Performance of bioprostheses and mechanical prostheses assessed by composites of valve-related complications to 15 years after aortic valve replacement.

OBJECTIVE: This study was conducted to compare the composites of valve-related complications, namely reoperation, morbidity (defined as permanent neurologic or other functional impairment), and mortality, between bioprostheses and mechanical prostheses for aortic valve replacement. METHODS: Between 1982 and 1998, 2195 bioprostheses were implanted in 2179 patients and 980 mechanical prostheses were implanted in 883 patients. Total follow-up was 16,442 years and 5740 years for bioprostheses and mechanical prostheses, respectively. Eight variables were considered as predictors of risk for the composites of valve-related complications. RESULTS: Linearized rates for valve-related reoperation were 1.3%/patient-year and 0.3%/patient-year for bioprostheses and mechanical prostheses (P < .001), respectively. All age groups were differentiated, except >70 years. Valve-related morbidity was differentiated for all age groups and overall, for bioprostheses and mechanical protheses, was 0.4 %/patient-year and 2.1%/patient-year, respectively (P < .001). Overall valve-related mortality was 1.0%/patient-year for bioprostheses and 0.7%/patient-year for mechanical prostheses (P = .018). Age and valve-type were predictive risk factors for reoperation and morbidity, whereas age alone was predictive of mortality. Actual freedom from valve-related reoperation favored mechanical prostheses for all age groups, except 61-70 years and >70 years. Actual freedom from valve-related morbidity favored bioprostheses in all age groups, except < or =40 years. Actual freedom from valve-related mortality was undifferentiated in patients 51-60, 61-70, and >70 years. CONCLUSION: No differences were observed in valve-related reoperation and mortality in patients >60 years. Comparative evaluation gives high priority for bioprostheses in patients >60 years based on improved morbidity profile. This evaluation extends this center's recommendation for bioprostheses in aortic valve replacement to include patients >60 years.

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.

Performance of bioprostheses and mechanical prostheses assessed by composites of valve-related complications to 15 years after mitral valve replacement.

OBJECTIVE: Predominant concerns of patients undergoing valve replacement surgery are risks of death, stroke, antithrombotic bleeding, and reoperation related to the replacement prosthesis. The purpose of this study was to compare valve-related reoperation, morbidity (permanent impairment), and mortality between bioprostheses and mechanical prostheses for mitral valve replacement. METHODS: Between 1982 and 1998, a total of 959 bioprostheses were implanted in 943 patients, and a total of 961 mechanical prostheses were implanted in 839 patients. Total follow-ups were 5730 years for bioprostheses and 5271 years for mechanical prostheses. Eight variables were considered as predictors of risk for the composites of valve-related complications. RESULTS: The linearized occurrence rates for valve-related reoperation were 3.7 events/100 patient-years for bioprostheses and 0.5 events/100 patient-years for mechanical prostheses ( P < .001), with all age groups differentiated except older than 70 years. Valve-related morbidity was undifferentiated for bioprostheses and mechanical prostheses. Valve-related mortalities were 1.7 events/100 patient-years for bioprostheses and 0.7 events/100 patient-years for mechanical prostheses ( P < .001). Predictors of valve-related reoperation were age and valve type. The only predictor of valve-related morbidity was age, whereas age and valve type were predictors for valve-related mortality. Actual freedom from valve-related reoperation favored mechanical prostheses in all age groups except older than 70 years (91.7% +/- 2.0% for bioprostheses at 15 years and 96.7% +/- 1.5% at 12 years for mechanical prostheses). Actual freedom from valve-related morbidity was not different between bioprostheses and mechanical prostheses. Actual freedom from valve-related mortality favored mechanical prostheses in all groups except older than 70 years. CONCLUSION: Comparative evaluation gives high priority in mitral valve replacement for mechanical prostheses relative to bioprostheses for freedom from valve-related reoperation and valve-related mortality but not valve-related morbidity. Freedom from valve-related reoperation and valve-related mortality favors mechanical prostheses for all age groups except older than 70 years. Valve-related morbidity, due to neurologic or functional impairments, does not differentiate between bioprostheses and mechanical prostheses.

Re-operation for bioprosthetic aortic structural failure - risk assessment.

