| | Health-related quality of life in survivors of open ruptured abdominal aortic aneurysm repair: A matched, controlled cohort studyReceived 15 February 2007; accepted 10 April 2007. ObjectiveThe objective of this study was to document the health-related quality of life (HRQOL) for patients who survived operative repair of a ruptured abdominal aortic aneurysm (RAAA) and to compare this with a matched group of patients who survived elective operative repair of an abdominal aortic aneurysm (EAAA). MethodsA matched, controlled cohort study of HRQOL was used to compare patients surviving RAAA with an EAAA control group. The study was conducted at two university-affiliated vascular tertiary care referral centers. Survivors of RAAA and EAAA during an 8.5-year period were identified and followed up. The RAAA and EAAA control patients were matched for age, serum creatinine concentration, gender, and duration of follow-up since surgery. HRQOL was measured with the Medical Outcomes Study Short Form-36 Health Survey (SF-36). Scores for the EAAA and RAAA cohorts were also compared with age-corrected SF-36 population scores. ResultsOf 267 patients operated for RAAA during the study period, 130 (49%) survived to hospital discharge. Death after discharge was documented in 35 patients, leaving a potential study population of 95 RAAA survivors. Thirteen were lost to follow-up, seven refused to participate, and four patients were not able to participate. The SF-36 was completed by 71 RAAA patients (75% of surviving RAAA patients). The 71 RAAA survivors and 189 EAAA control patients were similar for seven of eight domains of the SF-36: Physical Function, Role-Physical, Bodily Pain, General Health, Vitality, Mental Health, and Role-Emotional. There was also no difference in the Physical Health Summary and Mental Health Summary scores. The social function component of the SF-36 demonstrated a statistically significant decline in the EAAA group. Both the EAAA and RAAA SF-36 individual and summary scores compared favorably with population norms that were adjusted only for age. ConclusionLong-term survivors of RAAA enjoy a HRQOL that does not differ significantly from EAAA survivors. Scores for both groups compare favorably with population scores adjusted only for age. Identification of patients with an abdominal aortic aneurysm (AAA) is important to allow timely repair at an appropriate size to reduce the risk of death from rupture. Although open surgery is a major intervention, elective repair of an AAA (EAAA) is preferred because of the high risk of death and morbidity associated with a repair of a ruptured AAA (RAAA). The mortality rate associated with traditional open EAAA has improved over time, and rates <4% to 5% have been reported.1, 2, 3 This operative mortality has been further reduced to approximately 1.2% with the use of elective endovascular aneurysm repair (EVAR).4, 5, 6, 7 Unfortunately, operative repair of RAAA is associated with significant patient morbidity and has a mortality rate of about 50%, which has not demonstrated an improvement similar to EAAA over time.8, 9, 10, 11, 12, 13 Some case series have suggested a possible potential role for EVAR to reduce the operative mortality for RAAA; however, this potential reduction has not yet been reliably confirmed.14, 15, 16, 17, 18, 19, 20 Although much literature is devoted to the immediate morbidity and mortality of patients with a RAAA, few studies with valid tools have evaluated the long-term impact that repair of this catastrophic event has on a survivor’s health. The purpose of this study was to document the health-related quality of life (HRQOL), as measured by the Medical Outcomes Study Short Form-36 Health Survey (SF-36) in such a population. The resulting scores were compared with a matched, controlled group of survivors of traditional open EAAA. Age-corrected population scores for the SF-36 have also been reproduced for comparison with these two AAA populations. Methods  This study was conducted in Canada at two hospital sites associated with the University of Ottawa, Ottawa (The Ottawa Hospital–General and Civic Campus), and two hospital sites associated with the McGill University Health Centre (MUHC), Montréal (Montréal General Hospital and the Royal Victoria Hospital). The hospital sites of each university center were covered by the same surgical staff. All patients were operated on and cared for by these members of the Division of Vascular Surgery. Both centers function as tertiary care referral sites for major metropolitan centers. Approval for this study was granted by the Institutional Review Board Ethics Committee of the involved sites. All patients who underwent RAAA and EAAA repair between January 1, 1991, and July 30, 1999, were identified by using the computerized database of each institution’s medical records department. EVAR had not yet been introduced as an alternative for open elective or urgent AAA repair during this time at either site. From a chart review, we evaluated the operative