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Ann Thorac Surg 2002;74:1468-1475
© 2002 The Society of Thoracic Surgeons

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Original article: cardiovascular

Can late survival of patients with moderate ischemic mitral regurgitation be impacted by intervention on the valve?

^a The Minneapolis Heart Institute, Minneapolis, Minnesota, USA
^b Mayo Clinic, Rochester, Minnesota, USA
^c Washington University School of Medicine, St. Louis, Missouri, USA

Accepted for publication June 17, 2002.

* Address reprint requests to Dr Sundt, Mayo Clinic, 200 First St, SW, Rochester, MN, 55905, USA.
e-mail: sundt.thoralf{at}mayo.edu

	Abstract

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
BACKGROUND: Ischemic mitral regurgitation is known to be associated with poor long-term outcome after coronary artery bypass grafting; however, our ability to alter that outcome with intervention on the valve is unclear. The decision to address the valve is most challenging for patients with only moderate mitral regurgitation, particularly with the popularization of off-pump surgery. We therefore reviewed early and late outcomes of patients undergoing revascularization with or without mitral valve surgery.

METHODS: Patients with moderate mitral regurgitation undergoing revascularization with and without mitral surgery between January 1991 and September 1996 were identified retrospectively. Operative notes were reviewed and patients with structural valve disease excluded. Perioperative events and late outcomes as determined by telephone contact and search of the social security death index (survival data 97% complete) were compared.

RESULTS: One hundred seventy-six patients with moderate mitral regurgitation underwent revascularization alone (n = 142) or with mitral repair or replacement (n = 34). Those undergoing revascularization alone had a higher serum creatinine, somewhat less mitral regurgitation, and lower New York Heart Association functional class preoperatively. Operative mortality was greater with valve surgery (21% vs 9%, p = 0.047). Actuarial survival of both groups at 5 years was similar (52% vs 58%, p = NS); however, when stratified by preoperative functional class, those with more advanced heart failure preoperatively had superior late survival if their mitral valve was intervened upon.

CONCLUSIONS: The late survival of patients with ischemic mitral regurgitation undergoing coronary revascularization remains poor; however, intervention on the mitral valve appears to benefit those with symptomatic heart failure.

	Introduction

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The management of ischemic mitral regurgitation (MR) remains controversial. Patients with significant MR in the setting of coronary artery disease (CAD) have a dismal long-term prognosis whether treated medically or surgically [1–3], and those with MR of at least moderate severity may represent a higher risk surgical group [4, 5], although this is debated by some [6–8]. Furthermore, patients with postoperative MR exhibit worse late survival that those without [9]. It is uncertain, however, whether the MR represents a marker for poor outcome, or is causal. If the latter is the case, outcomes may be improved by correcting the valvular incompetence.

Historically, the debate over the prudence of adding a mitral valve procedure to coronary bypass has centered on the incremental increase in operative risk imposed by a more complex procedure [10–12]. With more recent improvements in perioperative management and myocardial protection as well as refinement of simplified techniques for repairing the incompetent mitral valve in the setting of ischemic disease, this incremental risk is likely less today than previously [7]. The lower risk observed in contemporary series may also be in part due to more widespread application of the procedure. The mortality observed in any retrospective, nonrandomized surgical series will vary, within limits, depending upon selection criteria imposed for the utilization of that procedure. If the procedure is reserved only for the most ill patients, as was mitral repair or replacement in the past, the apparent risk will be high, whereas more liberal application will result in a lower apparent incremental risk. Whatever the actual additional risk, mitral valve repair or replacement is only worthwhile if it can positively impact outcome.

The greatest clinical challenge is in the management of moderately severe MR. In most circumstances, patients with severe MR are likely to undergo mitral intervention, whereas those with only mild MR likely will not. Therefore, with the aim of examining the impact of correcting moderate MR in the setting of ischemic heart disease on late outcomes, we reviewed the results of coronary artery bypass (CAB) alone and CAB with mitral valve repair or replacement over a 5-year period.

	Material and methods

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Study population
Patients with coronary artery disease and coexistent moderate (2+ or 3+) MR undergoing CAB at Barnes-Jewish Hospital between January 1991 and September 1996 were identified using the computerized databases of the division of cardiothoracic surgery at Washington University. All operative notes were reviewed by a single surgeon (TMS) for the description of the valve and details of the repair in order to exclude those with structural (ie, myxomatous or rheumatic) mitral disease and incidental coexistent CAD. Patients were also excluded if they underwent other concomitant surgical procedures or had coexistent mitral stenosis or aortic valve disease (defined as moderate or greater aortic insufficiency or aortic stenosis with aortic valve area less than 1 cm).

