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.     

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.     

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.     

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.     

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)     

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

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

Tricuspid valve replacement with the St. Jude Medical valve

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.     

A case of thrombosed St. Jude Medical valve 16 years after initial mitral valve replacement]

We report successful surgery for a thrombosed St. Jude Medical (SJM) valve 16 years after the initial mitral valve replacement even under conditions of satisfactory anticoagulation therapy. A 61-year-old-female had intermittent claudication and was admitted to our hospital for examination. The prosthetic valve sounds were normal to auscultation and the left ankle-pressure index was decreased to 0.6. Transthoracic echocardiography revealed no mitral regurgitation and a mean mitral valve gradient of 6-7 mmHg. Furthermore, transesophageal echocardiography revealed that one of the leaflets of the prosthetic valve was entirely immobilized at the closing position and a mobile soft tissue mass, 5 mm in diameter, was detected at the atrial side of the obstructed leaflet. Although 96,0000 IU of urokinase was administered intravenously for a week, we could not confirm any change in leaflet mobility. At the time of surgery, the posterior leaflet of the SJM valve, which was implanted at an anatomical orientation, was obstructed at the closing position with old and fresh thrombi. We decided upon replacement with a CarboMedics 29 M prosthetic valve. Postoperative medication consisted of warfarin plus low-dose aspirin. Generally, valve thrombosis occurs within 5 years after valve replacement. However, valve thrombosis is possible even in a reliable SJM valve and as long as 16 years after replacement. Therefore, the implantation of an SJM valve at an anti-anatomical orientation might lower the incidence of valve thrombosis in addition to life-long anticoagulation 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.     

Long-term experience with the St. Jude Medical valve prosthesis.

BACKGROUND: All patients undergoing St. Jude Medical valve replacement at the Medical University of South Carolina since January 1979 have been followed prospectively at 12-month intervals. METHODS: This report describes long-term experience in 710 adult patients undergoing isolated aortic (AVR) (418) or mitral valve replacements (MVR) (292) with this prosthesis from January 1979 to December 1996. RESULTS: Ages ranged from 19 to 84 years (54.8 +/- 15.1 AVR, 51.8 +/- 12.9 MVR; mean +/- SD). Male gender predominated in the AVR group (70%) and female gender in the MVR group (62%). One hundred and fifty-seven patients (22%) had associated coronary artery bypass grafting (AVR 27%, MVR 15%). Thirty-day operative mortality was 5.3% (22/418) in the AVR group and 5.1% (15/292) in the MVR group. Follow-up is 96.9% complete and ranges from 1 month to 16.9 years (AVR, 2,376 patient-years, mean 5.7 +/- 4.5 years; MVR, 1,868 patient-years, mean 6.4 +/- 4.8 years). In the AVR group, 120 late deaths have occurred and actuarial survival was 78.0 +/- 2.3%, 58.0 +/- 3.2%, and 36.8 +/- 4.8%; at 5, 10, and 15 years, respectively. Forty-six patients have sustained 55 thromboembolic (TE) events (2.3%/patient-year). Fifty-one patients had anticoagulant-related bleeding complications (2.7%/patient-year). The mean improvement in New York Heart Association (NYHA) functional class from preoperative to postoperative was 3.0 +/- 0.8 to 1.7 +/- 0.1 (p < 0.05). In the MVR group, there have been 84 late deaths, and the actuarial survival was 79.3 +/- 2.5%, 60.1 +/- 3.5%, and 49.3 +/- 4.1% at 5, 10, and 15 years, respectively. Fifty-two patients have had 64 TE events (3.5%/patient-year). Twenty-three patients had anticoagulant-related bleeding complications (1.6%/patient-year). The mean improvement in NYHA functional class was from 3.3 +/- 0.6 to 1.8 +/- 0.1. There were no mechanical failures in either group. CONCLUSIONS: With a follow-up now extending to 17 years, the St. Jude Medical valve continues to be a reliable mechanical prosthesis with low and stable rates of valve-related complications.     

Ten years' experience with the St. Jude Medical valve prosthesis

Records of 1,298 consecutive patients who had received the St. Jude Medical prosthesis were reviewed (713 male and 585 female patients; mean age, 61.79 +/- 13.4 years). Early mortality was 5.7% (74 patients). Ninety-three percent complete follow-up was accomplished for the 1,224 patients who left the hospital (4,306.50 patient-years). One hundred ninety-two of these patients died, a late mortality of 16.9%. Sixty-four patients experienced thromboembolic episodes (17 major and 35 permanent). Twenty-four patients had anticoagulant-related bleeding, 4 had valve thrombosis, 7 had prosthetic valve endocarditis, 9 had paravalvular leak, and 10 underwent reoperation. There was no structural valve failure in this series. Twenty-two of the 118 patients who had valve-related complications died; another 15 patients died of sudden and unknown causes. Therefore, the total number of valve-related deaths was 37. Of those patients who survived, New York Heart Association functional class improved significantly (98% in classes II and III preoperatively and 96% in classes I and II postoperatively). Linearized rates for thromboembolism, valve thrombosis, and anticoagulant-related bleeding were 1.49% +/- 0.19%, 0.09% +/- 0.05%, and 0.56% +/- 0.11%/100 patient-years, respectively. The actuarial estimate of incidence free from all complications, operative death, and valve-related death was 66.9% +/- 8.2% at the end of 9 years. In spite of old age and advanced heart disease, the patients who received the St. Jude Medical prosthesis had very good results over a 10-year period.     

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.     

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.