TY - JOUR
T1 - Clinical outcome of transcatheter aortic valve replacement with TriGUARD 3™ cerebral embolic protection device
AU - Daal, Sayonara M
AU - Jimenez-Rodriguez, Gian M J
AU - Voskuil, Michiel
AU - Kraaijeveld, Adriaan O
AU - Dessing, Thomas C
AU - Ramjankhan, Faiz Z
AU - Mokhles, Mostafa M
AU - Stella, Pieter R
N1 - Funding Information:
The authors thank Nicole van Hemert and Astrid Links for careful collection of data. We thank Seema Biswas for English language assistance.
Publisher Copyright:
© 2023 The Authors
PY - 2023/5
Y1 - 2023/5
N2 - OBJECTIVE: Periprocedural stroke during transcatheter aortic valve replacement (TAVR) is a highly feared adverse event. The TriGUARD 3 cerebral embolic protection device (CEPD) may have the potential benefit of reduction of embolic events, but it still remains unclear whether it reduces the incidence of periprocedural stroke or transient ischemic attack (TIA). We aimed to investigate whether the latest TriGUARD 3 CEPD reduces the incidence of clinically overt stroke within 72 h or at discharge after TAVR.METHODS: In this prospective single-center study 117 patients (mean age 80.3 years, 53.8 % male) were included from July 2020 to December 2021.RESULTS: The primary efficacy endpoint of this study, periprocedural clinically overt stroke or TIA, within 72 h or at discharge after TAVR with the TriGUARD 3 CEPD occurred in 1/117 pts (0.8 %). Secondary endpoints (device related issues such as life-threatening or disabling bleeding, acute kidney injury, major vascular complications) were reported in 4/117 pts (3.4 %).CONCLUSIONS: This study suggests that the use of the latest TriGUARD 3™ CEPD in transfemoral TAVR seems to be associated with a low rate of clinically overt stroke and a low rate of device related adverse events, reflecting "real world" TAVR practice. However these results should be hypothesis generating and confirmed in a large RCT.
AB - OBJECTIVE: Periprocedural stroke during transcatheter aortic valve replacement (TAVR) is a highly feared adverse event. The TriGUARD 3 cerebral embolic protection device (CEPD) may have the potential benefit of reduction of embolic events, but it still remains unclear whether it reduces the incidence of periprocedural stroke or transient ischemic attack (TIA). We aimed to investigate whether the latest TriGUARD 3 CEPD reduces the incidence of clinically overt stroke within 72 h or at discharge after TAVR.METHODS: In this prospective single-center study 117 patients (mean age 80.3 years, 53.8 % male) were included from July 2020 to December 2021.RESULTS: The primary efficacy endpoint of this study, periprocedural clinically overt stroke or TIA, within 72 h or at discharge after TAVR with the TriGUARD 3 CEPD occurred in 1/117 pts (0.8 %). Secondary endpoints (device related issues such as life-threatening or disabling bleeding, acute kidney injury, major vascular complications) were reported in 4/117 pts (3.4 %).CONCLUSIONS: This study suggests that the use of the latest TriGUARD 3™ CEPD in transfemoral TAVR seems to be associated with a low rate of clinically overt stroke and a low rate of device related adverse events, reflecting "real world" TAVR practice. However these results should be hypothesis generating and confirmed in a large RCT.
KW - Cerebral embolic protection device
KW - Stroke prevention
KW - Transcatheter aortic valve replacement
KW - TriGUARD 3
UR - http://www.scopus.com/inward/record.url?scp=85147336726&partnerID=8YFLogxK
U2 - 10.1016/j.carrev.2023.01.008
DO - 10.1016/j.carrev.2023.01.008
M3 - Article
C2 - 36681530
SN - 1553-8389
VL - 50
SP - 8
EP - 12
JO - Cardiovascular revascularization medicine : including molecular interventions
JF - Cardiovascular revascularization medicine : including molecular interventions
ER -