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Ann Thorac Surg 2001;71:S224-S227
© 2001 The Society of Thoracic Surgeons

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Valvular bioprostheses over 15 years

Carpentier–Edwards supraannular porcine bioprosthesis: second-generation prosthesis in aortic valve replacement

^a Division of Cardiovascular Surgery, Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada

Address reprint requests to Dr Jamieson, St. Paul’s Hospital, 331-332 Burrard Bldg, 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada
e-mail: wrej{at}interchange.ubc.ca

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

	Abstract

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
Background. The Carpentier–Edwards supraannular porcine bioprosthesis experience for more than 18 years has been evaluated by actuarial and actual analysis to determine the clinical performance in aortic valve replacement.

Methods. From 1981 to 1998, 1,823 patients (mean age 68.5 years, range 20 to 90 years) underwent 1,846 procedures. Previous coronary artery bypass was performed in 3.1% (56) and previous valve repair/replacement in 6.0% (110). Concomitant coronary artery bypass grafting was performed in 41.5% (756).

Results. The overall valve-related complication rate was 4.5%/patient-year (567 patients) with a fatality rate of 0.9%/patient-year (110 patients). The patient survival, at 15 years, was 33.0% ± 3.7% for the 61 to 70 years age group and 13.5% ± 2.4% for the older than 70 years group. At 15 years, the overall actual, cumulative freedom from reoperation was 83.2% ± 1.4%, valve-related mortality was 88.0% ± 1.2%, and valve-related residual morbidity was 92.0% ± 0.8%. The actual freedom from structural valve deterioration at 15 years was 84.2% ± 2.8% for the 61 to 70 years group and 97.1% ± 0.9% for the older than 70 years group.

Conclusions. The Carpentier–Edwards porcine bioprosthesis provides excellent freedom from structural valve deterioration, and overall freedom from valve-related morbidity, mortality, and reoperation for aortic valve replacement for up to 15 years. The prosthesis is recommended for patients older than 70 years and for patients 61 to 70 years, especially when extended survival is not anticipated.

	Introduction

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
The Carpentier–Edwards supraannular (CE-SAV) porcine bioprosthesis was introduced in 1982. This second-generation porcine bioprosthesis has the porcine tissue fixed with glutaraldehyde at 2 mm Hg and treated with polysorbate 80, an antimineralization surfactant. The most extensive worldwide experience with this bioprosthesis has been documented at the University of British Columbia [1–5].

This report extends the experience with the CE-SAV in aortic valve replacement more than 18 years. The documentation will facilitate future comparison with the other second-generation porcine and pericardial bioprostheses, namely, Medtronic Intact, Hancock II and St. Jude Medical Biocor, and Carpentier–Edwards Perimount and Sulzer Mitroflow, and the current third-generation Medtronic Mosaic porcine bioprosthesis.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
The CE-SAV was implanted in 1,823 patients (1,846 procedures) for aortic valve replacement from 1981 to 1998 at the affiliated teaching hospitals of the University of British Columbia, namely, St. Paul’s Hospital, Vancouver General Hospital, and Royal Columbian Hospital. The mean age of the patient population at implantation was 68.5 years (range 20 to 90 years). Of the total population 3.1% (56 patients) had previous coronary artery bypass (CAB) and 6.0% (110 patients) had previous valve repair or replacement. Concomitant CAB was performed in 41.5% (756 patients).

The patient population was evaluated as an overall patient cohort and by age group distribution: 40 years or younger, n = 58 (3.1%); 41 to 50 years, n = 78 (4.2%); 51 to 60 years, n = 251 (13.6%); 61 to 70 years, n = 493 (26.7%); and older than 70 years, n = 966 (52.3%).

The total cumulative follow-up was 12,639.8 patient-years, with a mean (± standard deviation) of 6.9 ± 4.5 years. The total follow-up was 97% complete during the 4-month closing interval in late 1999 and early 2000.

The guidelines for reporting morbidity and mortality after cardiac valvular operations [6] were used to define valve-related complications and served as a basis for our methodology. Multivariate proportional hazard regression analysis was used to assess risk factors (age, previous cardiac operations [excluding valves], previous valve procedures, valve size, concomitant CAB and cardiac rhythm at follow-up as independent predictors of major thromboembolism [TE], structural valve deterioration [SVD], and composites of valve-related complications [mortality, residual morbidity or reoperation]). The valve-related complications are structural valve deterioration, nonstructural dysfunction, thromboembolism, hemorrhage, and prosthetic valve endocarditis (PVE).

Patient survival was assessed by actuarial methodology, and structural valve deterioration by both actuarial and actual (cumulative incidence) methodology [7–10]. The Kaplan–Meier method was used to estimate actuarial freedom from SVD, whereas an analogue of the Kaplan–Meier method, cumulative incidence, was used to estimate actual risk probabilities.

	Results

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
Early mortality was 5.6% (104 of 1,846 procedures). The early mortality with concomitant procedures (primarily CAB) was 6.7% (51 of 761) and without concomitant procedures was 4.9% (53 of 1,085).

The linearized rate of valve-related complications was 4.5%/patient-year (567 patients), whereas the fatality rate was 0.9%/patient-year (110 patients). The valve-related reoperation rate was 1.2%/patient-year (154 patients), SVD reoperation rate was 0.8%/patient-year (104 patients), and nonstructural dysfunction was 0.25%/patient-year (31 patients). The rate for PVE was 0.38%/patient-year (48 patients), and structural valve deterioration was 1.11%/patient-year (140 patients). The rate for overall thromboembolism was 2.3%/patient-year (291 patients), major thromboembolism was 1.21%/patient-year (153 patients), and hemorrhage was 0.45%/patient-year (57 patients).

The predictors of performance are detailed in Table 1. The predictors of overall survival were age, concomitant CAB, and cardiac rhythm. The predictors of major thromboembolism were rhythm and previous valve replacement. The patients who were in atrial fibrillation or paced rhythm had a higher incidence of major TE (15.6% versus 9.6%). The patients who had no previous valve procedure had a higher incidence of major TE (10.4% versus 3.6%).

The predictors of valve-related mortality were age, concomitant CAB, follow-up cardiac rhythm, and valve size. However, the predictors of residual morbidity (permanent impairment from major TE, hemorrhage, and PVE) were age, rhythm, and previous cardiac nonvalvular procedures. The only predictor of reoperation was previous valve procedures; negative predictors were age and concomitant CAB.

Patient survival at 15 years is illustrated in Figure 1. Patients 40 years and younger and those 41 to 50 years survival only documented to 10 years. The survival rate for patients older than 70 years was 14.1% ± 2.4%, and for patients 61 to 70 years it was 32.9% ± 3.7%.

View larger version (21K): [in this window] [in a new window]   Fig 1. Patient survival at 15 years.

The freedom from structural valve deterioration at 15 years is demonstrated for both actuarial and actual calculations in Figures 2 and 3. The actual freedom for patients 61 to 70 years was 84.2% ± 2.8% and for those older than 70 years, 97.1% ± 0.9%. The freedoms by actuarial determination were 69.4% ± 6.0% and 91.8% ± 3.6%, respectively.

View larger version (20K): [in this window] [in a new window]   Fig 2. Freedom from structural valve deterioration by age groups at 15 years (actuarial).

View larger version (20K): [in this window] [in a new window]   Fig 3. Freedom from structural valve deterioration by age groups at 15 years (actual).

	Comment

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

Structural valve deterioration remains the major valve-related complication of bioprostheses. The purpose of this extended evaluation was to determine the clinical performance of the CE-SAV to 15 years. The previously documented experience from the University of British Columbia has revealed satisfactory performance in aortic valve replacement [1–5, 11, 12]. However, performance has been less than satisfactory with the mitral CE-SAV prosthesis [11, 12]. The first identified problem was stent dehiscence in the mitral prosthesis [2]. In 1986 and 1987 the reduction of aortic wall trimming for all mitral and aortic sizes resolved the failures [1–3]. The authors identified only one case of stent dehiscence with the CE-SAV aortic prosthesis. The identified cases were, otherwise, restricted to the mitral prosthesis. The principal author conducted an evaluation comparing the failure incidence and modes of the CE-SAV porcine and the CE-Perimount pericardial mitral bioprostheses, and the investigators reported a greater incidence of structural failure with the CE-SAV [13]. There is no indication that the CE-SAV and CE-P aortic prostheses perform differently, but no formal study has been conducted.

Similarly, no comparative study has been conducted for the second-generation Hancock II and CE-SAV prostheses. David and coauthors [14] reported favorable results with the Hancock II aortic and mitral prostheses at the 12-year interval.

