- "FDA Will Believe it When They See It - Virtually (NAFEMS)"
- "Personalized Healthcare in..."(NAFEMS)
- "Stanford University and UberCloud..."(HPC Wire)
- 3D Digital Community..." (MDDI Device Talk)
- A Spatiotemporal Model..."(Scientific Computing)
- "Virtual Human Modeling..." (3Dprint.com)
- "Role of Digital Methods..."(Digital Engineering)
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 pacemaker leads and other cardiovascular devices are being evaluated, bringing the Living Heart Project closer to providing personalized, interventional cardiac-patient care.
The collaboration with the U.S. Food and Drug Administration was recently extended for an additional five-years to spur medical device innovation by enabling innovative, new product designs. This second phase of this ongoing collaboration supports the 21st Century Cures Act, using virtual patients based on computational modeling and simulation to improve efficiency of clinical trials for new device designs. A groundbreaking project with the Living Heart simulated 3D heart model will examine the use of heart simulation as a source of digital evidence for new cardiovascular device approvals. This includes an in silico clinical trial aimed to reduce animal testing or the number of patients required while still ensuring safety and efficacy of the device is demonstrated. The new digital process is intended to be more efficient and less expensive than current ones – whose delays and costs can impede patient access to novel treatments – without losing rigor or confidence in a device’s safety and efficacy. Researchers hope the first-of-its-kind process will increase industry innovation and pave the way for an efficient path for patients to access safe, effective new treatments for the world’s leading cause of death – heart disease.
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:
- Claire Conway, Ph. D. | Aston University
- Aswan Heart Center / Magdi Yacoub Heart Foundation
- Jacob Bortman, Ph.D. | Ben Gurion University of Negev
- Raymond Watrous, Ph.D. | Biomedical Engineering Scientist
- Emma Lejeune, Ph.D. | Boston University
- California Medical Innovations Institute, Inc.
- Alessio Gizzi, Ph.D. | Campus Bio-Medico University of Rome
- Daniel Burkhoff, Ph.D. | Cardiovascular Research Foundation
- Veysel Ödemis, M.D. | Carl-von-Ossietzky University Oldenburg
- Gregor Theilmeier, M.D. | Carl-von-Ossietzky University Oldenburg
- Sang-Eui Lee | Changwon National University
- Zdeněk Horák, Ph.D. | College of Polytechnics Jihlava
- W. Paul Segars, Ph.D. | Duke University
- Sandra Loerakker, Ph.D. | Eindhoven University of Technology
- Christian Stoeck, Ph.D. | ETH Zurich
- Sebastien Kozerke, Ph.D. | ETH Zurich
- Abas Abdoli, Ph.D. | Florida International University
- George Dulikravich, Ph.D. | Florida International University
- Harvard Medical School
- Declan O'Regan | Imperial College London
- Indian Institute of Technology Hyderabad
- Instituto do Coracao (Heart Institute), Hospital das Clinicas HCFMUSP
- Ellen Roche, Ph.D | Massachusetts Institute of Technology
- Kumaran Kolandaivelu, M.D., Ph.D. and Cardiologist | Massachusetts Institute of Technology
- Max Planck Institute for Dynamics and Self-Organization
- 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
- Alireza Heidari, Ph.D. | McGill University
- Rosaire Mongrain, Ph.D. | McGill University
- National Research Council Canada
- Oxford Brookes University
- Daniel Hurtado, Ph.D. | Pontificia Universidad Católica de Chile
- Chi-Seung Lee | Pusan National University
- Research Institute for Complex Issues of Cardiovascular Diseases
- Singapore Polytechnic
- Stephanie Reese, Ph.D. | RWTH Aachen University
- Simula Research Laboratory
- Ellen Kuhl, Ph.D. | Stanford University
- Alison Marsden, Ph.D. | Stanford University
- Daniel Bluestein, Ph.D. | Stony Brook University
- Gil Marom, Ph. D. | Tel-Aviv University
- Rami Haj-Ali, Ph.D. | Tel-Aviv University
- The American University in Cairo
- Tom Hund, Ph.D. | The Ohio State University
- Manuel Rausch, Ph. D. | The University of Texas at Austin
- University College London
- University of Bonn
- Ivan Costa, Ph. D | University of Brasilia
- Daniel Ennis, Ph.D. | University of California Los Angeles
- 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
- Philipp Kügler, Ph.D. | University of Hohenheim
- Paul Iaizzo, Ph.D. | University of Minnesota, Visible Heart Laboratory
- Salvatore Pasta, Ph.D. | University of Palermo
- Neil Bressloff, Ph.D. | University of Southampton
- Clark Meyer, Ph.D. | University of Texas at Dallas
- University of Ulsan
- Alexander Veress, Ph. D. | University of Washington
- West Virginia University
- Zienkiewicz Centre for Computational Engineering at Swansea University
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:
- 4RealSim Services B.V.
- Admedes Schuessler GmbH
- Bayer Pharmaceuticals
- Boston Scientific Corporation
- Computational Life
- Edwards Lifesciences
- enmodes GmbH
- Exponent, Inc.
- Front End Analytics
- Hewlett-Packard Enterprise
- Infosys Limited
- Insilicomed, Inc.
- Medtronic, Inc.
- NextFlow Software
- Nitinol Devices & Components, Inc. (NDC)
- Nuno Rebelo Associates LLC
- Olympus Corporation
- Optimal Device
- Philips Research
- Rize, Inc.
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Sorin Group
- St. Jude Medical, Inc.
- Strategic Simulation & Analysis (SSA)
- Terumo Interventional Systems Division
- Thornton Tomasetti, Weidlinger Applied Science
- 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:
- David Hoganson, M.D. | Boston Children's Hospital
- Volkmar Falk, M.D. | Deutsches Herzzentrum Berlin
- Fuwai Hospital
- Elazer Edelman, M.D., Ph.D. | Massachusetts Institute of Technology
- Marcello Gomide, M.D. | National Institute of Cardiology
- National Heart Centre Singapore
- James C. Perry, M.D. | Rady Children’s Hospital, San Diego
- Elaine Tseng, M.D. | San Francisco VA Medical Center
- Partho Sengupta, M.D.
- Shanghai Children's Medical Center
- Robert Schwengel, M.D., FACC | Southcoast Physicians Group
- The German Heart Competence Center at Tübingen
- Liviu Klein, M.D., M.S. | University of California, San Francisco
- Andrew Wisneski | University of California San Francisco
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.