reports for RAAA and EAAA repair. We recorded patient age in years, gender, preoperative renal function (preoperative serum creatinine concentration), and number of months since surgery. These patient variables were used to select and match approximately two control EAAA patients for each RAAA patient. An AAA was considered ruptured only if retroperitoneal or free intraperitoneal blood at the time of laparotomy was specified in the operative note. Only infrarenal aneurysm repairs were considered. Patients were excluded from the RAAA population if they underwent emergency aneurysm repair for a symptomatic AAA when blood was not noted to be present in the retroperitoneum or in the peritoneal space. Ruptured isolated iliac artery aneurysms were also excluded. Patients were excluded from the RAAA and the EAAA groups if there was a suprarenal component to the aneurysm, although patients who required suprarenal or supraceliac clamping of the aorta were included if the aneurysm itself was infrarenal. Mortality was defined as all in-hospital death that occurred after surgery, regardless of the time elapsed since the operation. We attempted to contact all RAAA patients who were discharged alive from the hospital after surgery for participation in the study. Mortality after discharge for the RAAA patients was documented by a review of the medical chart, by autopsy report, by correspondence with the primary care physician, or by telephone contact with family members. The matched EAAA patients were selected by using the described variables and then contacted for participation in the study. After explaining the study and obtaining telephone consent, those patients who agreed to participate were mailed the SF-36 in the language of their choice for completion and return. The SF-36 was used to assess HRQOL. The SF-36 is a generic questionnaire that can be reliably self-administered by an elderly population. It consists of 36 questions, which are used to define eight health concepts or dimensions: Physical Function, role limitations due to physical health problems (Role-Physical), Bodily Pain, General Health, Vitality, Social Function, Mental Health, and role limitations due to emotional health problems (Role-Emotional). Two summary scales are derived from the eight health concepts: Physical Health Summary and Mental Health Summary. For each of the eight dimensions of health, a raw score is computed using the responses to the 36 questions. The raw score is transformed to a scale of 0 (worst health) to 100 (best health). These scores can be compared with population norms derived from the Medical Outcomes Study.21 The French and English version of the questionnaire was available according to the patient’s preference. The RAAA patient data were also analyzed to estimate whether a time-sensitive relationship exists between postoperative HRQOL and the length of time after follow-up. The RAAA patient follow-up was divided into two groups: 42 subjects (group 1) who were evaluated before the overall mean follow-up time of 38 months (mean follow-up, 22.5 months) and 29 subjects (group 2) who were evaluated at or after the mean follow-up time of 38 months (mean follow-up, 59.8 months). The SF-36 scores were computed using commercial software (SF-36 Outcomes, IMF Consultants, Sharon, Ontario Canada). The computed scores and matching variables were entered into an Access 2003 database (Microsoft, Redmond, Wash). Statistical analysis was completed with NCSS 2004 software e (NCSS, Kaysville, Utah). Categoric variables were compared with χ2 statistics. Continuous variables and individual HRQOL scores were compared by t test. Population scores for the SF-36, adjusted only for age >65 years, are also reproduced for comparison. Results During the study period, 2453 open AAA repairs were completed at the two university centers (University of Ottawa, 1581; McGill University, 872). Emergency surgery for RAAA was done in 267 of these patients (135 University of Ottawa, 132 McGill University), and 133 were discharged alive from the hospital for an in-hospital mortality rate of 51% (Table I). This left a potential RAAA patient population of 130 for inclusion in the study. | | |  | Location | Patients | Discharged, n (%) | Hospital mortality, n (%) | |
|---|
| University of Ottawa | 135 | 67 (50) | 68(50) | | | McGill University | 132 | 63(48) | 69(52) | | | Total | 267 | 130(49) | 137(51) | | | | |
