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Ann Thorac Surg 2008;85:430-437. doi:10.1016/j.athoracsur.2007.08.040
© 2008 The Society of Thoracic Surgeons
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 Restrictive Mitral Annuloplasty Cures...
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Original Articles: Cardiovascular

Restrictive Mitral Annuloplasty Cures Ischemic Mitral Regurgitation and Heart Failure

Jerry Braun, MDa,*, Nico R. van de Veire, MDb, Robert J.M. Klautz, MD, PhD, Michel I.M. Versteegh, MD, Eduard R. Holman, MD, PhDb, Jos J.M. Westenberg, PhDc, Eric Boersma, PhDd, Ernst E. van der Wall, MD, PhDb, Jeroen J. Bax, MD, PhDb, Robert A.E. Dion, MD, PhDa

a Department of Cardiothoracic Surgery, Leids Universitair Medisch Centrum, Leiden, the Netherlands
b Department of Cardiology, Leids Universitair Medisch Centrum, Leiden, the Netherlands
c Department of Radiology, Leids Universitair Medisch Centrum, Leiden, the Netherlands
d Department of Cardiology, Erasmus Medisch Centrum, Rotterdam, the Netherlands

Accepted for publication August 21, 2007.

* Address correspondence to Dr Braun, Leids Universitair Medisch Centrum, Afdeling Thoraxchirurgie K6-S, Albinusdreef 2, Leiden, 2333 ZA, the Netherlands (Email: j.braun{at}lumc.nl).

Presented at the Forty-third Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 29–31, 2007.


Adult cardiac surgery: The Annals of Thoracic Surgery CME Program is located online at http://cme.ctsnetjournals.org. To take the CME activity related to this article, you must have either an STS member or an individual non-member subscription to the journal.

 

   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 References
 
Background: Restrictive mitral annuloplasty with revascularization is considered the best approach to ischemic mitral regurgitation with heart failure, but late results are controversial. We report late outcome in relation to preoperative left ventricular end-diastolic diameter (LVEDD) cutoff values, previously identified to predict intermediate-term left ventricular reverse remodeling.

Methods: One hundred consecutive ischemic mitral regurgitation patients underwent restrictive mitral annuloplasty (stringent downsizing by two ring sizes; median size, 26) and coronary revascularization. Survivors were clinically and echocardiographically assessed at intermediate (18 months) and late (mean, 46 months) follow-up.

Results: Early mortality was 8%, and late mortality was 18%. Actuarial 1-, 3-, and 5-year survival rates were 87% ± 3.4%, 80% ± 4.1%, and 71% ± 5.1%. Mortality predictors (Cox regression) were preoperative inotropic support (hazard ratio, 6.2; 95% confidence interval, 2.3 to 16.9) and preoperative LVEDD greater than 65 mm (hazard ratio, 4.5; 95% confidence interval, 1.9 to 10.9). Five-year survival rate for patients with LVEDD of 65 mm or less was 80% ± 5.2%, versus 49% ± 11% for LVEDD greater than 65 mm (p = 0.002). At 4.3 years’ follow-up, New York Heart Association functional class had improved from 2.9 ± 0.8 to 1.6 ± 0.6 (p < 0.01). Mitral regurgitation grade was 0.8 ± 0.7, and was less than grade 2+ in 85% of patients. Left ventricular reverse remodeling was sustained with time for the LVEDD of 65 mm or less group. Late deaths did not show intermediate-term systolic left ventricular reverse remodeling, indicating a more extensive intrinsic left ventricular abnormality.

Conclusions: At 4.3 years’ follow-up, intermediate-term cutoff values for left ventricular reverse remodeling proved to be predictors for late mortality. For patients with preoperative LVEDD of 65 mm or less, restrictive mitral annuloplasty with revascularization provides a cure for ischemic mitral regurgitation and heart failure; however, when LVEDD exceeds 65 mm, outcome is poor and a ventricular approach should be considered.


Dr Dion discloses that he has a financial relationship with Edwards Lifesciences.

