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Eur J Cardiothorac Surg 2001;20:949-955
© 2001 Elsevier Science NL

A prospective study of changes in the quality of life of patients following mitral valve repair and replacement

^a Department of Cardiothoracic Surgery, Walsgrave Hospital, Clifford Bridge Road, Coventry, CV2 2DX, UK
^b University Department of Medicine, City Hospital, Dudley Road, Birmingham, UK

Received 17 October 2000; received in revised form 9 July 2001; accepted 8 August 2001.

Corresponding author. Tel.: +44-2476-602020; fax: +44-2476-535105
e-mail: ira{at}iragoldsmith.freeserve.co.uk

	Abstract

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion Appendix References

 
Objective: The primary aim of medical care and surgery for mitral valve disease is to improve the overall functional capacity and health of patients. Aim: To assess whether there was an actual improvement in quality of life (QOL) of patients 3 months following primary mitral valve repair (MRr) or mitral valve replacement (MVR). Methods: Prospective study of 61 consecutive patients (34 males, mean age 64±12) who underwent primary, isolated mitral valve repair (MRr, n=40) or mitral valve replacement (MVR, n=21) from April 1997 to October 1998. QOL parameters using the validated short form 36 (SF-36) questionnaire were determined before and at 3 months after surgery and analysed using the Wilcoxon matched pairs rank test. Results: Mean QOL scores (scale 0–100) for all patients following mitral valve surgery showed clinical and statistically significant improvement in seven of eight QOL parameters, namely (i) physical function (post, 60±31 vs. pre, 44±29; P=0.0001); (ii) role limitation due to physical function (50±42 vs. 23±36; P=0.0002); (iii) social function (76±31 vs. 59±36; P=0.0006); (iv) role limitation due to emotional problems (65±42 vs. 44±45; P=0.003); (v) energy (57±24 vs. 40±24; P<0.0001); (vi) mental health (73±20 vs. 66±21; P=0.007); and (vii) general health perception (68±19 v 56±22; P=0.0001); but not pain (73±29 v 71±30; P=0.4). Following MRr there was significant improvement in seven of eight QOL parameters and following MVR there was significant improvement in three of eight QOL parameters. Whilst patients with ejection fraction 50% showed significant improvement in seven of eight QOL parameters, there was no significant improvement in any QOL parameters in patients with impaired left ventricular (LV) function. Similarly, patients with mitral regurgitation with end-systolic dimensions of 45 mm showed no significant improvement in any QOL parameters at 3 months follow-up. Conclusions: Our study suggests that following mitral valve surgery there was significant improvement in the QOL of patients especially in those patients requiring mitral valve repair. However, patients with impaired LV function and those with MR with end-systolic dimensions 45 mm were unlikely to demonstrate a significant improvement in QOL at 3 months follow-up.

Key Words: Mitral valve • Repair • Replacement • Quality of life

	1. Introduction

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion Appendix References

 
Outcome results of valve replacement or repair surgery are traditionally evaluated in terms of operative morbidity, mortality and valve related complications, namely, thromboembolism, anticoagulant-related haemorrhage, endocarditis, prosthesis failure, haemodynamic properties and reoperation [1]. Low rates of these adverse clinical outcomes are associated with favourable gains in the patient well being and functioning. However, in recent years, there has been growing recognition by providers and consumers of health care that morbidity and mortality data alone are incomplete measures of outcome following surgery. Patients’ own perceptions of their health are increasingly recognized as important considerations in the assessment of health outcomes. Thus, improvement in the patient's emotional state, performance of social roles, general satisfaction and return to work with the ability to live independently is recognized as being equally important [2–6].

With advancement in modern technology morbidity and mortality rates following valvular heart surgery have significantly improved and it is commonly perceived that 3 months following cardiac surgery most patients should be able to live independently. However, what has remained unclear until now is the impact mitral valve surgery has on the patients’ quality of life (QOL) and whether 3 months following surgery they are able to perform their daily physical and social activities and live independently.

Although numerous methods exist for evaluating QOL of patients [4,6–9], the validated Short Form 36 (SF-36) questionnaire [4], is comprehensive yet concise, can be completed in 10–15 min, and can be administered in person, by phone or by mail, even in elderly patients [10,11]. We used this questionnaire (SF-36) in the present study, where the aim was to prospectively evaluate the value of mitral valve repair and replacement, in terms of quality of life (QOL). We also hypothesize that the QOL parameters may be influenced by the pre-operative left ventricular function, namely ejection fraction whilst in those patients undergoing surgery for mitral regurgitation by their pre-operative left ventricular end-systolic dimension (LVIDs) as assessed by trans-thoracic echocardiography.

