St George's Vascular Institute Protocol: An Accurate and Reproducible Methodology to Enable Comprehensive Characterization of Infrarenal Abdominal Aortic Aneurysm Morphology in Clinical and Research Applications

Ghatwary, T.; Karthikesalingam, Alan; Patterson, Benjamin O.; Hinchliffe, Robert J.; Morgan, Robert; Loftus, Ian; Salem, A.; Thompson, Matt; Holt, Peter

doi:10.1583/11-3731mr.1

Cited by 49 publications

(59 citation statements)

References 35 publications

(30 reference statements)

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“…26 The repeatability of the key variables of maximum aortic diameter, neck diameter, neck length, neck conicality, proximal and distal neck angles and maximum common iliac diameter was assessed using Bland-Altman methods.…”

Section: Objectives Of the Improve Trialmentioning

confidence: 99%

“…NIHR Journals Library www.journalslibrary.nihr.ac.uk Using a standard methodology, 26 we measured the aortic morphology of 907 patients who had undergone elective repair of an intact AAA at St George's Hospital between 2009 and 2013 and 294 cases of ruptured AAA (blood outside the AAA sac and adequate-quality CT scan) from the IMPROVE trial. All CT scans were anonymised and held only trial numbers or St George's Hospital database identifying numbers.…”

Section: Collaborative Research Projects Emanating Directly From the mentioning

confidence: 99%

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Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT

Ulug

Hinchliffe

Sweeting

et al. 2018

Health Technol Assess

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Background Ruptured abdominal aortic aneurysm (AAA) is a common vascular emergency. The mortality from emergency endovascular repair may be much lower than the 40–50% reported for open surgery. Objective To assess whether or not a strategy of endovascular repair compared with open repair reduces 30-day and mid-term mortality (including costs and cost-effectiveness) among patients with a suspected ruptured AAA. Design Randomised controlled trial, with computer-generated telephone randomisation of participants in a 1 : 1 ratio, using variable block size, stratified by centre and without blinding. Setting Vascular centres in the UK (n = 29) and Canada (n = 1) between 2009 and 2013. Participants A total of 613 eligible participants (480 men) with a ruptured aneurysm, clinically diagnosed at the trial centre. Interventions A total of 316 participants were randomised to the endovascular strategy group (immediate computerised tomography followed by endovascular repair if anatomically suitable or, if not suitable, open repair) and 297 were randomised to the open repair group (computerised tomography optional). Main outcome measures The primary outcome measure was 30-day mortality, with 30-day reinterventions, costs and disposal as early secondary outcome measures. Later outcome measures included 1- and 3-year mortality, reinterventions, quality of life (QoL) and cost-effectiveness. Results The 30-day mortality was 35.4% in the endovascular strategy group and 37.4% in the open repair group [odds ratio (OR) 0.92, 95% confidence interval (CI) 0.66 to 1.28; p = 0.62, and, after adjustment for age, sex and Hardman index, OR 0.94, 95% CI 0.67 to 1.33]. The endovascular strategy appeared to be more effective in women than in men (interaction test p = 0.02). More discharges in the endovascular strategy group (94%) than in the open repair group (77%) were directly to home (p < 0.001). Average 30-day costs were similar between groups, with the mean difference in costs being –£1186 (95% CI –£2997 to £625), favouring the endovascular strategy group. After 1 year, survival and reintervention rates were similar in the two groups, QoL (at both 3 and 12 months) was higher in the endovascular strategy group and the mean cost difference was –£2329 (95% CI –£5489 to £922). At 3 years, mortality was 48% and 56% in the endovascular strategy group and open repair group, respectively (OR 0.73, 95% CI 0.53 to 1.00; p = 0.053), with a stronger benefit for the endovascular strategy in the subgroup of 502 participants in whom repair was started for a proven rupture (OR 0.62, 95% CI 0.43 to 0.89; p = 0.009), whereas aneurysm-related reintervention rates were non-significantly higher in this group. At 3 years, considering all participants, there was a mean difference of 0.174 quality-adjusted life-years (QALYs) (95% CI 0.002 to 0.353 QALYs) and, among the endovascular strategy group, a cost difference of –£2605 (95% CI –£5966 to £702), leading to 88% of estimates in the cost-effectiveness plane being in the quadrant showing the endovascular strategy to be ‘dominant’. Limitations Because of the pragmatic design of this trial, 33 participants in the endovascular strategy group and 26 in the open repair group breached randomisation allocation. Conclusions The endovascular strategy was not associated with a significant reduction in either 30-day mortality or cost but was associated with faster participant recovery. By 3 years, the endovascular strategy showed a survival and QALY gain and was highly likely to be cost-effective. Future research could include improving resuscitation for older persons with circulatory collapse, the impact of local anaesthesia and emergency consent procedures. Trial registration Current Controlled Trials ISRCTN48334791 and NCT00746122. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 31. See the NIHR Journals Library website for further project information.

