Hemiarch vs Extended Arch Surgery for Aortic Dissection

(HEADSTART Trial)

Recruiting at 6 trial locations

Overseen By Alice Black

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

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

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different surgeries for individuals with acute DeBakey type 1 aortic dissection, a serious condition affecting the main artery. The goal is to determine which surgery—hemiarch repair or extended arch repair (also known as total arch replacement)—results in better outcomes, such as fewer deaths or repeat surgeries, over three years. Participants will be randomly assigned to one of the two surgical options. Suitable candidates for this trial are those requiring emergency surgery for this specific heart problem and who have not undergone previous major heart surgeries. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially improve surgical outcomes for future patients.

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.

What prior data suggests that these surgical strategies are safe for aortic dissection?

Research has shown that both extended arch repair and hemiarch repair are generally safe for patients undergoing surgery for aortic dissection. Studies have found that extended arch repair does not result in more major early complications compared to hemiarch repair, allowing patients to typically recover well immediately after surgery.

However, hemiarch repair has demonstrated better early results in some studies, though it may carry a higher risk of later complications. This suggests that while patients initially do well, there could be more issues over time compared to extended arch repair. Despite this, hemiarch repair remains commonly used due to its proven success.

Both surgical methods are considered safe, each offering distinct advantages and potential downsides, making them viable options for treating aortic dissection. Patients should consider these findings when deciding whether to participate in a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments for aortic dissection because they offer innovative surgical options aimed at improving patient outcomes. Unlike the standard hemiarch repair which involves only the proximal arch, the extended arch repair includes replacement of the ascending aorta and potentially the head vessels, with the addition of a TEVAR device within a week. This approach could provide more comprehensive structural support and reduce the risk of future complications. The potential for a more durable repair and reduced need for subsequent interventions makes these surgical techniques particularly promising.

What evidence suggests that this trial's treatments could be effective for aortic dissection?

This trial will compare the effectiveness of extended arch repair and hemiarch repair for treating acute type A aortic dissection. Studies have shown that both approaches are effective, though they have different strengths. Extended arch repair tends to provide better long-term outcomes by reducing the risk of future complications, as it addresses the entire arch and an extra channel in the artery called the false lumen. Research indicates it may lower the need for additional surgeries later. In contrast, hemiarch repair often results in better early outcomes with lower immediate death rates, though it might lead to higher death rates later in some cases. Both approaches are viable, and the choice often depends on the specific details of the patient's condition. Participants in this trial will be assigned to either the extended arch repair arm or the hemiarch repair arm to evaluate these outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Munir Boodhwani, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Jehangir Appoo, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10405193/

Short- and long-term results of total arch replacement Total arch replacement achieves excellent operative outcomes and durability by both debranching and en bloc island reimplantation of the arch supra-aortic ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003497505006016

Long-Term Effectiveness of Total Arch Replacement for ... Total arch replacement for acute type A dissection may decrease the risk of late complications related to the false lumen and lead to excellent long-term ...

3. link.springer.com link.springer.com/article/10.1007/s12055-023-01576-7

Comparison of the outcomes between total arch ... Objective. To compare the outcomes between total arch replacement (TAR) and nontotal arch replacement (non-TAR) in patients with acute type ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2950605025000087

Root and arch replacements in acute type A aortic ... Conclusions. Root and total arch replacements in acute type A aortic dissection demonstrated reduced risk of reinterventions, particularly open reintervention ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4893527/

Hemiarch versus total aortic arch replacement in acute type A ... The 30-day mortality was 20.4% for total arch replacement and 12.9% for hemiarch replacement, although the results did not reach statistical significance (P= ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7330748/

The aortic arch management for type A aortic dissection At mid-term follow-up, extended-arch repair reduces the need for open surgical reoperation and improves aortic remodeling. Extended-arch repair was defined as ...

7. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(25)00547-8/fulltext

Outcomes of Redo Total Arch Replacement After Limited ... Surgical outcomes of redo total arch replacement after limited arch repair for ATAD have been acceptable and shown dramatic improvement over the ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666273625002256

Limited versus extended arch replacement during acute ... It remains controversial whether extended arch (EA) replacement should be indicated for arch vessel dissection (AVD) during acute type A aortic dissection ...

9. jtcvstechniques.org jtcvstechniques.org/article/S2666-2507(23)00146-3/fulltext

Short- and long-term results of total arch replacement Total arch replacement achieves excellent operative outcomes and durability by both debranching and en bloc island reimplantation of the arch supra-aortic ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39937874/

Total Arch Replacement is Safe as Hemiarch Repair in ... Total arch replacement does not increase the risk of major early postoperative complications in comparison to hemiarch repair.