Is it Time to Reappraise for Black-Box Warning on AngioJet Rheolytic Thrombectomy in Patients with Pulmonary Embolism: A Systematic Review and Meta-analysis.

ABSTRACT

BACKGROUND: AngioJet rheolytic thrombectomy (ART) system has been widely used as a catheter-directed treatment (CDT) method in acute pulmonary embolism (PE), however, there has been a controversy regarding the safety of its use. In this systematic review and meta-analysis, we evaluated the efficacy and safety outcomes of ART in patients with PE. METHODS: Our meta-analysis have been based on search in the MEDLINE, EMBASE, and Cochrane Library for studies published up to August 2022. The primary outcomes were overall pooled rates of major bleeding (MB) and minor bleeding (mB), worsening renal function (WRF), bradycardia/conduction disturbance (BCD), and PE-related and all-cause mortality in patients who underwent ART. RESULTS: Among the 233 studies documented at initial search, 24 studies were eligible for meta-analysis, and a total of 427 PE patients who underwent ART were evaluated. Overall pooled rates of MB and mB were 9.6% (95% CI 5.9%-15.2%) and 9.2% (95% CI 6.1%-13.6%), transient BCD and WRF were 18.2% (95% CI 12.4%-26%) and 15% (95% CI 10%-21.8%), and PE-related death and all-cause death were 12.7% (95% CI 9.1%-17.3%) and 15% (95% CI 11%-20%), respectively. However, significant heterogeneity and some evidence of funnel plot asymmetry and publication bias were noted for MB, BCD and WRF, but not for PE-related death and all-cause death. CONCLUSION: Overall pooled rates of bleeding events, BCD and WRF episodes, PE-related death and all-cause death may be considered as encouraging results for efficacy and safety issues of ART utilization in specific scenarios of acute PE, and a reappraisal for black-box warning on ART seems to be necessary.