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Evidence-based Practice |
1 From the Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Zero Emerson Pl, Suite 2H, Boston, MA 02114 (J.L.B., M.T.B., E.F.H., J.S.L., G.S.G.); Department of Epidemiology and Biostatistics, Erasmus University Medical Center, Rotterdam, the Netherlands (J.L.B.); and the Department of Health Policy and Management, Harvard School of Public Health, Boston, Mass (G.S.G.). Received December 13, 2000; revision requested January 26, 2001; revision received March 1; accepted March 23. Address correspondence to J.L.B. (e-mail: johanna@the-data-group.org).
| ABSTRACT |
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MATERIALS AND METHODS: All patients electively treated for infrarenal abdominal aortic aneurysm with endovascular repair (n = 182) or open surgery (n = 274) between January 1997 and September 1999 were included. From the hospital database, information on discharge destination, patient characteristics, complications, and length of stay was retrieved. Multiple logistic regression analysis was performed to determine predictors for discharge to home or to a rehabilitation center.
RESULTS: Patient characteristics did not differ significantly between the treatment groups, with the exception of age (mean age, 75.1 vs 72.9 years in the endovascular and open surgical group, respectively; P = .005). Patient discharge destinations differed significantly between the treatment groups (P = .001). After endovascular procedures, 156 (85.7%) of 182 patients went home and 19 (10.4%) of 182 patients went to a rehabilitation center. After open surgery, 187 (68.2%) of 274 patients went home and 64 (23.4%) of 274 patients went to a rehabilitation center. The odds ratio of discharge to a rehabilitation center, instead of home, following endovascular procedures versus open surgery was 0.23 (95% CI: 0.13, 0.43).
CONCLUSION: Following elective repair of infrarenal abdominal aortic aneurysm, significantly more patients went home after an endovascular procedure than after open surgery. Procedure type was a significant predictor of discharge destination.
Index terms: Aneurysm, abdominal, 981.73 Aneurysm, therapy, 981.1268, 981.1269
| INTRODUCTION |
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In the evaluation of a new technology, health outcomes and costs associated with the procedure should be examined (4). The authors of several studies (2,512) have reported early clinical results of endovascular repair. In addition, several studies (10,1315) have compared the hospital costs of endovascular repair with those of open surgical repair. The results of these studies demonstrated that endovascular repair may reduce complications, mortality, length of hospital stay, and hospital costs compared with open surgical repair. However, other authors (1620) have reported higher complication rates or hospital costs after endovascular repair than open surgical repair.
To compare open surgical and endovascular repair, the costs after discharge should be considered in addition to hospital costs (4). Because endovascular repair is less invasive, it is possible that patients who undergo an endovascular procedure would require less care after hospitalization than patients who undergo open surgical repair.
In our hospital, a large urban teaching facility, both elective open surgical and endovascular repair for abdominal aortic aneurysm have been frequently performed since 1997. The purpose of this study was to evaluate the discharge destination of all patients admitted to our hospital for elective repair of infrarenal abdominal aortic aneurysm and to determine predictors for discharge to home or to a rehabilitation center.
| MATERIALS AND METHODS |
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We used an additional database within our department to identify which patients underwent endovascular repair (n = 182) or open surgical repair (n = 274). The endovascular procedures were performed by using commercial stents (Ancure, Guidant Endovascular Technologies, Menlo Park, Calif; Vanguard, Boston Scientific/Meditech, Wayne, NJ; and Excluder, Gore & Associates, Flagstaff, Ariz) in sequential clinical trials (n = 103) or custom-made stents (n = 79) when no trial was ongoing. The most important criterion for the selection of treatment for abdominal aortic aneurysm is the size of the aneurysm (5-cm diameter or larger). The criteria for selecting endovascular repair rather than open surgery were aneurysm anatomy with respect to the device dimensions (eg, proximal aneurysm neck, 1.5 cm), absence of a major comorbid medical condition (eg, metastatic carcinoma), and patient treatment preference. In both treatment groups, endovascular repair and open surgery, the majority of patients underwent general anesthesia. More recently, the anesthesia protocol has been changed to epidural anesthesia for the endovascular procedures. In a previous study (23), with 91 patients participating in the endovascular clinical trials, we found that the proportion of patients who underwent epidural anesthesia was 24%. The institutional review board of our hospital approved all trial protocols, and written informed consent was obtained from all patients.
For each patient in our study, we retrieved information from the hospital database on their discharge destination. In addition, we retrieved information on patient demographics (age and sex), secondary diagnoses, all procedures performed during the hospital stay, the total number of days in the hospital, and the number of days spent in the intensive care unit. It should be noted that our system limits the number of listed secondary diagnoses or procedures to no more than 10; in our study group, however, no more than seven were reported for any one patient.
