Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · May 14, 2018

Keywords

ClinConnect Summary

The TITAN SvS trial is studying how to best manage patients with an enlarged ascending aorta, which is the large artery that carries blood from the heart to the body. When the aorta enlarges to between 5.0 cm and 5.5 cm, doctors often face a dilemma: should they recommend surgery to replace the aorta, or just monitor the patient closely? This trial will compare two groups of patients—those who have early surgery and those who are closely monitored without immediate surgery—to see which approach leads to better outcomes, such as fewer deaths or serious complications over two years.

To be eligible for this trial, participants need to be between 18 and 79 years old and have an ascending aortic aneurysm that measures between 5.0 cm and 5.4 cm. Patients who have a slightly smaller aneurysm (between 4.5 cm and 4.9 cm) will be monitored and can join the trial if their condition worsens. Throughout the study, participants will receive regular check-ups, and their progress will be tracked to determine which treatment works best. This research aims to provide clearer guidelines for doctors on how to treat patients with this condition safely and effectively.

Gender

ALL

Eligibility criteria

• 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)