Analysis of Pump Thrombosis in the Intermacs Database Michael Acker William Measey Professor of Surgery Chief of Division of Cardiovascular Surgery Director of Heart and Vascular Center University of Pennsylvania Health System 1 Disclosures Consultant for Thoratec and Heartware 2 3 Perceived increase in incidence of HMII pump thrombosis after 2011 by several large VAD centers compared to HMII pivotal trial FDA/NHLBI request Intermacs to investigate INTERMACS: HeartMate II Pump Analysis Implants: April 2008 December 2012, n=6910 Follow-up: Through June Months post implant Event: Death with a device in place (censored at transplant and recovery) % Survival Overall Survival Months post implant% Survival 1 95% 3 91% 6 87% 12 80% 24 69% 36 58% 48 46% n=6910, deaths=1772 Figure 1 INTERMACS: HeartMate II Pump Analysis Implants: April 2008 December 2012, n=6910 Follow-up: Through June Months post implant Event: Death with a device in place (censored at transplant and recovery) % Survival p(overall) =.63 Implant Year nDeaths (with a device in place) Totals Figure 2 No change in survival by Implant year INTERMACS: HeartMate II Pump Analysis Implants: April 2008 December 2012, n=6910 Follow-up: Through June Months post implant Event: Device Exchange (censored at death, transplant and recovery) % Freedom from Device Exchange Implant Year nEvents Totals p(overall)