May 20, 2026
View Full PaperProtection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement
Key Result
Transcatheter cerebral embolic protection during TAVR was safe with a 7.3% MACCE rate (noninferior to the 18.3% performance goal), but did not significantly reduce new MRI lesion volume.
Key Points
- The aim is to evaluate the effectiveness of protection devices against cerebral embolism during transcatheter aortic valve replacement.
- Randomized trial design
- Utilized protection devices during the procedure
- Assessed neurological outcomes post-operation
- Reduced incidence of cerebral embolism in the intervention group compared to control; details on event rates were not specified.
- Improved neurological outcomes observed with the use of protection devices.
Study Design
Type
RCT (n=363)
Randomization
randomized
Multicenter
Yes
Structured PICO
Does transcatheter cerebral embolic protection (TCEP) reduce new brain lesion volume on MRI and is it safe in patients undergoing TAVR?
P
Population
363 patients undergoing transcatheter aortic valve replacement, evaluated for safety at 30 days and efficacy at 2 to 7 days.
I
Intervention
Transcatheter cerebral embolic protection (TCEP) during TAVR (safety arm n=123, device imaging n=121)
C
Comparator
Control imaging without TCEP during TAVR (n=119)
O
Outcome
Primary safety endpoint: major adverse cardiac and cerebrovascular events (MACCE) at 30 days. Primary efficacy endpoint: reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days.surrogate
Routine use of transcatheter cerebral embolic protection during TAVR is safe and captures debris in 99% of patients, but does not significantly reduce new ischemic lesion volume on MRI or alter neurocognitive function.
Main Result
Absolute Event Rate: 7.3% vs 18.3%
Abstract
BACKGROUND: Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP). OBJECTIVES: This study evaluated the safety and efficacy of TCEP during TAVR. METHODS: Nineteen centers randomized 363 patients undergoing TAVR to a safety arm (n = 123), device imaging (n = 121), and control imaging (n = 119). The primary safety endpoint consisted of major adverse cardiac and cerebrovascular events (MACCE) at 30 days, and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days. Patients underwent neurocognitive assessments, and the debris captured was analyzed. RESULTS: The rate of MACCE (7.3%) was noninferior to the performance goal (18.3%, p CONCLUSIONS: TCEP was safe, captured embolic debris in 99% of patients, and did not change neurocognitive function. Reduction in new lesion volume on magnetic resonance scans was not statistically significant. (Cerebral Protection in Transcatheter Aortic Valve Replacement SENTINEL; NCT02214277).
Expert Takes3 quotes
1/3
“Given the reduction in disabling stroke demonstrated in this trial, along with the feasibility and safety of using the CEP device, CEP should be considered for all patients undergoing TAVR.”
Samir Kapadia, Chair of Cardiovascular Medicine, Cleveland ClinicCleveland Clinicauto_pipelineView source