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NCT Number: NCT04068337

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Triemli Hospital

Zurich, 8063, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. In-hospital mortality

    Time frame: 30 days after initial operation

    In-hospital mortality

  2. Major and minor in-hospital complications

    Time frame: 30 days after initial operation

    stroke, myocardial infarction, re-operation, pacemaker implantation

  3. Valve performance

    Time frame: earliest to longest follow up (longest follow up period of 10 years)

    Mean valve gradient of the implanted root prosthesis

Sponsors and collaborators

Lead sponsor

Triemli Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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