Five-year clinical evaluation of the St. Jude Medical valve prosthesis in 136 patients

One hundred and thirty-six patients (June 1979, through May 1984) underwent mitral, aortic or double valve replacement and apico-aortic bypass with the St. Jude Medical (SJM) prosthesis, at Ryukyu University Hospital, Okinawa. Operative mortality for the entire group was 4.4 per cent. Late mortality from 1979-1984 was 6.1 per cent. There were no deaths related to mechanical failure. Warfarin anticoagulation was recommended for all patients. The incidence of thromboembolism was 0.76/100 patient years. Post operative catheterization studies in 21 patients one year after operation showed a satisfactory recovery of cardiac function. The SJM valve seems to be the satisfactory artificial valve in present use.     

Influence of St. Jude medical valve in patients with aortic stenosis and small aortic annulus on cardiac function and late survival result

This clinical study analyzes our experience of postoperative cardiac function and long-term survival rate in patients with aortic stenosis and small-size St. Jude Medical (SJM) valve. Sixty-eight patients who underwent aortic valve replacement by SJM valve were divided into two groups by preoperative aortic annulus diameter. Group 1 consisted of 44 patients with small aortic annulus and small-size SJM valve (19 mm or 21 mm). In Group 1, small SJM standard valves were implanted in 16 patients, and small SJM Hemodynamic Plus (HP) valves were implanted in 28 patients. Group 2 consisted of 24 patients with large-size SJM standard valve (23 mm or larger). Preoperative left ventricular mass index, left ventricular dimension, the dimension of ascending aorta, and body surface area were significantly smaller in Group 1 than in Group 2. Average age at surgery was older in Group 1 than in Group 2. Effective orifice area index of the SJM valve measured by the manufacturer's data was smaller in Group 1 than in Group 2. Postoperative left ventricular mass indexes of Group 1 (standard valve or HP valve) and Group 2 significantly decreased in comparison with the preoperative mass indexes. Postoperative left ventricular ejection fraction and the peak ejection rate of Group 1 were not different from those of Group 2. The 10 year survival rate of Group 1 was 79%, and the rate of Group 2 was 77%. At 10 years after surgery, freedom from valve-related complication of Group 1 was 80%, and freedom from complication of Group 2 was 81%. Our results demonstrated that small-size SJM valve afforded satisfactory long-term survival rate and valve-related event-free rate for elderly patients with small body surface area and small aortic annulus.     

Hernodynamic Performance of the St. Jude Medical Hemodynamic Plus Valve

Abstract: The hemodynamic performance of the St. Jude Medical Hemodynamic Plus valve (HP) for a small aortic annulus was compared to that of the standard St. Jude Medical valve (SJM). Doppler echocardiographic parameters were evaluated in patients undergoing aortic valve replacement with either a 19 mm HP (HP19, n = 71, a 21 mm HP (HP21, n = S), a 19 mm SJM (SJM19, n = 16), or a 21 mm SJM (SJM21, n = 34). The peak and mean pres sure gradients and peak flow velocity were significantly (p < 0.05) lower in both patients with the HP21 and those with the HP19 than patients with the SJM21 and those with the SJM19, respectively. The echocardiographic parameters of the patients with the HP19 corresponded closely to those of patients with the SJM21. The left ventricular mass index regressed markedly in patients with the HP19 during the late postoperative period. The results suggested that the hemodynamic performances of certain sizes of the HP were superior to those of the same sue SJMs and were considered to be equivalent to those of the next size larger SJM.     

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.     

Noise Level and Perception of the Closing Click After Heart Valve Replacement with St. Jude Medical and Björk Shiley Monostrut Prostheses

