Hemiarch vs Extended Arch Surgery for Aortic Dissection

(HEADSTART Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Vamshi Kotha, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Calgary

Disqualifiers: Shock, Previous cardiac surgery, Cirrhosis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

Is hemiarch or extended arch surgery for aortic dissection safe?

Research shows that both hemiarch and extended arch surgeries for aortic dissection have been studied for safety, with a focus on outcomes like neurologic injury. Different strategies are used to protect the brain during surgery, and these procedures are generally considered safe, though they carry risks like any major surgery.

^{1 2 3 4 5}

How does the treatment for aortic dissection differ between hemiarch and extended arch surgery?

Hemiarch surgery is less invasive and focuses on repairing only part of the aortic arch, which may lead to a risk of future complications like dilation, while extended arch surgery involves a more comprehensive repair of the entire aortic arch, potentially reducing the risk of future issues but being more complex and invasive.

^{1 2 4 6 7}

Eligibility Criteria

This trial is for adults aged 18-70 with acute DeBakey Type 1 aortic dissection, where surgeons believe both hemiarch and extended arch repairs could work. It's not for those with cirrhosis, pregnant women, people in shock (very low blood pressure), prior major heart surgeries or thoracic endografts, patients unlikely to survive after surgery, severe brain injury (low GCS for over 6 hours), very large aortic arches needing replacement (>6cm), metastatic cancer, or chronic kidney failure.

Inclusion Criteria

I am between 18 and 70 years old.

My surgeon thinks both of my surgeries could be safe and work well.

I need urgent surgery for a major artery rupture.

Exclusion Criteria

I am not expected to survive after my current hospital treatment.

I have chronic kidney disease with an eGFR below 50.

My aortic arch is larger than 6cm and needs surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either hemiarch or extended arch repair for acute DeBakey type 1 aortic dissection

1 week

In-hospital stay for surgery and recovery

Early Post-operative Follow-up

Participants are monitored for peri-operative complications and early re-intervention needs

1 month

Regular in-person visits for clinical and imaging assessments

Long-term Follow-up

Participants are monitored for mortality, re-intervention, and aortic remodeling over a 3-year period

3 years

Periodic in-person and imaging follow-ups

Participant Groups

The HEADSTART trial compares two surgical methods—hemiarch repair and extended arch repair—for treating acute DeBakey type 1 aortic dissection. Patients will be randomly assigned to one of the procedures and monitored for outcomes like survival and need for additional interventions over three years.

Group I: Hemiarch repair Active Control 1 Intervention

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

Group II: Extended arch repair Active Control 1 Intervention

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

Extended arch repair is already approved in European Union, United States, Canada, China for the following indications:

🇪🇺 Approved in European Union as Total arch replacement for:

• Acute type A aortic dissection

🇺🇸 Approved in United States as Extended arch repair for:

• Acute DeBakey type 1 aortic dissection

🇨🇦 Approved in Canada as Total arch replacement for:

• Acute type A aortic dissection

🇨🇳 Approved in China as Extended arch repair for:

• Acute type A aortic dissection

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

New Brunswick Heart Centre Saint John, Canada

University of Calgary Calgary, Canada

Mazankowski Alberta Heart Institute Edmonton, Canada

London Health Sciences Centre London, Canada

Who Is Running the Clinical Trial?

University of Calgary Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Hemiarch versus extended arch repair for acute type A dissection: Results from a multicenter national registry. [2023] We compared perioperative outcomes of patients with acute type A aortic dissection undergoing hemiarch (HA) versus extended arch (EA) repair with or without descending aortic intervention.

2. United States pubmed.ncbi.nlm.nih.gov

Is hemiarch replacement adequate in acute type A aortic dissection repair in patients with arch branch vessel dissection without cerebral malperfusion? [2022] The study objective was to determine if hemiarch replacement is an adequate arch management strategy for patients with acute type A aortic dissection and arch branch vessel dissection but no cerebral malperfusion.

3. Netherlands pubmed.ncbi.nlm.nih.gov

Deep Hypothermia With Retrograde Cerebral Perfusion Versus Moderate Hypothermia With Antegrade Cerebral Perfusion for Arch Surgery. [2019] Patients undergoing aortic arch replacement are at high risk for neurologic injury. This study compared two different established neuroprotective strategies in patients undergoing elective transverse hemiarch replacement.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Hemiarch Versus Arch Replacement in Acute Type A Aortic Dissection: Is the Occam's Razor Principle Applicable? [2022] In patients with acute Type A aortic dissection (A-AAD) whether repair should be limited to ascending aorta/hemiarch replacement or extended to include the aortic arch is still debated. We have analyzed our experience to compare outcomes of patients with A-AAD treated with these 2 different surgical strategies.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Hemiarch and Total Arch Surgery in Patients With Previous Repair of Acute Type I Aortic Dissection. [2015] We examined our contemporary experience with hemiarch and total arch replacement in patients with previous acute type I aortic dissection.

6. Japan pubmed.ncbi.nlm.nih.gov

Predictors of patent false lumen of the aortic arch after hemiarch replacement. [2022] Hemiarch replacement for acute type A aortic dissection is less invasive than total arch replacement but involves increased risk of late aortic arch dilation because of patent false lumen of the aortic arch. If we can predict this risk, it may be a valuable prognostic indicator for selecting surgical procedures for acute type A aortic dissection.

7. Japan pubmed.ncbi.nlm.nih.gov

Long-term outcomes of tear-oriented ascending/hemiarch replacements for acute type A aortic dissection. [2022] Extended arch repair for acute type A aortic dissection remains controversial. Our strategy for acute type A aortic dissection was primary entry resection and tear-oriented ascending/hemiarch replacement for patients with the intimal tear in the ascending aorta or is not found in the ascending/aortic arch. Extended total/partial arch replacement was performed for patients with the tear located in the aortic arch. Here, we investigated the validity of our strategy from the viewpoints of long-term survival and reoperation.