The New Edwards Sapien 3 Balloon Expandable Transcatheter Aortic Valve
Thorsten N. Drews, Axel Unbehaun, Semih Buz, Stephan Dreysse, Christoph Klein, Volkmar Falk, Jörg Kempfert.
Deutsches Herzzentrum Berlin, Berlin, Germany.
OBJECTIVE: Transcatheter aortic valves (TAVIs) have undergone several product changes during the past years. The new Edwards Sapien 3 transcatheter heart valve has the addition of an outer skirt designed to minimize the risk of paravalvular leakage.
METHODS: Between 04/2008 and 12/2014, 939 consecutive patients underwent implantation of Edwards Sapien valves. Group A consisted of 424 patients with the first generation of Edwards Sapien valve, group B of 445 with the Edwards Sapien XT (second generation) and group C of 70 with the Edwards Sapien 3 (current generation). The three groups did not differ in gender, age or perioperative risk scores: group A, B and C: EuroScore I: 39% (range: 4-97), 31% (range: 2-96), 33% (range: 4-88); EuroScore II:, 17% (range: 1-95), 16% (range: 1-99), 16% (range: 2-76); STS PROM Score: 16% (range: 1-89%), 11% (range: 1-76), 11% (range: 1-63), respectively.
RESULTS: Technical success rate was 99% in groups A and B and 100% in group C. The transvalvular gradient [mean in group A, B and C: 4.6±2.4 mmHg, 4.1±2.4 mmHg, 4.8±3.2 mmHg, respectively] and the indexed effective orifice area [IEOA in group A, B and C: 1.15±0.2, 1.15±0.3, 1.1±0.3] did not differ between the three groups. The increase in the rate of pacemaker implantation was without statistical significance [group A: 6.6% (28/424), group B: 5.8% (26/445), group C: 10% (7/70)]. Although regurgitation was already low in groups A and B, it was significantly reduced with introduction of the new valve [paravalvular leakage in group A, B and C: absent or trace: 84% (357/424), 83% (369/445), 97% (68/70), mild: 15% (64/424), 16% (73/445), 3% (2/70), moderate: 1% (3/424), 1% (3/445), 0% (0/70)]. Central leakage was not observed in group C. Additionally, the rate of re-dilatation of the valve was significantly lower in group C (3%) than in A and B (5 and 10 %) and no patient in group C needed implantation of a second valve [group A and B: 3.7% and 1%].
CONCLUSIONS: Although the rate of pacemaker implantation seems to have increased slightly, the Edwards Sapien 3 valve has made paravalvular leakage a rarity.
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