Diode endovascular laser treatment in venous malformations of the upper aerodigestive tract

Journal of Cranio-Maxillo-Facial Surgery 44 (2016) 533e537

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Diode endovascular laser treatment in venous malformations of the upper aerodigestive tract François Simon a, b, *, Nicolas Le Clerc a, b, Didier Salvan a, b, Elisabeth Sauvaget d, Benoît Faucon a, b, Michel Borsik a, b, Philippe Herman a, b, Annouk Bisdorff b, c ^pital Lariboisi AP-HP, Ho ere, Department of Otorhinolaryngology, 2 Rue Ambroise Par e, 75010 Paris, France Paris Diderot University, Paris, France c ^pital Lariboisi AP-HP, Ho ere, Department of Radiology, 2 Rue Ambroise Par e, 75010 Paris, France d ^ Hopital Saint Joseph, Department of Otorhinolaryngology, 185 rue Raymond Losserand, 75014 Paris, France a

b

a r t i c l e i n f o

a b s t r a c t

Article history: Paper received 19 November 2015 Accepted 8 February 2016 Available online 15 February 2016

Purpose: Venous malformations of the upper aerodigestive tract can cause pain, dysphagia, obstructive sleep apnea, and rarely bleeding. We studied 980-nm diode endovenous laser therapy. Material and methods: This is a 2007e2014 retrospective study in our vascular anomalies center. Data on patients' clinical history, polysomnography, magnetic resonance imaging, and treatment were collected. Patients were contacted for Epworth Sleepiness Scale and Eating Assessment Tool (EAT-10) scores to evaluate sleepiness and dysphagia before and after laser therapy. Results: We included 32 patients (mean age 41 years) presenting with obstructive sleep apnea (n ¼ 18) and dysphagia (n ¼ 13). With a mean follow-up of 39 months, average Epworth Sleepiness Scale score fell from 17.3 to 10.4 (p ¼ 0.015), EAT-10 score from 8.2 to 3.5 (p ¼ 0.002) and apneaehypopnea index from 47.5 to 24.7 (p ¼ 0.01). Of the sleep apnea patients, 89% required continuous positive airway pressure before and 50% afterward (p ¼ 0.016). Conclusions: Diode endovascular laser treatment seems to be a safe and effective treatment option in venous malformations of the upper airways. © 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Keywords: Obstructive sleep apnea Dysphagia Venous malformation 980-nm Diode Endovenous laser treatment

1. Introduction Venous malformations are congenital low-flow vascular malformations that are most often found in the cervico-facial region (Zheng et al., 2013; Aboelatta et al., 2014; Wassef et al., 2015). The upper aerodigestive tract locations include the oral, pharyngeal, and laryngeal venous malformations. Symptoms usually include disfigurement, pain, hemorrhage, sleep apnea, dysphagia, and sometimes diction impairment. Sleep apnea is especially present, as the lesions' volumes increase in the supine position. Venous malformation management is complex. Several treatments exist, such as chemical sclerosis, surgery, and laser, ranging from Nd:YAG, to CO2, Potassium-titanyl-phosphate (KTP), and diode laser (Glade et al., 2010; Richter and Braswell, 2012; Colletti et al., 2014; Judith et al., 2014). Already successfully used in incompetent saphenous veins, 980-nm diode laser seems promising for venous

malformations due to its action on hemoglobin and water (Fan and Rox-Anderson, 2008; Vuylsteke and Mordon, 2012). Superficial and small (<2 cm) malformations are usually easily treated with various methods, however, larger and more infiltrative lesions can be more challenging in the upper airways due to their difficult access and possible life-threatening effects (Ohlms et al., 1996; Kishimoto et al., 2008; Eivazi et al., 2010; Stimpson et al., 2012; Alvarez-Camino et al., 2013; Leung et al., 2014; Wiegand et al., 2014). To our knowledge, no study has been published on the effects of any treatment in venous malformations regarding obstructive sleep apnea symptoms. The objective of this retrospective study was to evaluate the effectiveness of endovenous 980-diode laser treatment on sleep apnea and dysphagia in patients with venous malformations of the upper aerodigestive tract.

