Durability and low thrombogenicity of the St. Jude Medical valve at 5-year follow-up

Between November, 1978, and December, 1983, 736 patients had valve replacement with the St. Jude Medical valve prosthesis. There were 478 patients with aortic valve replacement (AVR), 188 with mitral valve replacement (MVR), 63 with double valve replacement, and 7 with tricuspid valve replacement (they were not included in this study). The mean age at the time of operation was 46.7 years for patients having AVR and 48.6 years for those having MVR and AVR + MVR. Follow-up totaled 1,116 patient-years (range, 4 to 82 months). Early (30-day) mortality was lowest for isolated MVR (2.3%) and AVR (3.7%), and increased with reoperation or when associated procedures were combined with valve replacement. Patients undergoing reoperation or having associated procedures made up 49% of the AVR and 54% of the MVR groups. All patients were advised of the need for long-term anticoagulation with warfarin sodium. Nine patients (7 with AVR, 1 with MVR, 1 with AVR + MVR) had suspected or confirmed episodes of systemic thromboembolism, a linearized incidence of 0.99% per patient-year for AVR, 0.36% per patient-year for MVR, and 0.98% per patient-year for AVR + MVR. Eight patients with AVR underwent reoperation for prosthetic valve endocarditis (5 of the 8 patients had endocarditis prior to initial valve replacement). There were no instances of structural valve failure. There were 37 late deaths. Actuarial survival at 5 years (excluding early mortality, 95% confidence limits) was 89.8% for AVR, 84.8% for MVR, and 95.2% for AVR + MVR.(ABSTRACT TRUNCATED AT 250 WORDS)     

Early clinical experience with the On-X prosthetic heart valve

The study aimed to assess the performance of the On-X valve (Medical Carbon Research Institute, Austin, TX). Between December 2000 and January 2003 On-X valves were implanted in 400 patients aged 19-85 years (mean: 55.6+/-16), 290 males and 210 females. There were 120 cases of aortic valve replacement (AVR), 258 mitral valve replacement (MVR) and 22 combined aortic and mitral valve replacement (DVR). Additional procedures were performed in 144 patients. Patients were followed up prospectively at 3- to 6-month intervals. Mean follow-up was 38.4+/-11.8 months (maximum 55.6 months). Overall hospital mortality was 3.5%. Freedom from adverse events at 4 years in the study were as follows: thromboembolism, 99.1% for AVR, 98.3% for MVR and 94.7% for DVR patients; thrombosis, 100% for AVR, 99.2% for MVR and 94.7% for DVR; bleeding events, 99.1% for AVR, 99.2% for MVR and 88.8% for DVR; prosthetic endocarditis, 98.2% for AVR, 99.2% for MVR and 94.7% for DVR. Overall survival at 4 years was 92+/-1%. At echocardiographical examination within 1 year of the AVR, the mean aortic valve gradient was 12.8+/-6, 10.3+/-3, 9.0+/-4, 8.3+/-3, and 6.2+/-3 mmHg for 19, 21, 23, 25, 27/29 mm valve sizes, respectively. MVR mean gradient was 4.9+/-2, 4.5+/-1.2 and 4.0+/-0.8 mmHg for 25, 27/29, 31/33 mm valve sizes, respectively. On-X valve is a highly effective mechanical valve substitute with low morbidity and mortality and good functional results.     

Mid-term surgical results after valve replacement with the carbomedics valve prosthesis

We present herein a review of 95 patients who underwent valve replacement with the CarboMedics (CM) valve prosthesis between April 1990 and December 1992. The operative mortality for the entire group was 4.2%: 0% following aortic valve replacement (AVR), 2.7% following mitral valve replacement (MVR), and 12.5% following double valve replacement (DVR). All patients were prescribed warfarin and bucolome for anticoagulation, and were followed up for a mean period of 29.9 months. Late mortality was 8.4%: 3.1% following AVR, 10.8% following MVR, and 12.5% following DVR. There were no cases of mechanical prosthetic valve failure, significant hemolysis, infective prosthetic valve endocarditis, or bleeding complications. After 44 months of follow-up, the actuarial freedom from complications was calculated as: thromboembolism, 97.8±1.6%; valve thrombosis, 97.8±1.1%; paravalvular leak, 96.7±1.9%; and reoperation, 98.9±1.1%. The overall survival rate was 84.3±6.3% and all survivors showed a significant improvement in NYHA functional class, from 81% in classes III and IV preoperatively to 99% in classes I and II postoperatively. The CM valve exhibited no significant differences in hemolytic parameters or hemodynamic performance after isolated AVR or MVR compared with the similar type of St. Jude Medical bileaflet valve. The evidence provided by the present study therefore suggests that the CM valve prosthesis can achieve excellent mid-term clinical results and hemodynamic performance with a low incidence of thromboembolism and valve thrombosis.     

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.     

Clinical experience with omniscience and omnicarbon prosthetic heart valves

Omniscience valves were implanted in sixty-two patients. Twenty-eight of these patients underwent aortic valve replacement (AVR), 15 had mitral valve replacement (MVR) and 8 had aortic and mitral valve replacement (DVR). Post-operative events occurred in nine (5.9%/patient year) of the AVR group, in three (1.7%/patient year) of the MVR group and in three (5.4%/patient year) of the DVR group. The actuarial freedom from all events at five years in the AVR, MVR and DVR was 74 +/- 8%, 88 +/- 6%, 67 +/- 16%, respectively. Cardiac death occurred in four (2.5%/patient year) of the AVR, one (0.6%/patient year) of the MVR and two (3.6%/patient year) of the DVR. The freedom at five years in the AVR, MVR and DVR was 88 +/- 6%, 96 +/- 4%, and 77 +/- 14%, respectively. Valve-related complications were noted in four patients. Post-operative cerebral hemorrhage was seen in three of the AVR. Maximum opening angle of the Omniscience valve was 39.1 +/- 4.5 degrees at the aortic position and 44.6 +/- 9.7 degrees at the mitral position. Omnicarbon valves implanted in ninety-five patients, fifty-eight of these patients underwent AVR, 24 had MVR and 13 had DVR. Events occurred post-operatively in four (2.6%/patient year) of the AVR group, in three (12.2%/patient year) of the MVR group, but in none of the DVR group. The freedom at five years was 89 +/- 6% in the AVR and 84 +/- 8% at three years in the MVR. Post-operative cardiac death occurred in one (0.7%/patient year) of the AVR and in two (8.1%/patient year) of the MVR.(ABSTRACT TRUNCATED AT 250 WORDS)     

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.     

Hematological complications with the St. Jude valve and reduced-dose Coumadin

We examined hematological complications in 415 patients having valve replacement with the St. Jude mechanical prosthesis (212, aortic valve replacement [AVR]; 159, mitral valve replacement [MVR]; and 44, AVR + MVR). There were 164 men and 251 women with a mean age of 59 years (range, 20 to 88 years). Preoperatively 386 patients were in New York Heart Association functional classes III and IV. There were 154 associated procedures (37%), the most common being myocardial revascularization. Overall hospital mortality was 7.5% (31/415), 7% after AVR, 8% after MVR, and 7% after AVR + MVR. All operative survivors were anticoagulated with Coumadin (crystalline warfarin sodium) to maintain the prothrombin time at 1.5 times control. During a mean follow-up of 21 months (range, 6 to 60 months), there were 29 late deaths (7.6%) and 5 patients (1.3%) lost to follow-up. No patient experienced structural valve degeneration. At 48 months, actuarial freedom from thromboembolism was 87% +/- 3% after AVR and 91% +/- 9% after MVR; from anticoagulation-related hemorrhage, 97% +/- 3% after AVR and 91% +/- 3% after MVR; and from hemolysis, 100% after AVR and 98% +/- 2% after MVR. Freedom from all valve-related morbidity at 4 years was 82% +/- 5% after AVR and 75% +/- 10% after MVR. Actuarial survival at 48 months was 80% +/- 4% after AVR and 65% +/- 7% after MVR.     

