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European Heart Journal Advance Access originally published online on September 21, 2007
European Heart Journal 2007 28(20):2510-2516; doi:10.1093/eurheartj/ehm375
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2007. For permissions please email: journals.permissions@oxfordjournals.org

Mitral valve repair for dilated cardiomyopathy: predictive role of right ventricular dysfunction

Michele Di Mauro1,2, Antonio Maria Calafiore2, Maria Penco3, Silvio Romano3, Gabriele Di Giammarco4 and Sabina Gallina1,*

1 Department of Cardiology, ‘San Camillo’ Hospital, via Forlanini 50, University ‘G D'Annunzio’, 66100 Chieti, Italy
2 Department of Cardiac Surgery, University of Catania, Catania, Italy
3 Department of Cardiology, University of L'Aquila, L'Aquila, Italy
4 Department of Cardiac Surgery, University ‘G. D'Annunzio’, Chieti, Italy

Received 25 January 2007; revised 19 July 2007; accepted 10 August 2007; online publish-ahead-of-print 21 September 2007.

* Corresponding author. Tel: +39 0871 41512; fax: +39 0871 402817. E-mail address: mdimauro{at}unich.it


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Conclusions
 References
 
Aims: To evaluate the impact of right ventricular (RV) dysfunction on early and mid-term outcome of patients with ischaemic or dilated cardiomyopathy (DCM) undergoing mitral valve annuloplasty.

Methods and results: From January 1997 to December 2005, 111 patients with DCM (89 ischaemic, 22 non-ischaemic) were enrolled in this retrospective study. Mean age was 67 ± 10 years. Average pre-operative NYHA class was 3.0 ± 0.6. Tricuspid annular plane systolic excursion (TAPSE), tricuspid annular pleak systolic velocity (TAPSV), and RV fractional area change were considered as an index of RV function. A strong relationship between TAPSE and TAPSV were found (r = 0.76). Thirty-day mortality was 10.8%. Five-year survival and possibility to be alive in NYHA classes I–II were 66.5 ± 5.0 and 59.5 ± 5.0%. TAPSE, TAPSV, and MV coaptation depth (MVCD) were found to be risk factors for worse early and mid-term outcome; functional class impaired mid-term outcome. ROC analysis identified TAPSE≤12 mm, TAPSV≤10 cm/s, and MVCD>10 mm as predictive cut-offs.

Conclusion: Pre-operative assessment of some echocardiographic parameters (TAPSE, TAPSV) is very easy, low cost, and provides accurate information on RV function. A good pre-operative clinical compensation has to be necessarily reached before the operation. MVCD should be evaluated to decide surgical strategy (repair or replace).

Key Words: Dilated cardiomyopathy • Mitral valve • Echocardiography • Right ventricle • Right ventricular dysfunction


   Introduction
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 Abstract
 Introduction
Methods
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 Discussion
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 References
 
The presence of functional mitral regurgitation (MR) is a crucial point in ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM), yielding a very poor prognosis either in medically treated patients or in those scheduled for isolated myocardial revascularization.1,2 Therefore, when the remarkable shortage of donors narrowed the field for heart transplantation, mitral valve annuloplasty (MVA) received a widespread consent, as alternative treatment for DCM, because it is easy to perform and effective to relieve MR.3–7

In spite of these two important features, the outcome of patients with ICM or DCM undergoing MVA still remains uncertain. Early mortality ranges from 1.3 to 11%5–7 and 5-year mortality ranges from 38 to 78%.3–6

Why should the results of such a standard and easy procedure appear so different? The different characteristics of patients scheduled for this procedure are the main question to answer, but the literature is lacking studies on this topic.

Recently, several studies demonstrated the impact of right ventricular (RV) dysfunction on survival and event-free survival of patients with medically treated heart failure.8–11 Since the prognostic role of pre-operative RV dysfunction in adult cardiac surgery has not been clearly depicted, we evaluate the importance of pre-operative echocardiographic routine assessment of RV function in patients with ICM or DCM treated by MVA.


   Methods
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 Abstract
 Introduction
 Methods
Results
 Discussion
 Conclusions
 References
 
Population
From January 1997 to December 2005, 111 patients with ICM (80%) or DCM (20%), and functional MR underwent MVA. Patients with organic MR or receiving contemporary tricuspid valve (TV) repair were excluded. Demographic, clinical, echocardiographic, and surgical data are listed in Table 1. The use of our database was authorized by the Institutional Review Board of the University of Chieti, on October 2004. The authorization waived patient consent.


