Key result
Use of the Sentinel Cerebral Protection System during TAVI reduced neurocognitive deterioration (4% vs. 27%, p=0.017) and the occurrence of ≥10 new brain lesions (0% vs. 20%, p=0.03).
Why the study?
The impact of filter-based Sentinel Cerebral Protection System during TAVI on early new brain lesions and neurocognitive performance was uncertain.
Does the filter-based Sentinel Cerebral Protection System reduce early new brain lesions and neurocognitive deterioration in patients undergoing transfemoral TAVI?
RCT (n=65)
1:1
Does the filter-based Sentinel Cerebral Protection System reduce early new brain lesions and neurocognitive deterioration in patients undergoing transfemoral TAVI?
The use of a filter-based cerebral protection system during TAVI reduces the incidence of multiple new brain lesions and preserves early neurocognitive performance.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“In our opinion, it would be inappropriate and unfair to close the book on cerebral protection after this chapter.”
Preserves option for cerebral protection during TAVI; extends surrogate RCT benefits but leaves open translation to clinical stroke reduction.
AIMS: Our aim was to determine whether use of the filter-based Sentinel™ Cerebral Protection System (CPS) during transcatheter aortic valve implantation (TAVI) can affect the early incidence of new brain lesions, as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI), and neurocognitive performance. METHODS AND RESULTS: From January 2013 to July 2015, 65 patients were randomised 1:1 to transfemoral TAVI with or without the Sentinel CPS. Patients underwent DW-MRI and extensive neurological examination, including neurocognitive testing one day before and five to seven days after TAVI. Follow-up DW-MRI and neurocognitive testing was completed in 57% and 80%, respectively. New brain lesions were found in 78% of patients with follow-up MRI. Patients with the Sentinel CPS had numerically fewer new lesions and a smaller total lesion volume (95 mm3 [IQR 10-257] vs. 197 mm3 [95-525]). Overall, 27% of Sentinel CPS patients and 13% of control patients had no new lesions. Ten or more new brain lesions were found only in the control cohort (in 20% vs. 0% in the Sentinel CPS cohort, p=0.03). Neurocognitive deterioration was present in 4% of patients with Sentinel CPS vs. 27% of patients without (p=0.017). The filters captured debris in all patients with Sentinel CPS protection. CONCLUSIONS: Filter-based embolic protection captures debris en route to the brain in all patients undergoing TAVI. This study suggests that its use can lead to fewer and overall smaller new brain lesions, as assessed by MRI, and preservation of neurocognitive performance early after TAVI. CLINICAL TRIAL REGISTRATION: Dutch trial register-ID: NTR4236. URL http://www.trialregister.nl/trialreg/admin/rctsearch.asp?Term=mistral.
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Mieghem et al. (2016) conducted an RCT in Transcatheter aortic valve implantation (TAVI) (n=65). Sentinel Cerebral Protection System (CPS) vs. TAVI without Sentinel CPS was evaluated on Neurocognitive deterioration (p=0.017). Use of the Sentinel Cerebral Protection System during TAVI reduced neurocognitive deterioration (4% vs. 27%, p=0.017) and the occurrence of ≥10 new brain lesions (0% vs. 20%, p=0.03).
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