St. Jude Medical prosthesis: valve-related deaths and complications

Despite the hemodynamic improvement in cardiac valve prostheses, valve-related deaths and complications have remained a substantial source of morbidity and mortality. This follow-up study was carried out in April, 1986, in a group of 816 patients who received 876 St. Jude Medical prostheses between October, 1977, and October, 1984. One hundred fifty-five patients (37%) of the 422 having aortic valve replacement (AVR) and 88 (29%) of the 300 having mitral valve replacement (MVR) had concomitant coronary artery bypass grafting, and 94 patients (12%) had miscellaneous procedures performed in addition to valve replacement. Sixty-three patients died within the operative period, an operative mortality of 7.7%. Follow-up was complete for 98% of the patients; the mean follow-up was 42 months. At that time, 87 more patients had died, a late mortality of 11.9%. There were 13 valve-related deaths (4 in the AVR group, 7 in the MVR group, and 2 in the miscellaneous group); the causes of death were thromboembolism (7), anticoagulant-related hemorrhage (2), valve thrombosis (2), prosthetic valve endocarditis (1), and perivalvular leak (1). There were 37 thromboembolic episodes (1.78/100 patient-years) and 67 anticoagulant-related hemorrhages (3.22/100 patient-years), 46% of which necessitated transfusion. The incidence of valve thrombosis was 0.6% (4 patients). Perivalvular leak and prosthetic valve endocarditis occurred in 7 patients (1.0%) and 5 patients (0.7%), respectively. Reoperation was carried out in 6 patients (0.8%), but only for perivalvular leak. There were no deaths, no complications, and no clinical evidence of malfunction of the prosthetic valve.(ABSTRACT TRUNCATED AT 250 WORDS)     

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.     

Simultaneous implantation of St. Jude Medical aortic and mitral prostheses

Since January 1980, 92 consecutive patients received St. Jude Medical aortic and mitral prostheses simultaneously. Mean age was 57.6 years (standard deviation 12.4); 14 were 70 years or older. Twenty-three had a previous cardiac operation and 22 had additional procedures performed at the time of double valve replacement. Before the operation 62% of the patients were in New York Heart Association functional class III and 29% were in class IV or required emergency operation. There were six (6.5%) deaths within 30 days. None of the hospital deaths were valve related; all occurred in patients who had additional risk concerns. Follow-up is 100% complete and ranges from 2 to 80 months, totaling 242 patient-years (mean 33.8 months). All except four hospital survivors reached class I or II and 40 patients (47%) remain asymptomatic. The actuarial survival rates are 82% at 1 year, 70% at 3 years, and 60% at 5 years. Causes of late death include heart failure (10), sudden, unexplained death (five), reoperation for coronary artery disease (one), noncardiac (four), and valve related (five). The linearized rate of fatal valve-related events is 2.1% pt-yr. A total of 22 valve-related complications (including five fatal) occurred is 18 patients, for a linearized rate or incidence of 9.1%/pt-yr. Eleven thromboembolic episodes (rate 4.6%/pt-yr) occurred in nine patients; three of these (1.2%/pt-yr) were fatal. Thromboembolic and bleeding complications represented 64% of all valve-related complications. Four patients had six episodes of prosthetic valve endocarditis (incidence 2.5%/pt-yr), of which one (incidence 0.4%/pt-yr) was fatal. Paravalvular leak contributed to the fifth valve-related death. At 5 years, 83% of patients were free of thromboembolic complications; 94% were free of anticoagulant-related hemorrhage; and 71% were free of all valve-related complications. There are few comparable data for patients who have had simultaneous replacement of aortic and mitral valves with other mechanical prostheses. The total incidence of valve-related complications for patients with bioprostheses ranges between 3.9%/pt-yr and 10.4%/pt-yr and is similar to the 9.1%/pt-yr observed in the present series. The type of valve-related complication (thromboemboli and bleeding versus valve deterioration) is the principal difference between St. Jude Medical and bioprosthetic valves in patients who require simultaneous replacement of aortic and mitral valves.     

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.     

Clinical and hemodynamic assessment of the Hancock II bioprosthesis.

