VALVE SOLUTIONSEPIC™ PLUS MITRAL AND AORTIC STENTED TISSUE VALVES
The latest generation of the Epic™ Platform continues the Epic product family’s history of excellence. The future-forward design of the Epic Plus mitral and aortic valves gives you and your patients more choices when it comes to preserving long-term treatment paths.
SURGICAL VALVE TREATMENT FOR MITRAL AORTIC VALVE DISEASE
The Epic™ Plus Mitral stented tissue valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native mitral heart valve. It may also be used to replace a previously implanted prosthetic mitral valve.
The Epic™ Plus Supra stented tissue valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used to replace a previously implanted prosthetic aortic valve.
While mitral valve repair is typically the treatment of choice to treat mitral valve dysfunction, it is not always feasible.
A bioprosthetic mitral or aortic valve may be a recommended option for patients under the following AHA/ACC treatment guidelines7:
- Patients with a contraindication for anticoagulation therapy or an anticipated nonadherence or inability to regulate vitamin K antagonists
- Patients over 70 years of age
- For patients 50-65 years of age, there is no clear consensus on choosing a mechanical vs a tissue valve; newer-generation tissue prostheses may show greater freedom from structural deterioration, often for older patients
Mitral valve replacement
When repair is not feasible
- Symptomatic patients with severe primary MR (Stage D)7
- Asymptomatic patients with severe primary MR and LV systolic dysfunction (LVEF ≤60%, LVESD ≥40 mm) (Stage C2)7
- Advanced endocarditis9
Aortic valve replacement
- Symptomatic adults with severe, high-gradient AS (Stage D1)7
- Asymptomatic patients with severe AS (Stage C) and either an LVEF <50% or who are undergoing cardiac surgery for other indications7
- Symptomatic patients with low-flow, low-gradient severe AS with reduced LVEF (Stage D2)7
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- Guler N, Ozkara C, Akyol A. Left ventricular outflow tract obstruction after bioprosthetic mitral valve replacement with posterior mitral leaflet preservation. Tex Heart Inst J. 2006;33(3):399-401.
- Epic Plus Instructions for Use.
- Allen KB, Adnan CK, Cohen DJ, et al. Bioprosthetic valve fracture to facilitate transcatheter valve-in-valve implantation. Ann Thorac Surg. 2017;104:1501-1508.
- Edelmann JJ, Khan JM, Rogers T, et al. Valve-in-valve TAVR: state-of-the-art review. Innovations. 2019;14(4):299-310.
- Jawad, Khalil, Sven Lehmann, Alex Koziarz, Maja Dieterlen, Stefan Feder, Martin Misfeld, Jens Garbade, Vivek Rao, and Michael Borger. "Midterm results after St Jude Medical Epic porcine xenograft for aortic, mitral, and double valve replacement." Journal of Cardiac Surgery 35, no. 8 (2020): 1769-1777.
- Adams DH, Rosenhek R, and Falk V. Degenerative mitral valve regurgitation: best practice revolution. Eur Heart J. 2010;31(16):1958-1967. doi:10.1093/eurheartj/ehq222.
- Otto, Catherine M., Rick A. Nishimura, Robert O. Bonow, Blase A. Carabello, John P. Erwin III, Federico Gentile, Hani Jneid et al. "2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines." Journal of the American College of Cardiology 77, no. 4 (2021): 450-500.
- Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2014;129(23):2240-2492.
- Mick SL, Keshavamurthy S, Gillinov AM. Mitral valve repair vs replacement for the management of valvular heart disease. Eur Heart J. 2017;38:2739-2791.
- Tests performed by and data on file at Abbott.
- Magna Mitral Ease Instructions for Use.
- Medtronic Mosaic Bioprosthesis Aortic and Mitral Brochure. #UC200103933b EN.
- Vyavahare, N, Hirsch, D, Lerner, E, et al. Prevention of bioprosthetic heart valve calcification by ethanol preincubation. Circulation. 1997:95;479-488. doi.org/10.1161/01.CIR.95.2.479.
- Kelly SJ, Ogle MF, Carlyle WC, et al. Biocompatibility and calcification of bioprosthetic heart valves. Presented at: Society for Biomaterials, Sixth World Biomaterials Congress Transaction. May 2000:1353.
- Frater RWM, Seifter E, Liao K, et al. Chapter 8. In: Gabbay, S, Wheatley DJ, eds. Advances in Anticalcific and Antidegenerative Treatment of Heart Valve Bioprostheses. 1st ed. Silent Partners, Inc; 1997:105-113.
- Vyavahare NR, Hirsch D, Lerner E, et al. Prevention of calcification of glutaraldehyde-crosslinked porcine aortic cusps by ethanol preincubation: mechanistic studies of protein structure and water-biomaterial relationships. J Biomed Mater Res. 1998;40:577-585. doi.org/10.1177/1556984519858020.