| | Patient-reported quality of life after abdominal aortic aneurysm surgery: A prospective comparison of endovascular and open repairReceived 23 January 2006; accepted 4 August 2006. PurposeThis study evaluated and compared changes over time in health-related quality of life reported by patients with infrarenal abdominal aortic aneurysm (AAA) undergoing elective endovascular (EVAR) and open aneurysm (OR) repair. MethodsA prospective, nonrandomized cohort of 76 patients (62 men, 14 women; age range, 42 to 89 years) undergoing elective, infrarenal AAA repair (EVAR, n = 43; OR, n = 33) at two university teaching hospitals during a 15-month period were administered the Medical Outcomes Study Short-Form 36-item (SF-36) health survey preoperatively and then 1 week, 1 month, and 6 months postoperatively. Patient demographics, procedural details, postoperative follow-up data, and SF-36 scores were compared between groups. ResultsBoth groups had total SF-36 scores that were significantly lower than preoperative scores at 1 week and 1 month after surgery but were not significantly different from the preoperative scores at 6 months (OR 66.2 ± 21.1 to 72.3 ± 19.8, P > .1; and EVAR 61.0 ± 17.7 to 58.7 ± 19.4, P > .1). Six-month total SF-36 scores were significantly higher in the OR group compared with the EVAR group (mean 72.3 ± 19.8 OR vs 58.7 ± 19.4 EVAR; P = .009). In the postoperative period, a significant drop occurred in mean scores in six of the eight domains of the SF-36 in the OR patients (physical function, PF; role physical, RP; bodily pain, BP; vitality, VT; social function, SF; role emotional, RE) and five domains for EVAR patients (PF, RP, BP, SF, RE). In two domains, RE and PF, scores returned to baseline values significantly sooner in EVAR patients than in OR patients (RE, EVAR 1 month vs OR 6 months; and PF, EVAR 1 month vs OR 6 months). In the VT domain, no significant postoperative drop occurred in the EVAR group, but in the OR group, mean scores were significantly lower at 1 week and 1 month compared with preoperative values. In the domains of general health and mental health, no significant drop occurred in SF-36 score postoperatively in either group. ConclusionsPatient reported health-related quality of life after infrarenal AAA repair is significantly impaired in the early postoperative period but returns to baseline by 6 months in patients treated with EVAR and OR. Patients having EVAR had significantly more rapid return to preoperative scores in selected domains of the SF-36. Even though EVAR is associated with shorter and less invasive perioperative hospital course and fewer postoperative complications, EVAR patients had lower quality of life scores 6 months after surgery than OR patients. Endovascular techniques have developed rapidly within the last 15 years, and as a result, endovascular aneurysm repair (EVAR) has developed as a viable noninvasive option for the treatment of patients with elective aneurysms.1, 2 Compared with the wealth of published information evaluating medical and technical outcomes, studies that evaluate outcome from a patient’s perspective are relatively rare. Studies measuring patient-perceived quality of life after conventional open aneurysm repair demonstrate stable or even improved quality of life scores after the postoperative recovery period.3, 4, 5 Although EVAR is a less invasive procedure and it therefore should intuitively have less negative impact on patient quality of life in the early recovery period, it is not clear what other factors, such as the need for long-term follow-up and the need for secondary interventions, will have on patient-reported quality of life. Only a few published reports have compared patient-perceived quality of life after endovascular and open surgery for abdominal aortic aneurysm (AAA), and the results of these studies are not consistent.6, 7, 8, 9 In this prospective non-randomized study, we used a validated measurement tool, the Medical Outcomes Study Short-Form 36-item (SF-36) (Medical Outcomes Trust, Inc, Boston, Mass), to compare the changes over time in patient-perceived quality of life during 6 months after elective EVAR and open repair (OR) for AAAs. Methods  During a period of 15 months, we conducted a prospective nonrandomized study to compare patient-perceived quality of life in patients after elective infrarenal AAA repair at two hospital sites associated with McGill University. Both centers are tertiary care referral sites for vascular surgery and both routinely perform both OR and EVAR for infrarenal AAAs. During the study period, EVAR was selected for patients with suitable anatomy who were considered high risk for open surgery by the treating surgeon. OR was performed using a transperitoneal approach in all cases. The Institutional Review Board Ethics Committees granted approval for this study for each site. All patients of surgeons who routinely perform both OR and EVAR of AAA were eligible for recruitment. Patients were excluded from the study if the treating surgeon did not perform EVAR, if the patient did not speak English or French, was unable to understand the quality of life questionnaire provided in this study, had follow-up in another institution, refused to participate, or if the procedure was performed to treat a symptomatic or ruptured AAA. During the study period, 66 patients with AAAs had elective EVAR and 121 patients had elective OR. Of those, 43 EVAR and 33 OR patients were recruited into the study. Recruitment