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Introduction
Standard surgical management of aortic root aneurysm in Marfan patients is either total root replacement (TRR) or valve-sparing root replacement (VSRR). Current ESC/EACTS guidelines for the management of valvular heart disease state that, whatever the severity of aortic regurgitation (AR), surgery should be considered in patients with Marfan syndrome, with risk factors (family history of dissection, size increase 2 mm/year in repeated examinations) who have aortic root disease with maximal ascending aortic diameter of ≥45 mm (Class IIa, Level C evidence). 1
The placement of a personalised external aortic root support (PEARS), computer designed and manufactured to match the aortic root morphology of the individual patient, was introduced in 2004 as a conservative approach for Marfan patients. The device manufacture and operative method were the result of research and development between 2000 and 2004 when the first operation was performed. 2 The computer aided design (CAD), manufacturing method and surgical technique have all remained consistent without the iterative development which has characterised the evolution of both TRR and VSRR. 3 After proof of principle 4 and prospective evaluation in the first 20 patients, 5 6 the technique has undergone Health Technology Appraisal by the British National Institute for Health and Care Excellence (NICE). 7
The purpose of this analysis is to describe the consecutive cohort of the first 30 patients to have undergone this procedure in two centres, the Royal Brompton Hospital, London, UK and the University of Leuven, Belgium, and who have had at least 1 year of follow-up. In this report, patient characteristics, procedural details and clinical outcomes to date will be presented. Survival and the incidence of aortic valve-related events are compared with a published meta-analysis of 1385 patients who received the current standard surgical treatments (TRR and VSRR) 8 9 to discover whether outcomes following PEARS approach equivalence with those following the existing standard of care.
Methods
PEARS technology employs spatial data from MRI or CT images to create a CAD model from which a replica of the individual aorta is made by rapid prototyping (RP) ( figure 1 ). On this former, a mesh support, customised for the individual patient, is manufactured from a macroporous textile knitted from a medical grade polymer yarn. 4 The surgical method has been...