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Section: Objectives Of the Improve Trialmentioning

confidence: 99%

Section: Collaborative Research Projects Emanating Directly From the mentioning

confidence: 99%

Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT

Ulug

Hinchliffe

Sweeting

et al. 2018

Health Technol Assess

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“…CT scans were acquired in DICOM format from hospital archives, anonymised, and transferred to the core laboratory at St George's Vascular Institute for three dimensional reconstruction and analysis 10 ; in total, 458 admission scans from patients with confirmed rupture were available. 11 Five morphological parameters (aortic diameter at 1 mm distal to the distal renal artery, aneurysm neck length from distal renal artery to sac, proximal neck angle a, maximum aneurysm diameter, and maximum common iliac diameter) were measured in a core laboratory and a sixth, neck conicality derived, as described previously.…”

Section: Methodsmentioning

confidence: 99%

Re-interventions After Repair of Ruptured Abdominal Aortic Aneurysm: A Report From the IMPROVE Randomised Trial

Powell¹,

Sweeting²,

Ulug³

et al. 2018

Journal of Vascular Surgery

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WHAT THIS PAPER ADDSThe mid-term re-intervention rate after ruptured abdominal aortic aneurysm repair by endovascular or open repair appears to be twice as high as after elective repair. This suggests the need for bespoke surveillance protocols after rupture. Limb ischaemia is a frequent early reason and distal aneurysms a frequent later reason for re-intervention to indicate where quality improvement programmes might be directed. Limb amputation is uncommon but higher after open repair than after endovascular aneurysm repair.Objective/Background: The aim was to describe the re-interventions after endovascular and open repair of rupture, and investigate whether these were associated with aortic morphology. Methods: In total, 502 patients from the IMPROVE randomised trial (ISRCTN48334791) with repair of rupture were followed-up for re-interventions for at least 3 years. Pre-operative aortic morphology was assessed in a core laboratory. Re-interventions were described by time (0e90 days, 3 monthse3 years) as arterial or laparotomy related, respectively, and ranked for severity by surgeons and patients separately. Rare re-interventions to 1 year, were summarised across three ruptured abdominal aortic aneurysm trials (IMPROVE, AJAX, and ECAR) and odds ratios (OR) describing differences were pooled via meta-analysis. Results: Re-interventions were most common in the first 90 days. Overall rates were 186 and 226 per 100 person years for the endovascular strategy and open repair groups, respectively (p ¼ .20) but between 3 months and 3 years (mid-term) the rates had slowed to 9.5 and 6.0 re-interventions per 100 person years, respectively (p ¼ .090) and about one third of these were for a life threatening condition. In this latter, mid-term period, 42 of 313 remaining patients (13%) required at least one re-intervention, most commonly for endoleak or other endograft complication after treatment by endovascular aneurysm repair (EVAR) (21 of 38 re-interventions), whereas distal aneurysms were the commonest reason (four of 23) for re-interventions after treatment by open repair. Arterial re-interventions within 3 years were associated with increasing common iliac artery diameter (OR 1.48, 95% confidence interval [CI] 0.13e0.93; p ¼ .004). Amputation, rare but ranked as the worst reintervention by patients, was less common in the first year after treatment with EVAR (OR 0.2, 95% CI 0.05e0.88) from meta-analysis of three trials. Conclusion: The rate of mid-term re-interventions after rupture is high, more than double that after elective EVAR and open repair, suggesting the need for bespoke surveillance protocols. Amputations are much less common in patients treated by EVAR than in those treated by open repair.

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“…For the St George's Vascular Institute group measurements were performed using 3-Mensio software (3-Mensio, Eindhoven, Netherlands) according to a protocol that was based on previous work validating a similar system for measuring the infra-renal aorta. 14,15 Use of the data from the commercial trials was covered by the initial consent procedure, and approval from the local IRB was given for the St Georges' data.…”

Section: Methodsmentioning

confidence: 99%

Predicting Mid-term All-cause Mortality in Patients Undergoing Elective Endovascular Repair of a Descending Thoracic Aortic Aneurysm

Patterson

Vidal‐Diez²,

Holt³

et al. 2016

Annals of Surgery

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St George's Vascular Institute Protocol: An Accurate and Reproducible Methodology to Enable Comprehensive Characterization of Infrarenal Abdominal Aortic Aneurysm Morphology in Clinical and Research Applications

Cited by 49 publications

References 35 publications

Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT

Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT

Re-interventions After Repair of Ruptured Abdominal Aortic Aneurysm: A Report From the IMPROVE Randomised Trial

Predicting Mid-term All-cause Mortality in Patients Undergoing Elective Endovascular Repair of a Descending Thoracic Aortic Aneurysm

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