The Carpentier-Edwards supraannular porcine bioprosthesis. A new generation tissue valve with excellent intermediate clinical performance

The Carpentier-Edwards supraannular porcine bioprosthesis, an investigational valve, was implanted in 1167 patients (1174 operations, 1274 valves) between November 1981 and December 1985 (age range 13 to 85 years, mean 61 years). The early mortality rate was 7.2% (with concomitant procedures 10.9%, without 4.8%; with previous operation 10.5%, without 6.6%). The late mortality rate was 4.5% per patient-year (aortic valve replacement, 4.0%; mitral valve replacement, 4.8%; multiple valve replacement, 5.6%). Total cumulative follow-up was 2272.3 years. The prevalence of thromboembolism was 2.6% per patient-year (fatal 0.4% per patient-year, major 1.4%, minor 1.2%); hemorrhage related to antithromboembolic therapy, 0.7% (fatal 0.1%); prosthetic valve endocarditis, 0.4% (fatal 0.2%); periprosthetic leak, 0.4% (fatal 0%); structural valve deterioration (primary tissue failure/structural failure), 0.1% per patient-year; and clinical valve dysfunction, 0.4%. The reoperation rate was 0.8% per patient-year (thromboembolism, 0.1%; clinical valve dysfunction, 0.1%; prosthetic valve endocarditis, 0.1%; periprosthetic leak, 0.4%; structural valve deterioration, 0.1%). Thromboembolism occurred throughout the observation period but with decreasing frequency, hemorrhage throughout the period in no predictable fashion, prosthetic valve endocarditis within 2 years, periprosthetic leak within 2 years, and structural valve deterioration occurred during the fourth year of assessment. The overall survival rate was 79.8% +/- 1.7% (4 years). Freedom (at 4 years) from thromboembolism was 92.2% +/- 1.2%; from structural valve deterioration, 98.8% +/- 0.8%; and from reoperation, 95.8% +/- 1.3%. Freedom from all complications (4 years) was 85.9% +/- 1.7%; from complication mortality, 98.4% +/- 0.4%; and from valve failure (mortality and reoperation), 94.3% +/- 1.3%. This investigational Carpentier-Edwards supraannular porcine bioprosthetic valve has provided excellent clinical performance and remains our overall prosthesis of choice.     

Carpentier-Edwards supra-annular porcine bioprosthesis. Clinical experience and implantation characteristics

The investigational Carpentier-Edwards supra-annular valve was implanted in 592 patients from November, 1981, to February, 1984 (aortic valve replacement in 286, mitral valve replacement in 259, and multiple valve replacement in 47, for a total of 638 prostheses). A previous cardiac operation had been performed in 77 patients (13%). Concomitant procedures were performed in 202 patients (34.1%), including coronary artery bypass in 163 patients. The patient evaluation was 98.6% complete. The early mortality was 7.4% (44 patients) and the late mortality was 6.2% per patient-year (41 patients). The valve-related causes of late mortality were thromboembolism (five), anticoagulant-related hemorrhage (one), and prosthetic valve endocarditis (one). The overall patient survival, including operative death, was 85% at 2 years. The linearized occurrence rate for valve-related complications was 5.6% per patient-year (37 events)--thromboembolism 2.7% per patient-year (18) anticoagulant-related hemorrhage 1.2% (eight), prosthetic valve endocarditis 0.8% (five), and periprosthetic leak 0.9% per patient-year (six). There were no cases of primary tissue failure or structural failure. At 2 years, the freedom from valve-related complications was 86.9%, from valve-related mortality, 98.7%, and from valve-related mortality and reoperation, 97.7%. This valve is fixed in glutaraldehyde at low pressure and is designed to improve durability. It has provided a low incidence of valve-related complications without structural failure. The structural design of the prosthesis does not always conform to the anatomy of bicuspid aortic valves.     

Our experience with the Carpentier-Edwards bioprosthesis.

