Pulmonary embolism (PE) is the third most common acute cardiovascular syndrome. Percutaneous catheter directed hydro-mechanical defragmentation (HMD) is one of the recommended treatment options for PE in patients with contraindications to thrombolytic therapy or failed systemic thrombolysis (ST). We aimed to identify the safety and outcomes of catheter directed HMD in patients with high-risk PE. This nonrandomized controlled trial enrolled all patients with confirmed diagnoses of high- and intermediate-high-risk PE from October 2019 till January 2021. Fifty patients were included and divided into two groups by the PE response team according to the presence or absence of a contraindication for ST. Group B (ST) consists of 25 patients and group A (HMD) of 25 patients who cannot receive ST. The two groups were comparable regarding baseline clinical characteristics with mean age 51 ± 13 years. In group A, systolic blood pressure (BP) and oxygen saturation increased after 24 h (p = 0.002) and 48 h (p < 0.001) compared to pre-HMD procedure. Mean pulmonary artery systolic pressure (PASP) and respiratory rate (RR) decreased after 48 h and at 30 days (p < 0.001) compared to pre-HMD procedure. The increase in systolic BP and oxygen saturation were significantly higher in HMD group compared with ST group after 48 h and at 30 days (p < 0.007). The decrease in PASP and RR was significantly higher in HMD group compared to ST group after 48 h and at 30 days (p < 0.001). Mortality rate at 30 days was 20% in HMD group compared to 32% in ST group. Catheter directed HMD for high-risk and intermediate-high-risk PE is safe and effective with acceptable mortality Trial registration Clinical trial ID: NCT04099186.

中文翻译：

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中高危肺栓塞中液压机械碎裂的有效性和安全性

肺栓塞 (PE) 是第三大最常见的急性心血管综合征。对于有溶栓治疗禁忌症或全身溶栓 (ST) 失败的 PE 患者，经皮导管定向液压机械碎片化 (HMD) 是推荐的治疗方案之一。我们旨在确定导管定向 HMD 在高危 PE 患者中的安全性和结果。这项非随机对照试验纳入了 2019 年 10 月至 2021 年 1 月期间确诊为高危和中高危 PE 的所有患者。 PE 响应小组将 50 名患者纳入并根据是否存在禁忌症分为两组为 ST。B组（ST）由25名患者组成，A组（HMD）由25名不能接受ST的患者组成。两组在基线临床特征方面具有可比性，平均年龄为 51 ± 13 岁。在 A 组中，与前 HMD 手术相比，收缩压 (BP) 和氧饱和度在 24 小时 (p = 0.002) 和 48 小时 (p < 0.001) 后增加。与前 HMD 手术相比，平均肺动脉收缩压 (PASP) 和呼吸频率 (RR) 在 48 小时和 30 天后降低 (p < 0.001)。48 小时后和 30 天时，HMD 组收缩压和氧饱和度的增加显着高于 ST 组（p < 0.007）。与 ST 组相比，HMD 组在 48 小时和 30 天后 PASP 和 RR 的降低显着更高（p < 0.001）。HMD 组 30 天死亡率为 20%，而 ST 组为 32%。