Mechanical versus bioprosthetic valve replacement in middle-aged patients.

OBJECTIVE: The current trend towards decreasing the age for selection of a tissue over a mechanical prosthesis has led to a dilemma for patients aged 50-65 years. This cohort study examines the long-term outcomes of mechanical versus bioprosthetic valves in middle-aged patients. METHODS: Patients (N = 659) aged between 50 and 65 years who had first-time aortic valve replacement (AVR) and/or mitral valve replacement (MVR) with contemporary prostheses were followed prospectively after surgery. The total follow-up was 3,402 patient-years (mean 5.1 +/- 4.1 years; maximum 18.3 years). Outcomes were examined with multivariate actuarial methods. A composite outcome of major adverse prosthesis-related events (MAPE) was defined as the occurrence of reoperation, endocarditis, major bleeding, or thromboembolism. RESULTS: Ten-year survival was 73.2 +/- 4.2% after mechanical AVR, 75.1 +/- 12.6% after bioprosthetic AVR, 74.1 +/- 4.6% after mechanical MVR, and 77.9 +/- 7.4% after bioprosthetic MVR (P=NS). Ten-year reoperation rates were 35.4% and 21.3% with aortic and mitral bioprostheses, respectively. Major bleeding occurred more often following mechanical MVR (hazard ratio [HR]: 3.3; 95% confidence interval [CI] 1.2, 9.0; P = 0.022), and the incidence of any thromboembolic event was more common after mechanical MVR (HR: 4.7; CI 1.4, 13.3; P = 0.01). Overall freedom from MAPE at 10 years was 70.2 +/- 4.1% for mechanical AVR patients, 41.0+/-30.3% for bioprosthetic AVR patients, 53.3 +/- 8.8% for mechanical MVR patients, and 61.2 +/- 9.2% for bioprosthetic MVR patients. Although a trend existed towards more MAPE amongst middle-age patients with tissue valves, multivariate analysis did not identify the presence of a bioprosthesis as an independent risk factor for MAPE (HR: 1.3; CI 0.9, 2.0; P = 0.22). CONCLUSIONS: In middle-aged patients, MAPE may occur more often in patients with bioprosthetic valves, but definitive conclusions necessitate the accumulation of additional follow-up. At present, these data do not support lowering the usual cutoff for implantation of a tissue valve below the age of 65.     

Long-term outcomes of valve replacement with modern prostheses in young adults.

OBJECTIVES: To examine the multiple impacts of valve replacement on the lives of young adults. METHODS: Patients (N=500) between age 18 and 50 who had aortic valve replacement (AVR) and/or mitral valve replacement (MVR) with contemporary prostheses were followed annually. Events, functional status, and quality of life were examined with regression models. RESULTS: Median follow-up was 7.1+/-5.3 years (maximum 26.7 years). Five, 10, and 15-year survival was 92.7+/-1.7, 88.3+/-2.4 and 80.1+/-4.7% after AVR, and 93.1+/-2.3, 79.5+/-4.3 and 71.5+/-5.4% after MVR, respectively. Survival decreased with concomitant coronary disease (hazard ratio (HR): 4.5) and preoperative LV grade (HR: 2.0/grade increase) in AVR patients, and with atrial fibrillation (HR: 5.5), coronary disease (HR: 5.7), preoperative left atrial diameter (HR: 3.0/cm increase) and NYHA class (HR: 2.1/class increase) in MVR patients. Despite reoperation, late survival was equivalent between bioprostheses and mechanical valves in both implant positions. The ten-year cumulative incidence of embolic stroke was 6.3+/-2.4% for mechanical AVR patients, 6.4+/-2.9% for bioprosthetic AVR patients, 12.7+/-3.9% for mechanical MVR patients, and 3.1+/-3.1% for bioprosthetic MVR patients. Atrial fibrillation (HR: 2.8) and smoking (HR: 4.0) were risk factors for stroke in MVR patients. In AVR patients, SF-12 physical scores, freedom from recurrent heart failure, and freedom from disability were significantly higher in bioprosthetic than mechanical valve patients. Career or income limitations were more often subjectively linked to a mechanical prosthesis in both implant positions. CONCLUSIONS: Late outcomes of modern prosthetic valves in young adults remain suboptimal. Bioprostheses deserve consideration in the aortic position, as mechanical valves are associated with lower physical capacity, a higher prevalence of disability, and poorer disease perception. Early surgical referral and atrial fibrillation surgery may improve survival after MVR.     

