Proximal Aortopathy in Scotland – Epidemiology and Surgical Outcomes

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Brief Title

Proximal Aortopathy in Scotland - Epidemiology and Surgical Outcomes

Official Title

An Investigation Into the Epidemiology and Surgical Intervention for Proximal Aortic Disease in Scotland

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.
    

Detailed Description

      The study has two principal aims:

        1. Determine the patient demographics, procedural types and related clinical outcomes in
           patients who underwent surgery of the proximal thoracic aorta in Scotland

        2. Describe the epidemiology of proximal aortopathy within the Scottish population, by
           determining the prevalence of disease, geographic distribution and patient demographics

      This study will be the first to look at outcomes from a nation-wide cohort of patients
      following surgery of the thoracic aorta in the UK. The investigators anticipate that results
      from this study will inform future aortic practice and guide decisions on intervention timing
      and type.

      Information on the prevalence and geographic distribution of aortic disease within Scotland
      will guide resource allocation and service configuration to allow equity in access to
      treatment. By raising awareness among the medical professionals and the wider community, the
      study should lead to improved recognition and better outcomes for patients with aortic
      disease.

      Data will be recorded in a contemporary and retrospective manner for two patient cohorts:

        1. Surgical cohort - Adult patients who have had a surgical intervention on the proximal
           aorta in the three Scottish Cardiothoracic Surgery units based in Glasgow, Edinburgh,
           Aberdeen in the last 13 years (2008 - 2021).

        2. Non-surgical cohort - Adult patients who have a diagnosis of proximal aortopathy, but
           have not had surgery. This cohort will be obtained from three sources:

             1. Patients with a diagnosis of thoracic aortopathy identified via National Interim
                Clinical Imaging Procedure (NICIP) codes sourced from the Scottish Radiology
                Information System (RIS) and Picture Archive and Communication System (PACS)
                databases.

             2. Patients with a diagnosis of thoracic aortopathy identified from regional genetic
                services via the Network for Inherited Cardiac Conditions Scotland.

             3. Deceased patients diagnosed with proximal thoracic aortopathy or a complication
                thereof (aortic dissection, aortic rupture) registered at death certification
                and/or post mortem accessed from Public Health Scotland using ICD-10 codes.

      The three data collection sites will be the Golden Jubilee National Hospital in Glasgow, the
      Edinburgh Royal Infirmary and Aberdeen Royal Infirmary.

      The surgical cohort sample size is expected to be around 1300 patients. The non-surgical
      cohort is difficult to estimate, but around 500 cases yearly are expected to be identified.
      The research project will be hosted by the NHS Golden Jubilee Research Department.

      The principal investigator (George Gradinariu) will undertake this research project as part
      of an postgraduate research programme (MD degree) at the University of Glasgow under the
      supervision of Professor Mark Danton (Congenital Cardiac Surgeon with interest in proximal
      aortic surgery), Professor Alex McConnachie Professor of Biostatistics, University of
      Glasgow) and Professor Faisal Ahmed (Samson Gemmell Chair of Child Health, University of
      Glasgow)

      Statistical analysis will be overseen and supervised by Professor McConnachie. Descriptive
      statistics will be applied. Survival data will be analysed using Kaplan-Meier. Multivariable
      survival and logistic regression models will be used to identify variables predicting the
      risk of adverse outcomes. Predictive modelling to estimate the risk of adverse outcomes based
      on aortic root dimension will be assessed using ROC analysis. In comparing survival by
      procedures propensity matching will be used to minimize confounding. Analysis will be
      performed using R statistical analysis software (R Foundation for Statistical Computing,
      Vienna, Austria).
    


Study Type

Observational


Primary Outcome

Early survival following surgery of the proximal aorta

Secondary Outcome

 Cardiovascular reintervention

Condition

Aortic Diseases

Intervention

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

Study Arms / Comparison Groups

 Surgical cohort
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

2000

Start Date

August 2022

Completion Date

August 2024

Primary Completion Date

August 2024

Eligibility Criteria

        Surgical cohort

        Inclusion Criteria:

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

        Exclusion Criteria:

          -  Isolated surgery on the descending thoracic aorta

        Non-surgical cohort

        Inclusion Criteria:

        - all adult patients (>18 years of age) with a radiological, genetic or post-mortem
        diagnosis of thoracic aortic disease
      

Gender

All

Ages

18 Years - N/A


Contacts

George Gradinariu, MD, 01419515000, [email protected]



Administrative Informations


NCT ID

NCT05389865

Organization ID

IRAS 309277


Responsible Party

Principal Investigator

Study Sponsor

Golden Jubilee National Hospital

Collaborators

 Aberdeen Royal Infirmary

Study Sponsor

George Gradinariu, MD, Principal Investigator, Golden Jubilee National Hospital


Verification Date

May 2022