TY - JOUR
T1 - Historic control comparison of outcome for matched groups of patients undergoing endoluminal versus open repair of abdominal aortic aneurysms
AU - White, G. H.
AU - May, J.
AU - McGahan, T.
AU - Yu, W.
AU - Waugh, R. C.
AU - Stephen, M. S.
AU - Harris, J. P.
AU - Veith, F. J.
AU - Hertzer, N. R.
PY - 1996
Y1 - 1996
N2 - Purpose: Currently no randomized studies show the relative morbidity and mortality of the open and endoluminal methods of abdominal aortic aneurysm (AAA) repair. The aim of this study was to analyze the outcome of two matched groups of patients with AAA, one undergoing open repair and the other undergoing endoluminal repair. Methods: Two groups of patients who had undergone repair of AAA by open technique (group 1) or by endoluminal methods (group 2) were compared. A historic control cohort of 27 patients was selected from 56 consecutive patients who underwent open repair of AAA between January 1991 and February 1992. Patients considered unsuitable fur the endoluminal method on the basis of computed tomography and aortography were excluded (n = 29). Between May 1992 and November 1994 prospective data were recorded for 62 consecutive patients who underwent endoluminal repair by tube or bifurcated endografts. Twenty-eight patients who had been specifically referred for endoluminal AAA repairs because of preexisting severe medical comorbidities were excluded. Six of the endoluminal cases had failure, requiring conversion to open operation, and were excluded for separate analysis, leaving 28 patients in group 2. Patients in both groups were thus fit and suitable for either open or endoluminal repair and were comparable in relation to age, sex, risk factors, dimensions, and form of AAA. Results: The mean values for operation time, blood loss, intensive care stay, and hospital stay for group 1 and group 2 were 2.6 versus 3.1 hours, 1422 versus 873 ml,* 1.8 versus 0.7 days,* and 12.4 versus 11.1 days, respectively (*p < 0.05). Local/vascular complications occurred in 15% of patients in group 1 compared with 25% in group 2 (p = 0.55), whereas remote/systemic complications occurred in 37% and 29%, respectively (p = 0.3). Five of 28 patients in the endoluminal group had complications requiring early operative repair (n = 3) or late revision (n = 2). When comparison was made on an intention-to-treat basis (with failed procedures included), the incidence of local/vascular complications was significantly greater for endoluminal repair (p = 0.047). Conclusions: The incidence of systemic/remote complications was similar for the two groups in spite of significantly less blood loss and shorter intensive care unit stay with endoluminal repair. The incidence of local/vascular complications had a tendency to be higher for endoluminal compared with standard open method (and was significantly greater if failed procedures were included). In this early experience with prototype devices, patients who were medically suitable fur open surgical procedures did not derive benefit from the less invasive endoluminal technique with respect to duration of operation, length of hospital stay, or perioperative morbidity and mortality. On the other hand, because they also did not have worse outcome, a randomized study is now justified in this group.
AB - Purpose: Currently no randomized studies show the relative morbidity and mortality of the open and endoluminal methods of abdominal aortic aneurysm (AAA) repair. The aim of this study was to analyze the outcome of two matched groups of patients with AAA, one undergoing open repair and the other undergoing endoluminal repair. Methods: Two groups of patients who had undergone repair of AAA by open technique (group 1) or by endoluminal methods (group 2) were compared. A historic control cohort of 27 patients was selected from 56 consecutive patients who underwent open repair of AAA between January 1991 and February 1992. Patients considered unsuitable fur the endoluminal method on the basis of computed tomography and aortography were excluded (n = 29). Between May 1992 and November 1994 prospective data were recorded for 62 consecutive patients who underwent endoluminal repair by tube or bifurcated endografts. Twenty-eight patients who had been specifically referred for endoluminal AAA repairs because of preexisting severe medical comorbidities were excluded. Six of the endoluminal cases had failure, requiring conversion to open operation, and were excluded for separate analysis, leaving 28 patients in group 2. Patients in both groups were thus fit and suitable for either open or endoluminal repair and were comparable in relation to age, sex, risk factors, dimensions, and form of AAA. Results: The mean values for operation time, blood loss, intensive care stay, and hospital stay for group 1 and group 2 were 2.6 versus 3.1 hours, 1422 versus 873 ml,* 1.8 versus 0.7 days,* and 12.4 versus 11.1 days, respectively (*p < 0.05). Local/vascular complications occurred in 15% of patients in group 1 compared with 25% in group 2 (p = 0.55), whereas remote/systemic complications occurred in 37% and 29%, respectively (p = 0.3). Five of 28 patients in the endoluminal group had complications requiring early operative repair (n = 3) or late revision (n = 2). When comparison was made on an intention-to-treat basis (with failed procedures included), the incidence of local/vascular complications was significantly greater for endoluminal repair (p = 0.047). Conclusions: The incidence of systemic/remote complications was similar for the two groups in spite of significantly less blood loss and shorter intensive care unit stay with endoluminal repair. The incidence of local/vascular complications had a tendency to be higher for endoluminal compared with standard open method (and was significantly greater if failed procedures were included). In this early experience with prototype devices, patients who were medically suitable fur open surgical procedures did not derive benefit from the less invasive endoluminal technique with respect to duration of operation, length of hospital stay, or perioperative morbidity and mortality. On the other hand, because they also did not have worse outcome, a randomized study is now justified in this group.
UR - http://www.scopus.com/inward/record.url?scp=0030025799&partnerID=8YFLogxK
U2 - 10.1016/S0741-5214(96)70264-1
DO - 10.1016/S0741-5214(96)70264-1
M3 - Article
C2 - 8637097
AN - SCOPUS:0030025799
SN - 0741-5214
VL - 23
SP - 201
EP - 212
JO - Journal of Vascular Surgery
JF - Journal of Vascular Surgery
IS - 2
ER -