Comprising of a proximal multi-branched graft and distal stent, Thoraflex™ Hybrid is designed for intuitive and accurate deployment, has the potential to reduce ischaemia time and enable a one-stage operation (1-4).
Product availability subject to local regulatory approval.
Not approved in the USA
Thoraflex™ Hybrid is the world’s first multi-branched
“Frozen Elephant Trunk” device.
Thoraflex™ Hybrid combines the benefits of the “Frozen Elephant Trunk“ procedure with the Gelweave™ Plexus graft to substantially increase solutions available to the surgeon in the treatment of complex and diverse aortic arch disease (3).
Indicated to treat patients with aneurysm and/or dissection in the ascending thoracic aorta, aortic arch and descending thoracic aorta (2), Thoraflex™ Hybrid consists of a Gelweave™ proximal multi-branch aortic arch plexus graft pre-sewn to a distal stent graft. Gelweave™ material is made from woven polyester sealed with gelatin.
The multi-branch aortic arch Plexus graft, designed for intuitive arch vessel reconstruction and arterial cannulation, provides the potential for reduced ischaemia times. (3,4)
The multiple independent ring stents of the distal stent graft allow excellent anatomical conformability, as they allow it to be shaped to cater for varying patient anatomies (4); radiopaque markers aid in vivo visualisation to confirm accurate deployment.
The compact intuitive delivery system is designed to provide controlled, accurate deployment (1,2). The Siena™ collar at the junction between the aortic arch plexus graft and distal stent graft facilitates the anastomosis (3,4).
Clinical Investigational Report.
Design history file 036.
Shrestha M, Pichlmaier M, Martens A, Hagl C, Khaladj N & Haverich A. Total Aortic Arch Replacement with a Novel 4-Branched Frozen Elephant Trunk Graft : First-in-Man Results. European Journal of Cardiothoracic Surgery. 2013.
Symposium October 2011. Innovative Product Designs & Emerging Implantation Techniques: First-in-Man Results with a Novel 4-Branched Elephant Trunk Graft for Total Aortic Arch Replacement. Shrestha M et al.
The Thoraflex™ Hybrid is the world’s first multi-branched
“Frozen Elephant Trunk” device.
This is also available in DVD format, please click here to request a copy
Total Aortic Arch replacement with the Thoraflex™ Hybrid Frozen elephant trunk Device
Malakh Shrestha M.D., Andreas Martens M.D. and Axel Haverich M.D. - Hannover Medical School, Germany.
In this case study Professor Haverich’s team perform an aortic valve-sparing ‘David’ procedure along with the replacement of the ascending and total aortic arch with the implantation of a partially stented device in the descending aorta.
The Hannover technique of ‘Beating Heart’ aortic arch surgery reduced the myocardial ischaemia time and the Thoraflex™ Hybrid device simplified the operation.
Professor Dr Med Axel Haverich’s team including, Professor Dr Med Malakh Shrestha and Dr Med Andreas Martens, Hannover Medical School, Germany Combined disease of the aortic arch and the proximal descending aorta remains a surgical challenge. The Frozen Elephant Technique (FET) with a hybrid device potentially allows for a ‘single stage’ operation.
The Thoraflex™ Hybrid device consists of a conventional proximal 4-branched arch graft with a self-expanding stent graft at the distal end. A sewing collar between the two sections simplifies the “distal” anastomosis. The proximal unstented and the distal stented parts are available in different diameters.
The patient presented for ‘live in a box’ surgery had a mega-aortic syndrome with an 8 cm ascending aorta, a 5 cm aortic arch and a 4 cm descending aorta at the ‘landing zone’. In addition, she also had a severe aortic valve insufficiency due to aortic root dilatation.
We decided to perform an aortic valve sparing ‘David’ procedure along with the replacement of the ascending and total arch and implantation of a stented graft in the descending aorta.
During the time the patient was cooled to a nasopharyngeal temperature of 26°C, the ‘David’ procedure was performed. After de-airing the heart, myocardial re-perfusion was started via a side arm at a rate of 100-250 ml//min under approximately70 mm Hg pressure and the aortic arch replaced under ‘Beating Heart’.
"This Hannover technique of ‘Beating Heart’ aortic arch surgery reduces the myocardial ischaemia time and the Thoraflex™ Hybrid simplifies the operation."
The systemic circulation (except the heart) was arrested and the aorta opened. With the patient in Trendelenburg position, catheters were introduced into the left carotid artery and the innominate artery for antegrade cerebral perfusion. The left subclavian artery was clamped, avoiding a steal phenomenon as well as to prevent blood flowing into the operative field.
Cerebral perfusion was performed at a rate of 10 ml/kg/min with cold blood (24°C). The aorta was transected between the left common carotid artery and the left subclavian artery. The ‘Frozen Elephant Trunk’ i.e. stented part of the device was deployed through the opened aortic arch in the descending aorta. A sewing collar between the graft segments simplified the ‘distal’ anastomosis. The perfusion to the lower part of the body was restarted via the 4th branch of the graft section.
The proximal end of the graft was then anastomosed to the ascending aortic graft and the perfusion clamps were removed so that the myocardium was directly perfused. ‘Re-warming‘ of the patient was initiated. In this way the myocardial ischemia and rewarming time and consequently the total operation time was reduced to a minimum.
The left subclavian artery was anastomosed to the third branch of the arch graft. The 1st and the 2nd branch of the polyester graft were anastomosed to the innominate and the left carotid artery, respectively. By this time the patient was already at 37°C. The patient was then ‘weaned’ from Cardiopulmonary Bypass (CPB).
CO2 insufflations were done in the operative field to reduce the risks of air-embolism,
The Thoraflex™ Hybrid device adds to the “Frozen Elephant Trunk” concept and increases the armament of the surgeon in the treatment of complex and diverse aortic arch pathology.