At the time of this study after discharge (mean follow-up time 38 months), 35 of the RAAA patient population were documented to have died (27% of the initial discharged survivors). Two of the deaths were related to aneurysm complications: one resulted from a graft enteric fistula and one resulted from a ruptured thoracic aneurysm. Similar to other reports, the remaining patients died of miscellaneous causes, including pneumonia, stroke, malignancy, and myocardial infarction.22, 23, 24 Thirteen of the patients discharged alive were lost to follow-up (10%), one of which had metastatic lung cancer and another would have been well past 90 years of age on follow-up. Although likely dead, these two patients were not included in the mortality group because we could not objectively document their death as described above. This left 82 RAAA patients who were presumed to be alive and available for the study. Seven of the survivors refused to participate in the study for undisclosed reasons. All seven were living independently. From the remaining 75 survivors of RAAA repair, two patients were unable to complete the questionnaire because of language difficulties, and two patients could not because of dementia. Pre-existing senile dementia was documented in one of these dementia patients before RAAA repair. This left us with 71 completed SF-36 questionnaires from the 130 of the RAAA population discharged alive (75% of the 95 patients with RAAA repair discharged and not documented to have died on follow-up). None of these patients were institutionalized for long-term care at the time of follow-up. During the study period, 189 EAAA patients who underwent repair at the two university centers were selected as controls by matching for preoperative serum creatinine concentration, age, gender, and time since operation. These variables were well matched for the EAAA and RAAA patient populations (Table II). The elective mortality rate for EAAA during the study time period was 4.2% at the Ottawa Hospital and 4.1% at the MUHC. | | | | Variable* | EAAA (% or 95% CI) | RAAA (% or 95% CI) | P | |
|---|
| Total | 189 | 71 | | | | Male gender | 161(85.2) | 57(80.3) | .31 | | | Age, mean years | 70.9(69.9-72.0) | 71.9(70.1-73.7) | .34 | | | Creatinine, mean mmol/L | 102.9(98.5-107.3) | 107.7(99.9-115.5) | .27 | | | Follow-up, mean months | 33.3(30.8-35-8) | 37.7(32.8-42.6) | .09 | | | | |
The SF-36 was administered after AAA repair after a mean of 33 months for EAAA and 38 months for RAAA. There was no significant difference in the HRQOL as measured by the SF-36 for the seven of the eight health domains: Physical Functioning Role-Physical, Bodily Pain, General Health, Vitality, Mental Health, and Role-Emotional. There was a statistically significant improvement recorded in the Social Function (SF) domain between the EAAA patients (SF score, 73.9), and the RAAA patients (SF score, 81.2, P = .04; Table III, Fig 1). There was no difference between the RAAA and EAAA study groups for the Physical Health Summary and Mental Health Summary scores (Table III, Fig 2). The RAAA and EAAA SF-36 scores after surgery compared favorably with population-based scores corrected only for age >65 (Fig 1, Fig 2). To evaluate whether follow-up time may have had an influence on the HRQOL results, we also evaluated the RAAA SF-36 scores for 42 patients with a follow-up of less than the mean (follow-up time, 22.5 months) and compared this with 29 patients with follow-up as long or longer than the mean (follow-up time, 59.8 months). There was no significant difference in the SF-36 scores between the two RAAA follow-up groups (Fig 3, Fig 4, Table 4). | | | | Variable | 22.5 months (n = 42) | 95% CI | 59.8 months (n = 29) | 95% CI | P | |
|---|
| Physical Functioning | 61.9 | 53.3-70.5 | 54.9 | 44.9-65.0 | .29 | | | Role-Physical | 45.2 | 31.7-58.8 | 38.8 | 23.4-54.2 | .6 | | | Body Pain | 79.3 | 71.6-87.0 | 71.8 | 60.9-82.8 | .25 | | | General Health | 69 | 62.8-75.3 | 60.1 | 51.1-69.1 | .09 | | | Vitality | 66 | 54.5-65.5 | 57.2 | 49.4-65.1 | .55 | | | Social Functioning | 84.4 | 78.8-90.0 | 76.8 | 66.8-86.9 | .15 | | | Role-Emotional | 68.2 | 56.1-80.4 | 49.4 | 32.9-65.9 | .06 | | | Mental Health | 79.6 | 74.7-84.4 | 75 | 69.1-80.9 | .22 | | | Physical Health Summary | 41.6 | 38.3-45.0 | 39.6 | 35.8-43.4 | .42 | | | Mental Health Summary | 50.4 | 46.8-54.0 | 48.2 | 44.0-52.3 | .42 | | | | |
Discussion Although open surgical repair of RAAA continues to be associated with high morbidity and mortality, this study suggests that those fortunate enough to survive and recover from surgery go on to enjoy a HRQOL that is similar to patients who survive open EAAA repair. In addition, both RAAA and EAAA patient populations appear to enjoy a HRQOL that is similar to population norms that have been adjusted only for age (65 to 74 years). In other studies, patients whose HRQOL has been measured with the SF-36 before and after EAAA repair appear to enjoy a HRQOL after recovery from surgery that is similar to their preoperative measure.25, 26, 27, 28 In the elective population, the introduction of EVAR does not appear to have had a significant positive impact on long-term HRQOL compared with open surgery.25, 28, 29, 30, 31 The potential for EVAR to affect HRQOL after RAAA repair has not yet been evaluated. Recent multicenter trials comparing EVAR with open surgical repair of RAAA have so far failed to document significant clinical benefit when traditional outcome measures were considered.19, 20 The concept of health is not only related to the absence of disease and infirmity but also to the presence of physical, mental, and social well