Streamlining the learning process for TAVI: Insight from a comparative analysis of the OCEAN-TAVI and the massy registries

Catheter Cardiovasc Interv. 2016 Apr;87(5):963-70. doi: 10.1002/ccd.26266. Epub 2015 Oct 22.


Backgrounds: 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.

Keywords: ethnicity; outcome; transcatheter aortic valve implantation.

Publication types

  • Comparative Study
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / therapy*
  • Aortic Valve* / diagnostic imaging
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation
  • Cardiac Catheterization / mortality
  • Clinical Competence
  • Female
  • France
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / education*
  • Heart Valve Prosthesis Implantation / instrumentation
  • Heart Valve Prosthesis Implantation / mortality
  • Humans
  • Japan
  • Learning Curve*
  • Male
  • Prosthesis Design
  • Registries*
  • Risk Factors
  • Time Factors
  • Treatment Outcome