Cardiovascular Research Foundation, New York, NY (A.F., S.C., B.R., M.C.A., A.C., T.M., O.B.-Y., M.B.L., D.B.).
IDF Medical Corps Headquarters, Israel (A.F.).
Circ Heart Fail. 2019 Aug;12(8):e005809. doi: 10.1161/CIRCHEARTFAILURE.118.005809. Epub 2019 Aug 1.
BACKGROUND: Impaired left ventricular function is associated with worse prognosis among patients with aortic stenosis treated medically or with surgical aortic valve replacement. It is unclear whether reduced left ventricular ejection fraction (LVEF) is an independent predictor of adverse outcomes after transcatheter aortic valve replacement. METHODS AND RESULTS: Patients who underwent transcatheter aortic valve replacement in the PARTNER 2 trials (Placement of Aortic Transcatheter Valves) and registries were stratified according to presence of reduced LVEF (<50%) at baseline, and 2-year risk of cardiovascular mortality was compared using Kaplan-Meier methods and multivariable Cox proportional hazards regression. Of 2991 patients, 839 (28%) had reduced LVEF. These patients were younger, more often males, and were more likely to have comorbidities, such as coronary disease, diabetes mellitus, and renal insufficiency. Compared with patients with normal LVEF, patients with low LVEF had higher crude rates of 2-year cardiovascular mortality (19.8% versus 12.0%, <0.0001) and all-cause mortality (27.4% versus 19.2%, <0.0001). Mean aortic valve gradient was not associated with clinical outcomes other than heart failure hospitalizations (hazard ratio [HR], 0.99; CI, 0.99-1.00; =0.03). After multivariable adjustment, patients with reduced versus normal LVEF had significantly higher adjusted risk of cardiovascular death (adjusted HR, 1.42, 95% CI, 1.11-1.81; =0.005), but not all-cause death (adjusted HR, 1.20; 95% CI, 0.99-1.47; =0.07). When LVEF was treated as continuous variable, it was associated with increased 2-year risk of both cardiovascular mortality (adjusted HR per 10% decrease in LVEF, 1.16; 95% CI, 1.07-1.27; =0.0006) and all-cause mortality (adjusted HR, 1.09; 95% CI, 1.01-1.16; =0.02). CONCLUSIONS: In this patient-level pooled analysis of PARTNER 2 patients who underwent transcatheter aortic valve replacement, baseline LVEF was an independent predictor of 2-year cardiovascular mortality. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01314313, NCT02184442, NCT03222128, and NCT02184441.
背景：在接受药物治疗或主动脉瓣置换术治疗的主动脉瓣狭窄患者中，左心室功能受损与预后较差相关。目前尚不清楚左心室射血分数（LVEF）降低是否是经导管主动脉瓣置换术后不良结局的独立预测因素。
方法和结果：根据基线时 LVEF（<50%）的存在情况，对 PARTNER 2 试验（主动脉瓣经导管置换术的放置）和注册研究中的接受经导管主动脉瓣置换术的患者进行分层，并使用 Kaplan-Meier 方法和多变量 Cox 比例风险回归比较 2 年心血管死亡率。在 2991 名患者中，839 名（28%）存在 LVEF 降低。这些患者年龄较小，男性较多，并且更可能患有合并症，如冠心病、糖尿病和肾功能不全。与 LVEF 正常的患者相比，LVEF 降低的患者 2 年心血管死亡率（19.8%对 12.0%，<0.0001）和全因死亡率（27.4%对 19.2%，<0.0001）的粗率更高。平均主动脉瓣梯度与心力衰竭住院以外的临床结局无关（风险比 [HR]，0.99；CI，0.99-1.00；=0.03）。多变量调整后，与 LVEF 正常的患者相比，LVEF 降低的患者心血管死亡的调整风险显著更高（调整 HR，1.42，95%CI，1.11-1.81；=0.005），但全因死亡的调整风险无显著差异（调整 HR，1.20；95%CI，0.99-1.47；=0.07）。当 LVEF 作为连续变量处理时，它与 2 年心血管死亡率（每降低 10%LVEF 的调整 HR，1.16；95%CI，1.07-1.27；=0.0006）和全因死亡率（调整 HR，1.09；95%CI，1.01-1.16；=0.02）的增加均相关。
结论：在接受经导管主动脉瓣置换术的 PARTNER 2 患者的这一患者水平汇总分析中，基线 LVEF 是 2 年心血管死亡率的独立预测因素。
临床试验注册：网址：https://www.clinicaltrials.gov。唯一标识符：NCT01314313、NCT02184442、NCT03222128 和 NCT02184441。
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