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Eur J Cardiothorac Surg 2003;23:1017-1022
© 2003 Elsevier Science NL

Mitral valve repair in patients with end stage cardiomyopathy: who benefits?

Department of Cardiac Surgery, University Leipzig, Heartcenter, Struempellstrasse 39, 04289 Leipzig, Germany

Received 7 October 2002; received in revised form 26 February 2003; accepted 3 March 2003.

^* Corresponding author. Tel.: +49-341-865-1422; fax: +49-341-865-1452
e-mail: gumj{at}medizin.uni-leipzig.de

	Abstract

Top Abstract 1. Introduction 2. Method and patients 3. Results 4. Discussion 5. Summary Appendix A. Conference... References

 
Objective: Patients with end stage cardiomyopathy frequently present with additional severe mitral regurgitation. We analyzed the outcome of mitral valve reconstruction in this high risk patient group. Methods: Sixty-six patients with significant mitral regurgitation and an ejection fraction (EF) below 30% (dilated cardiomyopathy=53, ischemic cardiomyopathy (ICM)=13) were retrospectively evaluated from 07/96 and 02/02. All received annuloplasty ring implantation and additional repair (n=4) if required. Mean follow-up was 28±18 months. Results: Mitral valve repair (MVR) was technically feasible in all patients. Intraoperative transesophageal echocardiography (TEE) revealed none (n=60) or only trivial (n=6) residual mitral regurgitation. Thirty day mortality was 6.1%. Actuarial survival after 1 and 5 years was 86±4 and 66±8%, respectively. During follow-up seven patients were transplanted due to lack of clinical improvement after 10±7 months (range 1–23). Echocardiography revealed a significant improvement in EF (25±10.5% pre-op, 34±15% post-op) and a slight decrease in left ventricular end-diastolic diameter (69±10 mm pre-op, 67±13 mm follow up). Patients were in NYHA functional -class 3 (median) preoperatively and in class 2 at long term-follow-up. Gender, left ventricular enddiastolic diameter, preoperative ejection fraction or type of surgical approach (sternotomy, right lateral minithoracotomy) had no significant influence on patient outcome. Patients with ICM or patients older than 60 years showed an increased risk for clinical events both early post-operatively and at long-term follow-up. Conclusion: MVR can be performed with low perioperative morbidity and mortality even in patients with advanced heart failure, modifying selection criteria for potential candidates may further improve long term outcome.

Key Words: Mitral valve repair • Cardiomyopathy • Heart failure

	1. Introduction

Top Abstract 1. Introduction 2. Method and patients 3. Results 4. Discussion 5. Summary Appendix A. Conference... References

 
Heart transplantation is the gold standard treatment for patients with end stage cardiomyopathy. However, due to the limited availability of donor organs and increasing number of older patients with significant comorbidities unsuitable for transplantation one must search for possible alternatives. Thus surgical approaches such as: (a) high risk coronary artery revascularization [1,2]; (b) left ventricular reconstruction (e.g. DOR procedure) [3]; and (c) mitral valve repair in high risk patients [2,4–8] are evolving as treatment options in this severely ill patient population.

Mitral valve regurgitation is an important pathology in end stage cardiomyopathy caused by dilatation of the mitral annulus and/or papillary muscle dysfunction. Mitral insufficiency leads to a vicious circle with increasing volume overload of the dilated left ventricle thus leading to progression of annular dilatation, worsening of mitral valve regurgitation and volume overload [9]. The resulting mitral valve insufficiency is often refractory to medical therapy and predicts a poor survival in this patient group [10]. It has been hypothesized that this vicious circle could be interrupted by correction of the mitral valve insufficiency. Mitral valve reconstruction in patients with congestive heart failure may lead to clinical and functional improvement, however it is often believed to be associated with a substantial perioperative risk. In general, mitral valve repair is thought to be superior to mitral valve replacement because of the preservation of the annular – chordal – papillary muscle continuity [11].

