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.
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.
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.
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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.
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.
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