Department of Cardiology, Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland.
Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.
JACC Cardiovasc Interv. 2017 Jul 24;10(14):1436-1446. doi: 10.1016/j.jcin.2017.04.034.
The aim of this study was to examine the frequency, timing, and association of access-site and non-access-site bleeding with mortality in the setting of transcatheter aortic valve replacement (TAVR) during long-term follow-up.
Bleeding is frequent and associated with impaired prognosis in patients undergoing TAVR. It is currently unknown whether the site of bleeding differentially influences the outcomes of TAVR patients.
In total, 926 consecutive patients undergoing TAVR from 2007 through 2014 were evaluated. Bleeding was assessed according to the Valve Academic Research Consortium 2 criteria. The primary outcome of interest was all-cause mortality up to 5 years of follow-up.
A total of 285 patients (30.7%) experienced at least 1 (minor, major, or life-threatening) bleeding event up to 5 years. Compared with patients not experiencing bleeding, the adjusted risk for all-cause mortality was significantly increased among patients with access-site (hazard ratio: 1.34; 95% confidence interval: 1.01 to 1.76; p = 0.04) and non-access-site bleeding (hazard ratio: 2.08; 95% confidence interval: 1.60 to 2.71; p < 0.001). However, non-access-site bleeding conferred a significantly higher risk for mortality compared with access-site bleeding (hazard ratio: 1.56; 95% confidence interval: 1.12 to 2.18; p = 0.009). At multivariate analysis, female sex was a significant correlate of access-site bleeding, whereas chronic kidney disease and the Society of Thoracic Surgeons score were significantly associated with non-access-site bleeding.
Among patients with severe aortic stenosis undergoing TAVR, access-site and non-access-site bleeding were independently associated with an increased risk for mortality, with the greatest risk related to non-access-site bleeding during long-term follow-up.
本研究旨在探讨经导管主动脉瓣置换术(TAVR)长期随访期间,心外膜入路和心外膜入路以外部位出血的发生频率、时间及与死亡率的相关性。
TAVR 患者出血频繁,且与预后不良相关。目前尚不清楚出血部位是否会对 TAVR 患者的结局产生不同影响。
本研究共纳入 2007 年至 2014 年期间接受 TAVR 的 926 例连续患者。根据 Valve Academic Research Consortium 2 标准评估出血情况。主要观察终点为 5 年随访期间的全因死亡率。
共有 285 例(30.7%)患者在 5 年内至少发生 1 次(轻微、严重或危及生命)出血事件。与未出血患者相比,心外膜入路(风险比:1.34;95%置信区间:1.01 至 1.76;p = 0.04)和心外膜入路以外部位(风险比:2.08;95%置信区间:1.60 至 2.71;p < 0.001)出血患者的全因死亡率风险显著增加。然而,与心外膜入路出血相比,心外膜入路以外部位出血的死亡风险更高(风险比:1.56;95%置信区间:1.12 至 2.18;p = 0.009)。多变量分析显示,女性是心外膜入路出血的显著相关因素,而慢性肾脏病和胸外科医师协会评分与心外膜入路以外部位出血显著相关。
在接受 TAVR 的严重主动脉瓣狭窄患者中,心外膜入路和心外膜入路以外部位出血与死亡率升高独立相关,在长期随访期间,心外膜入路以外部位出血与最大风险相关。