Clinical and neurocognitive outcomes after transcatheter aortic valve implantation (TAVI) with cerebral protection: initial experience with a novel dual-filter device in Southeast Asia

Abstract

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.

Keywords: Asia; aortic valve stenosis; cognition; stroke; transcatheter aortic valve replacement.

Fig. 1

Photograph shows the Evolut PRO self-expanding transcatheter heart valve (the Evolut R valve is similar but without the bottom external skirt denoted by the open bracket).

Fig. 2

Photograph shows the Edwards SAPIEN 3 balloon-expandable valve.

Fig. 3

Photograph shows the Portico valve, a self-expanding valve.

Fig. 4

Photographs show the SENTINEL cerebral protection system’s (a) filters, consisting of the proximal filter (arrow) and distal filter (arrowhead); and (b) delivery system.

Fig. 5

Fluoroscopic image shows the SENTINEL proximal filter in the innominate artery (arrow) and the distal filter in the left carotid artery (arrowhead). A pigtail catheter (black arrow) can be seen in the arch of the aorta.

Fig. 6

Photograph shows typical debris captured during the transcatheter aortic valve implantation procedure.