Abstract: The metallic click generated by the closure of mechanical heart valve prostheses may severely bother patients, but generated sound energy and the extent of complaints after implantation are not known. In 62 patients, after valve Replacement with St. Jude Medical (SJM) (n = 35) and Björk Shiley Monostrut (BSM) (n = 27) prostheses, sound energy was recorded with a calibrated noise level analyzer at 5, 10, and 100 cm distance from patients and correlated with their complaints. At a distance of 100 cm, the BSM valves produced a significantly higher sound pressure level, 30.5 ± 5 db(A), compared to the SJM valves, 24.1 ±4 db(A) (p = 0.0001). There was no significant difference at shorter distances. After splitting into frequency bands the highest sound pressure levels were observed in the high frequency ranges (8 to 16 kHz) representing the metallic click. BSM valves produced higher sound levels in all frequency ranges at 1 m distance. Seventy-three percent of all patients were aware of the noise generated by the valve; 20% had disturbed sleep; and 26% preferred a less noisy valve type. Twelve of 27 patients with BSM valves wanted less noisy valves, whereas only 4 of 35 patients with SJM valves wished to have a less noisy valve type (Chi-square p = 0.003). In patients who could hear their valve measured, sound level was higher than in patients who could not. In 9 of 27 patients with BSM (33%), versus 3 of 35 with SJM prostheses (9%), the clicking caused sleep disturbances. In 85% of BSM, versus 63% SJM, patients could hear their valve (p = 0.05). Since higher sound pressure levels generated by the closing click resulted in an increased rate of complaints, noise level should be regarded as a criterion when a mechanical heart valve prosthesis is selected.     

Acute renal failure in patients with malnutrition following mitral valve replacement

A retrospective study of 161 consecutive patients undergoing mitral valve replacement with or without other valve surgery was undertaken to examine the relation between cardiac cachexia and postoperative acute renal failure. The preoperative nutritional state was assessed according to percent of the ideal body weight (W/IW). There were 37 malnourished patients (W/IW<0.80) and 124 normally nourished patients (W/IW>=0.80). In nineteen in the malnourished group (51 per cent) and 37 of normal-nourished (28 per cent), postoperative acute renal failure developed. Malnourished patients showed a severe clinical picture preoperatively a complicated operative procedures had to be carried out. To match these clinical factors between the two groups, the observation was limited to the high risk patients who showed severe New York Heart Association Functional Class (III or IV) large cardiothoracic ratio (more than 65 per cent), and long cardio-pulmonary bypass time (exceeding 120 minutes). Even in this subgroup, malnourished patients were susceptible to renal failure (64 per centVersus 20 per cent, malnourishedversus normalnourished repectively). Thus when malnutrition is superimposed on diminished cardiac performance, acute renal failure may ensure.     

Replacement of the aortic valve in patients under 50 years of age: long-term follow-up of the St. Jude Medical prosthesis

BACKGROUND: Aortic valve replacement in the young adult (aged 18 to 50 years) is a choice between a mechanical prosthesis with attendant lifelong anticoagulation or biological prostheses of varying types that may have limited life expectancy in this age group. METHODS: The Cardiac Surgical Research Foundation database was accessed to determine long-term outcomes in patients having aortic valve replacement with the St. Jude Medical Valve. This database has been privately maintained since the world's first St. Jude Medical (SJM) valve implant in 1977. Patients were contacted by questionnaire or by telephone if the survey was not returned. Follow-up was 93% complete. RESULTS: From October 1977 through October 1997, 271 patients less than 50 years of age had isolated aortic valve replacement. Follow-up was 1957 patient years. Thirty-day operative mortality was 1.1% with 18 late deaths, 4 of which were valve related. Ninety percent of survivor INR responses indicated a frequency of monthly INR checks or less. Valve-related events including percent per patient year and mortality related to these events included thromboembolism, 6 episodes (0.3% per patient year, no deaths); anticoagulant-related bleeding, 6 events (0.3% per patient year, 2 deaths); paravalvular leak, 6 events (0.3% per patient year, 2 deaths); valve thrombosis, 2 events (0.1% per patient year, no deaths); and endocarditis, 3 events (0.15% per patient year, no deaths). There was no incidence of structural valve failure. CONCLUSIONS: The SJM valve has a long record of excellent performance with durability lasting more than 20 years. The incidence of untoward events is low and death over time due to valve-related complications is low (4 of 271). The SJM valve has become our valve of choice for younger patients.     

