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Ann Thorac Surg 2007;83:1381-1387
© 2007 The Society of Thoracic Surgeons


Original Articles: Cardiovascular

Improved Health-Related Quality of Life and Functional Status After Surgical Ventricular Restoration

Ulrik Sartipy, MD*, Anders Albåge, MD, PhD, Dan Lindblom, MD, PhD

Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital, and Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden

Accepted for publication November 13, 2006.


Abbreviations and Acronyms LV = left ventricular; MCS = mental component summary; NYHA = New York Heart Association; PCS = physical component summary; QOL = quality of life; 6MWT = 6-minute walk test; SF-36 = Medical Outcome Study 36-Item Short Form; SVR = surgical ventricular restoration; VT = ventricular tachycardia


* Address correspondence to Dr Sartipy, Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital, Stockholm SE-171 76, Sweden. (Email: ulrik.sartipy{at}karolinska.se).


    Abstract
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Background: Surgical ventricular restoration (SVR) has been shown to improve hemodynamics and survival among patients with coronary artery disease, left ventricular aneurysm, and heart failure. The aim of this study was to investigate functional status and health-related quality of life after SVR.

Methods: Over a period of 2 years beginning in March 2003, 23 patients with left ventricular aneurysm and depressed left ventricular function were included in a prospective study. Functional status and quality of life was analyzed preoperatively, 6 months postoperatively, and at late follow-up by assessment of New York Heart Association (NYHA) functional class, 6-minute walk test, and the Medical Outcome Study 36-Item Short Form.

Results: There was no early mortality. Before surgery, 17 patients (74%) were in NYHA class III to IV; and 6 months after SVR, 20 patients (87%) were in NYHA class I to II (p < 0.001). At late follow-up, (mean, 22 months postoperatively), all patients alive (n = 20) were in NYHA class I to II. Mean 6-minute walk distance increased by 41 meters (p = 0.06) at 6 months postoperatively and by 57 meters (p = 0.03) at late follow-up. Quality of life, assessed by the physical component summary score of the Medical Outcome Study 36-Item Short Form, improved significantly (p = 0.04) at 6 months postoperatively. A significant and clinically relevant improvement in both physical aspects (+25%, p < 0.001) and mental aspects (+37%, p = 0.003) of quality of life was found at late follow-up.

Conclusions: Functional status and quality of life improved 6 months after SVR, and the improvement was sustained at late follow-up almost 2 years after surgery.


    Introduction
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Surgical ventricular restoration (SVR) by the Dor procedure is a surgical option in patients with ischemic heart disease and heart failure. Indications for SVR include ischemic dilated cardiomyopathy or left ventricular (LV) aneurysm with symptoms of heart failure, angina, or ventricular tachycardia (VT). Surgical ventricular restoration includes complete revascularization, ventricular reconstruction to restore near-normal shape and volume, and when necessary, endocardectomy and cryoablation to remove substrate for VT [1, 2]. Mitral valve repair or replacement is performed as needed. The procedure has been extensively reviewed regarding hemodynamic improvement [3, 4]. Results pertaining to operative and long-term survival and freedom from VT are excellent [2, 5–8]. However, results regarding quality of life (QOL) and functional status are less well documented.

The aim of this study was to prospectively investigate functional status and QOL before and after SVR.


    Patients and Methods
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
This study was approved by the regional Human Research Ethics Committee, Stockholm, Sweden. Informed consent was obtained from all patients.

Patient Selection
During a 2-year period beginning March 2003, 23 patients with postinfarction dyskinetic LV aneurysm or large nonaneurysmal akinetic LV were included. Assessment of LV volume and geometry was made by ventriculography and also, in some patients, by magnetic resonance imaging. Patients were considered suitable for SVR if they demonstrated an either dyskinetic or akinetic enlarged left ventricle accompanied by LV dysfunction after myocardial infarction and had symptoms of angina or heart failure, or both. Patients who had previously undergone cardiac surgery or who had nonanterior dyskinesia/akinesia were excluded.

Patient Characteristics
There were 16 men and 7 women (n = 23), with a mean age of 65 ± 12 years (range, 44 to 80). Seventeen patients (74%) were in New York Heart Association (NYHA) functional class III or IV. Multivessel disease was present in 20 patients. The mean preoperative LV ejection fraction was 0.26 ± 0.08 (0.10 to 0.45). Baseline characteristics and indications for surgery are presented in Table 1. All patients were operated on electively. All patients but 1 underwent preoperative programmed electrical stimulation [8], and 17 patients had inducible VT preoperatively. Two patients had preoperative episodes of spontaneous VT.


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Table 1 Preoperative Patient Characteristics, Indications for Surgery, and Perioperative Data
 
Surgical Technique
Surgical ventricular restoration was performed according to the Dor technique [2, 9]. The operative procedure has been presented in detail elsewhere [8, 10]. In all patients, the left ventricle was reconstructed with an endoventricular patch.

