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Ann Thorac Surg 2006;82:819-826
© 2006 The Society of Thoracic Surgeons

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Original article: Cardiovascular

Survival Advantage and Improved Durability of Mitral Repair for Leaflet Prolapse Subsets in the Current Era

Division of Cardiovascular Surgery, Mayo Clinic College of Medicine, Rochester, Minnesota

Accepted for publication March 29, 2006.

^_* Address correspondence to Dr Suri, Division of Cardiovascular Surgery, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905. (Email: suri.rakesh{at}mayo.edu).

Presented at the Poster Session of the Forty-second Annual Meeting of The Society of Thoracic Surgeons, Chicago, IL, Jan 30–Feb 1, 2006.

	Abstract

Top Abstract Introduction Patients and Methods Results Comment References

 
BACKGROUND: Factors predicting long-term survival and reoperative risk after mitral valve repair for subsets with prolapse involving the anterior leaflet in the current era are unclear.

METHODS: Between January 1, 1980 and December 31, 1999, surgical correction of mitral regurgitation was performed in 2,219 patients. We analyzed a subset of 1,411 patients with isolated mitral regurgitation due to leaflet prolapse undergoing mitral repair or replacement (± coronary bypass).

RESULTS: Mean age was 64 years, and 1,003 (71%) were men. Mitral repair was performed in 1,173 (83%) patients. Factors independently predicting overall long-term survival included valve repair, younger age, better functional class, and the absence of significant coronary artery disease. After adjusting for these, smaller preoperative left ventricular end-systolic dimension and greater preoperative ejection fraction were associated with superior survival. Mitral reoperation occurred in 97 patients (75 repairs, 22 replacements), at a mean of 4.8 years after initial procedure. Cumulative risk of reoperation was similar for patients having valve repair or replacement. Factors predictive of need for reoperation after initial repair were younger age, anterior leaflet prolapse, chordal shortening, no leaflet resection, no prosthetic annuloplasty, greater than mild residual mitral regurgitation, and coronary artery disease. After valve replacement, the sole determinant of reoperation was use of a biological prosthesis. The durability of repair for prolapse of the anterior leaflet improved significantly during the second decade of the study.

CONCLUSIONS: Mitral repair affords superior long-term survival, with permanence comparable with mechanical valve replacement. In all categories of mitral leaflet prolapse, durability of valve repair has improved over the past decade.

	Introduction

Top Abstract Introduction Patients and Methods Results Comment References

 
The survival benefit associated with early surgical correction of severe mitral valve regurgitation (MR) before symptom onset, marked dilation of left heart dimension, or fall in ejection fraction (EF) has been well established [1–3]. Although the durability of mitral valve (MV) repair and replacement are similar, the survival advantage afforded by repair is clearly superior overall. It is still uncertain, however, which clinical and echocardiographic parameters are most important in determining the optimal timing of MV surgery, and whether outcomes are similar among all categories of leaflet prolapse. Moreover, there are few reports examining the updated results of MV surgery during the past decade, an era during which new valvuloplasty techniques have been applied to correct prolapse involving the anterior leaflet (AL) [4, 5]. The purpose of this study was to investigate the determinants of survival and reoperation after MV repair and replacement of routine posterior leaflet (PL) prolapse and more complex disease involving the AL in the current era.

	Patients and Methods

Top Abstract Introduction Patients and Methods Results Comment References

 
This was a retrospective review of patients undergoing primary surgical correction of MV insufficiency (repair or replacement) for regurgitation due to leaflet prolapse. The study was reviewed and approved by the Mayo Clinic Institutional Review Board (IRB). As per IRB ruling, the need for individual patient consent was waived due to the fact that data were stripped of relevant identifiers. Those who requested not to participate in clinical research were excluded. Also excluded from the study were those patients having valve leakage caused by ischemic heart disease or other forms of cardiomyopathy, patients with associated MV stenosis, patients with endocarditis causing leaflet defects-subvalvar abscess, and those who had previous MV surgery or concomitant cardiac procedures. We included patients having valve repair in conjunction with coronary artery bypass grafting (CABG) and closure of a secundum atrial septal defect-patent foramen ovale. Patients undergoing CABG were classified as having significant coronary artery disease (CAD).

Between January 1, 1980 and December 31, 1999, a total of 2,219 patients underwent surgical correction of MR at the Mayo Clinic Rochester. The subset of 1,411 patients with regurgitation due to leaflet prolapse meeting the above criteria form the study cohort.

