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Ann Thorac Surg 2001;71:S228-S231
© 2001 The Society of Thoracic Surgeons

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Valvular bioprostheses over 15 years

Carpentier-Edwards supraannular porcine bioprosthesis in aortic position: 16-year experience

^a Department of Cardiovascular and Thoracic Surgery, University Hospital Center, Rennes, France
^b Department of Cardiology, University Hospital Center, Rennes, France

Address reprint requests to Dr Corbineau, Chirurgie Cardiovasculaire, CHR, Centre Cardio-Pneumologique, 2, rue Henri Le Guilloux, 35000 Rennes, France
e-mail: herve.corbineau{at}chu-rennes.fr

Presented at the VIII International Symposium on Cardiac Bioprostheses, Cancun, Mexico, Nov 3–5, 2000.

	Abstract

Top Abstract Introduction Patients and methods Results Comment References

 
Background. The aim of the study was to evaluate the long-term results of aortic valve replacement with the Carpentier-Edwards supraannular porcine bioprosthesis.

Methods. A total of 278 patients who underwent aortic valve replacement between January 1983 and December 1986 were reviewed. Mean age was 69.4 ± 11.0 years (range 24 to 90 years).

Results. The operative mortality was 8.6% (24 patients). The total follow-up was 2367.1 years (mean 9.3 ± 4.3 years, maximum 15.5). The late mortality rate was 6.8%/patient-year (162 patients) and the overall survival at 15 years was 26.5% ± 3.6%. Structural valve deterioration (SVD) occurred in 19 patients (linearized rate 0.8%/patient-year). The mean time to onset of deterioration was 10.9 ± 2.9 years. This time was independent of the age at the time of implantation. The freedom from SVD at 10, 12, and 15 years for patients aged less than 60 was respectively 87.6% ± 6.8%, 77.8% ± 8.9%, and 44.2% ± 12.9% (linearized rate 3.3%/patient-year). For patients aged 61 to 70 years, freedom from SVD was, respectively, 100%, 97.3% ± 2.1%, and 80.8% ± 8.3% (linearized rate 0.63% patient-year). For patients older than 70 years, it was respectively 99.1% ± 0.9%, 95.6% ± 2.6%, and 93.3% ± 3.3% (linearized rate 0.31%/patient-year). No significant difference was observed below the age of 60 years (50 vs 51 to 60 years) or in the older subgroups (61 to 70 years, vs >70 years).

Conclusions. The Carpentier-Edwards supraannular bioprosthesis in aortic position provides low rate of structural valve deterioration at 15 years in patients aged more than 60 years at the time of implantation. The mean time to onset of SVD is independent of the subject’s age at the time of implantation. After 60 years, the risk of deterioration is low and does not present any significant variation. The Carpentier-Edwards supraannular bioprosthesis can reliably be used for aortic valve replacement in patients over the age of 60 years because, beyond this age, SVD is observed much more rarely.

	Introduction

Top Abstract Introduction Patients and methods Results Comment References

 
The widespread use of bioprostheses for more than 20 years is essentially related to the need to decrease hemorrhagic and thromboembolic complications, events predominantly related to mechanical valve prostheses and anticoagulant treatment, and responsible for mortality and long-term specific morbidity.

The weak point of bioprostheses remains the risk of structural valve deterioration (SVD), which requires reoperation for new valve replacement. Young age and the mitral position remain the main risk factors for SVD. However, the age beyond which the choice of a bioprosthesis in the aortic position is justified has still not been perfectly defined.

The second-generation Carpentier-Edwards supraannular bioprosthesis (CE SAV; manufactured by Baxter Edwards AG, Horw, Switzerland for Baxter Healthcare Corporation, Irvine, CA), designed to achieve a better hemodynamic profile and reduction of the risk of SVD by means of a low-pressure fixation technique with anticalcium treatment, has been available since 1982. We report our experience based on 278 patients undergoing aortic valve replacement by Carpentier-Edwards supraannular bioprosthesis and operated on between January 1983 and December 1986.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment References

 
A retrospective study was conducted on this consecutive patient cohort undergoing aortic valve replacement with the exclusion of any other type of valve replacement. Associated procedures consisted of coronary revascularization in 15 patients (5.3%) and mitral commissurotomy in 2 patients (0.7%). For 3 patients (1.1%), this procedure corresponded to a repeat aortic valve replacement.

The study population consisted of 123 women (44%) and 155 men (56%), with a mean age of 69.4 ± 11.0 years (range 24 to 90 years). The distribution by age group was as follows: less than 50 years, 18 patients (6.5%); 51 to 60 years, 11 patients (4.0%); 61 to 70 years, 86 patients (30.9%); and more than 70 years, 163 patients (58.6%).

Long-term data for the 254 surviving patients were obtained retrospectively between February and April 1999 using a questionnaire sent to the cardiologist, general practitioner, and patient. Patients and doctors were contacted directly in the case of discordance of the replies. Long-term events were analyzed according to the recommendations of the "Guidelines for Reporting Mortality and Morbidity After Cardiac Valvular Operations" [1]. Structural valve deterioration was defined by the presence of valve incompetence or regurgitation on clinical examination, on echocardiography, or at reoperation. No autopsies were performed.

Of the patients, 99.3% were reviewed (2 patients were lost to follow-up). The total follow-up was 2367.1 patient-years and the mean follow-up was 9.3 ± 4.3 years (range 0.2 to 15.5 years, median 10.2 years), with a mean of 12.8 ± 2.8 years (median 13.3 years) for the subgroup of patients alive at the time of the survey.

Statistical analysis
Specific data of the patients in this study were selected on a PC and analyzed with Statistical Package for Social Sciences software for PC (SPSS, Chicago, IL). Time-related events were analyzed by the Kaplan-Meier method. Percentages of freedom from event are presented with standard error of the mean and confidence intervals. Comparisons between curves were performed by the log-rank test. For the specific group of patients who experienced SVD, comparison of the time to onset of SVD in the various age groups was performed by analysis of variance and a nonparametric (Kruskal-Wallis) test. The follow-up times for the various age-groups were compared according to the same protocol.

	Results

Top Abstract Introduction Patients and methods Results Comment References

 
The operative mortality was 8.6% (24 patients), with 1 death related to the valve (ischemic cerebrovascular accident). The late mortality rate was 6.8% patient-years (162 patients), with a valve-related mortality rate of 0.8% patient-years (20 patients). The 10-, 12-, and 15-year survival rates were 49.4% ± 3.0%, 37.2% ± 3.0%, and 26.5% ± 3.6%, respectively. Survival by age-group is presented in Figure 1. In all, 92 patients (36.2% of operative survivors) were alive at the time of the survey (42.9% of patients in the age group 61 to 70 years, and 24.3% of patients more than 70 years of age). A total of 66 patients (72%) were classified as New York Heart Association functional class I or II.

View larger version (19K): [in this window] [in a new window]   Fig 1. Survival analysis by age group (operative mortality included).

View larger version (17K): [in this window] [in a new window]   Fig 2. Freedom from structural valve deterioration by age-group.

A thromboembolic event occurred in 17 patients. The 10-, 12-, and 15-year actuarial freedom from thromboembolic event rates were 93.5% ± 1.8%, 91.8% ± 2.1%, and 82.3% ± 6.7%, respectively. Of these 17 patients, 12 died as a result of this complication.

A hemorrhagic complication occurred in 5 patients. The 10-, 12-, and 15-year actuarial freedom from hemorrhagic complication rates were 98.4% ± 0.8%, 97.6% ± 1.2%, and 97.6% ± 1.2%, respectively. Three of these patients died as a result of this complication, all from hemorrhagic cerebrovascular accident.

Seven patients developed endocarditis, which was successfully treated medically in 5 cases and by reoperation in 1 case. The last patient died before the scheduled reoperation. The 10-, 12-, and 15-year actuarial freedom from endocarditis rates were 96.8% ± 1.3%, 96.8% ± 1.3%, and 95.6% ± 1.7%, respectively.

