Fifth INTERMACS annual report: Risk factor analysis from more than 6,000 mechanical circulatory support patients James K. Kirklin, MD, David C. Naftel,

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Presentation transcript:

Fifth INTERMACS annual report: Risk factor analysis from more than 6,000 mechanical circulatory support patients James K. Kirklin, MD, David C. Naftel, PhD, Robert L. Kormos, MD, Lynne W. Stevenson, MD, Francis D. Pagani, MD, PhD, Marissa A. Miller, DVM, MPH, J.T. Baldwin, PhD, James B. Young, MD The Journal of Heart and Lung Transplantation Volume 32, Issue 2, Pages 141-156 (February 2013) DOI: 10.1016/j.healun.2012.12.004 Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 1 Time of cumulative hospital participation and patients entered into the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. Between June 23, 2006 and June 30, 2012, 145 hospitals participated in INTERMACS, and 131 of these hospitals actively contributed information on 6,633 patients. Cumulative patient accrual and the number of participating hospitals over this time period are displayed. BTT, bridge to transplant; DT, destination therapy. HMII, HeartMate II. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 2 Categories of patients who received durable mechanical circulatory support devices in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database between June 2006, and June 2012 are shown. LVAD, left ventricular assist device; RVAD, right ventricular assist device; TAH, total artificial heart. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 3 Primary adult implants in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database are shown by year of implant. LVAD, left ventricular assist device; TAH, total artificial heart. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 4 Primary adult implants as destination therapy are shown by year of implant. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 5 Primary adult left ventricular assist devices (LVADs) and biventricular assist devices BIVADs) are shown stratified by continuous-flow vs pulsatile pumps. Patients were censored at time of transplant or device explant. The error bars indicate±1 standard error. BTT, bridge to transplant; DT, destination therapy. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 6 Actuarial and parametric survival is shown after implantation of primary continuous-flow left ventricular assist devices (LVAD) and biventricular assist devices (BIVAD). The lower curve indicates the hazard function, or instantaneous risk, over time. The dashed lines indicate the 70% confidence limits. BTT, bridge to transplant; DT, destination therapy. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 7 Actuarial survival is shown stratified by age at implant. The error bars indicate±1 standard error. BIVAD, biventricular assist device; BTT, bridge to transplant; DT, destination therapy; LVAD, left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 8 Actuarial survival is shown stratified by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile Level. The error bars indicate±1 standard error. BIVAD, biventricular assist device; BTT, bridge to transplant; DT, destination therapy; LVAD, left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 9 Nomogram depicts a solution of the multivariate risk factor equation, showing the interaction between age and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Levels. The average risk profile for each of the INTERMACS levels is illustrated. The dashed lines indicate the 70% confidence limits. BIVAD, biventricular assist device; BTT, bridge to transplant; DT, destination therapy; LVAD, left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 10 Actuarial survival is depicted stratified by implant strategy of destination therapy (DT), bridge to transplant (BTT), or bridge to candidacy (BTC). The error bars indicate±1 standard error. BIVAD, biventricular assist device; LVAD, left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 11 Nomogram depicts solution of the risk factor equations for destination therapy (DT) and bridge-to-transplant (BTT) plotted against age at implant. Dashed lines indicate the 70% confidence limits. BIVAD, biventricular assist device; LVAD, left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 12 Actuarial survival after device implant, stratified by severity of renal dysfunction. Error bars indicate±1 standard error. BIVAD, biventricular assist device; BTT, bridge to transplant; BUN, blood urea nitrogen; DT, destination therapy; LVAD, left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 13 Actuarial survival after device implant, stratified by severity of right ventricular dysfunction. Error bars indicate±1 standard error. BIVAD, biventricular assist device; BTT, bridge to transplant; DT, destination therapy; LVAD, left ventricular assist device; RAP, right atrial pressure; RHF, right heart failure. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 14 Nomogram depicts the solution of the risk factor equation for surgical complexities. Dashed lines indicate the 70% confidence limits. Hx Card Surg, history of cardiac surgery; Both, prior cardiac surgery and concomitant procedure(s) at time of implant. BIVAD, biventricular assist device; BTT, bridge to transplant; DT, destination therapy; LVAD, left ventricular assist device. Depiction is as in Figure 11. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 15 Actuarial freedom from stroke. The error bars indicate±1 standard error. LVAD, left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 16 Actuarial freedom from device exchange or death related to device malfunction, stratified by device type. MCSD, mechanical circulatory support device. The error bars indicate±1 standard error. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 17 Actuarial freedom from pump-related infections (PRI). Note: a patient can have multiple locations for a single infection episode, therefore the total number of infection locations will not add up to the total number of patients. The error bars indicate±1 standard error. LVAD, left ventricular assist device; RVAD, right ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 18 Actuarial freedom from pump-related infections (PRI), stratified by Interagency Registry for Mechanically Assisted Circulatory Support (NTERMACS) profile level. Error bars indicate±1 standard error. LVAD, left ventricular assist device; NYHA, New York Heart Association; RVAD, right ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 19 Actuarial freedom from any of the following adverse events: infection, bleeding, device malfunction, stroke, or death. Error bars indicate±1 standard error. BIVAD, biventricular assist device; BTT, bridge to transplant; DT, destination therapy; LVAD, left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 20 Freedom from adverse events listed in Figure 19, stratified by left (LVAD) or biventricular (BIVAD) support. Error bars indicate±1 standard error. BTT, bridge to transplant; DT, destination therapy. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 21 Freedom from adverse events listed in Figure 19, stratified by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level. Error bars indicate±1 standard error. BIVAD, biventricular assist device; BTT, bridge to transplant; DT, destination therapy; LVAD, left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 22 Freedom from adverse events listed in Figure 19, stratified by age. Error bars indicate±1 standard error. BIVAD, biventricular assist device; BTT, bridge to transplant; DT, destination therapy; LVAD, left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 23 Visual analog scale (VAS) of general well-being before and after device implant. The numbers in parenthesis indicate number of responses received by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). CF LVAD, continuous-flow left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 24 Self-care component of the study before and after device implant. CF LVAD, continuous-flow left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Figure 25 Usual activities component of study before and after device implant. CF LVAD, continuous flow left ventricular assist device. The Journal of Heart and Lung Transplantation 2013 32, 141-156DOI: (10.1016/j.healun.2012.12.004) Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions