Cerebral Embolic Protection Devices Fail to Prevent Strokes After TAVR Surgery: Study

While the cerebral embolic protection devices appeared to have few, if any, benefits, researchers also said they did not appear to increase the risks for patients, either.

According to the findings of a new study, using cerebral embolic protection (CEP) devices during transcatheter aortic-valve replacement (TAVR) surgery does not appear to help prevent strokes or reduce the risk of death following the proceedure.

TAVR surgery is used to treat aortic stenosis, but the procedure can cause debris to block the valve, potentially increasing the risk of serious side effects, like stroke. Therefore, doctors often use cerebral embolic protection devices to help clear debris from the valve to reduce the risk of stroke.

In a study published last week in the New England Journal of Medicine, researchers from the Cleveland Clinic indicate that CEP devices fail to prevent strokes after TAVR surgery, or reduced risk of death. In fact, the findings indicate that there may be no benefit to having the CEP procedure.

Researchers evaluated data involving total of 3,000 patients across North America, Europe, and Australia, who were randomly assigned to two groups; aortic stenosis to undergo transferal TAVR with CEP and those who underwent transferal TAVR without CEP.

The incidence of stroke within 72 hours after TAVR or before discharge from the hospital did not differ significantly between the CEP group and the control group, according to the findings. Rates were 2.3% for the CEP group compared to 2.9% for the control group.

Additionally, the rates of disabling stroke were 0.5% of patients in the CEP group and 1.3% for patients in the control group. There were no substantial differences in the rate of patients who died between CEP group and control group.

The proportion of patients who suffered a stroke, had a transient ischemic stroke or suffered delirium was 3.1% in the CEP group and 3.7% in the control group. The rates of patients who suffered acute kidney injury were also the same for both groups at 0.5%.

Researchers said the differences were not statistically significant, and that using CEP did not lead to fewer strokes, side effects or fewer deaths. They also determined that while using CEP devices did not provide improved outcomes during valve surgery, the device also did not lead to increased side effects or risks, such as stroke.

TAVR Health Concerns

TAVR is a type of heart procedure that allows the surgeon to replace the heart valve by threading it through an artery in the leg instead of via open chest surgery. It places the valve over the damaged aortic valve in a less invasive procedure.

While TAVR may be a safer alternative to open heart surgery, previous studies have suggested it poses many significant risks to the patients.

Other research indicates TAVR may increase the risk of death and inflammation of the heart’s inner lining, even among low-risk patients. The risk of death was nearly double within the first year, highlighting the many side effects which TAVR patients face.

Another study indicated patients who require an emergency second TAVR procedure face increased risk of severe bleeding events, strokes and death.

“Among patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP did not have a significant effect on the incidence of periprocedural stroke,” researchers concluded. “Although the trial did not definitively identify a role for CEP in all patients undergoing TAVR, the CEP device was safe and may be a reasonable choice for some patients and physicians.”