Linked databases aid in long-term device monitoring
By combining a national vascular registry with medical data records in Medicare claims for patients undergoing endovascular abdominal aortic aneurysm repair, a team of researchers from across the country was able to identify which devices posed the highest risk for revascularization. .
The study, published October 25 in the BMJ, is the first to use data from the linked registry claims for long-term device-specific monitoring after surgery for abdominal aortic aneurysm, or inflammation of the body’s main blood vessel called the aorta. Is. Endovascular devices strengthen the artery from within and must last for many years to be effective.
The US Food and Drug Administration is concerned about the durability of a device called the Endologics AFX device. Endologics replaced the fabric in all of its AFX devices in 2014, following reports of poor durability of its fabric. But it was unknown whether this change affected reinnervation rates, or the rate of patients needing additional procedures related to aneurysms. Little was also known about the real-world performance of similar devices from other manufacturers.
Researchers, including those at Weill Cornell Medicine, evaluated the long-term durability of four major devices used to repair endovascular abdominal aortic aneurysms: the Gore Excluder device, the Medtronic Endurant device, the Cook Zenith device, and the Endologix AFX device. Data for the Endologix AFC device was split into two categories so that researchers could separately analyze and compare early and later device generations of the device. They found that reinvestment rates were significantly higher for patients who received the AFX device early on than for other devices.
Weill Cornell Institute for Health Technologies and Interventional Care conducted the data linkage and provided methodological supervision for this study. “The fact that we were able to study the results of a later generation of devices was very unique and eye-opening,” said senior author Dr. Art Cedrakian, professor of population health sciences at Weill Cornell Medicine. Given the report to the FDA, we expected the Endologics AFX device to be harmful. However, the size and breadth of our linked registry claims dataset helped us identify this signal more than two years ago, leveraging the power of linked real-world datasets.
To study the four instruments, researchers created an advanced coordinated registry from VQI-VISION Medicare-claims linkage data, using the Vascular Quality Initiative (VQI), Medicare Claims and the Society for Vascular Surgery’s Quality Improvement Registry from 2003 to 2018. to be done. The database collects individual-level demographic and clinical details for patients receiving general vascular procedures at more than 600 centers in the United States and Canada. These analyzes linked more than 20,000 patients in the VQI to their respective Medicare claims files, and more patients are added each year.
Dr. Phil Goodney, who led the study in partnership with Cedrakyan’s team, said, “We wanted to help patients find a tool for their AAA that lasted – and put that determination in real-world practice. Use the best data available to do so.”
Goodney, professor of surgery at the Geisel School of Medicine at Dartmouth and a vascular surgeon at the Dartmouth Health Heart and Vascular Center located at Dartmouth Hitchcock Medical Center, said, “We were able to follow patients for many years, no matter where they received care. Are.” ,
This method, called VQI-VISION, showed that some devices performed better than others, and these results were soon available for regulatory oversight.
Data associated with the study identified the risk of reinfection in mid-2015, more than three years before the FDA issued its first regulatory warning about the device.
“This study shows that real-world data sources, such as registry data linked to billing claims, are scientifically the most robust and powerful tools to ensure patients receive cardiac devices that are safe over the long term. and are durable,” Cedrakyan said. “We hope that the FDA ensures that this type of evidence is an important part of their cardiovascular device monitoring strategies in the future.
“Through this study, we are highlighting for regulators, for the public, and for physicians that linking registries with Medicare data is a practical way to introduce medical device surveillance in the country.” “Investing in this method will help us maintain our low-cost infrastructure and conduct surveillance studies for most high-risk devices in the country.”
Molly Schulson Weill is a freelance writer for Cornell Medicine.
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