Khan Safi U, Zahid Salman, Alkhouli Mohamad A, Akbar Usman Ali, Zaid Syed, Arshad Hassaan B, Little Stephen H, Reardon Michael J, Kleiman Neal S, Goel Sachin S
Department of Cardiology, Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas, USA.
Sands-Constellation Heart Institute, Rochester General Hospital, Rochester, New York, USA.
Struct Heart. 2023 Apr 4;7(4):100178. doi: 10.1016/j.shj.2023.100178. eCollection 2023 Jul.
Transcatheter aortic valve intervention (TAVI) can lead to the embolization of debris. Capturing the debris by cerebral embolic protection (CEP) devices may reduce the risk of stroke. New evidence has allowed us to examine the effects of CEP in patients undergoing TAVI. We aimed to assess the effects of CEP overall and stratified by the device used (SENTINEL or TriGuard) and the surgical risk of the patients.
We selected randomized controlled trials using electronic databases through September 17, 2022. We estimated random-effects risk ratios (RR) with (95% confidence interval) and calculated absolute risk differences at 30 days across baseline surgical risks derived from the TAVI trials for any stroke (disabling and nondisabling) and all-cause mortality.
Among 6 trials (n = 3921), CEP vs. control did not reduce any stroke [RR: 0.95 (0.50-1.81)], disabling [RR: 0.75 (0.18-3.16)] or nondisabling [RR: 0.99 (0.65-1.49)] strokes, or all-cause mortality [RR: 1.23 (0.55-2.77)]. However, when analyzed by device, SENTINEL reduced disabling stroke [RR: 0.46 (0.22-0.95)], translating into 6 fewer per 1000 in high-risk, 3 fewer per 1000 in intermediate-risk, and 1 fewer per 1000 in low surgical-risk patients. CEP vs. control did not reduce the risk of any bleeding [RR: 1.03 (0.44-2.40)], major vascular complications [RR: 1.41 (0.57-3.48)], or acute kidney injury [RR: 1.36 (0.57-3.28)].
This updated meta-analysis showed that SENTINEL CEP might reduce disabling stroke in patients undergoing TAVI. Patients with high and intermediate surgical risks were most likely to derive benefits.
经导管主动脉瓣介入治疗（TAVI）可导致碎片栓塞。使用脑栓塞保护（CEP）装置捕获碎片可能会降低中风风险。新的证据使我们能够研究CEP在接受TAVI的患者中的作用。我们旨在评估CEP的总体效果，并按所使用的装置（SENTINEL或TriGuard）以及患者的手术风险进行分层评估。
我们通过电子数据库检索截至2022年9月17日的随机对照试验。我们估计了随机效应风险比（RR）及（95%置信区间），并计算了TAVI试验中不同基线手术风险患者在30天时发生任何中风（致残性和非致残性）及全因死亡率的绝对风险差异。
在6项试验（n = 3921）中，CEP与对照组相比，并未降低任何中风[RR：0.95（0.50 - 1.81）]、致残性[RR：0.75（0.18 - 3.16）]或非致残性[RR：0.99（0.65 - 1.49）]中风的发生率，也未降低全因死亡率[RR：1.23（0.55 - 2.77）]。然而，按装置分析时，SENTINEL可降低致残性中风的发生率[RR：0.46（0.22 - 0.95）]，在高风险患者中每1000人减少6例，中风险患者中每1000人减少3例，低手术风险患者中每1000人减少1例。CEP与对照组相比，并未降低任何出血风险[RR：1.03（0.44 - 2.40）]、主要血管并发症风险[RR：1.41（0.57 - 3.48）]或急性肾损伤风险[RR：1.36（0.57 - 3.28）]。
这项更新的荟萃分析表明，SENTINEL CEP可能会降低接受TAVI患者的致残性中风发生率。高手术风险和中等手术风险的患者最有可能从中获益。
