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Ann Thorac Surg 2001;72:753-757
© 2001 The Society of Thoracic Surgeons

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Original article: cardiovascular

Age and valve size effect on the long-term durability of the Carpentier-Edwards aortic pericardial bioprosthesis

^a Departments of Thoracic and Cardiovascular Surgery and Biostatistics and Epidemiology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
^b Department of Thoracic and Cardiovascular Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York, USA
^c Department of Thoracic and Cardiovascular Surgery, Good Samaritan Hospital, Portland, Oregon, USA

Accepted for publication June 11, 2001.

Address reprint requests to Dr Banbury, The Cleveland Clinic Foundation, 9500 Euclid Ave, Desk F25, Cleveland, OH 44195
e-mail: banburm{at}ccf.org

	Abstract

Top Footnotes Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Background. Bioprosthesis durability decreases with time and younger age. However, the time-scale and determinants of durability of the aortic Carpentier-Edwards stented bovine pericardial prosthesis are incompletely characterized.

Methods. Between September 1981 and January 1984, 267 patients underwent implantation of the pericardial aortic prosthesis at four centers. Mean age at implant was 65 ± 12 years (range 21 to 86 years). Follow-up averaged 12 ± 4.5 years. The primary end point was explant for structural valve dysfunction (SVD), which was analyzed multivariably in the context of death as a competing risk.

Results. Freedom from explant due to SVD was 99%, 94%, and 77% at 5, 10, and 15 years. Risk of SVD increased exponentially with time and younger age (p = 0.0001) at implantation; an increased risk of small valve size was not reliably demonstrated (p = 0.1). Considering the competing risk of death, patients aged 65 years or older had a less than 10% chance of explant for SVD by 15 years.

Conclusions. Durability of this stented pericardial aortic bioprosthesis is excellent and justifies its use in patients aged 65 or older.

	Introduction

Top Footnotes Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Clinical investigation of the Carpentier-Edwards stented bovine pericardial bioprosthesis (Edwards Lifesciences LLC, Irvine, CA) began in 1981. This device became available for commercial distribution in the United States in 1991. Results concerning its durability up to 14 years postimplant have been reported previously [1–3]. An additional 3 years of follow-up information permits study with considerable reliability of the rate of structural valve dysfunction (SVD) and its determinants. Recognizing the confounding of this event by the competing risk of death, the focus of this study was to estimate both age-specific durability of the prosthesis itself and the anticipated probability of patients living to experience explantation.

	Material and methods

Top Footnotes Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Patients
Between September 1981 and January 1984, 267 patients from four investigational centers were implanted with an aortic Carpentier-Edwards stented bovine pericardial prosthesis. This was part of a larger premarketing clinical investigation for the US Food and Drug Administration. Mean age at implant was 65 ± 12 years (range 21 to 86 years). Of these, 64% were men. Preoperatively, 45 (17%) of the patients were in New York Heart Association (NYHA) functional class IV, 115 (43%) in class III, 93 (35%) in class II, and 10 (4%) in class I (4 were not classified). Eight (3%) had had a previous aortic valve replacement. Coronary artery disease (n = 133, 50%), congestive heart failure (n = 58, 22%), and previous myocardial infarction (n = 45, 18%) were the most common preexisting conditions. The most frequent indication for valve replacement was pure aortic stenosis in 174 patients (65%), pure aortic regurgitation in 46 (17%), and mixed stenosis and regurgitation in 39 (15%).

Surgical technique
Aortic valve replacement was performed using standard techniques. Concomitant procedures, performed in 123 patients, included coronary artery bypass grafting (CABG) in 108, and ascending aortic grafting in 7. The size of the prosthesis implanted was 19 mm in 34 patients (13%), 21 mm in 83 patients (31%), 23 mm in 85 patients (32%), 25 mm in 48 patiets (18%), 27 mm in 12 patients (4.5%), and 29 mm in 5 patients (1.9%).

Follow-up
Patient status in this cohort of patients was assessed by study design on an annual basis, typically during an office or hospital visit, or by means of detailed patient questionnaires completed over the telephone or by mail. All valve-related complications were identified according to the guidelines for reporting morbidity and mortality after cardiac valve operations [4].

Two patients were lost to follow-up within the first year, 5 were lost after 1 to 5 years, and 10 were lost after 5 to 10 years of follow-up. Mean follow-up among the survivors was 12 ± 4.5 years, with a maximum of 17 years. Of the 267 patients, 16% were alive out to 15 years and 6% to 16 years. We considered the information to be reliable to at least 15 years, and have used this number for all depictions. A total of 2,342 patient-years of data were available for analysis.

