Predicting Major Outcomes after MCSD Implant 1 Risk Factors for Death, Transplant, and Recovery James Kirklin, MD David Naftel, PhD.

Slides:

Advertisements

Similar presentations

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n= Deaths * censored at transplant Percent Survival Months after Device Implant Deaths / Month Event:

Advertisements

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n= Deaths * censored at transplant Percent Survival Months after Device Implant Deaths / Month Event:

Can Comparative Effectiveness Study Tell Us What Is The Best Therapy For Class IV Heart Failure? Beta blockers or LVADs?

Hemolysis in Patients Supported with Durable, Long-Term Left Ventricular Assist Device Therapy Jason N. Katz, MD,MHS; Brian C. Jensen, MD; Patricia P.

Equipoise Does Not Exist for REVIVE IT Andrew Boyle, MD Heart and Vascular Center Director, Florida Chairman of Cardiology Medical Director of Heart Failure,

What have we learned? What is next? Panel B: Functional Capacity, Quality of Life and Outcomes H.Functional Capacity I.Neurocognitive Assessment J.Quality.

Biventricular Failure – Total Artificial Heart Francisco A. Arabía, MD Director, CHSI Center for Surgical Device Management Cedars-Sinai Heart Institute.

Predicting Patients at Risk for Poor Global Outcomes after DT- MCS Therapy Suzanne V. Arnold, MD, MHA Saint Luke’s Mid America Heart Institute/UMKC May.

Periportal Fibrosis Without Cirrhosis Does Not Affect Outcomes Following Continuous Flow Ventricular Assist Device Implantation Jonathon E. Sargent, BS,

Presentations: Quantifying the impact of adverse events on HRQOL early after implant Patient selection and estimation of prognosis using health status.

Predicting Major Outcomes after MCSD Implant 1 Risk Factors for Death, Transplant, and Recovery James Kirklin, MD David Naftel, PhD.

Interagency Registry for Mechanically Assisted Circulatory Support Marissa A. Miller, DVM, MPH National Heart, Lung, & Blood Institute.

Josef Stehlik, MD, MPH Associate Professor of Medicine Medical Director, Heart Transplant Program University of Utah School of Medicine Director, ISHLT.

MCS in Special Populations: The Use of Mechanical Support in Adults with Congenital Heart Disease 9 th Annual Meeting May 15, 2015 Christina VanderPluym,MD.

Survival following VAD complications: implications for transplant priority. Todd Dardas, MD, MS May 16, 2015.

Development of a novel predictive model for mortality post continuous flow LVAD implant using Bayesian Networks (BN) N. A. Loghmanpour 1, M. K. Kanwar.

INTERMACS: June 2006 – December 2012: CMS Report Adults: n=7849 All primary implants as of 12/31/2012 n= 7928 Pediatric patients: n=79 (patients < 19 yrs.

Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana Advanced Heart Failure, Transplant, & Mechanical.

“Rise of the Machines” Todd D. Edwards MD FACC FACP FASNC.

Mechanical Circulatory Support in Special Populations Renzo Y. Loyaga-Rendon MD.,PhD.. Assistant Professor Advanced Heart Failure Section University of.

01/20151 EPI 5344: Survival Analysis in Epidemiology Quick Review from Session #1 March 3, 2015 Dr. N. Birkett, School of Epidemiology, Public Health &

Analysis of Pump Thrombosis in the Intermacs Database Michael Acker William Measey Professor of Surgery Chief of Division of Cardiovascular Surgery Director.

1 Data Quality Report Quality Assurance Report Live Data Download Site Datasets (SAS) Research Datasets Customized Cohort Reports Outcome Analytics Patient.

Sixth INTERMACS annual report: A 10,000-patient database James K. Kirklin, MD, David C. Naftel, PhD, Francis D. Pagani, MD, PhD, Robert L. Kormos, MD,

Identifying patients for advanced heart failure therapy by screening patients with cardiac resynchronization therapy or implantable cardioverter-defibrillator:

Utility of the Seattle Heart Failure Model in patients with cardiac resynchronization therapy and implantable cardioverter defibrillator referred for.

Total Artificial Heart (TAH): Survival Outcomes, Risk Factors,

James K. Kirklin, MD, Francis D. Pagani, MD, PhD, Robert L

INTERMACS 10th Annual Meeting March , 2016 Quality of Life

Can the Seattle Heart Failure Model Be Used to Risk-stratify Heart Failure Patients for Potential Left Ventricular Assist Device Therapy? Wayne C. Levy,

Jennifer A. Cowger, MD, Matthew A

Impact of initial Norwood shunt type on young hypoplastic left heart syndrome patients listed for heart transplant: A multi-institutional study Waldemar.

