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.

Bileaflet mechanical prostheses for aortic valve replacement in patients younger than 65 years and 65 years of age or older: major thromboembolic and hemorrhagic complications.

OBJECTIVE: To determine major thromboembolic and hemorrhagic complications and predictive risk factors associated with aortic valve replacement (AVR), using bileaflet mechanical prostheses (CarboMedics and St. Jude Medical). DESIGN: A case series. SETTING: Cardiac surgical services at the teaching institutions of the University of British Columbia. PATIENTS AND METHODS: Patients 2 age groups who had undergone AVR between 1989 and 1994 were studied. Group 1 comprised 384 patients younger than 65 years. Group 2 comprised 215 patients 65 years of age and older. RESULTS: The linearized rates of major thromboembolism (TE) occurring after AVR were 1.54%/patient-year for group 1 and 3.32%/patient-year for group 2; the rates for major TE occurring more than 30 days after AVR were 1.13%/patient-year for group 1 and 1.55%/patient-year for group 2. The crude rates for major TE occurring within 30 days of AVR were 1.04% for group 1 and 3.72% for group 2. The death rate from major TE in group 1 was 0.31%/patient-year and in group 2 was 0.88%/patient-year. Of the major TE events occurring within 30 days, 100% of patients in both age groups were inadequately anticoagulated at the time of the event, and for events occurring more than 30 days after AVR, 45% in group 1 and 57% in group 2 were inadequately anticoagulated (INR less than 2.0). The overall linearized rates of major hemorrhage were 1.54%/patient-year for group 1 and 2.21%/patient-year for group 2. There were no cases of prosthesis thrombosis in either group. The mean (and standard error) overall freedom from major TE for group 1 patients at 5 years was 95.6% (1.4%) and with exclusion of early events was 96.7% (1.3%); for group 2 patients the rates were 90.0% (3.2%) and 93.7% (3.0%), respectively. The mean (and SE) overall freedom from major and fatal TE and hemorrhage for group 1 patients was 90.1% (2.3%) and with exclusion of early events was 91.2% (2.3%); for group 2 patients the rates were 87.9% (3.1%) and 92.5% (2.9%), respectively. The 5-year rate for freedom from valve-related death for group 1 patients was 96.3% (2.1%) and for group 2 patients was 97.2% (1.2%). CONCLUSION: The thromboembolic and hemorrhagic complications after AVR with bileaflet mechanical prostheses occur more frequently and result in more deaths in patients 65 years of age and older than in patients years younger than 65 years.

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.

Medtronic intact porcine bioprosthesis: 10 years' experience.

BACKGROUND: The Medtronic Intact porcine bioprosthesis experience was evaluated over a period of 10 years to determine the influence of structural valve deterioration by valve position in various age groupings. METHODS: From 1986 to 1996 inclusive, at three centers, 1,272 patients had the prosthesis implanted in 1,296 procedures. The mean age of the population was 67 years (range, 9 to 91 years). There were 836 aortic valve replacements (AVR) (64.5%), 333 mitral valve replacements (MVR) (25.7%), and 110 multiple valve replacements (MR) (8.5%). RESULTS: The early mortality was 7.3% (94 of 1,296 procedures). The early mortality with concomitant procedures (primarily coronary artery bypass grafting) was 9.8% (52 of 528) and without, 5.5% (42 of 768). The late mortality was 4.25%/patient-year. The linearized rate of major thromboembolism was 0.86%/patient-year. The rate of reoperation was 1.19%/patient-year and valve-related mortality, 1.06%/patient-year. There were 36 cases of structural valve deterioration for aortic valve replacement (16), mitral valve replacement (15), tricuspid valve replacement (2), and multiple valve replacement (3). The freedom from structural valve deterioration for aortic valve replacement was in patients 21 to 40 years, 62.5%+/-25.8% at 7 years; 41 to 50 years, 75.0%+/-15.3% at 7 years; 51 to 60 years, 91.0%+/-4.5% at 8 years; 61 to 70 years, 98.7%+/-0.7% at 10 years; and older than 70 years, 98.3%+/-1.0% at 10 years (p < 0.05). The freedom from structural valve deterioration for mitral valve replacement was for patients 41 to 50 years, 91.7%+/-8.0% at 7 years; 51 to 60 years, 85.9%+/-9.9% at 8 years; 61 to 70 years, 86.3%+/-6.8% at 8 years; and older than 70 years, 93.9%+/-4.8% at 8 years (not significant). CONCLUSIONS: The Medtronic Intact porcine bioprosthesis has acceptable freedom from structural valve deterioration in both the aortic and mitral positions approaching 10 years of evaluation.