Demographic, morphologic, echocardiographic, and surgical data were obtained from hospital records and a prospectively accrued database entered into the SAS system (SAS Institute, Inc, Cary, NC). Recent cross-sectional follow-up was obtained through the Mayo Survey Research Center by means of telephone calls and written correspondence. Those lost to follow-up or who refused further questionnaires had their last observed episode used for calculation purposes. The mean duration of follow-up in those surviving operation was 6.8 years.

Surgical Procedure
Indications for operation as well as surgical methods evolved during the 20-year period. During the second decade of the study, we adopted a strategy of earlier MV repair for regurgitation due to leaflet prolapse, based upon quantitative echo criteria [2]. The most frequent lesion for which patients underwent surgical correction of MR at the Mayo Clinic was isolated posterior leaflet prolapse of the middle scallop, caused by either chordal elongation or chordal rupture. The most common repair carried out was triangular resection and suture repair of the involved portion of the posterior leaflet supplemented by a standard length (63 mm) flexible posterior annuloplasty band [6, 7]. In the first decade of the study, anterior leaflet prolapse was corrected by chordal shortening, chordal transfer, or commissural annuloplasty. In the current era (1990s), we have utilized insertion of artificial Gore-Tex neochordae (W.L. Gore Assoc, Flagstaff, AZ) [4, 8] for repair of anterior leaflet prolapse.

Among the 238 patients undergoing MV replacement, 128 (54%) received a mechanical valve and 110 (46%) had a bioprosthesis. During valve replacement, chordal preservation was documented in 157 patients (66%).

Reoperation
Patient records, outside documentation, and follow-up surveys were reviewed to determine late clinical events. Patients requiring cardiac reoperation were separated into those requiring mitral specific versus other nonmitral procedures. In the analysis of risk of reoperation, we included only reoperation on the MV or prosthesis. Mitral reoperation was documented in 97 patients (75 had initial repair, 22 had initial replacement), at a mean of 4.8 years after initial operation.

Statistical Analysis
Group statistics were expressed as mean ± 1 standard deviation. Categoric variables were compared between groups using the ² test for independence. Analysis of variance was used to compare continuous factors between groups. Survival and reoperation endpoints were estimated using the Kaplan-Meier method. Multivariate models to identify potential risk factors for these endpoints were investigated using Cox proportional hazards and were constructed using stepwise selection in two stages. The first stage utilized only clinical variables as potential predictors. The second stage analyzed the importance of echocardiographic (echo) variables, which was necessary to account for the inability to collect all measurements from each study. Each of the second-stage variables was forced into the final clinical model to determine importance. P values less than 0.05 were considered significant.

	Results

Top Abstract Introduction Patients and Methods Results Comment References

 
Baseline Characteristics
In Table 1, baseline characteristics of patients are stratified according to the patterns of leaflet prolapse. Those with isolated AL prolapse had poorer functional class, lower EF, larger left ventricular end systolic dimension (LVESD), and a greater prevalence of both significant CAD and preoperative MI. Patients with involvement of only the AL also had a decreased repair rate compared with those having either isolated PL or bileaflet (BL) prolapse.

View larger version (20K): [in this window] [in a new window]   Fig 1. Probability of survival (death from any cause) among patients having mitral valve repair versus replacement divided into leaflet prolapse groups. Zero time on abscissa represents time of surgery and numbers at the bottom indicate patients at risk. (solid line = repair; broken line = replacement; AL = anterior leaflet; BL = bileaflet; HR = hazard ratio for survival of replacement group compared with repair group; PL = posterior leaflet.)

View larger version (12K): [in this window] [in a new window]   Fig 2. Probability of reoperation (mitral specific) after mitral valve repair versus replacement (biological or mechanical prosthesis). Zero time on abscissa represents date of operation and numbers at the bottom of the figure represent patients at risk. (Heavy solid line = biological prosthesis, HR = 2.4, *p = 0.0016; light solid line = mechanical prosthesis, HR = 0.7; broken line = repair; HR=hazard ratio for reoperation compared with repair group.)

View larger version (24K): [in this window] [in a new window]   Fig 3. Risk of reoperation (mitral specific) after mechanical mitral valve replacement (light solid line} versus repair subsets: isolated AL (dashed line), PL (dotted line), or BL (heavy solid line). The analysis is divided into three phases: A: overall 1980 to 2000; B: 1980 to 1989 (1980s); and C: 1990 to 2000. Zero time on abscissa represents date of operation and numbers at the bottom of the figure represent patients at risk. (AL = anterior leaflet; BL = bileaflet; HR=hazard ratio for reoperation compared with mechanical replacement group; PL = posterior leaflet.)

