Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) Registry Update

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Homer Sharp
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1 Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) Registry Update Takeshi Nakatani, MD, PhD Principal investigator, J-MACS (National Cerebral and Cardiovascular Center) Kazuhiro Sase, MD,PhD Vice Principal investigator, J-MACS (Clinical Pharmacology, Juntendo University) Hiroaki Oshiyama Vice Principal investigator, J-MACS (Japan Medical Devices Manufacturers Association) And J-MACS investigators

2 International Society of Heart and Lung Transplantation COI Disclosure Takeshi Nakatani, MD, PhD The author have no financial conflicts of interest to disclose concerning the presentation.

(cases) Clinical application of VAD by year in Japan Total:1773 cases Acute:785 cases CM:981 cases (1980 2014/8) Acute cardiogenic shock Cardiomyopathy 1

3 (cases) Clinical application of VAD by year in Japan Total:1773 cases Acute:785 cases CM:981 cases ( /8) Acute cardiogenic shock Cardiomyopathy 1 st Clinical Use (Zeon) (Toyobo) Japanese Association for Clinical Ventricular Assist Systems (JACVAS)

Framework of J-MACS Academic Societies Japanese Society for Artificial Organs Japanese Association for Clinical Ventricular Assist Systems The Japanese Association for Thoracic Surgery The Japanese

4 Framework of J-MACS Academic Societies Japanese Society for Artificial Organs Japanese Association for Clinical Ventricular Assist Systems The Japanese Association for Thoracic Surgery The Japanese Society for Cardiovascular Surgery The Japanese Circulation Society The Japanese Heart Failure Society The Japanese College of Cardiology Cooperation Participating institutions Case enrollment Follow-up study (data entry) Data Center (DC) Data Base (Japanese Registry for VAD) Investigation Information Pharmaceuticals and Medical Devices Agency Contract Data access (own company s) Malfunction reports, re-examinations applications (Based on Pharmaceutical Affairs Law) March, 2015 VAD companies Investigation in framework Harmonization by Doing (HBD) Data Base (International Registry) International relationship IMACS

5 Organization of J-MACS Management Organization Steering Committee (SC) Operating Committee (OC) Support Organization Administrative Office* Data Center (DC) Auditing Organization Observational Study Monitoring Board (OSMB) Adverse Event and Adjudication Committee Study Entity Participating institutions VAD companies * : Office of Medical Infomatics and Epidemiology, PMDA

6 Steering Committee Members

7 Operating Committee Members * * * *: Principal and Vice principal investigator

8 Device List for J-MACS Nipro-Toyobo (April 1990) HeartMate XVE (November 2009) EVAHEART (December 2010) DuraHeart (December 2010) Heartmate II (November 2012) Jarvik 2000 (November 2013) Implantable non-pulsatile type (Product approval) Nipro-Toyobo Extracorporeal type Intended long-term use as BTT Covered by medical insurance EVAHEART DuraHeart Heartmate II Jarvik 2000

At start: 6 hospitals A membership of J-MACS is one of the essential

9 Participating hospitals As of April 2015, 40 hospitals are participating and of those 7 hospitals are new members from this year. At start: 6 hospitals A membership of J-MACS is one of the essential conditions for authorized hospitals to use of implantable LVAD under medical insurance. 9

10 J-MACS: The number of Patient Enrollment Covered by insurance as BTT Jarvik2000 HeartMate II DuraHeart EVAHEART 10

11 Statistical Summary Patients included in this analysis The data of the total 384 patients who had been implanted with VAD between June 2010 and which were available as of December 7, 2014, were extracted. Of those, 272 patients who met the following criteria (Primary LVAD population) at the time of enrollment in J-MACS were included in this analysis. Patients who have never used VAD at the time of enrollment in J-MACS Patients who were assisted only by LVAD at the time of enrollment in J-MACS Patients who were 19 years of age or older at the time of implantation of LVAD

Total cases 累積数 Number of patient enrollment for Statistical analysis Primary LVAD (June, 2010 September,2014) 280 260 240 220 200

12 Total cases 累積数 Number of patient enrollment for Statistical analysis Primary LVAD (June, 2010 September,2014) 植込型 Implantable 体外設置型 Extracorporeal 植込み Month ( 装着 at implant ) 月 (Data at December 7, 2014) 12

13 Gender Patients demographics (Primary LVAD population) Age 13

14 Patients demographics (Primary LVAD population) Pre-Implant patient profile 14

15 Survival rate Actuarial 生存率曲線 survival Primary Primary LVAD LVAD ( 全体 ) Kaplan-Meier Plot +:Censored Survival rate 90 days 180 days 360 days Patients at risk (cases) Days after Device implant Days after Device implant 標的イベントが発生する可能性がある人 15

16 Survival rate Actuarial survival Primary LVAD (Implantable/Extracorporeal) Survival rate

17 Survival rate Actuarial survival Primary LVAD (Patient profile) Kaplan-Meier Plot Survival rate Level 1 Level 2 Level 3 90 days 180 days 360 days Level 4 +:Censored P= Level 1 Level 2 Level 3 Level 4 Patients at risk (cases) Level 1 Level 2 Level 3 Level 4 Days after Device implant

18 Freedom from Events Actual freedom from malfunction Primary LVAD (Implantable/Extracorporeal) Kaplan-Meier Plot +:Censored P= Freedom from events Implantable 90 days 180 days 360 days Extracorporeal - : Implantable, - : Extracorporeal Patients at risk (cases) Days after Device implant Implantable Extracorporeal

19 Freedom from Events Actual freedom from infection Primary LVAD (Implantable/Extracorporeal) Kaplan-Meier Plot +:Censored P= Freedom from events Implantable Extracorporeal 90 days 180 days 360 days - : Implantable, - : Extracorporeal Patients at risk (cases) Days after Device implant Implantable Extracorporeal

20 Freedom from Events Actual freedom from neurological events Primary LVAD (Implantable/Extracorporeal) Kaplan-Meier Plot +:Censored P= Freedom from events Implantable 90 days 180 days 360 days Extracorporeal - : Implantable, - : Extracorporeal Patients at risk (cases) Days after Device implant Implantable Extracorporeal

21 Freedom from Events Actuarial freedom from bleeding Primary LVAD (Implantable/Extracorporeal) Kaplan-Meier Plot +:Censored P= Freedom from events Implantable Extracorporeal 90 days 180 days 360 days - : Implantable, - : Extracorporeal Patients at risk (cases) Days after Device implant Implantable Extracorporeal

22 Summary J-MACS is useful for better clinical management and development of new VADs, while, the collected data are beneficial for assuring the safety of new devices. Continuity of J-MACS is future task.

Fifth INTERMACS annual report: Risk factor analysis from more than 6,000 mechanical circulatory support patients

http://www.jhltonline.org SPECIAL FEATURE Fifth INTERMACS annual report: Risk factor analysis from more than 6, mechanical circulatory support patients James K. Kirklin, MD, a David C. Naftel, PhD, a Robert