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A Risk-adjusted and Anatomically Stratified Cohort Comparison Study of Open Surgery, Endovascular Techniques and Medical Management for Juxtarenal Aortic Aneurysms: The UK COMplex AneurySm Study

UK-COMPASS

A Risk-adjusted and Anatomically Stratified Cohort Comparison Study of Open Surgery, Endovascular Techniques and Medical Management for Juxtarenal Aortic Aneurysms: The UK COMplex AneurySm Study
Funding NIHR HTA
Portfolio Clinical Specialties
Interventions Surgery
Randomised No
Status Recruiting
Start Date 09-Oct-2018

Abdominal aortic aneurysm is a common condition where the aorta, which is the main artery that
begins at the heart and travels down the torso, begins to bulge and expand at a portion just below the
chest, above the level of the navel. In the usual course of events, the bulge expands slowly over many
years and can eventually burst. This results in major internal blood loss often resulting in death and
when an emergency life saving operation is possible, they have high failure rate. Although the risk of
aneurysm rupture is generally low, it starts to increase if the aneurysm exceeds a certain size. A
planned operation can be performed to repair the bulging section of aorta to prevent a burst
aneurysm. However, not all abdominal aortic aneurysms are equal and technical aspects of aneurysm
repair depends upon their location in relation to important branch arteries of the aorta.
Over a quarter of aneurysms are classed as juxtarenal aneurysms because they are too close to the
arterial branches supplying blood to the kidneys. These aneurysms require more extensive and more
complex operations. There are different ways of managing such complex aneurysms and doctors are
unsure which method is better. The open repair method is the tried and trusted method, known to be
durable and lasts for the rest of most patients’ lives. However, it is quite a serious operation which
generally involves a longer stay in hospital and a higher chance of dying within 30 days of the
operation when compared to alternative methods called endovascular techniques, of which
Fenestrated Endovascular Aneurysm Repair (fEVAR) is the most established method. In a number of
patients with juxtarenal aneurysms, doctors are judiciously using standard endovascular repair (Offlabel
EVAR), a less complex technique that is originally intended for use in less complex aneurysms.
Endovascular methods are less of a strain on the patient’s body which results in a shorter recovery
time and a better chance of surviving the operation. The downside of this is that it is more common for
there to be problems following endovascular repairs that may require further small procedures to
correct them. In some cases, patients are not considered fit enough for the open repair operation as it
may be too much of a strain on their body and always requires a general anaesthetic. For these
patients, doctors find fEVAR or off-label EVAR quite attractive. In a proportion of patients no operation
may be considered to be in their best interest. This study is proposed to examine how these different
treatment methods compare in terms of clinical benefit and utilisation of valuable NHS resources. We
also like to establish if particular patient features will give better results with one type of operation than
the other. We intend to include in this study, all patients undergoing juxtarenal aneurysm treatment in
England during a period of 2 years and collect 5 year follow-up.
We plan to make use of data that is routinely collected for NHS use and for compulsory clinical quality
checks. We intend to examine the scans performed as a course of normal patient treatment in order
to accurately identify patients having a juxtarenal aneurysm repair. Available data will be analysed not
only to compare the safety and effectiveness of different management strategies, but also to see if a
particular strategy is better suited for particular features so that patients can be offered bespoke
treatment strategies.

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