Outcome Measures
Health-related quality of life
All patients were asked to complete the Medical Outcome Study 36-Item Short Form (SF-36) questionnaire 1 to 2 weeks before surgery, 6 months postoperatively, and at late follow-up. The primary outcome measures were the physical component summary (PCS) and mental component summary (MCS) scores from the SF-36 (Fig 1). The SF-36 is a standardized, self-administered survey measuring health-related quality of life [11]. The validity and reliability of the Swedish version has been evaluated [12]. The questionnaire consists of 36 items and measures health using eight subscales with two to 10 items per scale. The subscales and summary scores can be compared with the general population allowing for norm-based interpretation.


Figure 1
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Fig 1. The Medical Outcome Study 36-Item Short Form subscales and summary scores.

 
Scoring of the SF-36 was performed according to the methods described in the Swedish version of the SF-36 manual [11]. For each of the eight subscales, the score was summed and transformed to a scale of 0 to 100, representing the percentage of the highest possible score achieved. The scales are constructed in such a way that a higher score indicates better health. To estimate the summary measures (PCS and MCS scores), standard scoring algorithms was used. Several advantages of the PCS and MCS over the original eight scales of the SF-36 have been reported [11, 13]. For the PCS score, very high scores indicate no physical limitations, disabilities, or decrements in well-being as well as high energy level. Very low scores indicate substantial limitations in self-care, physical, social, and role activities, severe bodily pain, or frequent tiredness. For the MCS score, very high scores indicate frequent positive affect, absence of psychological distress and of limitations in usual social or role activities due to emotional problems. Very low scores indicate frequent psychological suffering, and substantial social and role disability due to emotional problems.

Six-minute walk test
The 6-minute walk test (6MWT) was administered 1 to 2 weeks before surgery, 6 months postoperatively, and at late follow-up by a standardized method [14] with a course length of 40 m. Patients were instructed to walk at their own pace while attempting to cover as much distance as possible during the allotted time. The test was supervised, and the time was called out every minute. No encouragement was offered. During the test, patients were allowed to rest or stop and then continue as soon as they could resume the walk. At the completion of 6 minutes, the patient was told to stop, and the distance covered was recorded. The self-paced 6MWT assesses the submaximal level of functional capacity. Most patients do not achieve maximal exercise capacity during the 6MWT, although the test may be more of a maximal exercise test for patients with severe heart failure. Because most activities of day-to-day life are performed at submaximal levels of exertion, however, the 6MWT may be more representative of the functional status in daily life [15].

New York Heart Association functional class
The NYHA functional class was assessed 1 to 2 weeks before surgery, 6 months postoperatively, and at late follow-up.

Survival and readmission for heart failure
Time to readmission was defined as the time from the operation to either first hospital readmission due to heart failure or death. The date for the first hospital readmission due to heart failure was ascertained by hospital records and the national In-patient Register, Centre for Epidemiology, at the National Board of Health and Welfare, Sweden. The date for death was established by use of a continuously updated population register, the Total Register of the Swedish Population, Statistics Sweden.

Statistical Analyses
Data are presented as mean and standard deviation or number of patients. Preoperative and postoperative intragroup comparisons were performed with parametric or nonparametric tests for dependent samples, as appropriate. The paired samples t test was used for the continuous variables PCS, MCS, and 6MWT distance; and the Wilcoxon signed ranks test for end-diastolic volume index and end-systolic volume index, and the marginal homogeneity test, which is an extension of the McNemar test, was used for categorical data (NYHA class). A two-tailed p value of 0.05 was used to indicate statistical significance. Statistical analyses were performed using SPSS 14.0 (SPSS, Chicago, Illinois).


    Results
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Operative Data
There was no early mortality, defined as death within 30 days of the operation or before hospital discharge. All patients underwent SVR by the Dor procedure, and 22 patients (96%) had concomitant coronary artery bypass graft surgery with a mean of 2.5 ± 1.2 grafts (range, 1 to 5). Mitral valve repair was performed in 4 patients (17%). Operative data are summarized in Table 1.

Left Ventricular Volumes
Left ventricular end-diastolic and end-systolic volumes decreased 6 months after surgery according to cardiac magnetic resonance imaging, as shown in Table 2.


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Table 2 Left Ventricular Volume Indices by Magnetic Resonance Imaging Before and Six Months After Surgical Ventricular Restoration
 
Survival and Readmission for Heart Failure
All patients were alive at follow-up 6 months postoperatively. However, 3 patients died later: 1 renal transplant recipient died of renal failure 2.1 years after surgery, and 2 patients died of heart failure 1.6 and 2.5 years after the operation at age 79 and 74 years, respectively. During a total follow-up of 43.7 patient-years, survival at 24 months was 93%, with 10 patients remaining at risk.

