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Using cerebral embolic protection devices during transcatheter aortic valve implantation (TAVI) procedures does not reduce a patient's risk of experiencing a stroke, according to a large UK clinical trial led by researchers from the Radcliffe Department of Medicine (RDM) and Oxford University Hospitals (OUH) NHS Foundation Trust.
The findings of the British Heart Foundation-funded BHF-PROTECT-TAVI trial have been presented at the American College of Cardiology conference and published in the New England Journal of Medicine.
RDM's Professor Rajesh Kharbanda, Associate Professor of Cardiovascular Medicine and OUH Consultant Cardiologist, led the trial. He said: 'The BHF-PROTECT-TAVI trial was the largest study to date to investigate the utility of CEP devices in TAVI, finding no difference in the number of strokes whether the device was used or not.
'Our trial made use of NHS research infrastructure to recruit over 7,600 participants over four years – around 30 per cent of all TAVI patients in the UK during that period. This trial provides persuasive evidence that the routine use of CEP offers no benefit on stroke risk for TAVI patients. However, we need to better understand which patients are at high-risk of stroke and whether embolic protection may work in those patients. This will be the basis of our ongoing research.'
During a TAVI, a catheter is inserted into a blood vessel and towards the aortic valve, where it guides and delivers a replacement aortic valve. Debris from the diseased heart valve or blood vessels may be dislodged during the procedure. If debris travels to the brain, it can cause a stroke.
Cerebral embolic protection (CEP) devices are designed to stop this debris reaching the brain, and they have been suggested as a solution to reduce stroke risk for TAVI patients. However evidence of their effectiveness to date has been inconclusive, and they are not recommended for routine use by NICE.
The trial, sponsored by the University of Oxford and coordinated by London School of Hygiene and Tropical Medicine, involved 32 of the 33 NHS TAVI centres across the UK. Between October 2020 and October 2024, 7,635 people scheduled to undergo a TAVI were recruited to the trial. Participants were randomly assigned to have the procedure either with the Sentinel CEP device or without.
There was no difference in the stroke rate between groups, with 81 (2.1 per cent) patients in the TAVI plus CEP group and 82 (2.2 per cent) patients in the TAVI without CEP group experiencing a stroke.
Similar results were also seen between the groups for severe strokes and all cause death, as well as disabling strokes at six to eight weeks after TAVI.
Professor Bryan Williams, Chief Scientific and Medical Officer at the British Heart Foundation, said: 'This excellent trial demonstrates the importance of British Heart Foundation research funding to answer internationally relevant clinical questions. It's clear that the benefits of CEP devices do not outweigh the additional cost and training requirements involved. Based on this strong evidence, we would not expect these devices to be recommended for routine use in the UK.'
This research was also funded by Boston Scientific and supported by the National Institute for Health and Care Research Oxford Biomedical Research Centre.