Failure of Hancock pericardial xenografts: is prophylactic bioprosthetic replacement justified?

The incidence of major valve-related complications was evaluated in a series of patients in whom the Hancock pericardial xenograft was used for aortic (AVR; n = 84), mitral (MVR; n = 17) and mitral-aortic (MAVR; n = 13) valve replacement. At 7 years actuarial survival is 66% +/- 8% after AVR, 64% +/- 13% after MVR, and 41% +/- 15% after MAVR, whereas actuarial freedom from valve-related death is 79% +/- 7% after AVR, 78% +/- 13% after MVR, and 81% +/- 12% after MAVR. Actuarial freedom from thromboemboli and anticoagulant-related hemorrhage at 7 years is 93% +/- 4% and 98% +/- 2% after AVR and 83% +/- 10% and 88% +/- 11% after MVR; no such complications occurred after MAVR. Structural valve deterioration determined at reoperation, at autopsy, or by clinical investigation was observed in 34 patients with AVR (10.0 +/- 0.2%/patient-year), in 10 with MVR (10.6 +/- 3.3%/patient-year), and in 9 with MAVR (16.6 +/- 5.5%/patient-year). After AVR, 19 patients underwent reoperation and 2 died before reoperation; 4 patients with MVR underwent reoperation, and 7 patients with MAVR underwent reoperation and 1 died before reoperation. Seventy-eight percent of the current survivors (13 patients with AVR, 7 with MVR, and 1 with MAVR) have clinical evidence of valve failure. At 7 years actuarial freedom from structural deterioration of the Hancock pericardial xenograft is 25% +/- 7% after AVR, 29% +/- 14% after MVR, and 0% after MAVR.(ABSTRACT TRUNCATED AT 250 WORDS)     

Elderly valve replacement with bioprostheses and mechanical prostheses. Comparison by composites of complications

AIM: The goal of aortic valve replacement (AVR) surgery in the elderly (= or >75 years) is to extend survival and minimize valve-related morbidity, mortality and reoperation. As the elderly population lives longer, those with implanted valves are at risk of suffering valve related complications. We hypothesize that bioprostheses are appropriate for the elderly. METHODS: The follow-up evaluation of 966 patients with valves (AVR, 666; mitral valve replacements [MVR], 226; multiple valve replacements [MR], 74) implanted between 1975 and 1999 was examined. There were 879 bioprotheses (BP) and 87 mechanical prostheses (MP). The mean age was 78.9+/-3.3 years (range 75-94.6 years). Concomitant coronary artery bypass was performed in AVR in 51.7%, MVR in 50.4% and MR in 28.4%. Valve type, valve lesion, coronary artery bypass (previous/concomitant), age and gender were considered as independent predictors of composites and survival. The total follow-up was 3905 patient-years. RESULTS: Early mortality was for AVR 9.6% (64), MVR 15.0% (34) and MR 25.7% (19). The late mortality was for AVR 8.8%, MVR 10.4% and MR 8.8%/patient-year. The only independent predictor of survival and valve-related mortality, morbidity and reoperation was age for survival in those with AVR, hazard ratio 1.15 [CL 1.03-1.27] p=0.0094). The BP reoperative rate was 0.5%/patient-year (reoperation was fatal in 6/15) of total, MP reoperative rate was 0% [reasons for reoperation structural valve deterioration (4), non-structural dysfunction (6), prosthetic valve endocarditis (5), reoperation fatality due to non-structural dysfunction (2), prosthetic valve endocarditis (4)]. Overall patient survival at 10 and 15 years, respectively, was 30.5+/-2.4% and 3.6+/-2.2% irrespective of valve position and type. Overall actual and actuarial freedom from valve-related morbidity at 15 years was 96.8+/-0.9% and 93.7+/-2.3%, respectively. Actual and actuarial overall freedom from valve-related mortality at 15 years was 84.3+/-2.4% and 58.4+/-0.9%, respectively. Overall actual and actuarial freedom from valve related reoperation at 15 years was 95.8+/-1.6% and 74.8+/-16.9%, respectively. CONCLUSIONS: BP valves are further confirmed to be a good option for AVR in patients = or >75 years of age.     