Hospital Readmission Due to Heart Failure
Freedom from a composite endpoint of first postoperative hospital readmission due to heart failure or death was 74% at 6 months and 65% at 12 months, with 12 patients remaining at risk.

Late Follow-Up
Late follow-up for functional and QOL assessment was performed at a mean of 22 months (standard deviation 9.5; range, 9 to 38) postoperatively.

Functional Status
New York Heart Association functional class
There was a significant improvement in functional status judged by NYHA class. Before surgery, 17 patients (74%) were in NYHA class III to IV, and 6 months after the operation 20 patients (87%) were in NYHA class I to II (p = 0.0001). At late follow-up, 2 of the 3 patients in NYHA class III at 6 months had died, and the third had improved to NYHA class II; thus, all patients alive (n = 20) were in NYHA class I to II. Preoperative and postoperative NYHA class for all patients is shown in Figure 2. Only 1 patient had a clinical worsening of heart failure, with an increase from NYHA class II to class III 6 months postoperatively; this patient’s postoperative condition was multifaceted owing to severe diabetic nephropathy with previous kidney transplants and progressive renal failure late after the cardiac procedure.


Figure 2
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Fig 2. New York Heart Association (NYHA) functional class before and after surgical ventricular restoration. (Black bars = preoperative; gray bars = 6 months postoperative; white bars = late postoperative.)

 
Six-minute walk test
Six-minute walk test distance increased in 12 of 17 patients who completed a preoperative and postoperative 6MWT, and the results are shown in Figure 3 and Table 3. Reasons for not completing the preoperative 6MWT were that 1 patient declined to participate, and 2 patients aborted the preoperative 6MWT due to chest pain. Three patients declined to participate in the 6-month postoperative 6MWT; however, all 3 had clinical improvement, signified by a two-step drop in NYHA class in 2 patients and a one-step drop in 1 patient. Excluding the patient who deteriorated after surgery, mean walking distance increased by 41 meters 6 months after the operation (p = 0.06). Fourteen patients were available for 6MWT at late follow-up. Two of the 3 patients who did not complete a 6MWT at late follow-up were in NYHA class I. One was working full time but had a recent foot injury, and the other was enjoying retired life by traveling abroad. The third patient had recently diagnosed skeletal cancer and declined to participate owing to undergoing numerous other investigations. As shown in Table 3, mean walking distance increased by 57 meters at late follow-up compared with baseline (p = 0.03).


Figure 3
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Fig 3. Six-minute walk test distance before and after surgical ventricular restoration. Each line represents a patient. (Postop = postoperative; preop = preoperative.)

 

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Table 3 Six-Minute Walk Test Before and After Surgical Ventricular Restoration
 
Health-Related Quality of Life
Preoperative and postoperative SF-36 questionnaires were completed by 21 patients (91%) and 17 patients (85%) at 6 months and at late follow-up, respectively. The mean preoperative and postoperative SF-36 scores are shown in Table 4. We observed a 15% mean increase in the PCS score (p = 0.02) and a 13% mean increase in the MCS score (p = 0.06) 6 months postoperatively. At late follow-up, we observed a mean increase in the PCS score of 25% (p < 0.001) and a 37% mean increase in the MCS score (p = 0.003) compared with baseline (Table 5). A 10% to 12% increase is generally accepted as a clinically relevant improvement after an intervention in cardiac patients [16, 17]. The PCS and MCS scores before and after surgery together with an age- and sex-matched reference sample from the general Swedish population are shown in Figure 4.


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Table 4 Short Form-36 Scores Before and After Surgical Ventricular Restoration
 

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Table 5 Short Form-36 Scores Before and After Surgical Ventricular Restoration
 

Figure 4
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Fig 4. Medical Outcome Study 36-Item Short Form (SF-36) physical component summary (PCS) score and mental component summary (MCS) score before and after surgical ventricular restoration compared with an age and sex-matched reference sample from the general Swedish population. (Heavy dashed line = PCS; heavy solid line = MCS; light dashed line = PCS reference; light solid line = MCS reference; preop = preoperative; postop = postoperative.)

 

    Comment
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
The main findings in this study were that functional status and QOL improved 6 months after SVR and that the improvement was sustained at late follow-up at a mean of 22 months after surgery. Enhanced hemodynamics, cardiac performance, and excellent short- and long-term survival has been demonstrated after SVR [2–7, 18]. Based on earlier studies, improvement of functional status and QOL is expected after SVR but has not been previously verified by validated health-related QOL instruments. Our study supports the hypothesis that SVR improves functional status and QOL in patients with coronary artery disease, LV aneurysm, and heart failure.

