An observational study in Thoracoabdominal Aortic Aneurysm, Ruptured Thoracic Aneurysm and Ruptured Aortic Aneurysm, sponsored by University of Bologna. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by University of Bologna · Observational
Ruptured thoracoabdominal aortic aneurysm (TAAA) represents an emergency medical challenge that needs to be treated promptly. Over the past years different endovascular techniques have emerged such as fenestrated or branched endovascular aortic repair (FB-EVAR). However, FB-EVAR is a technique that uses a custom-made device which needs to be manufactured and this process take months, therefore, it could not be used in urgent settings. Off-the-shelf graft stents are pre-made graft stents, which can be used in urgent cases.
A retrospective, multicenter cohort study was planned to include patients who underwent endovascular procedures between January 2015 and January 2022 (85 months) to evaluate the technical and survival outcomes of the use of off-the-shelf stent graft, physician-modified endograft and parallel graft technique in endovascular aortic repair of free and contained ruptured TAAA.
Data will be collected anonymously and retrospectively, including patient demographics, risk factors, diagnosis and anatomical details, procedure details and post-operative outcomes.
The presentation of a thoracoabdominal aortic aneurysm (TAAA) represents a major clinical challenge leading to a high risk of mortality Traditional open surgical repair has a perioperative mortality risk of 53% and therefore a less invasive option is mandatory. Endovascular abdominal aortic repair (EVAR) has been proposed as the main alternative treatment to reduce mortality compared to open surgical repair, with an advantage of decreasing the risk for renal and pulmonary complications. Over the last two decades, fenestrated and branched EVAR (FB-EVAR) have been implemented as an emerging endovascular techniques for patients with complex abdominal aortic aneurysms to preserve visceral and renal arteries.
FEVAR is a technique using a custom-made device, which requires a production and delivery time of about 90 days and therefore could not be used in urgent settings. However, in urgent cases off-the-shelf stent grafts have been used as alternative options, with a 30-day mortality of 14%. In these settings, and both early and follow-up survival outcomes are strongly affected by hemodynamic patient presentation that represents a main prognostic factor Nonetheless, in urgent cases in whom off-shelf stent grafts cannot be implanted due to complex anatomical configuration, physician-modified endografts (PMEG) have been proposed with an early survival rate ranging from 8% to 14%.
Parallel grafts can be used as a third option, with a comparable overall mortality but with a 24% risk of developing type Ia endoleak, without a complete exclusion of the aneurysmal sac.
Many papers consider free ruptures, contained symptomatic ruptures as well as large aneurysm (diameter >80 with a high risk of ruptures) as an urgent TAAA, but since the hemodynamic status and the symptoms presentation may be strongly different, they should be addressed separately and large-number paper with the focus specifically or ruptured TAAA are still lacking Currently, off-the-shelf stent grafts, PMEG and parallel grafts have been used in many centers across the world for the treatment of ruptured and symptomatic contained ruptured TAAA. Therefore, performing a multicenter study analyzing the data collected may lead to a better understanding of the clinical features as well as the used techniques, outcomes and applicability.
AIMS OF THE STUDY A retrospective multicenter, cross-sectional cohort study to evaluate the technical and survival outcomes of the use of off-the-shelf graft stent, physician-modified-endografts and parallel grafts in endovascular aortic repair of free ruptured and contained ruptured TAAA.
Results and postoperative events will be reported following the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery.
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 20 observational studies indexed under Aortic Aneurysm, Thoracoabdominal.
Browse Aortic Aneurysm, Thoracoabdominal studies →University of Bologna is the lead sponsor of 158 studies on the registry; 24 are open to participants now.
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Patients included were all treated for rupture TAAAs in urgent setting using an off-the-shelf stent grafts, or a custom made available fenestrated and branched device, or a physician-modified endografts with fenestrations/branches or in-situ laser fenestration or parallel endografting for renal and visceral arteries.
o An urgent procedure that is carried out immediately after patient admission or within the first 24-hours.
