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Ann Thorac Surg 2004;77:1359-1365
© 2004 The Society of Thoracic Surgeons

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Original article: cardiovascular

Health status, functional abilities, and quality of life after the Mustard or Senning operation

^a Center for Health Services and Nursing Research, Katholieke Universiteit Leuven, Leuven, Belgium
^b Belgian National Foundation for Research in Pediatric Cardiology, Halle, Belgium
^c Division of Congenital Cardiology, University Hospitals of Leuven, Leuven, Belgium
^d Department of Pediatric Cardiology, Cliniques Universitaires Saint Luc, Brussels, Belgium
^e Center for Congenital Heart Diseases, Anna Blancquaert, Ghent University Hospital–University Hospital of Antwerp, Ghent, Belgium
^f Division Pediatric Cardiology, University of Liège at CHR Citadelle, Liège, Belgium

Accepted for publication September 22, 2003.

^* Address reprint requests to Mr Moons, Center for Health Services and Nursing Research, Kapucijnenvoer 35, 4, B-3000 Leuven, Belgium
e-mail: philip.moons{at}med.kuleuven.ac.be

	Abstract

Top Abstract Introduction Patients and methods Variables and measurement Statistical analysis Results Comment Acknowledgments References

 
BACKGROUND: Life expectancy of patients who underwent atrial switch operation for the transposition of the great arteries is relatively good. However, many patients are faced with residua and sequelae, which may hamper their functioning and quality of life. This multicenter study assessed the perceived health status, functional abilities, and quality of life in long-term survivors of the Mustard or Senning operation.

METHODS: A group of 89 patients (58% male) were selected from four tertiary care centers, consisting of 37 Mustard and 52 Senning operation patients. Perceived health status was measured using a linear analog scale. The educational level, employment status, New York Health Association classification, ability index, and Baecke questionnaire were used to evaluate functional abilities. Quality of life was assessed with a linear analog scale, the Satisfaction with Life Scale, and the Congenital Heart Disease—TNO/AZL Adult Quality of Life.

RESULTS: Patients reported good to very good perceived health, functional capacities, and quality of life. The responses of patients with complex transposition were equivalent to those of patients with simple transposition. The most dominant concerns reported by survivors of the Mustard and Senning operations were experiences about physical limitations and worries about a current or future job or income.

CONCLUSIONS: Long-term survivors after atrial inflow correction demonstrated favorable perceived health, functional status, and quality of life; these conditions were, to a large extent, comparable with the status of the general population. These outcome variables were not negatively affected by the complexity of the transposition.

	Introduction

Top Abstract Introduction Patients and methods Variables and measurement Statistical analysis Results Comment Acknowledgments References

 
Until the mid-1980s, the Mustard and Senning operations were the preferential treatment method for transposition of the great arteries (d-TGA). These procedures have been abandoned in favor of the arterial switch operation because of multiple complications [1]. Long-term outcome studies revealed that approximately 75% to 80% of the patients who underwent a Mustard or Senning operation survived to adulthood [2–5]. Despite the relatively good life expectancy, many patients are faced with multiple residua and sequelae. Indeed, right ventricular failure, arrhythmia, tricuspid valve dysfunction, and baffle-related problems may significantly reduce patients' health status, functional outcome, and quality of life.

Outcome research in health care is traditionally focused on mortality and morbidity. Nonetheless, functional status, quality of life, customer services, and health care costs are also important outcome indicators in the evaluation of health care provision [6]. In particular, these outcome indicators were found to be essential in the evaluation of therapeutic modes. Although several studies have been conducted on the functional outcome and quality of life of patients after the Mustard or Senning operation [3, 4, 7–12], only two studies have investigated these issues in depth using appropriate instruments [7, 9].

Information on long-term function and quality of life is critically important to obtain a better understanding of the relevant issues or concerns of patients who have undergone a Mustard or Senning operation. Such understanding serves to facilitate the optimization of clinical follow-up procedures. Therefore, the aims of this study were: (1) to assess the perceived health status, functional abilities, and quality of life of long-term survivors after the Mustard or Senning operation, and (2) to examine whether differences could be observed based on the complexity of the transposition.

