Garg Vinay, Peterson Mark D, Chu Michael Wa, Ouzounian Maral, MacArthur Roderick Gg, Bozinovski John, El-Hamamsy Ismail, Victor Chu F, Garg Ankit, Hall Judith, Thorpe Kevin E, Dhingra Natasha, Teoh Hwee, Marotta Thomas R, Latter David A, Quan Adrian, Mamdani Muhammad, Juni Peter, David Mazer C, Verma Subodh
Department of Internal Medicine, University of Toronto, Toronto, Ontario, Canada.
Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
BMJ Open. 2017 Jun 10;7(6):e014491. doi: 10.1136/bmjopen-2016-014491.
Neurological injury remains the major cause of morbidity and mortality following open aortic arch repair. Systemic hypothermia along with antegrade cerebral perfusion (ACP) is the accepted cerebral protection approach, with axillary artery cannulation being the most common technique used to establish ACP. More recently, innominate artery cannulation has been shown to be a safe and efficacious method for establishing ACP. Inasmuch as there is a lack of high-quality data comparing axillary and innominate artery ACP, we have designed a randomised, multi-centre clinical trial to compare both cerebral perfusion strategies with regards to brain morphological injury using diffusion-weighted MRI (DW-MRI).
110 patients undergoing elective aortic surgery with repair of the proximal arch requiring an open distal anastamosis will be randomised to either the innominate artery or the axillary artery cannulation strategy for establishing unilateral ACP during systemic circulatory arrest with moderate levels of hypothermia. The primary safety endpoint of this trial is the proportion of patients with new radiologically significant ischaemic lesions found on postoperative DW-MRI compared with preoperative DW-MRI. The primary efficacy endpoint of this trial is the difference in total operative time between the innominate artery and the axillary artery cannulation group.
The study protocol and consent forms have been approved by the participating local research ethics boards. Publication of the study results is anticipated in 2018 or 2019. If this study shows that the innominate artery cannulation technique is non-inferior to the axillary artery cannulation technique with regards to brain morphological injury, it will establish the innominate artery cannulation technique as a safe and potentially more efficient method of antegrade cerebral perfusion in aortic surgery.
NCT02554032.
神经损伤仍然是开放性主动脉弓修复术后发病和死亡的主要原因。全身低温联合顺行性脑灌注（ACP）是公认的脑保护方法，腋动脉插管是建立ACP最常用的技术。最近，无名动脉插管已被证明是建立ACP的一种安全有效的方法。由于缺乏比较腋动脉和无名动脉ACP的高质量数据，我们设计了一项随机、多中心临床试验，以使用弥散加权磁共振成像（DW-MRI）比较两种脑灌注策略对脑形态学损伤的影响。
110例接受择期主动脉手术且近端主动脉弓修复需要进行开放性远端吻合的患者，将被随机分为无名动脉或腋动脉插管策略组，在中度低温下全身循环停止期间建立单侧ACP。本试验的主要安全终点是术后DW-MRI上发现的新的具有放射学意义的缺血性病变患者比例与术前DW-MRI相比。本试验的主要疗效终点是无名动脉和腋动脉插管组之间总手术时间的差异。
研究方案和知情同意书已获得参与研究的当地伦理委员会批准。预计2018年或2019年发表研究结果。如果本研究表明在脑形态学损伤方面无名动脉插管技术不劣于腋动脉插管技术，将确立无名动脉插管技术为主动脉手术中一种安全且可能更有效的顺行性脑灌注方法。
NCT02554032。
