Proximal Aortopathy in Scotland - Epidemiology and Surgical Outcomes

Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05389865
• Other study ID #: IRAS 309277
• Status: Not yet recruiting
• Start date: August 2023
• Est. completion date: August 2024

Study information

• Verified date: May 2023
• Source: Golden Jubilee National Hospital
• Contact: George Gradinariu, MD
• Phone: 01419515000
• Email: george.gradinariu2[@]nhs.scot
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Surgery on the proximal aorta (aortic root +/- ascending aorta)
Surgery involving replacing, repairing or reinforcing the proximal aorta (root and ascending aorta)

Other:
• Patients diagnosed with thoracic aortopathy but not operated upon
Radiological size criteria or Genetic mutations associated with aortopathies

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Golden Jubilee National Hospital	Aberdeen Royal Infirmary, Network for Inherited Cardiac Conditions Scotland, Royal Infirmary of Edinburgh, University of Glasgow

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Cardiovascular reintervention	Reinterventions (surgical/endovascular) related to the aortic implant or unoperated aorta Reintervention on Aortic valve (native or prosthesis)	1 year or latest available follow-up (whichever is longer)
Secondary	Specified adverse events following surgery	episodes of endocarditis, structural valve degeneration, thromboembolism, cerebral vascular accident, anticoagulant-related bleeding	1 year or latest available follow-up (whichever is longer)
Secondary	Left ventricular ejection fraction (LVEF) following surgery	Long-term left ventricular ejection fraction (>50% - good, 31-50% - moderate, 21-30% - poor, 20% or less -very poor) as measured by echocardiography or cardiac MRI after surgery	1 year or latest available follow-up (whichever is longer)
Secondary	Aortic valve mean gradient and degree of regurgitation following surgery	Long-term aortic valve function as assessed by mean gradient (mmHg) and degree of regurgitation (mild/moderate/severe) in operated patients assessed by echocardiography or cardiac MRI	1 year or latest available follow-up (whichever is longer)
Secondary	Genotypes and phenotypes prevalent in the Scottish population	Identify genotypes and phenotypes in the Scottish population and assess their prevalence	Previous 5 years