of patients was in a nonconsecutive fashion. After patients gave informed consent to participate in the study, they were interviewed by a vascular resident or research nurse before treatment. Functional status along with demographic data and cardiovascular risk factors were recorded. Procedural data and in-hospital outcome data were recorded in both groups, including mortality, morbidity, postoperative analgesia, time to resumption of oral intake, duration of urinary catheterization, time to full ambulation, intensive care unit stay, and postoperative length of stay. Health-related quality of life (HRQOL) was assessed with the SF-36.10 The SF-36 is a generic HRQOL measurement tool that can be reliably self-administered by an elderly population. It consists of 36 questions that are used to define eight health concepts or domains: physical function (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social function (SF), mental health (MH), and role emotional (RE). Two summary scales, physical health summary (PHS) and mental health summary (MHS), are derived from the eight health domains. For each domain, a raw score is transformed from 0 (worst health) to 100 (best health scale). The French and English version of the questionnaire was available according to the patient’s preference. The SF-36 was self-administered ≤1 week preoperatively to all EVAR and OR patients. It was then self-administered again in the postoperative period at 1 week, 1 month, and at 6 months. SF-36 scores were computed using commercially available software (SF-36 Outcomes, IMF Consultants, Sharon, Ontario, Canada). Statistical analysis was completed with the NCSS97desktop software package (Number Cruncher Statistical System, Dr. JL Hintze, Kaysville, UT). Categoric variables were compared with χ2 statistics. Continuous variables and individual HRQOL scores were compared by t test. Results Preoperative baseline patient characteristics During the 15 months of the study, 76 patients were recruited (43 EVAR and 33 OR) (Table I). The EVAR patients were significantly older than the OR cohort (mean, 76.1 years vs 68.6 years, P = .002). Preoperative functional status was similar in both groups, except that 15% of OR group were still working at the time of treatment. There was no significant difference in the prevalence of preoperative cardiovascular risk factors or American Society of Anesthesiologist class between the two groups. A history of cancer was significantly more common in the EVAR group (EVAR, 30.2% vs OR, 6.1%; P = .009). The mean preoperative baseline total HRQOL SF-36 scores between the two groups were not significantly different (66.2 ± 21.1 OR vs 61.0 ± 17.7 EVAR, P = .283). Intraoperative course and postoperative outcomes All OR procedures were preformed under general anesthesia, and almost all of the EVAR procedures (95.3%) were performed under regional anesthesia. The operative time did not differ between the two groups. However, the OR group had significantly higher mean intraoperative blood loss (300 ± 219 mL vs 1200 ± 1270 mL; P < .001), autotransfusion (0 vs 81.1% patients, 0 vs 652 ± 598.8 mL; P < .001), and number of patients requiring banked blood transfusion (6.9% vs 27.3%; P < .025, χ2). Significant differences were noted in the in-hospital recovery between the EVAR and the OR groups (Table II). No patients in either group died in-hospital or perioperatively (30-day postsurgery); however, three EVAR patients died in the study period (7 weeks postsurgery of pneumonia and 2 and 5 months postsurgery of myocardial infarction). The overall perioperative complication rate was significantly higher in the OR patients (57.6% vs 30.2%, P = .017). | | |  | | EVAR (n = 43) | Open (n = 33) | P | |
|---|
| Postoperative analgesia use | | | .001 | | |  Epidural, n (%) | 6(14) | 18(54.5) | | | | PCA, n (%) | 3(7) | 8(24.2) | | | | Nasogastric tube required, n (%) | 1(2.3) | 33(100) | <.001 | | | Median hours to full diet (mean ± SD) | 16(29.6±30.8) | 96(123.3±75.5) | <.001 | | | Patients with ileus >2days, n (%) | 2(4.7) | 7(21.2) | .027 | | | Median hours urinary cath (mean ± SD) | 16(42.7±85) | 72(93.1±54.7) | .033 | | | Median hours to unassisted ambulation (mean ± SD) | 24(69.7±132.2) | 96(136.9±86.9) | .011 | | | ICU monitoring, n (%) | 8(18.6) | 33(100) | <.001 | | | Median post-op hospital stay, days (mean ± SD) | 3(5.9±8.3) | 7(10.3±7.5) | .019 | | | | |
The need for reoperation or reintervention in the initial admission was not significantly different between the two groups: five patients in EVAR (graft limb thrombosis in 3, and one patient each with distal arterial embolization and endoleak) vs two patients in OR (graft limb thrombosis in 1 and wound dehiscence in 1; P = NS). EVAR patients were readmitted to hospital for vascular and non-vascular-related problems significantly more often ≤6 months of surgery (EVAR, 25.6% vs OR, 6.1%; P = .025). SF-36 results No significant difference was noted in mean preoperative baseline total HRQOL SF-36 scores between the two groups (66.2 ± 21.1 OR vs 61.0 ± 17.7 EVAR, P = .283). During the early postoperative period, SF-36 total scores were significantly lower than the baseline scores at 1 week and 1 month in both OR and EVAR patients. Compared with preoperative scores, no significant difference was found in mean 6 month SF-36 total scores in either group (66.2 ± 21.1 to 72.3 ± 19.8 OR, P > .1; 61.0 ± 17.7 to 58.7 ± 19.4 EVAR, P > .1). Although mean preoperative total SF-36 scores between OR