 

The deleterious effects of ischemic mitral regurgitation (MR), often accompanied by heart failure and leading to excess mortality, are well known [1, 2]. Although there is no evidence from randomized trials, observational studies have shown that treatment of ischemic MR by mitral valve repair and coronary artery bypass grafting leads to a better outcome with regard to recurrence of MR than coronary artery bypass grafting alone [3–6], but there is still debate with regard to survival benefit [4–8], which is also reflected in the latest American College of Cardiology/American Heart Association Guidelines [9].

The pathophysiology of ischemic MR is complex, and its poor outcome is related to left ventricular (LV) injury as a consequence of remodeling [10]. Although it is the ventricle that is diseased, the resulting functional MR can be successfully treated by a relatively simple intervention on the valve, ie, undersizing the mitral annulus by a restrictive mitral annuloplasty [11, 12]. In our institution, this means implanting a complete semirigid annuloplasty ring two sizes smaller than that which would be normally used if the patient had degenerative disease. We have reported a favorable clinical outcome and reverse left atrial and LV remodeling at 18 months’ follow-up in a subset of patients, namely those with a preoperative LV end-diastolic dimension (LVEDD) of 65 mm or less [13, 14]. However, the long-term benefit of mitral valve repair in ischemic MR is debated [7, 15].

In the present study, long-term clinical and echocardiographic outcome up to 7 years’ follow-up (mean follow-up, 4.3 years) in a consecutive series of 100 patients has been evaluated. We tried to identify predictors for early and late mortality, and to correlate late outcome with intermediate findings.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Discussion
 References
 
Study Population
One hundred nonselected, consecutive patients with ischemic MR, who all underwent restrictive mitral annuloplasty, either combined with (n = 90) or after prior (n = 10) coronary revascularization, between January 2000 and July 2004, had clinical and echocardiographic assessment before surgery, at intermediate follow-up (18 months), and late follow-up (mean, 4.3 years; range, 2.4 to 6.8 years). All patients had coronary artery disease and MR grade 3+ or 4+ (either at resting conditions or after intraoperative provocative testing) owing to restrictive systolic leaflet motion (Carpentier type IIIb) after previous infarction (n = 95) or ischemia in the inferior or posterolateral region. Intraoperative provocative testing was performed in patients scheduled for coronary artery bypass grafting with MR grade 2+ or fluctuating MR (n = 16), as previously described [16, 17]. Patients with concomitant aortic valve surgery or requiring surgical ventricular restoration for LV aneurysm were not included. All patients had symptoms of heart failure, and the majority presented in New York Heart Association (NYHA) class III (n = 54) or IV (n = 26). Thirty-four patients were operated on in a nonelective setting. Coronary artery bypass grafting was performed in 90 patients; revascularization was not performed in 10 patients with previous coronary artery bypass grafting and patent grafts. Mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 13 ± 14. Baseline characteristics of the study population are presented in Table 1.


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  		Table 1 Preoperative Clinical and Echocardiographic Characteristics (n = 100)
 
Our institution’s ethics committee approved conducting this study and waived the need for individual consent.

Operative Technique
All surgical procedures were performed through midline sternotomy under normothermic cardiopulmonary bypass with intermittent antegrade warm-blood cardioplegia. The mitral valve was exposed through a vertical transseptal approach along the right border of the foramen ovale, leaving the left atrial roof untouched. Ring size (Carpentier-Edwards Physioring; Edwards Lifesciences, Irving, CA) was determined after careful measurement of the height of the anterior leaflet, and then downsizing by two sizes (ie, size 26 when measuring 30). Rings were inserted using 14 to 16 deep U-shaped simple horizontal sutures using Ethibond 2-0 (Ethicon, Inc, Somerville, NJ) or Ti-Cron 2-0 (Syneture, Norwalk, CT). Tricuspid annuloplasty was performed with a Carpentier Edwards Classic or MC3 ring in patients with tricuspid regurgitation exceeding grade 2+, or (from the year 2003 onward) in the presence of a dilated tricuspid annulus exceeding 40 mm (or 21 mm/m2 indexed to body surface area) on transthoracic echocardiography. Surgical data are summarized in Table 2.


