Key Points
- The PROTECT H2H trial was the first head-to-head comparison of two embolic protection devices used during TAVR
- The Emboliner embolic protection system was noninferior to the Sentinel device for the primary composite endpoint of death, stroke, or acute kidney injury at 30 days (4.9% vs. 5.0%).
- Stroke rates were similarly low and comparable between groups (2.0% vs. 2.1%), representing the lowest stroke rates observed in a trial of this size.
- Emboliner demonstrated greater debris capture and higher technical success (96% vs. 87%; p=0.0005).
Embolic complications remain a key concern during transcatheter aortic valve replacement (TAVR), with debris dislodgement contributing to stroke and potential end-organ injury. Current embolic protection strategies, such as the Sentinel cerebral protection system, are limited to selective cerebral vessels, leaving other vascular territories unprotected. The PROTECT H2H trial (NCT: 02214277) was designed to evaluate whether a full-body embolic protection approach using the Emboliner device could improve procedural performance and clinical outcomes compared with the Sentinel system.
PROTECT H2H was a prospective, multicenter, randomized trial enrolling 522 patients (mean age 79 years; 33% women) with severe aortic stenosis undergoing TAVR across sites in the United States, Germany, and Brazil. Patients were randomized 1:1 to receive either the Emboliner embolic protection catheter or the Sentinel cerebral protection device during TAVR. The primary endpoint was a composite of all-cause death, stroke, or acute kidney injury at 30 days, with key secondary endpoints including stroke and quantitative debris capture.
At 30 days, the primary composite endpoint occurred in 4.9% of patients in the Emboliner group and 5.0% in the Sentinel group, demonstrating noninferiority. Stroke rates were nearly identical (2.0% vs. 2.1%), with both groups achieving among the lowest reported stroke rates in contemporary TAVR trials. Rates of bleeding, vascular complications, and thrombotic events were also similar between groups, confirming comparable safety profiles.
Regarding mechanistic endpoints, Emboliner captured more large debris particles ≥150 µm (93 vs. 31; p<0.0001) and the total debris burden (1,575 vs. 801 particles), including particles as small as 40 µm. Procedural success was also higher with Emboliner, with successful device deployment in 96% of cases compared with 87% for Sentinel (p=0.0005), despite operators having prior experience only with the control device.
These findings highlight a key distinction between embolic protection strategies: while clinical outcomes were similar at 30 days, Emboliner provides systemic embolic protection, capturing debris that may otherwise embolize beyond the cerebral circulation, including to the kidneys and peripheral vasculature. However, the trial was not powered to detect differences in downstream clinical outcomes related to non-cerebral embolization, and longer-term follow-up will be necessary to determine whether enhanced debris capture translates into improved patient outcomes.
Dr. Adam B. Greenbaum, the study’s presenting investigator, stated: “Any embolic debris during TAVR is neutral at best, potentially harmful, and as long as the system is safe and easy to use, the more debris captured, the better.”