Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance

Overview

About this study

The purpose of this study is to compare the composite outcome of the all-cause mortality and incidence of acute aortic events between surveillance and elective ascending aortic surgery for patients with degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow up.

The hypothesis is that the early surgery group will have a significantly lower all-cause mortality and incidence of acute aortic events at 2 years of follow up compare to the surveillance group. The result of this trial will provide evidence based guidance in the appropriate management of ascending aortic aneurysm based on the size criteria, and establish a large database for future investigations.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Patients between the age of 18 and 79 inclusive.

2. Ascending aortic aneurysm between 5.0cm and 5.4cm in maximal diameter as measured by
CT with contrast.

3. Patients with ascending aortic aneurysm with a diameter of 4.5 cm - 4.9 cm will be
observed with serial CT, and will be considered for enrollment into the trial once the
aneurysm reaches 5.0 cm.

Exclusion Criteria:

1. Patients who refused to be randomized

2. Patients with symptomatic attributable to ascending aortic aneurysms

3. Patients who are unable to provide informed consents

4. Patients who are unable to attend for regular follow-up/ remain compliant with
protocol

5. Previous cardiac surgery

6. Patients whose primary indication for cardiac surgery is non-AsAA related

7. Known AsAA expansion rate exceeding 0.5 cm/year during the past 5 years

8. Arch aneurysms with no ascending aorta involvement (no aneurysmal segments before the
innominate artery)

9. Ascending aortic and arch aneurysm with descending thoracic aorta involvement

10. Patients with known connective tissue disease (E.g. Marfan syndrome, Loey-Dietz
syndrome, Turner syndrome etc) syndrome, etc.)

11. Patients with possible genetic aortopathies (eg known family history of aortic
aneurysms/premature aortic dissections/ruptures)

12. Patients with inflammatory arteritis (e.g. takayasu's arteritis, syphilitic arteritis,
etc.)

13. Female patients who are pregnant or planning to become pregnant

14. Patients who have a history or presence of a medical condition or disease or
psychiatric condition that in the investigator's assessment would render the subject
ineligible for study participation.

15. Patients who, in the opinion of the investigator, are deemed unfit for surgery for
reasons that may include:

- Severe pulmonary disease

- Cr = 250umol/L

- Child Pugh Class B or C

- NYHA III or IV

- MI within the last 6 months

- Major surgical procedure or angioplasty within 3 months

- Expected survival less than 5 years because of other disease (e.g. invasive
cancer)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/17/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Gabor Bagameri, M.D.

Contact us for the latest status

Contact information:

Mary Timmons CCRP

(507) 255-8772

Timmons.Mary@mayo.edu

More information

Publications

Publications are currently not available