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Ann Thorac Surg 2001;72:20-27
© 2001 The Society of Thoracic Surgeons
Address reprint requests to Dr Gillinov, Department of Thoracic and Cardiovascular Surgery/F25, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195
e-mail: gillinom{at}ccf.org
Presented at the Thirty-seventh Annual Meeting of The Society of Thoracic Surgeons, New Orleans, LA, Jan 29–31, 2001.
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Abstract |
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 Top Abstract IntroductionPatients and methodsResultsCommentAcknowledgmentsAppendix. Variables studied in...DiscussionReferences |
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Methods. From 1979 through 1999, 158 patients underwent simultaneous aortic and mitral valve repair. Multivariable, multi-phase hazard function analysis was used to determine risk factors for the outcomes of death and reoperation.
Results. Hospital mortality was 3%. Survival after operation was 97%, 93%, 82%, and 62% after 30 days and 1, 5, and 10 years, respectively. Risk factors for late death included aortic stenosis (p = 0.0001), older age (p = 0.002), and abnormal left ventricular function (p = 0.007). Thirty-six patients required reoperation for valvular dysfunction, and freedom from reoperation was 94%, 82%, and 65% after 1, 5, and 10 years, respectively. Risk factors for reoperation included severe aortic regurgitation (p = 0.004), aortic cusp shaving (p = 0.05), mitral valve chordal transfer (p = 0.004), and bovine pericardial annuloplasty (p = 0.002). Five-year freedoms from endocarditis, thromboembolism, and hemorrhage were 97%, 98%, and 99%, respectively, with freedom from any of these valve-related morbidities of 99%, 95%, and 94% after 1, 5, and 10 years, respectively.
Conclusions. Double valve repair is associated with acceptable late survival and excellent freedom from valve-related morbidity, but limited durability. Therefore, double valve repair should be reserved for patients who cannot be anticoagulated, and should be used with caution in patients with aortic stenosis, rheumatic valve disease, or anterior mitral leaflet pathology.
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Introduction |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsAppendix. Variables studied in...DiscussionReferences |
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Patients and methods |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsAppendix. Variables studied in...DiscussionReferences |
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Definitions
Etiology and pathophysiology of valve disease were classified using standard criteria based upon analysis of clinical information, operative reports, pathology reports, findings at catheterization, and echocardiograms. Patients with mitral regurgitation, structurally normal mitral valves, and no history of myocardial infarction were considered to have functional mitral regurgitation, generally attributable to the effects of aortic valve disease. Valve-related morbidity and mortality are reported according to guidelines established by The Society of Thoracic Surgeons [7].
Patient characteristics
Mean age of patients having double valve repair was 57 ± 14 years (range 18 to 85 years). Other patient characteristics, details of the etiology and pathophysiology of valve disease, and cardiac comorbidity are given in Tables 1 and 2. One hundred fifty-two patients (96%) had cardiac catheterization, and 144 (91%) had a preoperative echocardiogram. The primary indications for surgery were severe mitral and aortic valve dysfunction in 73 patients (46%), severe mitral valve dysfunction with less severe aortic dysfunction in 69 (44%), and severe aortic valve dysfunction with less severe mitral dysfunction in 9 (6%); 7 patients (4%) had only mild to moderate valvular disease. The most common etiologies for aortic valve dysfunction were rheumatic (47%) and degenerative (41%), and pure aortic regurgitation was present in 76% (Table 2). Similarly, mitral valve disease was rheumatic in 46% and degenerative in 40%, with pure mitral regurgitation present in 65% (Table 2).
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Data analysis
General
Nonparametric estimates of time-related events, including survival, were obtained by the method of Kaplan and Meier [8]. A parametric method was used to resolve the number of phases of instantaneous risk of each event (hazard function) and to estimate its shaping parameters [9]. Exploratory analyses of the variables in the Appendix included correlation analysis, stratified life table analyses, and decile risk analysis of ordinal and continuous variables to determine possible transformations of scale needed to calibrate properly the variables to survival.
