1 Intermacs 10 th Annual Meeting and Scientific Sessions Intermacs: Products for the Sites Friday, March 11, 2016: 7:00-8:30pm Omni Hotel, Grand Ballroom Atlanta, Georgia Speakers: David C. Naftel, Kathryn Hollifield, Susan Myers, Devin Koehl, Ryan Cantor

Relevant Financial Relationship Disclosure Statement Intermacs 10 th Annual Meeting: Session I Intermacs Products for the Sites: David C. Naftel, PhD I will not discuss off label use and/or investigational use of the following devices: The following relevant financial relationships exist related to my role in this session: None

3 10 th Annual Meeting: Friday, March 11 th – Products for the Sites Kathryn Hollifield, BSN RN - Director of Clinical Affairs Devin Koehl, BS - Research Programming and Statistical Review Susan Myers, BS - Director, Data Management & Quality Control Ryan S. Cantor, MSPH - Director, Statistical Reporting Special thanks to Rama Rudraraju and Nick Timkovich for their continued, extensive programming efforts in the development of these web based reporting tools.

4 10 th Annual Meeting: Friday, March 11 th – Products for the Sites What is INTERMACS ? INTERMACS is the North American registry for patients who are receiving durable, FDA approved mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives.

5 10 th Annual Meeting: Friday, March 11 th – Products for the Sites Facilitate the refinement of patient selection to maximize outcomes with current and new device options. Identify predictors of good outcomes as well as risk factors for adverse events after device implantation. Develop consensus “best practice” guidelines to improve clinical management by reducing short and long term complications of MCSD therapy. Guide clinical application and evolution of next generation devices. Utilize Registry information to guide improvements in technology, particularly as next generation devices evolve. Original Goals of the Registry

6 10 th Annual Meeting: Friday, March 11 th – Products for the Sites Expanding the Purpose of Intermacs: Protocol 4.0 (Jun 2014) “INTERMACS® now serves as the national quality improvement system to assess the characteristics, treatments, and outcomes of patients receiving MCSDs approved by the Food and Drug Administration (FDA).”

7 10 th Annual Meeting: Friday, March 11 th – Products for the Sites Goals of the Registry: Protocol 4.0 (Jun 2014) The purposes of INTERMACS® include: 1.Collecting pertinent and standardized patient demographic, clinical and device related data elements from participating hospitals to measure and assess the quality of care and outcomes for patients receiving MCSDs; (nationally and hospital specific) 2.Providing confidential periodic reports to the participating hospitals, government agencies, and industrial partners to improve the quality of care of patients receiving mechanical circulatory support and to evaluate the effectiveness and optimal utilization and performance of these devices; 3.Fostering collaborative research based upon the data collected by means of INTERMACS®; and 4.Serving as a scalable data infrastructure for pre and post market studies.

8 10 th Annual Meeting: Friday, March 11 th – Products for the Sites FDA Hospitals Industry Clinicians CMS NHLBI FDA

9 10 th Annual Meeting: Friday, March 11 th – Products for the Sites Sites Intermacs NIH FDA Industry Researchers CMS

10 10 th Annual Meeting: Friday, March 11 th – Products for the Sites Sites Intermacs NIH FDA Industry Researchers CMS

11 10 th Annual Meeting: Friday, March 11 th – Products for the Sites Audience for this Session All stakeholders in the MCSD Community Personnel at the local Intermacs Hospitals MCSD Clinical Team Cardiac Surgeon Cardiologist Nurse Coordinator Analytical Team Site Administrator (key connection between the hospital and Intermacs)

12 10 th Annual Meeting: Friday, March 11 th – Products for the Sites Typical / Potential Questions from Sites (Coordinator, Surgeon, Cardiologist, etc) How do I get my data? How does our patient selection compare nationally? How many ‘Level 1’ patients have we implanted during the last 3 years? I need data for the Joint Commission What is the one year survival for our destination therapy patients? Is our driveline infection rate equivalent to the rate for the nation? What are our causes of death? For a specific patient (John Doe), what is the time course of his EQ5D How many Total Artificial Hearts (TAHs) have been implanted in women I have a statistician available to analyze risk factors for death in our patients What is my compliance rate for completing follow-up forms? How has the kidney function of a specific patient (John Doe) changed from pre- to post implant?