	Patients and methods

Top Abstract Introduction Patients and methods Variables and measurement Statistical analysis Results Comment Acknowledgments References

 
Study population
This study was part of a nationwide, multicenter research project on long-term outcomes (up to 30 years after the Mustard or Senning operation) [5]. The larger study included 339 patients who underwent either a Mustard or Senning operation or received postoperative follow-up in one of six pediatric cardiology centers in Belgium, or both. Patients could be included in this quality of life study if they survived the operation, if they were at least 18 years of age on January 1 2002, if they were literate and Dutch or French speaking, and if they did not exhibit learning difficulties. Hence, quality of life and health status of adolescents and patients with mental retardation were not addressed in this study, because these populations require a specific methodological approach, different from the methods used in this investigation. For logistical reasons, one center could not participate in this study. In another center, none of the patients meeting the inclusion criteria were available (Fig 1).

View larger version (20K): [in this window] [in a new window]   Fig 1. Flow-chart of patient selection.

This study was approved by the Institutional Review Board on July 1, 2002 and has been performed in accordance with the ethical standards. The introduction letter stated that refusing to participate in the study would in no way affect the quality of care received from health care professionals. It was expected that responders would have to spend approximately 20 minutes to complete the questionnaire.

	Variables and measurement

Top Abstract Introduction Patients and methods Variables and measurement Statistical analysis Results Comment Acknowledgments References

 
Health status
Perceived health status was measured by using a linear analog scale (LAS). This is a vertical, graded, 10-cm line, ranging from the worst imaginable health state of zero to the best imaginable health state of 100. The LAS is part of the EuroQol instrument and is considered to have good validity and reliability results [13].

Functional abilities
The variables that defined the functional status of the patients included educational level, employment status, New York Heart Association functional class [14], ability index [15], and Baecke questionnaire [16]. The Baecke questionnaire assesses habitual physical activity and consists of three dimensions: (1) physical activity at work, (2) sports during leisure time, and (3) physical activity during leisure time excluding sports. These assessments include 18 items, each rated 5 points, as well as one dichotomous item and three open questions. Using predefined algorithms, an index can be calculated for the three dimensions; this index ranges from 1 (lowest level of activity) to 5 (highest level of activity). This method has been shown to provide a valid assessment of an individual's level of physical activity [17].

Quality of life
Based on a thorough conceptualization (data on file), we define quality of life as a sense of overall life satisfaction that is positively or negatively influenced by an individual's perception of certain aspects of life that are important to them, including matters both related and unrelated to health. Consequently, quality of life has to be measured in terms of life satisfaction.

First, the overall quality of life was measured using an LAS, ranging from the worst imaginable quality of life of zero to the best imaginable quality of life of 100. Patients used this LAS to give a rating of their own perceived quality of life.

Second, the Satisfaction with Life Scale [18] was also used as an indicator of quality of life. This instrument consists of five statements and seven response categories ranging from "strongly disagree" to "strongly agree." An aggregate score can be calculated by summing the individual item scores. This results in a minimum score of 5 and a maximum score of 35. The validity and reliability of this scale have been studied extensively, indicating good psychometric properties [19].

A disease-specific tool for measuring the health-related quality of life of adults with congenital heart defects has recently been developed. The Congenital Heart Disease—TNO-AZL Adult Quality of Life (CHD-TAAQOL) [20]. This tool consists of 77 items that refer to specific problems or concerns of adults with congenital heart disease regarding physical functioning, symptoms, medication, activities of daily living, and social functioning. For each item, the perceived frequency is assessed using a 3-point rating scale denoting "no," "sometimes," and "often." If a problem occurred sometimes or often, then the level of distress associated with this problem was determined through the use of four response categories: "not at all," "a little," "quite a lot," and "very much." These two scales are transformed to an ordinal 5-point rating scale for coding purposes, with score 1 corresponding to "no" on frequency of the problem, and scores 2 to 5 corresponding to the respective emotional responses. For instance, if a patient indicated that the occurrence of a particular problem was frequent, but was not causing any distress, then a score of 2 was allocated. Although the CHD-TAAQOL was originally developed as an indicator of health-related quality of life, we use it to assess determinants of quality of life.

Because this tool is relatively new, data on reliability and validity are sparse. Based on factor analysis performed on data collected from 156 patients [20], the creators of the CHD-TAAQOL reduced the tool from 77 items to 26 items. Items that were not attributed to one of the three principal components (symptoms, impact of cardiac surveillance and worries) were removed from the scale. Although this scale reduction was inspired by an attempt to enhance construct validity, the modification may have compromised the content validity. This is because potentially relevant items were skipped as they were not related to other questions. It was therefore decided that the initial 77 items would be kept, but that the analyses would be limited to the item level, prevailing from calculating total scores or subscale scores.