OBJECTIVE: The predominant complication of bioprostheses is structural valve deterioration and the consequences of re-operation. Prosthesis choice for aortic valve replacement surgery (bioprostheses and mechanical prostheses), is influenced by valve-related complications (mortality and morbidity) of the prosthesis type chosen. The purpose of the study is to determine the mortality and risk assessment of that mortality for aortic bioprosthetic failure. METHODS: From 1975 to 1999, 3356 patients received a heterograft bioprosthesis in 3530 operations. The procedures were performed with concomitant coronary artery bypass (CAB) in 1388 procedures and without in 2142 procedures. Three hundred twenty-two re-operations for structural valve deterioration were performed in 312 patients with 22 fatalities (6.8%). Of the 322 re-replacements, 36 had CAB and 286 had isolated replacement; the mortality was 8.3% (3) and 6.6% (19), respectively. Eleven predictive factors inclusive of age, concomitant CAB, urgency status, New York Heart Association (NYHA) at Re-op and year of Re-op (year periods) were considered. RESULTS: The mortality for 1979-1986 was 6.1% (2/33); 1987-1992, 7.7% (8/104); and 1993-2000, 6.5% (12/185) (pNS). The mortality by urgency status for elective/urgent was 6.4% (19/299); and emergent, 13.0% (3/23) (pNS). The mortality for NYHA I/II was 2.0% (1/50), III 4.2% (8/191) and IV 16.0% (13/81) (P=0.00063), for gender was male 4.6% and female 13.3% (P=0.011), for age at implant 'No' (no re-operation) 51.6+/-12.2 years and 'Yes' (yes re-operation) 59.9+/-7.3 years (P=0.00004), for age at explant 'No' 62.6+/-12.7 years and 'Yes' 70.6+/-6.5 years (P=0.00001), and for age at explant <60 years 0.0% (0/110), 60-70 years 8.5% (10/117) and >70 years 12.6% (12/95) (P=0.0011). The predictive risk factor assessment by multivariate regression analysis revealed only NYHA III Odds Ratio 1.7 and IV 7.8 P=0.0082. For the period 1993-2000 of re-operations only gender was significant; age at implant, age at explant, CAB pre-Re-op, CAB concomitant with Re-op, urgency at Re-op, ejection fraction, valve lesion and NYHA at Re-op were not significant. CONCLUSIONS: Bioprosthetic aortic re-operative mortality can be lowered by re-operation in low rather than medium to severe NYHA functional class. The routine evaluation of patients can achieve earlier low risk re-operative surgery.

Reoperation for bioprosthetic mitral structural failure: risk assessment.

BACKGROUND: The predominant complication of bioprostheses is structural valve deterioration and the consequences of reoperation. The purpose of the study was to determine the mortality and risk assessment of that mortality for mitral bioprosthetic failure. METHODS AND RESULTS: From 1975 to 1999, 1 973 patients received a heterograft bioprosthesis in 2 152 operations. The procedures were performed with concomitant coronary artery bypass (CAB) in 694 operations and without in 1 458 operations. There were 481 reoperations for structural valve deterioration performed in 463 patients with 34 fatalities (7.1%). Of the 481 re-replacements, 67 had CAB and 414 had isolated replacement; the mortality was 11.9% (8) and 6.3% (26), respectively. Eleven predictive factors inclusive of age, concomitant CAB, urgency status, New York Heart Association (NYHA; reoperation), and year of reoperation (year periods) were considered. The mortality from 1975 to 1986 was 9.8% (6/61), from 1987 to 1992 it was 10.8% (20/185), and from 1993 to 2000 it was 3.4% (8/235) (I versus III P=0.0458, II versus III P=0.0047). The mortality by urgency status was elective/urgent 6.0% (26/436) and emergent 17.8% (8/45) (P=0.00879). The mortality was NYHA I/II 0.00% (0/37), III 5.1% (14/273), and IV 11.7% (20/171) (P=0.0069). The predictive risk factors by multivariate regression analysis were age at implant, odds ratio (OR) 0.84 (P=0.0113); age at explant, OR 1.2 (P=0.0089); urgency, OR 2.8 (P=0.0264); NYHA, OR 2.5 (P=0.015); 1975-1986 versus 1993-2000 of reoperations, OR 5.8 (P=0.0062); and 1987-19 92 versus 1993-2000, OR 4.0 (P=0.0023). For the period 1993 to 2000 of reoperations, only age at implant and age at explant were significant; NYHA class, urgency status, and concomitant CAB were not significant. CONCLUSIONS: Bioprosthetic mitral reoperative mortality can be lowered by reoperations on an elective/urgent basis in low to medium NYHA functional class. The routine evaluation of patients can achieve earlier low risk reoperative surgery.

Carpentier-Edwards supraannular porcine bioprosthesis: second-generation prosthesis in aortic valve replacement.

BACKGROUND: The Carpentier-Edwards supraannular porcine bioprosthesis experience for more than 18 years has been evaluated by actuarial and actual analysis to determine the clinical performance in aortic valve replacement. METHODS: From 1981 to 1998, 1,823 patients (mean age 68.5 years, range 20 to 90 years) underwent 1,846 procedures. Previous coronary artery bypass was performed in 3.1% (56) and previous valve repair/replacement in 6.0% (110). Concomitant coronary artery bypass grafting was performed in 41.5% (756). RESULTS: The overall valve-related complication rate was 4.5%/patient-year (567 patients) with a fatality rate of 0.9%/patient-year (110 patients). The patient survival, at 15 years, was 33.0%+/-3.7% for the 61 to 70 years age group and 13.5%+/-2.4% for the older than 70 years group. At 15 years, the overall actual, cumulative freedom from reoperation was 83.2%+/-1.4%, valve-related mortality was 88.0%+/-1.2%, and valve-related residual morbidity was 92.0%+/-0.8%. The actual freedom from structural valve deterioration at 15 years was 84.2%+/-2.8% for the 61 to 70 years group and 97.1%+/-0.9% for the older than 70 years group. CONCLUSIONS: The Carpentier-Edwards porcine bioprosthesis provides excellent freedom from structural valve deterioration, and overall freedom from valve-related morbidity, mortality, and reoperation for aortic valve replacement for up to 15 years. The prosthesis is recommended for patients older than 70 years and for patients 61 to 70 years, especially when extended survival is not anticipated.

