Department of Internal Medicine 2, Division of Cardiology, Medical University of Vienna, Vienna, Austria.
Department of Internal Medicine 3, University Hospital St. Pölten, Karl Landsteiner University of Health Sciences, Krems, Austria.
JACC Cardiovasc Interv. 2024 Sep 9;17(17):2054-2066. doi: 10.1016/j.jcin.2024.06.022.
Fluid overload (FO) subjects patients with severe aortic stenosis (AS) to increased risk for heart failure and death after valve replacement and can be objectively quantified using bioimpedance spectroscopy (BIS).
The authors hypothesized that in AS patients with concomitant FO, BIS-guided decongestion could improve prognosis and quality of life following transcatheter aortic valve replacement (TAVR).
This randomized, controlled trial enrolled 232 patients with severe AS scheduled for TAVR. FO was defined using a portable whole-body BIS device according to previously established cutoffs (≥1.0 L and/or ≥7%). Patients with FO (n = 111) were randomly assigned 1:1 to receive BIS-guided decongestion (n = 55) or decongestion by clinical judgment alone (n = 56) following TAVR. Patients without FO (n = 121) served as a control cohort. The primary endpoint was the composite of hospitalization for heart failure and/or all-cause death at 12 months. The secondary endpoint was the change from baseline to 12 months in the Kansas City Cardiomyopathy Questionnaire.
The occurrence of the primary endpoint at 12 months was significantly lower in the BIS-guided vs the non-BIS-guided decongestion group (7/55 [12.7%, all deaths] vs 18/56 [32.1%, 9 hospitalizations for heart failure and 9 deaths]; HR: 0.36; 95% CI: 0.15-0.87; absolute risk reduction = -19.4%). Outcomes in the BIS-guided decongestion group were identical to the euvolemic control group (log-rank test, P = 0.7). BIS-guided decongestion was also associated with a higher increase in the Kansas City Cardiomyopathy Questionnaire score from baseline compared to non-BIS-guided decongestion (P = 0.001).
In patients with severe AS and concomitant FO, quantitatively guided decongestive treatment and associated intensified management post-TAVR was associated with improved outcomes and quality of life compared to decongestion by clinical judgment alone. (Management of Fluid Overload in Patients Scheduled for Transcatheter Aortic Valve Replacement [EASE-TAVR]; NCT04556123).
在接受瓣膜置换术后，液体超负荷（FO）会使严重主动脉瓣狭窄（AS）患者心力衰竭和死亡的风险增加，并且可以使用生物阻抗谱（BIS）客观地量化。
作者假设在伴有 FO 的 AS 患者中，BIS 指导的消肿治疗可以改善经导管主动脉瓣置换术（TAVR）后的预后和生活质量。
这是一项随机对照试验，共纳入 232 名计划接受 TAVR 的严重 AS 患者。FO 是根据先前建立的截定点（≥1.0 L 和/或≥7%）使用便携式全身 BIS 设备定义的。FO 患者（n=111）被随机分为 1:1 接受 BIS 指导的消肿治疗（n=55）或仅根据临床判断进行消肿治疗（n=56）。无 FO 患者（n=121）作为对照组。主要终点是 12 个月时因心力衰竭住院和/或全因死亡的复合终点。次要终点是从基线到 12 个月时堪萨斯城心肌病问卷的变化。
12 个月时，BIS 指导组的主要终点发生率明显低于非 BIS 指导组（7/55[12.7%，均为死亡]vs.18/56[32.1%，9 例心力衰竭住院和 9 例死亡]；HR：0.36；95%CI：0.15-0.87；绝对风险降低率=-19.4%）。BIS 指导组的结局与正常血容量对照组相同（对数秩检验，P=0.7）。与非 BIS 指导组相比，BIS 指导的消肿治疗还与堪萨斯城心肌病问卷评分从基线的更高升高相关（P=0.001）。
在伴有 FO 的严重 AS 患者中，与仅根据临床判断进行消肿治疗相比，定量指导的消肿治疗和 TAVR 后强化管理与改善预后和生活质量相关。（经导管主动脉瓣置换术患者液体超负荷管理[EASE-TAVR]；NCT04556123）。
