In fact, ischemic cerebral damage has been shown to occur in more than 84% of TAVI patients.6
Ischemic cerebral lesions may lead to clinically apparent strokes or they may cause cerebral infarcts with no overt “visible” neurological dysfunction, which are often referred to as “silent” cerebral infarcts.6 These “silent” infarcts are associated with adverse neurological and cognitive consequences, including impaired mobility, physical decline, depression, cognitive dysfunction, and dementia.7 Results from the SENTINEL trial showed that the size and number of new ischemic cerebral infarcts correlate to cognitive outcomes, and with the protection of Sentinel CPS, incremental ischemic infarcts to the brain were reduced by 42%.8
These “silent” infarcts are only visible using neurological imaging – such as 3 Tesla DW-MRI – which is reviewed and assessed by a team of specialized radiologists and neurologists. As such, silent infarcts have not been recognized as significant by the cardiovascular surgeons or cardiologists until very recently. In fact, one of the key findings of the recent SENTINEL trial showed that including a neurologist in the process of assessing patients after the TAVI procedure is critical to fully appreciate the nuanced presentation of clinical stroke. It also showed that the stroke rate, when assessed proactively by a neurologist, is 9.1% in those patients who were not protected with Sentinel CPS.4
A meta-analysis that examined a number of prospective TAVI studies using neurological assessments showed that new ischemic brain lesions were detected in 77.5% of unprotected TAVI patients. This meta-analysis also assessed the overall use of cerebral protection systems in TAVI and found there is a significant reduction in total lesion volume with the use of filter embolic protections systems, including Sentinel CPS, versus deflection embolic protection systems.9
While Sentinel CPS is designed to capture and remove cerebral debris during TAVI to minimize the risk of stroke, another possible technique being investigated to prevent the release of cerebral debris is the use of new anticoagulation therapies during TAVI procedures. The BRAVO-MRI study investigated new pharmacologic approaches during TAVI and found these new anticoagulation regimes were not sufficient for preventing TAVI procedural stroke.10
Cerebral embolic protection (CEP) is on its way to becoming a standard of care to better protect the neurocognitive and neurological well-being of patients.