: 2014 INTERMACS 4.0 Launches June 2, 2014

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1 : 2014 INTERMACS 4.0 Launches June 2, 2014 David C. Naftel, PhD 1

2 June 2006 March 2014 UAB: DCC UNOS: WBDE 2

3 : 2006 What patients are receiving MCSDs? Do DT patients ever receive a transplant? What are the rates of the major adverse events? How do pulsatile and continuous pumps compare? Are driveline infections common? Characterize changes in in quality of life? What are the risk factors for the major outcomes? Is device strategy a useful construct? 3

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5 April 2014 UAB: DCC UAB: WBDE 5

6 : 2014 Predict time-related outcomes for a patient based on his/her risk factors Compare device types: Axial flow, centrifugal flow, TAH, Bi-VADs MCSD implant, Transplant Medical Therapy: contrast, compare, optimize timing MCSD in pediatric patients Is it worth it: Quality of Life, functional capacity Resource Utilization 6

7 : 2014 Predict time-related outcomes for a patient based on his/her risk factors Quality Assurance Analyses Compare device types: Axial flow, centrifugal flow, TAH, Bi-VADs Frontline of unanticipated events MCSD implant, Transplant Medical Therapy: contrast, compare, optimize timing MCSD in pediatric patients Industry Collaborations Is it worth it: Quality of Life, functional capacity Resource Utilization 7

8 : 2014 How does all of this happen? Protocol 4.0 8

9 : 2014 Key Features of Protocol 4.0: Revamped web site Waiver of consent Added HIV, Modified Rankin Scale Adverse event changes: Zones Dashboard: announcements, etc 9

10 INTERMACS Website

11 Protocol 4.0 Waiver of Informed Consent and Authorization

12 Justification for Waiver of Informed Consent and Authorization National Quality Improvement System Rare population (miss approx. 12% of patients) Minimal risk Joint Commission requires participation in a national registry Procedures are Standard of Care FDA Reporting Reimbursement oversight (CMS) Review of best medical practices by NHLBI

13 Time Line for Protocol 4.0 March 28, 2014 Distribution of Protocol 4.0 May 26, 2014 June 1, 2014 June 2, days for local IRB approval UNOS WBDE TURNED OFF IRB/EB Acknowledgment Deadline UAB WBDE TURNED ON Additional Web Ex training meetings are available

14 : 2014 Revamped web site Waiver of consent Added HIV, Modified Rankin Scale Adverse event changes: Zones Dashboard: announcements, etc 14

15 Captured Events Zones 1) Hemolysis Zone 2) Right Heart Failure Zone 3) Hypertension **

16 Right Heart Failure Definition Definition: Symptoms or findings of persistent right ventricular failure characterized by both of the following: Documentation of elevated central venous pressure (CVP) by: o Direct measurement (e.g., right heart catheterization) with evidence of a central venous pressure (CVP) or right atrial pressure (RAP) > 16 mmhg. or o Findings of significantly dilated inferior vena cava with absence of inspiratory variation by echocardiography, or o Clinical findings of elevated jugular venous distension at least half way up the neck in an upright patient. Manifestations of elevated central venous pressure characterized by: o Clinical findings of peripheral edema (>2+ either new or unresolved), or o Presence of ascites or palpable hepatomegaly on physical examination (unmistakable abdominal contour) or by diagnostic imaging, or o Laboratory evidence of worsening hepatic (total bilirubin > 2.0) or renal dysfunction (creatinine > 2.0). IF the patient meets the definition for right heart failure, the severity of the right heart failure will be graded according to the following scale below. (NOTE: For right heart failure to meet severe or severe acute severity, direct measurement of central venous pressure or right atrial pressure must be one of the criteria)

17 Right Heart Failure Zone Information that you provide in this section will be used to assess the existence of right heart failure and its degree. Clinical Findings CVP or RAP > 16 mmhg? Yes, No, or Unknown. Dilated Vena Cava with absence of Inspiratory Variation by Echo? Yes, No, or Unknown. Clinical findings of elevated jugular venous distension at least half way up the neck in an upright patient? Yes, No, or Unknown. Peripheral Edema? Yes, No, or Unknown. Ascites? Yes, No, or Unknown.

