Clinical trial NCT04068337: Freestyle Prosthesis for Aortic Root-replacement With and Without Hemiarch Replacement
Official title: Freestyle Prosthesis for Aortic Root-replacement With and Without Hemiarch Replacement in Various Pathologies: A Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm
Aortic Dissection
Endocarditis
Root Abscess
Valve Heart Disease
Keywords: hemiarch replacement
cardiopulmonary bypass
cannulation technique
selective cerebral perfusion
Lead sponsor: Triemli Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From September 2007 till March 2017, we performed 278 aortic root replacements with the Freestyle prosthesis at a single centre in Switzerland. Two groups were identified based on the additional replacement of the hemiarch resulting in 119 patients (HA) and 159 patients without an additional hemiarch replacement (non-HA). Patients with additional valve and coronary artery procedures were included as well. Out of the non-HA group, 7 patients were cannulated through the femoral artery and excluded for further analysis.

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.


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

Primary outcomes:
measure: In-hospital mortality
timeFrame: 30 days after initial operation
measure: Major and minor in-hospital complications
timeFrame: 30 days after initial operation
measure: Valve performance
timeFrame: earliest to longest follow up (longest follow up period of 10 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Triemli Hospital
Study officials:
affiliation: Triemli Hospital
name: Alicja Zientara, MD
role: PRINCIPAL_INVESTIGATOR
References: