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)     

Ten years experience with the St. Jude Medical valve prosthesis for mitral valve replacement

During the 10-year period between 1980 and December 1989, isolated mitral valve replacement (MVR) with the St. Jude Medical (SJM) valve prosthesis was performed on 404 patients at our hospital, and a long-term postoperative follow-up was conducted. There were 161 males and 243 females ranged in age from 1 year to 73 years. Early operative mortality was 5.2%. Follow-up period for 383 patients who discharged from the hospital was 1970.7 patient-years. Twenty of these patients died during the follow-up period, and a late mortality rate was 5.2%. During 10 years, thromboembolic event occurred in 8 patients. Four patients had anticoagulant-related bleeding, 4 had paravalvular leak, and 5 underwent re-operations. There was neither structural valve failure nor prosthetic valve endocarditis. Therefore, the actuarial survival rate and the valve-related death-free rate at 10 years were 83.2%, and 96.8%. Of the patients who survived, New York Heart Association class improved significantly (93% in classes II and III preoperatively and 71% in class I postoperatively). Linearized rates for thromboembolism, anticoagulant-related bleeding, and hemolysis were 0.41%, 0.20% and 0.36%/100 patient-years, respectively. The actuarial estimate of incidence free from all complications was 92.0% at 10 years. On the basis of this 10 years' experience, we believe that the SJM valve prosthesis is an excellent mechanical prosthesis for mitral valve replacement, in terms of hemodynamic performance and low thrombogenicity in patients receiving anticoagulants.     

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.     

A case report of thrombosed St. Jude Medical valve in a patient with macroglobulinemia]

A 66-year-old man who had undergone MVR using a ST. Jude Medical valve entered the hospital with acute heart failure and cardiogenic shock 3 months after surgery. He had had a symptom of petechiae due to macrogloburinemia after initial MVR and had been in the poor control of anticoagulation therapy because of presence of petechiae. He was diagnosed as prosthetic valve thrombosis using echocardiography and underwent emergency re-MVR using a Central Open Bioprosthesis (COB) which was developed by our department. He was doing well 8 month after re-MVR. Selection of prosthetic valve should be performed carefully in the patient with hemorrhagic disease, and careful observation and proper anticoagulant therapy should be carried out after valve replacement.     

Aortic and mitral valve replacement with the St. Jude Medical prosthesis

From April 1, 1979 to August 31, 1983, 228 patients underwent isolated aortic (AVR) (118) or mitral (MVR) (90) valve replacements with a new tilting disc valve prosthesis, the St. Jude prosthesis, at the Medical University of South Carolina. Age ranged from 6 to 84 years (mean 49.1 +/- 19.2 AVR, 44.5 +/- 16.5 MVR). Male sex predominated in the AVR group (68%) and female sex in the MVR group (68%). Thirty-five patients (16.8%) had associated coronary bypass surgery (AVR 23.7%, MVR 7.8%). There were seven deaths (3.4%) occurring during the same hospitalization (AVR: 3/118, 2.5%; MVR: 4/90, 4.4%). Follow-up is 97.6% complete and ranges from 1 to 54 months (mean 19.6 +/- 12.4). In the AVR group, nine late deaths have occurred and actuarial survival at 42 months is 86.7 +/- 3.8%. Three patients have sustained thromboembolic episodes for a linearized rate of 1.6% patient-year, and the probability of remaining free of thromboembolism at 42 months is 96.9 +/- 1.8%. The mean improvement in functional class from preoperative to postoperative is 3.1 +/- 0.7 to 1.2 +/- 0.4 (p less than 0.001). In the MVR group, there have been four late deaths, and the actuarial survival at 42 months is 89.3 +/- 3.8%. Two patients have sustained thromboembolic complications for a linearized rate of 1.2%/patient-year, and the probability of remaining free of thromboembolism at 42 months is 97.2 +/- 2%. The mean improvement in functional class from before to after surgery is 3.2 +/- 0.7 to 1.3 +/- 0.5 (p less than 0.001). There have been no thromboses of the St. Jude valve in the mitral or aortic position, no mechanical failures, and no patient has had significant valve-related hemolysis. Because of this experience, the St. Jude Medical heart valve prosthesis is our prosthesis of choice for any patient undergoing valve replacement with a mechanical prosthesis.     