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.

Fracture embolization of a Duromedics mitral prosthesis.

The Duromedics bileaflet pyrolitic carbon mechanical prosthesis was introduced by Hemex in 1982 and subsequently acquired by Baxter. This communication documents a case of sudden leaflet fracture of a Duromedics mitral valve 48 months after implantation, which was managed successfully by replacement with a St. Jude Medical mechanical prosthesis. The patient presented in acute distress with paroxysmal atrial tachycardia and pulmonary edema. Transesophageal echocardiography was used to diagnose the leaflet fracture. The fracture had occurred transversely, with the fragments embolizing bilaterally to the iliofemoral arteries. These were removed at a subsequent operation. Cases of such fractures of the Duromedics prosthesis have been reported, with cavitation damage being the postulated mechanism.

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.

Medtronic Intact porcine bioprosthesis: clinical performance to seven years.

The clinical performance of the Medtronic Intact porcine bioprosthesis was evaluated in 1,084 patients (mean age 66.4 years, range 9 to 91 years) who had a total of 1,099 implantations between 1985 and 1992, inclusive. There were 709 aortic valve replacements, 297 mitral valve replacements, and 80 multiple valve replacements. Concomitant procedures were performed in 432 (39.3%). The age group distribution (years) was 35 or younger in 20 patients, 36 to 50 in 64, 51 to 64 in 274, 65 to 69 in 225, 70 or older in 500. The total follow-up time was 2,741 patient-years (mean, 2.5 years) and was 97.5% complete. The early mortality rate was 7.1% and late mortality was 3.9% per patient-year. The overall patient survival at 7 years was 70% +/- 3%. The freedom from major thromboembolism was 94% +/- 1% at 7 years (p = not significant for valve positions). The freedom from reoperation at 7 years was 93% +/- 1%; freedom from valve-related mortality was 89% +/- 2%. The freedom from structural valve deterioration at 7 years was 97% +/- 1% (aortic valve replacement 97% +/- 1%; mitral valve replacement 97% +/- 2%). The freedom from structural valve deterioration among age groups was not different for the overall population, aortic valve replacement, or mitral valve replacement. Hemodynamic assessment revealed obstructive properties for aortic valve replacement sizes of 21 and 23 mm and for mitral valve replacement sizes of 25 and 27 mm.(ABSTRACT TRUNCATED AT 250 WORDS)

Porcine bioprostheses in the elderly: clinical performance by age groups and valve positions.

Porcine bioprostheses have been recommended and used for cardiac valve replacement in the elderly. A review of 1,984 patients with 2,042 operations, performed between 1975 and 1992, has afforded a detailed evaluation of clinical performance by valve positions and age groups within the elderly population. The numbers of operations performed by age groups were 65 to 69 years, 719; 70 to 74 years, 745; 75 to 79 years, 431; 80 to 84 years, 119; and 85 years or older, 28. The early mortality rate overall was 9.5% (195 patients), range 6.9% to 17.8% by age groups (p < 0.05), and 11.9% with concomitant procedures and 7.6% without (p < 0.05). The total cumulative follow-up was 10,060 patient-years (mean, 4.9 years). The late mortality rate was 7.0%/patient-year (for age groups, 5.8% to 13.4%/patient-year) (p = not significant). The patient survival at 15 years ranged from 25% +/- 4% for 65 to 69 years to 9% +/- 5% for 75 to 79 years (p < 0.05). The freedom from valve-related complications and composites at 10 years revealed differences (p < 0.05) by age groups only for structural valve deterioration: 85% +/- 2% for 65 to 69 years versus 98% +/- 2% for 80 to 84 years. The overall freedom from structural valve deterioration at 10 years for aortic valve replacement was 98% +/- 1%; for mitral valve replacement, 79% +/- 3%; and for multiple replacement, 86% +/- 7% (p < 0.05, aortic valve replacement > mitral valve replacement).(ABSTRACT TRUNCATED AT 250 WORDS)

Pregnancy and bioprostheses: influence on structural valve deterioration.