Intermacs and the Scientific Registry of Transplant Recipients (SRTR)

Pre-operative mortality risk assessment in patients with continuous-flow left ventricular assist devices: Application of the HeartMate II risk score

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

Robert J. Dabal, MD, James K

Prognosis of patients removed from a transplant waiting list for medical improvement: Implications for organ allocation and transplantation for status.

Determinants of repair type, reintervention, and mortality in 393 children with double- outlet right ventricle Timothy J. Bradley, MD, Tara Karamlou,

Endovascular versus open elephant trunk completion for extensive aortic disease Eric E. Roselli, MD, Sreekumar Subramanian, MD, Zhiyuan Sun, BS, Jahanzaib.

Belinda Gray et al. JCHF 2013;1:

The Optimal Timing of Stage-2-Palliation After the Norwood Operation

Duration of inotropic support after left ventricular assist device implantation: Risk factors and impact on outcome Soren Schenk, MD, Patrick M. McCarthy,

Surgical management of competing pulmonary blood flow affects survival before Fontan/Kreutzer completion in patients with tricuspid atresia type I Travis.

Results of palliation with an initial pulmonary artery band in patients with single ventricle associated with unrestricted pulmonary blood flow Bahaaldin.

Long-term mechanical circulatory support (destination therapy): On track to compete with heart transplantation? James K. Kirklin, MD, David C. Naftel,

Five-Year Outcomes after Randomization to Transcatheter or Surgical Aortic Valve Replacement: Final Results of The PARTNER 1 Trial Michael J. Mack, MD.

Outcomes in Patients Bridged With Univentricular and Biventricular Devices in the Modern Era of Heart Transplantation Joshua C. Grimm, MD, Christopher.

Outcomes of heart transplantation in children with hypoplastic left heart syndrome previously palliated with the Norwood procedure Bahaaldin Alsoufi,

Impact of Marital Status on LVAD Mortality: A Single Center Experience Linda Njoroge MD, Mohamed Khayata MD, Kevin Charnas, Paul Bate, Madison Edge, James.

Outcomes after implantation of partial-support left ventricular assist devices in inotropic- dependent patients: Do we still need full-support assist devices?

Cost-effectiveness of left ventricular assist devices (LVADs) for patients with advanced heart failure: Analysis of the British NHS bridge to transplant.

Nicholas G. Smedira, MD, Katherine J. Hoercher, RN, Dustin Y

Outcomes of multistage palliation of infants with functional single ventricle and heterotaxy syndrome Bahaaldin Alsoufi, MD, Courtney McCracken, PhD,

Palliation Outcomes of Neonates Born With Single-Ventricle Anomalies Associated With Aortic Arch Obstruction Bahaaldin Alsoufi, MD, Courtney McCracken,

Neal A. Chatterjee et al. JCHF 2014;2:

Outcomes on Continuous Flow Left Ventricular Assist Devices: A Single Institutional 9- Year Experience Jeffrey A. Morgan, MD, Pauline H. Go, MD, Linnea.

Ranjit John, MD, Yoshifumi Naka, MD, Soon J

Durability of left ventricular assist devices: Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 2006 to 2011 William L.

William L. Holman, MD, James K. Kirklin, MD, David C

Bahaaldin Alsoufi, MD, Cedric Manlhiot, BSc, Brian W

Truncus Arteriosus Associated with Interrupted Aortic Arch in 50 Neonates: A Congenital Heart Surgeons Society Study Igor E. Konstantinov, MD, PhD, Tara.

Francisco A. Arabía, MD, MBA, Carmelo A

Early Outcomes With Marginal Donor Hearts Compared With Left Ventricular Assist Device Support in Patients With Advanced Heart Failure Erin M. Schumer,

Cardiac transplant coronary artery disease: A multivariable analysis of pretransplantation risk factors for disease development and morbid events David.

James W. Long, MD, PhD, Aaron H. Healy, BS, Brad Y

Optimal timing for heart transplantation in patients bridged with left ventricular assist devices: Is timing of the essence? Chase R. Brown, MD, Fabliha.

