Flow-induced platelet activation and damage accumulation in a mechanical heart valve: numerical studies

A model for platelet activation based on the theory of damage, incorporating cumulative effects of stress history and past damage (senescence) was applied to a three-dimensional (3-D) model of blood flow through a St. Jude Medical (SJM) bileaflet mechanical heart valve (MHV), simulating flow conditions after implantation. The calculations used unsteady Reynolds-averaged Navier-Stokes formulation with non-Newtonian blood properties. The results were used to predict platelet damage from total stress (shear, turbulent, deformation), and incorporate the contribution of repeated passages of the platelets along pertinent trajectories. Trajectories that exposed the platelets to elevated levels of stress around the MHV leaflets and led them to entrapment within the complex 3-D vortical structures in the wake of the valve significantly enhanced platelet activation. This damage accumulation model can be used to quantify the thrombogenic potential of implantable cardiovascular devices, and indicate the problem areas of the device for improving their designs.     

In vivo hemodynamics of prosthetic St. Jude Medical and Ionescu-Shiley heart valves analyzed by computer

Using a method of our own design, we evaluated intraoperatively the function of prosthetic heart valves. The changing hemodynamics induced by a stress test were assessed by simultaneously measuring the mean transvalvular pressure gradient and the stroke volume. The effective orifice area (EOA) of the valves was determined for each stroke by computer analysis, and this value was compared with the actual orifice area. Data were collected from 19 patients undergoing aortic or mitral valve replacement or both with 17 St. Jude Medical and 12 Ionescu-Shiley valves. The mean pressure gradient increased with tachycardia and an increase in mean left atrial pressure in the mitral position, but decreased with a decrease in cardiac output and peak left ventricular pressure in the aortic position. The St. Jude Medical valve had a smaller mean pressure gradient than the Ionescu-Shiley bioprosthesis. For both valves, the EOA increased with valve size. The St. Jude Medical valve had a greater EOA than the Ionescu-Shiley bioprosthesis, regardless of the valve size (p less than 0.005). However, the performance of prosthetic leaflets was better with the Ionescu-Shiley bioprosthesis than with the St. Jude Medical mechanical valve (p less than 0.001). This method involving computer analysis of each cardiac cycle proved to be useful for evaluating prosthetic heart valve function in the presence of changing hemodynamics.     

Regurgitant flow field characteristics of the St. Jude bileaflet mechanical heart valve under physiologic pulsatile flow using particle image velocimetry

The regurgitant flow fields of clinically used mechanical heart valves have been traditionally studied in vitro using flow visualization, ultrasound techniques, and laser Doppler velocimetry under steady and pulsatile flow. Detailed investigation of the forward and regurgitant flow fields of these valves can elucidate a valve's propensity for blood element damage, thrombus formation, or cavitation. Advances in particle image velocimetry (PIV) have allowed its use in the study of the flow fields of prosthetic valves. Unlike other flow field diagnostic systems, recent work using PIV has been able to relate particular regurgitant flow field characteristics of the Bjork-Shiley Monostrut valve to a propensity for cavitation. In this study, the regurgitant flow field of the St. Jude Medical bileaflet mechanical heart valve was assessed using PIV under physiologic pulsatile flow conditions. Data collected at selected time points prior to and after valve closure demonstrated the typical regurgitant jet flow patterns associated with the St. Jude valve, and indicated the formation of a strong regurgitant jet, in the B-datum plane, along with twin vortices near the leaflets. Estimated ensemble-average viscous shear rates suggested little potential for hemolysis when the hinge jets collided. However, the vortex motion near the occluder tips potentially provides a low-pressure environment for cavitation.     

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.     

St. Jude Medical prosthetic aortic valve malfunction due to pannus formation.