Because of the small number of events occurring in this group of patients, we did not believe traditional stepwise or guided methods were sufficiently reliable for multivariable risk factor identification to avoid either type I or type II statistical errors. Therefore, variable selection was based entirely on bootstrap bagging [10]. For this, 500 bootstrap samples of size 118 (75% sample) were drawn with replacement, and an automated forward stepwise procedure was performed on each sample using a variable entry criterion of p = 0.12 and a variable selection criterion of p = 0.1. The hazard function methodology is set up in such a way that single numbers of a designated group of variables can be counted (eg, all age transformations or all expressions of valve stenosis are counted only once). Thereby, the frequency of occurrence of each variable can be assessed. We then retained all variables in the models that appeared in 50% or more of the bootstrap analyses.
Durability
Durability of valve repair was assessed by the event valvular reoperation, and, when available, results of late echocardiograms. The analysis of reoperation focused upon mitral or aortic valve replacement after double valve repair. The indications for valvular reoperation and etiology of recurrent valve dysfunction were determined by review of echocardiograms and operative reports. Aortic valve and mitral valve failures were analyzed separately in order to determine risk factors for recurrent dysfunction at each valvular position. The patient receiving a heart transplant was considered not at risk of these events after this operation.
Morbid events
Time-related events considered traditionally valve related were analyzed, including endocarditis, thromboembolism, and bleeding using the same criteria as if valve replacement had been performed [7]. However, for these events, follow-up extended only to the date of replacement of one or more valves (or heart transplant).
Presentation
Means are presented ± 1 SD. Regression coefficients are presented ± SE. Proportions and time-related event estimates are accompanied by confidence limits (CL) that are asymmetric, but that correspond to ± 1 SE.
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Results |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsAppendix. Variables studied in...DiscussionReferences |
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Other valve-related morbidity
Five-year freedoms from endocarditis (three occurrences), thromboembolism (three episodes), and hemorrhage (one occurrence) were 97%, 98%, and 99%, respectively. Freedom from any one of these morbidities was 99%, 95%, and 94% at 1, 5, and 10 years, respectively, after double valve repair (Fig 5).
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Comment |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsAppendix. Variables studied in...DiscussionReferences |
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The real issues are the durability of combined aortic and mitral valve repair and patient selection. Ten-year freedom from valve-related reoperation was 65%. Thus, double valve repair was a temporizing procedure for many patients. The most common indication for reoperation was combined mitral and aortic valve dysfunction, and the primary cause of recurrent valve dysfunction was progressive native valve disease, which was rheumatic in most of the patients. Correspondingly, the most common reoperative procedure was double valve replacement. Examination of risk factors for reoperation provides some insight into patient selection. Patient-related risk factors for reoperation included severe aortic regurgitation, aortic regurgitation accompanying mitral stenosis, and female gender. The procedural variables that jeopardized durability were aortic cusp shaving, mitral valve chordal transfer, and bovine pericardial annuloplasty. These results imply that rheumatic disease, which is associated with mitral stenosis and aortic cusp shaving, jeopardizes durability. Similarly, degenerative mitral valve disease affecting the anterior leaflet, which was treated by chordal transfer, was associated with decreased durability.
When examined in the context of the durability of single valve repair, the relatively high rate of reoperation after double valve repair is not surprising. The advantages of mitral valve repair over mitral valve replacement are well documented [11, 12]; however, the durability of mitral valve repair is not 100% [12, 13]. While 15-year freedom from mitral valve reoperation in patients with degenerative disease is 93%, this figure is only 76% for patients with rheumatic disease [12]. Durability of aortic valve repair has been less satisfying. In patients with aortic regurgitation, 5-year freedom from reoperation is 87% after repair of bicuspid aortic valves [14]. Repair of rheumatic aortic valves is associated with 30-month freedom from reoperation of 77% to 94% [15] and 22-year freedom from reoperation of only 25% [16]. Given these results, the appropriate indications for aortic valve repair remain a matter of investigation.
