Hemiarch vs Extended Arch in Type 1 Aortic Dissection (HEADSTART)

University of Ottawa Heart Institute

Status: Enrolling

Conditions: Aortic Dissection

Treatments: Procedure: Hemiarch repair; Procedure: Extended arch repair

Study type: Interventional

Funder types: Other

Identifiers

NCT03885635

HEADSTART

Details and patient eligibility

About

HEADSTART is a prospective, open-label, non-blinded, multicenter, randomized controlled trial that compares a composite of mortality and re-intervention in patients undergoing hemiarch and extended arch repair for acute DeBakey type 1 aortic dissection. Eligible patients will be randomized to one or the other surgical strategy and clinical and imaging outcome data will be collected over a 3 year follow up period.

Full description

DeBakey Type 1 aortic dissections continue to have high operative mortality and morbidity and there is equipoise in available literature with regards to the best operative strategy and patient selection criteria. Hemiarch repair is current standard of care in most centers but extended arch repair is gaining popularity aiming to address early post-operative malperfusion and improve long term aortic remodeling.

HEADSTART is a randomized controlled prospective trial of patients presenting to participating institutes with acute DeBakey 1 aortic dissection. Patients will be enrolled and randomized into one of two groups - 'hemiarch repair' and 'extended arch repair'. Pre-operative, early post-operative and long term follow clinical and CT imaging data will be collated on a centralized database and at a core lab respectively.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Emergent surgical repair of Acute DeBakey Type 1 aortic dissection
2. Age >18 years and <70 years
3. Operating surgeon believes that both surgeries could be safe and effective

Exclusion Criteria

1. Hemodynamic instability/shock defined as systolic BP < 90 mm Hg
2. Previous cardiac surgery with sternotomy or thoracic endograft placement
3. Aortic arch diameter > 6cm in which a concomitant arch replacement is judged necessary
4. Procedures deemed to be "salvage operations" where the patient is unlikely to survive hospital discharge.
5. GCS < 8 for more than 6 hours
6. History of cirrhosis.
7. History of chronic renal failure (baseline eGFR < 50)
8. Metastatic malignancy
9. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Hemiarch repair

Active Comparator group

Description:

Standard hemiarch repair with open distal anastomosis in the proximal arch without replacement of the head vessels.

Treatment:

Procedure: Hemiarch repair

Extended arch repair

Active Comparator group

Description:

Ascending aortic and arch replacement with or without head vessel re-implantation and single TEVAR device placement within 1 week.

Treatment:

Procedure: Extended arch repair