Grunkemeier and colleagues [7], using porcine bioprostheses performance data from Stanford University and the University of British Columbia, identified that actual analysis (cumulative incidence) was a more realistic evaluative method than actuarial analysis for assessment of the structural valve deterioration. Several authors have used the actual concept since the reports by Grunkemeier and coinvestigators [8–10]. Jamieson and colleagues [4] reported on a combined series of Carpentier–Edwards standard and supraannular bioprostheses, and in 2,237 aortic replacements at 15 years actual freedom from SVD was 87% for patients 61 to 70 years and 96% for patients older than 70 years. The current study, evaluating the CE-SAV bioprosthesis also at 15 years, showed actual freedom from SVD was 85% for patients 61 to 70 years and 97% for patients older than 70 years.

The Carpentier–Edwards supraannular porcine bioprosthesis provides excellent freedom from structural valve deterioration and overall freedom from valve-related morbidity, mortality, and reoperation for aortic valve replacement to 15 years. The prosthesis is recommended for patients older than 70 years and for patients 61 to 70 years, especially when extended survival is not anticipated.

	Acknowledgments

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
The authors extend appreciation to research coordinators Christine Collinge, Florence Chan and Charmaine Henderson for participation in the longitudinal follow-up of the patient population and to Judy Maxwell for her assistance in the preparation of the manuscript.

	References

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 

1. Jamieson W.R.E., Burr L.H., Tyers G.F.O., et al. Carpentier–Edwards supra-annular porcine bioprosthesis: clinical performance to twelve years. Ann Thorac Surg 1995;60:S235-S240.
2. 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.
3. Jamieson W.R., 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.
4. Jamieson W.R.E., Burr L.H., Miyagishima R.T., Germann E., Anderson W.N. Actuarial versus actual freedom from structural valve deterioration with the Carpentier–Edwards porcine bioprostheses: evaluation over 15 years. Can J Cardiol 1999;9:973-978.
5. Jamieson W.R.E., Miyagishima R.T., Burr L.H., Lichtenstein S.V., Fradet G.T., Janusz M.T. Carpentier–Edwards porcine bioprostheses: clinical performance assessed by actual analysis. J Heart Valve Dis 2000;9:530-535.[Medline]
6. 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]
7. Grunkemeier G.L., Jamieson W.R.E., Miller D.C., Starr A. Actuarial versus actual risk of porcine structural valve deterioration. J Thorac Cardiovasc Surg 1994;108:709-718.[Abstract/Free Full Text]
8. Grunkemeier G.L., Anderson R.P., Miller D.C., Starr A. Time-related analysis of nonfatal heart valve complications: cumulative incidence (actual) versus Kaplan–Meier (actuarial). Circulation 1997;96(Suppl):II70-II74.
9. Mahoney C.B., Miller D.C., Khan S.S., Hill J.D., Cohn L.H. Twenty-year, three-institution evaluation of the Hancock modified orifice aortic valve durability. Comparison of actual and actuarial estimates. Circulation 1998;98(Suppl):II88-II93.
10. Grossi E.A., Galloway A.C., Zakow P.K., et al. Choice of mitral prosthesis in the elderly—an analysis of "actual" outcome. Circulation 1998;98(Suppl):II116-II119.
11. Jamieson W.R.E., Rosado L.J., Munro A.I., et al. Carpentier–Edwards standard porcine bioprosthesis: primary tissue failure (structural valve deterioration) by age groups. Ann Thorac Surg 1988;46:155-162.[Abstract/Free Full Text]
12. Jamieson W.R.E., Tyers G.F.O., Janusz M.T., et al. Age as a determinant for selection of porcine bioprostheses for cardiac valve replacement: experience with Carpentier–Edwards standard bioprosthesis. Can J Cardiol 1991;7:181-188.[Medline]
13. Jamieson W.R.E., Marchand M.A., Pelletier C.L., et al. Structural valve deterioration in mitral replacement surgery: comparison of Carpentier–Edwards supra-annular porcine and perimount pericardial bioprostheses. J Thorac Cardiovasc Surg 1999;118:297-304.[Abstract/Free Full Text]
14. David T.E., Armstrong S., Sun Z. The Hancock II bioprosthesis at twelve years. Ann Thorac Surg 1998;66:S95-S98.

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