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

被引：5

作者：

Dona, Carolina ^{[1
]}

Koschutnik, Matthias ^{[1
]}

Nitsche, Christian ^{[1
]}

Winter, Max-Paul ^{[1
]}

Seidl, Veronika ^{[1
]}

Siller-Matula, Jolanta ^{[1
]}

Mach, Markus ^{[2
]}

Andreas, Martin ^{[2
]}

Bartko, Philipp ^{[1
]}

Kammerlander, Andreas Anselm ^{[1
,3
,4
]}

Goliasch, Georg ^{[1
]}

Lang, Irene ^{[1
]}

Hengstenberg, Christian ^{[1
]}

Mascherbauer, Julia ^{[1
,5
]}

机构：

[1] Med Univ Vienna, Dept Internal Med 2, Div Cardiol, A-1090 Vienna, Austria

[2] Med Univ Vienna, Dept Cardiac Surg, A-1090 Vienna, Austria

[3] Massachusetts Gen Hosp, Cardiovasc Imaging Res Ctr, Boston, MA 02115 USA

[4] Harvard Med Sch, Boston, MA 02115 USA

[5] Karl Landsteiner Univ Hlth Sci, Dept Internal Med 3, Univ Hosp St Poelten, A-3500 Krems, Austria

来源：

JOURNAL OF PERSONALIZED MEDICINE | 2022年 / 12卷 / 02期

关键词：

Sentinel (TM) Cerebral Protection System; transcatheter aortic valve replacement; stroke; mortality; AORTIC-VALVE-REPLACEMENT; CEREBROVASCULAR EVENTS; EMBOLIC PROTECTION; RANDOMIZED EVALUATION; TRANSCATHETER; IMPLANTATION; RISK; PREDICTORS; STENOSIS; DEVICE;

D O I：

10.3390/jpm12020320

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Background: Stroke associated with transcatheter aortic valve replacement (TAVR) is a potentially devastating complication. Until recently, the Sentinel (TM) 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 (TM) 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 (TM) 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 (TM) use with endpoints. Results: Of 411 patients (80 & PLUSMN; 7 y/o, 47.4% female, EuroSCORE II 6.3 & PLUSMN; 5.9%), Sentinel (TM) 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 (TM) 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 (TM). Sentinel (TM) 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 (TM) 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.

引用

页数：17