Donà Carolina, Koschutnik Matthias, Nitsche Christian, Winter Max-Paul, Seidl Veronika, Siller-Matula Jolanta, Mach Markus, Andreas Martin, Bartko Philipp, Kammerlander Andreas Anselm, Goliasch Georg, Lang Irene, Hengstenberg Christian, Mascherbauer Julia
Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, 1090 Vienna, Austria.
Department of Cardiac Surgery, Medical University of Vienna, 1090 Vienna, Austria.
J Pers Med. 2022 Feb 21;12(2):320. doi: 10.3390/jpm12020320.
: 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. 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. 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. 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; = 0.02) and, respectively, 76% less (multivariate analysis; OR 0.24, 95%CI 0.08-0.76; = 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; < 0.01) and lower 12-month all-cause mortality (OR 0.45; 95%CI 0.22-0.93; = 0.03). 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.
经导管主动脉瓣置换术（TAVR）相关的中风是一种潜在的毁灭性并发症。直到最近，Sentinel™脑保护系统（CPS；美国马萨诸塞州马尔伯勒市波士顿科学公司）一直是唯一可用于机械预防TAVR相关中风的商用设备。然而，其有效性仍未确定。为了探讨Sentinel™对单中心、真实世界、所有患者的TAVR队列中中风发生率、住院时间（LOS）和12个月死亡率的影响。在2019年1月至2020年8月期间，根据治疗操作人员的安排，连续患者以1:1的方式被分配接受有或没有Sentinel™的TAVR治疗。我们将TAVR后72小时内临床可检测到的脑血管事件定义为主要终点，将LOS和12个月死亡率定义为次要终点。采用逻辑回归和线性回归分析来评估Sentinel™的使用与终点之间的关联。在411例患者（80±7岁，47.4%为女性，欧洲心脏手术风险评估系统II评分为6.3±5.9%）中，213例（51.8%）使用了Sentinel™，其中189例（46.0%）两个滤网均正确植入。记录到20例（4.9%）脑血管事件，其中10例（2.4%）为致残性中风。与未使用Sentinel™的患者相比，使用Sentinel™的患者脑血管事件减少了71%（单因素分析；OR 0.29，95%CI 0.11 - 0.82；P = 0.02），分别减少了76%（多因素分析；OR 0.24，95%CI 0.08 - 0.76；P = 0.02）。使用Sentinel™还与较短的LOS（回归系数 -2.47，95%CI -4.08，-0.87；P < 0.01）和较低的12个月全因死亡率（OR 0.45；95%CI 0.22 - 0.93；P = 0.03）显著相关。在本前瞻性的所有患者TAVR队列中，使用Sentinel™的患者表现出：（1）脑血管事件发生率较低；（2）住院时间缩短；（3）12个月生存率提高。这些数据支持在植入TAVR瓣膜时使用CPS。
