CLINICAL INSIGHTS - EPIC™ MITRAL STENTED TISSUE VALVE WITH LINX™ AC TECHNOLOGY

Reported 15-Year Data: The Epic™ Mitral and the Magna Mitral Ease‡ Platforms1,2



Epic Mitral valve delivers excellent durability for patients of different age groups in long-term study. 




Discussion

The review examines the longest-published durability data for Biocor™ and Perimount ‡ mitral valves, with initial implants dating back to the early 1980s. Notably, studies by Mykén et al. (2009) and Bourguignon et al. (2014) offer reliable data up to 15 years, capturing over 10% of the original patient cohort for follow-up. Given that Biocor and Perimount are predecessors to the Epic™ Mitral and Magna Mitral Ease‡ valves, respectively, these studies provide crucial insights into the anticipated durability and performance of the latest generation devices.

Mykén and team found excellent actuarial freedom from reoperation due to structural valve deterioration (SVD) after 15 years for Biocor valves, with 79.3% overall freedom and 75.2% for patients aged 65 and under. In contrast, Bourguignon et al.'s study on Perimount valves showed lower durability, though not directly comparable. There were significant differences in overall freedom from reoperation due to SVD, especially in patients under 65. As bioprostheses are increasingly used in younger patients, the avoidance of lifelong anticoagulation therapy is crucial, making long-term performance in this demographic highly important.

When assessing hemodynamic performance in different devices, it's crucial to consider the actual dimensions of the valve, which may differ from the labeled size. For the Epic™ Mitral, the tissue annulus diameter aligns with the product and sizer set, while the Magna Mitral Ease‡ uses the valve stent diameter. Notably, the Perimount Magna Mitral Ease's labeled size "25" requires 28 mm of annular clearance. Proper sizing is essential for optimizing hemodynamics and reducing patient-prosthesis mismatch. Epic Mitral stands out with excellent hemodynamic profiles across all sizes, proving particularly beneficial for smaller patients.


THE IMPORTANCE OF LEAFLET BEHAVIOR 

The Epic Mitral valve differs as its porcine leaflets do not stand tall, creating a more open neo-left ventricular outflow tract (LVOT) area without forming a "curtain" between stent posts. In contrast, Bapat et al. noted that pericardial leaflets in other valves, which did not crumple during bench testing, might have the potential to increase LVOT obstruction in patients undergoing mitral valve replacement (MVR).


MAKING THE BEST CHOICE FOR EACH PATIENT

In the selection of replacement valves for mitral valve replacement (MVR), several factors are important, including proper sizing, long-term durability, and excellent hemodynamics. The data from Mykén and colleagues confirms the long-term durability of the Epic Mitral platform, emphasizing its suitability in MVR cases.

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