Carpentier-Edwards porcine bioprostheses: clinical performance assessed by actual analysis.

BACKGROUND AND AIM OF THE STUDY: The clinical performance of porcine bioprostheses for valve replacement has been evaluated for over three decades by actuarial analysis as the standard for reporting time-related results. Actual or cumulative incidence analysis provides a complementary method to determine the manifestations of valve-related complications due primarily to structural valve deterioration. Valve-related mortality and reoperation of porcine bioprostheses for aortic and mitral valve replacement was compared by actuarial and actual methodology. METHODS: The Carpentier-Edwards porcine bioprostheses were implanted between 1975 and 1995 as 2,237 aortic valve replacements (AVR) and 1,582 mitral valve replacements (MVR). Coronary artery bypass was performed in 36.4% of AVR, and 30.6% of MVR. Fatal valve-related complications occurred in 7.6% of AVR and 11.3% of MVR. The cumulative follow up was 14,810 patient-years (mean 6.6 years) for AVR and 9,718 patient-years (mean 6.1 years) for MVR. RESULTS: Patient survival, and actuarial and actual freedom from valve-related mortality and valve-related reoperation was reported at 15 years. For AVR, survival in the 61-70 years age group was 30.9%, freedom from valve-related mortality was 79.3% and 86.9% respectively, and freedom from valve-related reoperation 79.0% and 88.1% respectively. For AVR, survival in the >70 years age group was 18.1%, freedom from valve-related mortality 72.8% and 84.9% respectively, and freedom from reoperation 86.3% and 96.1% respectively. For MVR, survival in the 61-70 years age group was 16.1% at 15 years, freedom from valve-related mortality was 59.5% and 79.5% respectively, and freedom from valve-related reoperation 32.6% and 71.0% respectively. For MVR, survival in the >70 years age group was 2.8% at 15 years, valve-related mortality was 26.1% and 82.0% respectively, and freedom from valve-related reoperation 83.4% and 93.3% respectively. CONCLUSION: The actual freedom from valve-related mortality and valve-related reoperation (primarily from structural valve deterioration), provides further evidence to consider porcine bioprostheses for AVR in patients aged >60 years, and for MVR in patients aged >70 years. The freedom from valve-related mortality supports the use of porcine bioprostheses for MVR in patients aged 61-70 years. Patient survival is influenced to the greatest extent by factors other than valve-related mortality.

Actuarial versus actual freedom from structural valve deterioration with the Carpentier-Edwards porcine bioprostheses.

BACKGROUND: The clinical performance of porcine bioprostheses for valve replacement surgery has been evaluated for over three decades by actuarial analysis as the standard for reporting time-related results. The incidence of structural valve deterioration (SVD) is used for the selection of prostheses for various subsets of patients. Actual or cumulative incidence analysis may provide a superior method to determine durability of bioprostheses. OBJECTIVE: To compare actuarial versus actual methodology in determining the durability of porcine bioprostheses for aortic (AVR) and mitral valve replacement (MVR). PATIENTS AND METHODS: Carpentier-Edwards porcine bioprostheses were implanted between 1975 and 1995 in 2237 AVR and 1582 MVR. The mean age for AVR patients was 65.4+/-12 years and for MVR patients 61.7+/-12 years. The cumulative follow-up for AVR was 14,810 years (mean 6.6+/-4.7) and for MVR 9718 years (mean 6. 1+/-4.5). RESULTS: For AVR the actual freedom from SVD was 87.4+/-2. 0% and 95.6+/-1.8% in those aged 61 to 70 years and more than 70 years, respectively; the actuarial freedom was 75.9+/-4.2% and 82. 3+/-7.9%, respectively. For MVR the actual freedom from SVD was 69. 4+/-2.5% and 92.9+/-1.9% for those aged 61 to 70 years and more than 70 years, respectively; the actuarial freedom was 25.5+/-5.7% and 79. 5+/-6.0%, respectively. Predictors of freedom from SVD for AVR were identified as advancing age, falling into the age groups 61 to 70 and those older than 70 years, and intermediate valve sizes; predictors for MVR were advancing age and age older than 70 years. CONCLUSIONS: Comparison of methods of durability assessment revealed that actual freedom from SVD supports porcine bioprostheses for AVR in patients more than 60 years of age and for MVR in patients more than 70 years of age. This evaluation with experience to 15 years supports the indications for use of porcine bioprostheses.

Bileaflet mechanical prostheses performance in mitral position.