Previous studies of double valve repair in adults focus primarily upon patients with rheumatic disease and contain results similar to those in this report. As noted above, Bernal and coworkers documented 25% 22-year freedom from aortic valve reoperation and 21% 22-year freedom from mitral valve reoperation in patients with rheumatic disease [16]. In this study of repair of nonsevere rheumatic aortic valve disease during other valvular procedures, the authors concluded that conservative operations for rheumatic aortic valve disease are not appropriate. Furthermore, recent data from Israel demonstrate that mild rheumatic aortic regurgitation noted at the time of mitral valve surgery rarely progresses to severe aortic valve dysfunction; therefore, these authors concluded that prophylactic aortic valve surgery is not necessary in patients with mild rheumatic aortic valve disease [17]. Others, however, have demonstrated good durability of aortic valve repair in children and young adults with severe rheumatic disease [18]. Although follow-up is short, a strategy of double valve repair in younger rheumatic patients with severe aortic valve disease may be appropriate.
The current study reports the results of double valve repair in a heterogeneous group of patients. Data contained in this study and reports from the literature do not permit a definitive answer to the question, "Who benefits from a strategy of double valve repair?" Nevertheless, certain clinical inferences are possible. Double valve repair should not be abandoned; there are important advantages with respect to freedom from bleeding, thromboembolism, and endocarditis. Although rheumatic etiology per se did not emerge as a risk factor for reoperation in the current study, these data suggest and previous reports confirm that repair of rheumatic aortic and mitral valves in adults is associated with limited durability. Therefore, we have abandoned the strategy of double valve repair in adults with rheumatic disease. In addition, we rarely employ double valve repair in patients with regurgitant tricuspid aortic valves or stenotic aortic valves, as previous studies demonstrate that these findings limit durability [14, 19]. The ideal patient for double valve repair is young, desires to avoid Coumadin, and has anatomy most favorable for combined aortic and mitral valve repair. Such favorable anatomy includes degenerative mitral valve disease affecting the posterior leaflet and a bicuspid, nonrheumatic, regurgitant aortic valve. Repair should be guided by intraoperative echocardiography, and when an annuloplasty is employed, a prosthetic annuloplasty band should be used as part of the mitral valve repair. Before considering double valve repair, patients must be informed of the possibility of reoperation for recurrent valve dysfunction.
Limitations
This is a nonrandomized clinical study. The decision to repair the aortic and mitral valves was made by the operating surgeon after consideration of patient desires and findings at operation and echocardiography. Serial echocardiographic assessment of valve function was unavailable in a large number of patients, precluding an assessment of durability based on both reoperation and recurrent valve dysfunction. The primary outcomes analyzed were death and reoperation. No attempt was made to compare outcomes after double valve repair to those obtained after double valve replacement or aortic valve replacement and mitral valve repair; this comparison is part of an ongoing study. The relatively small number of patients in the study and their heterogeneity with respect to valve etiology and pathophysiology may be responsible for the inability to identify a larger number of risk factors for reoperation.
Clinical inferences and decision-making
Double valve repair should be offered to a minority of patients with combined aortic and mitral valve disease. After double valve repair, patients should be followed closely by echocardiography, as recurrent valve dysfunction is common.
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Acknowledgments |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsAppendix. Variables studied in...DiscussionReferences |
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Appendix. Variables studied in multivariable analysis of risk factors for death and reoperation |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsAppendix. Variables studied in...DiscussionReferences |
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Demography
Age (years) at operation, Gender
Cardiac comorbidity
New York Heart Association (NYHA) functional class (I to IV), History of ischemic heart disease, Left ventricular dysfunction, graded as none, mild, moderate, or severe.
Valve pathophysiology and etiology
Aortic valve
Aortic regurgitation (AR) and degree of regurgitation (grade 0 to 4), aortic stenosis (AS) and degree of stenosis (grade 0 to 6), pure aortic stenosis (AS > 1, AR < 2), pure aortic regurgitation (AS < 2, AR > 1), mixed aortic lesion (AS > 1, AR> 1). Degenerative tricuspid, degenerative bicuspid, rheumatic, annular dilatation, congenital, and endocarditis etiologies.
Mitral valve
Mitral regurgitation (MR) and degree of regurgitation (grade 0 to 4), mitral stenosis (MS) (grade 0 to 6), and degree of stenosis, pure mitral stenosis (MS > 1, MR < 2), pure mitral regurgitation (MS < 2, MR > 1), mixed mitral lesion (MS > 1, MR > 1). Degenerative, rheumatic, functional, ischemic, congenital, and endocarditis etiologies.
