Streamlining the learning process for TAVI: Insight from a comparative analysis of the OCEAN-TAVI and the massy registries.
BACKGROUND
To facilitate the learning process of transcatheter aortic valve implantation (TAVI) in Japan, unique supporting systems (e.g., on-site proctor and web-based screening systems) have been developed. Nevertheless, little is known about real-world clinical outcomes after TAVI in Japan compared with their European counterparts.


METHODS
From the optimized catheter valvular intervention (OCEAN-TAVI, Japan) and the Institut Cardiovasculaire Paris Sud (Massy, France) registries, we evaluated a total of 134 and 178 patients, respectively, who underwent transfemoral TAVI during the same time period.


RESULTS
Among the French cohort, about half of the patients (N = 81, 45.5%) were treated with the Edwards SAPIEN XT. Body surface area was significantly smaller in the Japanese cohort, although operative risks for both cohorts were almost the same. A greater percentage of patients in the Japanese cohort were implanted with 23 mm valves compared with the French cohort (73.1% vs. 23.0%, P < 0.001), reflecting the smaller annulus diameter (21.8 ± 1.6 vs. 23.8 ± 2.4 mm, P < 0.001). All-cause 30-day mortality (0% vs. 0.6%, P = 1.000) and 30-day combined safety endpoint based on the Valve Academic Research Consortium 2 (VARC2) criteria (9.7% vs. 11.2%, P = 0.713) were similar when limiting the analysis to patients treated with the Edwards SAPIEN XT.


CONCLUSIONS
Despite the unfavorable aortic anatomy of the Japanese patients, their clinical outcomes after transfemoral TAVI were excellent with the same degree of safety as in an experienced European institute. This minimized learning process achieved the use of unique support systems.
Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Taku
T
Inohara
Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Kentaro
K
Hayashida
Division of Cardiology, Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.
Yusuke
Y
Watanabe
Division of Cardiovascular Medicine, Toyohashi Heart Center, Toyohashi, Japan.
Masanori
M
Yamamoto
Interventional Cardiology Unit, New Tokyo Hospital, Chiba, Japan.
Kensuke
K
Takagi
Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Fumiaki
F
Yashima
Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.|Department of Interventional Cardiology, Institut Cardiovasculaire Paris Sud, Massy, France.
Takahide
T
Arai
Department of Cardiovascular Surgery, Keio University School of Medicine, Tokyo, Japan.
Hideyuki
H
Shimizu
Department of Interventional Cardiology, Institut Cardiovasculaire Paris Sud, Massy, France.
Bernard
B
Chevalier
Department of Interventional Cardiology, Institut Cardiovasculaire Paris Sud, Massy, France.
Thierry
T
Lefèvre
Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Keiichi
K
Fukuda
Department of Interventional Cardiology, Institut Cardiovasculaire Paris Sud, Massy, France.
Marie-Claude
MC
Morice
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D002983:Clinical Competence; D005260:Female; D005602:France; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000193:education* / Q000295:instrumentation / Q000401:mortality; D006801:Humans; D007564:Japan; D059032:Learning Curve; D008297:Male; D011474:Prosthesis Design; D012042:Registries; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
ethnicity; outcome; transcatheter aortic valve implantation