Novel filter device safe to use in patients undergoing TAVI

A novel dual-filter device called the SENTINEL cerebral protection system (CPS) has been safely deployed in 95 percent of patients undergoing transcatheter aortic valve implantation (TAVI) with 100-percent procedural success, according to a Singapore study. No filter-related complications, stroke, or mortality has occurred at 30 days.

“The use of Sentinel CPS was safe with a high rate of successful deployment and required approximately 8 minutes of additional procedure time,” the researchers said. “Only one (2.5 percent) patient developed cognitive impairment at 30 days.”

Forty consecutive patients (mean age 76.4 years, 75.0 percent men) undergoing TAVI with cerebral protection participated in this study. All procedures were performed via femoral access with the use of self-expanding Evolut R/PRO or Portico, or the balloon-expandable SAPIEN 3 bioprostheses.

The researchers recorded baseline characteristics, procedural, and clinical outcomes. They also assessed cognition at baseline and at 30 days using the abbreviated mental test (AMT).

All patients had uncomplicated TAVI, and 38 (95.0 percent) had a successful deployment of the filter device without experiencing any safety issues. At 30 days, neither stroke nor death occurred, while survival rate at 9 months was 95.0 percent. [Singapore Med J 2022;doi:10.11622/smedj.2022030]

No overall cognitive changes occurred (baseline vs 30-day AMT: 9.2 vs 9.0; p=0.12); only one patient (2.5 percent) experienced impaired cognition at 30 days. Participants with a reduced AMT score at 30 days were significantly older than those without (82.1 vs 74.4 years; p=0.019). Of note, patients with a lower AMT score were at least 76 years old.

“In our study, none of the patients developed a stroke,” the researchers said. “This compares favourably with recent real-world data where the incidence of 30-day stroke was 2.3 percent in >10,000 patients undergoing TAVI without cerebral protection and 1–2 percent in patients undergoing TAVI with the SENTINEL CPS. [JAMA 2019;321:2306-2315; Eur Heart J 2019;40:1334-1340; JACC Cardiovasc Interv 2017;10:2297-2303; JACC Cardiovasc Interv 2018;11:1683-1693]

Cognitive decline

Previous studies reported the incidence of cognitive decline in 8 percent to 12 percent of patients after TAVI, with silent cerebral ischaemic lesions showing a robust association with neurocognitive decline. [Circ Cardiovasc Interv 2016;9:e003590; JACC Cardiovasc Interv 2020;13:1291-1300; J Am Coll Cardiol 2017;69:367-377; J Am Coll Cardiol 2016;68:2129-2141]

“Cerebral protection with the SENTINEL CPS may reduce cognitive decline, although the current data is conflicting,” the researchers said. “This may be due to the fact that up to a quarter of these silent cerebral ischaemic lesions were in the vertebrobasilar territory, and some of these emboli via the left vertebral artery would not be protected with the SENTINEL CPS.” [J Am Coll Cardiol 2017;69:367-377; EuroIntervention 2016;12:499-507; JACC Cardiovasc Interv 2020;13:1291-1300]

The current study was limited by its single-centre design, limited number of participants, and only one intervention arm. There was no independent neurology assessment, and the neurocognitive assessment was not blinded.

“There was also no control group without the use of the SENTINEL CPS, and hence, no definite conclusions can be made on the efficacy of the device in stroke reduction or cognitive preservation,” the researchers said.

“Larger studies will be required to further evaluate the role of the SENTINEL CPS during TAVI in Asian patients,” they noted.