Assessment Of Clinical Effectiveness And Safety Of Hyaluronic Acid-Polidocanol Foam In Sclerotherapy For Head And Neck Venous Malformations

Background:Venous malformations(VMs)are common congenital vascular malformations tending to occur in the head and neck regions which could cause deformation,dysfunctions,swelling and pain.Foam sclerotherapy is effective in the treatment of venous malformation,while polidocanol(POL)is one of the most generally used sclerosant.Hyaluronic acid(HA)is a kind of lining glycosaminoglycan,as an additive agent with great biosafety,it can prolong the foam half-time of POL and improve the stability of POL foam significantly.The more stable polidocanol foam has been applied in the clinical practices for venous malformation.However,there are few reports concerning the efficacy and safety of the more stable HA-POL foam sclerotherapy,and the influencing factors of its efficacy and safety are not available,hence more studies are needed for further testify.Objective:To study the efficacy and safety of HA-POL foam sclerotherapy for VMs in head and neck region and its influencing factors.Methods:A single-center retrospective study was used to collect case data of patients diagnosed of head and neck venous malformations and treated by HA-POL foam(2mL 1%POL+0.1 mL 1%HA+8 mL air)from February 2015 to February 2022 in the Department of Oral and Maxillofacial Surgery,Qilu Hospital,Shandong University,and a follow-up study of them were executed to evaluate the safety and efficacy of HA-POL foam sclerotherapy.The statistical methods of binary Logistics linear regression and Pearson correlation analysis and SPSS 23.0 software package were used for statistical analysis of experimental research data.Results:A total of 223 patients diagnosed with head and neck venous malformations who received HA-POL foam sclerotherapy in the Department of Oral and Maxillofacial Surgery,Qilu Hospital,Shandong University,were included in the study.The male female ratio was 1:1.86.The total number of treatments was 380,and each patient received an average of 1.70±1.41 times treatment,the dose of HA-POL foam hardener was 9.82 ± 6.31 mL per treatment.The total effective rate of the treatments was 96.41%(n=215),of which 30.94%(n=69)of the patients reached the "cured" standard,and 65.47%(n=146)of the patients had"significant improvement" after treatment,that is,the volume of VMs lesion was reduced by more than 50%after treatment,and the original dysfunction completely returned to normal.After treatment,3.59%(n=8)of patients found that the lesions did not improve significantly through clinical physical examination and patient subjective survey,that is,"no effect".Age has nothing to do with the effectiveness of treatment[point two-column correlation coefficient:R=0.078,P>0.05].There was no significant difference in treatment efficacy between patients with multiple lesions or not[9.38%vs 2.62%,OR=3.848,95%CI(0.873,16.971),P>0.05].After treatment,141 patients(63.36%)had local swelling,2 patients(0.90%)had local pain,1 patient(0.45%)had fever,the overall rate of the complications was 64.57%(n=144),and no patient had pulmonary embolism or deep vein thrombosis,allergic and anaphylactoid reactions,shock and other serious complications.There was no significant difference in the risk of complications after treatment among patients aged 0-18 years old,19-59 years old and≥60 years old(P>0.05),and the risk of complications after treatment was not related to age[Point-two-column Correlation Coefficient:R=0.149,P>0.05].The dose of HA-POL foam sclerosing agent applied in a single treatment was weakly correlated with the risk of complications[Point-two-column Correlation Coefficient:R=0.209,P<0.05].Conclusion:The application of HA-POL foam sclerosing agent for the treatment of head and neck VMs is safe and effective,and the efficacy and safety of this treatment method are not affected by age,but the dose of HA-POL sclerosing agent foam in a single treatment.The safety of treatment will be reduced with increasing foam dose.