The perioperative mortality of mitral valve repair in patients with severely reduced left ventricular function has been reported to range between 2.1 and 11% [12]. On the other hand, mortality in patients with ischemic cardiomyopathy undergoing coronary surgery and concomitant mitral valve surgery has been described as high as 50% [5,13]. One year survival up to 82% has been achieved in some series of patients, which are comparable to the clinical outcome after heart transplantation [2,6]. However, a much higher mortality has been described in patients following mitral valve replacement and in patients older than 70 years of age [5]. Taken together it remains unclear for which subgroup of patients suffering from end stage cardiomyopathy correction of mitral valve insufficiency is beneficial.

The objective of this retrospective analysis was to: (a) evaluate perioperative and long term mortality in these high risk patients; and to (b) identify important patient variables for better prediction of the efficacy and safety of the surgical approach for individual patients.

	2. Method and patients

Top Abstract 1. Introduction 2. Method and patients 3. Results 4. Discussion 5. Summary Appendix A. Conference... References

 
2.1. Study group
Sixty-six patients with an ejection fraction (EF) <30% who were operated between July 1996 and February 2002 were analyzed in this retrospective study. All patients were followed by our online surgical database [14]. EF was quantified by angiography. The underlying pathology was dilated cardiomyopathy (DCM, n=53) or ischemic cardiomyopathy (ICM, n=13). Patients receiving concomitant triscuspid valve repair (n=7), intraoperative ablation therapy for atrial fibrillation (IRAAF, n=10) [15] and left atrial reduction plasty (n=2) were included. Patients with CorCap^TM [16] implants as well as concomitant aortic valve surgery, coronary surgery or other procedures were excluded from the study population.

Twenty-six patients (39%) were female, mean age was 59±12 years (range 23–87) and ten patients were above 70 years of age (15.2%). Mean EF was 23±6% by angiography and 25±6% by echo. Twenty-four (36.4%) patients had a left ventricular ejection fraction (LVEF) ≤20%. Mean preoperative left ventricular enddiastolic diameter (LVEDD) was 69±10 mm. All patients received maximal medical treatment for congestive heart failure (including ß – blockers, ACE – inhibitors, and diuretics), 15 patients (22.7%) were initially referred to be evaluated for heart transplantation, nine patients had a previous pacemaker implantation and four patients had a previous implantable cardiac defibrillator (ICD) implantation.

The underlying etiology of mitral regurgitation was defined according to patient history as well as echocardiographic and intraoperative findings.

Out of the 53 patients with DCM one had previously received aortic valve replacement and one patient had developed congestive heart failure several years after atrial myxoma resection.

All 13 patients with ICM had a history of myocardial infarction with nine patients having previous coronary artery bypass grafting surgery, one patient having previous percutaneous transluminal coronary angioplasty (PTCA), and in three patients coronary surgery or PTCA was deemed not possible. At the time of evaluation, in all patients no further revascularization was deemed possible prior to mitral valve surgery.

2.2. Surgical techniques
Mitral valve repair (MVR) was performed through a median sternotomy in 21 patients and via lateral minithoracotomy in 45 patients, respectively [17]. In ten patients with chronic atrial fibrillation additional left atrial ablation therapy with radiofrequency was performed, seven patients required an additional tricuspid valve repair and two patients received reduction plasty of an enlarged left atrium.

An undersized (median 28 mm) flexible annuloplasty ring (Carpentier Edwards Physio=62, others=4); ring was used in all patients. In 58 patients the repair was feasible by only reduction of the enlarged mitral annulus. Complex mitral valve repair was necessary in four patients and in four patients an additional Alfieri stitch was necessary. The mean procedure time was 156±46 min and cross clamp time was 48±24 min.

2.3. Follow-up
Due to the retrospective nature of this study, follow-up was performed at individual timepoints in our outpatient clinic and was supplemented by telephone interview with the patient, referring physician or both. A standardized simple questionnaire was used to evaluate the current functional status. One patient from Russia was lost to follow up. Total follow-up consisted of 141 patient years with a mean follow up of survivors of 28±18 months (range 7–74).

Sudden cardiac death was defined as the unexpected death of a symptomatically stable patient. Heart failure as the cause of death was defined as death despite maximum inotropic therapy.

2.4. Statistical analysis
All statistical analyzes were performed using SPSS^TM statistical 9.0 (SPSS Corp., Birmingham, AL, USA).