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  		Table 2 Surgery Factors (n = 100)
 
All patients had intraoperative transesophageal echocardiography assessment of LV and valve function. Mitral valve repair was considered successful if there was no residual MR and a leaflet coaptation height of at least 8 mm at the A2-P2 level was achieved. If these criteria were not met, further downsizing was performed (n = 2).

Echocardiography
Preoperative echocardiographic evaluation consisted of standard transthoracic echocardiography examination performed within 5 days before surgery, including grading of severity of MR (semiquantitatively from color-flow Doppler) and tricuspid regurgitation, tricuspid annulus diameter, left atrial diameter, LVEDD, LV end-systolic diameter (LVESD), and fractional shortening (Table 1). Postoperatively, transthoracic echocardiography was repeated before discharge, at early follow-up (3 to 6 months), intermediate follow-up (18 months)—as previously reported [14]—and at late follow-up (mean, 46 months; range, 25 to 72 months; all examinations performed in our institution between February 2006 and June 2006). During postoperative transthoracic echocardiography evaluation, all preoperative variables were reassessed with the addition of transmitral diastolic gradient and leaflet coaptation height.

Clinical Assessment and Follow-Up
Preoperative clinical status was determined according to the criteria of the NYHA (for heart failure) and the Canadian Cardiovascular Society (for angina) up to 5 days before surgery. This status was reassessed at intermediate and late follow-up in the outpatient clinic, and ultimately reassessed in the first week of December 2006 by telephone interview.

Statistical Analysis
Continuous data are expressed as mean ± standard deviation unless otherwise stated, and compared using Student’s t test for paired and unpaired data when appropriate. Proportions for dichotomous data were compared by {chi}2 analysis with Yates’ correction. Where appropriate, odds ratios are presented with 95% confidence intervals (CI). Actuarial survival and other time-related events were analyzed with the Kaplan–Meier method, using Cox regression analysis to assess the contribution of different factors. Factors that were found to be significant were subsequently tested in a multivariable comparison, with outcomes presented as hazard ratios (HR). For all tests, a probability value of less than 0.05 was considered significant. We used SPSS statistical software (SPSS version 14.0.0; SPSS Inc, Chicago, IL) for calculations.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Discussion
 References
 
Successful mitral valve repair was achieved in all patients, irrespective of the degree of leaflet tethering. Median ring size was 26 (range, 24 to 32). Intraoperative transesophageal echocardiography showed a competent mitral valve in all patients with a mean leaflet coaptation height of 9 ± 2 mm. There were no cases of mitral stenosis (mean transvalvular gradient, 3.0 ± 1.2 mm Hg; mean mitral valve area, 2.8 ± 0.6 cm2). These values were independent of the ring size used.

Immediate Outcome
There was no intraoperative mortality. One patient sustained a myocardial infarction requiring emergent repeat surgical revascularization. In 15 patients, perioperative intraaortic balloon counterpulsation was used (4 already preoperatively); 12 patients required temporary hemodialysis (2 already before surgery). Mean intensive care unit stay was 6.3 ± 6.7 days.

Early mortality (all in-hospital mortality and 30-day mortality) was 8.0% (n = 8), including 4 as a result of cardiac causes, as previously reported [14].

Long-Term Clinical Outcome
Clinical follow-up was complete, with a mean duration of 4.3 ± 1.4 years (range, 2.4 to 6.8 years). Seventeen patients died during further follow-up; 10 late deaths were as a result of cardiac causes (heart failure, arrhythmias, death from unknown cause). Actuarial survival rates at 1, 3, and 5 years were 87% ± 3.4%, 80% ± 4.1%, and 71% ± 5.1%, respectively (Fig 1). Two patients underwent reoperation for recurrent MR; 1 because of progressive LV dilatation requiring further downsizing annuloplasty (12 months after the initial procedure), and 1 for partial anterior ring dehiscence requiring refixation (after 3 months). Eleven patients (12.0%) were readmitted for congestive heart failure; 6 died during follow-up. Four patients received a biventricular pacemaker or defibrillator, of whom 1 died. Four patients underwent percutaneous coronary interventions, and 1 sustained a myocardial infarction. There were no cases of endocarditis or thromboembolic events. Adverse events are presented per subgroup (based on previously described baseline LVEDD and LVESD cutoff values) in Table 3. This shows that 82% of readmissions for congestive heart failure occurred in patients with higher LVESD, and all biventricular pacemakers or defibrillators were inserted in the larger dimension groups. Mean NYHA class improved from 2.9 ± 0.8 to 1.6 ± 0.6 (p < 0.01), with only 5 patients (6.7%) in NYHA class III.