OBJECTIVE: The experience with the Carbomedics (CM) and the St. Jude Medical (SJM) bileaflet mechanical prostheses was evaluated to determine thromboembolic and hemorrhagic complications and predictive risk factors. METHODS: From 1989 to 1994, a total of 625 patients had mitral valve replacement (CM, 240; SJM, 385); 32.5% (203), concomitant procedures and 32.8% (205), previous cardiac surgery, primarily valve replacement procedures. RESULTS: The pre-operative variables did not distinguish the populations, except for previous surgery CM 37.9% and SJM 29.6% (P < 0.05). The pre-operative variables (type of prostheses, cardiac rhythm, coronary artery bypass, NYHA III/IV, advancing age, gender, urgency status and previous surgery) were not predictive of overall thromboembolism (TE), major TE, minor TE, prosthesis thrombosis and hemorrhage (P not significant; P = NS). The linearized rate of total TE events for overall MVR was 5.0%/patient-year (CM 4.4; SJM 5.4). The < or = 30 day major crude rate was 0.44%, while the > 30 day late major event rate was 2.0%/patient-year. Of the total TE events 91% of < or = 30 days and 75%, > 30 days had an INR < 2.5 at or immediately prior to the event. The thrombosis rate (included in TE events) was 0.63%/patient-year (ten events, four managed successfully with thrombolysis, five successfully with reoperation, and one fatality identified at autopsy). The freedom, at 5 years, from major/fatal TE, thrombosis and hemorrhage from anticoagulation was 88.2%, and 89.5% exclusive of early events. CONCLUSIONS: This non-randomized prospective observational evaluation of the CarboMedics and St. Jude Medical prostheses has not revealed any differentiation in performance of the prostheses. The study serves as a single institution experience with the potential for future comparative evaluation.

Carpentier-Edwards standard and supraannular porcine bioprostheses: comparison of technology.

BACKGROUND: Performance with regard to structural valve deterioration (SVD) with the Carpentier-Edwards standard (CE-S) and supraannular (CE-SAV) (Baxter Healthcare Corp, Irvine, CA) porcine bioprostheses was evaluated to determine whether progress in reduction of structural failure has been achieved with technological changes. METHODS: The CE-S was implanted during 567 aortic valve replacement (AVR) and 486 mitral valve replacement (MVR) procedures, and the CE-SAV was implanted during 1,670 AVR and 1,096 MVR procedures. The failure mode of early stent dehiscence with the CE-SAV prosthesis, thought to be controlled by manufacturing changes in 1986 and 1987, supported comparison of the CE-SAV with censored cases of stent dehiscence. Stent dehiscence accounted for only 1.2% (1 of 81) and 14.1% (29 of 205) of AVR and MVR CE-SAV failures, respectively. RESULTS: The only difference for AVR for freedom from SVD occurred in the 21- to 40-year age group at 15 years and was 68% for the CE-SAV and 31% for the CE-S (p<0.05). In the 61- to 70-year age group, freedom from SVD at 15 years was 76% for the CE-S and 84% for the CE-SAV; for the 71-year or higher age group, freedom from SVD was 89% and 95%, respectively (p = NS). For MVR freedom from SVD was different only in the 71-year or higher age group and was 90% for the CE-S and 59% for the CE-SAV (p<0.05). Freedom from SVD was reduced but was similar (p = NS) for the other age groups. For AVR the actual freedom from SVD at 15 years for the CE-S and CE-SAV was, respectively, 79% and 72% for the 51- to 60-year age group, 86% and 91% for the 61- to 70-year age group, and 98% and 98% for the 71-year or higher age group. For MVR, these rates were, respectively, 69% and 75% for the 61- to 70-year age group and 96% and 89% for the 71-year and higher age group. CONCLUSIONS: The technologic advancements made in the second-generation CE-SAV bioprosthesis to reduce the incidence of structural failure have not uniformly been successful. The actual freedom from SVD provides evidence for implantation of porcine bioprostheses for AVR in age groups 61 to 70 years and 71 years or higher and for MVR in the age group 71 years or higher.

Prosthesis-patient mismatch: hemodynamic comparison of stented and stentless aortic valves.

Several centers have reported excellent clinical performance of stentless aortic xenografts. This study reports a hemodynamic comparison of the Medtronic Freestyle stentless and Mosaic stented valves. The prosthetic hemodynamics at discharge and 1 year after insertion in 95 patients who underwent aortic valve replacement with the Freestyle stentless bioprosthesis at Southern California Kaiser Permanente Medical Center were compared retrospectively with 115 unmatched individuals who received the Mosaic stented valve at the University of British Columbia. As assessed by echocardiography, there were no differences in the mean transvalvular gradient, effective orifice area (EOA), or EOA indexed to body surface area (EOAI) at discharge between the two groups. However, after 1 year, all corresponding Freestyle valve sizes had larger EOAs and lower gradients. Furthermore, fewer patients receiving Freestyle xenografts had prosthesis-patient mismatch (19% vs. 64%, P<.001) as defined by EOAI <0.85 cm2/m2. Although the Mosaic stented valve provides comparable immediate hemodynamic performance after implantation, there is significant improvement with the Freestyle bioprosthesis in terms of gradient, EOA, and prosthetic-patient mismatch at 1 year.