Continuous variables were expressed as mean±standard deviation and categorical data (NYHA class) as median. Continuous variables comparisons were analyzed using the Student's t-test, while categorical variables were compared by ² analysis and Fischer's Exact test when appropriate. Survival was analyzed using the Kaplan–Mayer method and survival curves were compared using the log rank test.

	3. Results

Top Abstract 1. Introduction 2. Method and patients 3. Results 4. Discussion 5. Summary Appendix A. Conference... References

 
3.1. Perioperative results
All patients survived the initial procedure. The mean intensive care/intermediate care time was 6±7 (1–42) days and the mean postoperative hospital stay was 13±10 days. Two patients required additional pacemaker implantation 5–7 days after MVR due to bradyarrhythmias and two patients required an upgrade of a preoperative implanted single chamber – pacemaker after successful treatment of atrial fibrillation by IRAAF. Forty-seven patients were discharged in sinus rhythm (SR), six with atrial fibrillation and 13 patients required pacing. An additional two patients with SR received a biventricular pacemaker system 19 and 38 months after MVR respectively because of progression of heart failure.

Overall 30 day – mortality was 6.1% (4/66 patients). Subgroup analysis revealed a 30 day mortality of 12.5% for patients older than 60 years of age versus 0% in patients younger than 60 years (P=0.05).

In the IRAAF subgroup (n=10) no procedure related complications were observed. The 30-day mortality in this subgroup was 10%, not statistically different compared to the overall 30 day mortality.

During follow-up 16 patients died 9±10 months following surgery. Four deaths were due to SCD, nine due to clinical worsening of heart failure and three due to non-procedure or cardiac related diseases.

3.2. Mitral valve function
In all patients mitral valve insufficiency improved after the initial surgery and mitral valve competence was well maintained in most patients in the longterm follow-up.

Early after surgery, residual incompetence was graded 0.7±0.7 as compared to grade 3±0.5 preoperatively. At long term follow-up there was a persisting improvement in mitral valve function with residual incompetence graded 1.0±0.9 (P<0.001).

Altogether three patients required reoperation because of progressing mitral incompetence. In one patient a mitral valve replacement was performed 3 days after the initial repair, in another a re-mitral valve repair was performed 19 days following the initial repair and the 3rd patient required a mitral valve replacement 800 days after initial repair.

3.3. Postoperative clinical status and ejection fraction
In the majority of the patients a major clinical improvement was recognized. NYHA class improved from a preoperative median of 3 (range 2–4) to 2 (range 1–4) (P<0.001) early postoperatively and a median of 2 (range 1–4) (P<0.001) at the long term follow-up.

This improvement of NYHA class was evident independent of the age of the patients. Patients above 60 years of age improved from a preoperative median 3 to a long term follow up median of 2 (P=0.009) and patients below 60 years improved from a preoperative median of 3 to a long term follow up median of 2 (P<0.001).

Preoperative ejection fraction improved from 25±6 to 31±10% before discharge and up to 34±15% at long term follow up (P=0.028). The LVEDD decreased from 69±10 to 65±12 mm before discharge and 67±13 mm in the long term follow up (P=0.093).

3.4. Postoperative late survival and transplantation
Overall mean survival was 55±4 months, the actuarial survival at 1 and 5 years was 86±4/66±8%, respectively. However, censoring transplanted patients together with deceased patients, actuarial event free survival was 86±4% at 12 months and 46±4% at 60 months (P<0.001 after 60 months). The mean age of transplanted patients was 47±12 years. The mean age of deceased patients was 62±10 years and the mean age of survivors was 59±12 years (Fig. 1) .

View larger version (15K): [in this window] [in a new window]   Fig. 1. Survival and event free survival after mitral valve repair. Event free survival was defined as survival without heart transplantation. The mean survival rate was 55±4 months, the event free survival 40±11 months.

3.5.2. Age subgroup analysis
Patients were divided in two subgroups with patients below 60 years (n=34) and above 60 years of age (n=32). Mean survival in patients above 60 years was 44±8 and 62±4 months in patients below 60 years, respectively (P=0.045). The actuarial survival after 5 years was 46±16% in patients above 60 years and 82±7% and in patients below 60 years, respectively (P=0.0125; log rank) (Fig. 2) . On the other hand the event free survival rates the actuarial 5-year survival was similar in both age groups (43±15 versus 41±15% in the older group, P=0.925).