New approach for replacement of degenerated mitral bioprostheses

OBJECTIVE: The most common indication for reoperation in patients with a mitral bioprosthetic valve is primary tissue failure. Explanation of the bioprosthesis is time-consuming and may be complicated by cardiac rupture at the atrioventricular junction or the posterior left ventricular wall where a strut is imbedded, injury to the circumflex artery and late perivalvular leak. A new approach to avoid these complications by excising only the bioprosthetic tissue and attaching a reversed aortic St. Jude valve to the intact stent has been developed and evaluated. METHODS: We have replaced degenerated mitral bioprostheses with a St. Jude valve in 73 patients during the last 12 years. In 57, including all who had their operation before 1991, explantation was used. The stent was preserved in 16 patients; in the first four we implanted a mitral St. Jude valve (SJM) within the stent, but this only allows a SJM 6-8 mm smaller than the bioprosthesis. We evolved our approach in the last 12 patients to suture a reversed aortic St. Jude valve with extended cuff to the atrial side of the bioprosthetic cuff; this allows the use of a St. Jude valve 2 mm smaller than the bioprosthesis with exact matching of the orifice sizes. The demographic and clinical profiles of the two groups were similar. RESULTS: Operative mortality was 8/57 (14%) in the explantation group and none in the stent-preservation group. Three late perivalvular leaks occurred in the explanation group, and none in the stent-preservation group. Thirteen late deaths occurred in the explanation group, with a 5-year survival rate of 68%, and one late death (cancer) in the stent-preservation group, but the follow-up is significantly shorter. CONCLUSIONS: Leaving the mitral bioprosthetic stent and cuff intact eliminates the need for extensive dissection, thus shortening and simplifying the procedure and diminishing its attendant mortality and morbidity. It offers a safe and logical approach to replacement of a degenerated mitral bioprosthesis with a St. Jude valve of comparable size which projects into the left atrium, rather than a smaller one jammed into the orifice of the bioprosthetic stent.     

Prospective randomized study of St Jude Medical versus Bj?rk-Shiley or Starr-Edwards 6120 valve prostheses in the mitral position. Three hundred and fifty-seven patients operated on from 1979 to December 1983

During a 5 year period (January 1979-December 1983) 357 patients were submitted to mitral valve replacement. These were performed by the same surgeon and were randomized in 2 groups: Group A consisted of 179 patients who received a St Jude Medical (SJM) prosthesis in the mitral position. Group B comprised 178 patients with a Bj?rk-Shiley valve (BSM) initially (113 patients from 1979 to December 1981 matched with 111 SJM) and later a Starr-Edwards 6120 valve prosthesis (65 patients matched with 63 SJM). Analysis of 21 preoperative clinical, hemodynamic data and operative variables showed the groups to be well randomized. All patients were anticoagulated postoperatively. A follow-up study was performed each year postop: at the end of 1986 there was a 35 to 95 months follow-up with a mean of 64.7 months (1596 patient years follow-up). Fifteen patients were lost to follow-up. There were 8.4% deaths related to the prosthesis in group A and 20.2% in group B (p less than 0.001). The difference was due mainly to deaths from thromboembolic complications and sudden deaths. The rate of peripheral arterial embolic complications was 2.3% in group A and 4.3% in group B per patient year (NS). The difference between the 2 groups is significant for all thromboembolic events including sudden deaths: 3.1% in group A and 7.9% per patient year in group B (p less than 0.001). There were no statistical differences in the rates of endocarditis per patient year (0.3% in group A, 0.9% in group B), reoperation (0.75% in group A, 0.89% in group B), or anticoagulant related hemorrhage (1.6% in group A, 2.4% in group B). Actuarial survival rate, including all postoperative deaths, is significantly different (p less than 0.05) at 5 years, 87.6% +/- 4.5 (group A) versus 77.4% +/- 6 (group B) and at 7 years follow-up, 83.4% +/- 6.5 (group A) versus 73.2% +/- 7.2 (group B). The probability of freedom from death and complications related to the prosthesis is significantly different (p less than 0.001) at 5 years postoperatively: 79% +/- 6.5 for group A versus 54% +/- 7.5 for group B and at 7 years: 72% +/- 7.5 (group A) versus 46% +/- 8.5 (group B). Comparison of subgroups, 113 BSM versus 111 SJM (1979-81) and 65 SE 6120 versus 63 SJM (1982-83) showed similar significant differences in the results: however there were more early deaths, valve thrombosis, valve dysfunctions and sudden late deaths in the BSM group and more peripheral arterial emboli in the SE 6120 group.(ABSTRACT TRUNCATED AT 400 WORDS)     

Left Ventricular Mass Regression After Implantation of St. Jude Medical Cardiac Valves in Small Aortic Roots