13 Topic Outline I. Accessing Your Data II. Patient Management Tools III. Patient Selection and Outcomes IV. Quality Initiatives V. Using Intermacs for Your Research 10 th Annual Meeting: Friday, March 11 th – Products for the Sites

14 Topic Outline I.Accessing Your Data How do I get my data? II.Patient Management Tools For a specific patient (John Doe), what is the time course of his EQ5D How has the kidney function of a specific patient (John Doe) changed from pre- to post implant? III. Patient Selection and Outcomes How does our patient selection compare nationally? How many ‘Level 1’ patients have we implanted during the last 3 years? Is our driveline infection rate equivalent to the rate for the nation? What are our causes of death? How many Total Artificial Hearts (TAHs) have been implanted in women IV. Quality Initiatives I need data for the Joint Commission What is my compliance rate for completing follow-up forms? V.Using Intermacs for Your Research What is the one year survival for our destination therapy patients? I have a statistician available to analyze risk factors for death in our patients 10 th Annual Meeting: Friday, March 11 th – Products for the Sites

15 Data Quality Report Quality Assurance Report Live Data Download Site Research Datasets (SAS) Customized Cohort Reports Outcome Analytics Patient Information I. Accessing Your Data Examining/Validating your data   Compliance Rates  Electronic copies of your data  II. Patient Management Tools Clinical timeline  Clinical measures across time  III. Patient Selection and Outcomes Quality Assurance Report  Cohort (subset) report  Benchmarking   IV. Quality Initiatives Joint Commission Internal Iniatives V. Using Intermacs for Your Research Within your site   Across Intermacs 10 th Annual Meeting: Friday, March 11 th – Products for the Sites Site Products Available Today Available July 1, 2016 “In testing” “In Development”

16 Data Quality Report Quality Assurance Report Live Data Download Site Research Datasets (SAS) Customized Cohort Reports Outcome Analytics Patient Information I. Accessing Your Data Examining/Validating your data   Compliance Rates  Electronic copies of your data  II. Patient Management Tools Clinical timeline  Clinical measures across time  III. Patient Selection and Outcomes Quality Assurance Report  Cohort (subset) report  Benchmarking   IV. Quality Initiatives Joint Commission Internal Iniatives V. Using Intermacs for Your Research Within your site   Across Intermacs 10 th Annual Meeting: Friday, March 11 th – Products for the Sites Site Products Available Today Available July 1, 2016 “In testing” “In Development”

17 10 th Annual Meeting: Friday, March 11 th – Products for the Sites July 1, 2016

18 10 th Annual Meeting: Friday, March 11 th – Products for the Sites Sites Intermacs Movement of data both directions follows all necessary regulatory and information security rules for PHI. Please note: Once we send your data back to you, then you are responsible for following your regulatory and information security rules for PHI. (Follow you hospital’s policies for thumb drives, laptops, Desktop, s, etc)

19 10 th Annual Meeting: Friday, March 11 th – Products for the Sites “Hospital X” We needed to create a generic hospital, including patient specific data, that could be used to generate: Site Data Quality report Site Quality Assurance Report Form Download tutorials and training SAS Research Dataset Customized Report training Outcome Analytic training Patient information examples With the advice and consent of the Intermacs regulatory and information security experts, we have created a ‘hospital x’ with 100 randomly identified patients from Intermacs. These patients have been totally “de-identified” and all dates have been ‘scrambled’.

20 Data Quality Report Quality Assurance Report Live Data Download Site Research Datasets (SAS) Customized Cohort Reports Outcome Analytics Patient Information I. Accessing Your Data Examining/Validating your data   Compliance Rates  Electronic copies of your data  II. Patient Management Tools Clinical timeline  Clinical measures across time  III. Patient Selection and Outcomes Quality Assurance Report  Cohort (subset) report  Benchmarking   IV. Quality Initiatives Joint Commission Internal Iniatives V. Using Intermacs for Your Research Within your site   Across Intermacs 10 th Annual Meeting: Friday, March 11 th – Products for the Sites Site Products Available Today Available July 1, 2016 “In testing” “In Development”