Thoracic Aortic Aneurysm
Conditions
Brief summary
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: 1. 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)? 2. 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? 3. How does QoL change from pre- to post intervention? 4. Can aneurysm or patient related predictors of good/poor treatment outcomes be determined? 5. What is the most cost-effective strategy in: 1. Patients eligible for either ESG or OSR? 2. Patients eligible for either ESG or best medical therapy (BMT)? 3. Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)? 6. What further research is required? What would be the most important research to pursue?
Interventions
PROCEDUREStent Grafting (ESR)
PROCEDUREOpen Surgery (OSR)
Sponsors
Papworth Hospital NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Thoracic Aortic Aneurysm \> 4cm * Age ≥18 years * Able to give informed consent
Exclusion criteria
* Intervention required below the level of the coeliac axis * Acute dissection or malperfusion syndromes (such as myocardial infarction,acute stroke or limb ischaemia)
Design outcomes
Primary
| Measure | 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 |
Countries
United Kingdom
Contacts
Primary ContactVikki Hughes, PhD
Outcome results
None listed