ACC 2026 | Protect The Head-To-Head Trial: Randomized Comparison Between Emboliner and Sentinel During TAVI

Ischemic stroke remains one of the most feared complications of TAVI, with a relatively low but persistent incidence of 2–4%, without significant reduction over time despite technological advances. The Emboliner system was designed to provide more comprehensive cerebral protection by covering the entire aortic arch, capturing embolic debris directed both to supra-aortic vessels and the descending aorta. In this context, the Protect The Head-To-Head trial was designed to directly compare the efficacy and safety of the Emboliner system versus the Sentinel device during TAVI procedures.

This was a prospective, randomized, open-label, multicenter trial evaluating safety and efficacy, conducted across centers in the United States, Europe, and Brazil. It included 522 patients with severe aortic stenosis undergoing transfemoral TAVI, randomized 1:1 to Emboliner (n=258) or Sentinel (n=264). The mean age was 78.7 years, with 31–35% women, a mean STS score of 3.5–3.6%, and a history of prior stroke in 9–11%, atrial fibrillation in 24–28%, and renal insufficiency in 28–30%.

The primary endpoint was a composite at 30 days of all-cause death, stroke, and stage 3 acute kidney injury, assessed under a non-inferiority design. A key secondary endpoint of safety and efficacy was the incidence of stroke at 30 days (also under a non-inferiority hypothesis), and a secondary efficacy endpoint was the number of captured particles ≥150 µm, evaluated under a superiority design.

Read also: ACC 2026 | PRO-TAVI Trial: Deferring Coronary Angioplasty in Patients Undergoing TAVI.

Results showed that the primary endpoint occurred in 4.5% of the Emboliner group versus 5.0% of the Sentinel group, meeting the criterion for non-inferiority (p for non-inferiority = 0.0004). Regarding individual components, all-cause mortality was 2.0% vs. 2.1%, stroke 2.0% vs. 2.1%, and stage 3 acute kidney injury 0.4% vs. 1.2% for Emboliner and Sentinel, respectively, with no significant differences. Bleeding complications were numerically lower in the Emboliner group (4.5% vs. 5.8%). Procedurally, Emboliner use was associated with slightly longer total procedure time (median 72 vs. 59 minutes) and fluoroscopy time (22 vs. 19 minutes), without relevant clinical impact.

Emboliner vs. Sentinel in TAVI: comparable safety without superiority in 30-day stroke reduction

In conclusion, the Protect The Head-To-Head trial demonstrates that the Emboliner system is non-inferior to the Sentinel device in terms of major clinical events at 30 days in patients undergoing TAVI, with comparable safety profiles. These findings position Emboliner as a valid alternative within cerebral protection strategies, offering theoretically more complete arterial coverage, although without evidence of clinical superiority in hard endpoints in this analysis.

Original Title: Protect The Head-To-Head Trial: A Randomized Comparison of Emboliner vs. Sentinel Cerebral Protection System During TAVR.