Building a Minnesota Congenital Heart Network

The Current Status of CHD Leading cause of infant deaths in the US #1 cause of birth defect related deaths 1,000,000 CHD births worldwide Cost for surgical repair: >$2.2 billion/yr in US Children’s Heart Foundation Fact Sheets

CHD Morbidity Feeding difficulties Learning difficulties –Lower IQ scores –25% require special education services –20-50% display gross or fine- motor dysfunction –Language delays Decreased functional independence Social/emotional maladjustment Increased parental risk for anxiety, depression, and reduced quality of life Majnemer et al Sem Ped Neur 1999; 6: Helfricht et al PCCM 2008;9:

The Good News! Current surgical mortality rate: 2 to 4% CHD death rates have declined by 30% in the last decade Estimated 2,000,000 CHD survivors in United States More than 50% of CHD survivors are adults

Changing Paradigm Quantity of Life Quality of Life

Risk Factors for Morbidity Cardiopulmonary bypass Deep Hypothermic Circulatory Arrest Peri-operative hemodynamic lability Undesirable pharmacotherapy effects Prolonged mechanical ventilation How do we define strategies that decrease risk for morbidity? that decrease risk for morbidity?

In a perfect world we would….. Compare current perioperative management through clinical trial investigation Identify superior strategies that translate into improved long term outcomes

Major Obstacles Lie Ahead

Clinical Obstacles Every institution is unique Congenital heart disease is relatively rare Establishing clinical equipoise

Investigational Obstacles Gauging improvement Measuring morbidity Choosing outcome measures –Morbidity is multi-factorial –Surrogate markers???? Delayed outcomes –Child must age –Losses to follow up

Overcoming the Obstacles +

Minnesota Congenital Heart Network Objectives Establish a collaborative multicenter multidisciplinary network to develop and implement clinical research proposals evaluating congenital heart disease management. Define the current perioperative environment. Develop strategies for long term follow up linked to acute perioperative interventions and outcomes.

MCHN Objective #1 Establish a collaborative multicenter multidisciplinary network to develop and implement clinical research proposals evaluating congenital heart disease management.

MCHN Infrastructure Clinical Investigators Core: Network members represent all the clinical areas involved in CHD perioperative care: Cardiology, Anesthesiology, Perfusion, Critical Care Nursing, and Pharmacy. This type of multidisciplinary representation is ensuring that clinical research questions are asked with a multidisciplinary voice and have a greater impact on a broader spectrum of patient care. Biostatistical Core: Designing and analyzing CHD clinical trials presents many challenges due to the heterogeneous patient populations and the potential confounding of diverse management strategies. Appropriate utilization of and design for collecting data requires experienced biostatistical support to maximize the potential clinical implications of research findings. The MCHN is addressing these concerns by involving experienced and advanced biostatistical support at all levels of the clinical research design and analysis process. Biomedical Informatics Core: The MCHN’s objective to collect and analyze clinical data generated during and after congenital heart surgery requires techniques for efficient and accurate data collection, sharing, and analysis. The bioinformatics core is essential for leveraging current informatic tools to facilitate MCHN CHD research initiatives.

MCHN Objective #2 Define the current perioperative environment.

Rationale Provides backdrop for interpreting future clinical investigations Highlights differences in peri-operative strategies for future clinical trial comparison Informs medical community regarding current clinical practice variation Establishes clinical equipoise

Defining the Perioperative Environment Comprehensive collection of acute perioperative vital statistics

Information Gained Representative graph of cohort Clinicians are informed of how the perioperative period looks Identify “vulnerable” peri-operative periods Compare changes in this background as new management strategies are introduced. Identifies an institution specific “fingerprint”

Overcoming Data Collection Obstacles

DATABASE DATABASE

Multi-institutional Sharing of MCHN Data Overview of System Design. CHD- specific terms will be identified and used to supplement existing biomedical ontologies, for the annotation of CHD-specific metadata. Secure data exchange between interoperable CHD systems will be achieved using caGrid. An internal CHD datamart will be developed at each institution, which will be queried by the grid-enabled CHD data service. The two EHR systems and the Mayo Clinic CHD datamart already exist; the caGrid nodes and CHD data services are being developed through an award from the MN Partnership for Bioinformatics and Genomics.

Accessing MCHN Data Querying the MCHN Data Infrastructure. The hashed arrows show the query being distributed via the caGrid to each institutional CHD datamart. The open arrows show data being returned to the investigator. Existing caGrid applications may be used where appropriate (i.e. Statistical Toolbox).

Inaugural MCHN Clinical Trial Defining the perioperative inflammatory/stress response

Trial Objective: To describe baseline adrenal function and the impact of congenital cardiac surgery on the hypothalamic-pituitary-adrenal axis.