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.
RCT (n=363)
randomized
Yes
Does transcatheter cerebral embolic protection (TCEP) reduce new brain lesion volume on MRI and is it safe in patients undergoing TAVR?
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.
Absolute Event Rate: 7.3% vs 18.3%
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).
“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.”
Kapadia et al. (2016) conducted an RCT in Transcatheter aortic valve replacement (TAVR) (n=363). Transcatheter cerebral embolic protection (TCEP) vs. Control imaging / performance goal was evaluated on Major adverse cardiac and cerebrovascular events (MACCE) at 30 days. 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.