Sixty Carpentier-Edwards porcine valve bioprostheses stabilized with glutaraldehyde were implanted in 55 patients with acquired and congenital heart disease. The follow-up period ranged between 1 and 12 months. There were 3 hospital deaths (5%) and 2 late deaths (4%) in 24 mitral, 24 aortic, 5 mitral-aortic, 1 tricuspid and 1 pulmonary valve replacements. All patients were anticoagulated from the second postoperative day onwards for a period of 3 months after which those with sinus rhythm had their anticoagulants withdrawn. Paravalvular leakage led to re-operation in 3 cases (4%). No valve failure due to cusp rupture was encountered and no thromboembolic complications have occurred. Thirty-three patients were studied postoperatively by non-invasive methods and the results are presented.     

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.     

Use of the Carpentier-Edwards porcine bioprosthesis: assessment of a patient selection policy.

The Carpentier-Edwards bioprosthesis was implanted in 369 patients (414 valves) between May 1977 and December 1987 (age 67.2 +/- 0.5 years); 242 had aortic valve replacement, 80 had mitral valve replacement, 44 had multiple valve replacement, of which 41 were aortic and mitral valve replacement, 2 had isolated tricuspid valve replacement, and 1 had a pulmonary valve replacement. The selection criteria were the following: shorter life expectancy (253 patients) or contraindications to anticoagulants for organic (113 patients) or psychologic (38 patients) reasons, or both. The early mortality rate was 11.1% (aortic valve replacement, 9.1%; mitral valve replacement, 12.4%; aortic and mitral valve replacement, 23.1%). Total cumulative follow-up was 1456 pt-yr (mean 4.4 years, range 1 to 148 months), and the patient evaluation was 99.5% complete. Late mortality was 4.9%/pt-yr. Five-year survival was 70.4% +/- 2.7% overall, 74.3% +/- 3.2% after aortic valve replacement, 60.9% +/- 6.2% after mitral valve replacement (p < 0.03), and 60.7% +/- 8.1% after aortic and mitral valve replacement. Eight patients were reoperated on for primary tissue failure, and freedom from reoperation for structural valve deterioration was 97.5% +/- 1.2% at 5 years and 95.6% +/- 1.8% at 8 years. Failing aortic bioprostheses were explanted in four patients (0.4%/pt-yr) and mitral bioprostheses in seven (1.6%/pt-yr). No patient whose valve was inserted after the age of 70 had to be reoperated on for structural valve dysfunction. The probability of freedom from thromboembolism after 5 and 8 years of follow-up was 93.1% +/- 1.6% and 92.2% +/- 1.8%, respectively. The prevalence of anticoagulant-related hemorrhage was 0.8%/pt-yr (major 0.6%, minor 0.2%). Anticoagulants had to be maintained in 16.3% of the patients: 5.9% after aortic valve replacement, 35.7% after mitral valve replacement, and 45.8% after aortic and mitral valve replacement, while 80.0% were on a regimen of antiplatelet drug therapy. Prosthetic valve endocarditis happened in five patients (0.3%/pt-yr). Freedom from all valve-related morbidity and mortality, including hospital deaths, was 71.0% +/- 2.7% at 5 years and 58.6% +/- 4.6% at 8 years and was significantly better in the aortic valve replacement group (61.3% +/- 6.6% at 8 years) compared with the mitral valve replacement group (54.4% +/- 7.7% at 8 years; p = 0.04). This study confirms the satisfactory performance of the Carpentier-Edwards valve after aortic valve replacement in elderly patients.(ABSTRACT TRUNCATED AT 400 WORDS)     

Long-term evaluation of Carpentier-Edwards porcine bioprosthesis for rheumatic heart disease