The Hancock II bioprosthesis was used for heart valve replacement in 614 patients from 1982 to 1990. Aortic valve replacement (AVR) was performed in 376 patients, mitral valve replacement (MVR) in 195, and aortic and mitral valve replacement (DVR) in 43. The mean age was 62.7 years, and 78% of all patients were in New York Heart Association functional class III or IV before operation. Coronary artery bypass graft was necessary in 232 patients and replacement of ascending aorta in 55. There were 31 operative deaths (AVR, 4%; MVR, 6%; DVR, 9%). Follow-up was complete in 98.5% of the patients and extended from 12 to 103 months, with a mean of 49 months. At the last follow-up, 85% of the patients were in New York Heart Association class I or II. The actuarial survival at 8 years was 79% +/- 3% for AVR, 68% +/- 4% for MVR, and 65% +/- 10% for DVR. The freedom from stroke at 8 years was 93% +/- 2% for AVR, 83% +/- 5% for MVR, and 90% +/- 5% for DVR. At the end of 8 years 96% +/- 1% of all patients were free from endocarditis, 92% +/- 1% were free from primary tissue failure, and 89% +/- 3% were free from reoperation. The actuarial freedom from valve-related death at 8 years was 98% +/- 1% for AVR, 86% +/- 5% for MVR, and 91% +/- 6% for DVR. Hemodynamic assessment was obtained by Doppler echocardiography in all operative survivors and demonstrated satisfactorily effective valve orifices and transvalvular gradients. The clinical results obtained with the Hancock II bioprosthesis have been gratifying, particularly in the aortic position. This bioprosthesis is our biological valve of choice.     

Single-center experience with the bicarbon bileaflet prosthetic heart valve in Japan

We analyzed midterm results using the Bicarbon valve in a single center. Forty-four patients had aortic valve replacement (AVR), 48 had mitral valve replacement (MVR), and 13 had both aortic and mitral valve replacement (DVR). The mean age of the 105 patients was 61.2 +/- 11.3 years. The mean follow-up was 1.8 +/- 1.1 years with a cumulative follow-up of 188 patient-years. There were 5 early deaths (4.7%: 4 in the AVR group and 1 in the MVR group) and 5 late deaths (2.7% per patient-year: 3 malignancy, 1 cerebral hemorrhage, 1 myocardial infarction). Survival at 3 years was 91 +/- 4% in the AVR group, 92 +/- 5% in the MVR group, and 66 +/- 23% in the DVR group. The linearized incidence of thromboembolic complications, hemorrhagic complications, and paravalvular leaks in all patients was 1.06 +/- 2.34%, 1.60 +/- 2.53%, and 0.53 +/- 2.22% per patient-year, respectively. No other complications were observed. In conclusion, the Bicarbon prosthetic heart valve has shown excellent clinical results associated with a low incidence of valve-related complications.     

Midterm experience with the Sorin Bicarbon heart valve prosthesis for rheumatic disease

BACKGROUND: In this study, we present a single center experience with Bicarbon bileaflet valve in 307 patients with rheumatic heart disease. METHODS: Between August 1998 and September 2000, 307 patients underwent heart valve replacement using the Bicarbon bileaflet valve (Sorin Biomedica, Saluggia, Italy) with an average age of 47.19+/-13.21 years (range 14 to 80 years), consisting of 147 males and 160 females at Alkan Hospital, Cardiovascular Surgery Department. Aortic valve replacement (AVR) was performed in 77 patients, mitral valve replacement (MVR) in 156 patients and double valve replacement (DVR) in 74 patients. RESULTS: The early mortality rate was 3.3% (10/307) and there was no late mortality. The actuarial survival rate, including hospital mortality, was 96.74+/-1.01% for the whole group, 96.5+/-1.5% for the MVR group, 97.4+/-1.8% for the AVR group and 97.3+/-1.9% for the DVR group at 35 months. One patient had obstructive valve thrombosis with MVR. The 35 months actuarial freedom from valve thrombosis was 99.58+/-0.4% for the whole group. Four patients were reoperated and the 35 months actuarial freedom from reoperation was 98.53+/-0.7% for the whole group, 98.65+/-0.9% for the MVR group, 96.73+/-02% for the DVR group and 100% for the AVR group. No instances of perivalvular leak, hemolysis, endocarditis or embolism were observed during the entire follow-up period. Mean follow-up duration was 16.5+/-7.9 months (ranged 4 to 35 months). CONCLUSION: We have presented our mid-term results with the Sorin Bicarbon bileaflet valve in patients with rheumatic heart disease, which provided good clinical performance combined with meticulous patient care and advanced surgical techniques.     

