1. Prospective comparison between three TAVR devices: ACURATE neo vs. CoreValve vs. SAPIEN XT. A single heart team experience in patients with severe aortic stenosis.
- Author
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Jatene T, Castro-Filho A, Meneguz-Moreno RA, Siqueira DA, Abizaid AAC, Ramos AIO, Arrais M, Le Bihan DCS, Barretto RBM, Moreira AC, Sousa AGMR, and Eduardo Sousa J
- Subjects
- Aged, Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis mortality, Aortic Valve Stenosis physiopathology, Brazil, Female, Hemodynamics, Humans, Male, Postoperative Complications etiology, Prospective Studies, Prosthesis Design, Recovery of Function, Registries, Severity of Illness Index, Time Factors, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement mortality, Treatment Outcome, Aortic Valve surgery, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Patient Care Team, Transcatheter Aortic Valve Replacement instrumentation
- Abstract
Objective: We sought to compare the new transcatheter aortic valve replacement (TAVR) device ACURATE neo (ACT) with the already established CoreValve (MCV) and SAPIEN XT (SXT) for the treatment of severe aortic stenosis (AS)., Background: Very few data on TAVR devices are available beyond MCV and SAPIEN and there is no previous study comparing ACT with MCV and SXT., Methods: We prospectively evaluated consecutive patients who underwent transfemoral TAVR for the treatment of severe AS. Clinical outcomes were reported following Valve Academic Research Consortium 2 (VARC-2) criteria., Results: A total of 162 patients (ACT n = 49, MCV n = 56, SXT n = 57), were included. MCV group had higher valve embolization/migration rates (ACT none; MCV 9%; SXT 2%; P = 0.034) causing lower device success rates (ACT 98%; MCV 86%; SXT 95%; P = 0.043). At 30 days, there was no significant difference in all-cause mortality (P = 0.22), cardiovascular mortality (P = 0.20), periprocedural myocardial infarction (P = 0.40), stroke (P = 0.64), major vascular complications (P = 0.48), life-threatening bleeding (P = 0.29), acute kidney injury stage 2/3 (P = 0.69), or VARC-2 composite early safety endpoints (P = 0.21). MCV group had higher rates of new permanent pacemaker implantation (ACT 6%; MCV 25%; SXT 11%; P = 0.013). Follow-up echocardiography showed no significant difference in aortic valve mean pressure gradient (P = 0.73) or moderate/severe aortic regurgitation (P = 0.19) between groups., Conclusions: In a "real world" registry, ACT compared favorably against the well-studied SXT and MCV devices in both safety and efficacy. MCV implantation was associated with lower device success rates and higher rates of new permanent pacemaker implantation. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)
- Published
- 2017
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