OBJECTIVES: The clinical results of Carpentier-Edwards standard bioprosthesis have been extensively studied for valvular heart surgery in America and Europe. However, the data of long-term performance of Carpentier-Edwards standard porcine valve in areas with a high prevalence of rheumatic heart disease are still lacking. In this study, we assessed the clinical performance of Carpentier-Edwards standard porcine bioprostheses in a patient group with high prevalence of rheumatic heart disease. METHODS: A total of 872 patients underwent valvular heart surgery with Carpentier-Edwards standard porcine bioprostheses replacement between 1975 and 1999 and the results were analyzed. Rheumatic etiology counts for 95% of the patients. Mean age of operation was 40 +/- 14 years (mitral valve), 43 +/- 19 years (aortic valve), and 45 +/- 13 years (double valve). Follow-up was 95.6% complete and continued up to 24 years (total 7017 patient-years) with mean of 8.9 +/- 5.1 years. RESULTS: The operative mortality rate was 5.85%. Actuarial patient survival rates after discharge at 5, 10, 15, and 20 years were 92.5%, 83.8%, 72.3%, and 35.8%, respectively. A total of 442 cases received reoperation due to failure of bioprostheses. The mean duration to valve failure is 12.2 +/- 0.4 years. Actuarial estimate of freedom from structural valvular failure at 5, 10, 15, and 20 years were 96.3%, 63.7%, 24.4%, and 7.7%, respectively. CONCLUSION: The long-term result of Carpentier-Edwards standard bioprostheses in the present patient group is satisfactory. However, freedom from valve failure is lower than that of Western series. Younger age at operation and higher prevalence of rheumatic etiology in this area are possible causes.     

Aortic valve replacement with a stentless porcine aortic root bioprosthesis

From April, 1999 to November, 1999, 8 patients underwent the aortic valve replacement using Medtronic Freestyle aortic root bioprosthesis. Mean age was 67.8 years old. Aortic valve etiology was as follows, AS: 1 case, AR: 2 cases, ASR: 3 cases, IE: 1 case, mechanical valve malfunction due to subvalvular pannus: 1 case. The implanted valve size was 25: 2 cases, 23: 3 cases, 21: 1 cases, 19: 2 cases. Surgical technique was subcoronary: 7 cases, full-root: 1 case. Post-op 2D-echo revealed tribial aortic valve incompetence in two cases because of size discrepancy between the aortic annulus and the ascending aorta. Pacemaker implantation was needed in 1 case because of the complete A-V block. In comparison with 5 cases of aortic valve replacement with Hancock II performed in same period, there were no significant differences about the implanted valve size and mean systolic pressure gradient, but the effective orifice area in Freestyle cases was significantly larger than Hancock II cases.     

Rapidly deteriorated failure of Carpentier-Edwards porcine bioprosthesis caused by three detached commissures: Report of a case

A 58-year-old man required an emergency redo mitral valve replacement due to a rapidly deteriorating failure of the Carpentier-Edwards porcine bioprosthesis only a few days after the initial operation. The removed bioprosthesis showed that its three commissures had all peeled off each stent, which may have occurred within a short time, and caused massive, rapidly progressive trans-bioprosthesic regurgitation.     

Twenty-year follow-up of the Carpentier-Edwards standard porcine bioprosthesis in the Oriental population

AIM: The 20-year period long-term results of porcine bioprosthetic valve use are limited. In addition, the majority of these reports come from Western countries. Given the scanty information reported in Oriental countries, this study was therefore designed to examine 20-year long-term results in patients who received a Carpentier-Edwards porcine bioprosthetic valve in an effort to contribute further information on the long-term clinical performance of porcine prosthetic valves from a viewpoint of results in the Oriental population. METHODS: From July 1979 to April 2001, 82 patients received valve replacement with a standard Carpentier-Edwards porcine valve. There were 40 men and 42 women with a mean age of 42.3+/-15.1 years (range 16 to 73 years). Follow-up time extended more than 20 years (mean 10.9+/-3.2 years, range 0.5 to 21.5 years ) for a total of 719.5 patient-years. RESULTS: The overall operative mortality was 16.9% (14 of 83 procedures). At 5, 10, 15, and 20 years, the actuarial survival rate of patients was 71.7%, 66.9%, 55.5%, and 44.4%, respectively. Actuarial estimates of freedom from structural valvular deterioration (SVD) at 5, 10, 15, and 17 years were 96.3%, 64.0%, 24.3%, and 24.3%, respectively; from reoperation 96.3%, 64.5%, 24.5%, and 24.5%; from operated valvular endocarditis 96.8%, 92.6%, 92.6%, and 92.6%; and from overall thromboembolism 96.3%, 88.5%, 67.2%, and 52.2%. In normal sinus rhythm, actuarial estimates of freedom from thromboembolism at 5, 10, 15, and 17 years were 100.0%, 100.0%, 81.8%, and 81.8%, respectively. Whereas for those in patients with atrial fibrillation, the estimates of freedom from thromboembolism were 94.5%, 82.4%, 57.7%, and 38.5%. CONCLUSION: This study demonstrates the very satisfactory 20-year period long-term performance of freedom from bleeding events, thromboembolism (except in patients with atrial fibrillation), and valvular endocarditis in Oriental patients undergoing replacement with a porcine valve. However, the remarkable rate of SVD and reoperation ensued at 6 years after bioprosthesis implanted which does not differ from the series reported from Western countries.     

