James K. Kirklin, M.D., received UAB's 2022 Most Prolific Inventor award. Now he and his team are using those inventions to launch a startup focused on predictive patient analytics and adverse event tracking.
(Photography: UAB Medicine)For more than 35 years, UAB’s James K. Kirklin, M.D., expanded the boundaries of cardiac surgery in children and adults. He was the first surgeon to support a baby with a single pumping chamber with a longer-term heart assist device to a successful heart transplant. Later, he implanted a heart assist device in a baby just 17 days old; after 136 days, the infant had a successful heart transplant. Even as he was changing the field in the operating room, where he performed more than 700 heart transplants, Kirklin was making a similar impact with his research on patient outcomes after cardiac procedures.
After Kirklin retired from clinical cardiac surgery in 2017, he focused on this outcomes research. He and his team use cutting-edge statistics and machine-learning algorithms to analyze clinical information from major heart transplant centers and pediatric heart surgery hospitals worldwide, which is maintained in databases at UAB. This work helps identify the best treatments based on patient characteristics; the group’s research publications often shift clinical guidelines.
Now, Kirklin, the recipient of the 2022 Most Prolific Inventor award from the Bill L. Harbert Institute for Innovation and Entrepreneurship at UAB, is ready for a “new chapter,” he said: launching his first startup.
“This is an opportunity to externalize all the things we have been able to do at UAB — to see if we can make an impact on a larger scale. And that requires working outside the university. We think it will be fun and a chance to make a new contribution to health care.”
– James K. Kirklin, M.D.
In some ways, this new adventure is intimidating for a world-renowned surgeon who is the son of a world-renowned surgical pioneer, UAB legend John Kirklin, M.D., and whose mother was a doctor as well. “My family and I have always been associated with academic institutions,” said Kirklin, who is a professor in the Department of Surgery. “I’ve never been out there in the free-enterprise world. But everyone has to decide what is the next chapter. This is an opportunity to externalize all the things we have been able to do at UAB — to see if we can make an impact on a larger scale. And that requires working outside the university. We think it will be fun and a chance to make a new contribution to health care.”
Introducing Kirklin Solutions
The “we” who make up the founding employees of Kirklin Solutions, LLC, includes some 21 programmers, statisticians and other members of UAB’s James and John Kirklin Institute for Research in Surgical Outcomes, or KIRSO, which Kirklin directs. The HIIE is licensing the intellectual property developed by Kirklin and KIRSO. The group already has more than $3 million worth of contracts from surgical societies and other associations for the ongoing maintenance and analysis of outcomes databases related to mechanically assisted circulatory support devices for adults (Intermacs) and children (Pedimacs), pediatric heart transplants, pediatric and congenital heart surgery, and aortic procedures. KIRSO also maintains the Children’s of Alabama Unified Cardiac Database and the UAB Adult ECMO Database.
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First-time inventors can find information about startups, patents, intellectual property and more in the HIIE's Inventors' Guide.
Do you have questions about intellectual property, technology transfer or the commercialization process? Talk with a licensing associate from the Bill L. Harbert Institute for Innovation and Entrepreneurship during weekly virtual drop-in office hours, Wednesdays at 1 p.m. on Zoom. Next session is Dec. 7.
ECMO, short for extracorporeal membrane oxygenation, is a machine for acute support of heart and lung failure. It is used in critical situations where a patient’s heart and lungs are incapable of removing carbon dioxide and oxygenating the bloodstream, or the heart and lungs need time to heal. Kirklin describes it as “an end-of-the-road, lifesaving salvage procedure.” UAB and some 400 other hospitals in the United States and worldwide use ECMO. (During the COVID-19 pandemic, ECMO was widely used in the care of patients who were experiencing severe lung complications from the disease.)
Predictive patient analytics
ECMO can be lifesaving, but it is also invasive and potentially distressing for patients and their loved ones. In general, patients placed on ECMO have a 50/50 chance of survival, Kirklin says. But there are dozens of variables — some known and others unknown — that affect these odds. Sifting through the flood of data for the vital signs or patient characteristics that are most predictive of good or bad outcomes, and tracking the results of interventions to improve these outcomes, is KIRSO’s specialty. “We use high-level programming and very sophisticated statistics to track and analyze complex, lifesaving interventions,” Kirklin said.
The first product from Kirklin Solutions will provide predictive analytics and track adverse events related to ECMO (extracorporeal membrane oxygenation) machines, used in critical situations where a patient’s heart and lungs are incapable of removing carbon dioxide and oxygenating the bloodstream, or the heart and lungs need time to heal.The ECMO database that Kirklin and his team are developing is the only one of its kind in the United States. Over the next year or so, they will build out their ECMO product to the point where they can offer it to other hospitals and health systems to track adverse events (a regulatory requirement) and provide predictive analytics. “We think, if this is successful, it could be an important paradigm shift,” Kirklin said. “There is nothing like it out there.” Similar algorithms could be used in many situations, he adds. “The areas of a hospital or health system that would benefit the most take care of really sick patients with a high risk of adverse outcomes,” Kirklin said. “Our initial focus is ECMO, but we’re hoping it will be translatable.”
Kirklin Solutions is now seeking outside investments as it develops its products.
“At the Harbert Institute, our mission is to protect intellectual property that arises from research here at UAB and help translate it into products that can have real-world practical impact,” said HIIE Director of Licensing and New Ventures Karthik Gopalakrishnan, Ph.D. “The software Dr. Kirklin and his team are developing is a perfect example of such a product. It will change lives immediately from the outset for patients placed on ECMO, but the system has the potential to adapt to other areas of high-risk patient care. That possibility is the true game-changer. We expect that other investors and hospital systems will recognize this value, and we look forward to seeing KIRSO grow.”
Answers in real time, rather than a week
Kirklin understands the urgency of clinical decision-making. “You have to have real problem-solving skills and bring all the information you have to bear at the time a decision is needed,” he said.
“After all these years of tedious, rigorous data collection and analytics, where we can spend months combing through data, I would like to bring this into real time.”
“If a little baby comes into Children’s Hospital, we want to know all the previous cases just like this one — not only the diagnosis but also additional syndromes or other medical conditions that influence the complexity, and adverse events following the surgery. That will give the patient care team a good idea of the likelihood of the new patient’s having similar problems. We are in the process of building such a database at Children’s of Alabama now.”
The previous state-of-the-art was to query individual databases with a remote team of programmers. “That required days or a week to generate the requested information,” Kirklin said. “By that time, you have already operated, and the patient is out of the hospital. We need that information rapidly from multiple databases, so that the information informs decisions among physicians and patient families. As a surgeon, I want to know what has happened and track it in near real time, not spend 20-40 hours going through charts or the EMR to find similar patients and their outcomes.
“That’s why I find this new challenge fascinating,” Kirklin said. “After all these years of tedious, rigorous data collection and analytics, where we can spend months combing through data, I would like to bring this into real time. I want to have solutions right now, at the bedside.”
