**2. Risk factors for cerebrovascular events**

The risk factors for post-TAVR stroke are divided into early (acute and subacute) and late (**Table 1**).

Indicators of an early stroke encompass features of the patient and the procedure itself. Procedure features associated with early stroke risk include a greater number of dilations of the aortic valve annulus, a greater degree of valve acceleration velocity before implantation (reflecting more severe plaques with more calcium deposits, or the need for additional instrumentation to cross the aortic valve and complete the procedure), and a greater number of pacing events [11].

In a study carried out in more than 20,000 patients from Europe and Canada, the predictors of post-TAVR stroke were evaluated. Age, previous stroke and peripheral arterial disease, chronic kidney disease, atrial fibrillation, and diabetes were identified as risk factors [9].

*Cerebral Protection Devices in Transcatheter Aortic-Valve Replacement DOI: http://dx.doi.org/10.5772/intechopen.112661*


#### **Table 1.**

*Risk factors for stroke in TAVR implantation.*

In a recent analysis of the Transcatheter Valve Therapy (TVT) registry by Thourani et al., which included 97,600 patients, the approach with an alternative access for TAVR (i.e., use of an access other than transfemoral or direct aortic access) was identified to had the highest relative risk for TAVR intrahospital stroke [12].

In the CoreValve studies, factors such as reduced body surface area, severe aortic calcification, and frequent falls in the past 6 months were found to be indicators of increased risk of subsequent stroke [13].

#### **3. Current evidence on the use of cerebral protection devices (CPD) in TAVR**

An analysis of 108,315 patients undergoing TAVR examined the use of CPD in 4380 patients (4.0%). The results revealed that adjusted mortality was lower in those patients who underwent TAVR with CPD compared with those without CPD (0.5% vs. 1.3%, p < 0.01).

In addition, neurological complications, including hemorrhagic stroke and ischemic stroke, were also lower in the CPD group compared with the non-CPD group (1.4% vs. 2.2%, p < 0.01). Likewise, patients who experienced a stroke after TAVR and used CPD were found to have a significantly lower in-hospital mortality rate compared with those without CPD (6.3% vs. 11.8%; p = 0.023). These findings suggest the possibility that CPDs may prevent more severe and debilitating strokes, which in turn could reduce stroke-related morbidity and mortality [14].

A recent meta-analysis demonstrated that the use of CPD was associated with a lower risk of mortality related to stroke (odds ratio 0.47; 95% CI, 0.28–0.80), lower risk of stroke (odds ratio 0.54; 95% CI, 0.39–0.75), transient ischemic attack (odds ratio 0.47; 95% CI, 0.31–0.71), and adverse cardiovascular and cerebrovascular events (odds ratio 0.70; 95% CI, 0.56–0.87). These data suggest that CPD should be considered during TAVR procedures to reduce the risk of stroke-related mortality and other complications [15].

An observational study was conducted in 2023 using the TriGUARD 3 ™ (**Figure 1**) device to assess the incidence of stroke and transient ischemic attacks (TIA) within 72 hours or at discharge after TAVR implantation. The results revealed stroke incidence of 0.8%, suggesting that the use of this device is associated with a low frequency of clinically detectable strokes and device-related adverse events [11].

The PROTECTED TAVR study evaluated the effectiveness of cerebral embolic protection (CEP) during TAVR in reducing the risk of stroke. The study involved 3000 patients, the primary endpoint being the identification of clinical stroke within

**Figure 1.** *TriGUARD ™ device.*

**Figure 2.** *Sentinel ™ device.*

72 hours of TAVR or before discharge. The study found that the use of CEP did not have a significant effect on the incidence of periprocedural stroke; however, it reduced the incidence of disabling stroke. The study concluded that among patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP had no significant effect on the incidence of periprocedural stroke [14] using Sentinel ™ (**Figure 2**).
