Epic™ Mitral Valve and Epic Supra Aortic Valve

Surgical Valve Treatment
for Mitral and Aortic
Valve Disease

The Epic™ 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™ 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.

Considerations When Choosing a Device for Mitral Valve Replacement1

  • Valve durability 
  • The valve’s expected hemodynamic performance

CONSIDERATIONS WHEN SELECTING BIOPROSTHESTIC VALVE CANDIDATES

A bioprosthetic mitral or aortic valve may be a recommended option for patients under the following treatment guidelines1:

  • 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 50-70 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
  • Chronic, severe mitral regurgitation (MR) patients undergoing cardiac surgery for other indications1
  • Symptomatic patients with chronic, severe MR and left ventricular ejection fraction (LVEF) > 30%2
  • Asymptomatic patients with chronic, severe MR and LV dysfunction (LVESD ≥ 45 mm and/or LVEF ≤ 60%)
  • Advanced endocarditis3

 

 

 

 

Aortic valve replacement
  • Severe aortic stenosis (AS) patients undergoing coronary bypass or surgery of the ascending aorta or of another valve2
  • Symptomatic patients with severe, high-gradient AS (mean gradient ≥ 40 mm Hg or peak velocity ≥ 4.0 m/s) and low surgical risk2
  • Symptomatic patients with severe low-flow, low-gradient (< 40 mm Hg) AS with reduced ejection fraction and evidence of flow (contractile) reserve excluding pseudosevere AS and low surgical risk2
  • Asymptomatic patients with severe AS and systolic LV dysfunction (LVEF < 50%) not due to another cause and low surgical risk2

 

MAT-2006197 v1.0

References
  1. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2017;135(25):e1159-e1195. 
  2. Baumgartner H, Falk V, Bax JJ et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease: The Task Force for the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2017;38(21):2739-2791.
  3. Mick SL, Keshavamurthy S,  and Gillinov AM. Mitral valve repair vs replacement for the management of valvular heart disease. Eur Heart J. 2017;38:2739-2791.

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