Cerebral Embolic Protection Devices: How Useful are they in TAVR?

During TAVR, we often fear the possibility of a stroke, which occurs in approximately 1 – 2% of cases.  In general, this phenomenon is caused by thrombi stemming from atherosclerotic or calcified plaque, depending on the etiology. Even though its incidence has declined with technology development and the increasing expertise of operators, it is still a challenge to overcome. 

¿Cuán útiles son los sistemas de protección cerebral en el TAVI?

In order to tackle this problem, several cerebral protection systems (CEPS) have been designed. However, studies, randomized or not, offer diverging results as to their associated complications. 

This meta-analysis incorporated 8 randomized studies totaling 4,043 patients; 53.8% (2,175) undergoing TAVR with CEPS. Primary end point was risk of stroke.

Among the used CEPS were the Sentinel (Boston Scientific), the Montage (Claret Medical), the TriGUARD (Keystone Heart) and the EMBOL-X (Edwards Lifesciences).

There were no significant differences in primary end point (relative risk [RR], 0.88; CI 95%, 0.65-1.18; p = 0.39; I2 = 0%). Neither were there differences in disabling stroke (RR, 0.67; CI 95%, 0.31-1.46; p = 0.32; I2 = 8.6%) or non-disabling stroke (RR, 0.99; CI 95%, 0.71-1.40; p = 0.97; I2 = 0%), all-cause mortality (RR, 0.87; CI 95%, 0.43-1.78; p = 0.71; I2 = 2.3%), bleeding, vascular complications, or renal injury.

Read also: Is TAVR Beneficial in Cardiogenic Shock?

The MRI did not show significant differences in total lesion volume or the number of ischemic lesions. 

The Sentinel CEPS, unlike its counterparts, did show a reduction in disabling stroke (RR, 0.42; CI 95%, 0.20-0.88; p = 0.022; I2 = 0%), even though there were no differences in stroke (total), non-disabling or all-cause mortality rates. 

Conclusion

Data from randomized studies on cerebral embolic protection systems did not reveal safety issues in clinical primary end points or on neuro-imaging. Specific analysis of the Sentinel CEPS showed a significant reduction in disabling stroke. Ongoing studies might contribute to validate these outcomes. 

Dr. Carlos Fava - Consejo Editorial SOLACI

Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.

Original Title: Cerebral Embolic Protection Devices During Transcatheter Aortic Valve Replacement: A Meta-analysis of Randomized Controlled Trials.

Reference: Rohin K. Reddy, et al. JSCAI https://doi.org/10.1016/j.jscai.2023.101031.


Subscribe to our weekly newsletter

Get the latest scientific articles on interventional cardiology

More articles by this author

Prospective Analysis of the Feasibility of the PASCAL System for Transcatheter Mitral Repair: OneForAll Registry

Courtesy of Dr. Juan Manuel Pérez. Mitral transcatheter edge-to-edge repair (M-TEER) is an effective option for patients with severe mitral regurgitation who are at high...

Left Bundle Branch Block after TAVR: What Is Its Impact?

Courtesy of Dr. Juan Manuel Pérez. Left bundle branch block (LBBB) is a common complication following transcatheter aortic valve replacement (TAVR), which can be either...

Multicenter Experience with 3D Intracardiac Echocardiography for Guiding Interventional Cardiac Procedures

Courtesy of Dr. Juan Manuel Pérez. Imaging techniques play a fundamental role in interventional cardiac procedures. Intracardiac echocardiography (ICE) appears as an alternative to transesophageal...

Pathology of Self-Expanding Transcatheter Aortic Bioprostheses and Hypoattenuated Leaflet Thickening

Courtesy of Dr. Juan Manuel Pérez. Despite the available long term followup data on of transcatheter aortic valve replacement (TAVR), bioprosthesis durability continues under debate....

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Related Articles

SOLACI Sessionsspot_img

Recent Articles

ACC 2025 | FAME 3: FFR Guided PCI vs CABG 5 Year Outcomes.

Earlier studies comparing percutaneous coronary intervention (PCI) vs coronary artery bypass graft (CABG) have shown fewer events at long term for the surgical strategy.  However,...

ACC 2025 | API-CAT: Reduced vs. Full Dose Extended Anticoagulation in Patients with Cancer Related VTE

The risk of cancer related recurrent venous thromboembolism (VTE) will drop over time, while bleeding risk will persist. At present, it is recommended we...

STRIDE: Semaglutide in Patients with Peripheral Arterial Disease and Type II Diabetes

Peripheral arterial disease (PAD) is a severe complication in patients with type II diabetes, primarily affecting peripheral vessels, especially below-the-knee (BTK) arteries. This condition...