Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience

Jochen Wöhrle, Birgid Gonska, Christoph Rodewald, Julia Seeger, Dominik Scharnbeck, Wolfgang Rottbauer, Jochen Wöhrle, Birgid Gonska, Christoph Rodewald, Julia Seeger, Dominik Scharnbeck, Wolfgang Rottbauer

Abstract

Aims: The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications.

Methods and results: 235 patients with severe symptomatic aortic stenosis were prospectively enrolled. Transcatheter aortic valve implantations (TAVI) were performed without general anesthesia by transfemoral approach. Patients were followed for 30 days. Patients received 23mm (N = 77), 26mm (N = 91) or 29mm (N = 67) valve based on pre-procedural 256 multislice computer tomography. Mean oversizing did not differ between the 3 valves. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation and regurgitation index did not differ between groups. There was no switch to general anesthesia or conversion to surgery. Rate of major vascular complication was 3.0% with no difference between valve and delivery sheath sizes. Within 30 days rates of all cause mortality (2.6%) and stroke (2.1%) were low.

Conclusions: In patients with severe aortic stenosis transfemoral TAVI with the Edwards Sapien 3 valve without general anesthesia was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complication, mortality and stroke within 30 days with no difference between the 3 valve sizes.

Trial registration: ClinicalTrials.gov NCT02162069.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. CONSORT flowchart.
Fig 1. CONSORT flowchart.
Fig 2. New generation Edwards Sapien 3…
Fig 2. New generation Edwards Sapien 3 valve with the outer skirt (polyethylene terephthalate) to reduce paravalvular aortic regurgitation.

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