Figure 1
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  		Fig 1. Actuarial survival rate for all patients.

 

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  		Table 3 Clinical Outcomes for Different Strata of Preoperative Left Ventricular Dilatation
 
Predictors of Mortality
Potential predictors for early and late mortality were tested using logistic and Cox regression, respectively. Seven predictors for early mortality were identified, mostly indicators of a critical preoperative state, but also preoperative LVEDD greater than 65 mm (Table 4). Preoperative need for inotropic support was the strongest univariable predictor and the only multivariable predictor positively associated with early mortality (odds ratio, 19.0; 95% CI, 4.6 to 81.6).


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  		Table 4 Predictors for Mortality
 
Positive predictors of late mortality were LVEDD greater than 65 mm, enlarged left atrium, and previous anterior myocardial infarction. Postoperative increased length of intensive care unit stay, higher NYHA functional status at intermediate follow-up, and readmission for congestive heart failure also led to increased late mortality. In a multivariable analysis, preoperative LVEDD greater than 65 mm proved to be the only significant predictor (HR, 2.4; 95% CI, 1.3 to 5.4; Table 4).

Total mortality, including hospital deaths, was predicted by preoperative need for inotropic support (HR, 6.2; 95% CI, 2.3 to 16.9) and preoperative LVEDD greater than 65 mm (HR, 4.5; 95% CI, 1.9 to 10.9; Table 4). When removing the latter factor from the model, LVESD greater than 50 mm proved to be the next significant predictor (HR, 3.5; 95% CI, 1.4 to 8.7). This confirms the value of the previously identified cutoff values at long-term follow-up.

The two absolute cutoff variables for end-systolic and end-diastolic LV dimensions are used for practical purposes in the majority of patients; however, in patients with extreme values of body surface area, indexed variables might be more suitable and further analysis revealed an indexed LVEDD cutoff value of 34 mm/m2, and an indexed LVESD of 26 mm/m2.

Mortality at all times is higher in larger LV dimension cohorts. Actuarial survival rates are plotted per preoperative LV dimension cohort in Figures 2 and 3. Go For LVEDD of 65 mm or less, actuarial survival rates at 1, 3, and 5 years are 93% ± 3.0%, 87% ± 4.0%, and 80% ± 5.2%, respectively, whereas for LVEDD greater than 65 mm these rates are 71% ± 8.5%, 61% ± 9.2%, and 49% ± 11%, respectively (HR, 3.4; 95% CI, 1.5 to 7.4; p = 0.002).


Figure 2
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  		Fig 2. Actuarial survival rates for two different preoperative left ventricular end-diastolic diameter (LVEDD) cohorts, comparing LVEDD greater than 65 mm and LVEDD 65 mm or less (hazard ratio, 3.4; 95% confidence interval, 1.5 to 7.4; p = 0.002). Patients at risk per cohort are shown under the x-axis (LVEDD greater than 65 mm in bold; LVEDD 65 mm or less in regular setting).

 

Figure 3
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  		Fig 3. Actuarial survival rates for two different preoperative left ventricular end-systolic diameter (LVESD) cohorts, comparing LVESD greater than 50 mm and LVESD 50 mm or less (hazard ratio, 2.8; 95% confidence interval, 1.3 to 6.4; p = 0.012). Patients at risk per cohort are shown under the x-axis (LVESD greater than 50 mm in bold; LVESD 50 mm or less in regular setting).

 
Long-Term Echocardiographic Outcome
Late echocardiographic examination was performed in all 75 survivors with a follow-up interval of 3.8 ± 1.3 years (range, 2.1 to 6.0 years). Mean MR grade was 0.8 ± 0.7; 11 patients had grade 2+ MR (LVEDD greater than 65 mm, 3 of 14 patients; LVEDD of 65 mm or less, 8 of 61 patients), 1 had grade 3+ (in the LVEDD 65 mm or less group). Mitral valve stenosis was not observed. Overall, there was a significant reduction in the dimensions of the left heart: LVEDD (from 60 ± 9 to 54 ± 9 mm), LVESD (from 46 ± 11 to 39 ± 11 mm), and left atrium size (from 45 ± 7 to 43 ± 6 mm). Echocardiographic results are summarized in Table 5.


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  		Table 5 Echocardiographic Findings at Baseline and Follow-up in Survivors (n = 75)
 
Comparison of Late Versus Intermediate Clinical and Echocardiographic Outcome
The 10 patients who died between intermediate and late follow-up differed from survivors in two ways: at intermediate follow-up they were in a significantly higher NYHA class, and they did not show systolic reverse remodeling.

Interestingly, in the LVEDD 65 mm or less group, all late survivors showed a sustained significant reduction of LVEDD at intermediate follow-up, with a further insignificant size decrease at late follow-up. In the LVEDD greater than 65 mm group, in which 14 of 28 patients died, 7 patients (25%) showed reverse remodeling at late follow-up.

Left ventricular end-systolic diameter did not decrease significantly at intermediate follow-up, but did between intermediate and late follow-up for patients with preoperative LVEDD of 65 mm or less; however, it failed to do so in the LVEDD greater than 65 mm group.


   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Discussion
 References
 
All patients in this series benefited from the same surgical procedure: complete revascularization and restrictive mitral annuloplasty using the same ring type and the same degree of downsizing. This consistency can explain the high level of absence of significant recurrent MR, even in the presence of severe tenting preoperatively, which contrasts with the findings of others [15,18]. In addition, echocardiographic follow-up was homogeneous as it was performed in the same institution at different intervals.

Operative mortality (8%) is in line with other studies [18–20] and is well below the logistic EuroSCORE for this group (13 ± 14). Our favorable overall long-term outcome with an actuarial 5-year survival rate of 71% is substantially better than that reported by Grossi and colleagues [21] and Gillinov and associates [22], but comparable to that reported by others [6, 7, 19]. Ninety-three percent of survivors are free from heart failure, and 85% have less than grade 2+ MR. Noteworthy are the decreased tenting area and the absence of significant mitral transvalvular gradient at late follow-up in spite of the stringent restrictive annuloplasty.

In a previous report, we identified preoperative LV dimension cutoff values (65 mm for LVEDD and 50 mm for LVESD) predictive for postoperative LV reverse remodeling at intermediate follow-up [14]. The present work also establishes these cutoff values as strong predictors for late mortality. Indeed, patients with a preoperative LVEDD of 65 mm or less have an 80% 5-year survival, whereas those with a preoperative LVEDD greater than 65 mm have only a 49% 5-year survival.

Considering the whole group of survivors, independently of their baseline dimensions, diastolic reverse remodeling has occurred in 52%, but, more interestingly, systolic reverse remodeling has occurred in 74%. In the LVEDD 65 mm or less group, LV reverse remodeling was sustained at late follow-up for both diastolic and systolic diameters. In the LVEDD greater than 65 mm group, only 7 patients (25%) showed reverse remodeling. The predictive value of our preoperative cutoff dimensions thus has also been confirmed for long-term reverse remodeling.

A large part of the LVEDD regression may be explained by the disappearance of the volume overload caused by MR, thereby reducing LV wall stress and allowing the myocardium to improve performance. Left ventricular end-systolic diameter regression at intermediate follow-up was almost absent in the LVEDD greater than 65 mm group. Owing to the nature of the study in which restrictive mitral annuloplasty was almost always combined with revascularization, the contribution of each cannot be studied separately. However, the results in patients with previous revascularization, as well as the observations by others in patients with revascularization alone in the presence of ischemic MR [3–6], suggest that our current favorable results could not have been achieved by revascularization alone. Obviously a randomized, controlled trial would be needed to fully elucidate this matter, but this is unlikely to happen.