The long-term performance of bioprostheses was evaluated in women 35 years of age or less to determine the influence of pregnancy on structural valve deterioration. Between 1972 and 1992, 237 female patients received 255 biological prostheses. Of the total operations, 53 were performed in patients who experienced pregnancy (P) and 202 in patients who were never pregnant (nonpregnant [NP]). The mean age of the P group was 23.0 +/- 5.8 years (standard deviation) (12 to 34 years) and of the NP group it was 27.1 +/- 6.3 years (8 to 35 years) (p < 0.05). The mean follow-up for the NP group was 6.8 years and for the P group it was 7.9 years. The late mortality was 2.26%/patient-year overall, 2.71%/patient-year for the NP group and 0.89%/patient-year for the P group (p = not significant [NS]). The P group of 52 patients had 94 pregnancies: 70 deliveries (74.5%) and 24 abortions (25.5%) (therapeutic, 14 [15%]). There were a total of 143 valve-related complications (P, 35; NP, 108); the majority for structural valve deterioration (SVD) 43% (109 patients), P 51% (27 patients) and NP 41% (82 patients) (p = NS). The valve-related reoperation rate paralleled the SVD rate at 42% (107 patients), P 51% (27 patients) and NP 40% (80 patients) (p = NS). The overall reoperative mortality rate was 6.0%. The interval from initial implant to reoperation was 99.6 +/- 3.6 months (p = NS groups P and NP).(ABSTRACT TRUNCATED AT 250 WORDS)

Comparison of porcine bioprostheses and mechanical prostheses in multiple valve replacement operations.

The performance of porcine bioprostheses and mechanical prostheses in multiple valve replacement operations was evaluated in 494 patients with 553 operations between 1975 and 1992. Porcine bioprostheses were implanted in 351 multiple replacement operations and 202 operations were performed with mechanical prostheses. The mean age of the bioprosthesis group was 59.1 +/- 14.4 years and of the mechanical prostheses group, 55.9 +/- 13.3 years. Concomitant procedures, primarily coronary artery bypass grafting, were performed in 27.4% (96 patients) of the bioprosthesis group and 20.8% (42 patients) of the mechanical prosthesis group (p = not significant [NS]). The early mortality for the bioprosthesis group (BP) was 12.0% (42 patients), whereas for the mechanical prosthesis (MP) group it was 10.9% (22 patients) with no difference (p = NS) for the performance with or without concomitant procedures, primarily coronary artery bypass grafting. The total cumulative follow-up was 1,914 years for BP and 458 years for MP group. The late mortality was different between the groups (p < 0.05), 6.1%/patient-year for BP and 3.7%/patient-year for MP. The difference in late mortality was not different (p = NS) for performance of concomitant procedures and not different (p = NS) for the absence of concomitant procedures, 5.6%/patient-year for BP and 2.2%/patient-year for MP. The freedom from thromboembolism- and antithromboembolic-related hemorrhage favored the biological population (p < 0.05) at 10 years with 79.7% +/- 3.4% for BP and 75.4% +/- 5.0% for MP. The freedom from structural valve deterioration was 100% for MP, whereas for the BP group, 94.7% +/- 1.6% at 5 years and 65.9% +/- 4.3% at 10 years.(ABSTRACT TRUNCATED AT 250 WORDS)

Reoperation in biological and mechanical valve populations: fate of the reoperative patient.