Durability and outcome of aortic valve replacement with mitral valve repair versus double valve replacement

BACKGROUND: The purpose of this study was to evaluate morbidity and mortality after double valve replacement (DVR) and aortic valve replacement with mitral valve repair (AVR + MVP). METHODS: From 1977 to 2000, 379 patients underwent DVR (n = 299) or AVR + MVP (n = 80). Actuarial survival and freedom from reoperation were determined by the Kaplan-Meier method. Potential predictors of mortality and reoperation were entered into a Cox multiple regression model. Propensity score was introduced for the multivariable regression modeling for adjustment of a selection bias. RESULTS: Survival 15 years after surgery was similar between the groups (DVR, 81% +/- 3%; AVR + MVP, 79% +/- 7%; p = 0.44). Freedom from thromboembolic event at 15 years was similar between the groups (p = 0.25). Freedom from mitral valve reoperation at 15 years was significantly better for the DVR group (54% +/- 5%) as compared with the AVR + MVP group (15% +/- 6%; p = 0.0006), primarily due to progression of mitral valve pathology and early structural deterioration of bioprosthetic aortic valve used for patients with AVR + MVP. After AVR + MVP, freedom from mitral reoperation at 15 years was 63% +/- 16% for nonrheumatic heart diseases, and 5% +/- 5% for rheumatic disease (p = 0.04). CONCLUSIONS: Although both DVR and AVR + MVP provided excellent survival, DVR with mechanical valves should be the procedure of choice for the majority of patients because of lower incidence of valve failure and similar rate of thromboembolic complications compared with AVR + MVP. MVP should not be performed in patients with rheumatic disease because of higher incidence of late failure.     

Late incidence and determinants of reoperation in patients with prosthetic heart valves.

OBJECTIVES: Reoperation is a relatively common event in patients with prosthetic heart valves, but its actual occurrence can vary widely from one patient to another. With a focus on bioprosthetic valves, this study examines risk factors for reoperation in a large patient cohort. METHODS: Patients (N=3233) who underwent a total of 3633 operations for aortic (AVR) or mitral valve replacement (MVR) between 1970 and 2002 were prospectively followed (total 21,179 patient-years; mean 6.6+/-5.0 years; maximum 32.4 years). The incidence of prosthetic valve reoperation and the impact of patient- and valve-related variables were determined with actual and actuarial methods. RESULTS: Fifteen-year actual freedom from all-cause reoperation was 94.1% for aortic mechanical valves, 61.4% for aortic bioprosthetic valves, 94.8% for mitral mechanical valves, and 63.3% for mitral bioprosthetic valves. In both aortic and mitral positions, current bioprosthesis models had significantly better durability than discontinued bioprostheses (15-year reoperation odds-ratio 0.11+/-0.04; P<0.01 for aortic, and 0.42+/-0.14; P=0.009 for mitral). Current bioprostheses were significantly more durable in the aortic position than in the mitral position (14.3+/-6.8% more freedom from 15-year reoperation; (P=0.018)). Older age was protective, but smoking was an independent risk factor for reoperation after bioprosthetic AVR and MVR (hazard ratio for smoking 2.58 and 1.78, respectively). In patients with aortic bioprostheses, persistent left ventricular hypertrophy at follow-up and smaller prosthesis size predicted an increased incidence of reoperation, while this was not observed in patients with mitral bioprostheses. CONCLUSIONS: These analyses indicate that current bioprostheses have significantly better durability than discontinued bioprostheses, reveal a detrimental impact for smoking after AVR and MVR, and indicate an increased reoperation risk in patients with a small aortic bioprosthesis or with persistent left ventricular hypertrophy after AVR.     

