Dassault’s Living Heart Project achieves significant milestone with collaborative research agreement between the FDA and Dassault on the use of the heart model for planning pacemaker surgery.
The Living Heart Project is an ambitious project to create a digital simulation model of the human heart being driven by the Simulia division of Dassault Systèmes. As the name suggests, the model is of a functioning heart that can be observed as it beats, and it is designed for medical uses including diagnosis, surgical training, pre-surgery run-throughs, what-it scenarios for treatment, etc. In the latest news around the project, the United States’ Food and Drug Administration (FDA) and Dassault have announced a five year collaborative research agreement to develop testing paradigms for pacemaker leads. The study is interested in using the human heart model for the insertion, placement, and performance of leads. The study will also cover other cardiovascular devices used to treat heart disease. The work researchers, Dassault, and the FDA are doing is just one step on the path to creating functional digital simulators for the entire human body.
The FDA agreement was announced during during the recent Dassault Systèmes 3D Experience Conference in Las Vegas. In an interview, Dassault Chief Strategy Officer Steve Levine said the researchers now have a heart and a shoulder. The shoulder helps simulate the strains that might be placed on pacemaker leads as a person stretches their arm, maybe to catch that tennis shot. Levine has a background in life sciences and he has had a long interest in the potential of simulation technology in life sciences. His experience has taught him to believe that everything that exists can be simulated. He has said, “if you can imagine it, you can simulate it.” He has a special interest in the science of the heart because his daughter was born with a congenital heart condition and lives a healthy and active life thanks to advances in medicine.
Levine was early into this research as a result of people he has known in the world of cardiology. In fact he says, one introduction to this work came as a result of a tennis game with a medical researcher. At Dassault, Levine has been driving the project with strong collaboration and support from people in the medical research community. There are over 30 contributing member organizations with over 100 cardiologists, medical device companies, and academics collaborating on the project. Their first realistic 3D heart simulator moved into beta testing in May, 2014. In addition, the Project has already been used on a real patient to validate the efficacy of a novel valve assist device prior to insertion.
The members have teamed with the Medical Device Innovation Consortium (MDIC) to focus on the approval process of medical devices with the aid of digital models to spur innovation, improve reliability, and reduce costs. Bill Murray, the President and CEO of MDIC, is enthusiastic about the potential for computational modeling and simulation for the medical and healthcare industries. In a published quote Murray says, “[computation modeling and simulation] holds the promise of going beyond empirical testing through human clinical trials to evaluating the interaction of devices with the human body that is not obtainable in any other way. The Living Heart Project is a leading example of a new tool that offers the medical device community a heart simulation that could be validated for use from device design to regulatory submission.”
The deal with the FDA, notes Levine catapults the U.S. ahead of the European regulatory agencies. He says the regulatory process in the U.S. is a huge burden on the medical device manufacturers and it slows advances. He notes that European researchers may be hesitant to work with US researchers because they don’t want to get caught up in the slow certification process. But this time, he says, European researchers are eager to get involved and he thinks the FDA’s participation is a good sign for U.S. medicine. In the case of the Living Heart Project he said the FDA was enthusiastic. “When we first started, they really loved the concept,” he says.
Right now, the Living Heart Project participants are concentrating on the development of a reference human heart to function as a base line. What that means is that have an average size, male heart to work with. A critical first step is to get the medical community collaborating and experimenting with exactly the same model. This first simulator models the mechanical functions of the heart. They are not yet tackling other issues that will be studied in the future such as the flow of blood in the heart or perhaps electrical aspects, they’re taking it one step at a time. At a certain point says Levine, the project members will freeze development and define a model for use in specific tests and then they’ll move on to do more in the next version.
The mechanical aspect of the heart says Levine is an engineering problem, and it can be put to work immediately for patients. “We’re understanding the structure in ways we never could before” he says. They’ll start with the reference platform and then build a library of models. The next step will be to design in in the ability to resize the heart with morphing tools so it can be customized to conform to the size and shape of a person’s heart as recorded with a scan and thus can be personalized. This next step isn’t a long way away, says Levine, who expects the model to be customizable within a year or so.
When that happens he says, he sees opportunities for challenges such as replacing valves in hearts. Today those valves can be placed in a person heart through the vein, but the surgeon is operating blind, and they basically have to guess at the size of the valve to use. The operation itself is relatively safe with a short recovery time, but it can be dangerous if the valve isn’t the right size or fit; it can give out unexpectedly. With a digital heart model matching that of the patient, surgeons can test different valves and find the one that will provide the best mechanical behavior before surgery.
As the project advances, says Levine, he expects more patients to be able to benefit from their work. There are people who can’t afford to wait, he says. In Dassault’s release about the project, Dr. Kumaran Kolandaivelu, an instructor at the Harvard Medical School and Medical Director at MIT’s Clinical Research Center, says “as physicians we have a moral imperative to use the best science available to ensure the highest quality care with minimal invasiveness and at the least possible cost. We are working with Dassault Systèmes because I believe the time is right to embrace the full potential of computational science in medicine as it has in other disciplines.”
The Living Heart research groups have devised a crowdsourcing method that protects the intellectual property of each member yet facilitates information sharing. Levine described it as being like the spokes of a wheel, the researchers communicate their work and their findings with the Dassault team but Dassault does not share information from one research group to another.