	2. Patients and methods

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion Appendix References

 
Walsgrave Hospital, Coventry (UK) is a tertiary referral regional cardiothoracic unit serving the population of West Midlands. Consecutive patients admitted to our regional cardiothoracic unit for primary, isolated mitral valve repair (MRr) or mitral valve replacement (MVR) surgery between April 1997 and October 1998 were identified for the study and their data entered on a computerized database. Patients admitted for double valve replacement surgery, surgical procedures in addition to mitral valve surgery (including coronary artery bypass surgery) and associated medical conditions known to influence the QOL parameters under investigation were excluded, namely, those patients with stroke, chronic renal failure, infection/inflammation or cancer [12–14] as were patients with diabetes mellitus and chronic liver failure. Informed consent was obtained and the study conducted in accordance with the Declaration of Helsinki and approved by the ethics committees of both Coventry and West Birmingham districts.

Although the surgical procedures were at the discretion of the individual surgeon, all eligible patients underwent mitral valve repair (MRr). Where the valve was not repairable, patients received a mechanical bileaflet prosthesis (MVR). As patients with mitral valve disease are usually considered for MRr and MVR performed in only those patients whose diseased valves are unsuitable for MRr, the two patient populations are intrinsically different. We, therefore, did not compare QOL parameters between the two patient subgroups although subgroup analyses were performed. Following surgery, all MRr and MVR patients were commenced on warfarin prophylaxis (target INR 2.5–3.5). However, warfarin therapy was routinely discontinued in MRr patients who were in sinus rhythm at outpatient review 6 weeks post-surgery.

Quality of life of patients following MRr and MVR surgery were prospectively assessed using the validated SF-36 questionnaire [4], prior to surgery and at 3 months following surgery by a single observer (I.G.). The questionnaire consisted of eight scales to measure health, namely, (i) physical function (PF); (ii) social function (SF); (iii) role limitation attributable to physical problems (RLP); (iv) role limitation attributable to emotional problems (RLE); (v) mental health (MH); (vi) energy (vitality) (E/V); (vii) pain; (viii) general health perception (GHP). Change in health (C-in-H) as perceived by the patient was assessed by asking the patient whether he/she felt their health was much better, better, about the same, worse or much worse now than before surgery. The responses to each of these questions were summed and transformed to give eight scores between 0 and 100, with higher scores indicating a better state.

Information obtained at the time of clinical assessment included the clinical diagnosis/presentation, the New York Heart Association (NYHA) functional class, left ventricular function, namely, end-systolic dimension (LVIDs) and ejection fraction [15], the latter two using transthoracic echocardiography by a single operator (I.G.) and validated for inter- and intra-observer difference of <10%. Operative data included the total bypass time, aortic cross-clamp time and type of valve procedure, namely, repair or replacement, whilst the 3-month follow-up assessment also included inspection of the surgical wound and pain.

Descriptive statistics were obtained using the package Statistica for Windows v. 4.3 (StatSoft Inc., USA). The pre-operative and post-operative scores for each QOL life dimension were calculated using standard criteria and expressed as a mean value±standard deviation. Since QOL data were from the same individual with paired data from before and after surgery, the recommended paired Wilcoxon sign rank test was used to analyse these results. Continuous variables were otherwise compared between groups using the unpaired t-test while changes in nominal variables were compared between the two groups using the McNemar test. To determine the influence of pre-operative factors on the overall improvement in QOL scores, patient variables that were considered to influence outcome (Appendix A) were analysed, using multiple linear regression analysis, with change in QOL measures (change in health and general health perception) as dependent variables. A value of P<0.05 was considered significant in all statistical analyses.

	3. Results

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion Appendix References

 
From 122 potential subjects listed for mitral valve surgery, only 61 patients (34 males, mean age 64±12 years; range 20–85 years) satisfied our inclusion and exclusion criteria (Table 1). Of these 40 (66%) patients underwent MRr and 21 (34%) MVR. Although there were no differences in the mean age between the 21 patients who underwent mechanical MVR and 40 patients who underwent MRr the two groups were essentially dissimilar (Table 1). Almost all patients who underwent MRr, unlike those who underwent MVR, did so for mitral incompetence (Table 1).

View larger version (12K): [in this window] [in a new window]   Fig. 1. Change in NYHA functional class following surgery in patients requiring mitral valve (a) repair (MRr) and (b) replacement (MVR).

View larger version (20K): [in this window] [in a new window]   Fig. 2. Change in health and change in QOL parameters in the total cohort prior to mitral valve surgery and at 3 months follow-up.

3.2.3. Mitral valve replacement
For those patients requiring mitral valve replacement although following surgery there was a significant improvement in health (Table 2), significantly higher scores were obtained for only three of the eight modalities tested following MVR when compared to scores before surgery (Table 2). There was, however, a non-significant trend towards improvement in social function and energy following MVR but no statistically significant improvement in general health perception.

3.2.4. Effect of gender
There were no differences in the mean age between male and females patients (males, 63±13 years vs. females, 66±12 years; P=0.3). Both groups noted a significant improvement in their general health perception and in six of the eight QOL parameters tested (data not shown).

3.2.5. Left ventricular function
Patients with good ejection fraction (50%) (n=39, 24 males; mean age 62±16 years) showed significant improvement in seven of the eight QOL parameters tested following surgery (Table 3). In particular, there was significant improvement in energy or vitality, with corresponding improvements in physical performance of daily activities and social function. However, patients with impaired left ventricular function (ejection fraction between 30 and 50%) (n=10, five males; mean age 60±16 years) showed no statistically significant improvement in any of the eight QOL parameters at 3 months following surgery (Table 3).