Clinical performance of the Duromedics bileaflet pyrolite mechanical prosthesis.

The Duromedics (Baxter Healthcare Corp., Edwards CVS Div., Irvine, Calif.) mechanical cardiac valvular prosthesis was implanted in 480 patients between 1984 and 1987 at the Montreal Heart Institute, the Hospital Clinic of Barcelona and the teaching hospitals of the University of British Columbia. The mean age of the patients was 52 years. The early mortality was 7.9% and the late mortality was 4.1% per patient-year. The overall survival at 4 years for aortic valve replacement (AVR) was 87.0% +/- 3.7% and for mitral valve replacement (MVR) was 81.9% +/- 2.9%. There were 16 valve-related reoperations in 14 patients--for prosthetic valve endocarditis in 9 patients, for thromboembolism in 1 patient and for nonstructural dysfunction in 4 patients. The freedom from thromboembolism at 3 and 4 years was 94.3% +/- 3.1% for AVR and 95.1% +/- 1.8% for MVR. The freedom from prosthetic valve endocarditis at 3 and 4 years was 95.3% +/- 2.2% for AVR and 96.2% +/- 1.6% for MVR. The freedom from structural valve deterioration for all positions was 100%. The freedom from reoperation at 4 years was 95.3% +/- 2.1% for AVR and 92.3% +/- 4.3% for MVR and from valve-related death was 98.7% +/- 1.3% for AVR and 96.2% +/- 1.6% for MVR. The freedom from all valve-related complications at 4 years was 87.7% +/- 3.8% for AVR and 85.7% +/- 2.9% for MVR. Long-term evaluation of the Duromedics prosthesis is required to determine the influence of documented structural valve deterioration.     

Aortic valve selection in the elderly patient

To determine the influence of valve selection on valve-related morbidity and mortality and patient survival, comparative long-term performance characteristics of mechanical (N = 68) and bioprosthetic (N = 73) heart valves were analyzed for 141 patients more than 70 years old who underwent isolated aortic valve replacement between 1970 and 1985. Cumulative patient follow-up was 491 patient-years (average, 4.3 years per patient). Hospital mortality was 18% and 19% for patients with mechanical valves and bioprosthetic valves, respectively. Survival at 5 years was 61 +/- 7% (+/- the standard error) and 67 +/- 10% for recipients of mechanical valves and bioprosthetic valves, respectively. Male sex (p = 0.014) and urgency of operation (p = 0.006) were independent risk factors for hospital mortality. Atrial fibrillation increased valve-related mortality (p = 0.01). No patient required reoperation or experienced structural valve failure. While anticoagulant-related hemorrhage was increased in recipients of mechanical valves (9.2 +/- 2.1%/patient-year) compared with recipients of bioprosthetic valves (2.3 +/- 1.1%/patient-year), it did not result in a death or lead to permanent disability. There was no difference in freedom from any valve-related complication at 5 years. However, when all morbid events are considered, recipients of bioprosthetic valves experienced fewer valve-related complications than patients receiving mechanical valves (10.7 +/- 2.3%/patient-year versus 17.6 +/- 2.5%/patient-year, respectively; p less than 0.05). The reduced incidence of anticoagulant-related hemorrhage and the infrequent need for warfarin sodium anticoagulation favor selection of a bioprosthetic heart valve in patients older than 70 years.     