Heart valve replacement with the Bj?rk-Shiley Monostrut valve: early results of a multicenter clinical investigation

To evaluate the clinical performance of the Bj?rk-Shiley Monostrut prosthesis, five centers combined their early experience. Between May, 1982, and June, 1985, 537 prostheses were implanted in 486 patients at these centers: 246 patients had aortic valve replacement (AVR), 163 underwent mitral valve replacement (MVR), and 47 had double-valve replacement (DVR). Thirty patients underwent other, more complex procedures. Concomitant cardiac procedures were performed in altogether 25%. Overall hospital (30 days) mortality was 5.1% (3.6% for AVR, 4.3% for MVR, 8.3% for DVR, and 16.6% for other procedures). The patients were followed up at 6- to 9-month intervals from 6 to 48 months (mean follow-up, 33 months). Follow-up was 99.6% complete. Late mortality was 7.2%. The three-year survival rate was 91.0% for AVR, 92.3% for MVR, and 76.2% for DVR. There was no structural failure of the prosthesis. No instances of valve thrombosis and fatal thromboembolism occurred in anticoagulated patients. The three-year incidence of freedom from thromboembolic events (including TIA) was 89.8% for AVR, 94.9% for MVR, and 90.2% for DVR. Preoperative and postoperative data for the assessment of mechanical hemolysis was available in 60% of the patients. The degree of mechanical hemolysis was low and did not change with time. Although the follow-up is still short, the Bj?rk-Shiley Monostrut prosthesis appears to represent an improvement over previous Bj?rk-Shiley models, particularly with regard to durability.     

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.     

Heart Valve Replacement with the Hancock Bioprosthesis: A 6-Year Review

All patients who had a mitral or aortic Hancock valve replacement between June, 1974, and June, 1979, were reviewed. A total of 734 bioprostheses were implanted in 632 patients: 291 had mitral (MVR), 239 had aortic (AVR), and 102 had both mitral and aortic valve replacement (MVR + AVR). In 228 patients, an associated surgical procedure was necessary. It involved conservative valve operation in 205 of them. The hospital mortality was 9.6% (28) for MVR (11.5% with associated operation), 4.6% (11) for AVR (8.7% with associated operation), and 13.7% (14) for MVR + AVR (13.0% with associated operation).The follow-up period was between 1 and 6 years with a total follow-up of 934.6, 714.6, and 288.3 patient-years for MVR, AVR, and MVR + AVR, respectively. The late mortality was 0.96% (9), 1.53% (11), and 2.08% (6) per patient-year for MVR, AVR, and MVR + AVR, respectively. The thromboembolic rate was 1.49%, 0.14%, and 2.08% per patient-year for MVR, AVR, and MVR + AVR, respectively. There were twelve valve failures (six were due to rupture; four, thrombosis; one, insufficiency because of intrinsic failure; and one, stenosis without evident cause at reoperation). This represents a failure rate of 0.53%, 0.13%, and 2.08% per patient-year for MVR, AVR, and MVR + AVR, respectively. These results encourage us to continue our routine use of the glutaraldehyde xenografts as the safest valve substitute at present.     

Eight year experience with the CarboMedics bileaflet valvular prosthesis.

