Hemiarch vs Extended Arch in Type 1 Aortic Dissection

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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

Первичные конечные точки

• Number of patients experiencing a composite end-point of mortality or re-intervention [Срок оценки: 3 years]

Вторичные конечные точки (6)

• Number of patients achieving complete false lumen thrombosis on CT imaging [Срок оценки: 3 years]
• Delta change in the ratio of true lumen to total aortic area (TL: Ao) [Срок оценки: 1 month]
• Delta change in maximum cross-sectional descending thoracic aortic dimension [Срок оценки: 3 years]
• Number of patients experiencing the listed peri-operative complications [Срок оценки: 1 month]
• Number of patients requiring open surgical or endovascular re-intervention [Срок оценки: 3 years]
• Preoperative malperfusion and perioperative mortality/early re-intervention [Срок оценки: 1 month]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 4 центра

• London Health Sciences Centre — London
• University Health Network — Toronto
• Montreal Heart Institute — Montreal
• Institut Universitaire De Cardiologie Et De Pneumologie de Québec — Québec

Публикации

• 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

Идентификаторы

NCT: NCT03885635 · HEADSTART

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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