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)     

Long-term clinical results after aortic valve replacement with mechanical heart valves and mitral valve replacement with porcine valves]

Long-term clinical results of aortic valve replacement (AVR) with mechanical heart valves and mitral valve replacement (MVR) with porcine valves were analysed. Sixty-three patients received isolated AVR and 48 received isolated MVR. Sixty-eight patients with MVR including double or triple valve replacement were also added in order to evaluate the primary tissue failure (PTF). The patients with operative deaths were excluded. Survival rate at 11 years in AVR was 68 +/- 10% and 67 +/- 15% in MVR without statistical difference. At 11 years, 76 +/- 8% of the patients in AVR were free from valve-related complications in contrast with the poor result of 34 +/- 31% in MVR (p less than 0.01). Main cause of this poor result in MVR was PTF as indicated in following event free rates; 83 +/- 9% at 7 years, 61 +/- 25% at 10 years and 49 +/- 31% at 13 years. There was no statistical difference between patients of above 50 years and below 49 years in PTF. Valve-related death event free was 93 +/- 5% in AVR and 86 +/- 11% in MVR at 11 years (not significant), however, there was statistical difference in re-operation event free rate as 94 +/- 5% in AVR and 76 +/- 11% in MVR at 11 years (p less than 0.001). These results suggest that the use of porcine valves in mitral position is confined to the selected patients.     

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.     

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.     

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.     

"Mosaic" medtronic bioprosthetic valve replacement clinical results and hemodynamical performance

BACKGROUND: We report the mid-term results of a prospective trial of a new bioprosthetic valve. The Mosaic bioprosthesis consists of porcine aortic valve that has been cross linked ed in glutaraldehyde solution under zero-pressure fixation and treated with alpha amino oleic acid to reduce the potential for calcification. METHODS: Mosaic bioprosthetic valve replacement was performed in 67 consecutive patients between January 1995 and August 1998. There were 37 patients having aortic valve replacement (AVR) and 30 having mitral valve replacement (MVR) who entered this study. The patients age ranged 56 to 86 years (mean 74.9); 38 were female and 29 were male; 44 were in NYHA grade 3 and 21 were NYHA grade 4. All mitral valve replacements were performed with total preservation of subvalvular apparatus. Echocardiographic assessment of valve and LV function were performed on 7th day, 6 months 1,2 and 3 years. RESULTS: There was no hospital mortality. 3 year survival was 85.9+/-5.9% for AVR and 100% for MVR. Freedom from antithromboembolic related haemorrhage has been 96.7% for MVR and 91.9% for AVR. Freedom from the transient neurological event was 96.7+/-3.3% for MVR and 100% for AVR Freedom from structural valve failure, permanent thromboembolism, thrombosis or endocarditis has been 100% for both AVR and MVR. In AVR group left ventricle mass, left ventricle mass index significantly decreased, when cardiac index and effective orifice area increased significantly during study period. Transvalvular gradient did not change. In MVR group transvalvular gradient, effective orifice area and cardiac index did not change. CONCLUSIONS: The valve was user friendly. The early results are very satisfactory. Echocardiography measurements after aortic valve replacement are showing very marked late postoperative remodelling of left ventricle. After mitral valve replacement there were exceptionally low transvalvular gradients, no left ventricle outflow tract obstruction.     

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)     

The Mitroflow pericardial bioprosthesis. Comparison of early clinical performance in aortic and mitral positions.

