Next-Generation TransCarotid Artery Revascularization: TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System To Reduce Strokes – TOPGUARD Study
Publication
The Journal of Cardiovascular Surgery 2024 June;65(3):181-94Author
Mariusz TRYS TULA, Isabelle VAN HERZEELE, Ralf KOLVENBACH, Lukasz TEKIELI, Charlotte FONTEYNE, Adam MAZUREK, Karolina DZIERWA, Jakub CHMIEL, Julie LINDSAY, Tomasz KWIATKOWSKI, Adam HYDZIK, Maksymilian OPLAWSKI, Krzysztof BEDERSKI, Piotr MUSIALEKFocus
Prospective analysis of 106 consecutive patients with high-grade carotid stenosis, symptomatic and asymptomatic, at high risk for CAS and standard risk for CEA treated at 3 European centers of excellence. BACKGROUND A metanalysis* of TCAR with the ENROUTE NPS (18 studies and 4,852 patients) with approved stents (Precise, etc.) showed: • a periprocedural death/stroke rate of 5% at 30-day. • a stroke/TIA rate of 1.9% at 30-day, with a statistically significant difference between symptomatic and asymptomatic patients, 2.5% and 1.2%, respectively.*Highlights
TCAR with the Enroute NPS and the CGUARD stent demonstrated 30-day rates of:
• Stroke = 0.9% (1/106)
• Death/Stroke = 0.9%
• DSMI = 0.9%
• Comprised of 1 minor stroke, no MI and no death
• The minor stroke was caused by damage to the intima during the arterial sheath introduction before the ENROUTE cerebral protection was established.
• In symptomatic patients (n=64; 60.4%): DSMI = 0%
Data suggests that combining flow reversal with CGUARD stent during TCAR has the potential to (1) improve outcomes, (2) equalize outcomes between symptomatic and asymptomatic patients.