The Living Heart Project
A Translational Research Initiative to Revolutionize Cardiovascular Science Through Realistic Simulation
What if physicians and surgeons could virtually analyze their patients’ health and plan therapies and surgeries using the same advanced simulation technology that the automotive, aerospace, energy and hi-tech industries rely on to test their product before they are built? What if medical devices could be designed and safely tested in the virtual world before ever being tested in the real world?
IF WE apply the power of realistic simulation to human modeling, we can revolutionize medical care.
The Living Heart Project is uniting leading cardiovascular researchers, educators, medical device developers, regulatory agencies, and practicing cardiologists on a shared mission to develop and validate highly accurate personalized digital human heart models. These models will establish a unified foundation for cardiovascular in silico medicine and serve as a common technology base for education and training, medical device design, testing, clinical diagnosis and regulatory science —creating an effective path for rapidly translating current and future cutting edge innovations directly into improved patient care.
The Living Heart Project is driven by a growing ecosystem that is fueling the collaborative development of validated, commercially available heart models and exploring novel digital therapies. The Living Heart Project signed a five-year collaborative research agreement with the United States Food and Drug Administration (FDA). Together with the Project participants listed below, testing paradigms beginning with the insertion, placement and performance of peacemaker leads and other cardiovascular devices will be evaluated, bringing the Living Heart Project closer to providing personalized, interventional cardiac-patient care.
Who is participating in The Living Heart Project
Decades of important research have already created a wealth of information on various aspects of heart function. Only recently have spectroscopic techniques advanced sufficiently to reveal the critical subtleties in geometric structure and physiological phenomena that are essential to developing a more complete understanding of the dynamics of the heart. Further complexities in heart function—particularly in congenitally defective and diseased hearts and their interaction with interventional medical devices and replacement structures—require additional research. 3D modeling of the heart, based on real-world, patient-specific input, can unite all of this data and support promising research in advanced surgical and therapeutic directions.
Current Project Members:
- California Medical Innovations Institute, Inc.
- Veysel Ödemis, M.D. | Carl-von-Ossietzky University Oldenburg
- Gregor Theilmeier, M.D. | Carl-von-Ossietzky University Oldenburg
- W. Paul Segars, Ph.D | Duke University
- Kumaran Kolandaivelu, M.D., Ph.D. and Cardiologist | Massachusetts Institute of Technology
- James F. Greenleaf, Ph.D. | Mayo Clinic College of Medicine, Ultrasound Research Laboratory
- Matthew W. Urban, Ph.D. | Mayo Clinic College of Medicine, Ultrasound Research Laboratory
- Daniel Hurtado, Ph.D | Pontificia Universidad Católica de Chile
- Research Institute for Complex Issues of Cardiovascular Diseases
- Simula Research Laboratory
- Ellen Kuhl, Ph.D. | Stanford University
- Claudio Capelli, Ph.D. | University College London
- Silvia Schievano, Ph.D. | University College London
- Ivan Costa, Ph. D | University of Brasilia
- Julius Guccione, Ph.D | University of California, San Francisco
- Neil Davies, Ph. D | University of Cape Town
- Thomas Franz, Ph. D | University of Cape Town
- Xiaoyu Luo, Ph.D | Unviersity of Glasgow
- Paul Iaizzo, Ph.D. | University of Minnesota, Visible Heart Laboratory
- Olga Barrera, Ph.D. | University of Oxford
- Zhong You, Ph.D. | University of Oxford
How are researchers supporting the Living Heart Project?
Academic and clinical researchers monitor, evaluate and influence the development of the heart models in a collaborative way as the project progresses. Their suggestions for model refinement, new applications, technological implementation or contributions of model or validation data contribute to the pursuit of realistic simulations capable of reliably replicating clinically observed behavior.
