TY - JOUR
T1 - Cerebral Protection in TAVR-Can We Do Without?
T2 - A Real-World All-Comer Intention-to-Treat Study-Impact on Stroke Rate, Length of Hospital Stay, and Twelve-Month Mortality
AU - Donà, Carolina
AU - Koschutnik, Matthias
AU - Nitsche, Christian
AU - Winter, Max-Paul
AU - Seidl, Veronika
AU - Siller-Matula, Jolanta
AU - Mach, Markus
AU - Andreas, Martin
AU - Bartko, Philipp
AU - Kammerlander, Andreas Anselm
AU - Goliasch, Georg
AU - Lang, Irene
AU - Hengstenberg, Christian
AU - Mascherbauer, Julia
N1 - Funding Information:
Conflicts of Interest: J.M. received speaker fees and institutional grant from Edwards Lifesciences; speaker fees from Boston Scientific, Medtronic, and Abbott; C.H. received proctor fees, speakers bureau, and institutional grant from Edwards Lifesciences and Boston Scientific. M.A. received proctor fees from Edwards Lifesciences and Abbott, Advisor fees from Medtronic. The remaining authors declare no conflict of interest.
Publisher Copyright:
© 2022 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2022/2/21
Y1 - 2022/2/21
N2 - Background: Stroke associated with transcatheter aortic valve replacement (TAVR) is a potentially devastating complication. Until recently, the Sentinel™ Cerebral Protection System (CPS; Boston Scientific, Marlborough, MA, USA) has been the only commercially available device for mechanical prevention of TAVR-related stroke. However, its effectiveness is still undetermined. Objectives: To explore the impact of Sentinel™ on stroke rate, length of hospital stay (LOS), and twelve-month mortality in a single-center, real-world, all-comers TAVR cohort. Material and Methods: Between January 2019 and August 2020 consecutive patients were assigned to TAVR with or without Sentinel™ in a 1:1 fashion according to the treating operator. We defined as primary endpoint clinically detectable cerebrovascular events within 72 h after TAVR and as secondary endpoints LOS and 12-month mortality. Logistic and linear regression analyses were used to assess associations of Sentinel™ use with endpoints. Results: Of 411 patients (80 ± 7 y/o, 47.4% female, EuroSCORE II 6.3 ± 5.9%), Sentinel™ was used in 213 (51.8%), with both filters correctly deployed in 189 (46.0%). Twenty (4.9%) cerebrovascular events were recorded, ten (2.4%) of which were disabling strokes. Patients with Sentinel™ suffered 71% less (univariate analysis; OR 0.29, 95%CI 0.11-0.82; p = 0.02) and, respectively, 76% less (multivariate analysis; OR 0.24, 95%CI 0.08-0.76; p = 0.02) cerebrovascular events compared to patients without Sentinel™. Sentinel™ use was also significantly associated with shorter LOS (Regression coefficient -2.47, 95%CI -4.08, -0.87; p < 0.01) and lower 12-month all-cause mortality (OR 0.45; 95%CI 0.22-0.93; p = 0.03). Conclusion: In the present prospective all-comers TAVR cohort, patients with Sentinel™ use showed (1) lower rates of cerebrovascular events, (2) shortened LOS, and (3) improved 12-month survival. These data promote the use of a CPS when implanting TAVR valves.
AB - Background: Stroke associated with transcatheter aortic valve replacement (TAVR) is a potentially devastating complication. Until recently, the Sentinel™ Cerebral Protection System (CPS; Boston Scientific, Marlborough, MA, USA) has been the only commercially available device for mechanical prevention of TAVR-related stroke. However, its effectiveness is still undetermined. Objectives: To explore the impact of Sentinel™ on stroke rate, length of hospital stay (LOS), and twelve-month mortality in a single-center, real-world, all-comers TAVR cohort. Material and Methods: Between January 2019 and August 2020 consecutive patients were assigned to TAVR with or without Sentinel™ in a 1:1 fashion according to the treating operator. We defined as primary endpoint clinically detectable cerebrovascular events within 72 h after TAVR and as secondary endpoints LOS and 12-month mortality. Logistic and linear regression analyses were used to assess associations of Sentinel™ use with endpoints. Results: Of 411 patients (80 ± 7 y/o, 47.4% female, EuroSCORE II 6.3 ± 5.9%), Sentinel™ was used in 213 (51.8%), with both filters correctly deployed in 189 (46.0%). Twenty (4.9%) cerebrovascular events were recorded, ten (2.4%) of which were disabling strokes. Patients with Sentinel™ suffered 71% less (univariate analysis; OR 0.29, 95%CI 0.11-0.82; p = 0.02) and, respectively, 76% less (multivariate analysis; OR 0.24, 95%CI 0.08-0.76; p = 0.02) cerebrovascular events compared to patients without Sentinel™. Sentinel™ use was also significantly associated with shorter LOS (Regression coefficient -2.47, 95%CI -4.08, -0.87; p < 0.01) and lower 12-month all-cause mortality (OR 0.45; 95%CI 0.22-0.93; p = 0.03). Conclusion: In the present prospective all-comers TAVR cohort, patients with Sentinel™ use showed (1) lower rates of cerebrovascular events, (2) shortened LOS, and (3) improved 12-month survival. These data promote the use of a CPS when implanting TAVR valves.
UR - http://www.scopus.com/inward/record.url?scp=85125361974&partnerID=8YFLogxK
U2 - 10.3390/jpm12020320
DO - 10.3390/jpm12020320
M3 - Journal article
C2 - 35207808
SN - 2075-4426
VL - 12
JO - Journal of Personalized Medicine
JF - Journal of Personalized Medicine
IS - 2
M1 - 320
ER -