“The device is very accurate to detect early bleeding… When you have half a liter of blood in the abdomen, the patient will be hypertensive, sweating and in shock. So we want to detect bleeding before this,” cardiologist Philippe Genereux told UPI.
Between August 2018 and December 2018, the researchers enrolled 60 patients at five sites throughout the United States. They used the Early Bird device to monitor bleeding during and after procedures, including percutaneous coronary intervention, Impella balloon aortic valvuloplasty, transcatheter mitral valve and endovascular aneurysm repair.
The Early Bird uses a sensor to detect when bleeding complications start during these procedures, as well as the severity of the event. Among study participants, the device identified 33 percent of bleeding at level 1, 23 percent at level II and 7 percent at level III, the highest level of bleeding.
“The device was used safely. We were able to use it without disturbing the workflow,” Genereux said.
Earlier this year, the Early Bird device received de novo classification from the FDA, and the researchers expect medical professionals to gradually begin using it.
About one in five people that undergo a large-bore endovascular procedure suffer bleeding complications, according to a 2017 study conducted by Genereux. The study read, “Bleeding complications were associated with a more than 2-fold higher adjusted risk of dying, longer hospitalization and higher health care cost.”
Those risks went up when the number of blood transfusions increased.
After rolling the devices out to some institutions, the researchers plan to collect more findings and continue to evaluate it.
“It’s going to be a progressive launch and adoption. We’re going to start to release the device in a limited number of centers and within one or two years we’re going to see broader adoption,” Genereux said. “I think the incorporation of this technology into the normal flow of work may result in an improved outcome in patients.”