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Asian Cardiovasc Thorac Ann 2006;14:200-205
© 2006 Asia Publishing EXchange Ltd

ORIGINAL CONTRIBUTIONS

15-Year Comparison of Supra-Annular Porcine and PERIMOUNT Aortic Bioprostheses

WR Eric Jamieson, MD, Eva Germann, MSc, Michel R Aupart, MD1, Paul H Neville, MD1, Michel A Marchand, MD1, Guy J Fradet, MD

Division of Cardiovascular Surgery, Department of Surgery, University of British Columbia Vancouver, Canada
1 Cardiac Surgery Service, Hopital Trousseau, Francois-Rabelais University Tours, France

For reprint information contact: WR Eric Jamieson, MD Tel: 1 604 806 8383 Fax: 1 604 806 8384 Email: wrej{at}interchange.ubc.ca, 486 Burrard Building, St. Paul’s Hospital, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada.


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
The second-generation Carpentier-Edwards bioprostheses, the supra-annular porcine valve and the PERIMOUNT pericardial valve, have been evaluated longitudinally for several years. This study compared clinical performance over 15 years. Aortic valve replacement was performed with a supra-annular porcine valve in 1,823 patients (group 1) aged 19–89 years (mean, 68.9 ± 10.9 years) and with a PERIMOUNT pericardial bioprosthesis in 1,430 patients (group 2) aged 16–90 years (mean, 69.5 ± 10.4 years). The groups were similar except for concomitant coronary artery bypass in 43% of group 1 and 18% of group 2 ( p < 0.001). Overall survival at 15 years was 29.3% ± 1.5% for group 1 and 35.2% ± 3.1% for group 2 ( p = 0.0009). The actual freedom from valve-related mortality was 88.5% ± 0.9% for group 1 and 84.9% ± 1.7% for group 2. The actual freedom from structural valve deterioration at 15 years was similar overall, and for patients aged > 60 years, between the groups, but was dissimilar (group 2 > group 1) for age ≤ 60 years. The predictors of structural valve deterioration were valve type (group 1 > group 2), sex (male > female), age, and concomitant coronary artery bypass. Both bioprostheses provided satisfactory clinical performance at 15 years after aortic valve replacement.


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
The Carpentier-Edwards supra-annular porcine valve (CE-SAV) and the Carpentier-Edwards PERIMOUNT (CE-P) pericardial bioprosthesis (Edwards Lifesciences, Irvine, CA, USA) have been evaluated longitudinally for several years.1–8 Implantation of the CE-SAV at the University of British Columbia commenced in 1981, and implantation of the CE-P at Francois-Rabelais University started in 1984. The major publications on these two prostheses have come from these two centers.2,3,7,8 Clinical performance has been excellent with both prostheses in the aortic position, but there has been no formal comparison of the two valves. They are both formulated with an Elgiloy wire stent. The CE-SAV is a non-composite porcine valve preserved with glutaraldehyde at less than 2 mm Hg pressure. The CE-P has 3 individual computer-generated leaflets preserved with glutaraldehyde by zero-pressure fixation. The CE-SAV is a supra-annular bioprosthesis with no intra-annular component, designed to improve hemodynamics over the first generation intra-annular bioprostheses. The CE-P has a supra-annular sewing ring and an intra-annular component. The purpose of this study was to compare the clinical performance of these bioprostheses over 15 years, specifically with regard to long-term durability and freedom from valve-related composites of complications, mortality, and re-operation.


   PATIENTS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
The CE-SAV was implanted in 1,825 patients between 1981 and 1999 in Vancouver, Canada. The CE-P was implanted in 1,430 patients between 1984 and 2001 in Tours, France. The mean age at implantation was 68.9 ± 10.9 years (range, 19–89 years) in the CE-SAV group, and 69.5 ± 10.4 years (range, 16–90 years) in the CE-P group ( p = 0.083). The total follow-up was 14,392.3 patient-years for the CE-SAV group and 7,722.8 patient-years for the CE-P group; mean follow-up durations were 7.89 ± 4.86 years and 5.4 ± 3.96 years, respectively ( p < 0.001). The patient profiles in each group are detailed in Table 1Go. The groups differed significantly in the number of patients who had previous coronary artery bypass (CAB) and the number who had concomitant CAB. The end-points compared were: structural valve deterioration (SVD), valve-related mortality, and valve-related re-operation. The "Guidelines for Reporting Morbidity and Mortality after Cardiac Valvular Operations" were used to define the complications.9


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  		Table 1. Profile of Patients Undergoing Aortic Valve Replacement with Each Bioprosthesis
 
Actuarial analysis was performed by the Kaplan-Meier method and is presented with standard error of the estimate. Actuarial freedoms were compared using the log-rank statistical test where p-values less than 0.05 were considered significant. The actual/cumulative incidence analysis promoted by Grunkemeier was used to assess the clinical performance of the two bioprostheses.10–12 It should be noted that actual freedoms were not compared statistically. The likelihood ratio test was used to compare linearized rates with p-values < 0.05 considered significant. Multivariate proportional hazard regression analysis was used to assess risk factors: age (continuous and age categories ≥ 65 and < 65 years), sex, valve type, valve size, previous valve surgery, previous CAB, and concomitant CAB, as independent predictors of SVD, valve-related mortality, and valve-related re-operation. The composites of valve-related complications are inclusive of SVD, non-structural dysfunction, thromboembolism, hemorrhage, and prosthetic valve endocarditis.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Early mortality was 5.0% (91 patients) in the CE-SAV group and 2.8% (40 patients) in the CE-P group ( p < 0.001). At the latest follow-up, 51.2% (933 patients) in the CE-SAV group and 25.7% (368 patients) in the CE-P group had died ( p < 0.001). The late mortality rate was 6.48% per patient-year in the CE-SAV group and 4.76% per patient year in the CE-P group. Survival at 15 years was 29.3% ± 1.5% in the CE-SAV group and 35.2% ± 3.1% in the CE-P group ( p = 0.0009). Survival in the subgroup of patients < 65 years was 51.0% ± 2.9% for the CE-SAV valve vs. 61.2% ± 4.7% for the CE-P valve ( p = 0.0165). For those ≥ 65 years, it was 19.6% ± 1.6% for CE-SAV vs. 17.6% ± 4.2% for CE-P ( p = 0.0104). For the subgroup of patients aged 61–65 years, survival was 39.6% ± 5.3% with the CE-SAV valve vs. 58.8% ± 6.8% with the CE-P valve ( p = 0.0337). Survival was not different in the 66–70-year-old subgroup (30.3% ± 3.1% with the CE-SAV valve vs. 25.9% ± 12.0% with the CE-P valve).

The predictors of SVD are detailed in Table 2Go. Significant predictors of SVD overall by multivariate analysis were valve type, age (continuous or categorical), sex, and concomitant CAB. A previous valve procedure was predictive when age subgroups (≤65 and > 65 years) were assessed, but not when age was evaluated as a continuous variable for both male and female sex. Valve type and concomitant CAB were only predictive of SVD in males. Only age was predictive of SVD with the CE-P, whereas age, sex, and concomitant CAB were predictive of SVD with the CE-SAV.


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  		Table 2. Predictors of Structural Valve Deterioration
 
The linearized occurrence rate of valve-related re-operation was 1.09% per patient-year for CE-SAV vs. 0.63% per patient-year for CE-P ( p = 0.0005). The predictors of valve-related re-operation (age, sex, previous valve surgery, and concomitant CAB) are detailed in Table 3Go. The linearized rate of valve-related mortality was similar for both types of prosthesis: 1.14% per patient-year for CE-SAV vs. 1.28% per patient-year for CE-P ( p = 0.3572). Age subgroup (≤ 65 years vs. > 65 years) was predictive with a hazard ratio of 4.7 ( p < 0.001).


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  		Table 3. Predictors of Valve-related Re-operation
 
The actuarial freedom from SVD for these prostheses is shown in Figures 1Go and 2Go. For the most common age subgroup (> 70 years), actuarial freedom from SVD at 15 years was 94.5% ± 2.3% for the CE-SAV and 99.4% ± 0.6% for the CE-P. The actual freedom from SVD is shown in Table 4Go, Figures 3Go and 4Go. For the age subgroup 61–65 years, the actual freedom from SVD at 15 years was 92.3% ± 2.8% for the CE-SAV and 86.6% ± 4.5% for the CE-P. For the age subgroup 66–70 years, the actual freedom from SVD at 15 years was reversed: 93.1% ± 1.8% for the CE-SAV and 99.1% ± 0.9% for the CE-P.


Figure 1
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  		Figure 1. Freedom from structural valve deterioration (actuarial) for the Carpentier-Edwards supra-annular valve.

 

Figure 2
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  		Figure 2. Freedom from structural valve deterioration (actuarial) for the Carpentier-Edwards PERIMOUNT valve.

 

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  		Table 4. Freedom from Structural Valve Deterioration (actual at 15 years)
 

Figure 3
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  		Figure 3. Freedom from structural valve deterioration (actual) for Carpentier-Edwards supra-annular valve.

 

Figure 4
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  		Figure 4. Freedom from structural valve deterioration (actual) for Carpentier-Edwards PERIMOUNT valve.

 
The actuarial and actual freedom from valve-related re-operation is presented in Figures 5Go and 6Go. The actuarial freedom at 15 years was 73.7% ± 2.3% for the CE-SAV and 81.9% ± 3.8% for the CE-P (not significantly different). The actual freedom from valve-related re-operation at 15 years was 87.8% ± 1.0% for the CE-SAV and 90.2% ± 1.7% for the CE-P. The actuarial and actual freedom from valve-related mortality is illustrated in Figures 7Go and 8Go. The overall actuarial freedom at 15 years was 82.0% ± 1.6% for CE-SAV and 79.3% ± 2.8% for CE-P (not significantly different). The actual freedom from valve-related mortality at 15 years was 88.5% ± 0.9% for CE-SAV and 84.9% ± 1.7% for CE-P.


Figure 5
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  		Figure 5. Overall freedom from valve-related re-operation (actuarial). CE-P = Carpentier-Edwards PERIMOUNT, CE-SAV = Carpentier-Edwards supra-annular valve.

 

Figure 6
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  		Figure 6. Overall freedom from valve-related re-operation (actual). CE-P = Carpentier-Edwards PERIMOUNT, CE-SAV = Carpentier-Edwards supra-annular valve.

 

Figure 7
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  		Figure 7. Overall freedom from valve-related mortality (actuarial). CE-P = Carpentier-Edwards PERIMOUNT, CE-SAV = Carpentier-Edwards supra-annular valve.

 

Figure 8
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  		Figure 8. Overall freedom from valve-related re-operation (actual). CE-P = Carpentier-Edwards PERIMOUNT, CE-SAV = Carpentier-Edwards supra-annular valve.

 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
The CE-SAV and CE-P bioprostheses are the most long-standing of the current second and third generations. Both were introduced in the early 1980s with advanced tissue preservation and calcium mitigation therapy to reduce the incidence of SVD. The use of a bioprosthesis for aortic valve replacement has been extended worldwide in the past 5 years, predominantly with stented bioprostheses. The trend away from mechanical valves was based on the anticipation of enhanced durability and optimization of hemodynamics with modern bioprostheses. This trend has also been fostered by the fact that advanced age protects against structural valve deterioration, in parallel with the advancing age of the population with degenerative aortic valve disease.11

