Endovascular treatment of aortic arch chronic dissection with a branched endograft following previous ascending aorta replacement for Acute Type A dissection: midterm results from an international multicenter study

• Register: ISRCTN
• Last refreshed on: 13 May 2019
• Main ID: ISRCTN16716994
• Date of registration: 11/06/2018
• Prospective Registration: No
• Primary sponsor: Centre Chirurgical Marie Lannelongue
• Public title: Endovascular treatment of aortic arch chronic dissection with a branched endograft following previous ascending aorta replacement for Acute Type A dissection: midterm results from an international multicenter study
• Scientific title: Endovascular treatment of aortic arch chronic dissection with a branched endograft following previous ascending aorta replacement for Acute Type A dissection: midterm results from an international multicenter study
• Date of first enrolment: 02/12/2017
• Target sample size: 70
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN16716994
• Study type: Observational
• Study design: Retrospective multicentre international observational study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Brazil, France, Germany, Hong Kong, Netherlands, Poland, Sweden, United Kingdom, United States of America

Contacts

• Name: Dorian Verscheure

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients aged 18 or older
2. With prior ascending aorta prosthetic replacement for Stanford A acute dissection
3. With chronic dissection of the aortic arch with arch dilatation
4. Treated with a custom-made branched endograft (Cook Medical, Bloomington, In, USA)

Exclusion criteria: Does not meet inclusion criteria

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Aortic arch chronic dissection following ascending aorta prosthetic replacement for acute Stanford A dissection
Circulatory System

Intervention(s)

Endovascular repair of aortic arch chronic dissection with a custom made branched endograft (Cook Medical, Bloomington, In, USA).
Endografts includes 2 branched (one for the brachiocephalic trunk and one for the left common carotid artery (LCC), requiring left subclavian artery (LSA) transposition or bypass) or 3 branched (one for each supra aortic trunk) devices.
In order to deliver the components, three arterial access sites are required:
1. Femoral access to insert the endograft over a stiff wire positioned through the aortic valve into the left ventricle.
2. Right common carotid or right axillary access to catheterize the innominate internal side branch and to insert the covered stent bridging the branch to the IT.
3. Left axillary or brachial access to catheterize the LCC through the LSA transposition or bypass, and the LCC internal side branch to deliver the covered stent bridging the side branch to the LCC.
After systemic heparinization with 100 IU/kg (target activated clotting time [ACT] > 300 seconds), catheters and/or sheaths are placed to mark the origins of the innominate artery and LCC or LSA, a catheter is positioned close to the apex of the left ventricle from the femoral access and a stiff wire (Lunderquist, Cook Medical) is advanced through this catheter. The position of the tip of the stiff wire is constantly visualized. Under fluoroscopy, the graft is verified outside the patient to get accustomed to the numerous radio-opaque markers and then delivered over the stiff wire to the aortic arch. The tapered short tip is brought through the aortic valve, into the left ventricle. An angiogram is performed. If the branches along with their associated markers are positioned adequately, the graft is deployed under cardiac output reduction using rapid pacing, inferior vena cava occlusion or pharmacologic cardiac arrest. Normal cardiac output is r

Primary Outcome(s)

Rates of in-hospital mortality and stroke, measured during the postoperative course (between surgical procedure and postoperative day 30)

Secondary Outcome(s)

1. Technical success, defined as successful delivery of the endograft without type 1 endoleak and evaluated on the preoperative angiogram, without death during the first 24 postoperative hours. Measured during the beginning of the surgical procedure and postoperative hour 24
2. Early complications, measured using evaluation of the presence of cardiac (troponin elevation with electrocardiogram modification), renal (elevation of creatinin level requiring extracorporeal epuration) or respiratory (hypoxemia, pneumoniae or reintubation) failure or necessity of secondary surgical procedure. Measured before postoperative day 30
3. Late complications, measured using the same measurement as early complications
4. Re-intervention and mortality rates measured during follow up (between postoperative day 30 and the most recent news)

Secondary ID(s)

063290

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Comité d'Ethique de Recherche Clinique de la Société Française de Chirurgie Thoracique et Cardio-Vasculaire (Ethical committee in clinical research of the French society of thoracic and cardiovascular surgery), 22/04/2018, ref: CERC-SFCTCV-2018-3-7-20-50-27-vedo

Results

• Results available: Yes
• Date Completed: 25/09/2018