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| ID | Type | Description | Link |
|---|---|---|---|
| 11/147/03 | Other Grant/Funding Number | NIHR Health Technology Assessment Programme |
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This is a prospective observational cohort study that will collect data from the point of referral through to secondary care, aiming for 3 years median follow-up (range 1-5 years). The data collected will allow estimation of the success of any intervention (in terms of reducing rate of aneurysm growth, rupture or dissection) as well as estimation of the risks associated with the three procedures. Clinical outcomes in the three treatment groups will be described.
Aims
We aim to answer the following questions:
Without procedural intervention for chronic thoracic aortic aneurysm (CTAA), what is the risk of aneurysm growth, dissection, rupture, permanent neurological injury or death? What is the effect on quality of life (QoL)?
If a patient has endovascular stent grafting (ESG) or open surgical repair (OSR), what is the risk of growth, dissection, rupture, permanent neurological injury or death?
How does QoL change from pre- to post intervention?
Can aneurysm or patient related predictors of good/poor treatment outcomes be determined?
What is the most cost-effective strategy in:
What further research is required? What would be the most important research to pursue?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Watchful Waiting | Patients with aneurysms considered to be at low risk of rupture will remain under surveillance with annual CT / MRI scans and multi-disciplinary team review (as per local practice). These patients' data will contribute to the natural history component of the study. | ||
| Best Medical Therapy | This refers to lifestyle modification (smoking cessation and dietary management) as well as medical management of hypercholesterolaemia and hypertension for patients who are considered unsuitable for, or who refuse, OSR / ESG. | ||
| Open Surgery (OSR) | Replacement of the aneurysmal aorta with prosthetic conduit via a sternotomy or thoracotomy with circulatory support. |
| |
| Stenting (ESR) | Endovascular repair of the aneurysm via transluminal introduction of a stent-graft under X-ray guidance. Hybrid procedures that comprise a combination of a conventional surgical component and a transluminal repair are to be included in this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent Grafting (ESR) | Procedure |
| ||
| Open Surgery (OSR) |
| Measure | Description | Time Frame |
|---|---|---|
| Aneurysm Growth | 1, 2, 3 , 4 and 5 years post recruitment | |
| Quality of life | 1, 2, 3 , 4 and 5 years post recruitment | |
| Freedom from reintervention | 1, 2, 3 , 4 and 5 years post recruitment | |
| Freedom from death or permanent neurological injury | 1, 2, 3 , 4 and 5 years post recruitment | |
| Costs to the NHS | 1, 2, 3 , 4 and 5 years post recruitment | |
| Incremental cost per quality adjusted life year gained | 1, 2, 3 , 4 and 5 years post recruitment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients being referred to a specialist centre for diagnosis and treatment of their aneurysm
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vikki Hughes, PhD | Contact | 01480 364821 | victoria.hughes@papworth.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Large, FRCS | Papworth Hospital NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papworth Hospital | Recruiting | Cambridge | Cambs | CB23 3RE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35094747 | Derived | Sharples L, Sastry P, Freeman C, Gray J, McCarthy A, Chiu YD, Bicknell C, McMeekin P, Vallabhaneni SR, Cook A, Vale L, Large S. Endovascular stent grafting and open surgical replacement for chronic thoracic aortic aneurysms: a systematic review and prospective cohort study. Health Technol Assess. 2022 Jan;26(6):1-166. doi: 10.3310/ABUT7744. |
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| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D061887 | Conversion to Open Surgery |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| D001018 |
| Aortic Diseases |