18 Right Heart Failure Zone Information that you provide in this section will be used to assess the existence of right heart failure and its degree Has the patient been on Inotropes since the last Follow-up or rehospitalization? Yes, No, or Unknown. If yes, select all that apply: Dopamine Dobutamine Milrinone Isoproterenol Epinephrine Norepinephrine Levosimendan Unknown Nesiritide? Yes, No, or Unknown. Has the patient had a RVAD implant since the last Follow-up or rehospitalization? Yes, No, or Unknown.

19 Download, print or copy your own patient listings or datasets DashBoard

20 Announcements Global Site specific DashBoard

21 Pending Forms Download Print Copy Sort DashBoard

22 Protocol 3.0 Web Based Data Entry 22

23 Protocol 4.0 Web Based Data Entry 23

24 INTERMACS Protocol and Data Entry Evolution Protocol 1.0 June 23, 2006 Data Mapping Protocol 2.0 March 9, 2007 Data Mapping Protocol 2.3 March 5, 2009 Data Mapping Protocol 3.0 May 12, 2012 Data Mapping Protocol 4.0 June 2, 2014

25 Mapped/ Cleaned Data New cause of death drop-down list: Mapping of OTHER Cause of Death into specified categories Removal of duplicate bleeding and infection adverse events (same date and location) Removal of ongoing infection adverse events Avoid complex mapping (but no data is lost) 25

26 Duo 2 Factor Login

27 THE END

28 Hemolysis Definition Minor Hemolysis: A plasma-free hemoglobin value greater than 20 mg/dl or a serum lactate dehydrogenase (LDH) level greater than two and one-half time (2.5x) the upper limits of the normal range at the implanting center occurring after the first 72 hours post-implant in the absence of clinical symptoms or findings of hemolysis or abnormal pump function.

29 Hemolysis Definition Major Hemolysis: A plasma-free hemoglobin value greater than 20 mg/dl or a serum lactate dehydrogenase (LDH) level greater than two and one-half times (2.5x) the upper limits of the normal range at the implanting center occurring after the first 72 hours post-implant and associated with clinical symptoms or findings of hemolysis or abnormal pump function. Major Hemolysis requires the presence of one or more of the following conditions: Hemoglobinuria ( tea-colored urine ) Anemia (decrease in hematocrit or hemoglobin level that is out of proportion to levels explainable by chronic illness or usual post-vad state) Hyperbilirubinemia (total bilirubin above 2 mg%, with predominately indirect component) Pump malfunction and/or abnormal pump parameters

30 Hemolysis Zone Information that you provide in this section will be used to assess the existence of hemolysis and its degree Please enter the peak Plasma-free hemoglobin (PFhg) since the last follow-up visit: mg/dl. ST= Unknown or Not Done. What is your hospital s upper limit of the normal range of PFhg: mg/dl. ST= Unknown or Not Done. Please enter the peak serum lactate dehydrogenase (LDH) since the last followup visit: U/L. ST= Unknown or Not Done. What is your hospital s upper limit of the normal range of LDH: U/L. ST= Unknown or Not Done.

31 Hemolysis Zone Information that you provide in this section will be used to assess the existence of hemolysis and its degree Enter the Maximum and Minimum HCT or HGB since the last Follow-up visit: Max. HCT: ST = Unknown or Not Done. Max. HGB: ST = Unknown or Not Done. Min. HCT: ST = Unknown or Not Done. Min. HGB: ST = Unknown or Not Done. Highest Total Bilirubin since the last Follow-up period: mg/dl. ST= Unknown or Not Done. Has the following been present at any time since the last Follow-up period? Physical Findings: Select all that apply: Hemoglobinuria (Tea-Colored Urine)? Yes, No, or Unknown. Pump malfunction and/or abnormal pump parameters? Yes, No, or Unknown. (If yes, please fill out the Device Malfunction Adverse Event Form)

32 Hypertension Definition New onset blood pressure elevation greater than or equal to 140 mm Hg systolic or 90 mm Hg diastolic (pulsatile pump) or 110 mm Hg mean pressure (rotary pump). PediMACS: Hypertension is defined as systolic, diastolic, or mean blood pressure greater than the 95th percentile for age which requires the addition of a new IV or oral therapy for management. The event shall be considered resolved upon the discontinuation of the treatment.