A message from Intermacs Principal Investigator

Greetings from Intermacs,

The Data Coordinating Center at Intermacs is once again glad to make this quarterly newsletter available to all clinicians, researchers, and industry representation interested in our organization’s activities. It is our intention to use this newsletter as a forum for providing various registry updates to the MCSD community. Managing data for over 16,000 patients requires contributions from all departments within Intermacs, and change can come from many of our moving parts. As an example, our nurse monitors collect and prioritize feedback they receive from center coordinators. This information is then reviewed by our administrators, and decisions are made that can affect areas of the registry ranging from web based data entry to data analysis, quality assurance reporting, or regulatory policies. With this newsletter, Intermacs has the opportunity to track the changes that so often occur within this fluid registry and to communicate updates to our users and consumers. Please take some time to read these quarterly offerings in order to gain a better understanding of how different parts of the organization influence registry operations. We are appreciative of the continued support we receive from all who have been part of the Intermacs adventure.

Kind regards,James. K. Kirklin

Interagency Registry for Mechanically Assisted Circulatory Support | intermacs@uab.edu | intermacs.org 1

Intermacs164 Active Sites16,621 Subjects Enrolled

MDR NoticeThe Food and Drug Administration has withdrawn the Single Reporter Exemption granted to Intermacs in 2007 and Intermacs is required to terminate all MDR-related activities effective immediately. Our understanding is that the FDA will be sending official notification of their decision to you in the next few weeks. In the meantime, Intermacs is amending the protocol and manual of operations and procedures (MOP) to reflect this change. Once you receive the official letter from the FDA, the staff at Intermacs would be happy to answer any questions.

Pedimacs63 Active Sites278 Subjects Enrolled

Research36 Published Articles75 Accepted Abstracts

10th Annual MeetingCelebrating a Decade of Progress

Omni Atlanta Hotel at CNN Center100 CNN Center Atlanta, GA 30303 USA

Coordinators Meeting Friday, March 11, 2016

Annual Meeting and Scientific Session Friday, March 11, 2016 Saturday, March 12, 2016

DAAP Decisions8/13/20156 proposals were reviewed5 received approval

MEMBERSHIP NEWSLETTER2015Volume 1, Fall Issue

Regulatory Reminders

Many Intermacs centers have been granted a waiver of informed consent and authorization during the past year with several more now exempt from the annual Institutional Review Board / Ethics Board (IRB/EB) review process. Even with these changes, there are still annual regulatory requirements that each center must meet to be considered an active participating center. Below is a brief explanation of those requirements.

Personnel RosterEach year Intermacs confirms the names, Intermacsroles, contact information and systems access foreach team member.

Financial Disclosure and Conflict of InterestAll team members must complete an annual Financial Disclosure and Conflict of Interest form.

Documentation of NIH Privacy Awareness TrainingEach team member is required to complete the NIHPrivacy Awareness Training course (Every two years or sooner if required by the local institution).

Clinical Laboratory Improvement Amendments (CLIA)

A current CLIA certificate for the hospital laboratoryand/or clinic is required.

Annual IRB/EB approvalDocumentation of annual Institutional ReviewBoard/Ethics Board (IRB/EB) approval is requiredand must be provided to the DCC prior to the expiration date on file. Centers that no longer require IRB/EB review are exempt.

The DCC will provide reminders whendocuments are due.

Interagency Registry for Mechanically Assisted Circulatory Support | intermacs@uab.edu | intermacs.org 2

Pedimacs Growth

Pedimacs continues to grow as noted by the August 2015 quarterly report showing 281 devices in 243 patients from 37 individual centers. In the next year, we will focus on enhanced participation from sites and individuals as well as auditing and monitoring enrolled sites for completeness of data. In addition, planned mergers with PHTS data and PHIS data are underway. The publications committee has been busy with several more analyses underway for ISHLT (infections post-VAD and temporary devices use in pediatrics) as well as the first look at the adult congenital group from Intermacs. With over 30 individual authors participating in writing groups thus far, the Pedimacs executive committee is committed to enhancing participation even more. Two upcoming meetings will attempt to do this, one at the AHA and the other at the Intermacs Annual meeting on March 11-12, 2016 in Atlanta. Plan to join us! Please feel free to reach out to Pedimacs leadership if you are interested.

Pedimacs Committee MeetingBroadening the Base of Participation

Sunday, November 8th 9:00am - 10:30am ESTBuena Vista Palace Hotel & Spa

1900 Buena Vista Dr, Lake Buena Vista, FL 32830

Data Security

Intermacs takes data protection very seriously. To keep data safe, we use a two-factor authentication for the web based data entry system. In the event that a password is stolen, the two-factor authentication will block unwanted access to the account. Setting up this additional security involves attaching a phone number or token to an account which will be used to verify the user’s identity when trying to access the system.

Intermacs is a FISMA compliant center. FISMA (Federal Information Security Management Act of 2002) is United States legislation that defines rigorous standards to ensure the protection of information from natural or man-made threats. Intermacs has gone through a series of evaluations to assess how we protect data. This process took approximately two years to complete. After the implementation of the plans, a third party investigation was also performed. Based on their evaluation and recommendations, the outcome was sent to the National Institute of Health (NIH) for approval stating that Intermacs has met the criteria to be a FISMA compliant center. Data entered into the web based data entry system is stored within the FISMA compliant data center. All this, and more, is to ensure that data entered into Intermacs is safe and secure.

