Presently, only a few studies with sufficient patient numbers have been conducted to compare surgical techniques and outcomes. While the literature is replete with observational studies, demographic and technique heterogeneities between institutions preclude robust examination of critical variables and endpoints.
To overcome these limitations, and to provide convincing evidence for different surgical techniques, a multicenter database for operations involving the aortic arch is required to better compare overall survival outcomes. The collaborative pooling of data will generate hypotheses, identify prognostic factors, assess optimal operative strategies, and aid in the formulation of evidence-based surgical guidelines. Furthermore, this will enable an evaluation of the influence that cerebral perfusion strategy, temperature, and the location of cannulation has on patient outcomes such as mortality and neurological dysfunction.
Institutions that have published series between 2000-2013 with more than 100 aortic arch operations have been contacted and invited to submit their prospectively collected data. Expert advice was sought from the Research Steering Committee regarding recruitment of other centers.
To view the list of participating centres, click here.
Patients and Methods
Ethics approval is obtained from participating institutions through their institutional review boards or through the chairperson of the ethics committee, who will waive the need for patient consent for the study as individual patients will not be identified. The study population is defined as patients who were considered for hemi-arch or total arch replacement surgery between 2000 and 2013 from the participating international institutions. The inclusion criteria are aortic arch pathologies (elective or emergent) and treatment strategies that utilized hemi-arch replacement, total arch replacement or an endovascular approach. Pediatric patients will be excluded. Standardized clinical data on consecutive patients from each of the participating institutions will be entered into a central database. Follow-up data from most recent reviews will also be included. Each institution must confirm that the pooled data represent consecutive operative procedures performed in the study period by participating surgeons.