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Ann Thorac Surg 1999;68:421-425
© 1999 The Society of Thoracic Surgeons

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Original Articles

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

^a Clinique Chirurgicale Cardiovasculaire et Thoracique, Hopital Pontchaillou, Centre Hospitalier Universitaire de Rennes, Rennes, France

Address reprint requests to Dr Logeais, Centre Cardio Pneumologique, Service de Chirurgie Thoracique et Cardiovasculaire, Hôpital Pontchaillou, Rue Henri Le Guilloux, 35033 Rennes Cedex 09, France

	Abstract

Top Abstract Introduction Patients and methods Results Comment References

 
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 supra-annular 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 supra-annular 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.

	Introduction

Top Abstract Introduction Patients and methods Results Comment References

 
Thirty-five years after the introduction of artificial heart valves, discussion remains open as to the choice of the best valve substitute [1]. We report a series of 1,108 aortic valve replacements with the Carpentier-Edwards supraannular porcine bioprosthesis, model 2650 (CE-SAV; Baxter Healthcare Corp, Santa Ana, CA). Introduced in 1982, the CE-SAV, a second-generation bioprosthesis, had several modifications to increase its durability, including low glutaraldehyde tissue fixation pressure (2 mm), 20% to 30% increase of the orifice area due to the supra-annular position, reduced transvalvular gradients, wide-mouthed mount preventing contact wear on the valve tissue, flexibility of the elgiloy fitting reducing the impact of the diastolic load, low profile for easier insertion, and anticalcification treatment with a surfactant (polysorbate 80). In our service at the University of Rennes, from 1971 to December 1996, 8,150 valve replacements have been performed, with more mechanical valves (5,367, 66%) used than bioprostheses (2,783, 34%). Bioprostheses have been reserved almost exclusively to elderly patients (70 years or more) [2, 3].

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment References

 
From June 30, 1983 to July 10, 1995, 1,108 patients were operated on for an aortic valve replacement using the CE-SAV porcine bioprosthesis. Patients who had single replacement of the native aortic valve (1,100 patients) or replacement of a previously implanted prosthesis (8 patients), exclusive of other cardiac valve replacement, were included.

The age ranged from 24 to 91 years (mean, 73.8 ± 8.3 years), and 906 patients were 70 years old or more (906, 81.8%), 159 patients (14.4%) were between 60 and 69 years, and 43 (3.9%) patients were less than 60 years old (Fig 1). The distribution of the two genders was roughly equivalent, with 562 women (50.7%) and 546 men (49.3%). The predominant lesion was aortic stenosis, either pure (915 patients) or combined with an aortic insufficiency (134 patients), with isolated aortic insufficiency being present in only 58 patients (19 had infective endocarditis). Ten patients had aneurysm of the ascending aorta. Preoperative coronary arteriography was done in 786 cases (70.9%). Coronary artery lesions were found in 351 cases (44.7%). The functional class, according to the New York Heart Association classification, was as follows: 13 patients in class I (1.2%), 346 in class II (31.2%), 636 in class III (57.4%), and 113 in class IV (10.2%). Left ventricular failure was present in 493 cases (44.6%) and right ventricular failure in 80 cases (7.2%). Extracardiac diseases were present in 417 patients (37.6%), including chronic obstructive pulmonary disease in 105, peripheral arterial disease in 88, previous gastro duodenal ulcer in 77, cerebral arterial disease in 57, previous cancer in 56, renal insufficiency in 23, liver insufficiency in 21, and central nervous system deficit in 14. Seventy-one patients (6.4%) had emergency operations. Prosthesis sizes most commonly used were 21 mm and 23 mm, followed by 25 mm and 19 mm. Aortic valve replacement was associated with coronary revascularization in 176 cases, myotomy for septal hypertrophy in 70 cases, and endarterectomy or replacement of the ascending aorta in 37 cases. One hundred twenty-eight patients died after the operation (11.6%), primarily of myocardial causes (74 patients, 58%). As shown by univariate analysis, the operative mortality rate was increased by urgency (29.6%, p < 10^-7), New York Heart Association class IV (26.5%) and III (11.8%, p < 10^-6), and associated coronary revascularization (18.6%, p < 10^-3). Seven patients presented early valve-related complications, including 1 patient with infective endocarditis who required a reoperation (one death) and 4 with thromboembolic accidents (2 with valve thrombosis resulting in two deaths).

View larger version (14K): [in this window] [in a new window]   Fig 1. Distribution of patients according to age.

Data were collected prospectively in the cardiovascular surgery clinical data base. Statistical processing was accomplished by SPSS software (SPSS Inc, Chicago, IL). The mortality risk factors were investigated with the ² test for the qualitative variables and analysis of variance or the Kruskal-Wallis test when the variances were unequal for the quantitative variables (inequalities found by the Levene test). Analysis of the actuarial survival factors was done by the Kaplan-Meier method. Comparison of the survival profiles was done with the Mantel-Haenszel, Breslow, and Tarone-Ware tests. The total analysis used the Cox model, in ascending and descending procedure, with the help of the Wald test. The mortality rate of the studied population was compared with that of the French population from 1988 to 1990 matched in age and gender. The mortality quotients used were annual quotients. The comparison was done by the Mantel-Haenszel adjustment method. The advent of death was taken into account, as recommended by Starr and Grunkemeier [5]. Actuarial curves were limited to 12 years, where 60 patients were still alive.

	Results

Top Abstract Introduction Patients and methods Results Comment References

 
Late mortality and patient survival
Late deaths were observed in 29.4% (288 patients), at a mean age of 75 years (range, 47 to 91 years), occurring within a period of 2 months to 12 years postoperatively (mean, 56 ± 39 months). Predominant causes of death (Table 1) were myocardial complications (25.7%, 74 cases) and cancer (17%, 49 cases). The risk factors of late mortality (Table 2) shown by univariate analysis were age (p < 0.0009), preoperative associated diseases, in particular peripheral arterial disease (50%, p < 0.0009), left heart failure (36%, p < 0.00004), rhythm disturbances (p < 0.00001), and cardiothoracic ratio (p < 0.008). Use of the Cox model confirmed the risk for preoperative electrocardiographic disturbances, with an odds ratio of 1.94 for atrial fibrillation. The survival of the 1,108 patients, including operative mortality, was 84.3% ± 1.1% at 1 year, 69.8% ± 1.5% at 5 years, 43.6% ± 2.3% at 10 years, and 27.3% ± 3.3% at 12 years (Fig 2). Comparison with matched French population for the years 1988 to 1990 showed a higher early mortality rate in the surgical group, followed by a decrease and, at 12 years, the survival of the surgical group is equivalent to that of the normal French population (Fig 2). Analysis of the actuarial survival as a function of the diameter of the prosthesis found no significant difference.

View larger version (12K): [in this window] [in a new window]   Fig 2. Actuarial survival of operated patients (thick line) compared with a normal French population matched for age and sex (thin line) (95% confidence interval).

Early and late morbidity
Among the 1,108 patients, 9.7% (107) had valve-related complications, 13 during the postoperative course, and 95 later (one patient appears in both intervals). A total of 112 complications were observed, representing an actuarial probability of freedom from complication of 96.4% ± 0.6% at 1 year, 90.2% ± 31.1% at 5 years, 81.8% ± 2.2% at 10 years, and 69.4% ± 4.7% at 12 years. Linear rates are presented in Table 3 and represent an overall rate of 2.4% patient-years.

View larger version (12K): [in this window] [in a new window]   Fig 3. Risk of structural deterioration of the valve (hazard function). Actuarial risk (solid line) increases significantly after the 11th year; comparatively, actual risk (dashed line) appears lower.

Infective endocarditis of the prosthesis was observed in 17 cases. the actuarial freedom was 99.6% ± 0.2% at 1 year, 98.2% ± 0.5% at 5 years, 96.6% ± 1.0% at 10 years. The risk factors were young age (71 years versus 75 years, p < 0.06) and male gender (2.4% versus 0.7% for women, p < 0.04).

Periprosthetic leaks were observed in 29 cases. The actuarial freedom was 98.5% ± 0.4% at 1 year, 97.3% ± 0.6% at 5 years, 95.3% ± 1.2% at 10 years, and 94% ± 1.8% at 12 years. The risk factors identified were younger age (median 71 versus 75 years; p < 0.0005) and male gender (3.5% versus 1.6%; p < 0.05). Only the gender factor was confirmed by actuarial analysis (p < 0.02 with the Breslow test).

Fourteen hemorrhagic accidents were observed (two with excessive anticoagulant treatment). One patient died from gastrointestinal hemorrhage and liver cirrhosis. The actuarial rate for freedom was 99.2% ± 0.3% at 1 year, 98.4% ± 0.5% at 5 and 10 years, and 97% ± 1.5% at 12 years.

Reoperations for prosthesis-related complications were necessary in 30 patients, within an average interval of 5 years and 3 months (range, 2 months to 13 years) for structural deterioration (15 patients), periprosthetic leak (8 patients), infection (6 patients), or chronic thrombosis (1 patient). The actuarial freedom of reoperation was 99.4% ± 0.2% at 1 year, 97.8% ± 0.6% at 5 years, and 94.5% ± 1.4% at 10 years. The operative mortality rate of the whole group was 6.6% (2 patients). Among the 28 operative survivors, six late deaths occurred after a median of 2 years and 9 months (range, 2 months to 9 years). One patient with an aortoventricular disjunction and multiple abscessed endocarditis had a second reoperation in which an aortoventricular valved tube was inserted.

