Disabling stroke risk after TAVR procedure can be reduced using CEP device, trial finds

A trial led by Cleveland Clinic has found that the CEP device (Cerebral Embolic Protection) lowered the risk of disabling strokes by apprehending and eliminating tiny calcium pieces and other remains from the TAVR (transcatheter aortic valve replacement) before they successfully reach the brain.

Researchers assessed the stroke reduction during the procedure or right after it, and neurologic outcomes in patients with aortic stenosis treated with either TAVR alone, or with a CEP device during TAVR. Data revealed a 21% risk reduction in strokes after 3 days (72 hours) or at discharge time (whichever came first). Overall stroke numbers were less and the decrease was statistically insignificant in terms of meeting the primary endpoint (2.9% with TAVR only and 2.3% with CAP with TAVR, P=0.30).

A secondary analysis showed different results. Among patients treated with a CEP device, a 60% risk reduction in disabling stroke was demonstrated through 3 days’ time (72 hours) or time of hospital discharge time (1.3% with TAVR only and 0.5% in CEP with TAVR, P=0.2).

Chairman of Cardiovascular Medicine at the Cleveland Clinic, and also the lead author of the study said, “In the practice of TAVR, an important question for physicians and patients is the risk of stroke. This trial informs the doctor that the disabling stroke was reduced by the use of the CEP device and the device is safe to use.”

A condition that can cause constriction of the heart’s aortic valve (aortic stenosis) can cause hindrance in blood flow. TAVR is the general treatment for aortic stenosis patients. TAVR is the least intrusive method in which a catheter replaces the aortic valve in the heart.

The blockage caused by debris during the procedure or straight after can cause a stroke and may lead to severe injury or even death. As always, stroke is still a sinister complication of TAVR and stays patients’ top concern with a 16.7% death rate in 30 days.

Even though strokes are very unpredictable, the risk lies in the TAVR procedure as most strokes are a result of embolic material released during the valve implantation process.

Between January and February of this year, a total of 3,000 patients were registered and randomized in over 50 centers in Australia, Europe, and North America, in a TAVR trial. All the patients received a neurological exam pre and post-procedure.

Disabling stroke was experienced by 8 patients out of 1,501 in the CEP group (0.5%), while the other group saw 20 patients out of 1,499 suffering from the same (1.3%). Analyses showed that the reduced risk of disabling stroke was across the subgroups, gender, age, valve type, operative risk, and history of cardiovascular disease.

Samir Kapadia says that the study offers the largest randomized CEP trial data that can be used by healthcare providers as well as patients. He also said despite technological advancements, the risk for stroke remains high in TAVR.