3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 9 sources, which was discussed by the committee. The evidence included 2 systematic reviews and meta-analyses, 4 randomised controlled trials, 1 non-randomised comparative study, 1 patient-level pooled analysis and 1 case series, and is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcome to be: reduction in TAVI-related embolic strokes.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: vascular damage and bleeding.
3.4 Patient commentary was sought but none was received.
3.5 There are different types of devices available to prevent cerebral embolism during TAVI, and they work in different ways. The committee noted that most of the evidence it reviewed came from 1 type of device, and that the technology is evolving.
3.6 Embolic stroke following TAVI is rare, but when it happens it can be devastating. The studies reviewed by the committee had limited statistical power to evaluate rare outcomes.
3.7 Using a cerebral protection device does not eliminate the risk of embolic stroke following TAVI.
3.8 Detecting cerebral lesions resulting from incomplete protection is challenging and the methods for doing it may have differed between the studies.
3.9 The valves used for the TAVI procedure differ, but cerebral protection benefit during TAVI has been demonstrated across all valve types.