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,Irene Lang,Christian Nitsche,Max-Paul Winter,Jolanta Siller-Matula,Markus Mach,Veronika Seidl,Georg Goliasch,Andreas Anselm Kammerlander,Martin Andreas,Philipp Bartko,Christian Hengstenberg,Julia Mascherbauer

doi:10.3390/jpm12020320

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.

Highlights

Stroke associated with transcatheter aortic valve replacement (TAVR) is a potentially devastating complication
No widely accepted algorithms currently exist that would allow the prediction of TAVR-related cerebrovascular events
We investigated the efficacy of SentinelTM using clinically detectable cerebrovascular events within 72 h after TAVR as primary and length of hospital stay (LOS) and 12-month mortality as secondary endpoints

Summary

Introduction

Stroke associated with transcatheter aortic valve replacement (TAVR) is a potentially devastating complication. The SentinelTM Cerebral Protection System (CPS; Boston Scientific, Marlborough, MA, USA) has been the only commercially available device for mechanical prevention of TAVR-related stroke. Transcatheter aortic valve replacement (TAVR) has revolutionized treatment options in this common disease, especially in patients with high surgical risk. Factors that have been shown to predispose for TAVR-associated cerebrovascular events include age, atrial fibrillation, history of cerebrovascular events, very severe and calcified AS, and implantation of more than one valve [4,5,7]. Only the SentinelTM (Boston Scientific) CPS has been commercially available. While several small studies failed to demonstrate a reduction of clinically relevant stroke in TAVR with SentinelTM [9–11], three larger studies reported significant reductions in cerebrovascular event [12–14] and in-hospital mortality [11,12]

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