An editorial authored by Dr. Hani Jneid, director of the Sealy Heart and Vascular Institute at UTMB, examines findings from a large clinical trial that found special “brain-protection” devices used during a common heart valve procedure did not reduce the risk of stroke or death for most patients.
The procedure, called transcatheter aortic-valve implantation, or TAVI, is a minimally invasive way to replace a narrowed heart valve. TAVI has helped many people live longer and feel better. However, stroke remains one of its most serious possible complications. Today, about 2% of patients experience a stroke shortly after the procedure. While that number is relatively low, strokes can lead to death, disability, and higher medical costs.
Cerebral embolic protection devices (CEPDs) are small filters placed in blood vessels during TAVI to catch debris that may break loose and travel to the brain, which could cause a stroke. Earlier, smaller studies showed that CEPDs could safely capture debris and reduce tiny brain lesions seen on scans. Because of this, their use has steadily increased in the United States over the past several years.
Larger, more recent studies, however, are now raising questions about whether the devices improve patient outcomes.
The newest research, called the BHF PROTECT-TAVI trial, was conducted at 33 medical centers across the United Kingdom and included more than 7,600 patients with severe aortic stenosis. Participants were randomly assigned to undergo TAVI either with or without a CEPD. Researchers then tracked whether patients experienced a stroke within 72 hours of the procedure or before leaving the hospital.
The results showed almost no difference between the two groups, Jneid reported in his editorial, “Cerebral Embolic Protection during TAVI – The Failed Promise,” published in The New England Journal of Medicine. About 2.1% of patients who received the protection device had a stroke, compared with 2.2% of those who did not. Rates of disabling stroke, severe stroke, and death were also nearly identical.
These findings closely match those of another large international trial published earlier, which also found no meaningful reduction in stroke rates with routine use of CEPDs.
“This large, well-conducted trial provides important clarity for clinicians and patients,” said Jneid, who is also chair of the Department of Cardiovascular Medicine and vice president of Cardiovascular Operations at UTMB. “While cerebral embolic protection devices can capture debris during TAVI, the evidence now shows that routine use does not translate into fewer strokes or improved survival for the average patient."
“As stroke rates after TAVI have declined with better technology and operator experience, the incremental benefit of additional devices appears limited,” Jneid said. “These findings encourage us to be thoughtful and evidence driven, focusing on strategies that meaningfully improve patient outcomes while continuing to investigate whether certain high-risk subgroups might still benefit.”