View larger version (16K): [in this window] [in a new window]   Fig. 2. Survival and age. Patients were divided into to age subgroups (below (n=34) and above 60 years (n=32) at the time of surgery). The mean survival rate was 55±4 months in the younger age group and 40±11 months in the older age group.

3.5.4. Ischemic cardiomyopathy versus dilative cardiomyopathy
Mean survival/event free survival in patients with ischemic cardiomyopathy (n=13) was 17±4/17±4 months, respectively. In patients with dilative cardiomyopathy (n=53) mean survival/event free survival was 60±4/51±5 months, respectively (P<0.001). The actuarial survival/event free survival after 24 months was 62±14/62±14% in ICM patients and 79±6/73±7% in DCM patients respectively (P<0.001) (Fig. 3) .

View larger version (14K): [in this window] [in a new window]   Fig. 3. Survival related to etiology of cardiomyopathy. Survival data were analyzed according to the etiology of mitral valve insufficiency. Thirteen patients were identified with ICM and 53 patients with DCM. The mean survival rate was 60±4 months in the DCM group and 17±4 months in the ICM group.

	4. Discussion

Top Abstract 1. Introduction 2. Method and patients 3. Results 4. Discussion 5. Summary Appendix A. Conference... References

The major conclusion of this study is that that mitral valve reconstruction can be done with acceptable low hospital mortality in patients with cardiomyopathy and MI. This suggests that MVR is a feasible therapeutic option for most patients with significant mitral valve incompetence. Follow up data reveal that in the majority of the patients mitral valve competence is maintained and that persisting improvement in functional status can thus be expected. Thus our results compare favorably to those reported by other groups [5,8,9].

4.1. Mitral valve reconstruction versus heart transplantation
We were unable to identify any predictors in the seven patients that required heart transplantation. In all patients an initial improvement could be demonstrated. It is very important to follow these patients very closely in a heart failure clinic setting in order not to miss the best timepoint for heart transplantation in order to reduce the overall mortality.

4.2. Clinical implications for cardiomyopathy patients
Our data demonstrate that in: (a) older patients; and in (b) patients with ischemic cardiomyopathy the results are inferior compared to younger patients with dilative cardiomyopathy. Older patients certainly have a higher mortality in this patient population as seen in other studies [5]. However, postoperative NYHA class improvement is seen in both age groups thus supporting our policy not to exclude the elderly from this procedure. The clinical improvement after correcting the mitral insufficiency in older patients justifies the higher risk of the procedure.

Another reason for the higher mortality in the older patient population can be attributed to our policy to generally exclude patients above 65 years from transplantation. Correspondingly, the actuarial event free survival rate at 5 years was comparable in both age groups.

Mitral valve repair in patients with ischemic cardiomyopathy is certainly a high risk procedure and has been shown to be associated with a high perioperative mortality [13]. Comparably in our own patient population the long term survival seem to be very poor and heart transplantation should be considered when possible in these patients. However, in patients not suitable for heart transplantation mitral valve repair seems justified despite the poor long term prognosis because of the effective relief of heart failure symptoms. Under such circumstances, the palliative character of the procedure has to be kept in mind. In the future, perhaps other options like permanent ventricular assist devices may become an option for these patients.

4.3. Improvement of left ventricular performance
The present results underline, that an immediate functional and hemodynamic improvement can be expected after mitral valve repair. The pathophysiological background for this improvement remains speculative and was not the focus of this analysis. The improvement in these patients may be attributed to the fact that one factor of left ventricular failure before surgery – volume overload – has been effectively corrected [9]. By this mechanism it can be explained why not all individual patients show an immediate clinical benefit. Only in patients with significant volume overload a perioperative improvement can be expected.

Other groups have demonstrated in patients with left ventricular assist devices that acute unloading the left ventricle leads to left ventricular recovery [18,19].

Further studies are needed to address the problem how to predict a positive effect of the correction of mitral valve insufficiency for the individual patient.