Little is reported regarding QOL outcome after SVR. In a study comparing midterm outcome after SVR or heart transplantation, QOL was assessed after surgery and was found to be better after SVR in psychological and social relation scores. Heart transplant recipients scored higher in the physical capacity domain. There was, however, no QOL comparison before and after surgery in this study [19]. The patients in our study reported a significant and clinically relevant improvement in the PCS score of the SF-36 6 months after SVR. There was a further improvement that was demonstrated at late follow-up, and the improvement was more pronounced in the mental domain. In a large cohort study, lower preoperative PCS score was associated with higher mortality rate at 6 months after coronary artery bypass graft surgery surgery [20]. In another study [16], undertaken to investigate changes in QOL after coronary artery bypass graft surgery surgery, an average improvement of 16% in physical health status and an average improvement of 4% in mental health status was found. It was also found that patients with lower preoperative PCS and MCS scores were most likely to have an improvement in QOL. Preoperative health status was the major determinant of change in QOL after surgery.

Cardiac resynchronization reduces the risk of death among patients with moderate or severe heart failure and QRS interval of at least 120 ms, and has favorable effects on QOL [21]. The effects on QOL is, however, small in comparison with other surgical strategies used in heart failure such as implantation of an assist device [22, 23] or transplantation [19, 24].

We found a prominent and significant improvement in functional status judged by NYHA class. This finding was confirmed by an increase of 6MWT distance. The improvement in functional status was also reflected in a satisfactory freedom from hospital readmission due to heart failure. In a recent systematic review of the 6MWT as an outcome measure for treatment assessment in heart failure intervention trials [15], it was observed that there was little relationship between the 6MWT distance and symptom severity, judged by NYHA class. The authors concluded that the 6MWT has not yet been proved to be a robust test for pharmacologic treatment effects, but it appears useful for the assessment of cardiac resynchronization therapy. The results of the 6MWT were concordant with changes in symptoms, however, suggesting that it may be used as supportive evidence for symptom benefit [15]. One possible drawback with the 6MWT is that measuring exercise capacity of patients who have little disability at baseline may be an inadequate tool to assess response to treatment. In our study, 4 patients had a preoperative walking distance of more than 500 meters. Future studies in the field of heart failure surgery would benefit from measurements of peak exercise oxygen consumption in addition to 6MWT. It is a noninvasive, objective measurement of cardiac performance, and widely used in evaluation for heart transplantation [25, 26].

The primary goal of heart failure surgery is to enhance survival in patients with advanced heart disease and poor prognosis. By applying the concepts of SVR, it is possible to reach results comparable to those of heart transplantation [2, 5, 7, 19]. Because a curative treatment can not be offered, another very important concern is to improve well-being and functional capacity. It is therefore desirable to find adequate surrogate outcome measures for mortality in this patient population. We have previously reported our experience of SVR regarding survival, freedom from arrhythmia, and clinical data [8, 10]; and in this study we strived to analyze "softer" outcome measures by reliable and generally accepted methods as described above. Evaluating well-being in patients with heart failure appears more complex, partly because of the time-dependent dynamics of the condition. Improved NYHA class may be too insensitive in its predictive capability of outcome in these patients. Improvement in ejection fraction is likewise an inappropriate indicator of success after SVR, because an increased ejection fraction is a mathematical consequence of the operation owing to the surgical reduction of end-diastolic LV volume.

Another aspect of functional and QOL assessment after surgery that needs to be taken into account is the patient’s inclination to not disappoint the surgeon at follow-up. Many patients feel indebted and thankful to the surgeon and are reluctant to disclose their true functional status, and tend to exaggerate their physical capability. One way of possibly minimizing this effect is, of course, to leave the follow-up to another doctor not affiliated with the surgical team. In our opinion, the SF-36 may partly solve this problem. Patients fill out the form themselves. The questionnaire is quite short and only takes a few minutes to fill out, yet it is complex enough to prohibit immediate interpretation. This setting may provide patients with sufficient confidence to express a more honest or genuine view of their physical and mental health status.

Limitations of the Study
Intervention studies such as ours are always prone to selection bias. We have tried to minimize selection bias by including all patients eligible for the procedure at our institution, with the exception of patients matching exclusion criteria. A limited number of patients declined to participate in the study, however, and therefore our herein presented material was not truly consecutive. The underlying assumption in this study was that a change in QOL resulted from the operation. Naturally, other major life events with impact on the QOL may have occurred during the time between the assessments. Another limitation in our study is the small sample size.

In conclusion, among patients with ischemic heart disease and heart failure, we found an improvement in QOL and functional status 6 months after SVR, which was sustained at late follow-up. Specifically, there was a significant improvement in NYHA functional class, 6MWT distance, and the PCS and MCS scores of the SF-36. Assessment of QOL by SF-36 is meaningful and applicable in evaluating outcome after SVR.


    Acknowledgments
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
This work was supported by grants from the Swedish Heart Lung Foundation and Capio Research Foundation.


    References
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 

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