t h e s u r g e o n x x x ( 2 0 1 5 ) 1 e4
Available online at www.sciencedirect.com
ScienceDirect The Surgeon, Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland www.thesurgeon.net
Endovascular versus open repair of ruptured abdominal aortic aneurysm S.M. McHugh*, T. Aherne, T. Goetz, J. Byrne, E. Boyle, M. Allen, A. Leahy, D. Moneley, P. Naughton Department of Vascular Surgery, Beaumont Hospital, Dublin 9, Ireland
article info
abstract
Article history:
Introduction: Endovascular aneurysm repair (EVAR) is a comparatively less invasive tech-
Received 3 December 2014
nique than open repair (OR). Debate remains with regard to the benefit of EVAR for patients
Received in revised form
with ruptured abdominal aortic aneurysm (RAAA). We sought to evaluate and report
7 May 2015
outcomes of EVAR for RAAA in an Irish tertiary vascular referral centre.
Accepted 24 May 2015
Methods: Patients undergoing emergency surgery for ruptured or symptomatic AAA were
Available online xxx
identified from theatre logbooks and HIPE database. Retrospective chart review was undertaken. Data were exported to IBM SPSS version 21 for statistical analysis with p < 0.05
Keywords:
considered significant.
EVAR
Results: A total of 41 patients underwent surgery for RAAA. The mean age was 74 years old
AAA
with a range from 55 to 89 years. The majority (n ¼ 25, 61%) were baseline American Society
Aneurysm
of Anaesthesiology (ASA) grade 3e4. Of these 56% underwent EVAR with the remaining 44%
Rupture
repaired open. Mortality rate in those undergoing emergency EVAR was 34.8%, compared with 38.9% in those undergoing open surgery. This difference was not statistically significant. The mean overall length of stay was 13 days. With regard to prognostic indicators of patient outcome, increasing patient age was noted to be significantly associated with increased mortality (p ¼ 0.013), as was increased ASA score at time of surgery (p ¼ 0.029). Conclusions: Mortality rates in those undergoing EVAR for RAAA are comparable with those undergoing open repair. Increasing age and ASA score are significant predictors of mortality in patients with RAAA undergoing intervention. © 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
Introduction Despite advances in operative technique and peri-operative management ruptured abdominal aortic aneurysm (RAAA) repair carries a high rate of death and complications. Endovascular aneurysm repair (EVAR) is a comparatively less
invasive technique than OR. The EVAR-1 trial in 2005 noted a significant decrease in aneurysm related death in patients undergoing EVAR compared with OR (4%vs 7%; p ¼ 0.04).1 These patients were scheduled electively however, and debate remains with regard to definitive benefit in EVAR for patients with RAAA.
* Corresponding author. Tel.: þ353 1 8093000. E-mail address: [email protected] (S.M. McHugh). http://dx.doi.org/10.1016/j.surge.2015.05.004 1479-666X/© 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: McHugh SM, et al., Endovascular versus open repair of ruptured abdominal aortic aneurysm, The Surgeon (2015), http://dx.doi.org/10.1016/j.surge.2015.05.004
2
t h e s u r g e o n x x x ( 2 0 1 5 ) 1 e4
Most recently the IMPROVE trial noted a 30 day mortality of 24.7% for RAAA treated with EVAR, which was not significantly better than patients undergoing open surgery.2 Other recent publications have reported a high variability in mortality rate of up to 53% in patients undergoing EVAR for RAAA.3,4 We sought to evaluate and report outcomes of EVAR for RAAA in an Irish tertiary vascular referral centre.
and post-operative outcomes were recorded on a standardised proforma. Data were exported to IBM SPSS version 21. Both Chi squared analysis and Independent sample T test were used to compare open and endovascular groups, with p < 0.05 considered statistically significant.