4.4. Study limitations
Several factors may have affected the findings of this study and the applicability to larger patient populations. Compared to the DCM group with 53 patients the ICM group was rather small with only 13 patients. This can be attributed to the fact that in the majority of patients suffering from ICM additional coronary surgery is still an option. But those patients were excluded from the analysis like in other studies [18]. In patients with correctable coronary pathology improvement of ejection fraction could be attributed only to the treatment of ischemia thus making the interpretation of the results more difficult.

This analysis may be further limited by the heterogeneity in terms of surgical techniques like the lateral approach and additional procedures like IRAAF and tricuspid valve repair. However, the most important factors in all patients were left ventricular failure combined with mitral valve insufficiency.

The retrospective character of this study with a non-standardized follow up is another limitation, such that a prospective trial based on our data is certainly justified.

Furthermore, the assessment of functional status preoperative and postoperative was subjective. However, the bias was reduced largely by the fact that the functional assessment was done largely by a single investigator.

	5. Summary

Top Abstract 1. Introduction 2. Method and patients 3. Results 4. Discussion 5. Summary Appendix A. Conference... References

 
In summary mitral valve repair is an important and useful procedure in cardiomyopathy patients in an effort to prolong the time to heart transplantation or even avoid heart transplantation. Care must be taken to follow these patients closely in order to reduce long term mortality in this high risk patient population.

	Footnotes

 
Presented at the 16th Annual Meeting of the European Association for Cardio-thoracic Surgery, Monte Carlo, Monaco, September 22–25, 2002.

	Appendix A. Conference discussion

Top Abstract 1. Introduction 2. Method and patients 3. Results 4. Discussion 5. Summary Appendix A. Conference... References

 
Dr P. Sergeant (Leuven, Belgium): You made an incorrect statement. No inference can be made from actuarial curves with less than ten patients at risk.

Dr Gummert: Thank you very much for that correction. That is due to the graphic software.

Dr M. Emara (Cairo, Egypt): I have two questions, one practical and one theoretical. The practical, you didn't tell us what you do for myocardial preservation for such a low ejection fraction heart. My theoretical question is, in the literature for rheumatic mitral regurg, when you put in a mitral valve or you correct a mitral valve usually the ejection phase in this comes down because it is falsely high due to the low vent through the mitral regurg. Would you think that end-systolic phase in this is much better in evaluating this improvement in the heart rather than the ejection phase, and how can you explain that the ejection fraction increases?

Dr Gummert: First of all, the preservation method, we used in most of the patients crystalloid cardioplegia with Bretschneider cardioplegia, and, as you have seen from the perioperative mortality, I don't think preservation method was an issue here in these patients, because we didn't lose any patient in the operating room. The 30-day mortality was almost always due to some multiorgan failure later in the intensive care unit.

Theoretically, you are absolutely correct. It is difficult to judge the ejection fraction preoperatively in patients with mitral valve insufficiency. However, I think if you interrupt this vicious circle I have shown to you on the second slide, you may see an improvement in the early follow-up 10 days before discharge.

Dr F. Maisano (Milan, Italy): How do your early postoperative results compare with the long term ones?

Dr Gummert: Well, in four patients altogether, additional surgery was needed for correction of the mitral valve repair, but that didn't seem to influence the long-term results because in almost all patients there was either 0 mitral regurg or 0–1 mitral regurg. So there was no problem in this direction. So all patients were corrected.

Dr Maisano: The other question is, do you think there is any technical or anatomical contraindication for mitral valve repair in this subset of patients?

Dr Gummert: If it is feasible to do a mitral valve repair, you should always do it. It is, of course, preferable to a mitral valve replacement. So as long as you are able to do it, there is no contraindication for mitral valve repair if you take the risk that you may need to go back to do mitral valve repair after a few months or years.

Dr G. Kleikamp (Bad Oeynhausen, Germany): One comment on your last remark. I would not recommend doing mitral valve repair in every patient. As you showed, in patients with ICM, the use of mitral repair is not proven, because they have lots of other difficulties that kill them over the long term. So I would be very reluctant to recommend mitral valve repair in patients with ICM. In DCM it is not a problem.

Dr F. Mohr (Leipzig, Germany): You might also consider age; maybe the aging hearts don't remodel that well.

	References

Top Abstract 1. Introduction 2. Method and patients 3. Results 4. Discussion 5. Summary Appendix A. Conference... References

 

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