The ProtEmbo Cerebral Protection System met its primary safety endpoint but failed to meet its primary efficacy endpoint, adding to uncertainty regarding the routine use of cerebral embolic protection (CEP) in TAVR, according to findings from the PROTEMBO IDE trial presented on the final day of TCT 2026.

Susheel K. Kodali, MD, FACC, et al., sought to determine the safety and efficacy of the ProtEmbo device, designed to shield all three vessels to the brain during TAVR. They randomized 305 patients 2:1:1 to TAVR with ProtEmbo, Sentinel and no-CEP, respectively. Median total new lesion volume (TNLV) was measured at baseline and at 36 hours post procedure with MRI and follow up was conducted through 30 days.

The study's primary safety endpoint – major adverse cardiovascular and cerebrovascular events (MACCE) – was observed in 7.6% of patients in the ProtEmbo group, well below the prespecified performance goal of 19%. MACCE rates were 8.5% in the Sentinel group and 11.6% in the no-CEP group.

The primary efficacy endpoint of median TNLV was 402 mm³ in the ProtEmbo group, 357 mm³ in the Sentinel group and 366 mm³ in the no-CEP group. Ultimately, the study stopped early due to futility.

Additional late-breaking TAVR research at TCT 2026 compares one-year outcomes of TAVR vs. surgical intervention in patients with symptomatic, severe aortic regurgitation (AR) at intermediate or high surgical risk.

In their prospective, randomized study of 168 patients across eight centers, Yaofu Zheng, MD, et al., found that 2.4% of TAVR patients and 1.2% of SAVR patients experienced a primary endpoint of all-cause mortality at one year. They note that their "current findings are encouraging and consistent with the prespecified noninferiority criterion."

Secondary analyses point to high rates of procedural success in both groups (98.8% in TAVR vs. 100% in surgery; p=1.000) as well as higher KCCQ quality of life scores among patients undergoing TAVR (84.9 vs. 77.0; p=0.018).

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Magnetic Resonance Imaging

Keywords: Transcatheter Cardiovascular Therapeutics, TCT26, Aortic Valve Insufficiency, Transcatheter Aortic Valve Replacement, Magnetic Resonance Imaging