Computer simulation is increasingly being viewed as an essential design tool by cardiac device and services companies. Computer simulation helps them visualize what they cannot see, replicate in vivo conditions, more fully explore the design space, refine ideas faster, and develop novel service solutions that are more effective and safer for patients. All of which leads to better designs and a reduction in expensive prototyping and testing, allowing companies to get products and services to market faster.
Current Project Members:
- Admedes Schuessler GmbH
- Exponent, Inc.
- Infosys Limited
- Insilicomed, Inc.
- Medtronic, Inc.
- Nitinol Devices & Components, Inc. (NDC)
- Optimal Device
- Philips Research Suresnes
- Sorin Group
- St. Jude Medical, Inc.
- Strategic Simulation & Analysis (SSA)
- W.L. Gore
- zSpace, Inc.
- Zygote Media Group
How are industry members supporting the Living Heart Project?
Information-gathering for the project is taking place in a pre-competitive manner – i.e., not device-specific, but disease-specific—so that product information and patent protection is assured. Companies are evaluating the model for applications in their areas of interest. Their suggestions for model refinement, new applications, technological implementation or contributions of model or test-validation data contribute to the pursuit of realistic simulations capable of reliably replicating clinically observed behavior.
The vast amount of public and private money that is spent on CVD research is never translated into clinical reality. At the core of this challenge is the difficulty in exploring new and innovative treatment options cost-effectively while meeting regulatory requirements for safety and efficacy.
In silico techniques hold great promise in their ability to yield unprecedented insight into basic function and, when sufficiently refined and validated, offer a risk-free environment for predicting in vivo results that may be unobtainable any other way. Determining the appropriate clinical treatment for CVD can be greatly enhanced when combined with the insight and guidance revealed through accurate simulation of heart function.
Clinicians are participating in The Living Heart Project to evaluate the readiness of such simulation tools to current problems, and to help drive the development of state-of-the-art technologies and applications that will further improve patient care.
Current Project Members:
- Elazer Edelman, M.D., Ph.D. | Massachusetts Institute of Technology
- James C. Perry, M.D. | Rady Children’s Hospital, San Diego
- Elaine Tseng, M.D. | San Francisco VA Medical Center
- Robert Schwengel, M.D., FACC | Southcoast Physicians Group
- Volkmar Falk, M.D. | University Hospital of Zurich
How are clinicians supporting the Living Heart Project?
Clinical practitioner involvement in the project is critical to ensure a patient-centered focus on the development of viable technologies that will improve diagnoses and treatment plans. By collaborating with project participants, clinicians provide valued guidance in how best to use the power of simulation to diagnose and treat patient-specific conditions.
Clinicians monitor and evaluate the development of the model in a collaborative way as the project progresses over time. Their suggestions—based on actual patient experience, ideas about applications to specific disease states, and/or thoughts about model enhancement or refinement derived from clinical data—contribute to the pursuit of realistic simulations capable of reliably replicating observed behavior.
Regulatory compliance is a key component of device development. The U.S. Food and Drug Administration (FDA), through initiatives such as the creation of a simulation model repository and Medical Device Design Tools (MDDTs), has stepped up efforts to more actively encourage the use of simulation. The FDA recognizes the value of simulation for device development, for cardiac services and treatments, and for virtual testing that supports the approval of device submissions. Simulation is also understood to help reduce animal testing and clinical trial costs, improve upon bench testing, and provide deeper understanding of in vivo behavior where traditional methods of assessing devices simply aren’t possible.
Through sponsorships and active participation in organizations like the Medical Device Innovation Consortium (MDIC) the FDA is exploring how to leverage simulation to advance regulatory science through various initiatives.
How are regulatory agencies supporting the Living Heart Project?
Perhaps the greatest challenge for any medical regulatory agency is accessing the safety of new devices without relying on costly and invasive human testing. Regulatory science stakeholders monitor and evaluate the development of the model in a collaborative way as the project progresses over time. Their participation is valuable in assessing the validity of the heart model for its mechanical and material properties, in developing test protocols, and in creating strategies for validation of the heart model for specific contexts of use.