostrut Bj?rk-Shiley prosthesis. There were 136 aortic valve replacements, 128 mitral valve replacements, and 54 multiple replacements. A total of 373 valves were implanted. Associated procedures were done in 79 (25%) of the patients. Hospital (30-day) mortality rate was 5.6% (18 patients): 2.9% (n = 4) after aortic, 7.8% (n = 10) after mitrals and 7.4% (n = 4) after multiple valve replacement. Follow-up was obtained in all 300 operative survivors, for a total of 500 patient-years (mean 18 months). Actuarial survival rate, excluding operative deaths, at 4 years was 94.7% +/- 1.5% (mean +/- standard error of the mean). There were 16 thromboembolic episodes (3.2/100 patient-years). Freedom from all valve-related complications was 87% +/- 2.4% at 3 1/2 years. Neither valve thrombosis nor structural failure has been observed. Eighty percent of the patients are in New York Heart Association functional class I. Forty-two patients (26 with aortic and 16 with mitral valve replacement) underwent cardiac catheterization a mean of 6 1/2 months after the operation. In the aortic position, peak gradients were an average of 6.9 +/- 1.2 mm Hg. Mean systolic gradients were 12.4 +/- 6.3 mm Hg and did not increase with exercise. In the mitral position, end-diastolic gradients were an average of 2.1 +/- 2 mm Hg and mean gradients, 5.9 +/- 2 mm Hg. Discharge coefficient (estimated orifice area/geometric area) was 0.63 +/- 0.2 for the aortic and 0.53 +/- 0.2 for the mitral prostheses. Disc opening was maximal in most patients. These results indicate that the Monostrut prosthesis has a low rate of thromboembolic events, no structural failures or thrombotic obstructions and excellent hemodynamic performance, especially in the small aortic sizes (discharge coefficient for 19 and 21 mm valves, 0.77).     

St. Jude Medical valve replacement: clinical experience with 1,039 patients

St. Jude Medical valve replacement was performed in 1,039 patients; 320 had aortic (AVR), 543 mitral (MVR), and 176 had double valve replacement (DVR). There were 44(4.2%) early deaths. Follow-up extended in 995 patients from 10 to 130 months, with a cumulative period of 2,730 patients-years. The overall survival rates of AVR, MVR, and DVR patients at 10 years were 60.5%, 89.6%, 90.3% respectively. The linearized incidences of valve thrombosis, thromboembolism, anticoagulation-related hemorrhage, prosthetic valve endocarditis, and significant hemolysis were as follows: 0.11%/pt-yr, 1.33%/pt-yr, 0.04%/pt-yr, 0.18%/pt-yr, and 0.11%/pt-yr, respectively. There were no structural failure after 10 years follow-up. Reoperation (explant and re-replacement or suture repair) was required in 10 patients. Seven of them had periprosthetic leakage, 2 had valve thrombosis, and one underwent reoperation because of a technical error. Actuarially over 98% of patients were free of valve-related mortality at 10 years. St. Jude Medical valve is an excellent alternative for use in the surgical treatment of valvular heart disease.     

Tricuspid valve replacement with the St. Jude Medical valve: 19 years of experience.

OBJECTIVE: The choice of the valve substitute in the tricuspid position remains controversial. A St. Jude Medical valve is a choice of valve substitute and its lower thrombogenicity and excellent hemodynamic performance have been reported even in the tricuspid position. However, little is known of the long-term durability of the St. Jude Medical valve in the tricuspid position. Our long-term experience of tricuspid valve replacement showed the higher thrombogenicity than we had expected, therefore, this study was done to reconsider our strategy for valve choice. METHODS: This study reviewed 23 patient who underwent 25 tricuspid valve replacements with the St. Jude Medical valves from 1980 to 1997. The mean age was 40 years. Eleven patients (48%) were men. There were four in-hospital deaths (17%). The remaining 19 patients were all alive and followed from 2.2 to 19.0 years (mean 11.8 years). RESULTS: The overall survival, including hospital mortality, was 83%, 10 and 15 years after surgery. Valve thrombosis occurred in six patients. Freedom from valve thrombosis was 78 and 70%, 10 and 15 years after surgery, respectively. The linearized rate of the valve thrombosis was 2.9%/patient-years. Six patients required reoperation. The mean interval to reoperation was 9.5 years. Freedom from reoperation was 83% and 75%, 10 and 15 years after surgery, respectively. The linearized rate of the reoperation was 2.8%/patient-years. No structural valve deterioration was found. Echocardiographic study showed that the function of the St. Jude Medical valve without valve-related complications was well maintained. CONCLUSIONS: The higher thrombogenicity of the St. Jude Medical valve in the tricuspid position altered our choice of valve substitutes from the St. Jude Medical valve to a bioprosthesis which is lack of need for anticoagulant therapy except for juvenile patients who are able to maintain potent anticoagulant therapy.     

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.     

Up to 8-year follow-up of valve replacement with carbomedics valve

BACKGROUND: The aim of this study was to report midterm valve replacement (VR) results with the Carbo-Medics valve (Sulzer Carbomedics, Austin, TX). METHODS: From 1991 to 1999, 468 patients aged 13 to 76 years (mean 56 years) underwent VR with CarboMedics valve: 239 aortic (A), 167 mitral (M), and 62 A+M or double valve replacement (DVR). Mean follow-up time was 4.4 years; follow-up was 99.1% complete for 2,016 patient-years (PY). The anticoagulation level was targeted to an international normalized ratio of 1.47 to 2.8. RESULTS: The hospital mortality rate was 1.2%. Actuarial analysis for the entire group at 7 years for survival was 87%+/-2.3%. Freedom from valve-related death was 94%+/-1.9%. Freedom from thromboembolic and bleeding events, respectively, were as follows: for AVR, 82%+/-4.9% (2.4%/PY) and 88%+/-2.9% (1.6%/PY); for MVR, 95%+/-2.1% (0.8%/PY) and 91%+/-3.1% (1.3%/PY); and for DVR, 96%+/-3.2% (0.7%/PY) and 85%+/-9.7% (1.0%/PY). Actuarial freedom from reoperation was 98%+/-1.4%. CONCLUSIONS: The CarboMedics valve can be implanted with satisfactory early mortality and a low incidence of valve-related events even under low-intensity anticoagulation, as shown in a Japanese population.