Results Methods The study was carried out between March 2008 and December 2012 in Beaumont Hospital. Beaumont hospital is a tertiary vascular referral centre located in North Dublin with a vascular surgery catchment area of 1.3 million. In 2008 we established a ruptured AAA EVAR protocol. This entailed considering all RAAA for EVAR when physiologically and anatomically possible. Our EVAR protocol centred upon the three areas of the RAAA patient journey: the Emergency Department, Radiology Department and operating theatre [Fig. 1]. This involved vascular surgeons, anaesthetics, operating room staff, radiographers and the availability of a variety of stent-graft sizes and types, and an operating room that was adequately equipped with a mobile Siemens© C-arm (www. healthcare.siemens.com) to perform endovascular intervention and open repair. The repair was carried out by one of four consultant vascular surgeons. Endovascular repair was performed by deploying either bifurcated or aorto uni iliac (AUI) stent grafts from Medtronic, Inc.© (www.medtronic.com). Patients who underwent emergency AAA surgery for rupture or symptomatic AAA were identified from theatre logbooks and HIPE database. Retrospective chart review was undertaken. Patient demographics, intra-operative details
A total of 54 patients underwent emergency surgery AAA during the time period. This included 13 patients with symptomatic AAA without radiological evidence of rupture. These 13 patients were excluded from analysis. The remaining 41 patients underwent surgery for RAAA. Of these 41 patients 23 (56%) underwent EVAR with the remaining 18 (44%) repaired open. With regards to the endovascular stent deployed, the majority (n ¼ 19, 82%) had an AUI placed with the remaining 4 (18%) having a bifurcated stent graft. The mean age was 74 years old with a range from 55 to 89 years. With no significant differences in age between the EVAR and OR cohorts. Of these 18 (44%) were male and the remainder (n ¼ 23, 56%) female. The majority (n ¼ 25, 61%) were American Society of Anaesthesiology (ASA) grade 3e4. The mean overall length of stay was 13 days. The majority (n ¼ 33, 80.5%) were transferred from other hospitals. The mean transport distance was 81 km (range 15e233). Mean follow up overall post discharge was 21 months (range 1e55 months). Overall mortality rate in those undergoing emergency EVAR was 34.8% (n ¼ 8/23), compared with 38.9% (n ¼ 7/18) in those undergoing open surgery. This difference was not statistically significant (p ¼ 0.786). Excluding inpatient mortalities length of stay (LOS) in the EVAR was 13.7 days compared with 12 days in the open group
Fig. 1 e Key point summary of Inter-departmental Ruptured EVAR Protocol. Please cite this article in press as: McHugh SM, et al., Endovascular versus open repair of ruptured abdominal aortic aneurysm, The Surgeon (2015), http://dx.doi.org/10.1016/j.surge.2015.05.004
t h e s u r g e o n x x x ( 2 0 1 5 ) 1 e4
(p ¼ 0.671). Of those undergoing EVAR, 72.2% (n ¼ 13) required ICU admission post operatively, compared with 65.2% (n ¼ 15) in those undergoing OR (p ¼ 0.632). Length of stay in ICU was noted to be 5.9 days in the OR group compared with 8.1 days in the EVAR group. The difference in ICU LOS was not statistically significant (p ¼ 0.538). With regard to morbidity, in those undergoing EVAR the rate of surgical site infection (SSI) was 8.7% (n ¼ 2), myocardial infarction (MI) 4.3% (n ¼ 1), respiratory tract infection (RTI) 34.8% (n ¼ 8), acute kidney injury (AKI) 52.2% (n ¼ 12). Reintervention rate 21.7% (n ¼ 5) with a mean follow up of 16.9 months. Comparatively in patients undergoing open surgery, the SSI rate was 5.6% (n ¼ 1), MI 5.6% (n ¼ 1), RTI 27.8% (n ¼ 5), AKI 27.8% (n ¼ 5) and re-intervention rate was 0% with a mean follow up of 24.9 months. These differences were not found to reach statistical significance. With regard to prognostic indicators of patient outcome, increasing patient age was noted to be significantly associated with increased mortality (p ¼ 0.013), as was increased ASA score at time of surgery (p ¼ 0.029). Previous history of hypertension, acute coronary syndrome (ACS) or diabetes mellitus were not significantly associated. Whether the patient was a transfer from another hospital was not a statistically significant predictor of patient mortality.