View larger version (11K): [in this window] [in a new window]   Fig 4. Linearized risk of reoperation (mitral specific) for patients undergoing surgical correction of MR in the 1990s. Results from the current era demonstrate that PL repair has the lowest risk of reoperation at 0.5% per year followed by mechanical valve replacement (0.66% per year), BL repair (0.92% per year), and AL repair (1.64% per year). (Filled bars = repair groups; unfilled bar = mechanical replacement group; AL = anterior leaflet; BL = bileaflet; MR = mitral repair; PL = posterior leaflet.)

	Comment

Top Abstract Introduction Patients and Methods Results Comment References

Survival Advantage of Valve Repair
Several series have demonstrated that MV repair bestows clear early [1, 2, 9–12] and late survival advantage over valve replacement, and that repair returns patients to a normal life expectancy [1, 3, 9, 11, 13]. Our findings are in agreement with these studies; the 30-day mortality after repair was 0.7%, while after replacement it was 5.6% (Table 2). This trend continued, with survival at 5, 15, and 15 years after repair being superior to valve replacement. The survival advantage of repair is similar in magnitude to data published previously by ourselves [2, 3, 9, 11] and others [1, 13–15].

In order to determine the predictors of increased survival after surgical correction of MR, we performed univariate and multivariate analyses of clinical and echocardiographic variables. As shown in Table 3, survival after surgical correction of MR was improved in patients having MV repair, who were younger and less symptomatic preoperatively (lower NYHA class). Each of these has been designated as important in predicting long-term survival in prior studies [1, 2, 11, 16]. After adjusting for these factors, increased preoperative EF and decreased LVESD were both associated with improved survival [17–19].

Although it has been established for some time that MV repair is preferable to replacement in optimizing early and late survival, the advantage seen in various subgroups of leaflet prolapse is still uncertain. This study suggests a definite survival benefit after repair of isolated PL or BL disease (Fig 1), but the advantage is less certain after repair of isolated AL prolapse; it is possible that the difference in outcome may become apparent with additional follow-up. Similar findings have been demonstrated in previous studies [3, 20]. The diminished longevity of patients with AL prolapse might be explained by differences in preoperative risk factors (Table 1). This hypothesis is supported by that fact that although isolated AL prolapse predicted excess mortality univariately (HR = 1.445, p = 0.02), it was not an independent predictor in the multivariate model. Variables such as poorer functional class, greater prevalence of significant CAD-preoperative MI, diminished EF, and larger LVESD might account for the inferior long-term survival of these patients. These factors are largely consistent with the hypothesis that patients with isolated AL prolapse underwent surgical correction at a later period in their disease progression. It is possible that the perception of a diminished likelihood of successful repair of the AL compared with isolated PL or BL disease may have resulted in a bias toward later referral of these patients. We are unable to address this hypothesis in the current study, which would require a prospective randomized trial for definitive assessment.

Repair of All Leaflet Subsets is as Durable as Mechanical Replacement
Several studies have searched for factors contributing to the durability of MV repair [1, 3, 13, 21–23] and have identified modifications that have led to improvement in the current era [3]. The present study analyzes a large homogeneous population of patients with isolated MR due to leaflet prolapse over 20 years. These features are important in drawing accurate conclusions regarding the failure rate of MV repair. Additionally, although others have followed the echocardiographic endpoint of MR recurrence after repair [24], we continue to feel that the most important clinical determinant of surgical durability is the need for MV-specific reoperation. Mitral valve reoperation after repair was as low as that found after replacement. Moreover, repair versus replacement was not an independent predictor of mitral reoperation after surgical correction of MR by multivariate analysis. Risk factors for reoperation overall, using multivariate analysis, included increasing degrees of residual predischarge MR, isolated AL prolapse, BL prolapse, and the presence of significant CAD. Independent predictors of reoperation after repair were younger age, AL prolapse, chordal shortening-transfer, no leaflet resection, no prosthetic annuloplasty, increasing degrees of predischarge MR, and the presence of significant CAD. The majority of these factors have been implicated in prior reports [3]. The identification of young age as a predictor for reoperation might be explained by the increased number of years the repair is at risk.

An unexpected finding was that significant CAD is an independent predictor of reoperation after mitral valve repair. It may be that patients with significant CAD may develop some degree of chronic ischemia, possibly predisposing them to progressive ventricular dilation, altering MV geometry and leading to recurrent MR. We have no data to either support or refute this hypothesis at the current time, but the issue will be investigated in the future.