Two hundred and two patients (97 female and 105 male; mean age: 45. 5+/-9 years) received CarboMedics bileaflet valves during a period of eight years. Ninety-one patients received mitral, 72 aortic and 39 aortic+mitral valve prosthesis. Tricuspid plasty and coronary artery bypass surgery were the concomitant operations in 17 and 12 patients, respectively. The mean follow-up period was 24.7 months and the ratio was 91%. Overall operative mortality was 3.96% (8 patients); 2.78% for aortic valve replacement (AVR), 3.29% for mitral valve replacement (MVR) and 7.7% for double valve replacement (DVR). The late mortality rate was 2.89% for AVR, 2.2% for MVR and 8. 3% for DVR. The main cause of mortality was low cardiac output. The overall survival rate was 91.5% in 2 years. The actuarial freedom from thromboembolism in 2 years was 97% for AVR, 95% for MVR and 84% for DVR. No mortality due to heamorrhagic events was observed. CarboMedics prosthetic heart valves may be used satisfactorily with a low incidence of valve-related morbidity and mortality.     

Aortic Valve Replacement With the St. Jude Medical Prosthesis and Fixed Dose Anticoagulation

A bstract Over a 10-year period, between 1986 and 1996, 865 patients underwent primary aortic valve replacement (AVR) with the St. Jude Medical mechanical prosthesis. Patients who had undergone valve replacement with a different type of prosthesis previously were excluded from this study. Patient age ranged from 11 to 79 years. The mean age was 42.9 ± 14.54. The gender distribution was 396 men (45.8%) and 469 women (54.2%). All patients received 2.5 mg/day Coumadin after extubation. A combination of the antiagregant therapy (Dypridamole 3 × 75 mg/day, Asprine 100 mg/day) was added after removal of the chest tubes. The dosage of Coumadin was maintained constant regardless of the prothrombin time (PT) or cardiac rhythm. There were 101 valve-related complications (4.2% per patient year [ppy]) occurring in the late follow-up period. Of these complications; 38 were anticoagulant-related hemorrhage (1.58% ppy), 3 were paravalvular leak (0.12% ppy), and 36 were thromboembolism (1.4% ppy). There were 24 reoperations (0.99% ppy) and 17 late deaths. The linearized late mortality rate was 0.7% ppy. Long-term survival estimates at 5 and 10 years were 97.14 ± 0.82% and 94.86 ± 1.54%, respectively. We conclude from the data that the St. Jude Medical valve may allow the use of a low level of anticoagulation. This study shows that fixed dose oral anticoagulation does not increase the rate of thromboembolism in patients with the St. Jude aortic valve. This protocol does not result in reduction of bleeding complications, however.     

Mechanical heart valves: Changes in patient survival and valve failure rates

The effect of patient related variables and mechanical heart valve substitutes on survival and valve failure rates was studied in 2,778 patients operated between 1966 and 1986. Of these 48.2% were operated without cardioplegic protection (phase I) and 51.8% thereafter (phase II). Mitral vlave replacement (MVR) was performed in 1,257 patients (phase I: 51.58%, phase II: 48.42%); aortic valve replacement (AVR) in 931 (phase I: 54.78%, phase II: 45.22%) and combined procedures in 590 (phase I: 31%, phase II: 69%) patients. Starr-Edwards valves (SEv) were used in 642, Bjork-Shiley valves (BSv) in 1993, and St Jude Medical valve (SJv) in 143 patients. At 15 years, ‘valve failure’ rate was 32±5, 48.31±6 and 361±3% for all AVR, MVR and AVR with MVR patients respectively. At 22 years, ‘valve failure’ rate was 51% for SEv model A 1200/60 patients and 56% for SEv model M 6120 patients. Valve related events (488) contributed to 13.4% late deaths. Overall incidence of thromboembolism was 10.18%, anticoagulant related haemorrhage 2.92%, valve thrombosis (SEv and BSv only) 1.56%, paravalvular leak 2.58%, endocarditis (PVE) 1.12%, mechanical failure (BSv and SEv A1200) 0.54%, haemolysis (SEv only) 0.4% and reoperations 5% in 2,505 survivors. Mortality following PVE was 56% and that due to thrombosed BSv 35%. Hospital mortality for elective reoperations was 18% in phase I and 5.4% in phase II (p<0.01). During the second decade of implantation cardiac related deaths increased but ‘valve failure’ rate decreased.