According to the literature, the incidence of pannus formation with the St. Jude Medical prosthetic aortic valve has been reported at 0.03% and 0.14% (per patient-year), with no case report of St. Jude Medical prosthetic aortic valve malfunction due to pannus formation. Between 1980 and 1999, 1,186 patients underwent aortic valve replacement at our institute. We encountered 2 aortic valve malfunctions due to pannus formation, including the case of a 53-year-old woman who suffered a St. Jude medical aortic valve malfunction 13 years after the initial operation. A second aortic valve replacement was successful and the postoperative course was uneventful. The possibility of pannus formation on St. Jude Medical aortic valves must thus be considered and its mechanism clarified.     

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.     

Thrombosed St. Jude Medical valve prosthesis in the right side of the heart in patients with tetralogy of Fallot

Five patients who previously had had repair of tetralogy of Fallot underwent pulmonary valve replacement with a St. Jude Medical valve prosthesis for progressive right ventricular failure. One also underwent tricuspid valve replacement. Two of the valves subsequently became thrombotic despite anticoagulant therapy. Because of the high incidence of thrombosis, we conclude that the St. Jude Medical valve prosthesis is not a suitable prosthesis in the right side of the heart in patients with tetralogy of Fallot.     

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.     

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.     

Leaflet arrest in St Jude Medical and CarboMedics valves: an experimental study

Objective: Two patients who suffered acute failure of their St Jude Medical Masters aortic valve prostheses due to leaflet arrest that were unrelated to suture material are presented. It was hypothesized that the valves failed because force applied to bear upon the valve annulus caused the hinge mechanism to become restricted or to arrest. Methods: A study was designed to measure the force that would cause leaflet arrest in three sizes of St Jude Medical Masters valves and CarboMedics mechanical valves. A specially manufactured pushrod device was used to apply a variable force to the sewing cuff, low annulus level, or to the pivot guards of all the valves. Results: For every valve size tested, the St Jude Medical Masters valves required significantly less force applied than did the CarboMedics valves to cause one or both leaflets to arrest (P<0.0004). Conclusions: A force applied on the valve ring of mechanical valves can cause leaflet arrest. The force required to arrest the leaflets is within an order of magnitude of that measured in other in vivo animal studies. We conclude that force on the valve rings in patients after aortic valve surgery could cause leaflet malfunction and even arrest in some patients.     

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.     

Time-related risk of the St. Jude Silzone heart valve.

OBJECTIVE: The St. Jude Medical Silzone heart valve had a silver-impregnated sewing ring designed to reduce the incidence of prosthetic valve endocarditis. Recruitment to the randomized AVERT study comparing Silzone valves with non-Silzone Control valves was stopped because of an increased risk of reoperation for paravalvular leak, but patient follow-up continues. Determining the time-related risk profile of the Silzone valve is important for helping physicians manage the approximately 28,000 patients currently alive with a Silzone valve. METHODS: Between 1998 and 2000, 403 Silzone and 404 Control patients were enrolled in AVERT. As of July 2005, there were 1819 Silzone and 1842 Control patient-years of follow-up (mean 4.5, median 5.1 years). Analysis emphasized the use and interpretation of hazard functions, since they are more meaningful than event-free percentages to currently surviving patients. To this end, instead of Cox regression, which estimates the hazard ratio, assuming it is constant over time, we employed primarily Aalen additive regression, which measures the hazard difference, and produces a plot of it over time. We assessed the risks of major paravalvular leak, endocarditis, bleeding and thrombo-embolism. RESULTS: The Silzone valve had a higher initial risk of major paravalvular leak than Control in the mitral (p=0.02) position, but not in the aortic (p=0.42) position. Analysis of this risk using additive regression, with all valve positions combined, showed that the initial risk due to Silzone lost statistical significance by 2 years and disappeared by 4 years after implant. In the mitral position, the Silzone valve had a higher initial risk of thrombo-embolism plus bleeding than Control; this risk also lost statistical significance by 2 years and subsided to zero by 4 years. The risks for death and endocarditis were similar for Slizone and Control valves. CONCLUSIONS: The additional risks of the Silzone valve, compared to Control, diminish over time and disappear by 4 years after implant. The minimum time after implant of the patients currently alive with Silzone is now well beyond 5 years; thus, these current patients now have a risk profile similar to that of patients with a standard St. Jude valve.     