It is instructive to compare durability of MV repair to durability of specific types of valve prostheses. The only predictor of reoperation after valve replacement was the use of a biological prosthesis (Table 4). Additionally, Kaplan-Meier analysis (Fig 2) demonstrated that whereas the long-term durability of MV repair was similar to mechanical valve replacement, the risk of reoperation was substantially elevated for patients undergoing replacement with a biological prosthesis. The rate of reoperation increased markedly ten years after replacement with a biological valve. The longevity of these devices might improve in the future with novel tissue treatments, but currently there is no clear proven durability benefit over mitral repair.

We also examined the durability of valve repair by stratifying outcomes of various leaflet subsets in comparison with those patients having mitral valve replacement with mechanical prostheses. As shown in Figure 3, repair of isolated AL prolapse was associated with an elevated risk of subsequent mitral reoperation during the first decade of the study. During the second decade, durability of valve repair in all leaflet subsets improved to the extent that risk of reoperation among all categories of leaflet prolapse was similar to mechanical valve replacement (Fig 3). The linearized risk of reoperation after repair of the PL was 0.5% per year, approximately half that for a BL procedure (0.92% per year), and a third of that for an AL repair (1.64% per year). These findings do not support the perception by many clinicians that results of valve replacement for mitral prolapse are more predictable as regards subsequent risk of reoperation (0.74% per year overall).

The identification of BL prolapse as a unique entity has recently gained attention [20]. Our data suggest that outcome of correction of BL disease approaches that of PL repair. It may be that there are structural [25] and physiologic implications of severe AL prolapse, which are distinct from those prevalent when the PL is involved.

The evolution of mitral valvuloplasty techniques in to the current era have been well described [6, 20, 23, 26], and we believe that these improvements have led to better outcome of repair for all subsets [3]. In the current analysis, we have found substantially better durability of AL repair in the most recent decade compared with results from the 1980s. Indeed, the durability of AL repair is currently statistically indistinguishable from repair of other leaflet subsets and mechanical valve replacement (Fig 3). Our approach to a repair of anterior leaflet prolapse can be summarized as follows. For patients with diffuse anterior leaflet prolapse where the free edge of the leaflet overrides the posterior leaflet along a broad plane, we initially perform posterior annuloplasty (trigone to trigone) with a flexible band 63 mm in length; this is sufficient for most such patients. When there is segmental prolapse of the anterior leaflet as occurs with ruptured or elongated groups of chords, we favor insertion of polytetrafluorethylene (Gore-Tex) neochordae [8]. In selected patients, small areas of anterior leaflet prolapse are corrected with limited triangular resection [27]. The edge-to-edge repair is rarely used as a primary technique but may be useful to supplement the above methods when there is residual leakage [28]. We have largely abandoned use of chordal shortening and chordal transfer although others still report satisfactory results with these techniques.

Limitations
This retrospective analysis has inherent limitations. Follow-up data were obtained from hospital records, outside reports, and survey information; many patients live some distance from our Clinic and do not come for regular care. We have, however, made every effort to obtain important clinical information on those patients. We recorded death as obtained through hospital records and social security database information; these data are accurate but incomplete as to cause of death. Multivariable analyses were employed to control for disparities in preoperative risk factor profiles. Although valid, this method cannot account for other factors, such as surgical judgment and referral bias, that may influence outcome. Finally, we acknowledge that the most objective method to assess durability of mitral valvuloplasty would be to follow recurrence of MR over time by echocardiography. In reality, such tracking of healthy patients is impractical in a large cohort such as this. It may be that our study, and others like it, underestimate the failure of repair as judged by recurrent valve leakage, but we believe that the recurrence of significant MR and referral for surgical assessment are closely linked in our patient population.

Conclusion
Mitral valve repair for leaflet prolapse restores longevity to that expected in the normal population and yields better survival compared with valve replacement using either a mechanical or biological prosthesis. Moreover, the previously held perception that valve replacement is more predictable and durable is no longer valid. Our data indicate that the durability associated with repair of all leaflet subsets has improved over time, and now approximates or exceeds the benchmark permanence of mechanical valve replacement. The standardization of simplified valvuloplasty techniques has led to a decrease in the risk of reoperation after AL repair. These outcomes support the strategy of performing MV repair for all types of leaflet prolapse causing severe MR early before symptom onset and deterioration in left ventricular size or function in order to optimize long-term survival.

	References

Top Abstract Introduction Patients and Methods Results Comment References

 

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