Multiple mechanical valve replacement surgery comparison of St. Jude Medical and CarboMedics prostheses.

OBJECTIVE: The experience with the St. Jude Medical (SJM) and CarboMedics (CM) bileaflet mechanical prostheses was evaluated to determine thromboembolic and hemorrhagic complications and predictive risk factors. METHODS: From 1989 to 1994, a total of 246 patients had multiple valve replacement (SJM, 140; CM, 106); concomitant procedures 20.3% (50) [coronary artery bypass 10.6% (26)] and 53.7% (132) previous cardiac surgery, primarily valve replacement procedures. The pre-operative variables [coronary artery disease, previous cardiovascular surgery, concomitant procedures, valve lesion (except mitral stenosis), status, atrial fibrillation, and NYHA III/IV] did not distinguish the prosthesis-type (pNS). RESULTS: The prosthesis-type and the pre-operative variables, including atrial fibrillation, were not predictive of overall thromboembolism (TE). The linearized rate of total TE events for overall multiple replacements (MR) was 5.4%/patient-year (minor, 2.52; major 2.85); the total TE for CM and SJM was 5.4%/patient-year, respectively. The < or = 30 day major TE crude rate was 0.82%, while the > 30 day major event rate was 2.7%/patient-year. Of the total (major and minor) TE events 100% (3) of < or = 30 days and 72% (29), > 30 days had an INR < 2.5 at or immediately prior to the event. The thrombosis rate (included in total TE events) was 0.67%/patient-year (4 events, 100% INR < 2.5). Of the various TE event categories the prosthesis-types (CM and SJM) were not differentiated (pNS). The freedom, at 5 years, from major/fatal TE, thrombosis and hemorrhage from anticoagulation was 89.3 +/- 3.8% for CM and 87.9 +/- 3.7% for SJM and, 91.3 +/- 3.5% and 89.3 +/- 3.7%, respectively, (pNS) exclusive of early events. CONCLUSIONS: The performance of the CarboMedics and St. Jude Medical prostheses in multiple valve replacement surgery in this non-randomized prospective study revealed no significant differences in performance with regard to thromboembolic and hemorrhagic complications.

Carpentier-Edwards standard porcine bioprosthesis: a 21-year experience.

BACKGROUND: The Carpentier-Edwards standard porcine bioprosthesis experience to 21 years has been evaluated to determine the influence of structural valve deterioration by valve position in various age groupings. METHODS: From 1975 to 1988, 1,181 patients had the prosthesis implanted in 1,198 procedures. The mean age of the population was 57.9+/-12.5 years (range, 21 to 85 years). Aortic valve replacement was performed in 564 patients (47.8%); mitral valve replacement, 478 (40.5%); and multiple valve replacement, 132 (11.2%). Concomitant procedures were performed in 337 patients (28.5%), and 140 (11.9%) had previous operations. RESULTS: The early mortality was 8.1% (97), only 0.4% (5) of which were valve-related. The total follow-up was 10,405 years (mean, 8.8+/-5.2 years). The late mortality was 5.7%/patient-year (591), with the valve-related component 1.6%/patient-year (168) with a 13% reoperative mortality (56). The linearized rate of structural valve deterioration was 3.8%/patient-year (395), with overall complications of 7.1%/patient-year (737). The overall survival at 20 years was 17.2%+/-3.1% (p < 0.05; aortic valve replacement greater than mitral valve replacement or multiple valve replacement). The freedom from structural valve deterioration was, at 18 years, 25.8%+/-2.8% overall, AVR 40.6%+/-4.2%, and MVR 8.5%+/-3.4% (p < 0.05, aortic valve replacement greater than mitral valve replacement or multiple valve replacement). The freedom from structural valve deterioration for aortic valve replacement was, at 15 years, for patients older than 70 years, 82.9%+/-9.1%; 61 to 70 years, 73.2%+/-4.7%; 51 to 60 years, 58.8%+/-5.4%; 41 to 50 years, 41.7%+/-8.2%; and 21 to 40 years, 25.5%+/-7.8%. The freedom from structural valve deterioration for mitral valve replacement was, at 15 years, for patients older than 70 years, 89.8%+/-7.6%; 61 to 70 years, 22.8%+/-6.3%; 51 to 60 years, 26.3% +/- 5.7%; 41 to 50 years, 11.7%+/-5.6%; and 21 to 40 years, 7.0%+/-4.7%. CONCLUSIONS: The prosthesis is recommended for aortic valve replacement for patients older than 70 years and for patients 61 to 70 years (when extended longevity is not anticipated) and for mitral valve replacement for patients older than 70 years.

Carpentier-Edwards supraannular porcine bioprosthesis evaluation over 15 years.

