CAPTIS, a Novel Cerebral Embolic Protection System in TAVR

The incidence of stroke after TAVR ranges between 2 and 5%, depending on the series, which has been associated with higher morbimortality, affecting patient quality of life and their psycho-social environment. 

CAPTIS, un novedoso sistema de protección cerebral en el TAVI

Many cerebral embolic protection systems have been developed in response, and even though they have been shown beneficial in many studies, their role in the current practice still remains to be defined clearly.   

Looking to make progress in this area, a new analysis of the CAPTIS (First in Man), was carried out, including 20 patients with severe symptomatic aortic stenosis. The CAPTIS is a cerebral embolic protection system designed to safeguard the full body against thrombi in the neck vessels. 

Safety primary end point was defined as MACCE at 72 hours, including all cause death or any stroke. 

Read also: AHA 2023 | MINT: Liberal vs Restrictive Transfusion in Patients with Acute Coronary Syndrome.

Mean Age was 76, with 9 women in the group. 14 patients presented diabetes, 17 dyslipidemia, 8 had prior PCI and 4 prior myocardial revascularization surgery (CABG).

The most used valve was the Sapien 3 (14 patients), while the rest received Evolute Pro. Predilation was used tin 7 patients and neither received post-dilation. The device was positioned, deployed and retrieved without complications in all cases. Device deployment took 7 minutes and retrieval 4. TAVR was carried out successfully in all patients. 

The safety primary end point was not observed in any patient. However, 2 patients presented bleeding requiring transfusion. 

Read also:AHA 2023 | SELECT Trial: Semaglutide in Patients Without Diabetes.

Histopathological analysis revealed debris particles in all patients, 1.448 particles per patients on average, 112 larger than 150 µm. 17 patients presented particles larger than 1 mm, and 13, larger than 2 mm. Debris particles were comprised of fresh and organized thrombi, arterial and valvular tissue. 9 patients showed calcium particles, and myocardial tissue was identified in 4.

Conclusion

Applying the CAPTIS protection system, which safeguards the whole body during TAVR, was shown safe and effective, capturing a substantial number of particles. No patients experienced cerebrovascular events. We should highlight the need for further randomized research to assess their efficacy more conclusively. 

Dr. Carlos Fava - Consejo Editorial SOLACI

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

Original Title: First-in-human study of the CAPTIS embolic protection system during transcatheter aortic valve replacement.

Reference: Haim D. Danenberg, et al. EuroIntervention 2023;19-online publish-ahead-of-print October 2023.


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...