In the first head-to-head comparison of two devices intended to protect against stroke in patients undergoing transcatheter aortic valve replacement (TAVR), the investigational Emboliner device performed comparably to the Sentinel device, which is approved by the U.S. Food and Drug Administration. The research was presented at the American College of Cardiology’s Annual Scientific Session (ACC.26).

“For the primary endpoint of death from any cause, stroke or kidney failure at 30 days, the investigational Emboliner device and the approved Sentinel device performed nearly identically,” said Adam Greenbaum, MD, an associate professor of medicine and co-director of the Structural Heart and Valve Center at Emory School of Medicine in Atlanta and study author. “Findings for the secondary endpoint of stroke alone were also nearly identical—and, at about 2% in both arms, are the lowest rates of stroke that have been achieved in a trial of this size.”

Patients enrolled in the trial underwent TAVR, a minimally invasive procedure to replace the aortic valve. One of four valves in the heart, the aortic valve controls blood flow between the heart's main pumping chamber (left ventricle) and main artery (aorta). A diseased aortic valve can restrict the flow of blood from the heart to rest of the body, a condition known as aortic stenosis that can lead to heart failure. TAVR involves using a catheter (a long flexible tube) to place a replacement aortic valve in the patient’s poorly functioning one.

Stroke is an uncommon but well-known adverse event following TAVR, Greenbaum said. During the procedure, bits of tissue, calcium and blood clots can break off from the heart and the artery walls and enter the bloodstream. This debris can cause a stroke if it becomes lodged in an artery that carries blood to the brain, resulting in a blockage of the artery. According to one study, 3% of patients receiving TAVR experienced a stroke within 30 days of the procedure, and they also had an elevated risk of stroke for two years following the procedure, compared with patients matched by age and sex who had not undergone TAVR.

The Sentinel Cerebral Protection System is approved to be used with the TAVR catheter like a filter, to capture the TAVR-generated debris and keep it from getting into the bloodstream and to the brain. To date, however, studies have not shown that its use in TAVR reduces strokes or patient deaths within 30 days of the procedure.

“While the Sentinel is a great advance in the field, it leaves open the question of whether preventing other downstream effects of TAVR-generated debris—for example, in the gut, the legs, the kidneys—could improve patient outcomes,” Greenbaum said.

The Emboliner Embolic Protection System is an investigational full-body filter designed to capture TAVR-generated debris and prevent it from getting into the arteries that carry blood not only to the brain but also to other organs and tissues. The device is a soft, mesh sleeve designed to capture all debris in the descending aorta. It has a port to allow passage of the transcatheter valve and other devices.

The Protect H2H randomized trial was designed to directly compare the safety and effectiveness of the Sentinel and Emboliner devices in patients undergoing TAVR. The study enrolled 522 patients (average age 79 years, 33% women) in the United States, Germany and Brazil. All of the patients had severe aortic stenosis and were randomly assigned to undergo TAVR with protection provided by either the Sentinel or the Emboliner device. Patients’ other health conditions included prior stroke (9%), high blood pressure (84%) and atrial fibrillation (25%), all of which were similar across both groups.

The trial’s primary endpoint was a composite of death from any cause, stroke or kidney failure within 30 days of the procedure. Key secondary endpoints were stroke within 30 days and the number of debris particles larger than 150 microns (roughly the size of a dust mite or a grain of table salt) that the filter captured. Patients were followed up on discharge from the hospital after their procedure and again at 30 days.

Results at 30 days showed that 4.9% of patients whose procedure was performed using the Emboliner device had experienced a primary endpoint event, compared with 5% of those whose procedure was performed using the Sentinel device. The secondary endpoint of stroke at 30 days occurred in 2% of patients in the Emboliner group and 2.1% of those in the Sentinel group. The number of adverse events such as bleeding and blood clots was similar in both groups.

In other findings, the Emboliner device captured three times as many debris particles larger than 150 microns as the Sentinel device did (93 vs. 31), and almost twice as many total particles (1,575 vs. 801), including some as small as 40 microns (less than the width of a human hair), Greenbaum said.

“While the trial was not powered to detect differences in terms of other outcomes from debris elsewhere. Any embolic debris during TAVR is neutral at best, potentially harmful, and it would therefore be intuitive that as long as the system is safe and easy to use, the more debris captured, the better,” he said.

The Emboliner also had fewer issues with placement. Operators were unable to position the catheter in the protective filter in the patient’s body prior to placing the replacement heart valve in only 4% of patients in the Emboliner group compared with 13% in the Sentinel group, Greenbaum said.

A limitation of the study is that it provides no information about patient outcomes beyond the 30-day follow-up period. In addition, the trial was not large enough to identify whether the incidence of kidney failure differed between the two groups.

The study was funded by Emboline, Inc., the manufacturer of the Emboliner Embolic Protection System.

Greenbaum will present the study, “Protect the Head to Head Trial: Randomized Comparison of Emboliner Embolic Protection Catheter Vs. Sentinel Cerebral Protection System During Transcatheter Aortic Valve Replacement” on Sunday, March 29, at 4:00 p.m. CT / 21:00 UTC in the Main Tent, Great Hall.

ACC.26 will take place March 28-30, 2026, in New Orleans, bringing together cardiologists and cardiovascular specialists from around the world to share the newest discoveries in treatment and prevention. Follow @ACCinTouch, @ACCMediaCenter and #ACC26 for the latest news from the meeting.

The American College of Cardiology (ACC) is the global leader in transforming cardiovascular care and improving heart health for all. As the preeminent source of professional medical education for the entire cardiovascular care team since 1949, ACC credentials cardiovascular professionals in over 140 countries who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. Through its world-renowned family of JACC Journals, NCDR registries, ACC Accreditation Services, global network of Member Sections, CardioSmart.org patient resources and more, the College is committed to ensuring a world where science, knowledge and innovation optimize patient care and outcomes. Learn more at ACC.org.