BACKGROUND: The Carpentier-Edwards supraannular porcine bioprosthesis experience during 15 years has been evaluated to determine the incidence of structural valve deterioration by valve position in various age groupings. METHODS: From 1981 to 1995, 2,943 patients older than 20 years had the prosthesis implanted in 3,024 procedures. The mean age of the population was 65.5+/-11.9 years (range, 21 to 89 years). Aortic valve replacement was performed in 1,657 patients (54.8%); mitral valve replacement, 1,092 (36.1%); multiple valve replacement, 253 (8.3%); pulmonary valve replacement, 2 (0.1%); and tricuspid valve replacement, 20 (0.7%). Concomitant procedures were performed in 1,332 patients (45.3%), and 352 (12.0%) had previous procedures. RESULTS: The early mortality was 8.9% (270), only 0.4% (11) valve-related. The total follow-up was 17,471 years (mean, 5.9+/-4.1 years). The late mortality was 5.2%/ patient-year (901) with the valve-related component 1.0%/patient-year (171). The reoperation rate was 2.1%/ patient-year (369) with 4.3% mortality (16). The linearized rate of structural valve deterioration was 2.0%/patient-year (341), and overall complications, 5.9%/patient-year (1,019). The overall survival, at 15 years, was 31.1%+/2.8% (p < 0.05; aortic valve replacement greater than mitral valve replacement or multiple valve replacement). The freedom from structural valve deterioration for aortic valve replacement was, at 12 years, for patients older than 70 years, 95.3%+/-2.7%; 61 to 70 years, 92.9%+/-2.1%; 51 to 60 years, 70.1%+/-5.3%; 41 to 50 years, 60.0%+/-8.8%; and 21 to 40 years, 75.7%+/-7.3%. The freedom from structural valve deterioration for mitral valve replacement was, at 12 years, for patients older than 70 years, 66.1%+/-9.7%; 61 to 70 years, 53.1%+/-4.7%; 51 to 60 years, 52.6%+/-5.5%; 41 to 50 years, 39.3%+/-6.9%; and 21 to 40 years, 42.1%+/-9.4%. CONCLUSIONS: The prosthesis is recommended for aortic valve replacement for patients older than 70 years and for patients 61 to 70 years (when extended longevity is not anticipated) and for mitral valve replacement for patients older than 70 years (when extended longevity is not anticipated).

Bileaflet mechanical prostheses in mitral and multiple valve replacement surgery: influence of anticoagulant management on performance.

BACKGROUND: The St. Jude Medical (SJM) mechanical prosthesis has been the predominant mechanical prosthesis worldwide since its introduction in 1977. The CarboMedics (CM) mechanical prosthesis, also a bileaflet pyrolite carbon prosthesis, was introduced in 1986 and was approved by the Food and Drug Administration of the United States in 1993. The experience of the two prostheses was evaluated in a parallel, nonrandomized study commencing with the CM investigational study in 1989. METHODS AND RESULTS: The clinical performance of the two prostheses was evaluated in accordance with the Guidelines for Reporting Morbidity and Mortality After Cardiac Valvular Operations. The CM prosthesis was implanted in 239 mitral valve replacements (MVR) and 106 multiple valve replacements (MR), and the SJM prosthesis was implanted in 379 MVR and 137 MR. The CM and SJM populations were not distinguished within MVR and MR for mean age, previous surgery, concomitant surgery, mean follow-up, and late mortality (P=NS). The linearized occurrence rate for the combined experience for major thromboembolic and hemorrhage events >30 days was 3.4% of patients per year for MVR (inclusive of cerebral thromboembolism reversible, major; systemic; thrombosis; and fatal; and major systemic hemorrhage) and for MR was 3.9% of patients per year (P=NS between prostheses by position). The major crude event rate for < or =30 days was 1.3% for MVR and 1.2% for MR (P=NS between prostheses by position). The inadequacy of anticoagulation (as determined by international normalized ratio 2.5) for all thromboembolic events (major and minor) < or =30 days was 93%, and that for >30 days was 75%. The freedom from major thromboembolism for MVR at 3 years was 92.7+/-1.9% for CM and 94.0+/-1.5% for SJM; for MR, it was 94.2+/-3.0% for CM and 93.5+/-2.5% for SJM (P=NS). The freedom from major thromboembolism exclusive of early events for MVR at 3 years was 94.4+/-1.8% for CM and 94.8+/-1.4% for SJM, and for MR, it was 94.2+/-3.0% for CM and 95.0+/-2.2% for SJM (P=NS). The freedom from major thromboembolism and hemorrhage for prostheses (CM and SJM) by valve positions (MVR and MR) was also indistinguishable (P=NS). CONCLUSIONS: There are no distinguishing performance characteristics with regard to thromboembolic and hemorrhagic events between the CM and the SJM mechanical prostheses in MVR and MR. There was an identified need for improvement in the early and late anticoagulant management. A randomized trial with optimization of anticoagulant management between the CM and SJM mechanical prostheses is recommended.

Tranexamic acid reduces blood loss and transfusion in reoperative cardiac surgery.