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Age: Adults Gender: Male and Female Diagnosis of TAAA (Crawford I-V), penetrating aortic ulcers, or failure of previous EVAR, which require proximal landing zone above the celiac trunk. Different etiologies will be accepted with similar anatomical extend (degenerative, post-dissection, inflammatory, etc.) Free and contained ruptured TAAA confirmed by pre-operative computed tomography angiography (CTA).
Patient presenting with and without hemodynamic instability. A free-rupture is considered an aortic rupture with evidence of bleeding outside the aortic wall.
A contained rupture is considered if the integrity of the aortic wall is lots, without clear evidence of bleeding, but with periaortic structures imbibition and periaortic hematoma.
Hemodynamic instability is defined as the presence of cardiopulmonary arrest or the inability to achieve or to maintain a systolic blood pressure > 90 mmHg despite appropriate fluid resuscitation.
Exclusion Criteria:
Patients treated with open or hybrid repair. Patients with TAAA without any sign of aortic wall rupture or without pre-operative CTA.
Patient with contained rupture presenting with no symptoms and discovered accidentally Patient that were transferred to normal wards in the period from diagnosis to procedure or can be treated in elective setting.
Included population were consecutive patients presented with evidence of active bleeding (frank ruptures), or without active bleeding but with periaortic structures infiltration/hematoma (contained rupture); undergoing urgent/emergent endovascular RTAAA (Crawford's extend I-IV + suprarenal AAA) repair within the first 24 hours, requiring a proximal landing zone above the celiac trunk with off-the-shelf, F/B-EVAR, PMEG and PG.
Device: REVAR
Endovascular repair of ruptured TAAAs with available technique and devices: endovascular treatments were performed in urgent or emergent setting, compulsory within the first 24 hours, using an off-the-shelf stent grafts, or an available custom-made fenestrated/branched device or a physician-modified endografts with fenestrations/branches or parallel endografting for renal and visceral arteries
Rate of Technical Success
successful endovascular access and deployment of all devices at the intended aortic location, successful catheterization and stenting of all planned target vessels, absence of type I /III endoleaks at the final angiography. The presence of hemodynamic instability at the end of procedure with evidence of bleeding and intra-operative mortality without possibility of completing the procedure, were considered technical failures.
Time frame: Within first post-operative day
Rate of early mortality
We considered as a cumulative endpoint composed by perioperative mortality (within the first 48hours), 30-day Mortality, if the patient died in the first 30-day period after intervention and In-hospital mortality, if the patient died in-hospital with hospitalization time longer than 30-days.
Time frame: Within 30-days from the procedure.
Rate of overall survival
Overall survival regardless the aortic relationship of the reported cause of death.
Time frame: Within 60-months from the procedure
Rate of Major Adverse events (MAEs) and rate early re interventions
cardiac complications (including myocardial infarction, congestive heart failure, and myocardial ischemia requiring intervention); respiratory complications (including required prolonged \>24 hours mechanical ventilation or respiratory insufficiency/pneumonia requiring reintubation and/or ventilatory assistance); acute kidney injury, defined as renal function decline resulting in \>30% reduction in baseline eGFR or new-onset dialysis; major stroke, defined as the presence of invalidting neurological sequelae; spinal cord ischemia (SCI) defined as the presence of paraplegia or paraparesis, being temporary if had a complete resolution and expected return to baseline, and permanent if the injury had partial or no improvement compared with baseline examination; bowel ischemia requiring surgical resection or not resolving with medical therapy;
Time frame: Within 30-days from the procedure.
rate of freedom from reintervention
Overall freedom from need for re interventions related in some extend to the REVAR procedure or RTAAAs condition
Time frame: Within 60-months from the procedure
Plan to share: Undecided — This study is a multicenter, observational, cross-sectional cohort study to evaluate the outcomes of endovascular aortic repair of symptomatic contained and free ruptured TAAAs using off-the-shelf stent grafts and physician-modified stent grafts. The study will be a multicenter retrospective cohort including international centers. As soon as we receive positive answers from the invited centers, we will proceed to update the protocol, accordingly.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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