End points
The primary end point for this study was valve explant for SVD. Because death often occurs before recognition of SVD and reoperation, we simultaneously considered death before explant from all causes as a competing risk. Information after explant was not considered because patients were no longer at risk of SVD for their prosthesis.

Data analysis
Descriptive
Descriptive statistics were summarized as the mean and standard deviation for continuous variables and as frequencies and percentages for categorical variables. Nonparametric estimates of events were obtained by the method of Kaplan and Meier. A parametric method was used to resolve the number of phases of instantaneous risk (hazard function) and to estimate their shaping parameters [5].

Multivariable analysis
Initial screening of variables included simple contingency tests, t tests, and univariable Cox proportional hazard models. Variables available for multivariable analysis included age, sex, previous valve procedure, NYHA functional class, indication (stenosis, regurgitation, mixed lesion), labeled size of prosthesis, concomitant CABG and ascending aortic aneurysm repair, and date of procedure. Continuous and ordinal variables were assessed univariably by decile risk analysis to suggest transformation of scale for incorporation into the multivariable analysis to ensure that the relation of these variables to outcome were well calibrated with respect to model assumptions.

Multivariable analysis was performed simultaneously in each of the hazard phases using a guided technique of entry of variables into the multivariable models [6]. Variables were retained in multivariable models if p was less than 0.1. This value was chosen to avoid type II errors. However, in part because of the small number of events in this study, 500 bootstrap resamplings of the dataset were used to assess the reliability of the models using the technique of so-called "bagging," again with a p value less than 0.1 criterion for variable retention [7].

Competing risks
The competing risks analysis considered three mutually exclusive time-related outcomes: alive without valve explant (event-free survival), death before explant, and explant for SVD. The common time interval for each event was the time to the earliest event, or censoring alive without explant. We used nonparametric competing risks estimates as described by Andersen and colleagues [8]; parametric competing risks estimates were obtained using the hazard functions and numerical integration. Risk-adjusted parametric competing risks estimates used the multivariable hazard function equations from the two-risk factor analyses, solved for a specific set of values for variables, and integrated numerically across time.

Presentation
Asymmetric 68% confidence limits were given for survival and competing risks estimates.

	Results

Top Footnotes Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Valve explantation
Thirty-six pericardial valve explants were performed, 30 of which were deemed valve-related. The cause of explant was SVD in 27 patients, generally because of aortic stenosis from prosthesis calcification. Other causes of valve-related explant were prosthetic valve endocarditis in 2 patients, and periprosthetic leakage in 1 patient. Six explants were considered prophylactic during subsequent CABG or mitral valve replacement.

Explant for structural valve dysfunction
At 5, 10, and 15 years, risk-unadjusted freedom from SVD was 99%, 94%, and 77% (Fig 1A). The instantaneous risk of SVD (hazard function) increased exponentially (p < 0.0001) across time (Fig 1C). Younger patients came to operation for SVD sooner than did older patients (Fig 2A).

View larger version (25K): [in this window] [in a new window]   Fig 1. Explant for structural valve dysfunction (SVD) and the competing risk of death before explant. (A) Freedom from SVD. Each square represents an event positioned by the method of Kaplan and Meier. Vertical bars are asymmetric 68% confidence limits. The number in parentheses is the number of patients still traced beyond the various points given. The solid line is the parametric estimate of freedom from SVD, and is enclosed within dashed 68% confidence limits. (B) Survival without explantation. The format is as in (A). (C) Rates of SVD and death (hazard functions). These hazard functions are used to generate the competing risks estimates. (D) Competing risks estimates. The proportion of patients alive without explant (event-free survival), death before explant, and explant for SVD are depicted across time. Each patient can only be in one of these categories at any given moment in time, so they add to 100%. The depiction is similar to that of (A) and (B). (E) "Actuarial" versus "actual" structural valve dysfunction estimates. The depiction contrasts the so-called actuarial estimate of SVD, an estimate that relates directly to the rate at which the valve experiences sufficient dysfunction to warrant explant, as opposed to the "actual" estimate of the proportion of patients likely to survive sufficiently long to experience SVD.

View larger version (17K): [in this window] [in a new window]   Fig 2. Impact of age on survival and structural valve dysfunction (SVD). Each of the depictions is similar to that of Figure 1A and 1B, except that the patients have been stratified into broad age groups. Twenty-seven patients were younger than 50 years (•), 150 patients were between 50 and 70 years (), and 90 patients were 70 years and older (). •, , and represent Kaplan–Meier estimates. (A) Explant for SVD. (B) Survival before prosthesis explant for any reason.