Discussion Endovascular Aneurysm Repair has emerged as the treatment of choice in the elective repair of AAA.5e7 Definitive evidence supporting the role of EVAR for RAAA is less convincing.2,3,8 There are several publications noting an improved outcome in patients undergoing EVAR for RAAA. One such study reported on 124 patients, 33 of whom underwent EVAR.9 Although a single centre retrospective study, it noted an overall 30-day mortality for EVAR of 30% compared with 46% for open repair. Furthermore a 27% severe complication rate was recorded for EVAR patients compared to 33% for open surgery. Similarly a Canadian study of 126 patients with RAAA noted a trend towards increased survival amongst patients undergoing EVAR compared with open repair.10 More recently a large study based upon administrative coding data of 42,126 cases of ruptured AAA was recently reported in 2013.11 This study noted that EVAR patients had lower in-hospital mortality (25.9 vs. 39.1%, p < 0.001) and shorter hospital stay (10.4 vs. 13.7 days, p < 0.001). Despite these previous studies, the recent publication of a randomised UK based study (the IMPROVE trial) which included 613 patients failed to demonstrate an improvement in outcome in patients undergoing EVAR for RAAA. Mortality rates were noted to be relatively high when compared with the previously referenced publications, with a mortality of 35.4% in the endovascular group 37.4% in the open repair group. More recently a meta-analysis of short term survival following surgery for RAAA which also included the IMPROVE trial concluded that EVAR was not inferior to open repair.12 This is the first study reporting outcomes for patients undergoing endovascular repair of RAAA in an Irish setting. Our mortality rate of 34.8% in those undergoing EVAR compares with previously reported international mortality rates in this
3
patient cohort. Our re-intervention rate was 21.7%. This is higher than would be expected for elective repair.13 There exists a paucity of literature with regard to re-intervention rates amongst those undergoing EVAR for RAAA. However it might be expected that in such patients re-intervention rates would be increased compared to those undergoing elective surgery as time available for measuring and planning the endovascular approach is significantly limited in the setting of a RAAA. Furthermore a larger percentage of RAAA are treated with AUI compared with elective AAA repair. As this is an extra-anatomical bypass it is more susceptible to complications requiring re-intervention.14 This was evident in our own results where 82% of patients undergoing EVAR had an AUI stent graft placed. In addition in selected cases we have performed EVAR on anatomically borderline RAAA cases deemed unfit for open repair, wherein a neck length of
Available online at www.sciencedirect.com
ScienceDirect The Surgeon, Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland www.thesurgeon.net
Endovascular versus open repair of ruptured abdominal aortic aneurysm S.M. McHugh*, T. Aherne, T. Goetz, J. Byrne, E. Boyle, M. Allen, A. Leahy, D. Moneley, P. Naughton Department of Vascular Surgery, Beaumont Hospital, Dublin 9, Ireland
article info
abstract
Article history:
Introduction: Endovascular aneurysm repair (EVAR) is a comparatively less invasive tech-
Received 3 December 2014
nique than open repair (OR). Debate remains with regard to the benefit of EVAR for patients
Received in revised form
with ruptured abdominal aortic aneurysm (RAAA). We sought to evaluate and report
7 May 2015
outcomes of EVAR for RAAA in an Irish tertiary vascular referral centre.
Accepted 24 May 2015
Methods: Patients undergoing emergency surgery for ruptured or symptomatic AAA were
Available online xxx
identified from theatre logbooks and HIPE database. Retrospective chart review was undertaken. Data were exported to IBM SPSS version 21 for statistical analysis with p < 0.05
Keywords:
considered significant.
EVAR
Results: A total of 41 patients underwent surgery for RAAA. The mean age was 74 years old
AAA
with a range from 55 to 89 years. The majority (n ¼ 25, 61%) were baseline American Society
Aneurysm
of Anaesthesiology (ASA) grade 3e4. Of these 56% underwent EVAR with the remaining 44%
Rupture
repaired open. Mortality rate in those undergoing emergency EVAR was 34.8%, compared with 38.9% in those undergoing open surgery. This difference was not statistically significant. The mean overall length of stay was 13 days. With regard to prognostic indicators of patient outcome, increasing patient age was noted to be significantly associated with increased mortality (p ¼ 0.013), as was increased ASA score at time of surgery (p ¼ 0.029). Conclusions: Mortality rates in those undergoing EVAR for RAAA are comparable with those undergoing open repair. Increasing age and ASA score are significant predictors of mortality in patients with RAAA undergoing intervention. © 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
Introduction Despite advances in operative technique and peri-operative management ruptured abdominal aortic aneurysm (RAAA) repair carries a high rate of death and complications. Endovascular aneurysm repair (EVAR) is a comparatively less
invasive technique than OR. The EVAR-1 trial in 2005 noted a significant decrease in aneurysm related death in patients undergoing EVAR compared with OR (4%vs 7%; p ¼ 0.04).1 These patients were scheduled electively however, and debate remains with regard to definitive benefit in EVAR for patients with RAAA.
