The balloon-expandable Edwards Sapien 3 valve is superior to the self-expanding Medtronic CoreValve in patients with severe aortic stenosis undergoing transfemoral aortic valve implantation.
BACKGROUND
Residual paravalvular moderate or severe aortic regurgitation (AR) has been an independent risk factor for mortality after transcatheter aortic valve implantation (TAVI). The design of the third generation Edwards Sapien 3 (ES3; Edwards Lifesciences, Irvine, CA, USA) valve was optimized with an outer skirt to address the issue of paravalvular AR.


RESULTS
We compared 100 consecutive patients treated with the ES3 for severe aortic stenosis with 100 patients treated with the Medtronic CoreValve (CV; Medtronic, Minneapolis, MN, USA) (Clinical Trial Registration: NCT02162069). We evaluated post-procedural AR, rate of permanent pacemaker implantation, device success, and 30-day clinical outcome according to the criteria of the Second Valve Academic Research Consortium (VARC-2). Frequency of post-procedural moderate or severe AR was significantly lower with ES3 compared to CV (0% vs. 20%, p<0.01), none or trace AR significantly higher with ES3 (69% vs. 38%, p<0.01) as well as device success (97% vs. 73%, p<0.01). There was a significantly lower need for permanent pacemaker implantation with ES3 compared with CV (14% vs. 31%, p<0.01). Cardiovascular mortality at 30 days was significantly lower with ES3 (0% vs. 6%, p=0.01), and the combined endpoint "early safety" was met significantly less with ES3 (10% vs. 21% with CV, p=0.03).


CONCLUSIONS
Transfemoral TAVI with the ES3 compared with the CV was associated with a significantly lower rate of moderate or severe AR, significantly lower need for pacemaker implantation, and a significantly higher rate of device success according to VARC-2.
Department of Internal Medicine II - Cardiology, University of Ulm, 89081 Ulm, Germany.
Birgid
B
Gonska
Department of Internal Medicine II - Cardiology, University of Ulm, 89081 Ulm, Germany.
Julia
J
Seeger
Department of Internal Medicine II - Cardiology, University of Ulm, 89081 Ulm, Germany.
Justus
J
Baarts
Department of Internal Medicine II - Cardiology, University of Ulm, 89081 Ulm, Germany.
Christoph
C
Rodewald
Department of Internal Medicine II - Cardiology, University of Ulm, 89081 Ulm, Germany.
Dominik
D
Scharnbeck
Department of Internal Medicine II - Cardiology, University of Ulm, 89081 Ulm, Germany.
Wolfgang
W
Rottbauer
Department of Internal Medicine II - Cardiology, University of Ulm, 89081 Ulm, Germany. Electronic address: jochen.woehrle@uniklinik-ulm.de.
Jochen
J
Wöhrle
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000517:prevention & control; D001024:Aortic Valve Stenosis / Q000601:surgery*; D006328:Cardiac Catheterization; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects; D016896:Treatment Outcome
Aortic regurgitation; Edwards Sapien 3; Medtronic CoreValve; Transcatheter aortic valve implantation