The grade of MR was based on the interpretation of preoperative ventriculography from cardiac catheterization or transthoracic echocardiography using the criteria conventional at the time at this institution [13, 14]. Hence, in most instances, this assessment was made by a third-party cardiologist uninvolved in the clinical care of the patient. Quantitative echocardiography was not the standard of care at Washington University during the study interval, nor were transesophageal echocardiograms routinely performed or systematically interpreted. Although not quantitative, these data were those available to the clinician at the time the surgical decisions were made. In cases of discrepant grading by ventriculography and echocardiography, the greater severity was accepted for this study. The demographic characteristic and clinical variables of the study population are shown in Tables 1 and 2.

All procedures were performed using cardiopulmonary bypass (CPB) with moderate hypothermia and cardioplegic arrest. As shown in Table 3, in the majority of cases, the mitral valve was repaired with an annuloplasty band or ring. In a small number of cases, mitral valves were replaced with mechanical or biological prostheses, again at the discretion of the operating surgeon.

Statistical methods
Descriptive statistics are listed with the means ± standard deviation and percentages for categorical variables. The two treatment groups were compared by means of nonparametric tests: Wilcoxon’s rank sum test for continuous and Fisher’s exact test for binomial baseline variables. Cochran-Mantel-Haenszel method for 2 x 2 tables was used for risk ratios. Stepwise logistic regression allowed multivariate discrimination between the two CAB groups. The calculated probability to undergo CAB alone instead of CAB plus mitral intervention served as a propensity score. For univariate survival analyses, subgroups were compared by log-rank tests. For multivariate survival analyses, Cox’s proportional hazard model was employed with stepwise regression. Only variables with p values less than 0.1 in univariate analyses were considered for a multivariate model. The selection process was terminated when none of the remaining variables would contribute significantly (p < 0.05) to the multivariate model or when the not-yet-selected variables, as a group, would not contribute much (p > 0.2) to the model. A p value (two-sided) larger than 0.05 was interpreted as likely due to random variability. As the group undergoing mitral intervention may have represented a somewhat sicker patient population given the severity of MR, a subset of patients from the CAB alone group was matched in the ratio 2:1 to patients in the combined procedure group with regard to MR severity (grade 2 vs 3), New York Heart Association (NYHA) functional class (> 1), and ejection fraction (< 40%). Groups were then evaluated in the Cox model for predictors of survival. Late follow-up echocardiographic data were partitioned by interval using Probit analyses.

	Results

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During the study interval, 3,512 patients underwent CAB alone and 122 underwent CAB with mitral repair or replacement at Washington University. Of these, 176 had moderate MR on preoperative studies, including 142 who underwent CAB alone and 34 who underwent CAB with mitral valve repair (n = 29) or replacement (n = 5). Because of the already small numbers, patients undergoing both repair and replacement were included.

The two groups were similar with respect to most baseline variables (Tables 1 and 2). Ejection fractions were similar, although patients undergoing intervention on their mitral valve had a somewhat higher mean grade of MR possibly disguising somewhat worse ventricular function in this group. Left ventricular end-diastolic pressures, however, were not statistically significantly different. Pulmonary artery pressure data were available in only 40 patients. Among them, there was no difference in pulmonary artery pressure between the patients undergoing CAB (48.6 ± 17) compared with patients undergoing CAB/MV (42.8 ± 15.5, p = NS). The CAB + MVR group also more often had NYHA class III or IV symptoms and was more likely to have had a previous CAB procedure. Patients undergoing CAB alone more often had an elevated serum creatinine. A propensity analysis identified MR severity (odds ratio [OR] 11.3, p = 0.0001) and NYHA class (OR 2.46, p = 0.001) as the driving variables associated with the choice of operative procedure.

Operative variables are listed in Table 3. There were no differences between groups with respect to use of left internal thoracic artery or the number of distal anastamoses. Cardiopulmonary bypass and aortic occlusion times were longer in the combined procedure group.

Operative risk
The operative risk observed in this subset of patients was significant: 9% for CAB alone versus 21% for the combined procedure (p = 0.047). This is higher than one would expect in the current era, and may in part have been attributable to the unstable status of 95% of patients undergoing CAB and 93% of those undergoing the combined procedure (Table 1). In this study, unstable status was defined as myocardial infarction (MI) within 2 weeks or unstable angina pectoris requiring intravenous heparin or nitroglycerine. This population reflects the referral pattern to Washington University at the time of the study. This interpretation is supported by the observation that over two-thirds of patients had experienced a prior MI, and when patients were stratified according to the presence of MI, the difference in mortality within the first 30 days with repair was even more pronounced (OR 3.7, p = 0.018).

