BEST EVIDENCE TOPIC – VASCULAR
Interactive CardioVascular and Thoracic Surgery 20 (2015) 135–139 doi:10.1093/icvts/ivu329 Advance Access publication 3 October 2014
Is endovascular repair of ruptured abdominal aortic aneurysms associated with improved in-hospital mortality compared with surgical repair? George A. Antonioua,*, Naseer Ahmeda, George S. Georgiadisb and Francesco Torellaa a b
Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Liverpool, UK Department of Vascular and Endovascular Surgery, University Hospital of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece
* Corresponding author. Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK. Tel: +44-7507112461; e-mail:
[email protected] (G.A. Antoniou). Received 20 June 2014; received in revised form 5 September 2014; accepted 9 September 2014
Abstract A best evidence topic in vascular surgery was constructed according to a structured protocol. The question addressed was whether patients with ruptured abdominal aortic aneurysm (AAA) treated with endovascular aneurysm repair (EVAR) have improved in-hospital outcomes compared with conventional surgical repair. The reported search retrieved 1398 reports, of which 6 papers were thought to represent the best available evidence to answer the study question. Three randomized trials were identified. The first was a pilot trial conducted in a single centre in the UK, which recruited 32 patients and found similar 30-day mortality in the patient groups. The second trial, conducted in Netherlands, recruited 116 patients anatomically suitable for EVAR. This trial found no significant difference in the composite of death and severe complications within 30 days of intervention between patients subjected to EVAR and those undergoing open repair (42 vs 47%; absolute risk reduction 5.4%, 95% confidence interval: −13% to +23%). The IMPROVE trial, based on a pragmatic design, demonstrated similar 30-day mortality in the 613 patients randomized to endovascular strategy or open repair (35.4 vs 37.4%, P = 0.62). The average hospital costs within the first 30 days of randomization were similar between the randomized groups, with an incremental cost-saving for the endovascular strategy vs open repair of £1186. Meta-analysis of all three randomized trials in a Cochrane review found no difference in 30-day or in-hospital mortality between EVAR and open repair (odds ratio: 0.91, 95% confidence interval: 0.67–1.22; P = 0.52). In contrast, a systematic review and meta-analysis, mainly of observational, cohort studies, and another large, nationwide study demonstrated EVAR to be associated with improved in-hospital results compared with open repair, as expressed by mortality, severe complications, length of hospital stay and proportion of patients discharged home. Even though randomized trials demonstrate equivalent in-hospital mortality with EVAR and open repair, large-scale, nationwide, observational studies and meta-analyses have shown EVAR to confer improved in-hospital mortality and morbidity in patients with favourable aneurysm morphology stable enough to undergo imaging. Reconfiguration of acute aortic services and establishment of standardized institutional protocols might be advisable for improvements in the management of ruptured AAA.
INTRODUCTION
CLINICAL SCENARIO
A best evidence topic was constructed according to a structured protocol [1]. This extends the findings of our previously published meta-analysis [2], incorporating emerging evidence, and is an update to a previous best evidence topic [3].
You attend an M and M meeting. A 74-year old patient with a ruptured AAA treated with open surgical repair is being discussed. His postoperative course was complicated by cardiorespiratory failure and acute kidney injury. He died of multiorgan failure on day 25. On assessment of the preoperative CT with a radiologist, the aneurysm was considered anatomically suitable for EVAR. A departmental audit of outcomes of conventional repair for ruptured AAA revealed an in-hospital mortality rate of 48%. You are asked whether establishment of an institutional protocol and implementing changes in healthcare delivery infrastructure and logistics, with around-the-clock availability of EVAR, applying an ‘EVAR-first policy’, would be justified by the existing literature data. Current guidelines (including those of the European Society for Vascular Surgery [ESVS] [4], the Society for Vascular Surgery [SVS]
THREE-PART QUESTION In [patients with ruptured abdominal aortic aneurysm (AAA) who have aneurysm morphology suitable for endovascular repair (EVAR), as demonstrated on computed tomography (CT) or intraoperative angiogram] is [EVAR] associated with [decreased in-hospital or 30-day mortality compared with conventional surgical repair]?
© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
BEST EVIDENCE TOPIC
Keywords: Abdominal aortic aneurysm • Ruptured aneurysm • Endovascular aneurysm repair
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Table 1: Best evidence papers Author, date, journal and country Study type (level of evidence)
Patient group
Hinchliffe et al. (2006), Eur J Vasc Endovasc Surg, UK [7]
15 patients randomized to EVAR
RCT (level III evidence)
17 patients randomized to open repair
Outcomes
• Perioperative mortality • Postoperative complication • Hospital stay • Blood loss • Time between diagnosis and
Key results
Comments
Perioperative mortality: EVAR, 53%; open repair, 53%
Intention-to-treat analysis for perioperative mortality only
Postoperative complications: EVAR, 77%; open repair, 80%
intervention
Hospital stay (median and IQR, days): EVAR, 10 (6–28); open repair, 12 (4–52)
(only patients considered fit for open repair were randomized)
Blood loss (median and IQR): EVAR, 200 (163–450); open repair, 2100 (1150–3985)
No differences in perioperative mortality and complications No long-term data reported Feasibility of a large RCT demonstrated
Time interval between diagnosis and intervention (median and IQR, minutes): EVAR, 75 (64–126); open repair, 100 (48–138) Reimerink et al. (2013), Ann Surg, Netherlands [8] RCT (level II evidence)
57 patients randomized to EVAR 59 patients randomized to open repair (only patients anatomically suitable for EVAR and physiologically suitable for open repair were included)
Primary outcome
• Composite of death and
severe complications within 30 days
Secondary outcomes
• Length of hospital/ICU stay • Duration of intubation/
Combined death and severe complications within 30 days: EVAR, 42%; open repair 47% (P = 0.58) 30-day mortality: EVAR, 21%; open repair, 25% (P = 0.66)
Intention-to-treat analysis No differences in mortality and severe complications at 30 days and 6 months between EVAR and open repair
ventilation
• Use of blood products • Endoleaks (for EVAR)
Severe complications within 30 days: EVAR, 32%; open repair, 37% (P = 0.56) Renal insufficiency: EVAR, 11%; open repair, 31% (P = 0.01) Combined death and severe complications within 6 months: EVAR, 46%; open repair, 47% (P = 0.85) Length of hospital stay (median and IQR, days): EVAR, 9 (4–21); open repair, 13 (5–21) (P = 0.57) Length of ICU stay (median and IQR, hours): EVAR, 28 (11–87); open repair, 48 (15–161) (P = 0.14) Duration of mechanical ventilation (median and IQR, hours): EVAR, 5 (0–29); open repair, 11 (4–98) (P = 0.14) Blood products during surgery (median and IQR, units): EVAR, 4 (0–8); open repair, 9 (4–14) (P = 0.02)
Continued
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Table 1: (Continued) Author, date, journal and country Study type (level of evidence)
Patient group
Outcomes
Key results
Comments
Total blood products during stay (median and IQR, units): EVAR, 9 (4–20); open repair, 13 (8–22) (P = 0.148) Endoleaks during initial EVAR: 42% Powell et al. (2014), Br Med J, UK [9]
316 patients randomized to endovascular strategy
RCT (level II evidence)
Secondary outcomes 297 patients • 24-hour mortality randomized to open • In-hospital mortality repair • Re-interventions during primary admission (endovascular strategy • Time to discharge consisted of immediate • Place to which discharged CT and emergency • Cost of primary admission EVAR, with open repair if anatomically unsuitable for EVAR)
Primary outcomes
• 30-day mortality
30-day mortality: endovascular strategy, 35.4%; open repair, 37.4% (P = 0.62) 30-day mortality in women: endovascular strategy, 37%; open repair, 57% (P = 0.02)
Intention-to-treat analysis 30-day mortality similar in endovascular strategy and open repair No long-term data available
24-hour mortality: endovascular strategy, 22%; open repair, 19% (OR: 1.15, 95% CI: 0.78–1.71) Reinterventions within 30 days: endovascular strategy, 14%; open repair, 16% Length of ICU stay (mean, days): endovascular strategy, 4.2 (SD: 5.9); open repair, 6.3 (SD: 7.7) Length of hospital stay (mean, days): endovascular strategy, 9.8 (SD: 9.0); open repair, 12.2 (SD: 10.2) Discharged directly home: endovascular strategy, 94%; open repair, 77% (P
