Hemiarch vs Extended Arch in Type 1 Aortic Dissection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hemiarch repair, Extended arch repair.
- Who it may be relevant to
- Registry conditions: Aortic Dissection. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)
Overview
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.
Detailed description
DeBakey Type 1 aortic dissections continue to have high operative mortality and morbidity and there is equipoise in available literature with regards to the best operative strategy and patient selection criteria. Hemiarch repair is current standard of care in most centers but extended arch repair is gaining popularity aiming to address early post-operative malperfusion and improve long term aortic remodeling.
HEADSTART is a randomized controlled prospective trial of patients presenting to participating institutes with acute DeBakey 1 aortic dissection. Patients will be enrolled and randomized into one of two groups - 'hemiarch repair' and 'extended arch repair'. Pre-operative, early post-operative and long term follow clinical and CT imaging data will be collated on a centralized database and at a core lab respectively.
Interventions
- Procedure Hemiarch 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. - Procedure Extended 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
Primary outcome measures
- Number of patients experiencing a composite end-point of mortality or re-intervention [Time frame: 3 years]
Secondary outcome measures (6)
- Number of patients achieving complete false lumen thrombosis on CT imaging [Time frame: 3 years]
- Delta change in the ratio of true lumen to total aortic area (TL: Ao) [Time frame: 1 month]
- Delta change in maximum cross-sectional descending thoracic aortic dimension [Time frame: 3 years]
- Number of patients experiencing the listed peri-operative complications [Time frame: 1 month]
- Number of patients requiring open surgical or endovascular re-intervention [Time frame: 3 years]
- Preoperative malperfusion and perioperative mortality/early re-intervention [Time frame: 1 month]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 4 centers
- London Health Sciences Centre — London
- University Health Network — Toronto
- Montreal Heart Institute — Montreal
- Institut Universitaire De Cardiologie Et De Pneumologie de Québec — Québec
Publications
- Elbatarny M, Stevens LM, Dagenais F, Peterson MD, Vervoort D, El-Hamamsy I, Moon M, Al-Atassi T, Chung J, Boodhwani M, Chu MWA, Ouzounian M; Canadian Thoracic Aortic Collaborative Investigators. Hemiarch versus extended arch repair for acute type A dissection: Results from a multicenter national registry. J Thorac Cardiovasc Surg. 2024 Mar;167(3):935-943.e5. doi: 10.1016/j.jtcvs.2023.04.012. Epub PMID 37084820
Identifiers
NCT: NCT03885635 · HEADSTART