Univariate predictors of 30-day mortality are shown in Table 4. Of note, neither NYHA classification nor severity of MR was a significant predictor of early mortality. In the multivariate model, creatinine and CBP time were confirmed as independent risk factors for death within 1 month of surgery; however, the choice of surgical procedure was not a risk factor for death in either analysis. It is possible that CPB time was a surrogate for intervention on the valve, although we would have expected aortic cross-clamp time to be even more strongly associated and it was not a predictor of death. This may relate to the institutional philosophy of prolonged reperfusion on bypass after removal of the cross-clamp in cases in which the heart was "struggling" to get off pump. We therefore believe that prolonged CPB time is a marker for poor ventricular function and, therefore, survival.

Late survival
Late survival was, as expected, rather disappointing in both groups. As shown in Figure 1, there was no statistically significant difference between groups in late survival. The median survival was 5.0 years for the CAB alone and 4.9 years for the CAB + MVR group (p = NS). Although the curves separate in the early hazard phase, they are remarkably similar in the later phase. By univariate analysis (Table 7), the strongest predictors of long-term mortality included elevated serum creatinine, NYHA class, diabetes, and preoperative cerebrovascular disease (CVD). In multivariable analysis, NYHA class dropped out, but elevated creatinine, history of cerebrovascular disease, and diabetes remained significant. Cardiopulmonary bypass time was significant in both analyses, but procedure was not in either. Because of the high operative mortality in the CAB with mitral intervention group, we were concerned that predictors of operative death might dominate the analysis. We therefore repeated the analysis, eliminating the operative deaths. The results were unchanged, with Cox regression yielding elevated serum creatinine (RR = 3.0, p = 0.0001), diabetes mellitus (RR1.8, p = 0.02), and CVD (RR2.1, p = 0.006) as predictors of late death. In this analysis, CPB time was no longer significant. The choice of procedure was, again, not predictive.

View larger version (24K): [in this window] [in a new window]   Fig 1. Actuarial survival for patients with moderate mitral regurgitation undergoing coronary artery bypass surgery (CAB) with and without valve repair or replacement. Actuarial survival curve is shown for patients with moderate mitral regurgitation undergoing CAB or CAB plus mitral repair or replacement (CAB/MVR). Survival is similar (p = NS). Data regarding late survival were obtained for 97% of the study group. Five patients were lost to follow-up as of May 1, 1998, with 2 of them being alive at last follow-up date. The mean follow-up for the CAB alone group was 5.1 ± 0.3 (range 0 to 9) years and that for the combined procedure group was 4.7 ± 0.6 (range 0 to 8.1) years (p = NS).

A significant difference in late survival was detected, however, when patients were stratified by preoperative functional class, as shown in Figure 2. Despite small numbers, the subgroup of 21 patients with NYHA class III or IV failure undergoing CAB alone had significantly worse late survival than the subgroup of 14 patients of similar functional class in whom the mitral valve was addressed (p = 0.005, log-rank). On the contrary, for those with NYHA class I or II symptoms, valve repair or replacement had no apparent effect. The same result was obtained when considering only operative survivors. When only patients with serum creatinine less than 1.6 gm/dL were considered, the result was even more striking, with the p value dropping to 0.026. The same result was obtained among the patients matched for the severity of MR in the subset analysis noted above. This difference was not apparent when the stratification was performed by ejection fraction less than 30% rather than NYHA class, perhaps because ejection fraction is favorably influenced by worse mitral regurgitation (data not shown). Information regarding postoperative use of ACE inhibitors was unavailable for the study groups.

View larger version (31K): [in this window] [in a new window]   Fig 2. Actuarial survival in patients with moderate MR undergoing CAB or CAB + MVR stratified by NYHA class. Survival for the two groups for patients undergoing CAB or CAB + MVR is stratified by NYHA classification (p = 0.005). (CAB = coronary artery bypass; MR = mitral regurgitation; MVR = mitral valve repair or replacement; NYHA = New York Heart Association.)

	Comment

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
The principle finding of this study is that intervention on the mitral valve likely improved survival over CAB alone in patients with advanced heart failure symptoms. Although this has been argued previously by others, there are little previous data comparing the survival of patients who do and do not undergo valve repair or replacement. The data presented here do not demonstrate a positive impact on survival of valve repair or replacement in the setting of lesser degrees of failure symptoms, although the numbers of patients are quite small, making it possible that such an effect was not detected. In addition, consonant with previous studies, a significant number of patents undergoing CAB alone continued to have moderate MR postoperatively. Although serial studies on the same patients were not available, comparison of the results of echocardiograms taken early and late postoperatively suggests progression of MR in the CAB alone group, with an increasing incidence of significant MR with time. In contrast, although a disappointing percentage of patients continued to have moderate MR after repair, this number appeared stable with time.

