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Clinical safety and efficacy of tolvaptan for acute phase therapy in patients with low-flow and normal-flow severe aortic stenosis

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Abstract

Conventional diuretic therapy for low-flow (LF) severe aortic stenosis (SAS) often has an inadequate effect or causes hemodynamic instability. Tolvaptan is used for acute heart failure in addition to conventional diuretics, and it does not cause intravascular dehydration. This study aimed to retrospectively investigate the safety and efficacy of tolvaptan in the acute phase in 56 consecutive patients with SAS and compared LF-SAS with normal-flow (NF) SAS. The primary endpoints were adverse clinical events (death, worsening heart failure, worsening renal failure, fatal arrhythmia, cardiogenic or hypovolemic shock, and use of inotropic agents) and the volume of urine within 48 h of tolvaptan administration. Among 56 patients, 16 had LF-SAS (29%), and 40 had NF-SAS (71%). Severe adverse clinical events were not observed 48 h after tolvaptan administration. In both groups, the urine volume significantly increased after tolvaptan administration in comparison to 24 h before tolvaptan administration (both, p < 0.01). There were no changes in the urine volume during the initial 24 and 48 h. In the LF-SAS group, tolvaptan resulted in a significant decrease in fluid balance during the initial 24 and 48 h compared to 24 h before tolvaptan administration (p < 0.05). Adding tolvaptan to conventional treatment is safe and effective without renal dysfunction and hypotension in patients with SAS, including those with LF.

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Acknowledgments

The authors thank Mr. Miyoshi Sakai, MPH for providing statistical assistance.

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Authors and Affiliations

  1. Division of Cardiology, Department of Internal Medicine, Teikyo University, 2-11-1 Kaga, Tokyo, 173-8606, Japan

    Miho Mitsui, Akihisa Kataoka, Yugo Nara, Fukuko Nagura, Hideyuki Kawashima, Hirofumi Hioki, Makoto Nakashima, Yusuke Watanabe, Naoyuki Yokoyama & Ken Kozuma

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  1. Miho Mitsui
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  2. Akihisa Kataoka
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  3. Yugo Nara
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  4. Fukuko Nagura
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  6. Hirofumi Hioki
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  7. Makoto Nakashima
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  8. Yusuke Watanabe
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Correspondence to Akihisa Kataoka.

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The author(s) declare that they have no competing interests.

Ethical approval

The ethics committee of our institution approved the study protocol (number TEIRIN 17-111). The study protocols were developed in accordance with the ethical guidelines of the Declaration of Helsinki. This observational trial was registered with the University Hospital Medical Information Network (number UMIN R000036168).

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The need for informed consent was waived because of the retrospective study design.

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Mitsui, M., Kataoka, A., Nara, Y. et al. Clinical safety and efficacy of tolvaptan for acute phase therapy in patients with low-flow and normal-flow severe aortic stenosis. Heart Vessels 34, 1684–1691 (2019). https://doi.org/10.1007/s00380-019-01411-3

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  • DOI: https://doi.org/10.1007/s00380-019-01411-3

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