Just when it seemed the HeartMate 3 was gaining momentum, Abbott warned physicians that outflow graft twisting may occur after the left ventricular assist device (LVAD) is implanted. The problem can trigger a persistent low-flow alarm that may signal a potential safety risk to patients, such as blood flow or clotting.
The Abbott Park, IL-based company has not recalled any of the devices from patients or hospitals, but there have been 32 reports of outflow graft twisting (an incidence rate of 0.72%), including reports of low blood flow, clotting, and three patient deaths.
Twisting of the outflow graft can occur at any point after the LVAD is implanted, Abbott said.
Low-flow alarms in LVAD patients can also indicate unrelated conditions like hypertension, the company noted. For patients who experience a persistent low-flow alarm and such causes have been ruled out, a CT scan can help detect any possible outflow graft twisting. Abbott said that physicians managing patients who exhibit a persistent low-flow alarm should determine patient care based on each unique case.
The company also reminded implanting physicians that properly hand tightening the screw ring at the time of implant may reduce the chance of outflow graft twisting.
In March, Abbott reported data from its MOMENTUM 3 study that showed the HeartMate 3 has improved survival and lowered rates of stroke and pump thrombosis. The company plans to submit the data to FDA to support a destination therapy indication for the device.
The device was originally developed by Thoratec, which St. Jude Medical bought in 2015 before it was acquired by Abbott.