Cerebral protection devices for transcatheter aortic valve replacement

Abstract

Aortic stenosis is the most prevalent primary valve disease in developed countries. Its prevalence is increasing due to population aging. Transcatheter aortic valve replacement (TAVR) is a sterling therapy for symptomatic patients with severe aortic stenosis and high or intermediate surgery risk. The number of procedures has increased exponentially expanding to younger and lower risk patients. Despite newgeneration TAVR devices and enhanced operator skills, cerebrovascular events (CVEs) carry on being one of the most severe complications, increasing morbi-mortality. CVE might be under reported because there are few studies with rigorous neurological clinical assessment. Several imaging studies show most of CVE after TAVR has a probable embolic etiology. The risk of CVE ranges from 2.7% to 5.5% at 30 days. As TAVR expands to younger and lower risk patients, the prevention of stroke plays an increasingly important role.Cerebral protection devices (CPD) were designed to reduce the risk of CVE during TAVR. This review describes the scientific evidence on CVE after TAVR and summarizes the performance and results of the main CPDs.

Embolic Protection with the TriGuard 3 System in Nonagenarian Patients Undergoing Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis

“…No CEPD dislocation was recognized before the valve deployment step of TAVR. This is a higher success rate compared to other studies, such as the DEFLECT I and II studies, which have shown a lower positioning success rate [ 22 , 46 , 47 ].…”

Novel use of the Sentinel cerebral protection device during thrombosed septal occluder explant and Atriclip appendage closure

“…3,4 The CLEAN-TAVI trial evaluated new brain lesions with DW-MRI 2 days after TAVR and found a statistically significant decrease in the onset of new brain lesions (4 vs. 10; p < .001). 3,5 The largest trial using SCPD was the SENTINEL trial which included 363 patients in a multicenter, single-blinded, randomized design. 6 The volume of new brain lesions and rate of stroke at 30 and 60 days postoperatively were numerically inferior in the SCPD group (102.8 vs. 178 mm 3 ; p = .33), (5.6% vs. 9.1%; p = .25).…”

“…Recognizing the risk of thrombus embolization during surgery, a multidisciplinary approach between interventional cardiology and cardiothoracic surgery was 87%; p = .31), in addition to less cognitive disability (4% vs. 27%; p = .017). 3,4 The CLEAN-TAVI trial evaluated new brain lesions with DW-MRI 2 days after TAVR and found a statistically significant decrease in the onset of new brain lesions (4 vs. 10; p < .001). 3,5 The largest trial using SCPD was the SENTINEL trial which included 363 patients in a multicenter, single-blinded, randomized design.…”

“…6 The volume of new brain lesions and rate of stroke at 30 and 60 days postoperatively were numerically inferior in the SCPD group (102.8 vs. 178 mm 3 ; p = .33), (5.6% vs. 9.1%; p = .25). 3,6 Further research is necessary to implement the routine use of cerebral protection devices. Enrollment is currently active for PROTECTED-TAVR, the largest multi-center, randomized controlled trial comparing the rate of stroke after TAVR with SCPD.…”

Routine use of cerebral protection devices during transcatheter aortic valve implantation: what does the evidence say?

“…So far, several CEPD have been developed by many manufactures, including ProtEmbo, Sentinel, TriGUARD, Emblok, Emboline, Embrella, and Embol-X [20][21][22] . They vary not only in the mechanism for protection, for instance, capture versus deflection, but also in the access site and delivery sheath size [ Table 1].…”