	Statistical analysis

Top Abstract Introduction Patients and methods Variables and measurement Statistical analysis Results Comment Acknowledgments References

 
The data were analyzed using SPSS 9.0. Nominal level data were expressed in percentages. Medians and quartiles were calculated for continuous, nonnormally distributed variables. The Mann-Whitney U test and ² test were used for two-group comparisons of continuous and nominal data. The level of significance was set at p less than or equal to 0.05.

The CHD-TAAQOL was measured at the ordinal level. Therefore, ridit analysis, a sensitive statistical method to analyze ordinal data [21], was chosen. A ridit represents the relative probability to an identified distribution. The ridit of a subsample is always compared with the ridit of a chosen reference group. The reference group used to rank the most distressing items was obtained by using the frequency distribution of the whole sample for all items. The ridit of a particular item is the probability that a randomly selected individual scores higher on that item than on another randomly selected item of the questionnaire.

	Results

Top Abstract Introduction Patients and methods Variables and measurement Statistical analysis Results Comment Acknowledgments References

 
Patient characteristics
Eighty-nine patients were included in the study, of which 52 (58%) were male and 37 (42%) were female (Table 1). The median age of the patients was 24 years. This relatively young age implied that most patients were unmarried and living with their parents. Simple d-TGA, without concomitant anomalies or with only minor heart defects, was observed in 76% of the patients. Transposition in the remaining 24% was associated with other cardiac lesions, such as large ventricular septal defects, pulmonary valve stenosis, or coarctation of the aorta. The median elapsed time from atrial switch repair to data collection was 23 years. The time period between the final examination and the mailing of the questionnaires was 9 months, indicating that the data accurately reflects the current status of the survivors.

The relatively young median age indicated that most patients were still students. Only a few patients from the overall sample were unable to work. No differences between simple and complex transposition was observed.

Using the New York Heart Association functional classification, 93% of the patients were categorized in class I and 7% in class II. This indicated a good functional status (Table 2). Patients with simple d-TGA are more often assigned to the New York Heart Association functional class I than patients with complex d-TGA, although this difference was not statistically significant. The ability index showed that 85% of the patients were able to lead a "normal life" (class 1), whereas 15% were "able to work, but experienced intermittent symptoms and some interference with life" (class 2).

The Baecke questionnaire showed that 93% of patients had occupations with low levels of physical activity. Nevertheless, 21% of patients thought that their workload was physically heavier than that of their healthier peers. Slightly more than one-half of the patients were engaged in sporting activities (52%). Of these patients, 21% performed mild sports (eg, walking, darts, snooker), 52% performed moderate sports (eg, cycling, swimming, gym at school), and 27% performed high intensity sports (eg, football, cycle-racing, rugby). In comparison with their healthier peers, 43% of the patients estimated that they had the same level of physical activity during leisure time. The same percentage of patients (43%) believed that they had a lower degree of physical activity.

The median occupational, sport, and leisure activity indices were 2.75, 2.25, and 2.75, respectively on a scale from 1 to 5. No differences were found with respect to the complexity of the transposition.

Quality of life
The median LAS score for quality of life for the overall group was 80 (Table 2). For the Satisfaction with Life Scale, the median score was 27 on a scale from 5 to 35. No significant differences were observed between simple and complex d-TGA, suggesting that patients experience a good quality of life, irrespective of the complexity of the lesion.

Analysis of the CHD-TAAQOL at item level resulted in a ranking order of the most distressing problems or concerns of Mustard and Senning patients (Table 3). They were most worried about their health. Most dominant in the top-10 list of issues reported by survivors of the Mustard and Senning operations were experiences about physical limitations and worries about a current or future job or income.

	Comment

Top Abstract Introduction Patients and methods Variables and measurement Statistical analysis Results Comment Acknowledgments References

Health status, functional abilities, and quality of life
It was found that adult survivors of the Mustard or Senning operation perceive themselves to be in good health, exhibit good functional status, and report good quality of life. Although transposition of the great arteries can be considered to be a severe congenital heart defect [22], the patients' perception of their health was good. This is in line with previous findings indicating that between 84% [3] and 88% [7] of the Mustard patients described their health as being between good to excellent. In the general Belgian population, about 90% of individuals between 15 and 34 years of age rated their health as being good to very good [23].

Functional abilities included the level of education and employment status and were assessed in addition to using the New York Heart Association functional class, the ability index, and the Baecke questionnaire. The degree of employment and unemployment of the patients was equivalent to that of the general Belgian population. In our sample, 53% of patients were employed, compared with 50% in the same age group of the general population [24]. The level of unemployment was 11% in the Mustard and Senning patients and 12% in the corresponding age group of the general population. These results indicate that survivors of the atrial inflow correction operation are able to assume productive roles in society, resulting in an optimal social integration.

The results obtained by the New York Heart Association functional class and the ability index are comparable, to a large extent, with previously published data [7–9, 25]. Half of the patients surveyed reported participating in sporting activities on a regular basis. This proportion is somewhat higher than the age-corrected data of the general population (44.5%) [23], however, the level of intensity was lower. In the sample used, 13% of the patients participated in sporting activities at a high level of intensity compared with 22% of the general population corrected for age [23]. The available data on physical activities confirms what many studies have indicated, that is, while exercise capacity is below normal levels, most patients are able to perform normal physical activities without having adverse symptoms [26].

Mustard and Senning patients reported a good to very good quality of life indicating a general level of satisfaction with their life; this may be against all odds, because transposition of the great arteries is a complex heart defect that results in a chronic condition. A quality of life survey is currently being conducted in the general population using the same tools as were used in this study. To date, 138 individuals have been included. Preliminary results showed a median quality of life score of 80 on the LAS. Overall, this study indicated that patients following the Mustard or Senning procedures are generally in good clinical condition, displaying a functional status and quality of life that is to a large extent equivalent to that of their healthier counterparts.

Methodological issues
We investigated a sample of adult survivors after atrial inflow correction procedures in Belgium. Although data were obtained by postal survey, the response rate was considerably high. No specific selection bias was observed.

However, inclusion criteria implied that the sample was not necessarily representative of the entire population of Mustard and Senning patients. We did not include patients less than 18 years of age or patients with mental retardation. The former group was excluded because questionnaires developed for adult populations are not valid for adolescent use. The latter group was debarred from inclusion because self-report by questionnaires require intact intellectual abilities. Excluding patients with learning disabilities did not dramatically impact the overall results because only 12 patients from this group were excluded. Therefore the results of this study can only be generalized to adult survivors of the Mustard or Senning operation who had normal cognitive functions.

Quality of life is a problematic concept. Although it is an increasingly important outcome indicator, there is no consensus still on its definition or measurement. In this study, quality of life was defined in terms of life satisfaction as influenced by multiple external factors. The measurement of quality of life relied on a sound conceptual basis that clearly distinguishes between quality of life and health status [27].

To date, the CHD-TAAQOL is the only disease-specific tool related to congenital heart disease [20]. In a first attempt to optimize the validity of the instrument, factor analysis was performed [20]. The scale was subsequently reduced from 77 items to 26. This study revealed that the scale reduction resulted in removing items that were most relevant for Mustard and Senning patients. Indeed, 6 of the 10 items reported in the top-10 list of Mustard and Senning patients' most distressing experiences or concerns were removed from the scale because they could not be interrelated with other items to represent an underlying dimension. Therefore the findings of this study suggest that further validation research is needed with respect to the CHD-TAAQOL before an empirically-based scale reduction can be performed. In particular, more validity evidence on the tool's content is imperative. For instance, it may be that the distinction between "experiencing limitations in sporting" and "being worried about exertion or sports" is not always clear to the respondents. The validity and reliability of this tool is currently being tested by using a sample of 629 adults with congenital heart disease in order to make suggestions for improving the scale.

	Acknowledgments

Top Abstract Introduction Patients and methods Variables and measurement Statistical analysis Results Comment Acknowledgments References

 
This study was supported by the Belgian National Foundation for Research in Pediatric Cardiology.

	References

Top Abstract Introduction Patients and methods Variables and measurement Statistical analysis Results Comment Acknowledgments References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Moons, P. Articles by Vliers, A. Search for Related Content PubMed PubMed Citation Articles by Moons, P. Articles by Vliers, A. Related Collections Congenital - cyanotic