Cardiovascular 3: Cardiovascular Modeling
Tuesday, April 10, 4:00-5:30, Ballroom C, University Hotel Minneapolis

Organizer: Alex Hill, PhD, Principal Scientist, Structural Heart Research & Technology, Medtronic, Inc.

“Computational Modeling of Cardiovascular Devices”
Carl Popelar, PhD, Mechanics & Materials, Southwest Research Institute

"Comparison of the Motion at the Origin of the Left Subclavian between Pigs and Humans"
Srinivasan Varahoor, PhD, Sr R&D Engineer, Endovascular Innovation, Medtronic, Inc.

"Regulatory Perspective on Computational Modeling"
Tina Morrison, PhD, Mechanical and Biomedical Engineer, Food and Drug Administration

Session Abstract:

Computational modeling plays an important role in the development of cardiovascular devices.  In order for a computational model to be relevant, several factors need to be considered.  This session will include three presentations, which will focus on the definition of the boundary conditions used as inputs to the models, modeling and the impacts to device design and testing, and the regulatory perspective on computational modeling.

Session Organizer Bio:

Alex Hill, PhD, Principal Scientist, Structural Heart Research & Technology, Medtronic, Inc.
Dr. Alex Hill received a BA in biology from Gustavus Adolphus College in 1997, a MS in biomedical engineering from the University of Minnesota in 2000, and a PhD in biomedical engineering from the University of Minnesota in January 2004. In graduate school, he studied large mammalian comparative cardiac anatomy and physiology, as well as biomedical device design and testing; additionally, he worked on the Visible Heart preparation. Following graduate school, Dr. Hill joined Medtronic and worked for three years at the research laboratory, serving as an animal model consultant and developing techniques for infarct assessment using MRI. Following that, he joined Medtronic’s CardioVascular Division and is working as a principal scientist on transcatheter heart valves, specifically studying anatomy, imaging, and in vivo characterization. He was named a Medtronic Technical Fellow in 2011. Dr. Hill also serves as an adjunct assistant professor in the Department of Surgery at the University of Minnesota.

Speaker Bios:

Carl Popelar, PhD, Mechanics & Materials, Southwest Research Institute
Dr. Carl Popelar manages the Mechanics & Materials section at Southwest Research Institute, an independent nonprofit applied R&D organization. This section focuses on characterizing the mechanical behavior of materials for use in developing integrity and reliability assessments. Dr. Popelar’s research focuses on testing and analysis in the development of medical devices, with particular emphasis on fatigue and fracture of polymers. Prior to joining SwRI, he managed the Materials Technology and Reliability groups at CarboMedics, a leading heart valve manufacturer, and managed the Numerical Modeling group at Medtronic Cardiac Rhythm and Disease Management. He is the current chair of the ASME V&V 40 committee on Verification and Validation in Computational Modeling of Medical Devices. Dr. Popelar received his PhD in Engineering Mechanics from the University of Texas at Austin, and his MS (Engineering Mechanics) and BS (Metallurgical Engineering) from the Ohio State University.

Srinivasan Varahoor, PhD, Sr R&D Engineer, Endovascular Innovation, Medtronic, Inc.
Srinivasan “Konix” Varahoor is a Principal Engineer at the Endovascular division of Medtronic in Santa Rosa, CA. He has been with Medtronic for over six years, focusing on quantifying aorta geometry and boundary conditions, and developing patient-based models. He received his PhD from the University of Rochester, Rochester, NY.

Tina Morrison, PhD, Mechanical and Biomedical Engineer, Food and Drug Administration
Dr. Tina Morrison is a mechanical engineer who studied Cardiovascular Biomechanics for two years as a post doctoral fellow at Stanford University. Her research focused on quantifying the in vivo deformations of the thoracic aorta from CT imaging. She continues her research efforts at the Food and Drug Administration at the Center for Devices and Radiological Health in the Office of Device Evaluation. Currently she is the point-of-contact for the Office of Device Evaluation regarding computational modeling and medical device simulation. She has been a scientific reviewer and principal investigator on two projects, and a technical expert on another since 2008. She is a co-principal investigator on a Critical Path Initiative (CPI)-funded project titled "Leveraging the Simulation-Based Engineering and Medical Imaging Technology Revolutions for Cardiovascular Devices", where she is greatly involved in an effort to enhance the use of simulation-based engineering and computational modeling in the evaluation of medical devices. Additionally, she is the principal investigator on a CPI project titled “Characterization of Human Aortic Anatomy Project (CHAP)”, a multicenter study examining the anatomical parameters of diseased aortas. She provides technical expertise regarding finite element analysis and medical imaging for another project titled “Assessment of plaque composition, dynamic biomechanics, and therapeutic outcomes in subjects implanted with endovascular devices (ASPECT)”. She received her PhD in Theoretical and Applied Mechanics from Cornell University in 2006.

Presentation Abstracts:

“Computational Modeling of Cardiovascular Devices”
Computation modeling of cardiovascular devices has become a valuable tool that can aid in the design and development of safe and effective devices. This increased emphasis on modeling necessitate increased emphasis on the development of validated model that accurate reflect relality. This paper will focus on the challenges and considerations in developing validated computational models of cardiovascular devices.

"Comparison of the Motion at the Origin of the Left Subclavian between Pigs and Humans"
Understanding how preclinical models compare with the use-conditions in humans is critical for assessing the relevance of the outcomes of a preclinical study. The porcine model is widely-accepted for the preclinical evaluation of endovascular stent graft devices intended for the thoracic region. In this study, we aim to characterize the non-radial arterial deformation to understand the overall motion at the Left Subclavian (LSC) origin, and evaluate how deformation in the juvenile porcine model compares to that in older humans.

"Regulatory Perspective on Computational Modeling"
Computational modeling has been recognized by the Center for Devices and Radiological Health as an innovative tool for advancing medical device evaluation and regulatory science. One of the strategic priorities for 2012 is the development of a Public-Private-Partnership centered around advancing regulatory science with computational modeling. Many efforts are underway in the Division of Cardiovascular Devices to help further this initiative, including projects to collect data on boundary and loading conditions. Thus, the goal of my presentation is to highlight the current uses of computational modeling in device applications, present some of the challenges and limitations, and discuss what we can do as a community to advance regulatory science with computational modeling.

Related Sessions:

Cardiovascular 1 Cardiac Keynote Presentations
Cardiovascular 2 Pre-Clinical Testing of Novel Cardiovascular Devices
Cardiovascular 4 Cardiac Electrophysiology and Mapping
Cardiovascular 5 Cardiac Ablative Therapies
Cardiovascular 6 Cardiac Devices in the Pediatric Population