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Ann Thorac Surg 2002;73:1460-1465
© 2002 The Society of Thoracic Surgeons
a Department of Thoracic and Cardiovascular Surgery, Cleveland, Ohio, USA
b Department of Cardiology, Cleveland, Ohio, USA
c Department of Biostatistics and Epidemiology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
d Good Samaritan Hospital, Portland, Oregon, USA
e Montefiore Medical Center/Albert Einstein, Bronx, New York, USA
Accepted for publication January 4, 2002.
* Address reprint requests to Dr Banbury, The Cleveland Clinic Foundation, 9500 Euclid Ave, Desk F25, Cleveland, OH 44195 USA
e-mail: banburm{at}ccf.org
| Abstract |
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Methods. Of 267 patients at four institutions in the Premarket Approval cohort, 85 had a total of 168 echocardiographic studies during a 17-year period of yearly follow-up examinations. These were reviewed and quantified in a core echocardiographic facility. Longitudinal data analysis was used to account for repeated, censored data.
Results. Mean transvalvular gradient was inversely related to prosthesis size (p = 0.01), and possibly (p = 0.06) increased somewhat during the first 10 years of follow-up, then stabilized. Effective orifice area was larger in larger valve sizes (p = 0.01), declined somewhat during the first 10 years, and then began to increase again. Ejection fraction declined minimally (p = 0.2). In contrast to the rather stable hemodynamics, aortic regurgitation steadily increased from none to 1 to 2+ (p = 0.005), but rarely (< 10% at 17 years) progressed to 3+ or 4+.
Conclusions. The Carpentier-Edwards aortic pericardial bioprosthesis can be anticipated to have an acceptable long-term transvalvular gradient and effective orifice size that will change trivially up to 17 years after implantation. Mild aortic regurgitation will develop progressively. This anticipated hemodynamic resilience supports continued clinical use of the Perimount Carpentier-Edwards bovine pericardial stented bioprosthesis.
| Introduction |
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Follow-up now extends to 17 years, permitting long-term characterization of prosthesis-related hemodynamic changes from echocardiograms performed for clinical indications during follow-up [6]. The objective of this study, therefore, was to determine the time-related pattern and correlates of hemodynamics of this stented bovine pericardial aortic valve bioprosthesis.
| Patients and methods |
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Surgical technique
Aortic valve replacement was performed using standard techniques. Concomitant procedures, performed in 123 patients, included coronary artery bypass grafting in 108 and ascending aortic grafting in 7. Size of the prosthesis implanted was 19 mm in 34 (13%), 21 mm in 83 (31%), 23 mm in 85 (32%), 25 mm in 48 (18%), 27 mm in 12 (4.5%), and 29 mm in 5 (1.9%).
Follow-up
Patient status in this cohort was assessed on an annual basis, typically during an office or hospital visit, or by means of detailed patient questionnaires completed by telephone or mail. All valve-related complications were identified according to the guidelines for reporting morbidity and mortality after cardiac valve operation [7].
Two patients were lost to follow-up within the first year, 5 after 1 to 5 years, and 10 after 5 to 10 years. Mean follow-up among survivors was 12 ± 4.5 years, with a maximum of 17 years. Of the 267 patients, 16% were alive at 15 years and 6% at 16 years.
Outcomes
Survival declined from 96% at 30 days to 89%, 76%, 52%, and 26% at 1, 5, 10, and 15 years, respectively. Thirty-six prostheses were explanted, 30 for valve-related complications and 27 for structural valve dysfunction. Risk of structural valve dysfunction was strongly age-related and time-related, with less than 10% chance of explant by 15 years in patients 65 years and older.
New york heart association functional class
New York Heart Association functional class declined slowly with time (Fig 1).
Among the 240 patients with NYHA assessment, the last NYHA class was I in 120 patients, II in 88, III in 26, and IV in 6. Shorter individuals, generally women, experienced a somewhat more rapid decline in functional status (Table 1).
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Methods of echocardiographic study
Transthoracic echocardiograms were reviewed and quantified in the Echocardiographic Core Facility of The Cleveland Clinic Foundation. The simplified Bernoulli equation (
p = 4v2) was used to calculate mean pressure gradient across the valve. Left ventricular outflow tract (LVOT) area was calculated by measuring the diameter (D) of the LVOT and assuming circular shape (ALVOT =
D2/4). Effective orifice area (AAVR) was calculated by the continuity equation using the time velocity integral of LVOT velocity (VLOT, by pulsed-wave Doppler) and prosthetic valve velocity (VAVR by continuous-wave Doppler): AAVR = ALVOT (VLVOT/VAVR). Left ventricular end-diastolic and end-systolic volumes (LVEDV and LVESV) were calculated from the apical four-chamber and two-chamber views using the biplane Simpson method. Ejection fraction was calculated as (LVEDV-LVESV)/LVEDV. Aortic regurgitation was estimated on a 0 to 4+ semiquantitative scale by integrating information from (1) size of regurgitant jet, (2) aortic pressure half-time, (3) presence of a proximal convergence zone above the aortic valve, and (4) presence of flow reversal in the aortic arch.
Data analysis
Echocardiographic variables included in the analysis were transprosthesis mean gradient (104 measurements in 51 patients), in vivo effective orifice area (60 measurements in 33 patients), left ventricular ejection fraction (42 measurements in 32 patients), and aortic regurgitation grade (121 assessments in 63 patients).
The challenges in data analysis were (1) repeated measurement and assessment in some of the patients across time (41 of 85 patients), requiring that we take into account intrapatient correlation; (2) nonuniform time intervals between serial echocardiographic sessions, with censoring at valve explant or death; (3) violation of statistical model assumptions from skewed distributions of echocardiographic continuous measurements and lack of proportional odds for the ordered qualitative assessment of aortic valve regurgitation and NYHA functional class; and (4) the need for multivariable analysis. These challenges were met by using both linear (mean gradient, effective orifice area, and ejection fraction) and ordinal (aortic regurgitation) longitudinal mixed-model repeated-measures analyses [810].
The skewed continuous echocardiographic measurements were logarithmically transformed for analysis to achieve a more normal distribution of dependent variables. The proportional odds assumption was not met for aortic valve regurgitation data. We traced this to a scarcity of patients in certain of the ordinal categories of regurgitation. Therefore, patients were regrouped into four categories: (1) regurgitation grade 0 or trace, (2) mild regurgitation (grade 1+), (3) mild-to-moderate and moderate regurgitation (grades 1.5+ and 2+), and (4) moderately severe and severe regurgitation (grades 3+, 3.5+, and 4+). By this means, the proportional odds assumption was met (p > 0.1).
We initially screened the variables listed in the Appendix using multivariable linear regression for continuous echocardiographic measurements and ordinal logistic regression for aortic regurgitation [9]. The identified candidates were then entered at once into the mixed models, and eliminated one by one until all variables remaining had a probability value less than or equal to 0.1. However, for all models, the best transformation of time interval and prosthesis size was incorporated no matter what the magnitude of the probability value.
| Results |
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| Comment |
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Comparison of valve performance requires uniform measurement of valve size. Manufacturers labeled valve size has no standard and can be misleading [13]. Labeled valve size is related to different features of the external diameter of the prostheses; thus, the internal orifice for a given label size may vary widely among types of prostheses. This is especially true when comparing intraannular with supraannular valves. The EOA may be the most reliable method of comparing hemodynamic performance, because it takes into account both transvalvular gradient and flow across the valve [1416]. Effective orifice area was smaller in the smaller sized valves, as expected. Interestingly, EOA decreased with time until approximately 10 years and then began to increase. This phenomenon was seen in all valve sizes.
Mean EOA at 17 years ranged from 0.97 to 2.03 cm2 for valve sizes 19 to 29 mm, an increase from the overall median range of 0.82 to 1.5 cm2 (Fig 3). David and colleagues [17] reported echocardiographic findings for the Hancock II porcine valve at 1 year that demonstrated EOAs of 1.18 to 1.60 cm2 for valve sizes 21 to 29 mm. These findings are similar to those for the pericardial valve early and late (EOA range 1.19 to 2.03 cm2 for valves 21 to 29 mm at 17 years), but are slightly better than at midterm, as depicted in Figure 3. It is unknown whether porcine valves demonstrate the same decrease and then increase in EOA as we have found with aortic bovine pericardial valves.
Cohen and colleagues [18] compared the hemodynamic performance of stented versus stentless valves and found no difference in peak or mean transvalvular gradients with 6-month follow-up. They were able to detect an increase in EOA with stentless valves; however, this did not result in a difference in left ventricular mass index reduction between the groups at 6 months. These findings were confirmed by Rao and coworkers [19] in a comparison of pericardial valves with stentless valves in patients with small aortic roots.
Ejection fraction tended to be higher in women than in men. Implanted valve size was not reliably related to ejection fraction or changes in ejection fraction with time.
Initially, the majority of valves showed no or trace aortic regurgitation. As time passed, this group diminished in size, whereas those with mild and then moderate regurgitation began to increase. At 17 years, the proportion of patients with severe regurgitation remained low (13%). The pattern of prosthetic pericardial valve deterioration does include slow progression of aortic regurgitation, but most patients are spared clinically significant aortic regurgitation.
Limitations
One of the principal limitations of this study is the nonrandom selection of the echocardiographic cohort (n = 85) from the Premarket Approval cohort (n = 267). Only patients presenting with clinical indications had echocardiograms; thus, they may represent a group with more advanced valvular dysfunction. Countering this is the possibility that patients who died during the study period may have died with, or because of, unrecognized valvular dysfunction. There is little or no autopsy data available for this study group.
A strength of this study is that by using the systematically followed Premarket Approval cohort, we know well in advance what might be expected for patients in whom U.S. Food and Drug Administration approved valves have been used. However, this was a relatively small group of patients, with few details recorded about their clinical history and operation.
The recent development and implementation of methods for longitudinal data analysis have made a study such as this possible; that would not have been the case even a decade ago. These methods permit statistically valid characterization of repeated measurements across time, with unequal time points, and censoring. An important assumption is that censoring at death is noninformative. This may not be true. Thus, the estimates provided should be interpreted as echocardiographic status in surviving patients.
Conclusions
Hemodynamic assessment of the Carpentier-Edwards stented aortic pericardial prosthesis demonstrates reliable function as late as 17 years after implantation. Increases in mean transvalvular gradients are seen early in the life of the valve, and later changes are limited. Effective orifice area shows an early decrease and then increases in magnitude such that at 17 years, it is similar to that found at 3 years. Ejection fraction was not clearly related to time or valve size. Aortic regurgitation increased gradually with time, but rarely became severe.
The Carpentier-Edwards aortic pericardial bioprosthesis can be anticipated to have an acceptable long-term transvalvular gradient and effective orifice size that will change trivially up to 17 years after implantation. Mild aortic regurgitation will develop progressively. This anticipated hemodynamic resilience supports continued clinical use of the Perimount Carpentier-Edwards bovine pericardial stented bioprosthesis.
| Acknowledgments |
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| Footnotes |
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| Appendix |
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| References |
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