Abstract
BACKGROUND: 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. RESULTS: 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. CONCLUSIONS: Catheter directed HMD for high-risk and intermediate-high-risk PE is safe and effective with acceptable mortality Trial registration Clinical trial ID: NCT04099186.