We transformed secondary diagnosis codes to complications and comorbidities by using a published measure of Elixhauser et al (24). This measure was developed for use with large administrative inpatient databases. A comprehensive list of ICD 9 CM diagnoses was reported to transform these codes into complications and comorbidities. A complication was defined as an acute condition that could result from performance of medical procedures (24). A comorbidity was defined as a clinical condition that existed before a patient was admitted to the hospital, was not related to the principal reason for hospitalization, and was likely to be a substantial factor influencing mortality and resource use in the hospital (24). We defined the comorbidities as hypertension, diabetes, chronic pulmonary disease, peripheral vascular disorders, and renal failure. According to Elixhauser et al (24), cardiac arrhythmia and congestive heart failure would be considered further specifications of the principal diagnosis (diagnosis-related groups codes 110, 111) and would not likely be a discrete and separate coexisting condition. However, for the interest of our study (ie, principal diagnosis of abdominal aortic aneurysm without rupture), we report these cardiac comorbidities.
To validate the accuracy of the coding and the definition of comorbidities and complications, a review of 50 patient charts randomly selected from the study group was performed by two authors (J.L.B., M.T.B.), who worked together in consensus. In this review, the coding was accurate with respect to the presence of diabetes, chronic pulmonary disease, neurologic disorders, or depression. Both false-positive and false-negative coding errors were found regarding the presence of hypertension (false-positive rate of 2%, false-negative rate of 4%). The presence of peripheral vascular disorders, cardiac arrhythmia, and heart failure (false-positive rates of 8%, 6%, and 4%, respectively) was overestimated in the hospital database. The presence of renal failures, however, was underestimated (false-negative rate of 3%). Overall, the comorbidities were accurately coded in 39 (78%) of 50 patients. The indication of a complication was accurately coded in 47 (94%) of 50 patients. In three patients, both false-positive and false-negative complications were found (one patient was treated for a hematoma and one patient was treated for an unrelated complication of acidosis). The number of coding errors was equally divided between the treatment groups. In the analyses, we included the codes derived from the hospital database.
Data Analysis
Descriptive statistics (proportions, means, and SDs) were calculated for patient characteristics, discharge destinations, comorbidities, complications, mortalities, intensive care unit admissions, and postoperative length of stay. Comparisons between the treatment groups, endovascular repair and open surgery, were performed by using the
2 test, Student t test, and, if not normally distributed, the nonparametric Mann-Whitney test (two-sided,
= .05).
Multiple logistic regression analyses were performed to determine predictors for discharge destination. Because the majority of the patients went either home or to a rehabilitation center, we limited the regression analysis to 426 (93.4%) of 456 patients in our study group. Thirty (6.6%) of 456 patients were excluded from the analysis because these patients either died during the hospital stay or were transferred to another institution. The sample sizes in these discharge groups were too small to determine predictors. Therefore, the outcome of interest (dependent variable) was "discharge to home" (represented as zero) or "discharge to a rehabilitation center" (represented as one).
Two models were fit. In the first model, the independent variables included were patient characteristics (age and sex), comorbidities (hypertension, diabetes, renal failure, chronic pulmonary disorders, peripheral vascular disease, depression, and neurologic disorders), and the type of procedure performed (endovascular or open surgery). In the second model, we included, in addition to the variables in the first model, variables associated with the outcomes of the procedure (more than 1 full day in the intensive care unit, complication, postoperative length of stay in days). Furthermore, cardiac comorbidities (ie, congestive heart failure and cardiac arrhythmia) were included in the second model and not in the first model, as these, according to Elixhauser et al (24), may be associated with the principle procedure. All analyses were performed by using a software program (SPSS for Windows, version 9.0; SPSS, Chicago, Ill).
| RESULTS |
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Table 2 shows the discharge destinations. There was a significant difference between the treatment groups (P = .001). The majority of the patients went home with health service (eg, received part-time nursing care, physical therapy). However, the proportion of patients discharged to home, with or without health service, was significantly higher in the endovascular group (156 [85.7%] of 182 patients) than in the open surgery group (187 [68.2%] of 274 patients) (P < .001). In addition, the proportion of patients who went to a rehabilitation center was significantly lower in the endovascular group (19 [10.4%] of 182 patients) than in the open surgery group (64 [23.4%] of 274 patients) (P < .001). In both treatment groups, few patients went to a skilled nursing facility; there was no significant difference between the treatment groups (P = .42). Furthermore, 11 patients died prior to discharge. The mortality rate was higher in the open surgery group than in the endovascular group; however, this difference was not statistically significant (P = .21).
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| DISCUSSION |
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In our study, we found that the type of treatment performed was a major predictor of discharge destination. After adjustment for patient characteristics and comorbidities, discharge to a rehabilitation center was reduced when an endovascular procedure was compared with open surgery. Other variables that increased the chance of going to a rehabilitation center were older age and the presence of a chronic pulmonary disease, depression, neurologic disorders, or cardiac arrhythmia. In addition, endovascular procedures resulted in fewer intensive care unit admissions and shorter postoperative length of stay than did open surgery. Even after including these outcome variables in the regression analysis (the second model), the type of procedure was still a significant predictor of discharge destination. Thus, discharge to a rehabilitation center was not fully explained by a longer length of stay or more intensive care unit admissions, both of which were associated with open surgery. These results suggest that a reduction in the chance of discharge to a rehabilitation center or, in other words, an increase in the chance of discharge to home is due to the procedure itself. Patients undergoing elective repair of abdominal aortic aneurysm thus more likely require less care in the recovery period than those undergoing open surgery.
