Cerebral Protection in TAVR—Can We Do Without? A Real-World All-Comer Intention-to-Treat Study—Impact on Stroke Rate, Length of Hospital Stay, and Twelve-Month Mortality
Carolina Donà, Matthias Koschutnik, Christian Nitsche, Max‐Paul Winter, Veronika Seidl, Jolanta M. Siller‐Matula, Markus Mach, Martin Andreas, Philipp E. Bartko, Andreas A. Kammerlander, Georg Goliasch, Iréne Lang, Christian Hengstenberg, Julia Mascherbauer
Abstract
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.