Document Detail


Pseudoaneurysm Formation After Medtronic Freestyle Porcine Aortic Bioprosthesis Implantation: A Word of Caution.
MedLine Citation:
PMID:  25301369     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: A growing literature describes aneurysmal deterioration after implantation of the stentless porcine aortic Medtronic Freestyle bioprosthesis (MFB; Medtronic Inc, Minneapolis, MN), with some suggesting inadequate tissue fixation with immune response as a cause. However, disjointed reports make the significance of these findings difficult to interpret. We address this concern by aggregating available data.
METHODS: We reviewed institutional data, the Food and Drug Administration's Manufacturer and User Facility Device Experience registry, and the medical literature for mention of aneurysm or pseudoaneurysm after MFB. Case details were aggregated, and the rate of aneurysmal deterioration was estimated. Immunohistopathologic examination of institutional explanted specimens was performed to elucidate a cause.
RESULTS: We found 42 cases of aneurysmal deterioration with adequate detail for analysis; all occurred with full root replacement and valve sizes ranging from 23 to 29 mm. The rate of aneurysmal deterioration considering all data sources was 1.1% (9 of 851; 95% confidence interval, 0.5% to 2.0%) vs 4.7% (4 of 86; 95% confidence interval, 1.3% to 11.5%) at our institution, where yearly surveillance imaging is performed. Rate of aneurysmal deterioration appeared constant until 5 years after the operation; however, events are reported out to 10 years. Consistent with previous reports, histopathology demonstrated an immune cell infiltrate in areas of MFB wall breakdown.
CONCLUSIONS: Aneurysmal deterioration is an increasingly described complication of MFB implantation as a full root, with an incidence as high as 4.7%. Given the observed immune reaction and lack of occurrence in smaller (19-mm and 21-mm) valve sizes, inadequate pressure fixation of larger valves is a potential etiology. Patients with MFB require annual surveillance imaging, and consideration of this complication should factor into preoperative decision making because treatment mandates redo root replacement, which may not be feasible in high-risk patients.
Authors:
Brian R Englum; Elizabeth N Pavlisko; Molly C Mack; Asvin M Ganapathi; Matthew A Schechter; Jennifer M Hanna; G Chad Hughes
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-10-6
Journal Detail:
Title:  The Annals of thoracic surgery     Volume:  -     ISSN:  1552-6259     ISO Abbreviation:  Ann. Thorac. Surg.     Publication Date:  2014 Oct 
Date Detail:
Created Date:  2014-10-10     Completed Date:  -     Revised Date:  2014-10-11    
Medline Journal Info:
Nlm Unique ID:  15030100R     Medline TA:  Ann Thorac Surg     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
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