and EVAR patients were not significantly different, the mean SF-36 scores for OR patients at 6 months were significantly higher than for EVAR patients (72.3 ± 19.8 OR vs 58.7 ± 19.4 EVAR, P = .009) (Table III). The scores within individual domains of the SF-36 (Fig 1 and Table IV), show a postoperative drop occurred in six of the eight domains after surgery for OR patients (physical function, PF; role physical, RP; bodily pain, BP; vitality, VT; social function, SF; role emotional, RE) and in five domains for EVAR patients (PF, RP, BP, SF, RE). In the RE and PF domains of the SF-36, scores returned to baseline values significantly sooner in EVAR patients than in OR patients (RE, EVAR 1 month vs OR 6 months; and PF, EVAR 1 month vs OR 6 months). In the domain of vitality, there was no significant postoperative drop in the EVAR group, but in the OR group, scores were significantly lower at 1 week and 1 month compared with preoperative values. In the domains of general health and mental health, no significant drop occurred in the SF-36 score postoperatively in either group. Because the univariate analysis of baseline characteristics showed that the mean age of patients in the EVAR group was significantly older (mean, 76.1 years vs 68.6 years, P = .02), we repeated the analysis of the SF-36 data with age-adjusted values. Analysis of age-adjusted SF-36 scores showed that EVAR patients had significantly lower mean scores within the domains of general health and vitality preoperatively. This age-adjusted analysis did not significantly change the postoperative outcomes (Table III, Table IV, Table V (online only), Table VI (online only)). Furthermore, repeat analysis excluding patients who were readmitted to hospital after the initial hospitalization or excluding patients requiring reoperation did not change any of the outcomes. Discussion The management of infrarenal AAAs has changed in the last decade with the introduction of endovascular techniques. EVAR is less invasive than open repair, and some of the reported advantages of EVAR are lower perioperative morbidity and mortality, shorter hospital stay, lower blood loss, and faster recovery.1, 2 On the other hand, EVAR demonstrated disadvantages, including the need for continuous postoperative surveillance, a higher reintervention rate, and endoleak in up to 20% of patients.11, 12, 13, 14 Because EVAR is considerably less invasive than OR, intuitively, it should be less likely to impact negatively on patient quality of life in the postoperative period. In this nonrandomized prospective cohort study, we examined the longitudinal changes in quality of life reported by patients undergoing elective EVAR or OR. Analysis of the data revealed that patients report significant deterioration in quality of life in the early postoperative period regardless of the type of procedure. We found significant drops in mean scores in six of the eight domains of the SF-36 in OR patients and in five of the eight domains in EVAR patients in the postoperative period. Quality of life scores had returned to preoperative values in both groups by 6 months after the procedure. In three domains, vitality, physical function, and role emotional, the postoperative drop in mean scores was evident for longer in the OR patients. This longer short-term drop in mean scores might be a reflection of the less invasive EVAR procedure. In this study, we clearly documented a less invasive, shorter, and less complicated hospital stay in the EVAR patients. Quality of life assessment tools such as the SF-36 can help surgeons evaluate a patient’s perception of his or her health and well being before and after surgery.15, 16 The standardized SF-36 health survey is a valuable instrument to measure patient-perceived quality of life owing to its high validity, reliability, psychometric propriety.17, 18 In addition, the ease with which it can be self-administered removes third-party bias. The American College of Surgeons and the American Society of Vascular surgery have both promoted the use of SF-36 in the surgical population,18, 19 and the SF-36 has been validated for patients with vascular diseases.20 Our study has weaknesses. The small sample size and the fact that treatment type was not assigned randomly in these patients introduced the potential for bias. During the study period, EVAR was selectively used at our institution in patients who were considered high risk for open surgical repair because of medical comorbidity but who had suitable anatomy for EVAR. Although most of the preoperative characteristics were comparable between the two patient groups, the EVAR patients were older and had a significantly higher incidence of cancer. This older population might be expected to score lower than a younger and healthier population. The possibility of a type II error also exists (wrongfully concluding to accept the null hypothesis) because of the small sample size and heterogeneity of both groups. Other nonrandomized studies comparing quality of life after EVAR and OR have not demonstrated any difference in scores between the two groups in the late postoperative period >3 months.5, 6, 7, 8, 9 This significant difference in mean SF-36 scores between the two groups at 6 months might be because this was not a randomized trial. At our institution, patients were selectively treated by EVAR if they were older, considered higher risk because of medical comorbidity, or considered too frail to undergo OR. The possibility of