Efficacy and safety of transcatheter aortic valve implantation with Edwards SAPIEN 3 and XT in smaller Asian anatomy

• Published in: Cardiovascular intervention and therapeutics Vol. 33; no. 4; pp. 384 - 390
• Main Authors: Nakashima, Makoto, Watanabe, Yusuke, Hioki, Hirofumi, Nara, Yugo, Nagura, Fukuko, Hosogoe, Naoyoshi, Kawashima, Hideyuki, Kataoka, Akihisa, Otsuki, Shuji, Konno, Kumiko, Kyono, Hiroyuki, Yokoyama, Naoyuki, Kozuma, Ken
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01.10.2018
• Subjects: Aged, 80 and over; Aortic Valve - surgery; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - surgery; Asian Continental Ancestry Group; Cardiology; Female; Heart Valve Prosthesis - adverse effects; Hospital Mortality; Humans; Interventional Radiology; Male; Medicine; Medicine & Public Health; Original Article; Prospective Studies; Prosthesis Design - adverse effects; Prosthesis Design - methods; Transcatheter Aortic Valve Replacement - adverse effects; Transcatheter Aortic Valve Replacement - instrumentation; Transcatheter Aortic Valve Replacement - methods; Treatment Outcome; Transcatheter aortic valve implantation; Prosthesis–patient mismatch; SAPIEN 3; SAPIEN XT; Smaller anatomy, paravalvular leaks
• ISSN: 1868-4300; 1868-4297
• DOI: 10.1007/s12928-017-0502-9

We aimed to compare the efficacy and safety of transcatheter aortic valve implantation (TAVI) using Edwards SAPIEN 3 (S3) valve and SAPIEN XT) in smaller anatomy. The new generation S3 TAVI device has been used worldwide; however, its efficacy and safety in smaller Asian anatomy remain unknown. Between February 2014 and March 2017, 166 consecutive patients (S3, 54; XT, 112) were treated with balloon-expandable TAVI in a single center and their outcomes were analyzed. Median patient age was 85 (range: 81–88) years and mean body surface area was 1.41 ± 0.15 m 2 . A 23-mm size valve was used in S3 and XT groups (70 vs. 62%, p  = 0.224). The transfemoral approach was more frequently used in the S3 than in the XT group (96 vs. 72%, p  < 0.001). Although, the minimal luminal diameter of the femoral artery was smaller in the S3 group (5.9 vs. 6.4 mm, p  = 0.001), the rates of major (2 vs. 11%, p  = 0.226) and minor (11 vs. 5%, p  = 0.107) vascular complications did not increase. The frequency of paravalvular leaks (PVL) ≥ 2 was significantly reduced in the S3 group (11 vs. 61%, p  < 0.001); however, pre- (24 vs. 91%, p  < 0.001) and post- (4 vs. 19%, p  < 0.001) dilatations were less frequently performed. Pacemaker implantation incidence did not increase (4 vs. 5%, p  = 1.0) and peak velocity of the transcatheter heart valve was significantly higher in the S3 group (2.3 vs. 2.2 m/s, p  = 0.046). Device success was high (89 vs. 93%, p  = 0.387) while the 30-day all-cause mortality was low (2 vs. 1%, p  = 0.583) in both groups. TAVI with the S3 device was safe and effective, with low incidence of vascular complications and reduced PVL, in smaller body-sized Asians.