From 1975 through 1992 inclusive, reoperative valve replacement (REOP) was required by 12.9% of patients (708/5,499). Of 1,355 patients with mechanical prostheses (MP), 46 (3.4%) came to REOP versus 662 of 4,144 patients (16%) with biological prostheses (BP). Early REOP mortality rate was 17.4% (8/46) for MP and 10.6% (70/662) for BP (p = not significant). It was higher with age greater than 75 years (p < 0.05) and trended higher with concomitant procedures and with increasing number of REOPs (p = not significant). The percentage freedom from REOP at 5 and 10 years for all BP was 96.0% +/- 0.4% and 74.9% +/- 1.1% compared with 93.6% +/- 1.2% and 87.9% +/- 2.5% for MP. The most common cause of REOP in the BP patients was structural valve deterioration, which was uncommon in patients with MP (72% versus 2% of REOP but only 15% versus 0.1% of initial implants). Nonstructural dysfunction was the leading cause of REOP in the MP group (65% versus 11%). Prosthetic valve endocarditis (18% versus 10%) and thromboembolic complications (10% versus 1%) were also more frequent causes of REOP in MP patients. However, the increased relative role of these factors with MP is due to the minimal incidence of structural valve deterioration. When related to the original choice of MP versus BP, only thromboembolic complication (3.8 times) was more prevalent as a cause of REOP in patients receiving MP at their previous procedure (p = not significant). For patients who previously received BP, structural valve deterioration (69 times) was more likely to lead to REOP than with MP (p < 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

Tricuspid valve replacement: porcine bioprostheses and mechanical prostheses.

The clinical performance of tricuspid valve replacement with bioprostheses and mechanical prostheses was assessed in a series of 5,489 total valve replacement operations performed from 1975 to 1992. There were 97 (1.8%) tricuspid valve replacements in 94 patients (16 men, 78 women) with a mean age of 55.4 +/- 13.8 years. Bioprostheses (mean patient age, 55.9 +/- 14.1 years) were used in 83 operations and mechanical prostheses (mean patient age, 52.1 +/- 11.9 years) were used in 14 operations. There were 30 isolated tricuspid valve replacements and 67 tricuspid valve replacements incorporated in multiple valve replacements. The total cumulative follow-up was 360 patient-years (bioprostheses, 321 years; mechanical prostheses, 39 years) (96.8% complete). The mean follow-up was 3.7 years (bioprostheses, 3.9 years; mechanical prostheses, 2.8 years) (p = not significant). The early mortality was 14.4% (bioprostheses, 14.5%; mechanical prostheses, 14.3%) (p = not significant) (isolated replacement, 13.3%; multiple replacement, 14.9%). The late mortality was 9.2% per patient-year (isolated replacement, 12.2% per patient-year; multiple replacement, 7.9% per patient-year). The freedom from structural valve deterioration at 5 and 7 years was 100% for mechanical prostheses and 97.1% +/- 2.9% for bioprostheses (p = not significant). For isolated tricuspid valve replacement, the freedom from structural valve deterioration for bioprostheses was 90.9% +/- 8.7% at 5 years and at 7 years (p = not significant). For the mechanical prostheses, the freedom was 100%.(ABSTRACT TRUNCATED AT 250 WORDS)

The Medtronic Intact porcine bioprosthesis: clinical performance to eight years.

The Medtronic Intact porcine bioprosthesis was implanted in 274 patients, in 278 operations, between 1984 and 1992 inclusive. Of the total patient population, 171 patients had 175 aortic valve replacements (AVR), 75 had mitral valve replacement (MVR), two had tricuspid valve replacement and 26 had multiple valve replacement (MR). Concomitant procedures, primarily coronary artery bypass, was performed in 97 (34.9%). The follow up was 98.2% complete; total follow up was 758 patient-years, mean 2.8 years. The early mortality was 6.5% (18 patients) and the late mortality 4.0% per patient-year (30 patients). Of the late deaths, 10 were valve-related-thromboembolism (n = 2), anticoagulant-related hemorrhage (n = 1), prosthetic valve endocarditis (n = 4), non-structural dysfunction (n = 2), and structural valve deterioration (n = 1). Only one death occurred as a consequence of reoperation. The freedom from thromboembolism at six and eight years was-overall 86 +/- 4%; major 96 +/- 1%; fatal 99 +/- 1%. The overall linearized rate of thromboembolism was 3.0% per patient-year. The freedom from anticoagulant-related hemorrhage was 93 +/- 3%; non-structural dysfunction 87 +/- 9%; and structural valve deterioration 97 +/- 2% (AVR 97 +/- 2% at six and eight years, MVR 100% at six years). The freedom from SVD by age groups was- < or = 35 years 100%; 36-50 years 94 +/- 6%; 51-65 years 98 +/- 2%; and > or = 65 years 97 +/- 2% (p = NS). The freedom from valve-related mortality at six and eight years was 86 +/- 8%; residual morbidity 96 +/- 1%; and reoperation 91 +/- 3%. The Medtronic Intact, zero-pressure glutaraldehyde fixed prosthesis requires continued long term assessment to determine if the low incidence of structural valve deterioration is maintained.