reintervention, failure of the endograft, and the uncertainty about the long-term outcome might adversely affect patient quality of life. However, when we reanalyzed our results excluding patients who required readmission or reoperation, or both, we found no significant difference in the outcome of patient-reported quality of life scores. Clarification of the reason for this finding will require further evaluation. The SF-36 results are displayed graphically for each of its eight domains using the same format used in the Dutch Randomized Endovascular Aneurysm trial7 (Fig 1). Interestingly, the results of this randomized trial are nearly identical to our results in a nonrandomized comparison. In the early postoperative period, they demonstrated a decrease in scores in six of the eight domains of the SF-36 (with the exception of general health and mental health, as in our study) in OR patients and in five of eight domains in EVAR patients. They also reported faster recovery of mean SF-36 scores to baseline in EVAR patients in the three domains of social function, role emotional, and vitality. In all domains of the SF-36, scores for the EVAR group reached baseline values by 6 weeks postoperatively. Also, as was found in our study, after 6 months the OR group scored significantly higher than the EVAR. Although one would not expect patients to feel physically better after full recovery from a procedure such as AAA repair, higher SF-36 scores in the OR patients at 6 months could be explained by a general feeling of physical or psychologic well being after survival and recovery from a treatment of a potentially life-threatening condition. Interestingly, in their report and in others,5 mental health scores continued to increase over time to reach significantly higher scores than baseline in both groups, which the authors felt might be explained by the relief of the anxiety after the aneurysm repair. Another prospective nonrandomized study6 that used the SF-36 to compare postoperative quality of life after OR and EVAR reported a significant decline in the four domains of physical function, social function, role physical, and vitality after aneurysm repair in both OR and EVAR patients. Mean scores for EVAR patients returned to baseline in all domains by 4 weeks, and the OR group scores returned to baseline by 8 weeks. The main difference in this study compared with ours is that the preoperative mean SF-36 baseline scores were significantly higher than the general US population, and this might explain fast recovery in all domains. In this study, the questionnaires where administered during office visits or by telephone interview, which may have biased patients responses since the SF-36 is designed to be self-administered. The Nottingham Health Profile (NHP) has been used in other studies to measure patient-perceived quality of life after EVAR and OR.9 The authors found no significant difference at any time between the OR and EVAR groups for NHP scores in the postoperative period up to 3 months. When the NHP and SF-36 were compared in patients with lower limb ischemia, both were found to be equally responsive to changes in physical activity and pain; however, the SF-36 is more responsive to changes in social activity and psychologic status.20 This may explain the negative findings in this study using the NHP instrument. Conclusion The findings of this nonrandomized prospective study show that patient-perceived quality of life after infrarenal AAA repair is significantly impaired in the early postoperative period but returns to baseline by 6 months in patients treated with EVAR and OR. Patients undergoing EVAR had significantly more rapid return to preoperative scores in selected domains of the SF-36. Even though EVAR is associated with a less invasive operative procedure, a more favorable perioperative hospital course, and a lower postoperative complication rate, patients undergoing EVAR have lower QOL scores 6 months after surgery than do patients undergo OR. Despite the limitations of this study, this data can be used to help inform our patients in the preoperative planning as part of the informed consent process, which will allow patients to be better informed about the recovery period and overall well-being. Author contributions Conception and design: BA, DA, KSM, DIO, OKS Analysis and interpretation: BA, GM, KA, DA, KSM, DIO, OKS Data collection: BA, KA, DA, OKS Writing the article: BA, KA, KSM, MC, OKS, GM Critical revision of the article: BA, DA, KSM, MC, DIO, OKS, GM Final approval of the article: BA, KA, DA, KSM, MC, DIO, OKS Statistical analysis: BA, MC, OKS, GM Obtained funding: OKS Overall responsibility: OKS References 1. 1EVAR trial participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomized controlled trial. Lancet. 2005;365:2179–2186. Abstract | Full Text |
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Division of Vascular Surgery, McGill University, Montréal, Québec, Canada.  Correspondence: Oren K. Steinmetz, MD, Division of Vascular Surgery, McGill University, Royal Victoria Hospital, 687 Avenue des Pins Ouest, Montréal, Québec H3A 1A1 Canada.
Competition of interest: Dr Steinmetz has a consulting agreement with Medtronic of Canada as a clinical preceptor. Additional material for this article may be found online at www.jvascsurg.org. PII: S0741-5214(06)01419-4 doi:10.1016/j.jvs.2006.08.015 © 2006 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. | |
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