CalendarQuarter

CoverageStop Date

DistributionDate

Q1Q2Q3Q4

March 31stJune 30thSeptember 30thDecember 31st

June 30thSeptember 30thDecember 31stMarch 31st

Quarterly Reports Schedule

Interagency Registry for Mechanically Assisted Circulatory Support | intermacs@uab.edu | intermacs.org 3

- New Feature -Live Data Download

We are excited to report that this fall Intermacs will launch a new feature in the Web Based Data Entry system where sites will be able to download data on a form by form basis. Sites will have access to all of the information they have entered into the system as a downloadable excel spreadsheet. Look for our announcement soon!

- New Feature -Site Datasets

Research datasets are now available to all participating centers. Datasets from the previous quarter will be uploaded alongside the quarterly reports and will be available for download from the web based data entry system for a period of 90 days.

Zip files containing these datasets are encrypted and can only be accessed by the site administrator. If problems occur downloading or extracting the files, contact either Jennifer Gunther (jgunther@uab.edu) or Maceo Cleggett (mclegg@uab.edu). Once you have downloaded and accessed the files, using statistical software available at your hospital, please contact John Pennington (kaseman@uab.edu) with any questions.

Data Requests

One of the goals of Intermacs is to develop consensus “best practice” guidelines to improve clinical management by reducing short and long term complications of MCSD therapy. Through Intermacs, data researchers have the opportunity to make critical, scientific insights about trends in mechanical support. Presenting and publishing these findings can be central to the aforementioned goal.

Interagency Registry for Mechanically Assisted Circulatory Support | intermacs@uab.edu | intermacs.org 4

Recent Publications

A New Bayesian Network-Based Risk Stratification Model for Prediction of Short-term and Long-term LVAD MortalityLoghmanpour NA, Kanwar MK, Druzdzel MJ, Benza RL, Murali S, Antaki JF.ASAIO J. May/June 2015; 61(3):313-323.

Regional Differences in Use and Outcomes of Left Ventricle Assist Devices: Insights from the Interagency Registry for Mechanically Assisted Circulatory Support RegistryKrim SR, Vivo RP, Campbell P, Estep JD, Fonarow GC, Naftel DC, Ventura HOJ Heart Lung Transplant. 2015 July; 34(7): 912–920.

Duration of Heart Failure Is an Important Predictor of Outcomes after Mechanical Circulatory SupportRenzo Y. Loyaga-Rendon, Deepak Acharya, Salpy V. Pamboukian, Jose A. Tallaj, Ryan Cantor, Randall C. Starling, David Naftel and James KirklinCirc Heart Fail. Published online before print August 6, 2015.

To see a list of all Intermacs publications and abstracts, visit:www.uab.edu/medicine/intermacs/existing-research/intermacs-existing-research/intermacs-publications

In order to receive data from the entire registry a researcher has the option to submit a data request along with a research proposal. There are two different types of data requests that can be submitted with both requiring approval from the Data, Access, Analysis, and Publications (DAAP) Committee:

If a researcher intends to do his/her own statistical analyses, a request for a de-identified, standardized dataset can be submitted. There is a dataset fee for non-Intermacs members. It is important to note that all datasets are provided in SAS format.

The other option is to submit a request for analysis by the Intermacs DCC. This benefit allows analyses from a collaboration between researchers and Intermacs statisticians and programmers.

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To submit a research request, please review the policies and forms:www.uab.edu/medicine/intermacs/research-proposals/intermacs-research-proposals

2015 ISHLT Meeting19 abstracts were presented using data from the Intermacs registry.15 of those abstracts/presentations had analyses performed by the Intermacs DCC.4 of those abstracts/presentations had analyses performed by researchers using de-identified datasets provided by the DCC.

2015 ISHLT References96 abstracts mentioned the term Intermacs, Pedimacs, or Medamacs

Clinical Affairs FAQ

Clinical Affairs often receives data collection and entry questions that may not be addressed in the Intermacs and Pedimacs Users’ Guides. Therefore, scenarios will be discussed in the ‘What Do I Do?’ section below, and in upcoming issues. We hope you find these suggestions helpful. Please do remember to reach out to the Clinical Affairs team when questions arise. Janella, Tammy, and Kathryn are eager to help and can be reached at the following:

Kathryn Hollifield: kathryn@uab.edu 205-996-9290 Janella Miller: jamiller@uab.edu 205-996-9291 Tammy Davis: trdavis@uab.edu 205-975-3119

What Do I Do?

Billy B. had a pump exchange 4 days after his primary implant. How do I enter this?An option has been added to the Implant Discharge Form for this scenario.

• Open the Implant Discharge Form• Select the option indicating the patient has a LVAD exchange during the primary implant hospitalization

• Include the date of the exchange

• Complete the remainder of the Implant Discharge Form• Complete and submit an Explant Form for the primary device• Click on ‘Add Device’ tab to enter the next device

Interagency Registry for Mechanically Assisted Circulatory Support | intermacs@uab.edu | intermacs.org 5