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Saadi et al. Vessel Plus 2020;4:41 I http://dx.doi.org/10.20517/2574-1209.2020.54 Page 7 of 14

Figure 3. TriGUARD device

6.00%, OR = 0.34, 95%CI: 0.17-0.68, relative risk reduction 66%; P = 0.0013) in the protected TAVI group.
[26]
The rate of disabling stroke was also substantially lower in the Sentinel group (0.38% vs. 2.44%; P = 0.0045) .
Furthermore, in the last months, evidence from two large US databases has suggested that Sentinel use
during TAVI was associated with statistically significant reduction in stroke risk. In the Society of Thoracic
Surgeons/American College of Cardiology (STS/ACC) TVT Registry, the rate of in-hospital stroke was not
significantly lower when the Sentinel device was used according to an instrumental-variable analysis (1.39%
vs. 1.54%; RR = 0.90; 95%CI: 0.68-1.13). A secondary propensity-weighted analysis of the data, however,
indicated that cerebral protection was associated with a reduction in the rates of in-hospital stroke (1.30%
vs. 1.58%; RR = 0.82; 95%CI: 0.69-0.97), in-hospital death or stroke (2.1% vs. 2.5%; RR = 0.84; 95%CI: 0.73-
0.98), 30-day stroke (1.9% vs. 2.2%; RR = 0.85; 95%CI: 0.73-0.99), and 30-day death (1.7% vs. 2.2%; RR = 0.78;
[27]
95%CI: 0.64-0.95) . Corroborating these findings, a propensity-weighted analysis of the National Inpatient
Sample showed that Sentinel use was associated with a lower risk of in-hospital ischemic stroke (1.0% vs.
[28]
3.8%; OR = 0.24; 95%CI: 0.09-0.62) and in-hospital death (0% vs. 1%; P = 0.036) .

Despite the aforementioned, it is essential to remember that the Sentinel does not protect the left vertebral
artery since it is a branch of the left subclavian artery. There are still concerns about leaving the left
vertebral artery unprotected, thus some companies are developing devices to eliminate this blind spot.

TM
TriGUARD (Keystone Heart, Herzliya, Israel)
The TriGUARD is the only CE mark approved system designed to cover and protect all three major cerebral
aortic arch vessels [Figure 3]. Currently, the device is only in investigational use in the US, planning to
apply for FDA approval.

The TriGUARD is inserted through a transfemoral 8F sheath, via the femoral artery access already in use
during TAVI, usually at the pigtail insertion side, thus eliminating the need for a third arterial puncture.
The device is made of nitinol and consists of a self-positioning, self-stabilizing polymetric mesh with pore
sizes 115 × 145 micrometers (μm) opened in the aortic arch, covering the three aortic arch vessels .
[29]
There are clinical trials already published showing the efficacy and safety of the device. The DEFLECT I
and DEFLECT III trial demonstrated that the technical success, which included complete 3-vessel cerebral
coverage, was achieved in 80%-90% of the patients. The DEFLECT III demonstrated that this device use is