2. Material and methods ^ pital Lariboisie re, Service d'Otorhinolar* Corresponding author. AP-HP, Ho , 75010 Paris, France. Tel.: þ33 6 86 32 71 11. yngologie, 2 Rue Ambroise Pare E-mail address: [email protected] (F. Simon).

We conducted a retrospective study in patients presenting venous malformations (VM) of the aerodigestive tract between

http://dx.doi.org/10.1016/j.jcms.2016.02.007 1010-5182/© 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

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2007 and 2014 at our reference vascular anomalies center. All patients were initially referred to our multidisciplinary clinic. Treatment options were discussed with the patients, and varied from sclerotherapy or surgery to 980-nm diode endovascular laser treatment (ELT) or a combination of those treatments. When diode ELT was decided, magnetic resonance imaging (MRI) and polysomnography were systematically performed before and after treatment. All of our patients were also checked for an intravascular coagulation disorder, as those are frequently seen in venous malformations (Mazoyer et al., 2008; Martin et al., 2009). An elevated D-dimer level over 1500 ng/ml required preventive low-molecularweight heparin (LMWH) treatment prior to ELT to prevent disseminated intravascular coagulation. These patients were treated 10 days before and after laser sessions with 0.01 ml/kg/day of LMWH. The same ELT technique was followed by all surgeons. The procedure was carried out in an ENT operating room on a tilting table and not in an interventional radiology suite, due to bleeding risk. A 980-nm diode laser (Biolitec, Vienna, Austria or FOX-A.R.C. Laser, Nürnberg, Germany) and 200- or 400-mm disposable fibers were used. The power was set at either 5 or 8 W depending on the habits of the operator, delivering approximately 300 J/cm3. Transoral laser punctures were made under general anesthesia and intubation, and, depending on the location of the lesion, a BoyleeDavis mouth gag or a suspension laryngoscopy was used. In order to control or prevent severe bleeding, X sutures were systematically used on the fiber puncture points (Fig. 1). Patients were then transferred to the ear, nose, and throat (ENT) department and usually discharged 48 h after the procedure. We reviewed all patients treated for VM of the head and neck region and selected those involving the upper aerodigestive tract. Of 61 patients treated over this period, 32 were included in the study. Inclusion criteria were at least one treatment using diode ELT and a follow-up period of at least 6 months. Patients with VM limited to the lip or tip of the tongue were excluded. Information on the lesion and obstructive site locations were collected. The number of diode ELT sessions, the technical procedure details (laser energy and power, hospital length of stay, and side effects) as well as previous or additional treatments of the lesion were registered. Due to the lesions' complex threedimensional structure and deep tissue extension, no precise measurements were made, and the efficacy of the treatment was evaluated solely according to the patients' symptoms and polysomnography results. All patients were contacted either by phone or by e-mail to evaluate outcomes. They were asked to give a global satisfaction score (1 ¼ dissatisfaction; 2 ¼ partial satisfaction; 3 ¼ satisfaction; 4 ¼ game changer) and to inform us of any short-

term or long-term side effects. Patients were administered an Epworth Sleepiness Scale for sleep apnea (Johns 1991) and the Eating Assessment Tool (EAT-10) for dysphagia (Belafsky et al., 2008), first at the time of the follow-up and then as they remembered before the first laser treatment. Both scores were then compared. Patients with obstructive sleep apnea (OSA) had additional follow-up with the apneaehypopnea index (AHI), and the fact that there was an indication for nocturnal continuous positive airway pressure (CPAP) was noted. The AHI before the first laser session and at the time of the follow-up was compared. The proportion of patients requiring CPAP according to their AHI before and after the laser treatment was compared as well. This was established ac de cording to the national French consensus of the “Haute Autorite ” (HAS, 2014), which indicates use of CPAP if AHI is over 30, or Sante if AHI is over 15 with sleep disorders, or if cardiovascular risk factors are present. Patients signed a written consent form, and the study was approved by a local ethics committee. Mean values were compared using a paired Student t test and proportions using a McNemar test. Calculations were made using XLstats© (Addinsoft, United-States) with a significance level set at 0.05. 3. Results Between 2007 and 2014, a total of 32 patients, including 16 male and 16 female patients, were treated with endovascular diode laser for VM of the upper aerodigestive tract. At the time of the first laser session, the mean age was 41 ± 17 years (including two children, aged 6 and 12 years). Two main obstruction sites were noted, in the tongue base or in the oropharynx (tonsils, palate, and pharyngeal wall). The symptoms were not correlated with a site. All lesions except three (limited to the tongue) involved at least two anatomical sites (tongue, tonsils, palate, pharynx, or larynx), and none were smaller than 2 cm (Fig. 2). A detailed description of anatomical locations can be found in Table 1 and initial symptoms in Table 2. Before entering our study, 15 patients had undergone other procedures to treat their VM (sclerosis in 11 cases and surgery in nine). It must also be noted that in 14 patients (44%), other extramucosal sites of the VM (such as in the cheek or neck) needed treatment. These patients underwent direct puncture sclerotherapy with ethanol or aetoxisclerol foam during the same general anesthesia as the ELT. The 32 patients had on average two laser sessions each (range, 1e6) over a mean period of 39 ± 24 months (range, 1e96). In 14

