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

NCT ID: NCT04068337

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 278 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-08-01

Brief Summary

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.

Conditions

Aortic Aneurysm; Aortic Dissection; Endocarditis; Root Abscess; Valve Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Hemiarch

Patients with Freestyle aortic root implantation receiving a hemiarch replacement by open anastomosis technique with axillary cannulation and antegrade cerebral perfusion

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

Intervention Type: PROCEDURE

Aortic root replacement with Freestyle biological prosthesis. Some patients receive additional hemiarch replacement performing an open anastomosis to the aortic arch under antegrade cerebral perfusion through axillary artery. Comparison with patients, who were cannulated and perfused systemically

Non-Hemiarch

Patients with Freestyle aortic root implantation without hemiarch replacement with normal systemic perfusion

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

Intervention Type: PROCEDURE

Aortic root replacement with Freestyle biological prosthesis. Some patients receive additional hemiarch replacement performing an open anastomosis to the aortic arch under antegrade cerebral perfusion through axillary artery. Comparison with patients, who were cannulated and perfused systemically

Interventions

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

Aortic root replacement with Freestyle biological prosthesis. Some patients receive additional hemiarch replacement performing an open anastomosis to the aortic arch under antegrade cerebral perfusion through axillary artery. Comparison with patients, who were cannulated and perfused systemically

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• all patients after implantation of a biological Medtronic Freestyle root prosthesis in the time frame from November 2007 till April 2017
• elective, urgent and emergency operations on ascending aneurysms, aortic dissections, endocarditis and aortic root pathologies
• combination of other procedures (coronary artery bypass grafting, operations on mitral and tricuspid valve, ablations)

Exclusion Criteria

• refused patient consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Triemli Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alicja Zientara

resident for cardiac surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alicja Zientara, MD

Role: PRINCIPAL_INVESTIGATOR

Triemli Hospital

Locations

Triemli Hospital

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

BASEC-Nr. 2018-01227

Identifier Type: -

Identifier Source: org_study_id