Aortic valve replacement with stentless porcine aortic bioprosthesis

Twenty-nine patients were entered in a clinical trial on aortic valve replacement with a stentless glutaraldehyde-fixed porcine aortic valve. This bioprosthesis is secured to the aortic root by the same technique used for aortic valve replacement with aortic valve homografts. The functional results obtained from this operation have been most satisfactory. To assess the hemodynamic benefit of eliminating the stent of a porcine aortic valve, we matched 22 patients with a stentless porcine bioprosthesis for age, sex, body surface area, valve lesion, and bioprosthesis size to 22 patients who had aortic valve replacement with a Hancock II bioprosthesis. Mean and peak systolic gradients across the aortic bioprosthesis and effective aortic valve areas were obtained by Doppler studies. Gradients across the stentless bioprosthesis were significantly lower than gradients across the Hancock II valve for every bioprosthesis size. Effective aortic valve areas of the stentless bioprosthesis were significantly larger than the valve areas of the Hancock II valve. Our data demonstrate that the hemodynamic characteristics of a glutaraldehyde-fixed porcine aortic bioprosthesis are greatly improved when the aortic root is used as a stent for the valve. This technique of implantation is expected to enhance the durability of the bioprosthesis, because the aortic root may dampen the mechanical stress to which the leaflets are subjected during the cardiac cycle.     

Performance of the Hancock porcine bioprosthesis following aortic valve replacement: considerations based on a 15-year experience

All patients undergoing isolated aortic valve replacement with a standard Hancock porcine bioprosthesis (PB), from 1970 to 1983, were reviewed. There were 196 patients, 162 male and 34 female patients, with a mean age of 48 +/- 12 years. Operative survivors were followed up from 3 to 15.6 years (mean follow-up, 6.6 +/- 1.5 years), with a cumulative follow-up of 1,140 patient-years, being 100% complete. Actuarial survival was 51 +/- 15% at 14 years. Eight patients sustained systemic embolic episodes (0.7 +/- 0.2%/patient-year); actuarial freedom from emboli is 89.4 +/- 4.3% at 14 years. Reoperation was performed in 53 patients: in 6 because of endocarditis (0.5 +/- 0.2%/patient-year), in 7 because of perivalvular leak (0.6 +/- 0.2%/patient-year), and in 40 because of PB primary tissue failure (3.5 +/- 0.5%/patient-year). Actuarial freedom from PB-related deaths, PB failure, and overall PB-related complications at 14 years was 66.3 +/- 19, 34.3 +/- 11, and 30 +/- 10%, respectively. This long-term experience shows that the performance of the Hancock PB appears satisfactory up to 8 years, while it progressively deteriorates beyond 10 years because of the impact of primary tissue failure on valve durability, justifying the restriction of its use in the aortic position in selected patients.     

