Oh the Places You Will Go: Brief Summary Highlighting Major Events and Changes during

the Transition from NHLBI to STS

Francis D. Pagani MD PhDOtto Gago MD Endowed Professor of Cardiac Surgery

University of Michigan

INTERMACS REGISTRY JOINS THE STS NATIONAL DATABASE

INTERMACS•Established at the UAB in 2005 as a joint effort of the

NHLBI, FDA, CMS and clinical centers•North American registry for patients who receive an

FDA-approved durable implantable, mechanical circulatory support (MCS) device to treat advanced heart failure

•Participation in a national registry is required by the Joint Commission for all US centers implanting MCS devices for destination therapy

Longitudinal Follow-up

•Inclusion of INTERMACS represents a new chapter in the history of the STS National Database in light of the registry’s collection of longitudinal data

•INTERMACS collects longitudinal data throughout the life of a patient with an MCS device

•This brings an entirely new perspective to the STS National Database

INTERMACS Clinical Site Enrollment:as of September 2019

STS Intermacs:• Active (Prior UAB

participants): 159• Active (New): 15• Pending: 3• Percent (prior UAB): 98%• Expected (prior UAB): 162• Total number of active

Intermacs sites: 174

STS Pedimacs:• Active (Prior UAB

participants): 41• Active (New): 6• Pending: 2• Percent (prior UAB): 95%• Expected (prior UAB): 43• Total Number of active

Pedimacs sites: 47

Multidisciplinary Task Force Composition

•INTERMACS Task Force brought into the STS current structure of its national databases

•Task Force is unique in that it is comprised of surgeons and cardiologists

•This unique collaboration is essential to the field and insures engagement and leadership from all stakeholders

Council on Quality, Research, and Patient Safety

Workforce Research

Development

Workforce on Evidence Based

Surgery

Workforce on National

Databases

Adult Cardiac Surgery Database

Taskforce

Congenital Heart Surgery Database

Taskforce

General Thoracic Surgery Database

Taskforce

IntermacsTaskforce

Workforce on Patient Safety

Frank Pagani, ChairDavid MoralesChris SalernoRobert HigginsJames YoungLynne Warner StevensonDanial GoldsteinDavid RosenthalBetsy BlumeIki AdachiJeff JacobsJeff Tueteburg

Jennifer CowgerJoe ClevelandJoe RossanoJonathan HaftJosef StehlikEzequiel MolinaPavan AlturiSimon MaltaisTom McGillivrayScott SilvestryNir UrielKristen NelsonDavid Peng

William Seward, STS Associate

Executive DirectorDonna McDonaldKathryn HollifieldElaine Weiss,

STS Executive Director

STS INTERMACS Leadership

Kathryn Hollifield, BSN RNSTS National Database Manager-IntermacsPhone: 312.202.5879Email: khollifield@sts.org

Important Priorities

•Emphasis of the registry on Quality Initiatives / Quality Assurance-Development of NQF-endorsed measures

•Ensuring the registry is relevant to Stakeholders•Quarterly Site Reports

-Data quality reports-Quality assurance reports

Current State of Intermacs

Current State of Intermacs

Current State of Intermacs

Future State of Intermacs

Developing Quality Measures

Developing Quality Measures

INTERMACS Task Force

•Annual Writing Group Report•Quality Initiative Sub-committee•Patient Reported Outcomes Sub-committee•Stakeholders group

Questions?

FAQ’S•Do I put my patient in both Intermacs and the STS

Adult Cardiac Surgery Database?•My patient is receiving a non-approved FDA

implantable LVAD. Do I put my patient into Intermacs?

•My patient is receiving a temporary mechanical circulatory support device (i.e., Impella or TandemHeart pump). Do I put my patient into Intermacs?