It was possible to define the functional status in 702 of 766 known surviving patients during the investigation. The functional improvement appeared to be very important, as 631 patients (90%) were in New York Heart Association class I or II. The heart rhythm was sinus in 83.3% (526 patients), and there was atrial fibrillation in 11.9% (75 patients). Thirty-six patients had a pacemaker. Of 651 informed cases (patients whose status was known for the particular item), 58 patients were given long-term anticoagulant treatment with coumadin (9%), and 593 (91%) received no anticoagulant treatment. Echocardiographic control was available in 130 patients (between 1 month and 12.4 years, average 4.7 years). The ejection fraction of the left ventricle ranged from 0.28 to 0.80 (average, 0.57), the maximum gradient from 10 to 60 mm (average, 28 mm), and the mean gradient from 5 to 36 mm (average, 16.9 mm). The mean gradients for diameters 19, 21, 23, and 25 mm were 20.2, 19, 15.8, and 14.3 mm Hg, respectively.

	Comment

Top Abstract Introduction Patients and methods Results Comment References

 
Porcine bioprostheses have been used for more than 20 years, since glutaraldehyde made preservation of biologic tissue possible. After an initial period of enthusiasm based on low thrombogenicity and absence of chronic anticoagulant treatment, disappointment appeared because of the limited durability, which was particularly distinct in younger patients. Structural alteration of the tissue is the predominant complication, even though its incidence is lower in elderly patients [6]. Thus, bioprostheses remain indicated for elderly patients or in particular patients presenting with a contraindication to long-term anticoagulant treatment. Although deterioration of bioprostheses is still a current problem, the definition of valve alteration generally is not so precise [5, 7]. Diagnosis of valve deterioration corresponds in most cases to substantial modifications (calcifications or rupture responsible for stenosis or regurgitation), often requiring reoperation. It is obvious that tissue deterioration begins earlier. Precise knowledge of when tissue deterioration begins would require regular echocardiographic controls, which are lacking in most series. Echocardiographic monitoring is therefore mandatory every year during the first 5 years, every 6 months from 6 to 10 years, and every 3 months after 10 years [7]. This protocol would also avoid most emergency reoperations, which carry a high mortality rate.

Every year there are approximately 500 publications concerning valve replacement [8]. Few are major series with a long follow-up, many deal with patients of different ages, and some include aortic and mitral valves. The first-generation porcine bioprostheses (standard Carpentier and Hancock) analyzed according to 11 series in the literature [7, 9–17] showed actuarial freedom of structural deterioration at 10 years between 70% and 93% [12], with averages between 75% and 85% [7, 9, 11, 15]. At 15 years, the trend is even more clear: with the exception of one series at 90% [16], rates of freedom from structural deterioration are between 37% [7] and 63% [11]. Grunkemeier and associates [8] showed that the structural deterioration curve is within the Weibull probability model, with a deterioration freedom of 80% at 10 years (extremes of 90% to 60%) and an average of 40% at 15 years (extremes of 60% to less than 20%). In these series, the different valve models do not have different results, but structural deterioration is age related and occurs earlier in younger patients. Jamieson and colleagues [6, 10, 14] showed that the freedom from deterioration is 100% at 10 years, 96% at 12 years, 58% at 15 years in patients older than 70 years, and the role of age is now well accepted.

Our series concerns a second-generation porcine valve and shows a good durability with an actuarial rate of 94.2% ± 1.5% at 10 years, the mean age of the series being 73.8 years. Jamieson and colleagues [15] studied the same valve and found higher rate of alteration (90% at 10 years, 82% at 12 years), but that population was younger (mean age, 64 years). In his elderly subgroup (70 years or more), the freedom from deterioration remains very high, at 99.4% at 10 and 12 years [15].

Thromboembolic morbidity was rare (25 patients), with an actuarial freedom of 96.3% at 10 years, and 86% of the patients were in sinus rhythm at the time of the investigation. Appreciation of overall thromboembolism should add to this morbidity the fact that, among 43 patients who died of stroke, embolism was the most common cause. The rate of infectious endocarditis appears low (actuarial freedom of 96.6% at 10 and 12 years). Hemorrhagic accidents were rare (8 patients), with 98.4% of the patients being free from them at 10 years and 97% at 12 years. This result could be attributed to the restrictive policy that we adopted in 1988, with early elimination of anticoagulation (except for patients with atrial fibrillation) at the time of hospital discharge after a limited heparinization of 8 to 10 days, to avoid long-term anticoagulation unduly maintained by cardiologists or physicians in patients with sinus rhythm. In our series, only 9% of the patients received long-term anticoagulant treatment.

