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Experience with 5% Ethanolamine Oleate for Sclerotherapy of Oral Vascular Anomalies: a Cohort of 15 Consecutive Patients*

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Experience with 5% Ethanolamine Oleate for Sclerotherapy of Oral Vascular Anomalies: a Cohort of 15 Consecutive Patients* Journal of Cranio-Maxillo-Facial Surgery 47 (2019) 106e111 Contents lists available at ScienceDirect Journal of Cranio-Maxillo-Facial Surgery journal homepage: www.jcmfs.com Experience with 5% ethanolamine oleate for sclerotherapy of oral vascular anomalies: A cohort of 15 consecutive patients* * Camila de Nazare Alves de Oliveira Kato a, , Michel Campos Ribeiro b, Marcio Bruno Figueiredo do Amaral c, Soraya de Mattos Camargo Grossmann d, Maria Cassia Ferreira de Aguiar a, Ricardo Alves Mesquita a a Department of the Oral Surgery and Pathology, School of Dentistry, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil b Department of Oral and Maxillofacial Surgery, Hospital Marcio Cunha, Ipatinga, Minas Gerais, Brazil c Department of Oral and Maxillofacial Surgery, Hospital Joao~ XXIII/FHEMIG, Belo Horizonte, Brazil d Department of Oral Pathology, Pontifical Catholic University of Minas Gerais (PUC Minas), Belo Horizonte, Minas Gerais, Brazil article info abstract Article history: Purpose: To describe the effectiveness and safety of a sclerotherapy protocol with 5% ethanolamine Paper received 5 July 2018 oleate (EO) at 0.1 mL/3 mm for oral vascular anomalies (OVAs). Our hypothesis is that EO applied at a Accepted 9 November 2018 concentration of 5% may decrease the number of sessions necessary for clinical healing. Available online 16 November 2018 Materials and methods: We describe a cohort of 15 consecutive patients. OVAs <20 mm were included. Clinical data of the OVAs were collected. Descriptive and bivariate statistical analyses were performed. Keywords: Results: Fifteen of the 19 OVAs were varicosities and the lower lip was the most affected site (n ¼ 7). The Ethanolamine median size was 6 mm, and one session was required in 89.5% of cases for clinical healing within 28 days. Sclerotherapy < > Varicose vein The pain/burning score was low ( 2) for most lesions (63.1%) and the degree of satisfaction was high ( 8) fi fi Vascular malformation for all OVAs. The number of applications, nal volume of drug and time to resolution differed signi - cantly according to the size of the anomaly. Conclusion: The protocol with 5% EO was shown to be effective and safe to treat OVAs <20 mm, and with a decrease in the number of sessions, volume and time to resolution, without complications and with high patient satisfaction. © 2018 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved. 1. Introduction Hemangiomas are rapidly growing benign vascular tumors of infancy that are uncommon in adolescence or adulthood. These tu- Anomaliesofvascularoriginarecommonintheheadand mors often begin proliferating shortly after birth and tend to involute neck region, including the oral mucosa. Although their classifi- spontaneously (Eivazi and Werner, 2013). Hemangiomas affect up to cation is controversial, the clinical and histological features and 10% of the pediatric population and are more prevalent in females biological behavior form the basis for the denomination and and premature and low-birthweight infants (Haggstrom and Drolet, diagnosis of these conditions (Greene, 2012). Vascular anomalies 2007; Drolet et al., 1999). Vascular malformations (VMs) are present are currently divided into two groups: tumors and vascular at birth and affect both females and males. Their incidence in the malformations (Sham and Sultana, 2012; Colleti et al., 2014; head neck region ranges from 14% to 65% (Haggstrom and Drolet, Fowell et al., 2017). 2007; Kobayashi et al., 2013). Unlike hemangiomas, VMs never involute. The International Society of Vascular Anomalies classifies fl fl * VMs into two groups: slow- ow (venous component) and high- ow This work should be attributed to the Department of the Oral Surgery and (arteriovenous component) (Fowell et al., 2017; Mulliken and Pathology, School of Dentistry, Universidade Federal de Minas Gerais (UFMG), Sala 3202D, Av. Antonio^ Carlos 6627, Pampulha e 31270-010, Belo Horizonte, Minas Glowacki, 1982; Buckmiller et al., 2010; ISSVA, 2014). In addition, Gerais, Brazil. (Head: Maria Cassia Ferreira de Aguiar, DDS, MSc, PhD). varicosities are acquired asymptomatic vascular anomalies charac- * Corresponding author. Department of Oral Pathology and Surgery, School of terized by an extensive and abnormal vein (Lazos et al., 2015). This Dentistry, Universidade Federal de Minas Gerais, Faculdade de Odontologia, Sala anomaly is more common in older adults (>60yearsofage)andmay 3202D, Av. Antonio^ Carlos 6627, Pampulha 31270-010, Belo Horizonte, Minas Ger- ais, Brazil. Fax: þ55 31 3409 2499. appear in the sublingual region, lips, and buccal mucosa (Lazos et al., E-mail address: [email protected] (C.N.A.O. Kato). 