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The purpose of the registry is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms.
The purpose of the study is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms. In particular, the study aims at comparing the short- and mid-term mortality, morbidity and reintervention rate after open surgery or endovascular repair of thoracoabdominal aortic aneurysms in comparable cohorts of patients according to preoperative characteristics and evaluating the cost-effectiveness of both techniques, according to the EUnetHTA core model.
The study results will contribute to the creation of a HTA Report regarding endovascular technology to treat thoracoabdominal aortic aneurysms which will be evaluated by the appropriate Health Authorities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open surgical repair | Aneurysmectomy and aortic reconstruction with a surgical graft |
| |
| Endovascular repair | Off-the-shelf or custom-made Fenestrated/Branched-Endovascular Aortic Repair - F/BEVAR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical repair | Procedure | Patients affected by a thoracoabdominal aortic aneurysm who received an open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft |
| Measure | Description | Time Frame |
|---|---|---|
| free survival | 1 year aortic-related and all cause mortality | 1 year |
| aortic-related reintervention | 1 year clinical success | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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We aim to include at least 650 patients in a 3-month period. Follow-up data will be recorded up to 1 year postoperatively. Data verification and analysis will request 2 months after study completion. The overall duration of the study will be 6 months
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3951025 | Background | Crawford ES, Crawford JL, Safi HJ, Coselli JS, Hess KR, Brooks B, Norton HJ, Glaeser DH. Thoracoabdominal aortic aneurysms: preoperative and intraoperative factors determining immediate and long-term results of operations in 605 patients. J Vasc Surg. 1986 Mar;3(3):389-404. doi: 10.1067/mva.1986.avs0030389. | |
| 32089506 | Background |
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| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D014945 | Wound Healing |
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D012038 | Regeneration |
| D001686 | Biological Phenomena |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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| Endovascular repair | Procedure | Patients affected by a thoracoabdominal aortic aneurysm who received endovascular repair (with off-the-shelf or custom-made Fenestrated/Branched-Endovascular Aortic Repair - F/BEVAR) |
|
| Bertoglio L, Grandi A, Melloni A, Kahlberg A, Melissano G, Chiesa R. Percutaneous AXillary Artery (PAXA) Access at the First Segment During Fenestrated and Branched Endovascular Aortic Procedures. Eur J Vasc Endovasc Surg. 2020 Jun;59(6):929-938. doi: 10.1016/j.ejvs.2020.01.027. Epub 2020 Feb 20. |
| 31690525 | Background | Rocha RV, Lindsay TF, Friedrich JO, Shan S, Sinha S, Yanagawa B, Al-Omran M, Forbes TL, Ouzounian M. Systematic review of contemporary outcomes of endovascular and open thoracoabdominal aortic aneurysm repair. J Vasc Surg. 2020 Apr;71(4):1396-1412.e12. doi: 10.1016/j.jvs.2019.06.216. Epub 2019 Nov 2. |
| 30470373 | Background | Rocha RV, Friedrich JO, Elbatarny M, Yanagawa B, Al-Omran M, Forbes TL, Lindsay TF, Ouzounian M. A systematic review and meta-analysis of early outcomes after endovascular versus open repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2018 Dec;68(6):1936-1945.e5. doi: 10.1016/j.jvs.2018.08.147. |
| D002318 |
| Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |