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经导管主动脉瓣置换术后的冠状动脉插管:RE-ACCESS 研究。

Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study.

机构信息

Division of Cardiology, A.O.U. Policlinico-San Marco, Catania, Italy.

Division of Cardiology, A.O.U. Policlinico-San Marco, Catania, Italy.

出版信息

JACC Cardiovasc Interv. 2020 Nov 9;13(21):2542-2555. doi: 10.1016/j.jcin.2020.07.006. Epub 2020 Oct 14.

DOI:10.1016/j.jcin.2020.07.006
PMID:33069648
Abstract

OBJECTIVES

The aims of this study were to investigate the feasibility of coronary ostia cannulation after transcatheter aortic valve replacement (TAVR) and to assess potential predictors of coronary access impairment.

BACKGROUND

Certain data concerning the feasibility and reproducibility of coronary cannulation after TAVR are lacking.

METHODS

RE-ACCESS (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent) was an investigator-driven, single-center, prospective, registry-based study that enrolled consecutive patients undergoing TAVR using all commercially available devices. All patients underwent coronary angiography before and after TAVR. The primary endpoint was the rate of unsuccessful coronary ostia cannulation after TAVR. Secondary endpoints were the identification of factors associated with the inability to selectively cannulate coronary ostia after TAVR.

RESULTS

Among 300 patients enrolled in the RE-ACCESS study from December 2018 to January 2020, a total of 23 cases (7.7%) of unsuccessful coronary cannulation after TAVR were documented. This issue occurred in 22 of 23 cases with the use of Evolut R/PRO transcatheter aortic valves (TAVs) (17.9% vs. 0.4%; p < 0.01). In multivariate analysis, the use of Evolut R/PRO TAVs (odds ratio [OR]: 29.6; 95% confidence interval [CI]: 2.6 to 335.0; p < 0.01), the TAV-sinus of Valsalva relation (OR: 1.1 per 1-mm increase; 95% CI: 1.0 to 1.2; p < 0.01), and the mean TAV implantation depth (OR: 1.7 per 1-mm decrease; 95% CI: 1.3 to 2.3; p < 0.01) were found to be independent predictors of unsuccessful coronary cannulation after TAVR. A model combining these factors was demonstrated to predict with very high accuracy the risk for unsuccessful coronary cannulation after TAVR (area under the curve: 0.94; p < 0.01).

CONCLUSIONS

Unsuccessful coronary cannulation following TAVR was observed in 7.7% of patients and occurred almost exclusively in those receiving Evolut TAVs. The combination of Evolut TAV, a higher TAV-sinus of Valsalva relation, and implantation depth predicts with high accuracy the risk for unsuccessful coronary cannulation after TAVR. (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent [RE-ACCESS]; NCT04026204).

摘要

目的

本研究旨在探讨经导管主动脉瓣置换术(TAVR)后进行冠状动脉口插管的可行性,并评估冠状动脉插管受损的潜在预测因素。

背景

关于 TAVR 后冠状动脉插管的可行性和可重复性,某些数据尚不清楚。

方法

RE-ACCESS(经导管主动脉瓣置换术后再次获取冠状动脉口插管)是一项由研究者驱动的、单中心、前瞻性、基于注册的研究,纳入了使用所有商业可用器械接受 TAVR 的连续患者。所有患者均在 TAVR 前后进行冠状动脉造影。主要终点是 TAVR 后冠状动脉插管不成功的发生率。次要终点是确定与 TAVR 后无法选择性插管冠状动脉口相关的因素。

结果

在 2018 年 12 月至 2020 年 1 月期间,RE-ACCESS 研究共纳入 300 例患者,其中 23 例(7.7%)TAVR 后冠状动脉插管不成功。在 23 例中,有 22 例使用 Evolut R/PRO 经导管主动脉瓣(TAV)(17.9%比 0.4%;p<0.01)。多因素分析显示,使用 Evolut R/PRO TAV(比值比[OR]:29.6;95%置信区间[CI]:2.6 至 335.0;p<0.01)、TAV-主动脉窦关系(OR:每增加 1 毫米增加 1.1;95%CI:1.0 至 1.2;p<0.01)和平均 TAV 植入深度(OR:每减少 1 毫米降低 1.7;95%CI:1.3 至 2.3;p<0.01)是 TAVR 后冠状动脉插管不成功的独立预测因素。结合这些因素的模型被证明可以非常准确地预测 TAVR 后冠状动脉插管不成功的风险(曲线下面积:0.94;p<0.01)。

结论

TAVR 后冠状动脉插管不成功发生率为 7.7%,几乎仅发生在接受 Evolut TAV 的患者中。Evolut TAV、更高的 TAV-主动脉窦关系和植入深度的组合可以高度准确地预测 TAVR 后冠状动脉插管不成功的风险。(经导管主动脉瓣置换术后再次获取冠状动脉口插管[RE-ACCESS];NCT04026204)。

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