Hemodynamic performances
Among the long-term survivors who did not undergo reoperation, echocardiographic data obtained during the previous 3 months were available at the time of the survey for 44 patients (60.3%). The mean pressure gradient was 15.7 ± 1.2 mm Hg for all bioprostheses, and 17.3 ± 6.6, 14.5 ± 7.6, and 15.1 ± 6.7 mm Hg for size 21, 23, and 25 bioprostheses, respectively. A periprosthetic leak of grade 2 or less without hemolysis was detected in 4 patients.

	Comment

Top Abstract Introduction Patients and methods Results Comment References

 
The age at which the use of a bioprosthesis for aortic valve replacement becomes legitimate is still highly controversial. The main obstacle remains the risk of structural valve deterioration, which is a serious complication requiring reoperation. Two types of modifications have been added to second-generation bioprostheses to decrease this risk: (1) reduction of the glutaraldehyde fixation pressure to preserve the structure of collagen fibers, and (2) addition of an antimineralization treatment to decrease the incidence of calcifications. The second-generation Carpentier-Edwards supraannular bioprosthesis includes these two modifications. It now has a follow-up of more than 15 years, allowing Jamieson and colleagues [2] to conclude that the incidence of SVD has not decreased significantly since the introduction of these technological modifications. More specifically, recent series have reported the long-term results by age group for various models of porcine bioprostheses [3–7] and for the Carpentier-Edwards Perimount pericardial bioprosthesis [8, 9]. These results confirm the legitimacy of using porcine or pericardial bioprostheses in patients over the age of 70 years, and their more limited value before the age of 60 years because of a high risk of SVD. However, the value of bioprostheses in the patients aged 61 to 70 years still remains unclear. Jamieson and colleagues [10] reported identical results at 12 years in the age groups 61 to 70 years and more than 70 years, with actuarial freedom from SVD rates of 93% and 95%, respectively. In a recent publication reporting the 15-year results after AVR by CE SAV or CE standard [6], the freedom from valve-related reoperation rates for the age groups 61 to 70 years and more than 70 years were 88% and 96%, respectively, by the real method, and 86% and 79% by the actuarial method. As the real 15-year rate of freedom from valve-related death was similar in these two groups (87% and 85%, respectively), the authors agreed on the possibility of using porcine bioprostheses in patients over the age of 60 years. The first 15-year results of the SJM Biocor porcine bioprosthesis [7] also show a lower alteration rate after the age of 70 years. This series reported a small number of structural valve deterioration, but this figure could be underestimated because of a mean follow-up of 5 years. Legarra and associates, studying the long-term results of the Hancock II bioprosthesis [3], reported a significantly higher incidence of SVD before the age of 65 years and recommended that aortic valve replacement with bioprosthesis be reserved for subjects over the age of 65. Cohn and associates [4] recommended an age more than 70 years for reliable use of the same bioprosthesis in the aortic position. However, this series included patients aged 50 to 69 years in the same subgroup.

To define more clearly the influence of age on the risk of SVD, we preferred to analyze separately the time to onset of SVD and the incidence of SVD according to age at the time of implantation. Actuarial or real analysis is unable to make this distinction. We found that young age is not a risk factor for early SVD, but has a marked influence on the incidence of SVD. Analysis of this series shows that the risk of SVD is markedly decreased after the age of 60 years, and no significant difference was observed between the age groups 61 to 70 years and more than 70 years, for a similar mean or median follow-up in these two groups. This long follow-up therefore justifies a new interpretation of the risk of SVD. The absence of difference in terms of the mean follow-up in these two age groups no longer supports the conclusion that after the age of 70 years, death "avoids" the development of possible SVD. In this series, patients over the age of 70 years presented a risk of SVD of 6% (9/147), and SVD occurred after a mean interval of 11 years.

