Hemiarch versus extended arch repair for acute DeBakey type 1 aortic dissection

Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)

This study will test whether an extended arch repair or the standard hemiarch repair leads to fewer deaths and fewer repeat operations in adults needing emergency surgery for acute DeBakey type 1 aortic dissection.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Ottawa Heart Institute Research Corporation (Academic / other)
• Locations: 4 sites (London, Ontario and 3 other locations)
• Trial ID: NCT03885635 on ClinicalTrials.gov

What this trial studies

HEADSTART is a prospective, open-label, randomized multicenter trial enrolling adults (18–70 years) who present with acute DeBakey type 1 aortic dissection and for whom the operating surgeon considers either hemiarch or extended arch repair feasible. Eligible patients are randomized to hemiarch repair or extended arch repair, with pre-operative, early post-operative, and regular long-term clinical follow-up and CT imaging collected over three years. Imaging is reviewed at a central core lab and clinical outcomes are entered into a centralized database to compare a composite endpoint of mortality and re-intervention.

Who should consider this trial

Good fit: Adults aged 18–70 presenting with acute DeBakey type 1 aortic dissection who are stable enough for surgery and where the operating surgeon believes both hemiarch and extended arch repair could be safe and effective.

Not a fit: Patients who are in shock (systolic BP <90 mm Hg), have prior sternotomy or thoracic endografts, very large arch diameters (>6 cm), severe organ failure, metastatic cancer, pregnancy, or other listed exclusion criteria are unlikely to qualify or benefit from randomization.

Why it matters

Potential benefit: If successful, the trial could identify which surgical approach lowers death and the need for repeat procedures, guiding surgeons to improve survival and long-term aortic outcomes.

How similar studies have performed: Observational and cohort studies have suggested extended arch repairs may help with early malperfusion and long-term aortic remodeling, but results are mixed and randomized evidence is currently lacking.

Eligibility 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

Where this trial is running

London, Ontario and 3 other locations

• London Health Sciences Centre — London, Ontario, Canada (Recruiting)
• University Health Network — Toronto, Ontario, Canada (Recruiting)
• Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
• Institut Universitaire De Cardiologie Et De Pneumologie de Québec — Québec, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Munir Boodhwani, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: Khatira Mehdiyeva

Conditions Aortic Dissection