View larger version (12K): [in this window] [in a new window]   Fig 3. Depiction of the age-related structural valve dysfunction (SVD) in the pericardial valve. (A) Freedom from SVD for a patient whose valve was implanted at ages 45, 55, 65, and 75. (B) Fifteen-year freedom from SVD across the entire spectrum of age.

Risk factors that modulated the early phase of hazard within the first year of implant included men (p = 0.02) and more advanced NYHA class (p = 0.0008). The late rising hazard phase beyond 1 year was modulated by older age (p < 0.0001), concomitant CABG (p = 0.06), concomitant repair of the ascending aorta (p = 0.005), and previous aortic valve replacement (p = 0.1).

Competing risks estimates
Because older patients not only had a lower probability of experiencing SVD, but a greater chance of dying before its appearance, the risk-unadjusted chance of a patient remaining alive to experience prosthesis explant overall was 0.4%, 3.9%, and 10.4% at 5, 10, and 15 years (Fig 1D). Some have characterized this difference between estimates relating to the behavior of the prosthesis, and those relating to the likelihood for explant in the face of dying as "actuarial" versus "actual" (Fig 1E).

Risk-adjusted estimates of SVD for a typical patient in the face of competing risks of death are illustrated in Figure 4.

View larger version (17K): [in this window] [in a new window]   Fig 4. Risk-adjusted estimates of explant for structural valve dysfunction (SVD) by competing risk analysis. For this figure, the patient was assumed to be a man in New York Heart functional class III, undergoing first valve replacement, and not undergoing concomitant coronary artery bypass or ascending aorta replacement. The depictions are so-called nomograms of the two risk-factor analyses, one for explant for SVD and the other for death before explant. (A) Evolution of SVD across time for a patient aged 45, 55, 65, and 75 years at implant. (B) Fifteen-year freedom from requirement for explantation for SVD in a similar patient, but across the continuous spectrum of ages.

	Comment

Top Footnotes Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Pericardial valves have been used since the early 1970s with excellent hemodynamic results. However, early model pericardial valves demonstrated limited durability because of design characteristics [9] or tissue preparation techniques [10]. The Carpentier-Edwards pericardial bioprosthesis incorporated a novel tissue-mounting technique under the stent to reduce areas of concentrated stress and a tissue treatment shown to reduce calcification in animal studies [11].

The principal finding from this study was that long-term durability of the pericardial valve is excellent, particularly in the elderly, and even patients as young as 65 years are predicted to have less than a 10% chance of requiring explant before the age of 80. This finding provides a reasonable trade-off between durability and need for anticoagulation with a mechanical valve [12]. These results compare favorably with those for stented porcine xenograft prostheses at 15 years. For example, Fann and colleagues [13] reported freedom from porcine structural valve dysfunction of 49% ± 4% at 15 years.

An unanticipated finding in this study was the increase risk of early mortality with male patients. This risk factor is lost after 1 year but an explanation remains ellusive.

Limitations of this study include its relatively small size. The competing risks estimates presumed that death and SVD were unrelated; in fact, 1 patient died at explant for SVD, so this assumption is incorrect in a small way. SVD is also a process and this study was an examination of only the end result when patients became sufficiently symptomatic to require intervention. Thus the incidence of SVD may have been underestimated compared with that which would be detected using echocardiographic criteria for SVD. In addition, patients who died with, or because of, SVD may have been missed because explant was used as an end point. Unfortunately, reliable postmortem information was not available for this patient population.

The question of small valve size and possible accelerated failure was not settled by this study. Small prosthesis size, small body size, old age, and female sex were all intercorrelated. Studies in the past found female sex to be a risk factor for SVD of stented porcine heterografts [14]. Sex as a risk factor warrants further investigation as additional follow-up evidence accrues.

The clinical inference from this study was that the durability of this stented bovine pericardial bioprosthesis is excellent, thus justifying its use in patients 65 and older and in younger patients with other life-limiting diseases or those who elect to trade lifelong anticoagulation risks for reoperative risks.

	Acknowledgments

Top Footnotes Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Supported in part by a research grant from Edwards Lifesciences LLC, Irvine, CA. William Anderson, PhD, wrote the SAS-based algorithms for the variance of the nonparametric competing risks estimates used in the figures, based on Andersen and associates [8].

	Footnotes

Top Footnotes Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Doctor Cosgrove discloses that he has a financial relationship with Edwards Lifesciences, L.L.C.

	References

Top Footnotes Abstract Introduction Material and methods Results Comment Acknowledgments References

 

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