• Olaf Stanger, Irina Bleuel, Sylvia Reineke, Yara Banz, Gabor Erdoes, Hendrik Tevaearai, Volkhard Göber, Thierry Carrel, and Lars Englberger.
• Clinic for Cardiovascular Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland olaf.stanger@insel.ch.
• Eur J Cardiothorac Surg. 2015 Oct 1; 48 (4): 562-70.

ObjectivesThis study reports a series of pitfalls, premature failures and explantation of the third-generation Freedom SOLO (FS) bovine pericardial stentless valve.MethodsA total of 149 patients underwent aortic valve replacement using the FS. Follow-up was 100% complete with an average observation time of 5.5 ± 2.3 years (maximum 8.7 years) and a total of 825 patient-years. Following intraoperative documentation, all explanted valve prostheses underwent histological examination.ResultsFreedom from structural valve deterioration (SVD) at 5, 6, 7, 8 and 9 years was 92, 88, 80, 70 and 62%, respectively. Fourteen prostheses required explantation due to valve-independent dysfunction (n = 5; i.e. thrombus formation, oversizing, aortic dilatation, endocarditis and suture dehiscence) or valve-dependent failure (acute leaflet tears, n = 4 and severe stenosis, n = 5). Thus, freedom from explantation at 5, 6, 7, 8 and 9 years was 95, 94, 91, 81 and 72%, respectively. An acute vertical tear along the non-coronary/right coronary commissure to the base occurred at a mean of 6.0 years (range 4.3-7.3 years) and affected size 25 and 27 prostheses exclusively. Four FS required explantation after a mean of 7.5 years (range 7.0-8.3 years) due to severe functional stenosis and gross calcification that included the entire aortic root.ConclusionsThe FS stentless valve is safe to implant and shows satisfying mid-term results in our single institution experience. Freedom from SVD and explantation decreased markedly after only 6-7 years, so that patients with FS require close observation and follow-up. Exact sizing, symmetric positioning and observing patient limitations are crucial for optimal outcome.© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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