Hemiarch vs Extended Arch Surgery for Aortic Dissection

(HEADSTART Trial)

Recruiting at 3 trial locations

Overseen By Vamshi Kotha, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Shock, Previous cardiac surgery, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

182 Participants Needed

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}

Research Team

Vamshi Kotha, MD

Principal Investigator

University of Calgary

Jehangir Appoo, MD

Principal Investigator

University of Calgary

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.

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

Treatment Details

Interventions

• Extended arch repair
• Hemiarch repair

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

In a study of 929 patients with acute type A aortic dissection, both hemiarch (HA) and extended arch (EA) repairs showed similar rates of in-hospital mortality (19% for HA vs 21% for EA) and neurological deficits, indicating comparable safety profiles for these surgical approaches.

However, extended arch interventions were associated with a higher risk of composite adverse events, suggesting that while they may help resolve malperfusion more effectively, they should be approached with caution due to the increased risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemiarch versus extended arch repair for acute type A dissection: Results from a multicenter national registry. Elbatarny, M., Stevens, LM., Dagenais, F., et al.[2023]

Hemiarch replacement is a suitable surgical strategy for patients with acute type A aortic dissection and arch branch vessel dissection who do not have cerebral malperfusion, as shown in a study of 276 patients over 11 years.

While postoperative outcomes like stroke and mortality rates were similar between patients with and without arch branch vessel dissection, those with dissection had a significantly higher risk of needing reoperation later on, indicating a long-term consideration for this patient group.

NCBI (Pubmed)

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? Norton, EL., Wu, X., Kim, KM., et al.[2022]

In a study of 20 patients undergoing elective transverse hemiarch replacement, moderate hypothermic circulatory arrest with antegrade cerebral perfusion (MHCA+ACP) was associated with a higher incidence of radiographic neurologic injury compared to deep hypothermic circulatory arrest with retrograde cerebral perfusion (DHCA+RCP), with 100% of MHCA+ACP patients showing lesions on MRI versus 45% in the DHCA+RCP group.

Despite the higher incidence of MRI-detected lesions in the MHCA+ACP group, there were no significant differences in clinically evident neurologic injuries, as both groups had equivalent outcomes in terms of stroke scale scores and neurocognitive test results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Hypothermia With Retrograde Cerebral Perfusion Versus Moderate Hypothermia With Antegrade Cerebral Perfusion for Arch Surgery. Leshnower, BG., Rangaraju, S., Allen, JW., et al.[2019]

In a study of 213 patients with acute Type A aortic dissection, those who underwent ascending aorta and arch replacement (Group 2) had a lower hospital mortality rate (5%) compared to those who had only ascending aorta/hemiarch replacement (Group 1) with a 12% mortality rate.

Long-term outcomes were better for patients in Group 2, with higher 5 and 10-year survival rates (77% and 66% respectively) and a lower incidence of late complications, suggesting that immediate aortic arch replacement is a more effective strategy without increasing mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemiarch Versus Arch Replacement in Acute Type A Aortic Dissection: Is the Occam's Razor Principle Applicable? Vendramin, I., Piani, D., Lechiancole, A., et al.[2022]

In a study of 137 patients who underwent hemiarch or total arch replacement after previous acute type I aortic dissection, the operations showed a 5-year survival rate of 73.2%, indicating respectable long-term outcomes.

Congestive heart failure and cardiopulmonary bypass time were significant predictors of operative mortality, while female sex and circulatory arrest time were linked to long-term mortality, highlighting important risk factors for patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemiarch and Total Arch Surgery in Patients With Previous Repair of Acute Type I Aortic Dissection. Preventza, O., Price, MD., Simpson, KH., et al.[2015]

In a study of 56 patients who underwent hemiarch replacement for acute type A aortic dissection, the overall in-hospital mortality rate was 7.1%, indicating a relatively low risk for this surgical procedure.

The presence of brachiocephalic artery dissection and the absence of tear resection were identified as significant predictors for the development of a patent false lumen in the aortic arch post-surgery, which could help in selecting appropriate surgical strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of patent false lumen of the aortic arch after hemiarch replacement. Uchino, G., Ohashi, T., Iida, H., et al.[2022]

In a study of 267 patients with acute type A aortic dissection, the strategy of tear-oriented ascending/hemiarch replacement showed similar long-term survival rates compared to total/partial arch replacement, with 5-year survival rates of 80.7% and 84.3%, respectively.

There were no significant differences in reoperation-free survival between the two surgical approaches, indicating that the ascending/hemiarch repair does not increase the risk of long-term complications or mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of tear-oriented ascending/hemiarch replacements for acute type A aortic dissection. Aizawa, K., Kawahito, K., Misawa, Y.[2022]

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]

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]

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

Deep Hypothermia With Retrograde Cerebral Perfusion Versus Moderate Hypothermia With Antegrade Cerebral Perfusion for Arch Surgery. [2019]

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]

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

Hemiarch and Total Arch Surgery in Patients With Previous Repair of Acute Type I Aortic Dissection. [2015]

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

Predictors of patent false lumen of the aortic arch after hemiarch replacement. [2022]

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

Long-term outcomes of tear-oriented ascending/hemiarch replacements for acute type A aortic dissection. [2022]