Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral transcatheter aortic valve implantation: Difference of valve selection in the real world.
The SAPIEN 3 (S3; Edwards Lifescience, Irvine, CA, USA) is a new-generation percutaneous aortic valve with better profile, more precise handling and positioning, designed to reduce the risk of post-procedural paravalvular aortic leak (PVL). The aim of this study was to compare the S3 valve and SAPIEN XT valve (SXT).



The last 89 transfemoral transcatheter aortic valve implantation (TAVI) cases using SXT were compared to the first 111 cases using the S3.



Patient age and logistic EuroSCORE were similar (83.1 years vs 83.0 years and 18.2% vs 16.6%) in the S3 and SXT groups, respectively as were other baseline characteristics. The ratio of valve diameter/calculated annulus average diameter (CAAD) by multi-detector row computed tomography was significantly lower in the S3 group (1.06 vs 1.09, p<0.001) as was the annular area oversizing percentage (11.3% vs 20.5%, p<0.001). Furthermore, a smaller valve was selected in S3 cases with borderline CAAD compared to SXT cases. Nevertheless, the frequency of paravalvular aortic leakage (PVL) ≥2 tended to be reduced in the S3 group (5% vs 9%, p=0.339). The rate of major vascular complications was significantly lower with S3 (3% vs 12%, p=0.013). In addition, 30-day mortality was significantly lower in the S3 group (0% vs 5%, p=0.044).



Although TAVI using S3 tended to be carried out with a less oversized valve compared to TAVI using SXT, the frequency of post-procedural PVL ≥2 tended to be lower in the S3 group. The outcomes including vascular complications and 30-day mortality showed a trend in favor of the S3 group.
Générale de Santé, Hopital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France.
Takahide
T
Arai
Générale de Santé, Hopital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France. Electronic address: t.lefevre@angio-icps.com.
Thierry
T
Lefèvre
Générale de Santé, Hopital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France.
Thomas
T
Hovasse
Générale de Santé, Hopital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France.
Marie-Claude
MC
Morice
Générale de Santé, Hopital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France.
Philippe
P
Garot
Générale de Santé, Hopital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France.
Hakim
H
Benamer
Générale de Santé, Hopital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France.
Thierry
T
Unterseeh
Générale de Santé, Hopital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France; Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Kentaro
K
Hayashida
Générale de Santé, Hopital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France; Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan.
Yusuke
Y
Watanabe
Générale de Santé, Hopital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France.
Erik
E
Bouvier
Générale de Santé, Hopital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France.
Bertrand
B
Cormier
Générale de Santé, Hopital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France.
Bernard
B
Chevalier
D000368:Aged; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D006801:Humans; D008297:Male; D011183:Postoperative Complications; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012307:Risk Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects; D016896:Treatment Outcome
SAPIEN 3; SAPIEN XT; Severe symptomatic aortic stenosis; Transcatheter aortic valve implantation