Left Ventricular Assist Device Performance With Long-Term Circulatory Support: Lessons From the REMATCH Trial Walter P. Dembitsky, MD, Alfred J. Tector,

Daisuke Yoshioka, MD, Hiroo Takayama, MD, Arthur R. Garan, MD, Veli K

Kathleen E. Simpson, MD, Elizabeth Pruitt, MSPH, James K

Presentation transcript:

Predicting Major Outcomes after MCSD Implant 1 Risk Factors for Death, Transplant, and Recovery James Kirklin, MD David Naftel, PhD

Predicting Major Outcomes after MCSD Implant 2 Two approaches: Simultaneous parametric modeling of the probabilities of the time related events based on a patient’s risk factors Simultaneous non-parametric estimation of the probabilities of the time related events based on sub-groups of patients

Months post implant Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 n at risk: Outcome Death Transplant Recovery Death Transplant Recovery Outcome/Month Instantaneous Rate (Hazard) of Outcomes

Months post implant % Freedom from Transplantation % Free from Device Strategy n txplTXPL at 1 yr BTT Listed % BTT Likely % BTT Mod Likely % BTT Unlikely % Destination Therapy % Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n= Event: Transplantation (censored at death or recovery) BTT Unlikely BTT Listed BTT Mod Likely BTT Likely Destination Therapy Device Strategy at Time of Implant

Months post implant Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 n at risk: Outcome Death Transplant Recovery Death Transplant Recovery Outcome/Month Instantaneous Rate (Hazard) of Outcomes

INTERMACS

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Device Strategy BTT: Listed BTT: Likely BTT: Moderately BTT: Unlikely DT Continuous Flow LVAD I N T E R M A C S L E V E L S

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Device Strategy BTT: Listed BTT: Likely BTT: Moderately BTT: Unlikely DT Continuous Flow LVAD I N T E R M A C S L E V E L S

Months after Implant Proportion of Patients Alive (device in place) 47% Transplanted 38% Dead 13% Recovery 1% Outcome % at 1 year 9 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD BTT Listed LEVEL 1, n= 317

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Device Strategy BTT: Listed BTT: Likely BTT: Moderately BTT: Unlikely DT Continuous Flow LVAD I N T E R M A C S L E V E L S

Months after Implant Proportion of Patients Alive (device in place) 63% Transplanted 4% Dead 31% Recovery 2% Outcome % at 1 year 11 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD Destination Therapy LEVEL 1, n=344

Months after Implant Proportion of Patients Alive (device in place) 70% Transplanted 3% Dead 26% Recovery 1% Outcome % at 1 year 12 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD Destination Therapy LEVEL 2, n=1128

Months after Implant Proportion of Patients Alive (device in place) 73% Transplanted 4% Dead 22% Recovery 1% Outcome % at 1 year 13 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD Destination Therapy LEVEL 3, n=1081

Months after Implant Proportion of Patients Alive (device in place) 76% Transplanted 3% Dead 21% Recovery 1% Outcome % at 1 year 14 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD Destination Therapy LEVELS 4-7, n=749

Months after Implant Proportion of Patients Alive (device in place) 46% Transplanted 40% Dead 13% Recovery 1% Outcome % at 1 year 15 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD BTT Listed LEVEL 2, n=1084

Months after Implant Proportion of Patients Alive (device in place) 51% Transplanted 39% Dead 9% Recovery 1% Outcome % at 1 year 16 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD BTT Listed LEVEL 3, n= 604

Months after Implant Proportion of Patients Alive (device in place) 45% Transplanted 42% Dead 12% Recovery 1% Outcome % at 1 year 17 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 CFLVAD BTT Listed LEVELS 4-7, n=394

Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 Competing Outcomes Analysis for Continuous Flow LVADs % at 1 year Alive nDeath TransplantRecovery (a device in place) Destination Therapy, n=3302 Level %4%2%63% Level %3%1%70% Level %4%1%73% Levels %3%1%76% BTT: Listed, n=2399 Level %38%1%47% Level %40%1%46% Level %39%1%51% Levels %42%1%45%

Months after Implant Proportion of Patients Alive (device in place) 9% Transplanted 59% Dead 32% (Recovery 0%) Outcome % at 1 year 19 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 TAH BTT Listed LEVEL 1, n=47

Months after Implant Proportion of Patients Alive (device in place) 11% Transplanted 70% Dead 19% (Recovery 0%) Outcome % at 1 year 20 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 TAH BTT Listed LEVEL 2, n=75

Months post implant % Survival Deaths/months Hazard (early + late) n=9359, Deaths=2280 Months% Survival 195% 1280% 2469% 36 59% 4847% Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 n at risk: Event: Death (censored at transplantation or recovery)

% Freedom Months from TXPL 199% 1276% 2462% 36 56% 4852% Months post implant % Freedom from Transplantation Transplants/months Hazard (early + constant) n=9359, Transplants= 2422 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 n at risk: Event: Transplantation (censored at death or recovery)

% Freedom Months from Recovery 1 100% 12 99% 24 98% 36 97% 48 96% Months post implant % Freedom from Recovery Recovery/months Hazard (constant) n=9360, Recovery= 89 Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9359 n at risk: Event: Recovery (censored at death or transplantation)