2015; Johann et al., 2005; Correa et al., 2007). https://doi.org/10.1016/j.jcms.2018.11.009 1010-5182/© 2018 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved. C.N.A.O. Kato et al. / Journal of Cranio-Maxillo-Facial Surgery 47 (2019) 106e111 107 Vascular anomalies can cause cosmetic distress, pain, ulceration, (Johann et al., 2005) and of undiluted 5% EO as a single application bleeding, secondary infection, tissue deformation, dental asym- of 0.1 mL for the treatment of OVAs measuring 10 mm (Costa et al., metry, impaired speech, and obstruction of the upper airways 2011). The proposal of the current study was to use 5% EO without (Greene, 2012; Sigaux et al., 2015). The treatment options for oral dilution to reduce the number of sessions and the final volume of vascular anomalies (OVAs) include sclerotherapy, surgery, emboli- drug, in addition to increasing the distribution of the sclerosing zation, laser therapy, systemic corticosteroids, cryotherapy, agent within the anomaly. interferon-alpha, and radiation therapy (Johann et al., 2005; The vascular anomalies were first evaluated and measured to Neuschl et al., 2014; Hiraoka et al., 2012; Sadick et al., 2017). The determine the volume of intralesional injection. Topical anesthetic ® choice of treatment depends on the size, location and hemody- (5% Xylocaine :5% Lidocaine, AstraZeneca, Cotia, SP, Brazil) was namics of the anomaly, degree of invasion into anatomic structures, applied for about 60 s, rubbing a cotton swab on the surface of the age of the patient, and feasibility of the technique to be employed anomaly to minimize puncture discomfort and to preserve the (Hiraoka et al., 2012; Hanemann et al., 2004). lumen of the lesion. The drug was injected with a BD Ultra-Fine II Sclerotherapy is of interest for the treatment of OVAs because it Short Needle Insulin Syringe, 1 CC (Becton Dickinson & Company, is an effective and minimally invasive technique, providing healing Franklin Lakes, NJ, USA). The OVA was aspirated, reflux of venous rates of 70%e100% (Bonan et al., 2007; Pradhan and Rahman, 2011; blood was confirmed, and 0.1 mL of 5% EO was applied per 3 mm of Costa et al., 2011; da Silva et al., 2014; Fernandes et al., 2018). the lesion. The patient returned within 7 days for evaluation. The Although many sclerosing agents are available, such as sodium interval between each application was 14 days until complete morrhuate, sodium psylliate, quinine urethrone, ethanolamine clinical healing of the OVA. A single operator performed the oleate (EO), polidocanol, sodium tetradecyl sulfate, hypertonic sa- treatment. line and absolute alcohol, EO is particularly useful because of its low toxicity compared to other sclerosis-inducing agents (Johann et al., 2.4. Protocol outcome assessment 2005; Costa et al., 2011; Dilsiz et al., 2009). Previous studies have shown the effectiveness of different concentrations of EO (1.25%, Demographic data of the patients (gender, age, and ethnicity) 2.5%, and 5%) for OVA treatment (Johann et al., 2005; Costa et al., were obtained. The relevant clinical data collected included diag- 2011; da Silva et al., 2014; Fernandes et al., 2018). However, the nosis, site and size of the anomaly, number of sessions, number of number of sessions and volume of EO used vary, and little is known applications, final volume of drug applied, clinical healing, pain/ about the complications of treatment and patient satisfaction. burning, and presence or absence of edema (Amaral et al., 2012), Considering the effectiveness and safety data on sclerotherapy ulcer, postoperative functional alterations (eating and/or speech), with EO reported in the literature, the objective this study was to bleeding, hematoma, infection and scarring. In addition, analgesic describe the effectiveness and safety of sclerotherapy with 5% EO at use, time to resolution, degree of patient satisfaction with the 0.1 mL/3 mm for the treatment of OVAs. Complications and patient treatment, and recurrence were investigated. satisfaction are also reported. Our hypothesis is that EO applied at a The diagnosis included varicose veins or varix (acquired OVAs), concentration of 5% may decrease the number of sessions necessary hemangiomas, and VMs. All OVAs were clinically superficial and for the complete clinical healing of OVAs. slow-flow lesions. The size of the anomalies was measured with a millimeter ruler in unique plane and corresponded to the largest 2. Materials and methods diameter of the anomaly. The number of sessions was defined as the number of times the patient was subjected to sclerotherapy. 2.1. Ethics considerations and study approval Thus, after 14 days the patients could undergo a new application. The number of applications refers to the number of points chosen The study
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