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

Aortic Aneurysm Clinical Trial

Official title:

Freestyle Prosthesis for Aortic Root-replacement With and Without Hemiarch Replacement in Various Pathologies: A Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068337
• Other study ID #: BASEC-Nr. 2018-01227
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2019
• Source: Triemli Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: August 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm
• Aortic Dissection
• Endocarditis
• Heart Diseases
• Heart Valve Diseases
• Root Abscess
• Valve Heart Disease

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Switzerland	Triemli Hospital	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Triemli Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality	In-hospital mortality	30 days after initial operation
Primary	Major and minor in-hospital complications	stroke, myocardial infarction, re-operation, pacemaker implantation	30 days after initial operation
Primary	Valve performance	Mean valve gradient of the implanted root prosthesis	earliest to longest follow up (longest follow up period of 10 years)