Key result
TAVI with the SENTINEL cerebral protection system was safe and feasible, resulting in 0% stroke or death at 30 days and preserved overall cognition.
Why the study?
A novel dual-filter system to reduce cerebral embolism during TAVI recently became available, but its feasibility, safety, and clinical and neurocognitive outcomes in Asian patients needed evaluation.
Is TAVI with a dual-filter cerebral protection device safe and feasible for preserving neurocognitive function in Asian patients?
Observational (n=40)
No
Is TAVI with a dual-filter cerebral protection device safe and feasible for preserving neurocognitive function in Asian patients?
TAVI with a novel dual-filter cerebral protection device is feasible and safe in Asian patients, with preserved overall cognition at 30 days.
Supports feasibility of cerebral protection during TAVI in Asians; leaves open neurocognitive benefit in larger trials.
INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is increasingly performed in patients with severe aortic stenosis. A novel dual-filter system to reduce cerebral embolism during TAVI recently became available. We aimed to assess the feasibility, safety, and clinical and neurocognitive outcomes of TAVI with cerebral protection in Asian patients. METHODS: 40 consecutive patients undergoing TAVI with cerebral protection were enrolled. All procedures were performed via femoral access using the self-expanding Evolut R/PRO or Portico, or the balloon-expandable SAPIEN 3 bioprostheses. Baseline characteristics, procedural and clinical outcomes were recorded. Cognition was assessed at baseline and 30 days using the abbreviated mental test (AMT). RESULTS: The mean age of the patients (75% male) was 76.4 ± 8.4 years. TAVI was uncomplicated in all patients. The filter device was successfully deployed in 38 (95.0%) patients without safety issues. There was no stroke or death at 30 days, and the survival rate at nine months was 95.0%. There was no overall cognitive change (baseline vs. 30-day AMT: 9.2 ± 1.1 vs. 9.0 ± 1.5, p = 0.12), and only 1 (2.5%) patient developed impaired cognition at 30 days. Patients with a decreased AMT score at 30 days were significantly older than those without (82.1 ± 4.5 vs. 74.4 ± 7.7 years, p = 0.019). All patients with decreased AMT scores were aged ≥ 76 years. CONCLUSION: In this early Asian experience of TAVI under cerebral protection, the filter device was successfully deployed in 95% of patients, with 100% procedural success. There were no filter-related complications and no stroke or mortality at 30 days. Overall cognition was preserved, although increased age was associated with a decline in AMT score.
No takes yet. Share an insight, caveat, or question.
Chiam et al. (2022) conducted an observational in Symptomatic severe aortic valve stenosis (n=40). TAVI with SENTINEL cerebral protection system was evaluated on Stroke or death at 30 days after TAVI. TAVI with the SENTINEL cerebral protection system was safe and feasible, resulting in 0% stroke or death at 30 days and preserved overall cognition.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: