Domestic and foreign trends in the prevalence of heart failure and the necessity of next-generation artificial hearts: A survey by the Working Group on Establishment of Assessment Guidelines for Next-Generation Artificial Heart Systems

Eisuke Tatsumi, Takeshi Nakatani, Kou Imachi, Mitsuo Umezu, Shun Ei Kyo, Kazuhiro Sase, Setsuo Takatani, Hikaru Matsuda

    Research output: Contribution to journalArticle

    18 Citations (Scopus)

    Abstract

    A series of guidelines for development and assessment of next-generation medical devices has been drafted under an interagency collaborative project by the Ministry of Health, Labor and Welfare and the Ministry of Economy, Trade and Industry. The working group for assessment guidelines of next-generation artificial hearts reviewed the trend in the prevalence of heart failure and examined the potential usefulness of such devices in Japan and in other countries as a fundamental part of the process of establishing appropriate guidelines. At present, more than 23 million people suffer from heart failure in developed countries, including Japan. Although Japan currently has the lowest mortality from heart failure among those countries, the number of patients is gradually increasing as our lifestyle becomes more Westernized; the associated medical expenses are rapidly growing. The number of heart transplantations, however, is limited due to the overwhelming shortage of donor hearts, not only in Japan but worldwide. Meanwhile, clinical studies and surveys have revealed that the major causes of death in patients undergoing long-term use of ventricular assist devices (VADs) were infection, thrombosis, and mechanical failure, all of which are typical of VADs. It is therefore of urgent and universal necessity to develop next-generation artificial hearts that have excellent durability to provide at least 2 years of event-free operation with a superior quality of life and that can be used for destination therapy to save patients with irreversible heart failure. It is also very important to ensure that an environment that facilitates the development, testing, and approval evaluation processes of next-generation artificial hearts be established as soon as possible.

    Original languageEnglish
    Pages (from-to)187-194
    Number of pages8
    JournalJournal of Artificial Organs
    Volume10
    Issue number4
    DOIs
    Publication statusPublished - 2007 Dec

    Fingerprint

    Artificial heart
    Artificial Heart
    Japan
    Heart Failure
    Guidelines
    Heart-Assist Devices
    Equipment and Supplies
    Heart Transplantation
    Developed Countries
    Life Style
    Cause of Death
    Industry
    Thrombosis
    Quality of Life
    Tissue Donors
    Mortality
    Surveys and Questionnaires
    Health
    Durability
    Infection

    Keywords

    • Artificial heart
    • Guideline
    • Heart failure
    • Heart transplantation
    • Ventricular assist device

    ASJC Scopus subject areas

    • Biophysics

    Cite this

    Domestic and foreign trends in the prevalence of heart failure and the necessity of next-generation artificial hearts : A survey by the Working Group on Establishment of Assessment Guidelines for Next-Generation Artificial Heart Systems. / Tatsumi, Eisuke; Nakatani, Takeshi; Imachi, Kou; Umezu, Mitsuo; Kyo, Shun Ei; Sase, Kazuhiro; Takatani, Setsuo; Matsuda, Hikaru.

    In: Journal of Artificial Organs, Vol. 10, No. 4, 12.2007, p. 187-194.

    Research output: Contribution to journalArticle

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