RecruitingNot ApplicableNCT03885635

Hemiarch vs Extended Arch in Type 1 Aortic Dissection

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

Sponsor

Ottawa Heart Institute Research Corporation

Enrollment

50 participants

Start Date

Jul 30, 2024

Study Type

INTERVENTIONAL

Conditions

Aortic Dissection

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

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

Exclusion Criteria9

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

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Interventions

PROCEDUREHemiarch repair

Current standard of surgical repair consisting of ascending aortic replacement with open distal anastomosis at level of proximal arch under a period of hypothermic circulatory arrest . No surgical or endovascular intervention is carried out in the mid arch or descending aorta. Intra-operative management, including cannulation, cardioplegia, cerebral perfusion technique, and neurologic monitoring will be done according to each institution's current standard of practice.

PROCEDUREExtended arch repair

Surgical replacement of the ascending aorta along with intervention on the arch and descending aorta. Techniques for distal aspect of extended arch technique include but are not limited to total arch replacement along with TEVAR, Frozen Elephant Trunk procedure or surgical proximal arch replacement with bare metal stents in arch and descending aorta. Intra-operative management, including cannulation, cardioplegia, cerebral perfusion technique, and neurologic monitoring will be done according to each institution's current standard of practice.