The Carpentier-Edwards standard porcine bioprosthesis. A first-generation tissue valve with excellent long-term clinical performance

The Carpentier-Edwards standard porcine bioprosthesis was implanted in 1190 patients (1201 operations, 1303 valves) between January 1975 and June 1986; most implants were before 1982. The mean age of the patients was 57.2 years (range 8 to 85 years). The early mortality was 7.6% (aortic valve replacement 5.1%, mitral valve replacement 8.8%, and multiple valve replacement 15.3%). Late mortality was 3.9% per patient-year (aortic valve replacement 3.6%, mitral valve replacement 4.2%, and multiple valve replacement 3.8%). The total cumulative follow-up period was 6737 years. Thromboembolism was 1.5% per patient-year (fatal 0.4% per patient-year) (minor 0.6%, major 0.9%); antithromboembolic therapy-related hemorrhage was 0.5% (fatal 0.1%); prosthetic valve endocarditis was 0.6% (fatal 0.2%); nonstructural dysfunction was 0.5% (fatal 0.2%); and structural valve deterioration and/or primary tissue failure was 1.5% per patient-year (fatal, 0.2% per patient-year). Thromboembolism and structural valve deterioration were the significant complications, structural valve deterioration occurring primarily between the sixth and 10th year of evaluation. The overall patient survival was 65.0% for aortic valve replacement and 54.8% for mitral valve replacement (p less than 0.05) at 10 years. The patients were classified as 92.9% New York Heart Association functional classes III and IV preoperatively and 92.3% classes I and II postoperatively. Freedom at 10 years from thromboembolism was 84.3% for aortic valve replacement and 76.5% for mitral valve replacement (p = 0.05); structural valve deterioration was 78.6% for aortic valve replacement and 71.6% for mitral valve replacement (p less than 0.05); reoperation was 74.4% for aortic valve replacement and 67.1% for mitral valve replacement (p less than 0.05). Freedom from all valve-related complications at 10 years was 58.9% for aortic valve replacement and 46.8% for mitral valve replacement (p less than 0.05); valve-related mortality was 89.5% for aortic valve replacement and 82.6% for mitral valve replacement (p = not significant); mortality and reoperation was 58.9% for aortic valve replacement and 46.8% for mitral valve replacement (p less than 0.05); mortality and residual morbidity (treatment failure) was 87.2% for aortic valve replacement and 75.1% for mitral valve replacement (p = not significant); mortality, residual morbidity, and reoperation were 66.3% for aortic valve replacement and 54.9% for mitral valve replacement (p less than 0.05). The standard Carpentier-Edwards porcine bioprosthesis has provided satisfactory clinical performance and has afforded patients excellent quality of life.     

The Carpentier-Edwards supra-annular bioprosthesis for aortic valve replacement. Clinical experience in 234 patients

Between January 1980 through December 1983, aortic valve replacement (AVR) was performed in 234 patients with a Carpentier-Edwards supra-annular bioprosthesis. There were 177 isolated AVRs and 18 AVRs combined with coronary artery bypass grafting (CABG): one bypass was done in 9 patients, 2 in 7 and 3 in 2 patients. Additional valve surgery was: mitral valve reconstruction in 14, mitral valve replacement in 12 and additional tricuspid reconstruction in 2. AVR combined with various other procedures was performed in 11 other patients. Early mortality for isolated AVR was 5%. Follow-up information was obtained until June, 1984. During this observation period (19.8 +/- 7 months), late mortality was 4%. Follow-up information was obtained on 212 of the 234 patients (91%). Preoperatively, 77% of the patients were in NYHA class III, 16% were in class IV. Postoperatively, 82.5% had improved to functional class I and II (I: 42.5%, II: 40%), only 17% were in class III. A diastolic murmur indicating aortic regurgitation was noted in 25 patients (11%). The murmur occurred early in 3, and late within 2 years in 21 instances: 7 patients required reoperation. Intraoperative findings were: leaflet perforation (3), leaflet rupture (1), suture dehiscence (2), and endocarditis (1). Histology and electron microscopy of the 4 malfunctioning valves showed changes in collagen structure and minimal calcification. The possible causes of valve failure are discussed.     

Polyurethane-covered mammary implants: a 12-year experience.

Polyurethane-covered mammary implants are the implants of choice in aesthetic and reconstructive mammary surgery. These implants give very good results in regard to breast contour and consistency, and have a very low complication rate. We present our 12-year experience using polyurethane-covered prostheses. We place the implant mostly in the subglandular or subcutaneous site, and their capsular contracture rate is extremely low (3.3%). Based on our experience, we also review the other complications and side effects occurring with polyurethane prostheses and discuss them in detail.