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.     

Aortic Carpentier-Edwards supraannular porcine bioprosthesis: a 12-year experience.

BACKGROUND: After 35 years of cardiac valve replacement, the ideal substitute remains to be found. Homografts are considered best but, due to their scarcity, cannot meet the need of valve replacement. Artificial valves (mechanical or biological) remain the most commonly used but controversy is still present as to the better choice. We tested the Carpentier-Edwards bioprosthesis for its efficacy in valve replacement operations. METHODS: From 1983 to 1995, 1,108 consecutive patients had an isolated aortic valve replacement with a porcine Carpentier-Edwards bioprosthesis, model 2650 supraannular valve. Mean age was 73.8+/-8.3 years. Aortic stenosis was the most common lesion (1,049 patients, 94.7%). The follow-up of 980 operative survivors was 96% complete and represented a total of 4,735 patient-years (maximum, 13.8 years; mean, 4 years and 10 months). RESULTS: Actuarial survival including operative mortality (128 patients, 11.6%) was 43.6%+/-2.3% at 10 years and 27.3%+/-3.3% at 12 years and, at that time, was not statistically different from those of the normal French population matched for age and sex. Structural deterioration of the valve was observed in 27 patients, an actuarial freedom of 94.2%+/-1.5% at 10 years and 83.8%+/-4.5% at 12 years. Hazard function revealed a stable and low risk of structural deterioration until 10 years and significantly increased risk after that. Young age was found to be an increasing risk factor of deterioration. Reoperation for valve-related complications was necessary in 30 patients, an actuarial freedom of 94.5%+/-1.4% at 10 years. CONCLUSIONS: The Carpentier-Edwards porcine supraannular valve affords a good durability up to 10 years, with a low rate of reoperation. The risk of structural deterioration decreases with older age. It is our valve of choice in elderly patients.     

Early experience with the mosaic bioprosthesis: a new generation porcine valve

Background. The Mosaic bioprosthesis is a new generation stented porcine valve.

Methods. Between May 1995 and April 1998, this valve was implanted in the aortic position in 98 patients (70 men; mean age, 69.2 years [34.2 to 83.6 years]). Preoperatively 35 patients were in New York Heart Association functional class 3 or 4. Fifty-nine patients underwent concomitant procedures. The mean duration at follow-up in January 1999 was 23.7 ± 10.2 months (0.3 to 39.4 months) and totaled 193 patient-years. All but one survivor was in New York Heart Association class 1 or 2.

Results. Early complications included 1 death, 3 reoperations for bleeding, greater than mild regurgitation (paravalvar) in 1 patient and thromboembolism in 4 patients. Late complications included four deaths, study-valve endocarditis in 3 patients, more than mild regurgitation or hemolysis in 2, and thromboembolism in 2 patients. Late follow-up echocardiography in all survivors showed a mean transaortic gradient of 13.6 ± 6.7 mm Hg, and an aortic valve area of 1.80 ± 0.61 cm². Valve replacement was followed by a significant and sustained decrease in left ventricular mass for all valve sizes. There has been no primary structural valve failure.

Conclusions. The early experience with the Mosaic valve in the aortic position has been promising.     

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)     

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.     

Comparison of Carpentier-Edwards pericardial and supraannular bioprostheses in aortic valve replacement.

OBJECTIVE: This study aimed at calculating and comparing the long-term outcomes of patients after aortic valve replacement with the Carpentier-Edwards bovine pericardial and porcine supraannular bioprostheses using microsimulation. METHODS: We conducted a meta-analysis of eight studies on the Carpentier-Edwards pericardial valves (2,685 patients, 12,250 patient-years) and five studies on the supraannular valves (3,796 patients, 20,127 patient-years) to estimate the occurrence rates of valve-related events. Eighteen-year follow-up data sets were used to construct age-dependent Weibull curves that described their structural valvular deterioration. The estimates were entered into a microsimulation model, which was used to calculate the outcomes of patients after aortic valve replacement. RESULTS: The annual hazard rates for thrombo-embolism after aortic valve replacement were 1.35% and 1.76% for the pericardial and supraannular valves, respectively. For a 65-year-old male, median time to structural valvular deterioration was 20.1 and 22.2 years while the lifetime risk of reoperation due to structural valvular deterioration was 18.3% and 14.0%, respectively. The life expectancy of the patient was 10.8 and 10.9 years and event-free life expectancy 9.0 and 8.8 years, respectively. CONCLUSIONS: The microsimulation methodology provides insight into the prognosis of a patient after aortic valve replacement with any given valve type. Both the Carpentier-Edwards pericardial and supraannular valve types perform satisfactorily, especially in elderly patients, and show no appreciable difference in long-term outcomes when implanted in the aortic position.     

The Carpentier-Edwards pericardial aortic valve: intermediate results.

