Long-term results of St. Jude Medical valve in the tricuspid position.

Little is known of the St. Jude Medical heart valve's long-term clinical performance in the tricuspid position. Fourteen patients underwent tricuspid valve replacement between 1981 and 1984. Ages of the patients ranged from 32 to 81 years. Eight patients (68%) were in New York Heart Association class IV preoperatively. Twelve patients had other concomitant cardiac operations. One patient (8%) died within 30 days after operation, due to cerebrovascular accident. Postoperatively, all patients were anticoagulated with warfarin sodium and showed improvement in functional class. There were no mechanical valve failures or thromboses in patients on the anticoagulation regimen. Follow-up in all patients extended over 7 to 10 years with a mean of 8 years. There were six late deaths unrelated to valve function. The actuarial survival curve with these patients is 50% over 10 years. In conclusion, the St. Jude Medical valve is a good mechanical substitute in the tricuspid position, and we recommend its use when reconstruction is not possible and there is no contraindication for anticoagulation.     

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.     

Mitral and mitro-aortic valve replacement with Sorin Bicarbon valves compared with St. Jude Medical valves

OBJECTIVE: We assessed the clinical results of two bileaflet mechanical valves: the St. Jude Medical (SJM) and the Sorin Bicarbon (Sorin Bicarbon) used either in single mitral valve replacement (MVR) or in double, aortic and mitral, valve replacement (DVR). METHODS: Between September 1990 and November 1995, 217 patients received either a St. Jude Medical (n=134) or a Sorin Bicarbon (n=86): 136 mitral valve replacement with 83 St. Jude Medical and 53 Sorin Bicarbon and 84 double valve replacement with 51 St. Jude Medical and 33 Sorin Bicarbon. There was no difference between both St. Jude Medical and Sorin Bicarbon cohorts in respect of mitral valve physiopathology, etiology of valve disease, associated lesions, echocardiographic and hemodynamic data. The only significant preoperative difference was the age of patients within the double valve replacement group and the size of implanted valves within the mitral valve replacement group. Follow-up was 100% complete with a mean of 39+/-18 months, ranging between 6 and 68 months. The total follow-up was 657 patient-years (pt-y): 396 pt-y in the mitral valve replacement group and 274 pt-y in the double valve replacement group. RESULTS: Hospital mortality (St. Jude Medical: 2.2%; Sorin Bicarbon: 6.9%) and late mortality (St. Jude Medical: 8.4%; Sorin Bicarbon: 6.3%) were not significantly different. Ten deaths were considered valve-related (St. Jude Medical 6, Sorin Bicarbon 4). The estimated 4-yr overall survival, including hospital mortality, was for St. Jude Medical--mitral valve replacement: 89+/-4% and St. Jude Medical--double valve replacement: 93+/-4%, and for Sorin Bicarbon--mitral valve replacement: 87+/-5% and Sorin Bicarbon--double valve replacement: 91+/-5%. The linearized incidence (% per pt-y) of valve-related complications was 6.39 in the St. Jude Medical cohort and 9.2 in the Sorin Bicarbon cohort. The linearized incidence (% pt-y) of the prevalent complication, valve thromboembolism and bleeding, was for St. Jude Medical-mitral valve replacement: 3.41, St. Jude Medical--double valve replacement: 3.16 and for Sorin Bicarbon--mitral valve replacement: 2.17 and Sorin Bicarbon--double valve replacement: 3.67. The differences between each group of an estimated 4-yr freedom from combined thromboembolism and bleeding were not significant (St. Jude Medical--mitral valve replacement: 90+/-4%, St. Jude Medical--double valve replacement: 84+/-6%, and for Sorin Bicarbon--mitral valve replacement: 94+/-3% and Sorin Bicarbon--double valve replacement: 75+/-17%). CONCLUSIONS: In this clinical non-randomized study, there was no evidence of any significant difference between St. Jude Medical and Sorin Bicarbon valves over a 4-yr follow-up.     

A case report of thrombosed St. Jude Medical valve in aortic position

We report a successful elective re-aortic valve replacement following thrombolysis therapy with Urokinase. Patient was a 56-year-old male with acute heart failure caused by thrombosed St. Jude Medical valve in aortic position. The thrombosed valve occurred 6 years after the implantation due to poor control of anticoagulation therapy. Surgical findings demonstrated the origin of thrombus at the hinge area. Prompt diagnosis and adequate therapy is essential for the thrombosed valve especially in case of mechanical valve. Thrombolysis therapy should be considered if possible, although emergency operation is always indicated.     