* Corresponding author. Tel.: þ353 1 8093000. E-mail address: [email protected] (S.M. McHugh). http://dx.doi.org/10.1016/j.surge.2015.05.004 1479-666X/© 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: McHugh SM, et al., Endovascular versus open repair of ruptured abdominal aortic aneurysm, The Surgeon (2015), http://dx.doi.org/10.1016/j.surge.2015.05.004
2
t h e s u r g e o n x x x ( 2 0 1 5 ) 1 e4
Most recently the IMPROVE trial noted a 30 day mortality of 24.7% for RAAA treated with EVAR, which was not significantly better than patients undergoing open surgery.2 Other recent publications have reported a high variability in mortality rate of up to 53% in patients undergoing EVAR for RAAA.3,4 We sought to evaluate and report outcomes of EVAR for RAAA in an Irish tertiary vascular referral centre.
and post-operative outcomes were recorded on a standardised proforma. Data were exported to IBM SPSS version 21. Both Chi squared analysis and Independent sample T test were used to compare open and endovascular groups, with p < 0.05 considered statistically significant.
Results Methods The study was carried out between March 2008 and December 2012 in Beaumont Hospital. Beaumont hospital is a tertiary vascular referral centre located in North Dublin with a vascular surgery catchment area of 1.3 million. In 2008 we established a ruptured AAA EVAR protocol. This entailed considering all RAAA for EVAR when physiologically and anatomically possible. Our EVAR protocol centred upon the three areas of the RAAA patient journey: the Emergency Department, Radiology Department and operating theatre [Fig. 1]. This involved vascular surgeons, anaesthetics, operating room staff, radiographers and the availability of a variety of stent-graft sizes and types, and an operating room that was adequately equipped with a mobile Siemens© C-arm (www. healthcare.siemens.com) to perform endovascular intervention and open repair. The repair was carried out by one of four consultant vascular surgeons. Endovascular repair was performed by deploying either bifurcated or aorto uni iliac (AUI) stent grafts from Medtronic, Inc.© (www.medtronic.com). Patients who underwent emergency AAA surgery for rupture or symptomatic AAA were identified from theatre logbooks and HIPE database. Retrospective chart review was undertaken. Patient demographics, intra-operative details
A total of 54 patients underwent emergency surgery AAA during the time period. This included 13 patients with symptomatic AAA without radiological evidence of rupture. These 13 patients were excluded from analysis. The remaining 41 patients underwent surgery for RAAA. Of these 41 patients 23 (56%) underwent EVAR with the remaining 18 (44%) repaired open. With regards to the endovascular stent deployed, the majority (n ¼ 19, 82%) had an AUI placed with the remaining 4 (18%) having a bifurcated stent graft. The mean age was 74 years old with a range from 55 to 89 years. With no significant differences in age between the EVAR and OR cohorts. Of these 18 (44%) were male and the remainder (n ¼ 23, 56%) female. The majority (n ¼ 25, 61%) were American Society of Anaesthesiology (ASA) grade 3e4. The mean overall length of stay was 13 days. The majority (n ¼ 33, 80.5%) were transferred from other hospitals. The mean transport distance was 81 km (range 15e233). Mean follow up overall post discharge was 21 months (range 1e55 months). Overall mortality rate in those undergoing emergency EVAR was 34.8% (n ¼ 8/23), compared with 38.9% (n ¼ 7/18) in those undergoing open surgery. This difference was not statistically significant (p ¼ 0.786). Excluding inpatient mortalities length of stay (LOS) in the EVAR was 13.7 days compared with 12 days in the open group
Fig. 1 e Key point summary of Inter-departmental Ruptured EVAR Protocol. Please cite this article in press as: McHugh SM, et al., Endovascular versus open repair of ruptured abdominal aortic aneurysm, The Surgeon (2015), http://dx.doi.org/10.1016/j.surge.2015.05.004
t h e s u r g e o n x x x ( 2 0 1 5 ) 1 e4