Several articles, however, have reported differences of long-term freedom from SVD rates between the age groups 61 to 70 years and more than 70 years [4, 7], but we did not confirm these results. A possible explanation is the particularly long mean follow-up in this series (9.3 years). The mean interval between implantation and explantation, when specified, was similar in the various series and of the order of 10 years [3, 8]. The incidence of SVD is then directly related to the mean follow-up and can be underestimated in the case of a short follow-up. A series by Frater and colleagues [8], reporting the 15-year results of the Perimount pericardial bioprosthesis, is particularly interesting in this context. This study, which has a similar sample size and mean follow-up, reports results that are also similar to those of our series, as 21 patients were reoperated for structural valve deterioration (0.9% patient-years) after a mean period of 9.7 ± 2.0 years. The 14-year actuarial freedom from reoperation for valve dysfunction was 85% versus 82.5% ± 4.7% in our series. Frater and colleagues noted that age less than 65 years was associated with a higher risk of reoperation for explantation.

As a result of our long mean follow-up, we can finally conclude that the risk of SVD is low for patients whose age at implantation is more than 60 years (9 of 225, or 4.0% in this series). In addition, this risk of SVD no longer presents any significant variations after the age of 60 years. Age less than 60 still remains the main risk factor for SVD for the CE SAV bioprosthesis in the aortic position, but for the subgroup of patients who developed SVD, the mean interval between implantation and SVD was similar for all age groups considered. This bioprosthesis can be reliably used for aortic valve replacement in patients over the age of 60 years because SVD is observed much more rarely beyond this age.

	References

Top Abstract Introduction Patients and methods Results Comment References

 

1. Edmunds L.H., Jr, Clark R.E., Cohn L.H., Grunkemeier G.L., Miller D.C., Weisel R.D. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ann Thorac Surg 1996;62:932-935.[Abstract/Free Full Text]
2. Jamieson W.R.E., Burr L.H., Janusz M.T., et al. Carpentier-Edwards standard, and supraannular porcine bioprostheses: comparison of technology. Ann Thorac Surg 1999;67:10-17.[Abstract/Free Full Text]
3. Legarra J.J., Llorens R., Catalan M., et al. Eighteen-year follow up after Hancock II bioprosthesis insertion. J Heart Valve Dis 1999;8:16-24.[Medline]
4. Cohn L.H., Collins J.J., Jr, Rizzo R.J., Adams D.H., Couper G.S., Aranki S.F. Twenty-year follow-up of the Hancock modified orifice porcine aortic valve. Ann Thorac Surg 1998;66:S30-S34.
5. Jamieson W.R.E., Burr L.H., Munro A.I., Miyagishima R.T. Carpentier-Edwards standard porcine bioprosthesis: a 21-year experience. Ann Thorac Surg 1998;66:S40-S43.
6. Jamieson W.R.E., Miyagishima R.T., Burr L.H., Lichtenstein S.V., Fradet G.J., Janusz M.T. Carpentier-Edwards porcine bioprostheses: clinical performance assessed by actual analysis. J Heart Valve Dis 2000;9:530-535.[Medline]
7. Myken P., Bech-Hanssen O., Phipps B., Caidahl K. Fifteen years follow up with the St. Jude Medical Biocor porcine bioprosthesis. J Heart Valve Dis 2000;9:415-422.[Medline]
8. Frater R.W., Furlong P., Cosgrove D.M., et al. Long-term durability, and patient functional status of the Carpentier-Edwards. Perimount pericardial bioprosthesis in the aortic position. J Heart Valve Dis 1998;7:48-53.[Medline]
9. Poirer N.C., Pelletier L.C., Pellerin M., Carrier M. 15-year experience with the Carpentier-Edwards pericardial bioprosthesis. Ann Thorac Surg 1998;66:S57-S61.
10. Jamieson W.R.E., Ling H., Burr L.H., et al. Carpentier-Edwards supraannular porcine bioprosthesis evaluation over 15 years. Ann Thorac Surg 1998;66:S49-S52.

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