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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aortic Aneurysm, Aortic Dissection, Endocarditis, Root Abscess, Valve Heart Disease

Intervention / Treatment
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* Procedure: Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemiarch<br>Patients with Freestyle aortic root implantation receiving a hemiarch replacement by open anastomosis technique with axillary cannulation and antegrade cerebral perfusion | Procedure: Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacement<br>* 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<br>|
| Non-Hemiarch<br>Patients with Freestyle aortic root implantation without hemiarch replacement with normal systemic perfusion | Procedure: Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacement<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemiarch replacement, cardiopulmonary bypass, cannulation technique, selective cerebral perfusion