being.32 Traditional measures of outcome in vascular surgery, such as graft patency and complication rates, are of considerable importance. These measures; however, tend to reflect a technical evaluation of the procedure rather than the impact that the intervention has on the patient as a whole.33, 34, 35, 36 Measurement of HRQOL is one means of evaluating a patient’s perception of their health and well-being before and after any surgical intervention. A change in a patient’s perception of their HRQOL may arguably be the most relevant outcome measure for a given patient. In the extreme situation, a technically successful operation might leave a patient significantly debilitated from the morbidity associated with the surgery. Such a concern might exist for survivors of RAAA repair given the high operative morbidity and mortality rates. The SF-36 is a generic (not disease-specific) HRQOL measurement tool that has been widely used in many types of patient populations. It has been promoted for use in surgical populations by The American College of Surgeons and The Society for Vascular Surgery.36, 37 The SF-36 has also been validated and recommended for use in patients with vascular disease.38 As a generic tool, it has been well documented to be valid and reliable.39 The SF-36 can be rapidly and easily self-administered, even in an elderly population. Such self-administration may remove bias associated with application of the survey by a third party. As a generic tool, it may be particularly appropriate for evaluation of an intervention intended to prolong life expectancy in a patient who is otherwise asymptomatic with respect to the disease. Generic measures, in contrast to disease-specific measures, are appropriate to evaluate for unintended or unexpected outcome after an intervention. Elective repair of an aneurysm is not generally intended to make a patient symptomatically better; however, the presumed extension of life expectancy would, it is hoped, not come with a significant cost to the patient’s HRQOL. The current literature has little reliable data that document the impact of RAAA repair on HRQOL. In 1992, Magee et al40 raised concern about possible deterioration of HRQOL in survivors of RAAA repair and used the Rosser index to measure HRQOL unmatched patients after RAAA and EAAA repair. The Rosser index is a health measurement tool that evaluates disability and distress. It has not been widely validated, particularly in a vascular population, and it has not been widely recommended for use in surgical populations. The Magee et al study asked 45 survivors of RAAA repair and 86 survivors of EAAA repair to compare their HRQOL after surgery with that which they could recall existed before surgery. The study concluded that HRQOL deteriorated with RAAA repair but not with EAAA repair. Patients were not matched for comorbidities, so it was difficult to be certain that the EAAA and RAAA populations were otherwise similar. In addition, the manner that changes in scores were recorded would be subject to considerable recall bias. The clinical significance of the absolute difference in scores was of also of concern when considering the conclusions of this study. In 1998, another small study also used the Rosser index to compare 14 patients after EAAA repair with 14 patients after RAAA repair.41 This study did not confirm the findings of Magee et al40 and did not document a difference in HRQOL as measured by the Rosser index. This finding was consistent with another small negative study that was limited by the use of an unestablished measure of HRQOL that had not been validated or demonstrated to be reliable.42 Two other studies have applied the SF-36 to patients who have survived RAAA repair.43, 44 These studies did not have EAAA controls, but both concluded that HRQOL in the survivors of RAAA repair was not significantly different than age-matched population norms. In another study, similar to our current report, Tambyraja et al45 evaluated an EAAA and RAAA population with the SF-36. Although their study was considerably smaller than our current study and had a shorter mean follow-up, they did document a similar finding that there was no significant difference in HRQOL between patients who had EAAA and RAAA repair. In contrast to our study, however, they documented a reduction in HRQOL for both patient populations compared with a normal population matched for age and gender. Hinterseher et al22 evaluated survivors of RAAA repair with the World Health Organization (WHO) QOL-BREF questionnaire. They used populations norms matched for age and gender for a control. Although also a relatively small study, with only 24 RAAA survivors completing the survey, it did not document a decline in HRQOL compared with the population scores. The WHO-QOL-BREF questionnaire, however, has not been validated in a vascular population and has not been used widely for reports of surgical outcomes. To our knowledge, our study measured HRQOL in the largest number of survivors of RAAA repair