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Ann Thorac Surg 1998;65:1545-1551
© 1998 The Society of Thoracic Surgeons
a Cardiac Surgical Unit, Massachusetts General Hospital, Boston, Massachusetts, USA
Address reprint requests to Dr Akins, Cardiac Surgical Unit, Massachusetts General Hospital, White 503, 32 Fruit St, Boston, MA 02114
Presented at the Thirty-fourth Annual Meeting of The Society of Thoracic Surgeons, New Orleans, LA, January 2628, 1998.
| Abstract |
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Methods. Records of 400 consecutive patients having reoperative mitral, aortic, or mitral and aortic bioprosthetic valve replacement from January 1985 to March 1997 were reviewed.
Results. Reoperations were for failed bioprosthetic mitral valves in 219 patients, failed aortic valves in 153 patients, and failed aortic and mitral valves in 28 patients. Including 26 operations (6%) for acute endocarditis, 153 operations (38%) were nonelective. One hundred nine patients (27%) had other valves repaired or replaced, and 72 (18%) had coronary bypass grafting. The incidence of death in the mitral, aortic, and double-valve groups was respectively, 15 (6.8%), 12 (7.8%), and 4 (14.3%); and the incidence of prolonged postoperative hospital stay (>14 days) was, respectively, 57 (26.0%), 41 (26.8%), and 8 (28.6%). Only 7 of 147 patients (4.8%) having elective, isolated, first-time valve reoperation died. Multivariable predictors (p < 0.05) of hospital death were age greater than 65 years, male sex, renal insufficiency, and nonelective operation; and predictors of prolonged stay were acute endocarditis, renal insufficiency, any concurrent cardiac operation, and elevated pulmonary artery systolic pressure.
Conclusions. Reoperative bioprosthetic valve replacement can be performed with acceptable mortality and hospital stay. The best results are achieved with elective valve replacement, without concurrent cardiac procedures.
| Introduction |
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| Material and methods |
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Definitions
Unstable angina pectoris was defined as either (1) new onset of angina that is rapidly progressive in frequency and severity, (2) rapid acceleration of an anginal pattern that was previously stable and related to exertion, or (3) severe recurrent rest angina or a bout of intense pain resembling an acute myocardial infarction but without evolution of infarction as evaluated by electrocardiogram or cardiac enzymes.
Urgent operations were defined as operative procedures performed in patients whose accelerated symptoms prompted urgent hospital admission for evaluation and who were judged to be too unstable to discharge before operative intervention. True emergency operations were defined as procedures performed in patients whose cardiovascular instability required an operative intervention that was outside of normal operating hours or displaced another patient on the surgical schedule. The predominant causes of nonelective operation, urgent or emergency, in this series were congestive heart failure that could be managed only with intravenous medications and unstable angina that required intravenous heparin and nitroglycerin.
Only previous cardiac operations performed through a median sternotomy were counted. Closed mitral commissurotomies performed through a left thoracotomy, which had been done in 54 patients, were not considered as previous cardiac operations because the attendant increased risk was not thought to be appreciable.
Perioperative myocardial infarction was defined as either a new Q wave or the elevation of the myocardial fraction of creatine kinase in association with persistent ST segment changes or a new conduction abnormality.
Transient ischemic attack was defined as a neurologic deficit lasting less than 1 hour. Reversible ischemic neurologic deficit was defined as a neurologic deficit lasting more than 1 hour but that resolved by the time the patient was discharged from the hospital. Stroke was defined as a neurologic deficit lasting through the time of hospital discharge.
Postoperative gastrointestinal complications included gastrointestinal bleeding requiring transfusion, pancreatitis, cholecystitis, or other gastrointestinal problems that required operative intervention. Sternal wound infections were defined as infections that required operative intervention. Postoperative renal failure was defined as new renal failure requiring dialysis.
Statistical analysis
To separate the impact of different cardiovascular pathologies on hospital events, we divided the patient population into three groups: (1) mitral valve failure (MVF) = 219 patients whose indication for reoperation was failure of a mitral bioprosthesis, (2) aortic valve failure (AVF) = 153 patients whose indication for reoperation was failure of an aortic bioprosthesis, and (3) double-valve failure (DVF) = 28 patients whose indication for reoperation was failure of both an aortic and a mitral bioprosthesis. In the MVF group 43 patients had concomitant aortic valve replacement, 28 for new native aortic valve disease and 15 for incidental replacement of a minimally diseased but old aortic bioprosthesis. In the AVF group 16 patients had concomitant mitral valve replacement, 12 for new native mitral valve disease and 4 for incidental replacement of a minimally diseased but old mitral bioprosthesis. During analysis, the groups were assessed only according to the failed bioprosthesis (or bioprostheses), not according to the reoperation performed.