To our knowledge, no other studies have been published investigating patient discharge destination after endovascular repair versus open surgery of abdominal aortic aneurysm. Early clinical results and hospital costs, however, have been reported for both treatment options. The results of these studies are conflicting. For example, a large range in complication rate has been reported following endovascular repair, and hospital costs have been reported to be greater or less than those associated with open surgery (13,1517,19,20,25). In a previous study (26), we compared the total actual hospital costs between treatment groups, which included the same patients as the current study. We found that even though intensive care unit admissions were fewer and postoperative length of stay was shorter, the actual total hospital costs for endovascular repair were significantly higher than those for open surgery. This was probably due to the higher costs of the stent-graft itself. Therefore, even though there may be no cost savings associated with endovascular repair from a hospital perspective, the cost of post-hospitalization care is typically less if it is received at home than if it is received at a rehabilitation center (27). The results of the present study suggest that a reduction in costs during the recovery period and a possibly of improvement in patient quality of life may be associated with endovascular procedures.
A limitation of our study was that we retrieved most of our data from the hospital database, which may be somewhat imprecise due to coding errors. If coding errors were present, this may have influenced our results with respect to the data we present on comorbidities, complications, and discharge information. To evaluate the degree of coding error in our study, we reviewed the medical records of 50 patients. The review study showed that comorbidity and complication rates were both underestimated and overestimated. Thus, bias due to the inaccuracy of the coding could go either way. The range in coding errors for the individual comorbidities varied between 0% (ie, diabetes, chronic pulmonary disease, neurologic disorders, and depression) and 8% (ie, peripheral vascular disorders). Furthermore, it should be noted that no coding errors were found in the significant predictors of the first regression model. Moreover, coding errors were found in both treatment groups. Therefore, we may assume that coding errors occurred at random and independently of the procedure (ie, nondifferential misclassification). However, it should be noted that the exact rate of coding error in our study group is unknown. Furthermore, several authors have reported larger coding error rates than found in our study and have confirmed that coding error may be a concern in evaluating large databases (28,29).
Another limitation of our study was that we have no information about a patients residence before hospitalization. However, the patients in the two treatment groups were similar with respect to patient characteristics and comorbidities. Therefore, it is unlikely that more patients in the open surgery group than in the endovascular group came from a rehabilitation center prior to hospitalization. In addition, we do not have cost or outcome data following discharge. For example, we do not know the duration of stay in the rehabilitation center; this would be necessary to estimate the absolute costs associated with the recovery period.
One final limitation of our study was that the patients in our study group were not randomly placed into the two treatment options. Therefore, selection bias may be present. For example, patients with a serious comorbid condition or patients with a lack of an adequate infrarenal neck were excluded from the endovascular clinical trials. Thus, perhaps the healthiest patients underwent endovascular treatment. Although the patient characteristics and comorbidities were similar between the treatment groups and were not significantly different, the vascular anatomy and the disease itself may have been more severe in the open surgery group. A limitation of our study was that we did not have the information to explore this in the analysis. Therefore, the proportion of patients discharged to a rehabilitation center after open surgery may have been overestimated. A randomized clinical trial should be performed to test the difference between endovascular repair and open surgery more accurately.
Currently, in the United States, two stent-grafts (Ancure, and AneuRX, Medtronic, Minneapolis, Minn) are commercially available, and many other grafts are under investigation in clinical trials. For future development and implementation of the technique, it is important to evaluate the benefits and the shortcomings of the technology. Although, recently, many studies have been published reporting early clinical results and hospital costs, clinical outcomes and costs of events in the follow-up should also be assessed. For example, after treatment, extensive imaging is required for patients who have undergone endovascular repair, and secondary interventions may be necessary due to the possibility of developing endoleaks or graft occlusions. The clinical outcomes and costs associated with imaging and repair of endoleaks and graft occlusions should be evaluated. In addition, further research is required to establish the absolute costs associated with recovery and to establish patient quality of life.
In conclusion, after endovascular procedures for elective repair of infrarenal abdominal aortic aneurysm, significantly more patients are discharged to home and fewer patients are discharged to a rehabilitation center, compared with the number of patients after open surgery. The type of procedure performed was a significant predictor of discharge destination. These results suggest that, in the recovery period, a reduction in costs and possible gains in patient quality of life might be achieved after an endovascular procedure is performed, compared with those after open surgery.
| ACKNOWLEDGMENTS |
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| FOOTNOTES |
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| REFERENCES |
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