Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement: REFLECT...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Neurology

Background:

• Cerebral embolization is common after transcatheter aortic valve replacement (TAVR).
• Procedure-related ischemic stroke occurs in 2-6% of TAVR patients within 30 days.
• The efficacy of cerebral embolic protection devices in TAVR is under investigation.

Purpose of the Study:

• To evaluate the safety and efficacy of the TriGuard 3 (TG3) cerebral embolic protection system during TAVR.
• To determine if TG3 reduces procedure-related cerebral injury compared to no protection.

Main Methods:

• A prospective, multicenter, single-blind, 2:1 randomized trial (REFLECT II).
• Enrolled 220 patients undergoing TAVR, with 121 receiving TG3 and 58 controls.
• Primary safety endpoint compared to a performance goal; primary efficacy endpoint was a hierarchical composite including death, stroke, NIHSS worsening, and MRI-detected lesions.

Main Results:

• The trial met its primary safety endpoint (15.9% vs. 34.4% performance goal, p < 0.0001).
• The primary efficacy endpoint was not met (TG3 vs. control, p = 0.857).
• Post hoc analysis showed reduced total lesion volume on MRI in the TG3 group, especially with full device coverage.

Conclusions:

• The TriGuard 3 (TG3) cerebral protection device demonstrated safety in TAVR patients.
• The study did not achieve its primary objective of proving superiority in reducing cerebral injury.
• Further research may explore optimal use or patient selection for cerebral protection during TAVR.