• Hanna Sofia Holmgren Dagnegård, Per Ejlstrup Sigvardsen, Nikolaj Ihlemann, Klaus Fuglsang Kofoed, Ismail El-Hamamsy, Kirstine Bekke, Jan Brink Valentin, Laurence Lefebvre, Søren Paaske Johnsen, Lars Søndergaard, Jens Teglgaard Lund, and Morten Holdgaard Smerup.
• Department of Cardiothoracic Surgery, The Heart Center, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark; Department of Cardiology, The Heart Center, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark. Electronic address: hanna.dagnegaard@regionh.dk.
• J. Thorac. Cardiovasc. Surg. 2023 Apr 1; 165 (4): 12851297.e61285-1297.e6.

ObjectiveIn complex and high-risk aortic root disease, the porcine Freestyle stentless bioprosthesis (Medtronic Inc, Minneapolis, Minn) is an important surgical treatment option. We aimed to determine prevalence and clinical effect of structural and functional abnormalities after full-root Freestyle implantation.MethodsOur cross-sectional 2-center study combined with clinical follow-up included 253 patients with full-root Freestyle bioprostheses implanted from 1999 to 2017. Patients underwent transthoracic echocardiography (TTE) and contrast-enhanced, electrocardiogram-gated 4-dimensional cardiac computed tomography (4DCT) at median age 70 (interquartile range, 62-75) years. After 4DCT, clinical follow-up continued throughout 2018. Median follow-up was 3.3 years before 4DCT and 1.4 years after.ResultsWe identified abnormalities in 46% of patients, including pseudoaneurysms (n = 32; 13%), moderate or severe coronary ostial stenosis (n = 54; 21%), and moderate-severe leaflet thickening or reduced leaflet motion (n = 51; 20%). TTE only identified 1 patient with pseudoaneurysm. After 4DCT, the unadjusted hazard ratio for surgical reintervention among patients with abnormal 4DCT was 4.2 (95% confidence interval, 1.2-15.3), in all, 10% required a reintervention. 4DCT abnormalities were associated with a statistically nonsignificant increased risk of death, stroke, or myocardial infarction (hazard ratio obtained using Cox proportional hazards regression analysis, 2.4; 95% confidence interval, 0.7-7.6). In all, 4.0% died, 3.6% had a myocardial infarction, and 2.0% had a stroke.ConclusionsStructural and functional abnormalities of the aortic root are frequent after Freestyle implantation and TTE appears to be insufficient for follow-up. Abnormalities might be associated with increased risk of reintervention and potentially adverse clinical outcomes. Longer follow-up and larger study populations are needed to further clarify the clinical implications of abnormalities identified with 4DCT.Copyright © 2021 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

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