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Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials.
Circulation: Heart Failure ( IF 9.7 ) Pub Date : 2019-08-01 , DOI: 10.1161/circheartfailure.118.005809
Ariel Furer 1, 2, 3 , Shmuel Chen 1 , Bjorn Redfors 1, 4 , Sammy Elmariah 5 , Philippe Pibarot 6 , Howard C Herrmann 7 , Rebecca T Hahn 8 , Susheel Kodali 8 , Vinod H Thourani 9 , Pamela S Douglas 10 , Maria C Alu 1, 8 , William F Fearon 11 , Jonathan Passeri 5 , S Chris Malaisrie 12 , Aaron Crowley 1 , Thomas McAndrew 1 , Philippe Genereux 13 , Ori Ben-Yehuda 1 , Martin B Leon 1, 8 , Daniel Burkhoff 1, 8
Affiliation  

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%, P<0.0001) and all-cause mortality (27.4% versus 19.2%, P<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; P=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; P=0.005), but not all-cause death (adjusted HR, 1.20; 95% CI, 0.99-1.47; P=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; P=0.0006) and all-cause mortality (adjusted HR, 1.09; 95% CI, 1.01-1.16; P=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.

中文翻译:

基线左心室射血分数对经导管主动脉瓣置换术后2年结局的影响:PARTNER 2试验的分析。

背景技术左心室功能受损与药物治疗或手术主动脉瓣置换的主动脉瓣狭窄患者的预后较差有关。尚不清楚降低左心室射血分数(LVEF)是否是经导管主动脉瓣置换术后不良预后的独立预测因子。方法和结果根据在基线时LVEF降低(<50%)的存在,对在PARTNER 2试验(主动脉导管置入术)和注册表中行经导管主动脉瓣置换的患者进行分层,并比较了2年的心血管死亡风险使用Kaplan-Meier方法和多变量Cox比例风险回归。在2991名患者中,有839名(28%)LVEF降低。这些患者年龄较小,男性较多,并且更容易合并疾病,例如冠心病,糖尿病和肾功能不全。与LVEF正常的患者相比,LVEF低的患者的2年心血管病死亡率(分别为19.8%和12.0%,P <0.0001)和全因死亡率(27.4%vs 19.2%,P <0.0001)更高。除心力衰竭住院外,平均主动脉瓣梯度与临床结局无关(危险比[HR],0.99; CI,0.99-1.00; P = 0.03)。经过多变量调整后,LVEF降低与正常的患者相比,调整后的心血管死亡风险显着较高(调整后的HR,1.42,95%CI,1.11-1.81; P = 0.005),但并非全因死亡(调整后的HR,1.20; 95) %CI,0.99-1.47; P = 0.07)。当LVEF被视为连续变量时,这与心血管疾病死亡率(LVEF每下降10%的调整后HR,1.16; 95%CI,1.07-1.27; P = 0.0006)和全因死亡率(校正后的HR,1.09; 95%)的2年风险增加相关CI,1.01-1.16; P = 0.02)。结论在对接受经导管主动脉瓣置换术的PARTNER 2病人进行的患者水平汇总分析中,基线LVEF是2年心血管疾病死亡率的独立预测因子。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT01314313,NCT02184442,NCT03222128和NCT02184441。基线LVEF是2年心血管疾病死亡率的独立预测因子。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT01314313,NCT02184442,NCT03222128和NCT02184441。基线LVEF是2年心血管疾病死亡率的独立预测因子。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT01314313,NCT02184442,NCT03222128和NCT02184441。
更新日期:2019-08-01
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