The operative risk observed in this study was significant, particularly in the combined surgical group, and may dissuade some from pursuing valve repair despite the demonstrated late survival advantage. Although the mortality observed in our study was within the 3% to 11% range reported previously by some authors for CAB alone in the presence of moderate MR [10, 16–18], and the 9% to 25% reported for combined procedures [8, 10, 17, 19–21], they are somewhat higher than several more contemporary series [6, 7, 22, 23]. This is likely in part explained by the unstable presentation of more than 90% of patients in this study, a recognized marker for a higher risk group [21, 24]. It should also be noted that contemporary thinking favors a somewhat simpler approach than previously, with undersized simple annuloplasty favored over valve replacement. Although there is controversy on this [19–21], it is possible that this too would reduce the operative risk of the combined procedure.

Several smaller previous studies focused on mitral regurgitation of moderate severity have shown heart failure classification to be a univariate predictor of long-term mortality [10, 18]. The earlier series have also suggested that MR severity and ejection fraction are important predictors [10, 18]. We did not find MR (2+ vs 3+) severity to be an important predictor of outcome, although, in contrast to the earlier studies [17, 18], we excluded the patients with severe MR and those with mild MR [17]. Because of this study design, the difference between 2 and 3+ MR is likely not discriminant enough to show a difference in outcome, particularly given the small number of patients in the study. Of note, the variables of creatine and diabetes, which we found significant predictors, were not systematically addressed in earlier comparisons. Our data are also in keeping with previous studies, which showed higher mortality if the revascularization arm included significant numbers of patients with advanced heart failure symptoms [10, 18]. In these studies, like ours, patients were more likely to undergo repair/replacement if they had a greater degree of mitral regurgitation [10, 17, 18] or a greater degree of heart failure symptoms [10, 17]. Finally, it should be noted that the 5-year survival of patients treated in our series with either approach was poor, but was comparable with that seen in other series [17–21].

Limitations
This study suffers from a number of limitations; principal among them is the relatively small number of patients available for analysis and the relatively short follow-up interval. Despite this, there was a demonstrable difference in survival for patients with advanced heart failure symptoms when the mitral valve was addressed surgically. This difference is even more striking given the other limitations of the study, including a high operative mortality rate and incomplete follow-up echocardiographic data to ensure adequate correction of MR in the repair group. Both of these should bias the results against addition of valve repair.

In addition, the study is limited by its retrospective nature and incomplete data sets. Like other retrospective, nonrandomized studies, it is potentially confounded by selection bias. Although a large number of clinicians were involved in the decision-making in an environment without clearly accepted guidelines, it is likely that the groups are not entirely comparable. Differences in symptoms, degree of mitral regurgitation, preoperative creatinine, and reoperative status speak to this point. In all factors save renal function, the mitral repair or replacement group appeared to be more ill than the CAB alone group.

Finally, late functional status and quality of life information were only available on a subset of patients in each group. The results were, however, all consistent with the hypothesis that valve repair improves or prevents progression of symptoms better than CAB alone. Therefore, despite these limitations, we believe these data support the notion that surgical correction of moderate mitral regurgitation at the time of CAB should be undertaken in patients with advanced heart failure with the aim of improving late functional status and long-term survival.

Clinical implications
The current ACC/AHA guidelines recommend intraoperative inspection of the mitral valve and consideration of repair when the regurgitation is 3+ or greater [25]. This approach is hindered by difficulty in quantifying MR under general anesthesia and the inherent difficulties of grading ischemic MR [26]. Obviously, mitral regurgitation is dynamic and difficult to quantitate, especially with varying afterload conditions. Our results suggest that, when confronted with a patient with moderate MR in the presence of heart failure symptoms and normal renal function, the clinician can feel comfortable recommending repair knowing that long-term outcome may be improved with this intervention. In contrast, if there is no structural abnormality to the valve and no significant CHF symptoms, the patient may do well with revascularization alone. This may be a reasonable approach, especially in cases of elevated creatinine, or known cerebrovascular disease when it is desirable to minimize or avoid cardiopulmonary bypass time. Patients with impaired renal function did poorly regardless of treatment and may represent an ideal group for off-pump techniques. These data are inconclusive regarding the value of intervention on the mitral valve in patients with lesser degrees of failure [15].

	Acknowledgments

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This work was supported in part by a Missouri Heart Association Grant-in-Aid (to Dr Harris). The subjects of this study underwent surgery at the Washington University Medical Center by the members of the Division of Cardiothoracic Surgery, Department of Surgery, Washington University School of Medicine: Hendrick B. Barner, MD, James L. Cox, MD, Thomas B. Ferguson, Sr, MD, T. Bruce Ferguson Jr, MD, William A. Gay, Jr, MD, Charles B. Huddleston, MD, Eric N. Mendeloff, MD, Michael K. Pasque, MD, Michael Rosenbloom, MD, Thomas L. Spray, MD, and Thoralf M. Sundt III, MD. We also acknowledge the thoughtful review and helpful suggestions of Drs Barry Maron and David Pryor.

	References

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