Department of Cardiology, Medical Clinic IV, Municipal Hospital Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Germany.
Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
Am J Cardiol. 2019 Jan 15;123(2):315-322. doi: 10.1016/j.amjcard.2018.10.008. Epub 2018 Oct 18.
End-stage renal disease (ESRD) affects approximately 2% to 4% of patients with severe aortic stenosis. It is because these patients have been excluded from clinical trials, the impact of transcatheter aortic valve implantation (TAVI) in this patient group has not been thoroughly investigated. Between April 2008 and March 2015, 2,000 patients (dialysis group, n = 56 [2.8%]) were consecutively enrolled when diagnosed with severe aortic stenosis and eligible to undergo TAVI. Procedural and longer-term outcomes were analyzed and adjusted for differences in baseline characteristics. Patients on dialysis had a higher periprocedural mortality (10.7% vs 1.7%; adjusted odds ratio [adjOR] 5.65, 95% confidence interval [CI] 1.91 to 16.67; p = 0.002) and a lower Valve Academic Research Consortium (VARC)-II (VARC) defined device success (adjOR 0.34, 95% CI 0.15 to 0.79; p = 0.012). At 30 days, there was an increased rate of all-cause mortality (21.4 vs 4.8%; adjOR 4.90, 95% CI 1.96 to 12.26; p = 0.001), cardiovascular (adjOR 3.67, 95% CI 1.43 to 9.41; p = 0.007) and noncardiovascular mortality (adjOR 6.28, 95% CI 1.36 to 9.41; p = 0.019), myocardial infarction (adjOR 9.39, 95% CI 1.84 to 48.03; p = 0.007), bleeding (adjOR 2.48, 95% CI 1.06 to 5.83; p = 0.036) as well as the VARC-II defined early safety combined end point (adjOR 2.97, 95% CI 1.28 to 6.90; p = 0.012) associated with dialysis. Dialysis was associated with poor survival at one (57.1% vs 84.2%) and 3 years (26.8% vs 66.9%) with or without the consideration of the first 72 hours (p <0.001; adjusted p <0.001). Although, in the multivariable regression analysis, reduced ejection fraction, peripheral arterial disease, pulmonary hypertension (PH), frailty and dialysis were associated with 1-year mortality, only PH (>60 mm Hg) remained significant in an analysis restricted to the dialysis patients (adjusted hazard ratio 2.68; 95% CI 1.18 to 5.88; p = 0.018). PH had a sensitivity of 45.8%, a specificity of 81.3%, and a positive predictive value of 64.7%. In conclusion, dialysis is an independent predictor of mortality in patients who underwent TAVI. Long-term mortality in dialysis patients appears to be largely determined by the kidney disease and/or dialysis itself whereas VARC-II defined complications are largely unaffected. An increased short-term mortality still calls for (pre-) procedural optimization.
终末期肾脏疾病（ESRD）影响约 2%-4%的严重主动脉瓣狭窄患者。这是因为这些患者已被排除在临床试验之外，因此经导管主动脉瓣植入术（TAVI）在这组患者中的影响尚未得到彻底研究。2008 年 4 月至 2015 年 3 月，连续纳入 2000 名被诊断为严重主动脉瓣狭窄且符合 TAVI 条件的患者（透析组，n=56[2.8%]）。分析了手术过程和长期结果，并根据基线特征的差异进行了调整。透析患者围手术期死亡率更高（10.7%比 1.7%；调整后的优势比[adjOR]5.65，95%置信区间[CI]1.91 至 16.67；p=0.002），且 Valve Academic Research Consortium（VARC）定义的器械成功率更低（adjOR 0.34，95%CI 0.15 至 0.79；p=0.012）。在 30 天时，全因死亡率增加（21.4%比 4.8%；adjOR 4.90，95%CI 1.96 至 12.26；p=0.001），心血管（adjOR 3.67，95%CI 1.43 至 9.41；p=0.007）和非心血管死亡率（adjOR 6.28，95%CI 1.36 至 9.41；p=0.019），心肌梗死（adjOR 9.39，95%CI 1.84 至 48.03；p=0.007）和出血（adjOR 2.48，95%CI 1.06 至 5.83；p=0.036）以及 VARC-II 定义的早期安全性联合终点（adjOR 2.97，95%CI 1.28 至 6.90；p=0.012）与透析有关。透析与 1 年（57.1%比 84.2%）和 3 年（26.8%比 66.9%）生存率较差相关，无论是否考虑前 72 小时（p<0.001；调整后 p<0.001）。尽管在多变量回归分析中，射血分数降低、外周动脉疾病、肺动脉高压（PH）、虚弱和透析与 1 年死亡率相关，但仅 PH（>60mmHg）在仅透析患者的分析中仍然具有显著意义（调整后的危险比 2.68；95%CI 1.18 至 5.88；p=0.018）。PH 的灵敏度为 45.8%，特异性为 81.3%，阳性预测值为 64.7%。总之，透析是 TAVI 患者死亡的独立预测因素。透析患者的长期死亡率似乎主要由肾脏疾病和/或透析本身决定，而 VARC-II 定义的并发症则基本不受影响。短期死亡率的增加仍需要（术前）进行优化。