Hemodynamics and early clinical performance of the St. Jude Medical Regent mechanical aortic valve

BACKGROUND: The St. Jude Medical Regent valve is the next-generation bileaflet aortic prosthesis, modified from the currently marketed St. Jude Medical mechanical valve to achieve a larger geometric orifice without changing the existing design of the pivot mechanism or blood-contact surface areas. The present study reports the hemodynamic and early clinical results of an ongoing multicenter trial investigating the performance of the Regent valve. METHODS: Between July 1998 and July 2001, 361 patients at 17 centers in North America and Europe underwent implantation of a Regent mechanical aortic valve prosthesis. Clinical status was prospectively recorded, and echocardiography with Doppler was performed at discharge and at 2 months, 6 months, 1 year, and 2 years after operation. RESULTS: Follow-up to date is 300 patient-years (average, 0.8 +/- 0.7 years per patient; range, 0.0 to 2.7 years). There were low rates of clinical adverse events. Mean gradient at 6 months was 9.7 +/- 5.3 mm Hg, 7.6 +/- 5.2 mm Hg, 6.3 +/- 3.7 mm Hg, 5.8 +/- 3.4 mm Hg, and 4.0 +/- 2.6 mm Hg, respectively, for 19-mm, 21-mm, 23-mm, 25-mm, and 27-mm valves; effective orifice area was 1.6 +/- 0.4 cm2, 2.0 +/- 0.7 cm2, 2.2 +/- 0.9 cm2, 2.5 +/- 0.9 cm2, and 3.6 +/- 1.3 cm2, respectively. Indexed effective orifice area was equal to or greater than 1.0 cm2/m2 for all valve sizes. Left ventricular mass index decreased significantly between early postoperative (165.9 +/- 57.1 g/m2) and 6-month follow-up (137.9 +/- 41.0 g/m2; delta = -28.0 +/- 49.1 g/m2; p < 0.0001). CONCLUSIONS: The St. Jude Medical Regent aortic valve has excellent hemodynamics and early clinical results, with rapid and significant left ventricular mass regression. Long-term clinical assessment is ongoing.     

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)     

Clinical comparison of St. Jude and porcine mitral valve prostheses

One hundred and six consecutive patients who had mitral valve replacement with either a St. Jude or porcine heterograft prosthesis were prospectively studied. The 2 groups are similar with respect to 67 clinical and operative factors and allow comparison of valve performance as an independent variable. Total follow-up is 3,312 patient-months (mean 36 months, range 2-57 months, 94% complete). There are no statistical differences in symptomatic improvement or mortality by life table analysis. Valve-related complications expressed as percent per patient-year are: reoperation: 1.8 St. Jude and 3.8 porcine; endocarditis: 1.2 and 1.9; regurgitant murmur: 2.3 and 1.9; hemolysis: 1.8 and 0.0; late thromboembolism: 1.8 and 1.0; hemorrhage: 2.9 and 2.9; and valve failure: 0.0 and 1.0. There were no significant differences found. Actuarial survival at 3 years was 78% in St. Jude and 81% in porcine patients. Forty-six percent of patients with St. Jude valves and 55% of patients with porcine valves were alive and free of all complications at latest follow-up. The clinical performance of St. Jude and porcine mitral valves are similar over this period of intermediate follow-up.     

Experience with St. Jude Medical valve prosthesis in children. A word of caution regarding right-sided placement

