Pitfalls and premature failure of the Freedom SOLO stentless valve.

Stanger, Olaf; Bleuel, Irina; Reineke, Sylvia; Banz Wälti, Yara; Erdös, Gabor; Tevaearai, Hendrik; Göber, Volkhard; Carrel, Thierry; Englberger, Lars (2015). Pitfalls and premature failure of the Freedom SOLO stentless valve. European journal of cardio-thoracic surgery, 48(4), pp. 562-570. Oxford University Press 10.1093/ejcts/ezu473

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OBJECTIVES This study reports a series of pitfalls, premature failures and explantations of the third-generation Freedom SOLO (FS) bovine pericardial stentless valve. METHODS A 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. RESULTS Freedom 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. CONCLUSIONS The 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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic and Policlinic for Anaesthesiology and Pain Therapy
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiovascular Surgery
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Forschungsbereich Mu50 > Forschungsgruppe Herz und Gefässe
09 Interdisciplinary Units > Microscopy Imaging Center MIC

UniBE Contributor:

Stanger, Olaf; Reineke, Sylvia; Banz Wälti, Yara; Erdös, Gabor; Tevaearai, Hendrik; Göber, Volkhard; Carrel, Thierry and Englberger, Lars

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1010-7940

Publisher:

Oxford University Press

Language:

English

Submitter:

Jeannie Wurz

Date Deposited:

17 Feb 2015 08:24

Last Modified:

15 Feb 2019 11:48

Publisher DOI:

10.1093/ejcts/ezu473

PubMed ID:

25543174

Uncontrolled Keywords:

Aortic valve, Bioprosthesis, Cardiac surgery, Stentless

BORIS DOI:

10.7892/boris.63186

URI:

https://boris.unibe.ch/id/eprint/63186

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