Obstruction of St Jude Medical valves in the aortic position: histology and immunohistochemistry of pannus

OBJECTIVE: This study aims to reveal the morphological, histological, and immunohistochemical mechanism of pannus formation using resected pannus tissue from patients with prosthetic valve dysfunction. METHOD: Eleven patients with prosthetic valve (St Jude Medical valve) dysfunction in the aortic position who underwent reoperation were studied. We used specimens of resected pannus for histological staining (hematoxylin and eosin, Grocott's, azan, elastica van Gieson) and immunohistochemical staining (transforming growth factor-beta, transforming growth factor-beta receptor 1, alpha-smooth muscle actin, desmin, epithelial membrane antigen, CD34, factor VIII, CD68KP1, matrix metalloproteinase-1, matrix metalloproteinase-3, and matrix metalloproteinase-9). RESULTS: Pannus without thrombus was observed at the periannulus of the left ventricular septal side; it extended into the pivot guard, interfering with the movement of the straight edge of the leaflet. The histological staining demonstrated that the specimens were mainly constituted with collagen and elastic fibrous tissue accompanied by endothelial cells, chronic inflammatory cells infiltration, and myofibroblasts. The immunohistochemical findings showed significant expression of transforming growth factor-beta, transforming growth factor-beta receptor 1, CD34, and factor VIII in the endothelial cells of the lumen layer; strong transforming growth factor-beta receptor 1, alpha-smooth muscle actin, desmin, and epithelial membrane antigen in the myofibroblasts of the media layer; and transforming growth factor-beta, transforming growth factor-beta receptor 1, and CD68KP1 in macrophages of the stump lesion. CONCLUSIONS: Pannus appeared to originate in the neointima in the periannulus of the left ventricular septum. The structure of the pannus consisted of myofibroblasts and an extracellular matrix such as collagen fiber. The pannus formation after prosthetic valve replacement may be associated with a process of periannular tissue healing via the expression of transforming growth factor-beta.     

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.     

St. Jude prosthetic valve obstruction in the mitral position

We report a surgical case of prosthetic valve obstruction after mitral valve replacement by a St. Jude Medical valve. A 66-year-old woman was admitted because of congestive heart failure. Prosthetic valve obstruction was diagnosed by transthoracic echocardiography and cine-fluoroscopy. Re-do cardiac surgery was indicated after a week of heparinization. Circumferential pannus formation into the orifice beyond the pivot guard of the prosthesis on the atrial side and one piece of the leaflet was covered with a fibrous overgrowth on the atrial side. We concluded that once the diagnosis of valve thrombosis is established, urgent operation is preferred in patients with hemodynamic instability before the development of cardiogenic shock or multiple organ failure.     

Long-term follow-up of St. Jude Medical valve

St. Jude Medical bileaflet valve replacement was performed on 182 patients--aortic in 90, mitral in 70, both sites in 20 and tricuspid in two. The 30-day mortality was 4.3%, and was related to poor preoperative condition (NYHA class III or IV). The late mortality during observation up to 8 years was 9.3%, with actuarial survival 87.4% at 5 years and 86.3% at 8 years. For aortic, mitral and double valve replacement the respective 8-year figures were 88, 87.3 and 76.2%. Late death was associated with high preoperative pulmonary vascular resistance in five cases, dysrhythmia in four, myocardial infarction in two, thromboembolism, paravalvular leakage, prosthetic endocarditis or bleeding, each in one case, and was accidental in two cases. Calculated per 100 patient years the incidence of late thromboembolic events was 1.0, of bleeding complications 0.9 and of prosthetic valve endocarditis and paravalvular leak 0.26 (8, 7, 2 and 2 cases). The NYHA class in the 144 cases available for follow-up was I in 63%, II in 27% and III in 10%. The St. Jude Medical prosthesis thus was reliable, with good long-term performance.     

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.     

Evaluation of St. Jude Medical valve's long-term function by Doppler echocardiography.

In this study, the long-term function of St. Jude Medical valve (SJM valve) is evaluated by Doppler echocardiography. The subjects were 191 patients who underwent mitral or aortic valve replacement using SJM valve in our institute since July 1978 and had no clinical problem showing more than 50% of left ventricular ejection fraction. The patients were classified into 3 groups according to measurement period (within 5 years, 10 years and 15 years and more), and further classified by size and their results were compared. In every group by size, there was no significant difference among groups by measurement period. In the mitral valve position, peak pressure gradient and pressure half-time were not significantly different among groups by size. On the other hand, in the aortic valve position, pressure gradient in 21-mm group was significantly high among 21-mm, 25-mm, and 27-mm groups, showing a negative correlation with size. As the result, it was suggested that SJM valve kept a good function more than 15 years after operation. From these results, it was considered that the patients with small annlus of the aortic valve needed annulus-enlarging procedure or use of Hemodynamic Plus series valves to keep the size of more than 23 mm.     

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.     

Obstruction of St Jude medical valves in the aortic position: a consideration for pathogenic mechanism of prosthetic valve obstruction

Between 1995 and 2000, 8 patients with St. Jude Medical (SJM) valves in the aortic position required 9 redo valve replacement for prosthetic valve obstruction. Obstruction of the prosthetic valve was diagnosed by simultaneous echocardiography and cineradiography, and process of restricted leaflet movement that progressed to hemodynamic impairment was observed by serial studies in three recent patients. An oral anticoagulation was considered to be adequate in all patients except one patient who had withdrawal of warfrain. Pannus was the sole cause of valve obstruction in seven events in 6 patients, and both thrombus and pannus in 2 patients. Pannus overgrowth was found on the inflow aspect of the SJM valve, and involved the ends of the straight edge of the leaflets over pivot guards. These results suggest that pannus might play the primary role in development of obstruction of aortic SJM valves in patients on adequate oral anticoagulation.     

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

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