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Pseudoaneurysm formation after medtronic freestyle porcine aortic bioprosthesis implantation: a word of caution.

Publication ,  Journal Article
Englum, BR; Pavlisko, EN; Mack, MC; Ganapathi, AM; Schechter, MA; Hanna, JM; Hughes, GC
Published in: Ann Thorac Surg
December 2014

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.

Duke Scholars

Published In

Ann Thorac Surg

DOI

EISSN

1552-6259

Publication Date

December 2014

Volume

98

Issue

6

Start / End Page

2061 / 2067

Location

Netherlands

Related Subject Headings

  • Young Adult
  • Tomography, X-Ray Computed
  • Swine
  • Respiratory System
  • Prosthesis Failure
  • Prosthesis Design
  • Prospective Studies
  • Postoperative Complications
  • Male
  • Magnetic Resonance Imaging, Cine
 

Citation

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ICMJE
MLA
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Englum, B. R., Pavlisko, E. N., Mack, M. C., Ganapathi, A. M., Schechter, M. A., Hanna, J. M., & Hughes, G. C. (2014). Pseudoaneurysm formation after medtronic freestyle porcine aortic bioprosthesis implantation: a word of caution. Ann Thorac Surg, 98(6), 2061–2067. https://doi.org/10.1016/j.athoracsur.2014.06.062
Englum, Brian R., Elizabeth N. Pavlisko, Molly C. Mack, Asvin M. Ganapathi, Matthew A. Schechter, Jennifer M. Hanna, and G Chad Hughes. “Pseudoaneurysm formation after medtronic freestyle porcine aortic bioprosthesis implantation: a word of caution.Ann Thorac Surg 98, no. 6 (December 2014): 2061–67. https://doi.org/10.1016/j.athoracsur.2014.06.062.
Englum BR, Pavlisko EN, Mack MC, Ganapathi AM, Schechter MA, Hanna JM, et al. Pseudoaneurysm formation after medtronic freestyle porcine aortic bioprosthesis implantation: a word of caution. Ann Thorac Surg. 2014 Dec;98(6):2061–7.
Englum, Brian R., et al. “Pseudoaneurysm formation after medtronic freestyle porcine aortic bioprosthesis implantation: a word of caution.Ann Thorac Surg, vol. 98, no. 6, Dec. 2014, pp. 2061–67. Pubmed, doi:10.1016/j.athoracsur.2014.06.062.
Englum BR, Pavlisko EN, Mack MC, Ganapathi AM, Schechter MA, Hanna JM, Hughes GC. Pseudoaneurysm formation after medtronic freestyle porcine aortic bioprosthesis implantation: a word of caution. Ann Thorac Surg. 2014 Dec;98(6):2061–2067.
Journal cover image

Published In

Ann Thorac Surg

DOI

EISSN

1552-6259

Publication Date

December 2014

Volume

98

Issue

6

Start / End Page

2061 / 2067

Location

Netherlands

Related Subject Headings

  • Young Adult
  • Tomography, X-Ray Computed
  • Swine
  • Respiratory System
  • Prosthesis Failure
  • Prosthesis Design
  • Prospective Studies
  • Postoperative Complications
  • Male
  • Magnetic Resonance Imaging, Cine