Insights on Embolic Protection, Repositioning, and Stroke: A Subanalysis of the RESPOND Study

Area of Science:

• Cardiology
• Neurology
• Medical Devices

Background:

• Transcatheter aortic valve replacement (TAVR) is a common procedure for aortic stenosis.
• Neurologic complications, particularly stroke, remain a concern following TAVR.
• Cerebral embolic protection (CEP) devices and valve repositioning are potential strategies to mitigate these risks.

Purpose of the Study:

• To assess the impact of cerebral embolic protection (CEP) devices on neurologic complications in TAVR patients.
• To evaluate the effect of prosthetic valve repositioning on stroke risk in patients receiving the Lotus Valve.
• To identify predictors of stroke in the RESPOND postmarket study population.

Main Methods:

• Prospective, single-arm study (RESPOND) enrolling 1014 TAVR patients.
• Analysis of 996 patients implanted with the Lotus Valve, examining CEP use (9.2%) and valve repositioning (31.4%).
• Adjudication of stroke events by an independent reviewer; multivariate analysis for stroke predictors.

Main Results:

• The overall stroke/transient ischemic attack (TIA) rate was 3.0% at 72 hours post-TAVR.
• Patients using CEP had a 72-hour stroke/TIA rate of 1.1% versus 3.2% without CEP (absolute reduction 2.1%, p=0.51).
• Valve repositioning showed similar 72-hour stroke/TIA rates (2.9%) compared to no repositioning (3.1%, p=0.86).

Conclusions:

• Selective use of CEP devices in the RESPOND study was associated with a nonsignificant trend toward lower stroke risk within 72 hours.
• The repositioning feature of the Lotus Valve did not increase stroke risk.
• Further research may be needed to confirm the benefit of CEP in reducing neurologic events during TAVR.