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.     

Intractable hemolysis caused by perivalvular leakage following mitral valve replacement with St. Jude Medical prosthesis

Nine patients with intractable hemolysis caused by perivalvular leakage following mitral valve replacement with a St. Jude Medical prosthesis are presented. All patients had dark-colored hemoglobinuria, which appeared from 1 day to 44 days after the operation, with moderate or severe hepatorenal insufficiency. One patient died of multiorgan failure. The other 8 patients underwent reoperation, and all survived. Reoperation revealed that all leakages were tiny and had no adverse effect on hemodynamics. In all the patients having reoperation, hemoglobinuria disappeared immediately after the procedure. Surface-scanning electron microscopy of the sewing cuff of the St. Jude Medical prosthesis revealed the rough surface structure of the sewing ring. Because of this irregular, shaggy surface structure, greater shearing forces against erythrocytes can be generated when there is perivalvular leakage.     

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.     

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.     

A case of aortic valve replacement with St. Jude Medical Regent valve (first implant in Japan).

The St. Jude Medical (SJM) Regent valve was developed as a new mechanical valve by improving the conventional SJM valve. The effective orifice area is wider than that of Hemodynamic Plus (HP) series. The efficacy of the new valve has been reported in Europe and the United States. On October 26, 2004, we first performed aortic valve replacement (AVR) with the SJM Regent valve for aortic valve stenosis in Japan. A 64-year-old female was admitted to our hospital with dyspnea on exertion. She was diagnosed with aortic valve stenosis. She underwent AVR with a 17 mm SJM Regent valve. According to the results of echocardiography conducted two months postoperatively, the peak pressure gradient of the prosthetic valve was 32.0 mmHg, the mean pressure gradient was 13.2 mmHg, and the effective orifice area index (EOAI) was 0.92 cm2/m2. Cinefluoroscopy showed the valve opening angle of 85 degrees indicating full opening. She was discharged 15 days after surgery without complications. As demonstrated by the present case, implantation of a 17 mm SJM Regent valve produced a satisfactory result reflected by lower pressure gradient and absence of patient-prosthetic mismatch. In the future, the new valve is expected to be the optimum mechanical valve for a narrow annulus.     

40 Years experience in mitral valve replacement using Starr-Edwards, St. Jude Medical and ATS valves.

BACKGROUND: We have used the Starr-Edwards ball (S-E) valve since 1963, the St. Jude Medical (SJM) valve since 1978, and the ATS valve, since 1993 as the first choice of mechanical valve. In this study, the results with each valve during the 40 years were investigated in single mitral valve replacement (MVR) cases. PATIENTS AND METHODS: The mean age for S-E valves was 32.8+/-11.1 years old (y.o.), for SJM it was 47.2+/-12.6 y.o. and for ATS it was 56.3+/-11.4 y.o., indicating the aging of patients over time. The operative mortality decreased over the same time from 10.3% to 5.2% then 1.4% respectively. A significant difference was observed among the 3 groups with regards to the valve-related complication-free rate and cardiac event-free rate. However, there was no significant difference among the 3 groups with the other complications. CONCLUSION: Although there are many cases of valve-related complications with S-E valves, they have a role as an initial stage mechanical valve. In view of the long-term results extending over 20 years, the SJM valves is considered as the most reliable valve. The ATS valve is expected to achieve favorable results in the future because it may improve the quality of life (QOL) of patients and produce fewer valve-related complications.     

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.     

A case of pyoderma gangrenosum after mitral valve replacement]

A 48-year-old male with treated hypothyroidism underwent mechanical valve replacement for mitral valve regurgitation. After the operation, the patient developed progressive median chest wound ulceration. The wound did not heal with conventional therapies for mediastinitis such as administration of antibiotics, debridement of necrotic tissue or continuous irrigation. The entire surgical wound opened spontaneously. Bacterial cultures yielded negative and the wound biopsy specimen revealed non-specific inflammatory change. The anti-TSH receptor antigen level was high. Pyoderma gangrenosum based on auto-immune deficiency was diagnosed and high dose corticosteroid therapy was started. The wound healed completely in 5 months.     

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.     

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.