Combinations of valve pathophysiology
Pure aortic and mitral stenoses, pure aortic and mitral regurgitation, pure aortic regurgitation and pure mitral stenosis, pure aortic stenosis and pure mitral regurgitation, pure aortic regurgitation and mixed mitral lesion, pure aortic stenosis and mixed mitral lesion, pure mitral regurgitation and mixed aortic lesion, pure mitral stenosis and mixed aortic lesion.
Operative procedures
Date of operation, minimally invasive procedure, need for second pump run.
Aortic repair procedures
Commissuroplasty, commissure closure, commissurotomy, cusp debridement or shaving, cusp resection, cusp plication, cusp patch.
Mitral repair proceures
Annuloplasty, annuloplasty type (Carpentier-Edwards, Cosgrove-Edwards, pericardial, Duran), commissure closure, Alfieri stitch, commissurotomy, posterior leaflet quadrangular resection, sliding repair, anterior leaflet resection, leaflet debridement, leaflet patch closure, chordal transfer, chordal shortening.
Mitral repair site
Annulus, commissure, posterior leaflet, anterior leaflet.
Concomitant procedures
Coronary artery bypass grafting, tricuspid valve repair.
Intraoperative echocardiography
Use of intraoperative echo, residual aortic regurgitation (graded 
1, or 2), mitral regurgitation (graded 1, or 2 [125 of 158 patients had intraoperative echo; no patient had this procedure before 1986]).
Experience
Continuous time from July 1979 to the date of surgery (years of CCF experience).
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Discussion |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsAppendix. Variables studied in...DiscussionReferences |
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DR GILLINOV: That precise data are available and I do not have it at hand, but the 10-year freedom from reoperation if you put a pericardial valve in the aortic position in a 57-year-old is going to be better than this freedom from reoperation that we have reported after aortic valve repair. Of course, by 15 to 20 years, most of these bioprostheses will have failed.
DR ADAMS: So given that, would these patients be better served by an effort to repair the mitral valve and then an aortic valve replacement with a pericardial bioprosthesis?
DR GILLINOV: A lot of factors need to go into the decision as to what strategy you follow, but in somebody who is approaching 60 years of age, I think it is perfectly reasonable to place a bioprosthesis in the aortic position and repair the mitral valve if possible. The survival with mitral repair and aortic replacement is better than the survival with two prostheses and equal to the survival with two repairs.
DR IVAN KEITH CROSBY (Charlottesville, VA): I certainly enjoyed your presentation, and I am sure the techniques of repair that you have utilized over these 20 years with an average of 9 patients a year have varied. It seems to me from your data that most of the problems were due to recurrent aortic stenosis and the early attempts at repair were commissurotomy and debridement, and your postoperative follow-up showed that you did not have huge amounts of regurgitation but you must have had for reoperation stenosis. Could you sort out your numbers a little bit and tell us some information about your techniques of repair and the late results for aortic regurgitation, namely, your leaflet reconstruction or extending your leaflets? I would be very interested in what you feel about that in the year 2001. Thank you very much.
DR GILLINOV: I think your question centers on the issues of aortic valve repair: how to do it and for whom. You are correct. Early on we did have many patients with some element of aortic stenosis in whom we attempted aortic valve repair. We have since abandoned aortic valve repair in patients with aortic stenosis, even if the predominant lesion is regurgitation. If there is an important component of stenosis, durability is jeopardized. So now we concentrate on repairing regurgitant aortic valves, and the ideal regurgitant aortic valve for repair is a bicuspid valve with prolapse of the conjoined cusp. In that situation, our 7-year freedom from reoperation is about 85%. It is lower if it is a tricuspid regurgitant aortic valve with prolapse, because those valves are more difficult to repair. If you leave the operating room with any degree of aortic regurgitation after repair, durability is jeopardized. So the ideal patient has a bicuspid, regurgitant, degenerative valve, and gets a repair that is perfect. That will give the optimal durability for aortic valve repair.
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