Between 1983 and 1987 the Mitroflow pericardial prosthesis was implanted in 354 patients, ranging in age from 14 to 94 years (mean 60.1 years). The early mortality was 5.7% and the late mortality 2.9% per patient-year. The total cumulative follow-up was 853 years (mean 2.4 years). Patient survival at 4 years for aortic valve replacement (AVR) was 81.5% and for mitral valve replacement (MVR) 74.8%. The overall rate of valve-related complications was 4.8% per patient-year (41 complications): thromboembolism, 15; hemorrhage related to antithromboembolic therapy, 1; prosthetic valve endocarditis, 15; nonstructural dysfunction, 3; and structural valve deterioration, 7. At 4 years the freedom from thromboembolism was 91.5% +/- 2.7% for AVR and 91.1% +/- 4.0% for MVR, from prosthetic valve endocarditis 93.5% +/- 2.3% for AVR and 94.0% +/- 2.9% for MVR, from structural valve deterioration 97.3% +/- 2.1% for AVR and 92.6% +/- 3.2% for MVR, from valve-related mortality 96.9% +/- 1.4% for AVR and 97.5% +/- 1.8% for MVR, and from reoperation 93.5% +/- 2.8% for AVR and 83.1% +/- 5.1% for MVR. The freedom from the composite of all valve-related complications at 4 years was 81.1% +/- 4.2% for AVR and 75.3% +/- 2.8% for MVR. The Mitroflow valve has provided satisfactory clinical performance at the 4-year evaluation. Structural valve deterioration is greater in the mitral position than in the aortic position. Long-term evaluation of the Mitroflow valve is necessary to determine the impact of structural valve deterioration on its clinical performance.     

Aortic valve replacement in patients age 70 years and older: early and late results

This retrospective analysis was performed to determine the early and late outcome in patients 70 years and older undergoing aortic valve replacement (AVR). From October 1994 to May 2001, 49 patients (24 men and 25 women, age 70 to 88 years [mean 74 +/- 4.6 years]) underwent primary AVR with or without concomitant procedures. Twenty-one received mechanical valves and 28 bioprostheses. Age was different between both groups: 72 +/- 2.3 years (mechanical) and 76 +/- 5.1 years (bioprosthetic) (p = 0.0005). Aortic stenosis was present in 25 patients (51%). Follow-up was 100% complete at a mean follow-up of 2.9 years (range 0.3-6.5 years). Overall hospital mortality was 4.1% (2/49). There were no postoperative complications in 24% of patients. Postoperative hospital stay or hospital survival was 27 +/- 13 days. Survival at 3 and 5 years was 89 +/- 5% and 80 +/- 7%, respectively. Three late deaths were due to noncardiac causes and 1 each had a cardiac or valve-related cause (thromboembolism). Other valve-related complications such as anticoagulant-related hemorrhage, perivalvular leak, endocarditis, prosthetic valve failure, and reoperation were not noted in any of the 49 patients. The actuarial survival curve was similar in each group of bioprosthetic versus mechanical and septuagenarians versus octogenarians. Under the selection criteria for AVR currently applied in our hospital, geriatric patients showed a satisfactory early outcome and medium-term survival benefit.     

Midterm evaluation of the Sorin Bicarbon heart valve prosthesis: single-center experience

BACKGROUND: The purpose of this study was to perform midterm evaluation of the clinical performance of the Sorin Bicarbon mechanical heart valve prosthesis. METHODS: From November 1992 to December 2002, 328 patients underwent isolated aortic (AVR; 156) or mitral (MVR; 172) valve replacement with the Sorin Bicarbon mechanical valve. Concomitant surgery was performed in 83 patients (25.2%). RESULTS: Total hospital mortality was 5.2%. Survival at 7 years was 79.5% for AVR and 82.4% for MVR. Kaplan-Meier freedoms from valve-related complications were as follows: thromboembolism 92.7% (AVR 94.8%, MVR 92.1%); bleeding 93% (AVR 91.9%, MVR 94.5%); nonstructural dysfunction 96.6% (AVR 94.7%; MVR 97.9%); endocarditis 97.7% (AVR 97.4%, MVR 98.1%); and reoperation 95.7% (AVR 96.6%, MVR 93.9%). Overall freedom from valve-related death was 93.2% (AVR 99.3%, MVR 91.2%). At the end of follow-up, 88.9% of survivors were in New York Heart Association class I or II. CONCLUSIONS: The Sorin Bicarbon valve is a satisfactory mechanical valve prosthesis with low mortality and morbidity and good functional results.     

