Soon after a study appeared in The New England Journal of Medicine on Oct. 5 finding potential issues with bioprosthetic aortic valves, the results generated national attention, causing some to question the use of transcatheter aortic valve replacement (TAVR) treatment.
Nine days later, the study’s lead researcher and other experts spoke at a special press conference at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco. The session was called to help reduce anxiety among patients and providers and stress that no definitive conclusions should be drawn from the study.
Raj R. Makkar, MD, who led the trial, said the “findings related to neurologic events were preliminary and inconclusive” and that more studies needed to be done to understand the situation.
The researchers found 40 percent of a small group of patients enrolled in a TAVR clinical trial and 13 percent of patients from two clinical registries who underwent TAVR or surgical aortic valve replacement (SAVR) had reduced leaflet motion.
When the results were published, the FDA announced it was working with the American College of Cardiology, the Society of Thoracic Surgeons and device manufacturers to design clinical studies to evaluate the association between TAVR, SAVR and reduced leaflet motion.
To assess reduced leaflet motion, the researchers used a 4D, volume-rendered CT, which one researcher mentioned could be effective at understanding the early signals for mechanisms of valve degeneration.
“Clinical decisions in how we treat patients are made [based on] properly conducted clinical trials with hard outcomes,” said Makkar, director of the cardiovascular interventional center at Cedars-Sinai Medical Center in Los Angeles. “In this particular case, what we would like to do is learn from this imaging finding and do further research. But we should not take a leap from this imaging finding and make the conclusion that everybody that is getting transcatheter aortic valves should be on blood thinning medications, which have a risk in themselves. But what is required is to study this in a proper context.”