Early and late mortality and overall survival differentiate the populations in this study and favor the CE-P over the CE-SAV. This is related to the preponderance of concomitant CAB in the CE-SAV population. These second-generation bioprostheses have been evaluated periodically since their initial use in the two centers.2,3,7,8 This comparative study revealed that the actual freedom from SVD did not differentiate the populations; but in the age groups ≤ 60 years, the CE-P was superior to the CE-SAV. Valve type was predictive of SVD but did not contribute to valve-related re-operation or mortality. The type and mode of presentation of SVD differed between the two prostheses. The predominant mode of failure of the CE-P was calcified stenosis, presenting with a mean gradient > 40 mm Hg or insufficiency grade III or IV with or without symptoms. The presentation of CE-SAV failure was predominantly deterioration of functional class with symptomatic insufficiency, with or without echocardiographic documentation of calcification accompanying leaflet tears, or stenotic dystrophic calcification.8 The mode of failure of the CE-SAV was 25% calcified stenosis and 75% insufficiency with or without calcification. Structural failure of the CE-P was confirmed at re-operation in 92% of cases, whereas only 83% of CE-SAV failures were confirmed at re-operation. The different modes of failure of these prostheses and their presentation and diagnostic criteria at the two evaluating centers may be important in the comparative analysis.

The most recent report evaluated CE-SAV performance to 18 years.8 The actual freedom from SVD was 98% (actuarial, 95%) for patients > 70 years of age and 91% (actuarial, 78%) for patients aged 61–70 years. The diagnosis of SVD was made at re-operation, autopsy, or echocardiographically in patients with reducing functional class. The CE-P has been extensively implanted.1–11 Frater and colleagues1 reported the regulatory trial of 267 patients in 1998 and found actuarial freedom from SVD re-operation at 14 years of 76% for patients ≤ 65 years and 96% for patients > 65 years. Banbury and colleagues4 reported on the same patient cohort in 2001, identifying an overall freedom from explant for SVD at 15 years of 77%. They reported < 10% chance of explant for SVD by 15 years, considering actual freedom from SVD, for patients ≥ 65 years. The freedom from SVD of the CE-P was reported by Aupart and colleagues2,3 as 96% and 94% at 10 and 12 years, respectively. Dellgren and colleagues5 found an overall actuarial freedom from SVD at 12 years of 86%. In 1998, Poirier and colleagues6 determined 93% and 80% actuarial freedom from SVD at 10 and 14 years, respectively, for aortic valve replacement. The currently marketed second and third generations of aortic bioprosthesis have been used for shorter durations.13–17

The main aim of this study was to compare the durability of the CE-SAV and CE-P. However, the groups differed in the proportion undergoing concomitant CAB which influences survival. Concomitant CAB likely decreased the incidence of SVD in the CE-SAV group because of the reduced survival. The groups also differed in the sizes of prostheses implanted, a small size of CE-P was used more often on the assumption that it provided superior hemodynamic performance, which was subsequently shown not to differ from the CE-SAV bioprosthesis.18 A further limitation of this study was the shorter mean follow-up in the CE-P group because of its later commencement of use. Nevertheless, it was concluded that both bioprostheses have excellent and comparable durability at 15 years. Although the modes of presentation of valve failure differ, both require long-term echocardiographic surveillance. This may be more important for the CE-P because of its predominant mode of failure. Both bioprostheses provide excellent clinical performance for aortic valve replacement, especially in patients over 60 years of age.

Presented at the Biennial Meeting of the Society for Heart Valve Disease, Paris, France, June 29–July 1, 2003.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 

  1. Frater RW, Furlong P, Cosgrove DM, Okies JE, Colburn LQ, Katz AS, 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]

  2. Aupart MR, Sirinelli AL, Diemont FF, Meurisse YA, Dreyfus XB, Marchand MA. The last generation of pericardial valves in the aortic position: ten-year follow-up in 589 patients. Ann Thorac Surg 1996;61:615–20.[Abstract/Free Full Text]

  3. Neville PH, Aupart MR, Diemont FF, Sirinelli AL, Lemoine EM, Marchand MA. Carpentier-Edwards pericardial bioprosthesis in aortic or mitral position: a 12-year experience. Ann Thorac Surg 1998;66(6 Suppl):S143–7.[Medline]