This series of 1,108 porcine Carpentier-Edwards supra-annular valves had good results during a time span of 12 years. Little mentioned in the literature, this bioprosthesis is one of the best biologic substitutes. Because of its low thrombogenicity, it does not require long-term anticoagulation. Its limitation, like other bioprostheses, is durability, but the rate of alteration remains low. The Carpentier-Edwards supra-annular porcine valve is a standard against which the new substitutes will have to be measured [20]. Bioprostheses are our substitute of choice in elderly patients, whereas mechanical prostheses are preferred for younger patients. Situations that require long-term anticoagulation (chronic atrial fibrillation, major cardiac failure, associated diseases accelerating the deterioration of the bioprostheses such as hyperparathyroidism and chronic renal insufficiency) indicate a mechanical valve, regardless of the patient’s age [18, 19]. Better durability of new bioprostheses (pericardial or stentless valves) or, better control of anticoagulation might modify the choice in the years to come.

	References

Top Abstract Introduction Patients and methods Results Comment References

 

1. Jamieson W.R.E., Burr L.H., Tyers G.F.O., et al. Carpentier-Edwards supraannular porcine bioprosthesis. Ann Thorac Surg 1995;60:S235-S240.
2. Logeais Y., Langanay T., Roussin R., et al. Surgery for aortic stenosis in elderly patients. A study of surgical risk and predictive factors. Circulation 1994;90:2891-2898.[Abstract/Free Full Text]
3. Logeais Y., Roussin R., Langanay T., et al. Aortic valve replacement for aortic stenosis in 200 consecutive octogenarians. J Heart Valve Dis 1995;4(Suppl 1):64-71.
4. Edmunds L.H., Jr, Clark R.E., Cohn L.H., et al. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ann Thorac Surg 1996;62:932-935.[Abstract/Free Full Text]
5. Starr A., Grunkemeier G.L. The expected lifetime of porcine valves. Ann Thorac Surg 1989;48:317-318.[Medline]
6. Jamieson W.R.E., Rosado L.J., Munro A.L., et al. Carpentier- Edwards standard porcine bioprosthesis. Primary tissue failure (structural valve deterioration) by age groups. Ann Thorac Surg 1988;46:155-162.[Abstract]
7. Magilligan D.J., Lewis J.W., Stein P., et al. The porcine bioprosthetic heart valve. Ann Thorac Surg 1989;48:324-330.[Abstract]
8. Grunkemeier G.L., Starr A., Rahimtoola S.H. Prosthetic heart valve performance. Curr Prob Cardiol 1992;17:331-406.
9. Akins C.W., Carroll D.L., Buckley M.J., Daggett W.M., Hilgenberg A.D., Austen W.G. Late results with Carpentier-Edwards porcine. Bioprosthesis. Circulation 1990;82(Suppl 4):65-74.
10. Jones E.L., Weintraub W.S., Craver J.M., et al. Ten-year experience with the porcine bioprosthetic valve. Ann Thorac Surg 1990;49:370-384.[Abstract]
11. Burdon T.A., Miller D.C., Oyer P.E., et al. Durability of porcine valves at fifteen years in a representative North American patient population. J Thorac Cardiovasc Surg 1992;103:238-252.[Abstract]
12. Pelletier L.C., Carrier M., Leclerc Y., et al. Influence of age on late results of valve replacement with porcine bioprostheses. J Cardiovasc Surg 1992;33:526-533.[Medline]
13. Sarris G.E., Robbins R.C., Miller D.C., et al. Randomized, prospective assessment of bioprosthetic valve durability. Circulation 1993;88:55-64.[Abstract/Free Full Text]
14. Jamieson W.R.E., Burr L.H., Tyers G.F.O., Munro A.I. Carpentier-Edwards standard and supra-annular porcine bioprostheses. J Heart Valve Dis 1994;3:59-65.[Medline]
15. Jamieson W.R., Burr L.H., Miyagishima R.T., et al. Structural deterioration in Carpentier-Edwards. Standard and supraannular porcine bioprostheses. Ann Thorac Surg 1995;60:S241-S247.
16. Pupello D.F., Bessone L.N., Hiro S.P., et al. Bioprosthetic valve longevity in the elderly. Ann Thorac Surg 1995;60:S270-S275.
17. Yun K.L., Miller D.C., Moore K.A., et al. Durability of the Hancock MO bioprosthesis compared with standard aortic valve bioprostheses. Ann Thorac Surg 1995;60:S221-S228.
18. Mazzucotelli J.P., Bertrand P.C., Loisance D.Y. The mitroflow pericardial valve. J Heart Valve Dis 1995;4:407-413.[Medline]
19. Aupart M., Neville P., Dreyfus X., et al. The Carpentier-Edwards pericardial aortic valve. Eur J Cardiothorac Surg 1994;8:277-280.[Abstract]
20. Grunkemeier G.L., Bodnar E. Comparative assessment of bioprosthesis durability in the aortic position. J Heart Valve Dis 1995;4:49-55.[Medline]

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