to date compared with a matched controlled population of EAAA patients. We are also able to report the outcomes of long-term survivors. These patients were compared with a well-matched contemporary control population of survivors of EAAA from the same institutions during the same time period (Table II). The matching variables were selected for their potential prognostic importance on outcome and by our ability to reliably measure or document the variables in the RAAA population.3 One of the study centers, the Ottawa Hospital, is regional center responsible for all RAAA patients. These unselected sequential patients likely approximate a population study and their outcomes should be generalizable. The selection of the SF-36 tool was based on our previous experience, general recommendations, and the availability of population scores.26, 27, 36, 37, 38 We obtained completed SF-36 questionnaires for 75% the survivors of all RAAA repair, and surprisingly, none of the survivors, including those who refused or could not complete the questionnaires, were institutionalized. Although the HRQOL in this surviving population appears to be excellent compared with age-controlled population norms and survivors of EAAA repair, we were still only able to evaluate 71 (55%) of the initial 130 patients who were discharged alive after RAAA repair. This was primarily due to death after discharge in the survivors of RAAA repair, which does tend to be higher than that in the general population. The HRQOL in the patients who died after discharge—but before they could be evaluated by this study—might have been different than that of those who survived to complete the survey. As a consequence, the results of this study might not be generalized to all initial survivors of RAAA repair; instead, it applies to long-term survivors of RAAA. We did, however, attempt to evaluate the potential effect of follow-up time on the HRQOL results. When we evaluated HRQOL scores for patients with short-term (mean, 22.5 months) and long-term (mean, 59.8 months) follow-up, the difference in the individual (Fig 3) or summary scores (Fig 4) for the SF-36 was not significant. It is also interesting to note that the SF-36 scores reported by Tambyraja et al45 in EAAA and RAAA patients 6 months after surgery are remarkably similar to the SF-36 scores reported in our study. We did not evaluate the impact that postoperative complications and length of stay had on the long-term HRQOL scores. It is possible that those patients with longer and more difficult recovery periods may have scored lower on follow-up; however, as an overall group, the long-term RAAA survivors appear to do well. The mortality rate for RAAA repair in this study is comparable with most published reports from large centers for similar patients.24, 46, 47, 48 The mortality outcomes for the two institutions in two different cities was remarkably similar for both EAAA and RAAA repair. Failure to repair a RAAA almost always leads to early death. This study, however, provides reassurance that for long-term survivors of surgical repair of a RAAA: the extended longevity does not appear to come at a significant cost to HRQOL compared with an EAAA control population and with age-matched population scores. Previous work suggests that for the EAAA population, the HRQOL after recovery from surgery is not significantly different from that enjoyed before the aneurysm repair.26, 27, 28 It might be reasonable to assume a similar conclusion for the RAAA patients because it would be difficult to explain how RAAA repair might lead to an increase in the HRQOL that existed before the rupture. We did document a statistically significant difference in the SF domain between the EAAA patients (SF score, 73.9), and the RAAA patients (SF score, 81.2; P = .04; Table III,Fig 1). The absolute difference between these scores is not likely clinically significant and did not influence the summary scores. The significance of this finding is not evident. Conclusion This study suggests that long-term survivors of RAAA repair enjoy a HRQOL similar to that enjoyed by those who survive traditional open EAAA repair. This information should be reassuring to surgeons faced with managing the significant morbidity that follows RAAA repair and would tend to justify the considerable effort and expenditure of resources devoted to the recovery of these patients. 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a Division of Vascular Surgery, Department of Surgery, The University of Ottawa, Ottawa Hospital, Ottawa, Ontario, Canada b Division of Vascular Surgery, Department of Surgery, McGill University Health Science Center, Montréal, Québec, Canada.  Correspondence: Andrew B. Hill, MDCM, FACS, FRCS, Ottawa Hospital - Civic Campus, A280-1053 Carling Ave, Ottawa, Ontario K1Y 4E9, Canada.
Competition of interest: none. PII: S0741-5214(07)00636-2 doi:10.1016/j.jvs.2007.04.033 © 2007 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. | |
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