In this study, we analyzed the extent of regression of left ventricular hypertrophy in patients who received small St. Jude Medical (SJM) aortic valves and compared the results with those of another group receiving larger valves. Eighty-eight patients received either 19 or 21 mm valves (Group 1, 25 patients) or either 23 or 25 mm valves (Group 2, 53 patients). Echocardiographic studies were done before the operation and 5 years postoperatively. At follow-up a significant reduction in the left ventricular mass was found for both patient groups (p < 0.0001). Doppler echocardiography derived pressure gradients for both groups were obtained during the follow-up period. As expected, the patients in Group 1 had higher peak pressure gradients than did those in Group 2. However, there was no significant difference between the 2 groups or any significant correlations between peak pressure gradients and body surface area (BSA). Actuarial survival was 84.7% at 15 years for Group 1 and 85.9% at 17 years for Group 2. Actuarial freedom from valve related events was 91.4 % at 15 years for Group 1 and 82.7% at 17 years for Group 2. There was no significant difference in survival or valve related event free curves between the 2 groups. After implantations of SJM valves in small aortic roots, significant left ventricular mass regression was obtained, and the results were comparable to those for valves of other sizes. The long-term performance of aortic valve replacement with small valves was satisfactory as judged by improvement in the functional class of patients and survival statistics, the durability of the prosthesis, and valve related morbidity comparable to that of valves of other sizes.     

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

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

Results of mitral valve replacement with the Beall prosthesis in 209 patients.

In this 3 year study of 209 patients who underwent mitral valve replacement with the newer Beall prostheses (Models 104 and 105) the operative mortality rate was 5.2 per cent. None of these deaths was related to the valve. This prosthesis features a larger frustrum area and a "turtle-neck" sewing ring which permits its rapid insertion with a continuous suture technique. Of the 20 (9.5 per cent) late deaths, two were due to thrombosis of the valve. Among the 178 survivors, 17 developed thromboembolic complications; however, 10 of these patients recovered. Late clinical results have been quite satisfactory in over 90 per cent of the survivors. In the 15 patients who underwent hemodynamic studies postoperatively, the cardiac index and pulmonary artery pressure showed significant improvement; however, they still had transvalvular gradients at rest. The improvement in the design of this prosthesis has been an important factor in lowering the operative risk and improving the late results of mitral valve replacement.     

Selection of a prosthetic valve for mitral valve replacement

The early and the late results of mitral valve replacement were retrospectively evaluated to delineate the concept of selection of the prosthetic valve for the mitral position. The mitral valve was replaced with porcine bioprosthesis (P-B) in 102 patients and with St. Jude Medical prosthesis (SJM) in 341 patients between 1975 and 1987. Operative mortality was 5.3% for the SJM and 8.8% for the P-B group (N.S.). Cumulative duration of follow up was 1479.8 patient-years for the SJM and 888.9 patient-years for the P-B group. Actuarial survival rate was 90% for the SJM at 9 years and 81%, 76% for the P-B group at 10 and 13 years (N.S.). Freedom from valve-related death was 94% for the SJM at 9 years and 94% for the P-B at 13 years (N.S.). Thrombo-embolic complications occurred at an incidence of 0.47%/patient-years (p-y) for the SJM and 0.67%/p-y for the P-B group (N.S.). Freedom from prosthetic valve dysfunction due to primary tissue failure (PTE) lowered rapidly after the seventh postoperative year from 88% to 35% in the P-B group. Prosthetic valve dysfunction free rate was significantly lower in the P-B group compared with the SJM between the seventh post operative year and ninth postoperative year (p less than 0.01). From this analysis, we believe that the SJM prosthesis is suitable cardiac valve prosthesis to the mitral position.     

