Proximal Aortopathy in Scotland - Epidemiology and Surgical Outcomes

NCT05389865 | Active Not Recruiting

• 1 other identifier: IRAS 309277
• Study Type: observational
• Target: 1,662
• Locations: 1 country
• Sites: 1

Brief Summary

The aorta is the principal arterial vessel arising from the left heart that transfers blood to the body. Certain genetic and familial disease processes are known to weaken the aortic wall resulting in dilation and potential rupture. These aortic complications carry high mortality (\>25%) and current management is orientated towards early detection and preventive treatment. Aortic dilation can also result in aortic valve dysfunction leading to heart failure. The estimated UK incidence of aortic disease per year is around 10 per 100,000 individuals, with 2000 people per year dying from aortic complications. The 2017-2020 National Adult Cardiac Surgery Audit report identified the number of people receiving surgery for aortic dissection in Scotland is per population proportionately lower compared to England (4.6 per million per year in Scotland vs. 6.6 per million per year in England). The reasons for this are unclear but may relate to the prevalence of aortic disease or a large geographic distribution with compromised access to specialized centres. Currently surgery is recommended when the aortic diameter exceeds a certain threshold. There are several types of effective surgical procedures, but there is still limited information on their long-term outcomes and the advantage of one procedure over another. The aims of the project are firstly to determine the clinical outcomes of the surgical procedures that are currently employed in Scotland to treat proximal aortic disease and secondly to describe the prevalence and distribution of proximal aortic disease within the Scottish population. The project will be hosted by the Golden Jubilee Research Institute. Contemporary and retrospective data will be collected from all the Scottish Cardiothoracic Surgery units which are based in Glasgow, Edinburgh and Aberdeen. This will be the first study to analyse surgical outcomes for ascending aortic disease in Scotland, and the first to describe the epidemiology of aortic disease within the population. It is anticipated that the results will guide current surgical practise, and provide data to inform national service provision for the management of proximal aortic disease.

Conditions

Aortic Diseases; Aortic Dissection; Aortic Aneurysm, Thoracic; Aortic Ectasia; Aortic Valve Insufficiency; Bicuspid Aortic Valve; Marfan Syndrome; Ehlers-Danlos Syndrome; Loeys-Dietz Syndrome

Keywords

aortic surgery; aortic root; ascending aorta; surgical outcomes; thoracic aortopathy epidemiology

Outcome Measures

Primary Outcomes (3)

• Early survival following surgery of the proximal aorta

  In-hospital or 30 days survival following surgery of the proximal aorta

  In-hospital or 30 days (whichever is longer)

• Late survival following surgery of the proximal aorta

  Long-term survival following surgery of the proximal aorta

  5 years or latest available follow-up (whichever is longer)

• Patient demographics and geographic distribution of thoracic aortopathy within the Scottish population

  Identify the demographics (age, gender, relevant risk factors) and geographic distribution (area codes) of patients diagnosed with thoracic aortopathy within the Scottish population

  Cross-sectional analysis (2011-2021)

Secondary Outcomes (5)

• Cardiovascular reintervention

  1 year or latest available follow-up (whichever is longer)

• Specified adverse events following surgery

  1 year or latest available follow-up (whichever is longer)

• Left ventricular ejection fraction (LVEF) following surgery

  1 year or latest available follow-up (whichever is longer)

• Aortic valve mean gradient and degree of regurgitation following surgery

  1 year or latest available follow-up (whichever is longer)

• Genotypes and phenotypes prevalent in the Scottish population

  Previous 5 years

Study Arms (2)

Surgical cohort

Adult patients (18 years of age and above) who have had a surgical intervention on the proximal aorta in the three Scottish Cardiothoracic Surgery units based in Glasgow, Edinburgh, Aberdeen.

Procedure: Surgery on the proximal aorta (aortic root +/- ascending aorta)

Non-surgical cohort

\- Adult patients (18 years of age and above) who have a diagnosis of proximal aortopathy, but have not had surgical intervention (non-surgical/un-intervened proximal aortopathy). This cohort will be obtained from three sources: 1. Scottish national radiological database based on specific imaging codes 2. Regional genetic/inherited cardiac conditions services 3. Public Health Scotland via specific diagnostic ICD-10 codes.

Other: Patients diagnosed with thoracic aortopathy but not operated upon

Interventions

Surgery on the proximal aorta (aortic root +/- ascending aorta) PROCEDURE

Surgery involving replacing, repairing or reinforcing the proximal aorta (root and ascending aorta)

Surgical cohort

Patients diagnosed with thoracic aortopathy but not operated upon OTHER

Radiological size criteria or Genetic mutations associated with aortopathies

Non-surgical cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Surgical cohort (Observational cohort design)- Adult patients (18 years of age and above) who have had a surgical intervention on the proximal aorta in the three Scottish Cardiothoracic Surgery units based in Glasgow, Edinburgh, Aberdeen. 2. Non-surgical cohort (Cross-sectional design) - Adult patients (18 years of age and above) who have a diagnosis of proximal aortopathy, but have not had surgical intervention (non-surgical/un-intervened proximal aortopathy). This cohort will be obtained from three sources: 1. Scottish national radiological database based on specific imaging codes 2. Regional genetic/inherited cardiac conditions services 3. Public Health Scotland via specific diagnostic ICD-10 codes.

You may qualify if:

• all adults (\>18 years of age) that underwent surgical intervention on the proximal aorta in Scotland between 2008 and 2021.

You may not qualify if:

• Isolated surgery on the descending thoracic aorta
• Non-surgical cohort
• \- all adult patients (\>18 years of age) with a radiological, genetic or post-mortem diagnosis of thoracic aortic disease

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead
• Aberdeen Royal Infirmary: collaborator
• Royal Infirmary of Edinburgh: collaborator
• Network for Inherited Cardiac Conditions Scotland: collaborator
• University of Glasgow: collaborator

Study Sites (1)

Golden Jubilee National Hospital

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Aortic Diseases; Aortic Dissection; Aortic Aneurysm, Thoracic; Aortic Valve Insufficiency; Bicuspid Aortic Valve Disease; Marfan Syndrome; Ehlers-Danlos Syndrome; Loeys-Dietz Syndrome

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dissection, Blood Vessel; Aneurysm; Acute Aortic Syndrome; Aortic Aneurysm; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Abnormalities, Multiple; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Skin Diseases, Genetic; Collagen Diseases; Skin Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities

Study Officials

• George Gradinariu, MD

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Cardiothoracic Surgery Specialty Registrar

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 25, 2022
• Study Start: December 18, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)