PURPOSE: The objective of this study was to assess the effect of tranexamic acid (TA), a synthetic antifibrinolytic, on blood loss and the need for transfusion of blood products following repeat cardiac valve surgery. METHODS: After ethics committee approval, 41 patients scheduled for reoperative valve replacement were enrolled in this randomized, double blind, placebo controlled study. Patients were randomized to receive TA (10 g in 500 ml NSaline) or placebo (NSaline) as an iv bolus over 30 min, after anaesthesia induction and prior to skin incision. Intraoperative blood loss was assessed by estimating blood volume on drapes, weighing surgical sponges, and measuring suction bottle returns. Postoperative blood loss was measured from mediastinal chest tube drainage following surgery. Blood products were transfused according to a standardized protocol. RESULTS: Patient demographics were similar for age, sex, cardiopulmonary bypass pump time, cross clamp time, surgical time, preoperative haemoglobin, coagulation profile, and the number of valves replaced during surgery. Tranexamic acid administration reduced intraoperative blood loss [median (range)] from 1656 (575-6270) to 720 ml (355-5616) (P < 0.01) and postoperative blood loss from 1170 (180-4025) to 538 ml (135-1465) (Intent to Treat n = 41, P < 0.01). The total red blood cells transfused (median, range) was reduced from 1500 (0-9300) ml to 480 (0-2850) ml (P < 0.01) in the TA group. In hospital complications and mortality rates were not reduced in the TA group. CONCLUSION: Tranexamic acid reduced blood loss and the need for blood product transfusion and appears to be an effective treatment for patients undergoing reoperative cardiac valvular surgery.

Influence of coronary artery bypass and age on clinical performance after aortic and mitral valve replacement with biological and mechanical prostheses.

The influence of prosthetic type, age, and coronary artery bypass grafting (CABG) on valve-related complications by valve position was evaluated in a population of 2353 bioprosthesis patients (mean age, 66.5 years; range, 13 to 89 years) and in a population of 1112 mechanical prosthesis patients (mean age, 59.1 years; range, 13 to 91 years). The follow-up was complete to 96% and 98%, respectively, for the bioprosthesis and mechanical prosthesis groups. The patient groups were evaluated by actuarial assessment of survival and valve complications and composites. Preoperative factors were evaluated for determination of significant independent predictors by multivariate proportional-hazard regression analysis. CABG was an influential factor in the actuarial analysis. Survival was superior for aortic mechanical replacements without CABG and for mitral replacements, both biological and mechanical, without CABG (P < .05). The freedom from thromboembolism (TE) and antithromboembolic hemorrhage (ATH) was greater for biological prostheses with and without CABG for aortic replacements (P < .05) but not for mitral replacements (P = NS). The freedom from valve-related mortality was not influenced by CABG for either position (P = NS). The freedom from valve-related reoperation was greater for biological prostheses with CABG than without CABG for both aortic and mitral replacements (P < .05). The evaluation of covariates as independent predictors revealed CABG to be a nonpredictor for aortic valve replacement (AVR) (P = NS) but a predictor of survival and valve-related reoperation for mitral valve replacement (MVR) (P < .05).(ABSTRACT TRUNCATED AT 250 WORDS)

Carpentier-Edwards standard porcine bioprosthesis: clinical performance to seventeen years.

BACKGROUND: The role of porcine bioprostheses in cardiac valve replacement has been under review for several years. The literature deals primarily with age as a determinant of durability, as well as the intermediate-term performance of various prostheses. The performance of the Carpentier-Edwards first-generation standard porcine bioprosthesis is presented over the long-term with further documentation on age determinants. METHODS: The "Guidelines for Reporting Morbidity and Mortality After Cardiac Valvular Operations" were used for definitions of valve-related complications, categorization, and statistical methods. The valve-related complications were evaluated in a time-related manner by actuarial life-table techniques. The Lee-Desu statistic test was used for comparison of performance by valve positions and age groups. Hazard function rates were demonstrated for complications and composites. RESULTS: Of the Carpentier-Edwards porcine bioprostheses implanted in 1,195 patients (1,214 operations, 1,315 valves) commencing in 1975 the early mortality was 7.6% (92). The early mortality without concomitant procedures was 6.1% and with 11.7%. The late mortality was 5.3% per patient-year; 4.6% patient-year without and 7.5% per patient-year with concomitant procedures. The valve-related causes of late mortality (131) were thromboembolism (41), antithromboembolic hemorrhage (14), prosthetic valve endocarditis (20), nonstructural dysfunction (12), and structural valve deterioration (44). The valve-related deaths (early, 7; late, 124) were 21.2% of the total 617 total deaths. Reoperation for valve-related complications was performed in 406 patients (4.1% per patient-year), of which 327 were for structural valve deterioration (3.3% per patient-year). Mortality for reoperation was 0.5% per patient-year (49 patients) or 12.1%. Of the 49 deaths, 33 were caused by structural valve deterioration. The linearized occurrence rate for thromboembolism was 1.6% per patient-year (major, 0.9% per patient-year, and minor, 0.7% per patient-year). The fatal thromboembolic rate was 0.4% per patient-year (41), undifferentiated by valve position. The freedom from thromboembolism was 76% at 17 years (p = not significant by valve position) (major, 87%; fatal, 93%). The freedom from prosthetic valve endocarditis was 92% at 17 years (p = not significant by valve position). The freedom from reoperation, at 15 years, was 38%: aortic (AVR), 55%; mitral (MVR), 20%; and multiple valve replacement (MR), 24% (p < 0.05 AVR > MVR, MR). The freedom from structural valve deterioration, at 15 years, was 41%; AVR, 58%; MVR, 21%; MR, 36% (p < 0.05 AVR > MVR, MR). The freedom from structural valve deterioration was greater for advancing age groups (p < 0.05); AVR > or = 70 years 96% at 12 years, and 65 to 69 years 94% at 12 years and 82% at 15 years; MVR > or = 70 years 85% at 12 years, and 65 to 69 years 54% at 12 years. The freedom from valve-related mortality was 73% at 17 years: AVR, 80%; ; MVR, 61%; and MR, 67% (p < 0.05 AVR > MVR, MR). The freedom valve-related residual morbidity was 94% (p = not significant by valve position). CONCLUSIONS: The Carpentier-Edwards standard porcine bioprosthesis continues to provide satisfactory clinical performance to 17 years. Thromboembolism is a more serious problem than structural failure: 92 major thromboembolic events with 41 fatalities compared with 44 fatalities of which 33 occurred with reoperation. The prosthesis is especially recommended for patients more than 65 years of age for AVR and more than 70 years of age for MVR.