A six-year study of the Omniscience valve in four Canadian centers

Stimulated by the recent controversy over the Omniscience valve, we conducted a follow-up study on 413 hospital survivors in whom this prosthesis was implanted at four Canadian centers from 1979 to 1985. One hundred forty-seven underwent aortic valve replacement (AVR), 203 had mitral valve replacement (MVR), 10 had tricuspid valve replacement (TVR) and 53 underwent multiple valve replacement (45 AVR + MVR, 5 MVR + TVR, and 3 AVR + MVR + TVR). The mean age was 50.8 +/- 13 years (range, 2 months to 75 years). Follow-up of 96% was achieved for a mean of 2.6 years and a maximum of 6 years with a total of 1,076 patient-years. Complications were defined and graded according to severity. Analyses were performed to yield linearized and actuarial rates for complications. There were 30 late deaths (2.8% per patient-year). At 5 years, the actuarial survival was 89 +/- 3% (AVR, 89 +/- 3% and MVR, 91 +/- 3%). Percentages for freedom from each complication are as follows: endocarditis, 96 +/- 1% (AVR, 96 +/- 2% and MVR, 98 +/- 1%); periprosthetic leak, 99 +/- 0.6% (AVR, 98 +/- 1% and MVR, 99 +/- 0.6%); thrombotic complications, 87 +/- 3% (AVR, 84 +/- 6% and MVR, 90 +/- 3%); valve thrombosis 99.4% (AVR and MVR, 100%); anti-coagulant-related hemorrhage, 94 +/- 2% (AVR, 97 +/- 2% and MVR, 94 +/- 2%); and all valve-related complications, 77 +/- 3% (AVR, 77 +/- 6% and MVR, 79 +/- 4%). Reoperation was required at the rate of 1.2% per patient-year.(ABSTRACT TRUNCATED AT 250 WORDS)     

Carpentier-Edwards standard porcine bioprosthesis: primary tissue failure (structural valve deterioration) by age groups

Primary tissue failure (structural valve deterioration) has been documented as the most prominent complication of porcine bioprostheses. The influence of age on primary tissue failure has received limited consideration. From 1975 to 1986, 1,301 Carpentier-Edwards standard porcine bioprostheses were implanted in 1,183 patients in 1,201 operations. Of the total number of prostheses, 97.7% were implanted prior to 1983. The mean follow-up was 5.6 years and was 97.5% complete. Primary tissue failure was identified in 96 patients (98 operations) at reoperation (95) or autopsy (3). One hundred four (104) prostheses were involved. Thirty-one failed after aortic valve replacement (AVR), 49 after mitral valve replacement (MVR), and 24 after multiple-valve replacement (18 patients). There were 47 male and 49 female patients. The mean age at implantation was 47 years (range, 8 to 72 years). The mean implantation time was 74.0 months. The freedom from primary tissue failure at 10 years is 77.0 +/- 2.9% overall; for AVR, 83.1 +/- 3.7%; for MVR, 72.1 +/- 4.9%; and for multiple-valve replacement, 65.5 +/- 7.8%. The freedom from deterioration for patients less than 20 years of age is significantly less than that for other age groups. The freedom from deterioration increased by decades; the greatest freedom was noted in patients 70 to 80 years old and 80 years old or older. The freedom from deterioration at 10 years for patients less than 30 years of age is 26.8 +/- 17.2%; 30 to 59 years, 77.4 +/- 3.0%; and 60 years and older, 83.1 +/- 4.2%.(ABSTRACT TRUNCATED AT 250 WORDS)