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A proctoring system to manage the learning curve associated with the introduction of transcatheter aortic valve implantation in Japan

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Abstract

As transcatheter aortic valve implantation (TAVI) requires multidisciplinary collaboration, operators and the entire heart team must overcome a steep learning curve. A web-based screening and traditional on-site proctoring system were developed for the introduction of TAVI in Japan. To assess the learning curve involved with the introduction of TAVI under the supervision of a novel proctoring system. We divided 749 consecutive patients enrolled in the OCEAN-TAVI study between October 2013 and August 2015 into the trans-femoral (TF, n = 608) and transapical (TA, n = 141) approach groups to compare outcomes in patients who underwent TAVI during the early proctoring period (proctoring group) and after the procedures began to be performed independently (independent group). The primary endpoint was the rate of composite events regarding early safety (at 30 days) according to the valve academic research consortium-2 criteria. For TF-TAVI, the logistic EuroSCORE and the rate of peripheral artery disease were significantly lower during the independent period. The rate of device success significantly increased during the independent period (90.5 vs. 81.8%, p = 0.005). The rate of the primary endpoint was significantly reduced during the independent period compared to that during the proctoring period for TA-TAVI (21.3 vs. 37.9%, p = 0.031); however, no difference was observed for TF-TAVI (16.8 vs. 13.1%, p = 0.283). No deaths occurred within 30 days during the proctoring period for TF-TAVI. After adjustment using propensity score matching, the procedure time for TF-TAVI (88 ± 43 vs. 102 ± 36 min, p = 0.004) and the rate of life-threatening bleeding for TA-TAVI (3.6 vs. 25%, p = 0.026) reduced during the independent period compared to the values during the proctoring period. During the introduction of TAVI under the supervision of a new proctoring system in Japan, clinical outcomes and technical aspects improved significantly. There are differences in the steepness of the learning curve between TF-TAVI and TA-TAVI.

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Authors and Affiliations

  1. Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, 230-8765, Japan

    Masahiro Yamawaki, Motoharu Araki & Yoshiaki Ito

  2. Tokyo Women’s Medical University/Waseda University Joint Institution for Advanced Biomedical Science, Tokyo, Japan

    Masahiro Yamawaki & Kiyotaka Iwasaki

  3. Department of Cardiovascular Surgery, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan

    Tsutomu Ito

  4. Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan

    Norio Tada

  5. Department of Cardiology, New Tokyo Hospital, Chiba, Japan

    Kensuke Takagi

  6. Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan

    Futoshi Yamanaka

  7. Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan

    Yusuke Watanabe

  8. Department of Cardiology, Toyohashi Heart Center, Toyohashi, Japan

    Masanori Yamamoto

  9. Department of Cardiology, Nagoya Heart Center, Nagoya, Japan

    Masanori Yamamoto

  10. Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan

    Shinichi Shirai

  11. Department of Cardiology, Keio University School of Medicine, Tokyo, Japan

    Kentaro Hayashida

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  1. Masahiro Yamawaki
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  2. Kiyotaka Iwasaki
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  9. Yusuke Watanabe
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  10. Masanori Yamamoto
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  11. Shinichi Shirai
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  12. Kentaro Hayashida
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On behalf of the OCEAN-TAVI Registry

Corresponding author

Correspondence to Masahiro Yamawaki.

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Funding

This research was financially supported by Edwards Lifesciences and Medtronic.

Conflict of interest

Motoharu Araki, Tsutomu Ito, Norio Tada, Yusuke Watanabe, Kensuke Takagi, Masanori Yamamoto, Shinichi Shirai, and Kentaro Hayashida are proctors of Edwards Lifesciences. Yusuke Watanabe is a proctor of Medtronic. The other authors have no conflicts of interest to declare regarding this manuscript.

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Yamawaki, M., Iwasaki, K., Araki, M. et al. A proctoring system to manage the learning curve associated with the introduction of transcatheter aortic valve implantation in Japan. Heart Vessels 33, 630–639 (2018). https://doi.org/10.1007/s00380-017-1098-9

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  • DOI: https://doi.org/10.1007/s00380-017-1098-9

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