Carpentier-Edwards standard and supra-annular porcine bioprostheses: 10 year comparison of structural valve deterioration.

From 1975 to 1986 the Carpentier-Edwards standard (CE-S) and supra-annular (CE-SAV) porcine bioprostheses were implanted in 1213 and 1000 patients, respectively. The mean age of the standard group was 57.6 years (range 8 to 85 years) while in the supra-annular group it was 60.7 years (range 13 to 85 years). The freedom from structural valve deterioration (SVD) at 10 years for the entire patient population was 79.4% +/- 3.1% with CE-SAV and 76.1% +/- 1.6% with CE-S (p < 0.05). The overall freedom from SVD for those patients undergoing mitral valve replacement (MVR) was 74.5% +/- 4.6% for CE-SAV and 68.7% +/- 2.8% for CE-S (p = NS), while for those undergoing aortic valve replacement (AVR) it was 86.5% +/- 4.3% for CE-SAV and 84.1% +/- 2.0% for CE-S (p = NS). In those patients under 35 years of age undergoing MVR, the freedom from SVD for CE-SAV and CE-S was 94.4% +/- 5.4% and 62.9% +/- 8.6%, respectively (p < 0.05 at 8 years); for those aged 36-50 years, it was 75.6% +/- 7.4% and 61.7% +/- 6.0%; for those aged 51-65 years, it was 76.2% +/- 7.4% and 69.6% +/- 4.2%; for those over 65 years, it was 74.1% +/- 7.1% and 82.2% +/- 5.2%; for those aged 65-69 years, it was 70.2% +/- 8.7% and 63.7% +/- 8.1%; and for those over 70 years of age, it was 79.2% +/- 8.7% and 95.3% +/- 3.2%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Structural valve deterioration in elderly patient populations with the Carpentier-Edwards standard and supra-annular porcine bioprostheses: a comparative study.

From 1975 to 1989, over 1400 patients in the elderly population and over 1700 patients under 65 years of age received the Carpentier-Edwards standard (CE-Standard) and supra-annular porcine (CE-SAV) bioprotheses. The mean ages of the patients receiving the two protheses within the three subgroups of the elderly population-65-69 years, 70-79 years, and 80 years and over-were relatively similar. There was no statistically significant difference in the performance of the prostheses regarding structural valve deterioration (SVD) at seven years. The freedom from SVD for aortic valve replacement in the 65-69 years group at seven years was 98.7% +/- 1.3% for the CE-Standard and 98.7% +/- 1.0% for the CE-SAV, for both the 70-79 years group and the 80 years and over group the figure was 100% for both prostheses (p = NS). The freedom from SVD after mitral valve replacement in the 65-69 years group at seven years was 90.0% +/- 4.3% for the CE-Standard and 84.8% +/- 7.5% for the CE-SAV, for the 70-79 years group it was 95.3% +/- 3.2% and 95.5% +/- 3.6% respectively and for the 80 years and over group the figure was 100% for both prostheses (p = NS within groups). The long term freedom from SVD after aortic valve replacement was 98.4% +/- 3% at 15 years for the CE-Standard in the 65-69 years group, 94.9% +/- 5% at 13 years for the 70-79 years group and 100% at 13 years for the 80 years and over group.(ABSTRACT TRUNCATED AT 250 WORDS)