The Edwards pericardial aortic valve has unique design features that minimize cusp stress and reduce abrasion wear. Wear tests and in vivo fluid dynamic tests have shown superior performance compared with other bioprostheses. Between August 1981 and July 1985, 719 isolated aortic valves were implanted in 10 US centers. Patients were aged 18 to 90 years (mean, 64 years). Men were 63.3% of the patients. Aortic stenosis was present preoperatively in 63.4% of patients. New York Heart Association functional classes III and IV were assigned to 62% of the patients. Valve sizes were 21 mm or less in 49% of patients. Concomitant procedures (most often coronary artery bypass grafting) were performed in 48% of patients. Hospital mortality was 4.7%. There was one valve-related death due to anticoagulant hemorrhage. Late mortality yielded 23 valve-related deaths: endocarditis (13), anticoagulant hemorrhage (4), thromboembolism (3), structural (2), and pannus overgrowth (1). Freedom from valve-related death at 7 years was 95.5%. Regarding valve survival, cusp tears were not seen. There were 11 calcified valves and eight explants (57 to 107 months). Seven-year freedom from all valve reoperation was 95.5%, with 11% of the patients receiving warfarin sodium, freedom of the total series from hemorrhage at 7 years was 93.3%, and from major thromboembolism, 95.8%. Echocardiographic follow-up of hemodynamics at 7 years yielded the following calculated effective orifice areas: 19 mm, 1 cm2; 21 mm, 1.3 cm2; and 23 mm, 1.4 cm2. Average mean gradient for 19-mm valves was 15 mm Hg. New York Heart Association class improved in 78% of the patients. The Carpentier-Edwards pericardial valve, carefully studied by the Food and Drug Administration guidelines, is easy to use and has excellent hemodynamics.(ABSTRACT TRUNCATED AT 250 WORDS)     

Clinical and hemodynamic evaluation of the 19-mm Carpentier-Edwards supraannular aortic valve.

The clinical and hemodynamic performance of the 19-mm Carpentier-Edwards supraannular aortic valve is largely unknown compared with that of the larger valves. Over 4 years we implanted the 19-mm Carpentier-Edwards supraannular aortic valve into 21 patients (20 female) with a mean age of 75 +/- 1.2 years (range, 59 to 86 years) and a mean body surface area of 1.6 +/- 0.03 m2 (range, 1.3 to 1.7 m2). There were four deaths, one operative and three late noncardiac deaths. Follow-up of the 17 survivors for a mean of 20 +/- 3.1 months (range, 2 to 42 months) demonstrated symptomatic improvement in all 17 (all are now in New York Heart Association functional class I or II). There were no valve-related complications and no patient required long-term anticoagulation. Doppler echocardiographic studies were used to assess the in vivo hemodynamic profile of the valve. Mean postoperative aortic valve gradient was 34.1 +/- 2.7 mm Hg (range, 19 to 52 mm Hg). Functional valve orifice area was 1.1 +/- 0.09 cm2 (range, 0.6 to 1.8 cm2). Mean cardiac output was 3.92 +/- 0.17 L/min (range, 3.2 to 5.1 L/min) with a mean cardiac index of 2.5 +/- 0.11 L.min-1 x m-2 (range, 2.1 to 3.2 L.min-1 x m-2). In conclusion, we have demonstrated that aortic valve replacement with the 19-mm Carpentier-Edwards supraannular aortic valve has a low operative mortality and offers major clinical benefits despite moderate transprosthetic gradients. This approach provides an alternative management strategy in elderly patients who would otherwise require low-profile mechanical valves or aortic root enlargement.     

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.     

Late hemodynamic and clinical outcomes of aortic valve replacement with the Carpentier-Edwards Perimount pericardial bioprosthesis

OBJECTIVES: The aim of this study was to investigate the long-term clinical and hemodynamic outcomes after aortic valve replacement with the Carpentier-Edwards Perimount bioprosthesis (Edwards Lifesciences, Irvine, Calif), which has been used in our institution since 1984. METHODS: From January 1984 to December 1995, the Carpentier-Edwards pericardial bioprosthesis was used for aortic valve replacement in 254 patients (male/female ratio 117:137) with a mean age of 71 years (range 25-87 years). Before the operation, 216 patients (85%) were in New York Heart Association functional class III or IV. The predominant diagnosis was aortic stenosis (n = 219, 86%). Associated surgical procedures included coronary artery bypass grafting in 130 cases (51%), mitral valve replacement in 11 cases (4%), and tricuspid or mitral valve repair in 12 cases (5%). Previous cardiac operations had been performed in 36 cases (14%). Follow-up was 100% complete at a mean of 60 +/- 31 months. Univariate estimates of time-related cumulative probabilities were calculated by the Kaplan-Meier method. Multivariable adjustment was performed by Cox proportional hazards regression. Echocardiography was performed in 61% of long-term survivors. RESULTS: There were 11 early deaths (4%) and 58 late deaths. Actuarial survivals at 5, 10, and 12 years were 80% +/- 3%, 50% +/- 8%, and 36% +/- 9%, respectively. At 12 years the freedom from cardiac death was 73% +/- 7%, the freedom from valve-related death was 84% +/- 11%, the freedom from valve reoperation was 83% +/- 9%, the freedom from primary tissue failure was 86% +/- 9%, the freedom from thromboembolism was 67% +/- 13%, and the freedom from endocarditis was 98% +/- 1%. Echocardiography was performed on long-term survivors (mean follow-up 67 +/- 25 months) and showed that transvalvular peak and mean pressure differences measured with Doppler echocardiography were 23.2 +/- 9.6 and 12.3 +/- 4.8 mm Hg, respectively. Aortic regurgitation was found by Doppler echocardiography to be none or trivial, mild, moderate, and severe in 64%, 30%, 3%, and 1% of patients, respectively. Mean left ventricular mass index was 107.2 +/- 35.3 g/m(2) (118.9 +/- 40.2 g/m(2) in men and 98.8 +/- 28.8 g/m(2) in women) at late follow-up. One third of all patients, regardless of sex (n = 26/64 women and n = 14/45 men), had evidence of left ventricular hypertrophy. However, our analyses indicate that the residual left ventricular hypertrophy was not caused by valve mismatch but was probably multifactorial. CONCLUSION: The Carpentier-Edwards Perimount bioprosthesis has provided satisfactory clinical and hemodynamic outcome. However, at long-term follow-up about one third of the patients being investigated still had left ventricular hypertrophy examined by echocardiography.     

