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Clinical efficacy of transcatheter aortic valve replacement for severe aortic stenosis in high-risk patients: the PREVAIL JAPAN trial

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Abstract

Purpose

Transcatheter aortic valve replacement (TAVR) is suggested to be less invasive and/or equally effective in comparison to conventional aortic valve replacement for high-risk symptomatic aortic stenosis patients. We herein report the initial results of a pivotal clinical trial of TAVR in Japan (the PREVAIL JAPAN).

Methods

Sixty-four aortic stenosis patients (mean age 84.3 ± 6.1 years) not suitable for surgery were enrolled at three centers in Japan, with a primary composite endpoint of the 6-month post-procedure improvements in the aortic valve area and New York Heart Association (NYHA) functional classification.

Results

A transfemoral approach was used in 37 patients and a transapical approach was used in 27. The device success rate was 91.9 %. After 30 days and 6 months, the rates of mortality from any cause were 8.1 and 11.3 %, respectively. At 6 months, symptomatic stroke was found in 3.1 % of the patients, and silent infarction in 7.8 %. The aortic valve area and mean pressure gradient were significantly improved over time with both approaches (p < 0.001). At 6 months, the NYHA functional classification based on a conventional physician’s assessment was improved in 87.9 % of the patients.

Conclusions

We found results that were equivalent to those in other major TAVR trials, such as an acceptable 30-day survival (91.9 %), suggesting that balloon-expandable TAVR is effective for small Japanese AS patients classified as high-risk or inoperable.

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Acknowledgments

We thank Dr. Koichi Maeda for his excellent assistance. Funded by Edwards Lifesciences Limited; ClinicalTrials.gov number, NCT01113983.

Conflict of interest

Yoshiki Sawa and Shuichiro Takanashi are consultants and advisory board members, and Morimasa Takayama and Kazuaki Mitsudo are advisory board members for Edwards Lifesciences Limited.

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Authors and Affiliations

  1. Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-Oka, Suita, Osaka, 565-0871, Japan

    Yoshiki Sawa, Shinsuke Nanto & Toru Kuratani

  2. Sakakibara Heart Institute, 3-16-1 Asahi-cho, Fuchu, Tokyo, 183-0003, Japan

    Morimasa Takayama, Shuichiro Takanashi & Tetsuya Tobaru

  3. Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama, 710-8602, Japan

    Kazuaki Mitsudo, Tatsuhiko Komiya & Tsuyoshi Goto

Authors
  1. Yoshiki Sawa
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  2. Morimasa Takayama
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  3. Kazuaki Mitsudo
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  4. Shinsuke Nanto
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  5. Shuichiro Takanashi
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  6. Tatsuhiko Komiya
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  7. Toru Kuratani
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  8. Tetsuya Tobaru
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  9. Tsuyoshi Goto
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Corresponding author

Correspondence to Yoshiki Sawa.

Additional information

On behalf of the PREVAIL JAPAN investigators.

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Sawa, Y., Takayama, M., Mitsudo, K. et al. Clinical efficacy of transcatheter aortic valve replacement for severe aortic stenosis in high-risk patients: the PREVAIL JAPAN trial. Surg Today 45, 34–43 (2015). https://doi.org/10.1007/s00595-014-0855-y

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  • DOI: https://doi.org/10.1007/s00595-014-0855-y

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