BackgroundBleeding and stroke are frequent complications after transcatheter aortic valve implantation (TAVI). The mortality risk associated with these events has been reported before, but data regarding their impact on health‐related quality of life (QoL) is limited.AimTo evaluate the impact of bleeding and stroke occurring within 30 days after TAVI, on mortality and QoL during the first year after TAVI.MethodsPOPular TAVI was a randomized clinical trial that evaluated the addition of clopidogrel to aspirin or oral anticoagulation in patients undergoing TAVI. Besides clinical outcomes, QoL was assessed using the Short Form‐12 and EuroQoL Five Dimensions questionnaires before, and at 3, 6, and 12 months after TAVI.ResultsMajor or life‐threatening bleeding occurred in 81 patients (8.3%) and was associated with an increased risk of death (hazard ratio [HR] 1.95 [95% confidence interval (CI) 1.00–3.79]); minor bleeding occurred in 104 patients (10.6%) and was not associated with mortality (HR 0.75 [95% CI 0.30–1.89]). Stroke occurred in 35 patients (3.6%) and was associated with an increased risk of death (HR 2.90 [95% CI 1.23–6.83]). Mean mental component summary (MCS‐12) scores over time were lower in patients with major or life‐threatening bleeding (p = 0.01), and similar in patients with minor bleeding, compared to patients without bleeding; mean physical component summary (PCS‐12) scores, EQ‐5D index, and visual analog scale (VAS) were similar between those patients. Mean MCS‐12 scores were lower in patients with stroke (p = 0.01), mean PCS‐12, EQ‐5D index, and VAS were similar compared to patients without stroke.ConclusionMajor or life‐threatening bleeding and stroke were associated with an increased risk of death and decreased mental QoL in the first year after TAVI.

中文翻译：

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中风和出血对 TAVI 术后第一年死亡率和生活质量的影响：流行的 TAVI 亚分析


背景出血和中风是经导管主动脉瓣植入（TAVI）后常见的并发症。与这些事件相关的死亡风险之前已有报道，但有关其对健康相关生活质量 (QoL) 影响的数据有限。目的评估 TAVI 术后 30 天内发生的出血和中风对死亡率和 QoL 的影响。 TAVI 后第一年。MethodsPOPular TAVI 是一项随机临床试验，评估接受 TAVI 的患者在阿司匹林或口服抗凝药物中添加氯吡格雷。除了临床结果外，还使用 ​​Short Form‐12 和 EuroQoL 五维问卷评估 TAVI 之前以及术后 3、6 和 12 个月的生活质量。结果 81 名患者 (8.3%) 发生严重或危及生命的出血，并且与死亡风险增加（风险比 [HR] 1.95 [95% 置信区间 (CI) 1.00–3.79]）； 104 名患者 (10.6%) 发生轻微出血，且与死亡率无关（HR 0.75 [95% CI 0.30–1.89]）。 35 名患者 (3.6%) 发生中风，并与死亡风险增加相关 (HR 2.90 [95% CI 1.23–6.83])。与没有出血的患者相比，随着时间的推移，有严重或危及生命的出血的患者的平均精神成分总结（MCS-12）得分较低（p = 0.01），而轻微出血的患者则相似；这些患者的平均身体成分总结 (PCS-12) 评分、EQ-5D 指数和视觉模拟量表 (VAS) 相似。与非中风患者相比，中风患者的平均 MCS-12 评分较低 (p = 0.01)，平均 PCS-12、EQ-5D 指数和 VAS 相似。 结论TAVI 后第一年的死亡风险和精神生活质量下降。