Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada.
Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
J Am Coll Cardiol. 2014 Mar 25;63(11):1100-9. doi: 10.1016/j.jacc.2013.10.058. Epub 2013 Nov 27.
OBJECTIVES: This study sought to identify the incidence, predictors, and prognostic impact of bleeding complications (BC) after surgical aortic valve replacement (SAVR) compared with transcatheter aortic valve replacement (TAVR). BACKGROUND: Bleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis. METHODS: In the randomized controlled PARTNER (Placement of Aortic Transcatheter Valve) I trial, 657 patients from cohort A (operable high risk) were randomly assigned to SAVR or TAVR (transfemoral [TF] if iliofemoral access was suitable or transapical [TA] if not) and received the designated treatment. First-generation Edwards SAPIEN valves and delivery systems (Edwards Lifesciences, Irvine, California) were used for TAVR, through a 22- or 24-F sheath. The 30-day rates of major BC (modified Valve Academic Research Consortium definitions), predictors of BC, and their association with 1-year mortality were assessed. RESULTS: A total of 71 (22.7%), 27 (11.3%), and 9 (8.8%) patients had major BC within 30 days of the procedure after SAVR, TF-TAVR, and TA-TAVR, respectively (p < 0.0001). SAVR was associated with a significantly higher 30-day rate of transfusion (17.9%) than either TF-TAVR (7.1%) or TA-TAVR (4.8%; p < 0.0001). Independent predictors of major BC were the occurrence of major vascular complications and use of intraprocedural hemodynamic support among TF-TAVR patients, severe procedural complications requiring conversion to open surgery among TA-TAVR patients, and the presence of low hemoglobin at baseline among SAVR patients. Major BC was identified as the strongest independent predictor of 1-year mortality among the full cohort. However, risk-adjusted analyses demonstrated a significant interaction between BC and treatment strategy with respect to mortality, suggesting that BC after SAVR have a greater impact on prognosis than after TAVR. CONCLUSIONS: Among high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial, BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
目的：本研究旨在比较经导管主动脉瓣置换术（TAVR）与外科主动脉瓣置换术（SAVR）后出血并发症（BC）的发生率、预测因素和预后影响。
背景：SAVR 和 TAVR 后 BC 较为常见，且可能与不良预后相关。
方法：在随机对照的 PARTNER（经导管主动脉瓣置换）I 试验中，A 队列（可手术的高危）的 657 名患者被随机分配至 SAVR 或 TAVR（如果适合股髂入路则采用经股动脉[TF]，否则采用经心尖[TA]），并接受指定的治疗。第一代 Edwards SAPIEN 瓣膜和输送系统（爱德华生命科学公司，加利福尼亚州欧文）用于 TAVR，通过 22 或 24-F 鞘。评估 30 天内主要 BC（改良 Valve Academic Research Consortium 定义）的发生率、BC 的预测因素及其与 1 年死亡率的关系。
结果：SAVR、TF-TAVR 和 TA-TAVR 后 30 天内分别有 71 例（22.7%）、27 例（11.3%）和 9 例（8.8%）患者发生主要 BC（p<0.0001）。SAVR 与 30 天内输血率（17.9%）显著高于 TF-TAVR（7.1%）或 TA-TAVR（4.8%；p<0.0001）相关。TF-TAVR 患者中，主要 BC 的独立预测因素是主要血管并发症的发生和术中血流动力学支持的使用；TA-TAVR 患者中，需要转为开放手术的严重手术并发症以及 SAVR 患者基线时低血红蛋白是独立预测因素。在全队列中，主要 BC 是 1 年死亡率的最强独立预测因素。然而，风险调整分析显示，BC 与治疗策略之间存在显著的交互作用，表明 SAVR 后 BC 对预后的影响大于 TAVR 后。
结论：在 PARTNER I 随机试验中纳入的高危主动脉瓣狭窄患者中，SAVR 后 BC 比 TAVR 后更常见，且与长期预后较差相关。
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