Conrotto Federico, Salizzoni Stefano, Andreis Alessandro, D'Ascenzo Fabrizio, D'Onofrio Augusto, Agrifoglio Marco, Chieffo Alaide, Colombo Antonio, Rapetto Filippo, Santini Francesco, Tarantini Giuseppe, Gabbieri Davide, Savini Carlo, Immè Sebastiano, Ribichini Flavio, Valsecchi Orazio, Aiello Marco, Lixi Giovanni, Iadanza Alessandro, Pompei Esmeralda, Stolcova Miroslava, Ornaghi Diego, Minati Alessandro, Cassese Mauro, Martinelli Gian Luca, Sbarra Pierluigi, Agostinelli Andrea, Audo Andrea, Pieroni Andrea, Fiorilli Rosario, Gerosa Gino, Rinaldi Mauro, Gaita Fiorenzo
Division of Cardiology, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.
Department of Surgical Sciences, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.
Am J Cardiol. 2017 May 1;119(9):1438-1442. doi: 10.1016/j.amjcard.2017.01.042. Epub 2017 Feb 10.
Advanced chronic kidney disease (CKD) is associated with poor outcomes in patients who underwent surgical aortic valve replacement, whereas its prognostic role in transcatheter aortic valve implantation (TAVI) remains unclear. This study aimed to investigate outcomes in patients with advanced CKD who underwent TAVI. A total of 1,904 consecutive patients who underwent balloon-expandable TAVI in 33 centers between 2007 and 2012 were enrolled in the Italian Transcatheter Balloon-Expandable Valve Implantation Registry. Advanced CKD was defined according to the estimated glomerular filtration rate: 15 to 29 ml/min/1.73 m stage 4 (S4), <15 ml/min/1.73 m stage 5 (S5). Edwards Sapien or Sapien-XT prosthesis were used. The primary end point was all-cause mortality during follow-up. Secondary end points were major adverse cardiac events at 30 days and at follow-up, defined with Valve Academic Research Consortium 2 criteria. A total of 421 patients were staged S5 (n = 74) or S4 (n = 347). S5 patients were younger and had more frequently porcelain aorta and a lower incidence of previous stroke. Periprocedural and 30-day outcomes were similar in S5 and S4 patients. During 670 (±466) days of follow-up, S5 patients had higher mortality rates (69% vs 39%, p <0.01) and cardiac death (19% vs 9%, p = 0.02) compared with S4 patients. Male gender (hazard ratio [HR] 1.6, 95% confidence interval [CI] 1.2 to 2.2), left ventricular ejection fraction <30% (HR 2.3, 95% CI 1.3 to 4), atrial fibrillation (HR 1.4, 95% CI 1.0 to 1.9), and S5 CKD (HR 1.5, 95% CI 1.0 to 2.1) were independent predictors of death. In conclusion, TAVI in predialytic or dialytic patients (i.e., S5) is independently associated with poor outcomes with more than double risk of death compared with patients with S4 renal function. Conversely, in severe CKD (i.e., S4) a rigorous risk stratification is required to avoid the risk of futility risk.
晚期慢性肾脏病（CKD）与接受外科主动脉瓣置换术患者的不良预后相关，而其在经导管主动脉瓣植入术（TAVI）中的预后作用尚不清楚。本研究旨在调查接受TAVI的晚期CKD患者的预后情况。2007年至2012年间，意大利经导管球囊扩张瓣膜植入注册研究纳入了33个中心连续接受球囊扩张式TAVI的1904例患者。根据估计的肾小球滤过率定义晚期CKD：15至29 ml/min/1.73m为4期（S4），<15 ml/min/1.73m为5期（S5）。使用爱德华兹Sapien或Sapien-XT假体。主要终点是随访期间的全因死亡率。次要终点是30天及随访时的主要不良心脏事件，根据瓣膜学术研究联盟2标准定义。共有421例患者为S5期（n = 74）或S4期（n = 347）。S5期患者更年轻，瓷化主动脉更常见，既往中风发生率更低。S5期和S4期患者围手术期及30天的预后相似。在670（±466）天的随访期间，与S4期患者相比，S5期患者的死亡率更高（69%对39%，p<0.01），心源性死亡发生率更高（19%对9%，p = 0.02）。男性（风险比[HR]1.6，95%置信区间[CI]1.2至2.2）、左心室射血分数<30%（HR 2.3，95%CI 1.3至4）、心房颤动（HR 1.4，95%CI 1.0至1.9）和S5期CKD（HR 1.5，95%CI 1.0至2.1）是死亡的独立预测因素。总之，与肾功能为S4期的患者相比，透析前或透析患者（即S5期）接受TAVI与不良预后独立相关，死亡风险增加一倍以上。相反，在重度CKD（即S4期）患者中，需要进行严格的风险分层以避免无效治疗的风险。
