Adding a cerebral embolic protection (CEP) device to standard transcatheter aortic valve replacement (TAVR) was associated with a threefold reduction of all-cause mortality or stroke within one week of the procedure, according to a new study in JACC: Cardiovascular Interventions.
Using propensity scoring, researchers matched 280 patients receiving the Sentinel CEP device (Claret Medical) with 280 patients in the control group. Patients with the device had a 2.1 percent incidence of all-cause death or stroke, compared to 6.8 percent in the control group. This translates into one stroke or death being prevented for every 21 TAVR patients treated with Sentinel, the only FDA-cleared device of its kind.
“In patients undergoing TAVR, use of cerebral embolic protection device demonstrated a significantly higher rate of stroke-free survival compared with unprotected TAVR,” wrote Julia Seeger, MD, with the department of internal medicine (cardiology) at the University of Ulm in Germany, and colleagues.
“[I]n addition, there are no safety issues with use of the protection device. Hence, cerebral embolic protection should become standard of care for the TAVR procedure, as there are no pre-procedural independent predictors identified for selection of patients at high risk for stroke.”
The trial enrolled 802 consecutive patients at a single center. Sentinel devices were positioned in 280 patients out of 305 attempts—a 91.8 percent success rate. The rest of the patients (65 percent) received TAVR without CEP.
One-week stroke rates were 1.4 percent in the protected group versus 4.6 percent in the unprotected group.
The CEP device is inserted through a sheath via the right radial, ulnar or brachial artery. It contains two filters, one positioned in the brachiocephalic trunk and the other in the left common carotid artery, designed to catch debris dislodged during TAVR before it can travel to the brain and potentially cause damage.
In the trial, debris was seen in 85.1 percent of the protection devices after they were removed.
“However, even with use of the protection device, there were some strokes, which is predominantly explained by two reasons,” Seeger and colleagues wrote. “First, brain regions supplied by the left vertebral artery, originating from the left subclavian artery, stay unprotected. Second, there is only one size of filter system available. Hence, complete sealing of the intended vessels after expansion of the proximal and distal filter might not be achieved in all aortic arch anatomies.”
The authors noted they chose a one-week follow-up time to assess the “periprocedural events as well as potential events triggered by device positioning. … A longer follow-up allows confounders such as atrial fibrillation to dilute the results.”