Immediate Management of the Patient With Aneurysm Rupture : Open Versus Endovascular Repair
Summary
Rupture of the main blood vessel of the body in the abdomen (ruptured abdominal aortic aneurysm) is fatal in over three-quarters of cases. In the past, those that survive have reached hospital alive and undergone emergency open surgery to repair the aneurysm and stop the bleeding: however, after this major emergency surgery only half the patients leave hospital alive. A newer, less-invasive method of aneurysm repair, endovascular repair, is based on repairing the aneurysm by inserting the repair graft up through one of the arteries in the groin. Endovascular repair has been tested in the elective situation and is associated with a 3-fold reduction in operative mortality versus the standard open surgery. Early work with selected patients has suggested that endovascular repair may be associated with up to a 2-fold reduction in operative mortality and more rapid recovery for ruptured abdominal aortic aneurysms. However, only 55-70% patients are anatomically suitable for endovascular repair.
Therefore, this research aims to determine whether a strategy of preferential emergency endovascular repair reduces both the mortality and cost of ruptured abdominal aortic aneurysm.
Critically ill patients with a clinical diagnosis of ruptured aneurysm will be randomised, in the emergency room, to a strategy of endovascular repair if possible (endovascular first) or to current standard care (immediate transfer to the operating theatre for emergency open surgery). Patients randomised to "endovascular first" will require a specialist radiological examination (CT scan) to assess anatomical suitability and plan for endovascular repair. This will cause a short delay before definitive repair can be commenced. Those patients not suitable for endovascular repair, after CT scan, will be taken for standard open surgery. Patients will be randomised at 16-20 specialist centres in the UK, who have already attained sufficient experience in using endovascular repair for ruptured aneurysms and can offer a routine service.
The primary outcome measure is 30-day operative mortality, which we hope will improve by 14% with the "endovascular first" strategy (from 47% to 33%). We also shall measure mortality (in-hospital, one year), costs, quality of life and cost-effectiveness as other key outcomes: all are expected to improve with endovascular repair.
The research team includes specialists in clinical trials, health economics, statistics, pre-hospital & emergency care, interventional radiology, vascular & endovascular surgery, critical care, aneurysm research and a service user.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Abdominal Aortic Aneurysm
Intervention
Open repair, EVAR
Location
Royal Cornwall Hospital
Truro
Cornwall
United Kingdom
TR1 3LJ
Status
Recruiting
Source
Imperial College London
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00746122
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Aortic Aneurysm, Abdominal
An abnormal balloon- or sac-like dilatation in the wall of the ABDOMINAL AORTA which gives rise to the visceral, the parietal, and the terminal (iliac) branches below the aortic hiatus at the diaphragm.
Aortic Rupture
The tearing or bursting of the wall along any portion of the AORTA, such as thoracic or abdominal. It may result from the rupture of an aneurysm or it may be due to TRAUMA.
Endoleak
Postoperative hemorrhage from an endovascular AORTIC ANEURYSM repaired with endoluminal placement of stent grafts (BLOOD VESSEL PROSTHESIS IMPLANTATION). It is associated with pressurization, expansion, and eventual rupture of the aneurysm.
Syphilis, Cardiovascular
Cardiovascular manifestations of SYPHILIS, an infection of TREPONEMA PALLIDUM. In the late stage of syphilis, sometimes 20-30 years after the initial infection, damages are often seen in the blood vessels including the AORTA and the AORTIC VALVE. Clinical signs include syphilitic aortitis, aortic insufficiency, or aortic ANEURYSM.
Bone Cysts, Aneurysmal
Solitary lesions of bone that typically cause a bulging of the overlying cortex bearing some resemblance to the saccular protrusion of the aortic wall in aortic aneurysm, hence the name. (Dorland, 27th ed)
Clinical Trials
Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC
The purpose of this study is to compare the cost effectiveness, quality of life and outcomes of the endovascular stent graft repair with the open surgical repair of abdominal aortic aneury...
Mechanism and Prevention of Remote Organ Injury Following Ruptured Aortic Aneurysm
It has been estimated that 80% of deaths from abdominal aortic aneurysms results from rupture. Endovascular Aneurysm Repair (EVAR) has been applied to RAAA (Ruptured Abdominal Aortic Aneur...
Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair
Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in dia...
Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
The purpose of this trial is to assess whether the new endovascular repair technique of the abdominal aortic aneurysm (AAA) is an adequate substitute of the conventional AAA repair.
Follow-up of Endovascular Aneurysm Treatment - The FEAT Trial
After endovascular abdominal aortic aneurysm repair, life-long follow-up is needed to monitor the effectiveness of exclusion of the aneurysm sac from blood flow. For this reason, aneurysm...
PubMed Articles
Abdominal aortic aneurysm can be treated by open surgical repair or by endovascular repair (EVAR) - a less invasive procedure, with lower 30-day mortality and morbidity rates. Twelve studies have been...
PURPOSE: We conducted this study to compare the cost of open surgical repair (OR) with that of endovascular aneurysm repair (EVAR) of an abdominal aortic aneurysm (AAA)....
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We present a patient with an aortic aneurysm and the epidemiology, etiology, screening, symptoms and therapeutic options of abdominal aortic aneurysms are discussed. A widening of the abdominal aorta...
PURPOSE: Our objective was to compare open and endovascular aortic aneurysm repair with respect to postoperative delirium. METHODS: After Institutional Ethics Review Board approval, we conducted a ret...
Percutaneous Drainage of Aortic Aneurysm Sac Abscesses Following Endovascular Aneurysm Repair.
Purpose: To report preliminary experiences with the treatment of aortic aneurysm sac abscesses following prior endovascular aortic aneurysm repair (EVAR) using computerized tomography (CT)-guided perc...
