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  • In Vivo Aniaml Test of CH-VAD in Sheep Model: Haibo Chen, MD. Fuwai Hospital National Center For Cardiovascular Diseases

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    This document summarizes research on the CH-VAD, a new implantable centrifugal left ventricular assist device (LVAD) developed in China. It discusses (1) the growing problem of heart failure in China and the need for more long-term mechanical circulatory support options; (2) the development of the CH-VAD prototype through collaborations between Chinese researchers and international partners; and (3) preclinical animal testing showing the CH-VAD's excellent hemodynamics and initial human use in a patient as a bridge to recovery, with signs of cardiac recovery observed after implantation. The research highlights the opportunity for new homegrown LVAD technologies in China but also the challenges of bringing such devices to market.

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    This ppt firstly introduce the development and clinical use of VAD in china

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    2017ISMCS PPT

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    This document summarizes research on the CH-VAD, a new implantable centrifugal left ventricular assist device (LVAD) developed in China. It discusses (1) the growing problem of heart failure in China and the need for more long-term mechanical circulatory support options; (2) the development of the CH-VAD prototype through collaborations between Chinese researchers and international partners; and (3) preclinical animal testing showing the CH-VAD's excellent hemodynamics and initial human use in a patient as a bridge to recovery, with signs of cardiac recovery observed after implantation. The research highlights the opportunity for new homegrown LVAD technologies in China but also the challenges of bringing such devices to market.

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    7 views17 pages

    In Vivo Aniaml Test of CH-VAD in Sheep Model: Haibo Chen, MD. Fuwai Hospital National Center For Cardiovascular Diseases

    Uploaded by

    andrew
    This document summarizes research on the CH-VAD, a new implantable centrifugal left ventricular assist device (LVAD) developed in China. It discusses (1) the growing problem of heart failure in China and the need for more long-term mechanical circulatory support options; (2) the development of the CH-VAD prototype through collaborations between Chinese researchers and international partners; and (3) preclinical animal testing showing the CH-VAD's excellent hemodynamics and initial human use in a patient as a bridge to recovery, with signs of cardiac recovery observed after implantation. The research highlights the opportunity for new homegrown LVAD technologies in China but also the challenges of bringing such devices to market.

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    © All Rights Reserved
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    of 17

    In vivo Aniaml Test of CH-

    VAD in Sheep Model

    Haibo Chen, MD.

    Fuwai Hospital
    National Center for Cardiovascular Diseases
    2017-10-19
    Heart Failure (HF):
    the Only Increasing Disease

    Proportion of HF Patients
    ESC Heart Failure (2015)
    Current situation in China：
    Double threat & heart failure keep increasing
    Aging population & Cardiac risk factor
    25.0
    Prevalance rate
    25
    Standardized prevalence rate

    20 17.65

    13.6
    15 12.3
    9.4
    10 7.737.5
    5.11
    5

    0
    1959 1979 1991 2002 2012
    male female
    High-cholesterol becomes
    The prevalence of hypertention
    a new threat

    4.5 million HF patients in China.


    New onset 200,000 per year
    Report on cardiovascular diseases in China 2016
    Mechanical circulatory support:
    the last battlefield in HF

    BTR • Bridge to Recovery

    BTT • Bridge to Transplant

    DT • Destination Therapy

    2016 ESC
    2013 ACCF/AHA
    Favorable Outcome: LVAD

    Widely Used & Comparable Survival with HTx

    JACC 2015:2542–55
    Circulation 2013;127(6):691-702
    Mechanical Circulatory
    Support in China
    and Fuwai Experience

    IABP ECMO BVS5000 FW-II


    Implanatable LVAD in China
    High-technology Devise in Cardiology

    Organization Devise
    Fuwai hospital FW-II Axial Clinical trail: 5 Cases
    Fuwai hospital FW-III Axial Animal Test
    Yong-an company 2st Axial Designed
    Yong-ren company 2st Centrifugal Clinical Use Abroad
    CH Biomedical, Inc. CH-VAD Recording
    Centrifugal
    Taida Hospital 3st Centrifugal Designed

    ➢ Shortage of Long-term LVAD in China


    CH-VAD:
    Collaboration of NCCD & CH Biomedical

    Sheep Jerry 9/2011


    PDR 3/2010 1st30-Day Success on X2 Anzhen 4/2013, X4 Test UofL/CII 3/2015, X5 Test

    X1 PDR/CDR X2 prototype size reduction X4prototype Integration X5 prototype


    Established prototype
    animal test animal test animal test

    2008 2009 2010 2011 2012 2013 2014 2015

    Model X5
    Model X1 Model X2 Model X4 Model X5

    Improving
    8
    CH-VAD:
    Smallest maglev Centrifugal VAD
    CH-VAD HeartMate 3 HVAD

    Maglev Centrifugal Maglev Centrifugal Centrifugal

    Diameter (mm) 50 55 50

    Thickness (mm) 26 33 24

    Weight (gram) 186 200 160


    Integration of Electronic System:
    High Reliability

    Microminiaturization technology
    Reduced wines in the cable
    Optimized Cable:
    Prevention of Infection
    CH-VAD HeartMate 3 HVAD HeartMate II
    No. of wines in cable 4 6 6 6
    Cable diameter (mm) 3.4 5.7 4.2 6.25

     Reduction of Infection Risk


     Improved reliability
    Preclinical in vivo test of CH-VAD
    ➢ Totally 29 cases ➢ CFDA requirement
    one -135 6 cases 60days

    Excellent haemodynamics, bleeding and


    coagulation control
    The first human use of CH-VAD
    ➢ Male，46，175cm，99kg ➢ Shengshou Hu
    ➢ Diagnosis： DCM ADCHF ➢ the first Human
    ➢ 2017-6-11 ECMO+IABP use of implantable
    ➢ 2017-6-22：unstable VAD in June 2017
    hemodynamics and no donor

    China Humanitarian Device Exemption


    Postoperative Cardiac Recovery

    PRE POD-8 weeks POD-16 weeks


    LVEDD 82mm 55mm 52mm
    LVEF 20% 35% 43%
    BNP 29561pg/l 503pg/l 165pg/l
    Postoperative Management

    POD 1 Day POD 7 DAY Pod 15day

    Improved QOL , Now 16 weeks


    Chance and Challenge
    Demand

    Fund Technology
    LVAD
    Policy Talent

    Hospital

    Life Quality

    Mortality

    Cost Performance
    Thank You For your
    attention

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