The necessity of reoperation for patients with Bjork-Shiley, St Jude Medical, Hancock and Carpentier-Edwards prostheses

The purpose of this study was to determine the criteria of valve selection from the long-term results of Hancock, Carpentier-Edwards, St Jude Medical and Bjork-Shiley prostheses, taking into special account the frequency of reoperation. Reoperations on the Hancock bioprosthesis were performed on six patients for tissue leaflet disruption with an incidence of 2.2 per cent/patient-year. Reoperations on the Carpentier-Edwards bioprosthesis were performed on 24 patients for tissue leaflet disruption in 23 patients and prosthetic valve endocarditis (PVE) in one, with an incidence of 3.8 per cent/patient-year. Reoperations on the Bjork-Shiley prosthesis were performed in two patients for severe hemolysis, with an incidence of 0.32 per cent/patient-year. Reoperations on the St Jude Medical prosthesis were performed on 3 patients, for valve thrombosis in one patient, PVE in one, and hemolysis in one, with an incidence of 0.23 per cent/patient-year. The overall mortality rate was 20 per cent, or 7 patients, and the indications for reoperation affected this. Patients with primary tissue failure had a mortality rate of 10.3 per cent; those with a thrombosed valve, 0 per cent; those with hemolysis, 66.7 per cent; and those with valve infection, 100 per cent. A good chance of survival may be achieved in patients facing prosthetic valve complications by performing reoperation as soon as possible after early detection, since mortality is high following emergency reoperation and in patients with severe symptoms. Currently, we recommend mechanical prostheses for valve replacement except in patients over 70 years old and in younger patients with absolute contraindications to anticoagulative therapy.     

The necessity of reoperation for patients with Bjork-Shiley,St Jude Medical,Hancock and Carpentier-Edwards prostheses

The purpose of this study was to determine the criteria of valve selection from the long-term results of Hancock, Carpentier-Edwards, St Jude Medical and Bjork-Shiley prostheses, taking into special account the frequency of reoperation. Reoperations on the Hancock bioprosthesis were performed on six patients for tissue leaflet disruption with an incidence of 2.2 per cent/patient-year. Reoperations on the Carpentier-Edwards bioprosthesis were performed on 24 patients for tissue leaflet disruption in 23 patients and prosthetic valve endocarditis (PVE) in one, with an incidence of 3.8 per cent/patient-year. Reoperations on the Bjork-Shiley prosthesis were performed in two patients for severe hemolysis, with an incidence of 0.32 per cent/patient-year. Reoperations on the St Jude Medical prosthesis were performed on 3 patients, for valve thrombosis in one patient, PVE in one, and hemolysis in one, with an incidence of 0.23 per cent/patient-year. The overall mortality rate was 20 per cent, or 7 patients, and the indications for reoperation affected this. Patients with primary tissue failure had a mortality rate of 10.3 per cent; those with a thrombosed valve, 0 per cent; those with hemolysis, 66.7 per cent; and those with valve infection, 100 per cent. A good chance of survival may be achieved in patients facing prosthetic valve complications by performing reoperation as soon as possible after early detection, since mortality is high following emergency reoperation and in patients with severe symptoms. Currently, we recommend mechanical prostheses for valve replacement except in patients over 70 years old and in younger patients with absolute contraindications to anticoagulative therapy.     

A clinical study of postoperative infections following open-heart surgery: Occurrence and microbiological findings in 782 cases

A total 782 consecutive patients underwent open-heart surgery with CPB between January, 1979 and December, 1988, at the Yamagata University Hospital. We assessed the incidence of postoperative infections in relation to age, the duration of surgery and antibiotic prophylaxis, and examined the causative organisms, after which the types of infecting flora were compared between the 1st period, from 1979 to 1983 and the 2nd period, from 1984 to 1988.Postoperative infection occurred in 104 of the 782 patients (13.3 per cent); in the form of a wound infection in 41 (5.2 per cent), pneumonia in 33 (4.2 per cent), urinary tract infection in 9 (1.2 per cent), prosthetic valve endocarditis in 6 (0.8 per cent), and other infections in 15 (1.9 per cent). Patients aged under 12 months or over 60 years showed a higher incidence of infection, being 17.4 per cent and 19.2 per cent, respectively. Patients who underwent an operation of over 8 hours duration also had a significantly higher incidence compared to those whose operation time was less than 4 hours, being 32.9 per cent and 6.3 per cent, respectively (p<0.0001). There was no significant difference in the incidence of postoperative infection between patients given or not given preoperative prophylaxis. A total 123 species of organisms were isolated from the 104 patients, 52.8 per cent being gram-negative bacteria (GNB), and 43.9 per cent grampositive bacteria (GPB), and a remarkable increase in the incidence of GPB was seen in the 2nd period compared to the 1st period from 31.7 per cent to 50.0 per cent.There has been a recent increase in the number of high risk patients compromised by the severity of an underlying disease. Thus, to control infection, the surgical environment and aseptic technique seem more important than antibiotic prophylaxis.     