Thirty-six children aged 6 months to 18 years, underwent insertion of 37 St. Jude Medical cardiac prostheses. In 20, the valve was placed in the aortic or mitral position, and in 16 in the pulmonary or tricuspid position. There was one (2.8%) hospital death. All patients received maintenance doses of salicylates and dipyridamole after the operation. Follow-up data are available for all patients for 12 to 24 postoperative months. There was no incidence of valve dysfunction or thromboembolic complication in any of the 20 patients with valves in the systemic (left) side of the circulation, and all manifested improvement in their functional class. In contrast, six (37%) of the 16 patients with valves in the pulmonary (right) side of the circulation developed dysfunction of the prosthesis 1 to 6 months after insertion. Prosthesis failure was associated with fibrous tissue growing into the struts, leading to leaflet immobilization. At 2 years, the actuarial functional life was 100% for mitral and aortic valves and 70% for pulmonary and tricuspid valves. The data illustrate the excellent hemodynamic function of the St. Jude Medical valve in children. The absence of thromboembolic complications warrant continued implantation of the prosthesis in the left side without warfarin anticoagulation therapy, but the high incidence of valve dysfunction in the pulmonary position does not justify its continued use in the right side.     

Clinical assessment of the St. Jude medical cardiac prosthesis. A 5-year experience

Mechanical prosthetic valves have established their long-term durability, but the incidence of thromboembolism has been less satisfying. Therefore, the search for the perfect valve continues. The choice of replacing a cardiac valve with a prosthetic valve is based upon its hemodynamics, durability, thromboembolic and hemolytic characteristics. The hemodynamic assessment of the St. Jude Valve demonstrates that it performs well in the aortic, mitral, and tricuspid positions. The central bileaflet flow design leads to minimal gradients, even in the small valves which make it ideal for its use in children. The purpose of its all-pyrolite construction is to decrease the incidence of thromboembolism. Replacement of heart valves with the St. Jude Medical prosthesis was initiated in April, 1979. An analysis of all patients undergoing valve replacement between April 1, 1979, and June 1, 1984, was carried out to assess the durability, incidence of thrombosis, and thromboembolic as well as other complications.     

St. Jude Medical cardiac valve prosthesis: in vitro studies.

The St. Jude Medical cardiac valve prosthesis is an all-pyrolitic carbon, bileaflet, low profile, central flow device. Prior to clinical use on intensive program of in vitro and in vivo testing was undertaken. Simulated radiographic studies determined that the tungsten impregnation needed to make the valve leaflets radiopaque was 0.013 inch. Steady-state flow and pulse duplicator studies demonstrated a high ratio of flow orifice to tissue anulus diameter with low transvalvular pressure gradients. Regurgitation was found to be acceptable. Flow visualization revealed central flow through all three flow orifices with minimal turbulence and vorticeal current formation. In vitro comparison with other available cardiac valve devices of various sizes demonstrated superior hemodynamic performance of the St. Jude Medical cardiac valve.     

Obstruction of St Jude Medical valves in the aortic position: significance of a combination of cineradiography and echocardiography

BACKGROUND: Obstruction of the St Jude Medical valve (St Jude Medical, Inc, St Paul, Minn) is a rare but serious complication. METHODS: Cineradiographic and echocardiographic evaluations of aortic St Jude Medical valves were simultaneously performed on 54 patients, with no signs of prosthetic valve dysfunction late after surgery. RESULTS: Although closing angles of the leaflets corresponded closely with the manufacturer data, restricted opening of the leaflets (opening angle >/= 20 degrees ) was found in 16 (group D) of the 54 patients by means of cineradiography. The opening angles were equal to or less than 14 degrees in the other 23 patients (group N) and between 15 degrees and 19 degrees in the remaining 15 (group M). Doppler-derived transprosthetic pressure gradients were significantly higher (P =.03) and the velocity index was significantly lower (P =.003) in group D than in group N. However, no significant differences were found in those values between group N and group M. Replacement of the aortic St Jude Medical valves was performed in 5 of the 16 patients, and the remaining 11 have been followed up because of relatively low pressure gradients. The cause of restricted leaflet movement was pannus formation without thrombosis in 4 patients and valve thrombosis with pannus formation in one. CONCLUSIONS: Reduced valve orifice area and restricted opening of the leaflets resulting from excess growth of pannus probably led to obstruction of the aortic St Jude Medical valves. A combination of cineradiography and echocardiography makes it possible to provide an accurate and detailed diagnosis of obstruction of the valve.     

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.