Department of Cardiology, University Heart & Vascular Center Hamburg, Germany (S.L., N.S.).
German Center for Cardiovascular Research: DZHK, Partner site Hamburg/Kiel/Lübeck, Germany (S.L., N.S.).
Circ Cardiovasc Interv. 2023 May;16(5):e012768. doi: 10.1161/CIRCINTERVENTIONS.122.012768. Epub 2023 May 16.
BACKGROUND: The potential benefit of transcatheter aortic valve replacement (TAVR) in patients with nonsevere aortic stenosis (AS) and heart failure is controversial. This study aimed to assess outcomes of patients with nonsevere low-gradient AS (LGAS) and reduced left ventricular ejection fraction undergoing TAVR or medical management. METHODS: Patients undergoing TAVR for LGAS and reduced left ventricular ejection fraction (<50%) were included in a multinational registry. True-severe low-gradient AS (TS-LGAS) and pseudo-severe low-gradient AS (PS-LGAS) were classified according to computed tomography-derived aortic valve calcification thresholds. A medical control group with reduced left ventricular ejection fraction and moderate AS or PS-LGAS was used (Medical-Mod). Adjusted outcomes between all groups were compared. Among patients with nonsevere AS (moderate or PS-LGAS), outcomes after TAVR and medical therapy were compared using propensity score-matching. RESULTS: A total of 706 LGAS patients undergoing TAVR (TS-LGAS, N=527; PS-LGAS, N=179) and 470 Medical-Mod patients were included. After adjustment, both TAVR groups showed superior survival compared with Medical-Mod patients (all <0.001), while no difference was found between TS-LGAS and PS-LGAS TAVR patients (=0.96). After propensity score-matching among patients with nonsevere AS, PS-LGAS TAVR patients showed superior 2-year overall (65.4%) and cardiovascular survival (80.4%) compared with Medical-Mod patients (48.8% and 58.5%, both ≤0.004). In a multivariable analysis including all patients with nonsevere AS, TAVR was an independent predictor of survival (hazard ratio, 0.39 [95% CI, 0.27-0.55]; <0.0001). CONCLUSIONS: Among patients with nonsevere AS and reduced left ventricular ejection fraction, TAVR represents a major predictor of superior survival. These results reinforce the need for randomized-controlled trials comparing TAVR versus medical management in heart failure patients with nonsevere AS. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04914481.
背景：经导管主动脉瓣置换术（TAVR）在非重度主动脉瓣狭窄（AS）合并心力衰竭患者中的潜在获益仍存在争议。本研究旨在评估非重度低梯度 AS（LGAS）且左心室射血分数降低的患者行 TAVR 或药物治疗的结局。
方法：本研究纳入了接受 TAVR 治疗的 LGAS 且左心室射血分数（<50%）降低的多国登记研究患者。根据 CT 衍生的主动脉瓣钙化阈值，将真正重度低梯度 AS（TS-LGAS）和假性重度低梯度 AS（PS-LGAS）进行分类。同时还纳入了左心室射血分数降低且中重度 AS 或 PS-LGAS 的药物治疗对照组（Medical-Mod）。比较了所有组之间的调整后结局。在非重度 AS（中重度或 PS-LGAS）患者中，采用倾向评分匹配比较 TAVR 和药物治疗后的结局。
结果：共纳入 706 例接受 TAVR 的 LGAS 患者（TS-LGAS，N=527；PS-LGAS，N=179）和 470 例 Medical-Mod 患者。校正后，TAVR 组患者的总生存均优于 Medical-Mod 组患者（均<0.001），而 TS-LGAS 与 PS-LGAS TAVR 患者之间无差异（=0.96）。在非重度 AS 患者中进行倾向评分匹配后，PS-LGAS TAVR 患者的 2 年总生存率（65.4%）和心血管生存率（80.4%）均优于 Medical-Mod 患者（48.8%和 58.5%，均≤0.004）。在包括所有非重度 AS 患者的多变量分析中，TAVR 是生存的独立预测因素（风险比，0.39[95%CI，0.27-0.55]；<0.0001）。
结论：在非重度 AS 且左心室射血分数降低的患者中，TAVR 是生存率的主要预测因素。这些结果进一步强化了在非重度 AS 合并心力衰竭患者中进行 TAVR 与药物治疗比较的随机对照试验的必要性。
登记：网址：https://www.。
临床试验：gov；唯一标识号：NCT04914481。
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