1 Data Quality Report Quality Assurance Report Live Data Download Site Datasets (SAS) Research Datasets 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 Quarterly Site (SAS) Datasets “Research Datasets” Susan Myers Director, Data Management & Quality Control

Relevant Financial Relationship Disclosure Statement Intermacs 10 th Annual Meeting: Session I Intermacs Products for the Sites: SAS Research Datasets Susan L. Myers, Director of Data Mgt 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 Putting the Pieces together for Research At your Hospital Hypotheses/Aims (What is your research question?) Analytical Team Statistician Data Manager

4 So, what are the differences between the LIVE form downloads and “Research datasets”? Live Form Downloads Real Time Live Data Each form is independent Exact data entered Site (SAS) Research datasets Quarterly Analytical ‘ready’ data Links all forms into 4 research datasets Contains derived intervals and indicators Integrity checks Built-in ‘30 day’ data entry allowance Recodes (e.g. ‘Other’ text boxes reviewed) Completed/Validated forms Putting the Pieces together for Research

5 Intermacs DCC MERGES Patient Dataset Device Dataset Follow-up Dataset Events Dataset “Research Datasets” All Forms “Live” Putting the Pieces together for Research

6 1 record per “patient” (contains demographics, primary implant information, overall outcomes) 1 record per “implant operation” per patient (contains demographics, ALL implant information, outcomes for a single implant) 1 record per “follow-up visit” per implant operation per patient (contains follow-up visit information, e.g. labs, hemodynamics, etc) 1 record per “adverse event” per implant operation per patient (contains adverse event information, e.g. date of occurrence, information based on Intermacs AE definition) What is contained in a ‘research dataset’? Patient Dataset Device Dataset Follow-up Dataset Events Dataset

Quarterly Site (SAS) Datasets “Research Datasets” Examples of statistical analyses that can be performed with your site’s SAS research datasets Overall survival Survival by Device type Time to First DLI by era Risk Factor analyses: Death Model

Quarterly Site (SAS) Datasets “Research Datasets” Hospital X: implants June 2006 – December 2015, n=100 patients Overall Survival Months post implant % Survival Months post implant% Survival 391% 688% 1278% 2455% 3639% Event: death on device (censored at transplant, recovery, exchange)

Quarterly Site (SAS) Datasets “Research Datasets” Hospital X: implants June 2006 – December 2015, n=100 patients Survival by Device Type Months post implant % Survival Event: death on device (censored at transplant, recovery, exchange) LVAD, n=85, deaths= 27 Bi-VAD, n=12, deaths= 4 TAH, n=3, deaths=0 P (overall) =.36

P (overall) = vs p= vs p= vs p=.03 Months post implant % Freedom of Driveline Infection Event: time to first driveline infection according to era , n=19, events= , n=34, events=3 Quarterly Site (SAS) Datasets “Research Datasets” Hospital X: implants June 2006 – December 2015, n=100 patients Time to First Driveline Infection by Era , n=47, events=12 % Freedom from DLI Era at 1 year post implant % % %

Quarterly Site (SAS) Datasets “Research Datasets” Hospital X: implants June 2006 – December 2015, n=100 patients Multivariable Hazard analyses for death Early hazardConstant hazard Risk Factors for Death Hazard Ratiop-valueHazard Ratiop-value Demographics Age (younger) Non-Cardiac Systems Diabetes Clinical Status NYHA Class Right Heart Dysfunction Total Bilirubin (higher)1.21<.0001

12 Only the Site Administrator at your Hospital can download your Site SAS Research Datasets! Reports

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14 Information Security Agreement when Downloading Intermacs data

Intermacs Site Datasets (SAS) Research Datasets: Patient Dataset: This file contains one record per patient at your site Device Dataset: this file contains one record per implanted device at your site Follow-up Dataset: this file contains all follow-up visits for each implant operation/patient at your site Events Dataset: this file contains all adverse events for each implant operation/patient at your site Text files: The DCC provides the 4 research datasets (patient, device, follow-up and events) as text delimited files Documentation: Intermacs Standard Formats ( ).sas Printable Forms v (a folder of pdf files) Annotated Printable Forms v3.0 (a folder of pdf files) Intermacs Users Guide v – Data Dictionary.docx What materials does your Site Administrator receive with your Research Site Datasets?

If you need assistance with using your site’s SAS Research Datasets please contact: John Pennington Data Analyst 16