To assess the predictors of hospital death, multiple risk factors were inserted into a stepwise logistic regression algorithm, BMDP program PLR [5]. Predictors of prolonged postoperative hospital stay (>14 days) were assessed by linear regression of the log postoperative hospital stay. Factors tested as predictors of the events are listed in Appendix 1. All mean values in the tables are expressed as the mean value ± standard deviation.
| Results |
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Pertinent cardiac history findings are recorded in Table 3. Approximately half the patients were in New York Heart Association class IV. Old bacterial endocarditis had occurred before the first bioprosthetic valve replacement in 49 patients, interval endocarditis occurred between the last bioprosthetic valve replacement and the current operation in 35 patients, and acute endocarditis prompted the patients admission for this operation in 26 patients.
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Prolonged postoperative hospital stay (>14 days) occurred in 106 patients (27%). However, during the course of the study interval the length of postoperative hospital stay gradually declined; from the period 1985 to 1986 to the period 1996 to 1997 the median postoperative hospital stay fell from 10.5 days to 7.5 days.
Significant multivariable predictors of hospital death and prolonged postoperative hospital stay are listed in Table 8. The important impact of renal insufficiency as a comorbid condition is obvious. Even though New York Heart Association class IV was a strong univariate predictor of hospital death, it was not statistically significant when placed with renal insufficiency in the multivariable model. Although the number of previous cardiac operations tended to increase hospital mortality, the number of previous operations was not a significant predictor of hospital death. Hospital mortality was 27 of 370 (7.3%) for first-time reoperations, 3 of 22 (13.6%) for second-time reoperations, and 1 of 7 (14.3%) for third-time reoperations.
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During this study from 1985 to 1997, the unadjusted annual hospital mortality did not change significantly, a finding also noted by Piehler and associates [6] in their five-institutional study of reoperations on prosthetic heart valves from 1963 to 1992. However, as the mean patient age rose from 57.5 to 67.4 years over the 12 years of this study, there was a trend toward slightly higher mortality rates in the later years of the study (see Fig 1). This relationship is verified by the fact that age greater than 65 years was a significant multivariable predictor of hospital death. When the reoperation was an isolated, elective valve replacement, then the operative mortality was less than 5%.
To put the hospital mortality data into perspective, Table 9 lists series published since 1986 with more than 100 valve reoperations. Direct comparison between those series and ours is complicated by several issues. All other series had average patient ages between 50 and 55 years (our mean age was 64.3 years), most reported data according to operation performed and not which valve failed, and several series excluded some concurrent procedures [6, 10]. On the other hand, several series combined mechanical and bioprosthetic replacement [79, 11]. Some reports suggest that reoperation for failed mechanical valves has a higher mortality than that for failed bioprostheses, being 17.4% for mechanical valves and 10.6% for biologic valves in one series [11] and 21.0% for mechanical valves and 10.3% for bioprostheses in another series [9], although other series show no difference [7]. The principal advantage of our series is all of the improvements that accrue to operating in a more recent time frame.
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Advanced patient age, a significant risk factor for death in this study, was also noted by Cohn and associates [8] and Tyers and associates [11]. Also, both of those studies identified concomitant procedures as predictors of death. We found a trend toward increased mortality with concomitant procedures that did not achieve multivariable statistical significance. Additional concurrent operations were significantly associated with prolonged postoperative hospital stay.
Nonelective operation, a significant predictor of mortality, was also documented as a predictor of death by Mazzucco and coworkers [10]. The fact that almost 40% of both mitral and aortic valve failure necessitated nonelective reoperation suggests that the contention that bioprosthetic valves fail slowly and with sufficient time to allow elective intervention does not hold for a substantial number of patients.
In several other series acute bacterial endocarditis was identified as a significant predictor of hospital death [6, 7, 9, 10]. In our series acute endocarditis was a univariable but not a multivariable predictor of hospital death. However, endocarditis was a significant multivariable predictor of prolonged postoperative hospital stay. We have tended increasingly to operate very early on patients with acute endocarditis unless the bacteria are very sensitive to antibiotics and there is no valve dysfunction.
Although there was a trend to higher operative mortality with increasing number of prior cardiac operations, this factor was not significant in multivariable analysis. This lack of significance may be a result of the small number of patients having more than one prior cardiac operation. In addition, the type of prior cardiac operation was not a predictor of hospital death.
One risk factor for hospital mortality in this study that is difficult to explain is male sex. Cohn and associates [8] identified female sex as a risk factor in their study. Presumably in larger series sex would not be a risk factor.
The role of bioprostheses in the cardiac surgeons armamentarium for valve replacement remains an unsettled issue. The lower thromboembolic potential and thus limited necessity for anticoagulation coupled with excellent freedom from structural valve failure in patients more than 70 years of age make bioprostheses particularly attractive in this elderly age group. In addition, the poorer patient survival that results when valvular heart disease occurs concomitantly with coronary artery disease has led some surgeons to lower the age limits for use of bioprostheses in the presence of associated coronary artery disease [12].
More than a decade ago Cobanoglu and colleagues [13] argued that focusing on valve failure was biased against bioprostheses and that treatment failure with attention to patient survival would be more appropriate. They contended that a successful reoperation for a failed bioprosthesis should not be counted as a treatment failure. Unfortunately, the patient, the patients family, and the third-party payor do not consider the need for reoperation, albeit successful, to be insignificant. Still, this argument has some merit; against the requirement for reoperation for failed bioprostheses must be weighed the valve-induced disability that attends the need for anticoagulation and (despite anticoagulation) considerable incidence of thromboembolism with mechanical prostheses [14]. Thus, the original issue remains, namely that the application of bioprostheses to younger patient populations requires not only an acceptably low requirement for reoperation for failed valves but also low mortality and morbidity when that reoperation is required.
In this study 38% of the operations were nonelective and 44% required another concurrent cardiac procedure, features that were associated with increased hospital mortality and morbidity. The best results were achieved when the valve replacement for a failed bioprosthesis was performed electively and without requirement for concurrent procedures. Thus the unpredictability of when bioprosthetic valves will fail, whether that valve failure can be managed electively, and what additional cardiac procedures will also be required at the time of valve replacement all combine to make the routine use of bioprostheses in younger patient populations still an unsettled issue.
| Discussion |
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Beginning about 6 years ago we started replacing degenerated bioprosthetic mitral valves by completely excising the leaflets that are degenerated, leaving the stent intact, and attaching a reversed aortic St. Jude valve to the inflow aspect of the stent. By sewing a mechanical valve, in our case a reversed aortic St. Jude valve, cuff-to-cuff to the stent, which is left in situ, one can achieve a rapid and very effective replacement using the same size valve. Rather than a valve inside the stent, this is a valve-on-valve. About 2
years ago we extended this concept to the aortic degenerated bioprosthetic valve, whereby we would completely excise the degenerated tissue, excise the struts, remove them, and then suture to the outflow aspect of the stent of this valve a new mechanical valve, in our case a CarboMedics valve, thus achieving a valve-on-valve seating. This gives us a very effective, hemodynamically excellent result, and, again, in a very expedient way and avoiding any of the complications of explantation of these valves. We have so far operated on 35 patients with this approach, 26 for mitral and 9 for aortic bioprosthetic valve replacement, with no operative mortality and only one late death caused by cancer.
Doctor Akins, I have a short question for you. What is your preference when you replace these degenerated valves? I think your abstract alludes to a predominance of mechanical valves. Do you still feel the same?
DR AKINS: We are aware of Dr Gehas innovative surgical approach, but we have not had the opportunity to use that yet.
In terms of which valve we choose, it has a lot to do with what we think the projected life expectancy of the patient is. We will use a bioprosthesis as patients get older. As can be seen in our Figure 2, there is an increasing incidence of bioprosthetic use in elderly patients, but certainly in this series about 70% of the valves that replaced the bioprostheses were mechanical valves.
DR HUGH E. SCULLY (Toronto, Ontario, Canada): I enjoyed your paper, Dr Akins, and I think you raise a very important question, which is the choice of the prostheses when one is doing multiple valve replacements in the younger patient.
Let me pose a specific question to you. What do you do with a 60-year-old woman whose mitral bioprosthesis has failed but whose aortic bioprosthesis, which has been in for 10 years, is still functioning? Do you do anything about the aortic valve under those circumstances, recognizing that in all likelihood that also will fail in time?
DR AKINS: Generally our approach recently has been to be more aggressive, and that is to replace both prostheses at the same time unless there is going to be a prolonged operation. Although there is variability in our group, I have become more aggressive about replacing bioprosthetic valves that have been in more than 8 to 10 years even though there is limited evidence of disease in them.
DR FRANCIS D. FERDINAND (London, England): Just to revisit the question of the type of prosthesis for the reoperation, were most of these patients referred from outside, and what had changed where your initial strategy was to place a bioprosthetic valve and then at reoperation change it to a mechanical valve? Second, could you just briefly describe the endocarditis cases preoperatively? Which type valves did they have, and what was your choice for replacement in the setting of endocarditis? Third, will the incidence of atrial fibrillation influence what you will use for a replacement device?