View this table: [in this window] [in a new window]   Table 4. Changes in quality of life parameters of patients with mitral regurgitation and left ventricular end systolic dimensions (LVIDs) (i) <45 mm and (ii) 45 mm prior to surgerya

	4. Discussion

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion Appendix References

Despite the relative elderly population in the present study, a high proportion of patients noted a positive change in health perception at 3 months following surgery, regardless of whether they underwent mitral valve repair or replacement. Indeed amongst the survivors, high scores were obtained for seven of the eight QOL parameters tested. Most patients believed their personal health to be much better following surgery and felt peaceful, calm and happy, and were able to perform their daily physical household activities and social activities without limitations due to physical health or emotional problems. High scores for physical function, energy and vitality, especially following mitral valve repair, indicated that a high number of patients were able to carry out their daily physical work/activities at home. The higher score for general health perception, at follow-up, indicates a more optimistic view to future health, whilst the high scores following surgery, for mental health and social function may reflect a sense of relief among the patients following months of shortness of breath, uncertainty and perhaps possible death prior to surgery. These trends need to be further explored, particularly with regard to their effects on long term clinical outcome.

Although all patients were assessed with the intention to repair the diseased valve, those patients in whom the valve was either not repairable and thus underwent MVR or required replacement from the outset differed significantly from those who underwent mitral valve repair. As expected most calcified, rheumatic and stenosed mitral valves were replaced and most of these patients were in atrial fibrillation, were receiving anticoagulant therapy and were in poorer NYHA functional class at the outset. Nevertheless, there was significant improvement in three of eight life dimensions following MVR at 3 months. Although it took significantly longer to repair the diseased mitral valve compared to MVR, the high post-operative scores obtained by patients who required MRr suggests significantly improved QOL in these patients.

In patients with mitral valve disease, prognosis is known to be poor if there is impaired left ventricular function with ejection fraction of <50% [18]. Moreover, in patients with mitral regurgitation, ventricular performance can also be gauged by measuring the end-systolic internal dimension on echocardiography, which is less dependent on pre-load than ejection fraction [18,19]. Indeed, prognosis worsens when the echocardiographic end-systolic dimension exceeds 45 mm in these patients [15]. In the present cohort, there were no significant improvements in any of the eight QOL dimensions at 3 months following surgery in patients whose ejection fraction was 30–50% and in patients with mitral regurgitation in whom the end-systolic dimension exceeded 45 mm. Indeed, end-systolic dimension was an independent predictor of patients’ own perception of change in their health following surgery. Conversely, high scores were obtained by patients with good left ventricular function and those with end-systolic dimensions of <45 mm. Thus, the present observations are in keeping with the suggestion that mitral valve surgery may need to be considered in these patients before left ventricular dysfunction has begun to develop or when the end-systolic dimensions approach 45 mm [15]. The present observations also suggest that pre-operative transthoracic echocardiography may help identify patients who were more likely to require intensive post-operative cardiac rehabilitation, namely those patients with impaired left ventricular function and those presenting with MR in whom the end-systolic dimensions exceed 45 mm.

It is generally perceived that in the early follow-up period, patients often complain of non-cardiac problems such as wound pain, wound infection, arthritis and other troubles that were considered to be of minor importance before surgery and may be of major importance following surgery [16]; thus, one would expect lower QOL scores for pain following surgery. At our 3-month follow-up there were no wound infections. However, in the whole cohort there was no significant change in QOL scores for pain, suggesting that patients continue to experience some pain or discomfort 3 months following mitral valve surgery which may contribute to their complete recovery following surgery.

In conclusion, this study suggests that 3 months following mitral valve surgery there was significant improvement in the QOL of patients, especially in patients with repairable mitral valve disease. However, patients with impaired LV function and those with MR with end-systolic dimensions 45 mm were less likely to demonstrate a significant improvement in QOL at 3 months follow-up, suggesting that these patients may require extensive cardiac rehabilitation in the immediate post-operative period.

	Footnotes

 
Presented at the 72nd Scientific Session of the American Heart Association, Convention Center, Atlanta, GA, USA, November, 1999.

	Appendix

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion Appendix References

 
Appendix A. Patient variables that were considered for multiple regression analysis

Age (years)

<70/70

Gender

Male/female

Timing of surgery

Elective/non-elective

Pre-operative NYHA class

I and II/III and IV

Cardiac rhythm

Sinus/atrial fibrillation

Diagnosis

Mitral stenosis/regurgitation

Aetiology

Rheumatic/non-rheumatic

Warfarin therapy

Yes/no

Procedure

Repair/replacement

Implant size (mm)

<28/28

Ejection fraction

<50%/50%

Left ventricular end-systolic dimension (LVIDs) (mm)

<45/45

Left atrial diameter (cm)

<4/4

	References

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion Appendix References

 

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