(p ¼ 0.671). Of those undergoing EVAR, 72.2% (n ¼ 13) required ICU admission post operatively, compared with 65.2% (n ¼ 15) in those undergoing OR (p ¼ 0.632). Length of stay in ICU was noted to be 5.9 days in the OR group compared with 8.1 days in the EVAR group. The difference in ICU LOS was not statistically significant (p ¼ 0.538). With regard to morbidity, in those undergoing EVAR the rate of surgical site infection (SSI) was 8.7% (n ¼ 2), myocardial infarction (MI) 4.3% (n ¼ 1), respiratory tract infection (RTI) 34.8% (n ¼ 8), acute kidney injury (AKI) 52.2% (n ¼ 12). Reintervention rate 21.7% (n ¼ 5) with a mean follow up of 16.9 months. Comparatively in patients undergoing open surgery, the SSI rate was 5.6% (n ¼ 1), MI 5.6% (n ¼ 1), RTI 27.8% (n ¼ 5), AKI 27.8% (n ¼ 5) and re-intervention rate was 0% with a mean follow up of 24.9 months. These differences were not found to reach statistical significance. With regard to prognostic indicators of patient outcome, increasing patient age was noted to be significantly associated with increased mortality (p ¼ 0.013), as was increased ASA score at time of surgery (p ¼ 0.029). Previous history of hypertension, acute coronary syndrome (ACS) or diabetes mellitus were not significantly associated. Whether the patient was a transfer from another hospital was not a statistically significant predictor of patient mortality.
Discussion Endovascular Aneurysm Repair has emerged as the treatment of choice in the elective repair of AAA.5e7 Definitive evidence supporting the role of EVAR for RAAA is less convincing.2,3,8 There are several publications noting an improved outcome in patients undergoing EVAR for RAAA. One such study reported on 124 patients, 33 of whom underwent EVAR.9 Although a single centre retrospective study, it noted an overall 30-day mortality for EVAR of 30% compared with 46% for open repair. Furthermore a 27% severe complication rate was recorded for EVAR patients compared to 33% for open surgery. Similarly a Canadian study of 126 patients with RAAA noted a trend towards increased survival amongst patients undergoing EVAR compared with open repair.10 More recently a large study based upon administrative coding data of 42,126 cases of ruptured AAA was recently reported in 2013.11 This study noted that EVAR patients had lower in-hospital mortality (25.9 vs. 39.1%, p < 0.001) and shorter hospital stay (10.4 vs. 13.7 days, p < 0.001). Despite these previous studies, the recent publication of a randomised UK based study (the IMPROVE trial) which included 613 patients failed to demonstrate an improvement in outcome in patients undergoing EVAR for RAAA. Mortality rates were noted to be relatively high when compared with the previously referenced publications, with a mortality of 35.4% in the endovascular group 37.4% in the open repair group. More recently a meta-analysis of short term survival following surgery for RAAA which also included the IMPROVE trial concluded that EVAR was not inferior to open repair.12 This is the first study reporting outcomes for patients undergoing endovascular repair of RAAA in an Irish setting. Our mortality rate of 34.8% in those undergoing EVAR compares with previously reported international mortality rates in this
3
patient cohort. Our re-intervention rate was 21.7%. This is higher than would be expected for elective repair.13 There exists a paucity of literature with regard to re-intervention rates amongst those undergoing EVAR for RAAA. However it might be expected that in such patients re-intervention rates would be increased compared to those undergoing elective surgery as time available for measuring and planning the endovascular approach is significantly limited in the setting of a RAAA. Furthermore a larger percentage of RAAA are treated with AUI compared with elective AAA repair. As this is an extra-anatomical bypass it is more susceptible to complications requiring re-intervention.14 This was evident in our own results where 82% of patients undergoing EVAR had an AUI stent graft placed. In addition in selected cases we have performed EVAR on anatomically borderline RAAA cases deemed unfit for open repair, wherein a neck length of