  4. Banbury MK, Cosgrove DM 3rd, White JA, Blackstone EH, Frater RW, Okies JE. Age and valve size effect on the long-term durability of the Carpentier-Edwards aortic pericardial bioprosthesis. Ann Thorac Surg 2001;72:753–7.[Abstract/Free Full Text]

  5. Dellgren G, David TE, Raanani E, Armstrong S, Ivanov J, Rakowski H. Late hemodynamic and clinical outcomes of aortic valve replacement with the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis. J Thorac Cardiovasc Surg 2002;124:146–54.[Abstract/Free Full Text]

  6. Poirier NC, Pelletier LC, Pellerin M, Carrier M. 15-year experience with the Carpentier-Edwards pericardial bioprosthesis. Ann Thorac Surg 1998;66(6 Suppl):S57–61.[Medline]

  7. Jamieson WR, Janusz MT, Burr LH, Ling H, Miyagishima RT, Germann E. Carpentier-Edwards supra-annular porcine bioprosthesis: second-generation prosthesis in aortic valve replacement. Ann Thorac Surg 2001;71(5 Suppl):S224–7.[Abstract/Free Full Text]

  8. Jamieson WR, Burr LH, Miyagishima RT, Germann E, MacNab JS, Stanford E, et al. Carpentier-Edwards supra-annular aortic porcine bioprosthesis: clinical performance over 20 years. J Thorac Cardiovasc Surg 2005;130:994–1000.[Abstract/Free Full Text]

  9. Edmunds LH Jr, Clark RE, Cohn LH, Grunkemeier GL, Miller DC, Weisel RD. Guidelines for reporting morbidity and mortality after cardiac valvular operations. The American Association for Thoracic Surgery, Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity. Ann Thorac Surg 1996;62:932–5.[Abstract/Free Full Text]

  10. Grunkemeier GL, Jamieson WR, Miller DC, Starr A. Actuarial versus actual risk of porcine structural valve deterioration. J Thorac Cardiovasc Surg 1994;108:709–18.[Abstract/Free Full Text]

  11. Jamieson WR, Burr LH, Miyagishima RT, Germann E, Anderson WN. Actuarial versus actual freedom from structural valve deterioration with the Carpentier-Edwards porcine bioprostheses. Can J Cardiol 1999;15:973–8.[Medline]

  12. Jamieson WR, Miyagishima RT, Burr LH, Lichtenstein SV, Fradet GJ, Janusz MT. Carpentier-Edwards porcine bioprostheses: clinical performance assessed by actual analysis. J Heart Valve Dis 2000;9:530–5.[Medline]

  13. David TE, Ivanov J, Armstrong S, Feindel CM, Cohen G. Late results of heart valve replacement with the Hancock II bioprosthesis. J Thorac Cardiovasc Surg 2001;121:268–77.

  14. Rizzoli G, Bottio T, Thiene G, Toscano G, Casarotto D. Long-term durability of the Hancock II porcine bioprosthesis. J Thorac Cardiovasc Surg 2003;126:66–74.[Abstract/Free Full Text]

  15. Jamieson WR, Fradet GJ, MacNab JS, Burr LH, Stanford EA, Janusz MT, et al. Medtronic mosaic porcine bioprosthesis: investigational center experience to six years. J Heart Valve Dis 2005;14:54–63.[Medline]

  16. 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;9:415–22.[Medline]

  17. Jamieson WR, David TE, Feindel CM, Miyagishima RT, Germann E. Performance of the Carpentier-Edwards SAV and Hancock-II porcine bioprostheses in aortic valve replacement. J Heart Valve Dis 2002;11:424–30.[Medline]

  18. Jamieson WR, Janusz MT, MacNab J, Henderson C. Hemodynamic comparison of second- and third-generation stented bioprostheses in aortic valve replacement. Ann Thorac Surg 2001;71(5 Suppl):S282–4.[Abstract/Free Full Text]




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