Early follow-up of patients with the Medtronic Intact porcine valve. A new cardiac bioprosthesis

A new-generation porcine valve fixed in glutaraldehyde at zero pressure and mounted on an acetal copolymer flexible stent was inserted in 97 patients between August 1983 and October 1986. The mean age of the patients was 51 years (range 10 to 76) and eight were under the age of 20 years. There were 57 mitral, 33 aortic, and 10 tricuspid valve replacements. Concomitant coronary artery bypass grafting was performed in 9% of patients, 40% underwent multiple valve operations, and in 40% the procedure was a reoperation. Mean follow-up was 26 months (range 12 to 49) and was 99% complete. There were no examples of primary tissue failure, and only to reoperations have been undertaken for infective endocarditis alone. The early mortality rate was 8.2% and the late mortality rate, 12.1%. Four late deaths were valve related (two caused by infective endocarditis and two by embolism). The actuarial 3-year survival rate was 70%, freedom from infective endocarditis 879%, freedom from embolism 87%, freedom from reoperation 90%, and freedom from valve-related complications 77%. All but three surviving patients were in New York Heart Association class I or II. Doppler echocardiography, performed in 62 of 76 survivors, showed thin and mobile leaflets in all patients and trivial or mild regurgitation in four (6%). The mean gradient across the Medtronic Intact valves (Medtronic Blood Systems Inc., Minneapolis, Minn.) in the aortic position was 17 +/- 5.2 mm Hg, in the mitral position 3.8 +/- 1.33 mm Hg, and in the tricuspid position 4.1 +/- 1.14 mm Hg. We conclude that early results with the Intact valve are encouraging.     

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.     

The clinical criteria for Carpentier-Edwards bioprosthesis in the mitral position

This is a comparative study of late results of mitral valve replacement between Carpentier-Edwards (C-E) and Bj?rk-Shiley (B-S) valve prosthesis. The purpose of this study is to clarify the clinical criteria for C-E valve. C-E valve was implanted in 202 patients. The mean follow up period was 5.8 years and the longest one was 11 years. For B-S valve, it was 132 patients, 5.3 years and 17 years, respectively. With respect to the incidence of thromboembolic episodes, in spite of no anticoagulant therapy in the C-E group, there was no statistical difference between the C-E and the B-S groups. The incidence of valve related complication in the C-E group was significantly lower than that in the B-S group 5 years postoperatively. But that in the B-S group was significantly low 10 years postoperatively. Since the over 60 years old patients in the C-E group had low incidence of primary tissue failure, over ten years durability might be secured. In conclusion, the present clinical criteria for C-E valve should be as follows: 1) the patient older than 65 years, 2) the patient with contraindication for anticoagulant therapy, 3) the woman who desires pregnancy and 4) the patient with hemorrhagic diathesis caused by cardiac cachexia, liver cirrhosis and so on.     

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.     

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)     

The porcine bioprosthesis. A review of 1,000 consecutive patients undergoing cardiac valve replacement

Early and late experience with 1,000 patients undergoing porcine xenograft replacement of cardiac valves from 1974 through 1981 at Emory University Hospital is presented. Hemodynamic performance of the modified orifice Hancock and the Carpentier-Edwards valves has been quite satisfactory. There has been a low incidence of thromboembolism in the absence of routine anticoagulation. Less than 20 per cent of our patients are anticoagulated long-term, the primary indication being chronic artrial fibrillation. Endocarditis has developed in 0.7 per cent of patients, an incidence comparing most favorably with that of mechanical prostheses. Valve dysfunction secondary to primary tissue failure is a definite problem. The highest incidence of tissue failure occurred in young patients after six years of implantation. Detailed analysis of long-term patient survival showed a low incidence of valve related deaths. The porcine xenograft is a satisfactory prosthesis for cardiac valve replacement. Our data suggests its use should be limited to older patients or to patients in whom anticoagulation is contraindicated. It should be explained to all patients that long-term durability is unknown and that re-replacement of these bioprostheses within a decade is quite likely.