In conclusion, restrictive mitral annuloplasty with coronary artery bypass grafting provides a cure for ischemic MR and heart failure in patients with preoperative LVEDD of 65 mm or less. Although only 25% of the patients with preoperative LVEDD greater than 65 mm show reverse remodeling, many patients did not show progressive dilatation either, suggesting that restrictive mitral annuloplasty stabilizes the disease to some extent in these patients. The absence of reverse remodeling, however, reflects a more advanced pathologic disease of the left ventricle, and it is our belief that to improve ventricular performance, the ventricle itself needs to be addressed, by either a ventricular restoration procedure or an external cardiac restraint device (CorCap; Acorn, St. Paul, MN) in patients with LVEDD greater than 65 mm and less than 80 mm. This device has shown promising early and mid-term results in functional MR [23], although long-term results have yet to be established.


   Discussion
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
References
 
DR MARC RADERMECKER (Liege, Belgium): Dr Braun, that was a beautiful presentation, and I would like to congratulate the group of Leiden and Professor Dion for setting a standard treatment of a very difficult problem. My question relates to the following. You observed reverse remodeling. Did you look at possible resynchronization of those very sick hearts? The point is that, as you know, many cardiologists are interested in desynchronization of those hearts because it has been shown, especially by a group, Lancellotti and colleagues, that resynchronization by itself may just improve ischemic MR (mitral regurgitation). So if you have a procedure that both can fix the MR very efficiently, as you have shown, and also improve the left ventricular function and resynchronization, then I think you are setting the standard treatment for those particular patients.

DR BRAUN: Thank you for your comments. This series is a reflection of a time period. We started this type of surgery in 2000, and the patients presented were operated on between 2000 and 2004. Currently, since 2005, we have a special heart failure program, in which all these patients have complete preoperative assessment including MRI (magnetic resonance imaging), and also they have, of course, assessment of left ventricular dyssynchrony. And in those patients who have significant dyssynchrony preoperatively, we now also leave behind an epicardial lead, on the left ventricle. I agree that ischemic MR might respond to resynchronization therapy alone, but in this group most patients have three-vessel disease and MR grade 3+ or more, and therefore primarily require surgery instead of resynchronization only. In this group of patients, we did not exactly look at dyssynchrony in all patients, but those patients who were in New York Heart Association class III postoperatively were especially evaluated on that point, and 4 of them were treated with resynchronization therapy with a biventricular ICD (implantable cardioverter defibrillator).

DR MICHAEL MACK (Dallas, TX): If I understood your presentation correctly, a greater than 65 mm diameter was predictive of less remodeling than below 65 mm, yet 25% of those patients still had left ventricular remodeling that occurred. Was there any analysis to be able to figure out which of those 25% with a diameter above 65 mm got better? And secondly, if you have a diameter of greater than 65 mm, is it still worthwhile performing an annuloplasty in those patients or do you think it just adds too much to the perioperative mortality and morbidity?

DR BRAUN: To answer your first question, the 25% of patients also includes 4 patients with a biventricular ICD. So that was a factor that also accounted for the further remodeling in this very sick patient group.

The second question: I think that it is still worthwhile to do this type of surgery, to have a complete revascularization with an undersized annuloplasty ring, because abolishing MR is of paramount importance, but in those patients exceeding 65 mm, we should add something else, and currently we use an external cardiac constraint device, and we are awaiting the long-term results of this patient group. So we still treat them.

DR EDWARD Y. SAKO (San Antonio, TX): You mentioned that one of the intraoperative criteria was to get 8 mm of coaptation, and it appeared that you were able to achieve it with a ring alone. There did not seem to be any cases in which you did another adjunctive procedure, as was described by one of the previous papers. You had a small percentage of patients that required reoperation for recurrent MR. Do you think in retrospect maybe that it would be more beneficial to selectively add a subvalvar procedure such as selective chord division?

DR BRAUN: From what we see, a careful measurement of the anterior leaflet and then downsizing by two ring sizes does lead to a cure for the MR; 85% of patients are free from grade 2 or more MR. We also examined the degree of preoperative tethering, and it did not influence the long-term clinical and echocardiographic outcome. So I think the additional techniques are focused on tethering and to reduce tethering. But in our institution we do not see that as a problem.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 References
 

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Jerry Braun
Robert J.M. Klautz
Michel I.M. Versteegh
Robert A.E. Dion
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