Reconstructive surgery for mitral and tricuspid valves —Principles and personal experience

We have experienced 246 cases of reconstructive surgery for mitral and tricuspid valves, with 17 deaths in the immediate post-operative period or during follow-up. This gives an overall mortality rate of 6.9 per cent whereas in 72 cases of mitral valve reconstruction we recorded only 2 deaths i.e. a mortality rate of 2.7 per cent although the post-operative period remains relatively short. Thus, we feel fully justified in pursuing our conservative surgery program, especially for younger patients who, given their superior myocardial state, can lead a fuller life after mitral reconstruction than after mitral replacement. It is our conviction that mitral and tricuspid valve reconstruction should not be overlooked and that prior to resection and replacement, the surgeon and the team should pause and scrupulously examine the valvular components with a view to conservative surgery. For certain lesions, reconstruction can be carried out rapidly and reliably. The mortality rate is not higher than conventional cardiac surgery and the patient’s long term prognosis is considerably improved.     

Surgical management of valve replacement in children

From 1965 to 1990, 49 valve replacements were performed on 43 patients under the age of 15. Mitral valve replacements were performed on 21 patients, and re-replacements were done on 4 of them afterwards. In the first 9 mitral valve replacements before 1974, Starr-Edwards (S-E) ball valves were used. Five of these patients died in the hospital (early mortality rate was 56%). Since 1975, bioprosthetic valves were used in three cases, but all of these valves ceased to function due to primary tissue failure (PTF) within 3 years. Consequently, SJM valves are now used as a first choice. Ten aortic valve replacements were performed on 9 patients with the results of one early death, two late deaths, and one late re-operation. Tricuspid valve replacements were performed on 11 patients, 5 of whom utilized S-E ball valves. Three of the five patients died in the hospital. One patient was re-operated on, swapping the S-E ball valve for the SJM valve. SJM valves were used primarily in 2 patients, and bioprosthetic valves in 4. Two patients died, one with a SJM valve, and the other with a bioprosthetic valve. Two pulmonary valve replacements were performed, one employing a SJM valve, the other a bioprosthetic valve. Two adult patients with SJM valve in the right side of the heart had thrombotic complications, though the patients with bioprosthetic valves had none. Atrioventricular valve replacements were performed on 5 patients under the age of 3, but all of them died.(ABSTRACT TRUNCATED AT 250 WORDS)     

Comparative analysis of Hancock and St. Jude Medical valve after mitral valve replacement]

Long term results were compared in 81 operative survivors with MVR using Hancock valve (Hancock group) and 83 using St. Jude Medical valve (SJM group). The cumulative follow-up was 709.0 patients-year (p-y) and 175.2 p-y in the Hancock and SJM groups. Twenty-four percent of the patients in the Hancock group was permanently anticoagulated, while 100% of patients in the SJM group anticoagulated. The 7-year actuarial survival rate including early mortality was 79.3 +/- 4.6% for the Hancock and 93.9 +/- 3.0% for the SJM group (p less than 0.01). The survival rate was significantly higher in the SJM group than that in the Hancock group. The 7-year actuarial event free rate of the valve-related complications in the Hancock and SJM groups were as follows; thromboembolism 88.6 +/- 3.8% vs 95.0 +/- 2.8% (NS), hemorrhage, 94.0 +/- 3.0% vs 98.7 +/- 1.8% (NS), paravalvular leak 92.6 +/- 3.2% vs 97.4 +/- 1.8% (NS), infection 93.9 +/- 3.0% vs 100% (p less than 0.05), valve malfunction 78.0 +/- 5.2% vs 100% (p less than 0.001), overall valve related complications 58.9 +/- 5.9% vs 91.1 +/- 3.5% (p less than 0.001), reoperation for valve-related complication 83.1 +/- 4.6% vs 100% (p less than 0.01). The event free rate of reoperation for valve related complication in the Hancock group was significantly lower than that in the SJM group. The Hancock valve had the acceptable antithrombogenicity, but had the limited long-term durability.(ABSTRACT TRUNCATED AT 250 WORDS)     

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

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