Michael T. Janusz

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)

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

Hemodynamic comparison of second- and third-generation stented bioprostheses in aortic valve replacement

BACKGROUND The hemodynamic performance of aortic replacement prostheses is of extreme importance. There is renewed interest in hemodynamics because of the influence of prosthesis-patient mismatch on left ventricular mass regression and the potential influence on survival. METHODS The hemodynamic performance of the second-generation Carpentier-Edwards supraannular porcine and pericardial (Perimount) bioprostheses and the third-generation Medtronic Mosaic porcine bioprosthesis were compared for mean gradient and effective orifice area index. The effective orifice area index of at least 0.85 cm2/M2 was considered as lack of prosthesis-patient mismatch. The study group included included 53 patients with Carpentier-Edwards supraannular porcine, 48 with pericardial, and 98 with Medtronic Mosaic porcine bioprostheses. RESULTS The mean gradients were not different between the prostheses by prosthesis size. The Medtronic Mosaic was not provided in size 19. The mean gradients for the prostheses, except in the very large sizes, were all double-digit values. The effective orifice area index was not different between the prostheses but there was a trend toward prosthesis-patient mismatch in smaller size prostheses. CONCLUSIONS There was no apparent hemodynamic advantage between porcine and pericardial bioprostheses in the aortic position.

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 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).

Additive effect of allopurinol and deferoxamine in the prevention of spinal cord injury caused by aortic crossclamping

Fourteen domestic swine were divided into two groups. Group A (n = 7) was the control group, in which no pharmacologic intervention was applied. In group B (n = 7), the ischemic-reperfused spinal cord was treated with the combination of allopurinol (50 mg/kg/day for 3 days before the day of operation) and deferoxamine (Desferal, 50 mg/kg administered intravenously over 3 to 4 hours). The administration of deferoxamine was completed 1 hour before crossclamping. The crossclamp was placed on the descending aorta just distal to the left subclavian artery for 30 minutes. Proximal hypertension was controlled with sodium nitroprusside and volume depletion. Methods of assessment included an evaluation of the neurologic status of the animals by quantitative Tarlov criteria, blood flow by radiolabeled microspheres, and histologic examination of the spinal cord. All animals in the control group, group A, were completely paraplegic with 0% recovery by Tarlov criteria at 24 hours after the removal of the crossclamp. In contrast, all animals in group B, in which the combination of allopurinol and deferoxamine was used, completely recovered (100% recovery by Tarlov criteria), and at 24 hours after the ischemic episode they were able to walk with no difficulty and had intact sensation. Functional parameters of these animals fully correlated with the morphologic findings. Widespread acute neuronal injury and vacuolation of neuropil were observed in the control group of animals. In contrast, animals in group B showed much less pronounced morphologic changes after the same period of ischemia. In summary, the combined use of these agents significantly (p < 0.001) reduced the incidence of paraplegia induced by aortic crossclamping with 82% additivity.

Experience with the Carpentier-Edwards Porcine Valve Prosthesis in 700 Patients

The Carpentier-Edwards porcine valve prosthesis has afforded our patients a satisfactory quality of life and a low incidence of valve-related complications at follow-up periods of up to five years. From December, 1975 to March, 1980, 768 prosthesis were implanted in 700 patients (aortic valve replacement [AVR], 334; mitral valve replacement [MVR], 292; tricuspid valve replacement [TVR), 6; and multiple valve replacement, 68). One hundred and thirty-seven patients (19.6%) had had previous cardiac operations. Concomitant aortocoronary bypass was performed in 127 patients (18.1%). There were 52 hospital deaths, for a mortality of 7.4% (AVR, 4.8%; MVR, 9.2%; multiple valve replacement, 11.8%). Total follow-up was 1,047 patient-years (range, 6 to 60 months, mean, 19.4 months). There were 33 late deaths (AVR, 1.7% per patient-year; MVR, 4.0% per patient-year; multiple valve replacement, 8.1% per patient-year). Eight percent of AVR patients and 47% of MVR and multiple valve replacement patients were taking anticoagulants. The valve-related complications (expressed as events per 100 patient-years) were as follows: (1) thromboembolism (AVR, 0.94; MVR,. 1.42; multiple valve replacement, 4.62); (2) infective endocarditis (AVR, 0.94; MVR, 0.24; multiple valve replacement, 2.31); (3) periprosthetic leak (AVR, 0.94; MVR, 0.71; multiple valve replacement, 3.46); and (4) valve dysfunction (MVR, 0.24). The only case of valve dysfunction was a calcified mitral prosthesis in a 13-year-old girl. Actuarial survival, including operative deaths, was as follows: AVR, 90.5% at 36 months; MVR, 84% at 36 months; and multiple valve replacement, 74% at 24 months. Of surviving patient, 93.6% were in New York Heart Association Class I or II at follow-up 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.

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)