Page 8 - Journal of Structural Heart Disease Volume 1, Issue 3

Original Scientific Article
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functions like a parachute by bulging outward [13]. The Edwards Commander transfemoral delivery sys- tem (Edwards Lifesciences, Irvine, CA, USA) has low- er profile and higher flexibility compared to the cur- rently used NovaFlex system (Edwards Lifesciences, Irvine, CA, USA). It contains a fine adjustment wheel that permits a precise positioning of the crimped valve in the aortic annulus without unnecessary pushing or pulling. A central radiopaque marker in the balloon also assists in valve positioning. The sys- tem uses a 14-F expandable eSheath (Edwards Life- sciences, Irvine, CA, USA), that intend to reduce the potential for arterial injury during introduction but can transiently expand to accommodate passage of the compressed valve and then return to its lower profile diameter.
Recently, the 30-day outcomes of 150 patients that underwent S3 valve implantation in Europe and Can- ada were published [14]. A transfemoral approach was chosen in 64.0% and transapical/direct aortic in the remainder. At 30 days, PV-AR was none to mild in 96.4% and moderate in 3.5%. No patient had se- vere regurgitation. Transfemoral implantation was associated with low 30-day mortality (2.1%) and no disabling stroke. Alternative access was associated with higher rates of 30-day mortality (11.6%) and stroke (5.6%). This device is available in 20-, 23-, 26-, and 29-mm sizes and is expected to facilitate fully percutaneous implantation in a broader range of pa- tients with the potential for more accurate position- ing and less PV-AR. The initial 30-day outcomes of the PARTNER II S3 Trial (n=1,659) have demonstrated 30- day mortality rate of 2.2% for the overall high-risk co- hort and 1.1% for the intermediate-risk cohort. Mod- erate or higher PV-AR at 30-days was present in 2.9% of the high-risk patients and 4.2% of the intermedi- ate-risk patients [15]. Since June 2015, Sapien 3 has a U.S. Food and Drug Administration (FDA) approval.
Currently ongoing trials with SAPIEN 3 valve are the PARTNER II trial (Placement of aortic transcatheter valves; ClinicalTrials.gov Identifier: NCT01314313) and the safety and performance study of the Edwards SA- PIEN 3 transcatheter heart valve trial (NCT01808287).
Medtronic CoreValve Evolute / Evolute R
The Evolute (Medtronic, Minneapolis, MN, USA) 23mm valve was the first next-generation CoreValve
Figure 3: The Evolute valve. A self-expandable valve composed of radiopaque nitinol support frame, supra-annular trileaflet por- cine pericardial leaflets, and porcine pericardium fabric skirt. The arrow corresponds to the nadir of the pericardial leaflets.
device (Figure 3). It is indicated for small (18–20 mm) aortic annuli and designed to be fully repositionable, resheathable and recapturable [16]. It has a Confor- mité Européenne (CE) mark for valve-in-valve implan- tations since 2013 and was previously described for this indication in case reports [17, 18].
The newly designed CoreValve Evolute R (Medtronic, Minneapolis, MN, USA) is a low-profile system that retains many of the characteristics of its predecessors: radiopaque self-expanding niti- nol support frame, supra-annular trileaflet porcine pericardial leaflets, and porcine pericardium fabric skirt [19]. The cell geometry and frame of this valve have been redesigned to optimize frame interaction with the native anatomy, to improve conformability to the aortic annulus and reduce PV-AR. The inflow has more consistent radial force across the sizing spectrum, and the outflow has been shortened and reshaped to provide improved alignment between valve housing and the native sinus. The valve leaflets are routinely treated with alpha-amino oleic acid to impede calcium deposition. The new EnVeo R deliv-
Structural Heart Disease, August 2015
Volume 1, Issue 3: 112-126