• Am J Cardiovasc Dis · Jan 2014

    A prospective, non-randomized comparison of SAPIEN XT and CoreValve implantation in two sequential cohorts of patients with severe aortic stenosis.

    • Albert Markus Kasel, Salvatore Cassese, Thomas Ischinger, Alexander Leber, Diethmar Antoni, Gotthard Riess, Jayshree Vogel, Adnan Kastrati, Walter Eichinger, and Ellen Hoffmann.
    • Klinik für Kardiologie und Intensivmedizin, Klinikum Bogenhausen Munich, Germany ; Deutsches Herzzentrum, Technische Universität Munich, Germany.
    • Am J Cardiovasc Dis. 2014 Jan 1; 4 (2): 87-99.

    ObjectivesFew data is available comparing Edwards SAPIEN XT - SXT (Edwards Lifesciences, Irvine, California) with Medtronic CoreValve - CoV (Medtronic Inc., Minneapolis, Minnesota) in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR).MethodsWe selected consecutive patients undergoing transfemoral TAVR with SXT or CoV at our Institution. Main outcomes were Valve Academic Research Consortium (VARC)-combined safety endpoints.ResultsA total of 100 patients (SXT, n=50 versus CoV, n=50) were analyzed. Both SXT and CoV showed good device success rates (98% versus 90%, p=0.20). SXT versus CoV reduced the occurrence of paravalvular regurgitation after TAVR (26% versus 90%, p<0.0001) though not affecting the rate of moderate/severe regurgitation (p=0.20). SXT versus CoV required less frequently a permanent pacemaker after TAVR (8% versus 38%, p<0.0001). In-hospital major vascular complications (8% versus 4%, p>0.99), life-threatening bleedings (2% versus 4%, p>0.99), stroke (4% versus 6%, p>0.99) and death (6% versus 2%, p>0.99) did not differ between SXT and CoV. However, safety endpoints favored SXT (17% versus 34.6%, p=0.01), due to a numerically higher incidence of ischemic stroke and Acute Kidney Injury Stage 3 after CoV. At multivariate analysis, TAVR with SXT (odds ratio=0.21, 95% confidence intervals [0.05-0.84], p=0.03) was predictive of fewer adverse events.ConclusionsTranscatheter valve implantation with Edwards SAPIEN XT was associated with lower VARC-combined safety endpoints as compared with Medtronic CoreValve. More extensive cohorts are needed to confirm these results.

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