How can you distinguish between a good surgeon and an exceptional surgeon?
According to some medical experts, it's that all-too-rare ability to visualize a human organ in three dimensions from little more than a scan.
"The handful of the top surgeons in the world are like sculptors," said Dr. Deepak Srivastava, a director at the Gladstone Institute of Cardiovascular Disease in San Francisco.
"When cardiovascular surgeons go in to repair a defect in the heart, their success is so often dependent on an ability to see the anatomy in 3-D in their minds," said Srivastava. "That's more difficult for younger, less experienced surgeons."
But recent advancements in the field of computational modeling may level the playing field in the coming years, particularly for heart surgeons.
One such technology comes from Dassault Systèmes, a French company that specializes in 3-D design software to help engineers that build cars and planes avoid potentially-fatal outcomes. So why not surgeons and medical researchers?
The hope is that universities and medical device makers will use the simulation to come up with new personalized treatments for common heart diseases and potentially improve surgical outcomes.
"We take a [patient's] scan, reconstruct it into a 3-D model, and test all the possibilities before a heart surgery," said Dr. Steve Levine, chief strategy officer and director for the Living Heart Project.
For now, the company is focusing its attention on simulating the heart, as opposed to other organs. That's because heart disease is the leading cause of death in the United States, and accounts for one in every four deaths.
Some hospitals are already using the design software to simulate the effects of routine medical procedures or experiment with solutions to common problems, like heart attacks. In the future, surgeons may leverage computational models before selecting a therapy or drug for individual patients.
Dassault hopes that medical device makers will also use the Living Heart Project's technology for research and development. It may help these companies pinpoint which new ideas are likely to prove effective, and whether it's worth the investment in clinical trials.
The software is available for free to organizations that agree to conduct research and share its findings with the project. Otherwise, its licenses start at $15,000 per year for commercial use, with educational licenses starting at $500 per year.
Recruiting Partners in Health Care
"Dassault is a $3 billion company few people have heard of," said Levine, who spoke with KQED during a recent trip to Europe. "We operate in the background."
In recent years, Dassault's executive team has re-focused the company on sectors outside of heavy manufacturing. Levine refers to this new approach as "modeling life and nature."
For the Living Heart Project, Levine's team put out calls to researchers at some of the top hospitals around the world to share their findings.
To date, it has recruited 45 "members" or partners from the scientific community, who were independently researching cardiac disease or a function of the heart. Researchers from the Mayo Clinic, Stanford University and the University of Oxford, among others, have opted to test-drive the simulation.
The company consolidated the research and used its engineering know-how to build a simulation of a baseline human heart. Now, the company can turn a 2-D scan, from an individual patient, and convert it into a 3-D model.
Levine said federal regulators initially wanted to take a 'watch and wait' approach when informed about the project.
"I told them [the U.S. Food and Drug Administration], you can't sit on the sidelines as non-participants. You have to get involved."
In 2014, the agency agreed to collaborate with Dassault on a five-year research project, which will focus on testing the reliability of pacemaker leads (the thin wires that carry an electrical impulse from the device to the heart.) But the agency stressed that it will not necessarily endorse any of the computational models that are developed as part of the research.
The FDA expects that doctors will someday use simulation technology for planning purposes and clinical decision-making. But it's still early days, so the agency cautioned doctors to invest resources into assessing the credibility of these new technologies and their potential drawbacks.
"Challenges to greater adoption of computer-modeling include a lack of data for some medical conditions, which makes realistic predictions difficult," said Donna Lochner, a senior scientific advisor in the FDA's Office of Science and Engineering Laboratories.
A Hammer Looking for a Nail?
At the University of California, San Francisco, a team of researchers in the cardiology division are hoping to use the Living Heart Project for one purpose in particular: Determining the optimal time for a patients' valve replacement.
Surgeons have to strike the right balance between swapping out a valve at the end of its life-cycle, but not leaving it so late that the heart function deteriorates.
Dr. Jeffrey Olgin, the division's chief, has been closely following the team's progress. But he is far from convinced that the Living Heart Project will fundamentally transform how we perform surgeries today.
He asked, "Is this a hammer looking for a nail? Or will this change how we practice medicine?"
Olgin said the Living Heart Project may be no more than a technological solution looking for a problem, but it's too soon to tell. He hasn't seen a convincing study yet that proves the simulation can improve patient outcomes.
Unlike manmade objects like cars and planes, it's very difficult to predict how the human heart will respond to stress in the real world. Olgin said he fears that doctors would come to rely too heavily on this technology and medical device makers could pull the plug on promising research if the simulation shows a negative result.
"The technology doesn't offer the same level of evidence as [medical research on] animals or small pilot human trials," he said.
"Unfortunately, the human body doesn't always follow the rules of physics."
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