Nearly one-third of patients had cognitive decline one year after undergoing left ventricular assist device (LVAD) implantation for advanced heart failure, according to an analysis of a large, multicenter, observational registry
Lead researcher Timothy J. Fendler, of St. Luke's Mid America Heart Institute in Kansas City, Mo., and colleagues published their findings online in the Circulation: Cardiovascular Quality and Outcomes on April 29.
“We were surprised to find that these cognitive decline events are relatively common,” Fendler said in an interview with Cardiovascular Business. “That implies that this is a common and potentially serious adverse event that’s really not been addressed in the literature thus far to this extent. We think these are surprising findings and have potentially some really important implications for patients who are considering this therapy.”
Fendler said LVADs are common for patients who become sick while awaiting heart transplants and for patients who are ineligible for transplants because of their advanced age or other health conditions.
Previous studies have found that LVADs improve the quality of life and prolong survival in advanced heart failure compared with medical management alone. In this trial, researchers examined the Interagency Registry for Mechanically Assisted Circulatory Support, a prospective national registry of patients with advanced heart failure receiving durable mechanical circulatory support.
They identified 1,173 patients who received durable LVADs from May 2012 to December 2013 and had cognitive functioning assessed using the Trail Making B Test, which was established in 1944 and has become a validated measure of cognitive functioning.
Researchers found that 29.2 percent of patients had cognitive decline in the 12 months following LVAD implantation. They also mentioned that patients experiencing cognitive decline tended to be older and were more likely to have received destination therapy.
Fendler et al are planning to extend the study to evaluate how cognitive decline events in these patients are associated with outcomes such as clinical stroke, death or quality of life.
“I think it’s very important when you have a novel and invasive device like LVADs to make sure that we represent both the benefits and the counterbalancing risks of the therapy when trying to help patients make decisions about what to do for their care,” Fendler said. “While a patient may derive a dramatic survival benefit from this device, if they’re suffering a number of adverse events like cognitive decline or more well-studied adverse events that are common in this population like [gastrointestinal] bleeding or strokes or device infections, then that may not be the kind of outcome they were expecting or that they were hoping for when they opted for the device.”