DR AKINS: Let me begin with whether we have a difference in the types of valves that were initially implanted. We, like most cardiac surgeons, became disappointed in the early 1970s with some of the problems with mechanical valves and jumped on the bioprosthetic bandwagon. We began to pay the price for that in the late 1970s and early 1980s, and that is when we began to see more bioprosthetic failure. If you will notice, the number of operations per year has actually fallen off a bit recently. Obviously, not all of the patients were operated on in our own institution.
For endocarditis patients, in terms of what valves we used to replace a failing prosthesis, it depends on the patients age. We do not believe that necessarily inserting a bioprosthesis or a mechanical valve has any particular advantage in the presence of endocarditis other than when the aortic root is destroyed. The German series has superb results with using all mechanical valves in the treatment of acute endocarditis, and we do not fear putting in a mechanical valve in a patient with acute endocarditis. In 1 or 2 of the patients in this series a homograft was used in the aortic root when the bioprosthesis failed. We do believe that there is some evidence out of New Zealand and Australia that supports the use of homografts as aortic root replacements for extensive endocarditis involving destruction of the aortic root.
DR FERDINAND: And then, finally, about the atrial fibrillation: will the incidence of atrial fibrillation influence what you will use for a replacement device?
DR AKINS: I do believe that probably does not influence us as much in terms of which valve we choose as does the intensity of anticoagulation that we may follow. Some people suggest that if the patient is going to be receiving warfarin anyway, why not just put in a mechanical valve? I happen to believe that there are some people who will still do better in the older age group with a bioprosthesis even in the mitral position. We know that many of these patients may eventually undergo other general surgical procedures, and it is a lot easier to stop the administration of warfarin for a day or two in those patients if there is a bioprosthesis in place than if they have a mechanical valve in place.
DR HARTZELL V. SCHAFF (Rochester, MN): There are a few notions in cardiac surgery that get carried forth from generation to generation, and one of them is that failure of a bioprosthesis is gradual, but your experience is similar to ours in that in many patients late failure of a bioprosthesis may be precipitous. What would your approach be to a patient who has a new murmur or new onset of moderate central regurgitation in a bioprosthesis that has been in place for 10 years?
DR AKINS: First we would have closer medical follow-up of that patient. In the past we would tend to treat that patient as we do somebody with native aortic regurgitation. If there is evidence of left ventricular enlargement, evidence of left ventricular failure, or a decrease in ejection fraction with exercise, we treat that patient with an aortic valve replacement, some might say somewhat more prematurely than if it were acute regurgitation.
DR SCHAFF: We generally operate early in such patients because the progression of regurgitation is not the same as in native aortic valve regurgitation.
DR AKINS: I agree with you. We are heading in that direction. The situation that you pointed out is something that needs more careful study.
DR JOHN D. OSWALT (Austin, TX): Do you have the total privilege of choosing which prosthesis you replace at the time of reoperation, or do your cardiologists get involved in this decision? We find it a little bit difficult sometimes to convince our cardiologists that the patients would do fine with a repeat bioprosthesis even if they are in atrial fibrillation and 81 or 82 years of age. Would you please comment?
DR AKINS: We allow them to recommend as much as they wish, but we decide.
DR W. R. ERIC JAMIESON (Vancouver, BC, Canada): What has been your reoperative mortality in the last 5 years for aortic valve replacement? Are there circumstances in which you may recommend two aortic bioprostheses in their lifetime? Has your reoperative mortality decreased to support such a recommendation?
DR AKINS: Exactly, we did not. Our mortality is actually slowly increasing in the last few years, but the operations have become more complex, there are more concurrent operations being done, and the patients now are a mean of 10 years older than in the earlier part of the study, so that confounds the issue. For an isolated aortic valve replacement, I have no fear about putting in a second bioprosthesis. Getting out to third and fourth bioprostheses, then I begin to have an issue. There was a slight increase in our operative mortality between first, second, third, and fourth reoperations, but our series was not large enough to demonstrate a statistically significant difference.
| Acknowledgments |
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| Footnotes |
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| Appendix 1. Factors assessed as predictors of hospital mortality and prolonged postoperative hospital stay |
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Sex
Prior cardiac operations
Congestive heart failure
New York Heart Association functional class
Angina pectoris
Coronary artery disease
Bacterial endocarditis
Preoperative intraaortic balloon
Renal insufficiency
Peripheral vascular disease
Cardiac index
Left ventricular ejection fraction
Pulmonary artery systolic pressure
Operative priority (elective versus nonelective)
Other concurrent cardiac operations
Type of prosthesis inserted (mechanical or bioprosthetic)
| References |
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