Carpentier-Edwards supraannular porcine bioprosthesis: clinical performance to twelve years.

The Carpentier-Edwards supraannular porcine bioprosthesis, a second-generation biologic prosthesis, has had clinical performance assessment to 12 years. This bioprosthesis was used in 2,489 operations in 2,444 patients between 1982 and 1992, inclusive (mean age 64.1 years, age range 6 to 89 years). There were 1,335 aortic valve replacements (AVR), 938 mitral valve replacements (MVR), and 200 multiple valve replacements (MR). Concomitant procedures were performed in 1,017 cases (40.9%). The age group distribution was: 35 years or younger, 83 patients; 36 to 50 years, 245; 51 to 64 years, 728; 65 to 69 years, 458; and 70 years and older, 975. The total follow-up was 12,785 patient-years (mean, 5.1 years) and was 96% complete. The early mortality rate was 7.4% (185 patients), and the late mortality was 4.9%/patient year (623). Concomitant procedures influenced both early and late mortality (p < 0.05). The overall patient survival at 12 years was 44% +/- 3% (p < 0.05, AVR > MVR, MR). The freedom from thromboembolism was not different by valve position. The freedom from major thromboembolism at 12 years was 82% +/- 4% (p = not significant by valve position). The overall freedom from antithromboembolic hemorrhage was 96% +/- 1% at 12 years (p < 0.05, AVR > MVR > MR). The overall freedom from valve-related reoperation at 12 years was 58% +/- 5% (p < 0.05, AVR > MVR, MR), and from valve-related mortality 89% +/- 2% (p < 0.05, AVR > MVR > MR). The freedom from residual morbidity (permanent impairment) at 12 years was 87% +/- 4% (p = not significant by valve position).(ABSTRACT TRUNCATED AT 250 WORDS)

Structural deterioration in Carpentier-Edwards standard and supraannular porcine bioprostheses.

The Carpentier-Edwards standard (CE-S) porcine bioprosthesis was implanted in 1214 operations (1975 to 1985) and the Carpentier-Edwards supraannular (CE-SAV) bioprosthesis was implanted in 2,489 operations (1982 to 1992 inclusive). The early mortality was 7.6% and 7.4% for the CE-S and CE-SAV groups, respectively; the late mortality was 5.3% per patient-year and 4.9% per patient-year, respectively. The cumulative follow-up was 9,968 patient-years for the CE-S group and 12,784 patient-years for the CE-SAV group. Concomitant procedures were performed in 26.8% of the patients who received a CE-S and in 40.9% of those who received a CE-SAV (p < 0.05). The mean age of the patients receiving a CE-S was 57.3 years (range, 8 to 85 years) and was 64.1 years (range, 6 to 89 years) in those receiving a CE-SAV. The CE-S group consisted of 578 atrial valve replacements (AVRs), 512 mitral valve replacements (MVRs), and 115 multiple valve replacements (MRs). The CE-SAV group consisted of 1,335 AVRs, 938 MVRs, and 200 MRs. There was a total of 165 cases of structural valve deterioration (SDV) in the CE-SAV group (AVR, 35; MVR, 98; and MR, 32). The effect of trimming the aortic wall was also considered: 20 of the 931 trimmed prostheses used for MVRs and MRs and none of the 207 reduced-trimmed prostheses exhibited SVD. The cumulative follow-up was 5,422 years for the patients with trimmed prostheses and 470 for those with reduced-trimmed prostheses.(ABSTRACT TRUNCATED AT 250 WORDS)