NCT04068337

Freestyle Prosthesis for Aortic Root-replacement With and Without Hemiarch Replacement

Completed Last updated 28 August 2019

What this trial tests

trial testing Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacement in Aortic Aneurysm in 278 participants. Completed in 1 August 2019.

Timeline

1 August 2018

Primary endpoint
1 March 2019

1 August 2019

Quick facts

Lead sponsor	Triemli Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	278
Start date	1 August 2018
Primary completion	1 March 2019
Estimated completion	1 August 2019
Sites	1 location across Switzerland

Drugs / interventions tested

• Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacement

Conditions studied

• Aortic Aneurysm — all drugs for Aortic Aneurysm →
• Aortic Dissection — all drugs for Aortic Dissection →
• Endocarditis — all drugs for Endocarditis →
• Root Abscess — all drugs for Root Abscess →

Sponsor

Triemli Hospital

Who can join

18 and older, any sex, with Aortic Aneurysm or Aortic Dissection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Freestyle® prosthesis (Medtronic plc, Dublin, Ireland) is a biological, porcine aortic root implanted in various combinations and techniques since the 1990s. The main indication for the choice of this prosthesis is a combined pathology with degenerated aortic valve and additional dilatation of the root often involving the ascending aorta.

The Freestyle® prosthesis is also used in cases of dissection of the ascending aorta with the involvement of the aortic valve, which opens the debate on how far the ascending aorta should be replaced for a sustainable solution with calculable low periprocedural risk. Considering a lower intraoperative risk in the life-threatening situation, an extended resection of the aorta can be avoided and only the aortic root replaced with a piece of ascending aorta. On the contrary, focusing on improved long-term outcome, the technique of total arch replacement in aortic dissection was developed in emergency situations with acceptable results, which, however, were often reproducible only in large, experienced centers.

Apart from the abovementioned options, the technique of proximal arch replacement can provide a tension-free anastomosis. The intention of hemiarch replacement is the attachment of the prosthesis to an aneurysm-free portion of the aortic arch helping to protect against further anastomotic aneurysms and spare the patient complex reoperation or interventional procedures in the future. As a possible drawback of the technique, especially in emergency situations, the potentially prolonged duration of surgery and the need of selective brain perfusion via axillary or carotid artery are discussed increasing the risk of stroke and further major events, which could not be reflected in current literature. However, there is still no convincing evidence of a long-term benefit in terms of re-operation and survival after hemiarch replacement.

The aim of this retrospective analysis was to assess the mid-term outcome of the biological Freestyle® prosthesis in combination with operations on the ascending aorta and the aortic arch with regard to prosthetic performance, reoperations, stroke and death.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Freestyle aortic root prosthesis in combination with aortic replacement and open anastomosis: a retrospective analysis.
   Zientara A, Rosselet-Droux K, Bruijnen H, Odavic D, et al · · 2021 · PMID 34174918 · DOI 10.1186/s13019-021-01562-3