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  		Table 1 Pre-operative demographic, clinical, echocardiographic, and surgical data

 
Echocardography
A pre-operative routine trans-thoracic echocardiogram (TTE) was performed by one of the authors (S.G.) for all patients. The grade of MR was differently assessed over the time: regurgitant jet area or jet/left atrium areas ratio, regurgitant volume, effective regurgitant orifice, and Doppler colour flow mapping of the vena contracta.12–14 The mitral annulus was measured as the leaflet hinge point and its size was measured in apical long axis, four and two chambers views, at the end-systole; the mean value was considered. The distance between the point where MV leaflets coapt and the mitral annulus plane was measured at the end-systole, in the two chambers apical long-axis view and defined as MV coaptation depth (MVCD).4 Resting left ventricular end-diastolic (LVEDV) and end-systolic volumes (LVESV) indexed to the body size and left ventricular ejection fraction (LVEF) were computed using a modified Simpson's biplane method.15 LV sphericity index was measured in end-diastole as the ratio between transversal and longitudinal diameter. Each representative value was obtained from the average of three measurements.

Right ventricle: pulsed tissue Doppler imaging (TDI) was performed using transducer frequencies of 2.5–3.5 MHz with spectral Doppler filters adjusted until a Nyquist limit of 15–20 cm/s. The minimal optimal gain setting was used. Doppler measurements were acquired with subjects in the lateral decubitus position during shallow respiration or end-expiratory apnea. Guided by the 2D four-chamber view, a 5 mm sample volume was placed at the lateral corner of tricuspid annulus, exactly at the attachment of the anterior leaflet of the TV. Care was taken to obtain an ultrasound parallel to the direction of tricuspid annular motion. Peak tricuspid annular velocities during systole (TAPSV) were recorded on videotape at a speed of 100 mm/s and analysed off-line. The resulting velocities were recorded for three to five cardiac cycles and were averaged. Using the apical four-chamber view, the M-mode cursor was placed through the junction of the TV plane and RV free wall in order to measure the systolic excursion of the tricuspid annular plane (TAPSE); TAPSE is the distance between the RV base and the tricuspid annular plane in systole and in diastole.16–18 Right ventricle fractional area change (RVFAC) used to determine the whole RV systolic function was derived by RV end-diastolic and end-systolic areas, calculated from the apical four-chamber view, using the following formula: FAC = [(diastolic area – systolic area)/diastolic area]x100%.19

The systolic pulmonary artery pressure (PAP) was estimated as the sum of the gradient across the TV (calculated from the simplified Bernoulli equation) and the right atrial pressure. Right atrial pressure was estimated using the size and respiratory response of the inferior vena cava in the sub-costal view.20

Surgery
Both cavae were cannulated and myocardial protection was achieved with intermittent antegrade warm blood cardioplegia21 till January 2004 and with hypothermic (29°C) Bretschneider-HTK solution (Custodiol, Dr F. Koehler Chemie GmbH, Alsbach-Haehnlein, Germany) in the last 2 years.

A posterior MVA was performed in all cases; first, a posterior double-suture annuloplasty was performed in 28 cases using a 2/0 Ti-cron (TI-CRON, Sherwood Medical, St Louis, MO, USA), adapted to a no. 26 sizer. In the same period, a 52 mm pericardial strip (treated with a solution of gluteraldehyde 0.625% for 15 min and then rinsed in saline for 15 min or more) was used to reduce the posterior annulus from commissure to commissure in 22 patients. From April 2001 to April 2002, the length of the pericardial strip was reduced to 40 mm in 47 patients; from April 2002 till now, the posterior MVA was always performed using a posterior ring: Sovering Mini Band in 39 cases (SORIN, Saluggia, Italy) and Mitral Repair System in six cases (Koehler Medical LTD, Swillington, Leeds, UK). Coronary bypass grafting was performed in 94.2% of ICM cases.

The success of surgical correction in terms of reduction in MR was assessed by means of intra-operative trans-oesophageal echocardiography. It was achieved in all 111 investigated patients. During the course of this study, MVA approach failed in two other patients; in such cases, we performed the CPB again and replaced the native valve; they were excluded from this retrospective analysis. Then, a routine post-operative TTE confirmed this result, showing a significant reduction of MR in all patients (from 3.2 ± 0.7 to 0.6 ± 0.4, P < 0.001).

Post-operative course and follow-up
After surgery, all patients were admitted to the intensive care unit (ICU) and from there moved to the surgery and later to the cardiology wards. All the patients were followed up in our outpatients clinic. Follow-up was 100% completed in June 2006.

Statistical methods
Continuous variables were expressed as mean ± SD. Categorical data were shown as counts and percentages. Modifications of NYHA class from pre-operative period to follow-up were analysed by means of Wilcoxon test. Linear regression was used to find a relationship between TAPSE and TAPSV. Candidate variables entered in unvaried analysis are listed in Table 2. From unvaried approach, variables with P ≤0.1 were then considered for stepwise logistic regression to identify the independent variables for higher early mortality. The linearity assumption for continuous variables was verified, dividing the range of the continuous, independent variable into groups, and for each group we plotted the logic of the outcome variable vs. the group midpoint. The consistency of the final models was verified using different model building strategies: forward conditional and backward conditional (entry, 0.05; removal, 0.05). The results of stepwise logistic regression were reported as odds ratio (OR), 95% confidence limits, and P-value. The model fit was evaluated using the Hosmer and Lemeshow goodness-of-fit statistic and residual analysis. The c-statistic is reported as a measure of predictive power. The presence of linear dependencies or correlation among the independent variables (multi-collinearity) was checked evaluating tolerance and the variance inflation factor (VIF). Five-year survival curves were obtained using Kaplan–Meier method; significant difference between groups (ischaemic or non-ischaemic) was evaluated with log-rank test. Time-to-event (mortality and mortality survival in NYHA classes III–IV) analysis was performed by a multivariable Cox proportional-hazard regression. The results of Cox analysis were reported as instantaneous relative risk ratio (hazard ratio, HR), 95% confidence limits, and P-value. Optimal cut-offs to predict worse early and mid-term outcome were determined by receiver operating characteristic (ROC) curve analysis. The optimal cut-offs were defined as those providing maximal accuracy (sensitivity = specificity) to distinguish between event and non-event; area under curve (AUC) with corresponding 95% confidence limits and P-value were reported for continuous variables; accuracy (sensitivity = specificity) and corresponding 95% confidence limits were reported for cut-offs. For all tests, a P-value <0.05 was considered significant. The SPSS software (SPSS Inc., Chicago, IL, USA) was used.


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  		Table 2 Candidate variables entered in the univariate analysis

 

   Results
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Discussion
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TAPSV and TAPSE were linked by the following equation: TAPSV = 5.0 + 0.44 x TAPSE (Figure 1). Given the low tolerance and the high VIF (multi-collinearity) of the regression model including both TAPSE and TAPSV, and the strong relationship between TAPSE and TAPSV (r = 0.76, P < 0.001), two different predictive models were built: (i) including TAPSE and excluding TAPSV; (ii) including TAPSV and excluding TAPSE.


Figure 1
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  		Figure 1 Linear regression between tricuspid annular plane systolic excursion (TAPSE) and tricuspid annular peak systolic velocity (TAPSV); Pearson-r and 95% confidence interval for the individual prediction were reported.

 
Early mortality was 10.8% (12 patients), 10 (11.2%) in ICM subset and two (10.0%) in the DCM group (P = 0.754); all but one died of cardiac events (irreversible bi-ventricular failure 7; sudden death 3, haemorrhage for atrioventricular junction rupture 1). From unvaried analysis, the following variables were found to be available for stepwise logistic regression: MVCD (P < 0.001), MV annulus (P < 0.001), TAPSE (P < 0.001), TAPSV (P = 0.001). Stepwise logistic regression confirmed that MVCD, TAPSE, and TAPSV were independent variables for higher 30-day mortality, in both overall and ICM group (Table 3).


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  		Table 3 Risk factors for worse early mortality both in overall and ischaemic group

 
Median follow-up of 21 patients who died was 2 months (1–39), with a 5 year survival of 66.5 ± 5.0% (Figure 2), 62.5 ± 5.6% in ICM group, and 79.2 ± 9.6% in DCM group, P = 0.200. The vast majority of deaths were cardiac related (irreversible ventricular failure 7, sudden death 6, acute myocardial infarction 4); in the remaining four cases, death was due to acute respiratory insufficiency (1), haemolysis (1), sepsis (1), and car accident (1). Seventy-eight patients are still alive after a mean follow-up of 52 ± 30 months.


Figure 2
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  		Figure 2 Kaplan–Meier curves: 5 year survival (—) and possibility to be alive in I–II NYHA (–––––––).

 
Median follow-up of survivors was 45 months (7–108); patients who survived showed a significant improving of NYHA class (1.7 ± 0.6 vs. 3.0 ± 0.7, P < 0.001). Globally, the functional class was improved in 65 patients (83.3%), remained stable in 12 (15.4%), and worsened in one (1.3%). Five-year possibility to be alive in NYHA classes I–II was 59.5 ± 5.0% (Figure 2), 56.2 ± 5.9% in ICM group, and 79.2 ± 9.6% in DCM group, P = 0.102. Table 4 summarizes the time-to-event analysis of the outcomes mortality and mortality survival in NYHA classes III–IV, confirming the impact of RV function on mid-term outcome along with pre-operative NYHA class and MVCD. Again, given the strong relationship between TAPSE and TAPSV, two different models were built (Table 4).


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  		Table 4 Time-to-event analysis (Cox regression) for mid-term outcome in overall group

 
All other candidate variables (i.e. LV volumes, LVEF) were not found to be a risk factor for either early or mid-term outcome.

Furthermore, ROC analysis allows us to identify some cut-offs for TAPSE, TAPSV (Figures 3 and 4), and MVCD for predicting worse early and mid-term outcomes (Table 5). In the case of early mortality, they were MVCD > 10 mm (sensitivity and specificity = 75%, 95 CI = 67–83%), TAPSE ≤ 12 mm (sensitivity and specificity = 77%, 95 CI = 69–85%), and TAPSV (sensitivity and specificity = 79%, 95 CI = 72–86%). Concerning mid-term mortality and mortality survival in NYHA classes III–IV, similar cut-offs were found (Table 5). All these cut-offs were then confirmed in ICM group as well.


Figure 3
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  		Figure 3 ROC curve analysis demonstrated that tricuspid annulus plane systolic excursion (TAPSE) was a good predictor of worse early mortality. Area under curve (AUC), 95% CL, and P-value were reported.

 

Figure 4
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  		Figure 4 ROC curve analysis demonstrated that tricuspid annular peak systolic velocity (TAPSV) was a good predictor of worse early mortality. Area under curve (AUC), 95% CL, and P-value were reported.

 

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  		Table 5 Receiver operating characteristic curve analysis: cut-off values and predictive power

 

   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Conclusions
 References
 
For several years, RV dysfunction has been only related to pulmonary hypertension;22 the latter induces RV geometric remodelling and, as a consequence, RV dissynchrony. In fact, time difference from inter-ventricular septal to RV wall activation, determined by TDI, is strongly correlated with RV dimensions in end-systole (r = 0.70) and in end-diastole (r = 0.79); moreover, it is correlated with the eccentricity index (r = 0.83), a well-known parameter in RV deformation due to RV pressure overload.23 However, RV dysfunction may be observed even in the patients with normal PAP, likely due to an ischaemic or primary reduction of RV contractility.24–26 In our series, although PAP was related to TAPSE (r = –533) and to TAPSV (r = –653), 26.9% of patients showed very low TAPSE (median = 10.9 mm) and TAPSV (median = 9.5 cm/s), even in presence of apparent normal PAP values (median = 38.5 mmHg).

Even if direct echocardiographic evaluation of RV morphology and function is difficult because of RV position, immediately below the sternum, M-mode and TDIs may easily provide some good indirect parameters of RV function,16–18,27 thus leading the echocardiography to become more and more the technique of choice for the routine assessment of the RV function. TAPSE, obtained in M-Mode, reflects the base to apex shortening of the RV in systole, and it can be easily measured irrespective of heart rate and rhythm;8,17 by employing pulsed-wave TDI to tricuspid annulus, it is possible to estimate its peak systolic excursion velocity (TAPSV). This index is directly correlated to RVEF (r2 = 0.428).27 Meluzin et al.18 demonstrated that TAPSV<11.5 cm/s is able to predict RV impairment.

Although it was well known that RV function is related to the outcome of patients with DCM and heart failure,8–11 no studies investigated the prognostic role of RV in case of ischaemic or DCM undergoing MVA. In this study, multivariable analyses demonstrated that TAPSE and TAPSV were good predictors of worse early and mid-term outcomes; furthermore, the identification of two cut-offs (TAPSE ≤ 12 mm and TAPSV ≤ 10 mm) can be very useful in clinical practice. We cannot compare these findings with other data reported in the literature due to limited surgical studies on this topic. Menicanti et al.28 stated that TAPSE below 1 cm should be considered a contraindication for scheduling dilated patients to Dor procedure. Similar cut-offs (TAPSE<14 mm and TAPSV<10.8 cm/s) were found out as predictors of poorer prognosis in dilated patients treated medically.8,9

The detrimental effect of cardiopulmonary bypass on RV function29 can explain the increased likelihood of post-operative cardiac failure and death for patients with pre-operative impaired RV function. MVA increases the forward quote of LV stroke volume, thus improving the systemic perfusion, even if the restoring of LV dimensions is still debated.3,4 But what happened to the right ventricle? Although, we have poor information on RV restoring, it is very difficult to expect it. Hence, dilated patients with RV dysfunction, surviving MVA, are more likely to have a worse mid-term outcome.

Two other important findings have been confirmed in this retrospective analysis. A good pre-operative clinical compensation needs to be necessarily reached before the operation. Gillinov et al.30 have already demonstrated that the higher the functional class, the poorer the prognosis. Patients with higher MVCD show poor early and mid-term results. The coaptation depth is a good index to predict MVA failure, MR recurrence, and consequent late clinical worsening.4 To overcome this problem, advanced surgical techniques were suggested to relocate papillary muscles in the right position and reduce MV tethering.31,32 Actually, we think that relocation of papillary muscles is not as easily reproducible as MVA, and moreover, few data about mid-term results of these approaches are available. So, in this case, we prefer to replace the native valve instead of performing other advanced surgical conservative approaches. However, in our series, 30 patients (24 ICM and six DCM) with pre-operative MVCD higher than 10 mm underwent MVA; this is related to the different strategies adopted in the different periods along this study: in the first part of our experience (until 2000), the role of MVCD as a parameter for repairing or replacing the native valve had not been already traced.4 From 2001 to 2004, all the mitral valves with MVCD above 10 mm were replaced. In later period, the patients became sicker and we decided to perform MVA also in patients with MVCD = 11 mm.

If the impact of MVCD on mid-term results can be easily explained by recurrence of MR, it is more difficult to understand its role on early mortality; the only possible explanation we found is that patients with MVCD>10 had more dilated ventricles (EDV: 131 ± 26 mL/m2 vs. 118 ± 27 mL/m2, P = 0.040; ESV: 131 ± 26 mL/m2 vs. 118 ± 27 mL/m2) and lower contractility (EF: 29.5 ± 5% vs. 30.7 ± 4%, P = 0.036). Although we failed to demonstrate the prognostic role of LV volumes and function, other authors have already reported this relationship,6 so we might suppose that MVCD>10 can be a surrogate index, mirroring the most dilated and dysfunctional ventricles.

The limitations of the study
The retrospective nature of our study and the change of the method to quantify MR over time represent important limitations. Moreover, the assessment of the models' performance (quantified as AUC, sensitivity, specificity, and c-statistics) is over-optimistic since it is not validated by bootstrap methods.33


   Conclusions
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
References
 
Pre-operative routine echocardiography assessment of RV function is important for patients with ischaemic or DCM undergoing MVA. Few easily measured parameters (TAPSE, TAPSV) are able to provide relevant information on RV function that could make the difference in terms of outcome. MVCD should be evaluated to decide surgical strategy (repair or replace). In spite of the above-mentioned limitations, we think that the identification of some cut-offs can be very helpful in surgical scheduling of dilated patients. Further, employing non-invasive techniques (Echo 3-D, MRI) and studies involving a larger cohort of patients may provide more useful information in the near future.

Conflict of interest: none declared.


   References
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 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 References
 

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