Fig. 1. Extensive venous malformation of the tongue (mobile tongue and base of the tongue). (Left) Before ELT; (right) 2 weeks after. Note the X suture on the fiber puncture point.

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Fig. 2. MRI axial and coronal T2 SAT FAT images. (Upper) Before diode laser treatment; (lower) 1 year after the last laser session. This is a good example showing the efficacy of diode laser to liberate the upper aerodigestive tract. It also shows the difficulty of making reliable measurements with MRI due to the complex shape of the malformation and the need to focus on clinical results. This is the case of a 23-year-old male patient presenting with a venous malformation of the pharynx and larynx with severe OSA. He underwent three diode laser treatments over a period of 1 month (average 1500 J at 8 W) requiring preventive tracheotomy before each treatment. After a 19-month follow-up, the patient had a good result, with AHI falling from 34 to 13. The patient's feedback on the treatment was that it was game-changing, especially as he was able to abandon CPAP treatment. Table 1 Anatomical location of the venous malformations. Main region

Number

Percentage

Total Base of the tongue Pharynx Mobile tongue Outer cheek Lip Deep tissue Larynxa Palate

32 24 23 14 12 11 8 8 6

100 75 72 44 38 34 25 25 19

a

Supraglottic.

patients, only one procedure was performed. A total of 65 procedures were carried out under general anesthesia by four different operators with a mean total energy of 3914 ± 4056 J delivered per procedure (depending on the lesion size). The mean hospital stay was of 2.7 ± 1 days (range, 1e7). A preventive tracheotomy (for the duration of the hospital stay) was decided for only six patients, essentially for lesions extending to the larynx or of great size. Preventive heparin treatment 10 days before and 10 days after was also implemented in 15 patients to prevent

Table 2 Initial symptoms of the venous malformations. Symptoms

Number

Percentage

Total Dyspnea OSA Pain Dysphagia Aesthetic defects Diction impairment Bleeding issues ESS scorea EAT-10 scorea

32 20 18 13 12 12 6 6 9 13

100 63 56 40 38 38 19 19 25 41

EAT-10 ¼ Eating Assessment Tool; ESS ¼ Epworth Sleepiness Scale. a Pathological score (ESS >11 and EAT-10 >3).

disseminated intravascular coagulation, either if the lesion was large or painful or if the D-dimers were over 1500 ng/ml (mean, 1708 ng/ml). Out of 65 procedures, short-term complications occurred in 15 cases (23%): pain (six cases, 9%), bleeding requiring transfusion (four cases, 6%), severe swelling leading to dysphagia (two cases, 3%), paresthesia (one case, 2%), and local infection (one

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case, 2%). Disseminated intravascular coagulation occurred in one case (2%), although the patient had received LMWH treatment (Ddimer value 829 ng/ml). No emergency tracheotomy was required. The mean follow-up to the last laser procedure was of 39 ± 24 months (range, 6e86). The majority of patients were satisfied with ELT (20%e63%); one patient was dissatisfied (3%) due to persistence of symptoms and pain. Five patients (16%) considered the diode laser a game-changing treatment. Lesion reduction was initially obtained in 30 patients (94%) but was not quantified. Diction impairment was better in all cases, and especially Epworth Sleepiness Scale and EAT-10 scores significantly improved in patients who initially had abnormal scores (Table 3). Long-term complications for the 32 patients included local recurrence in five cases (16%) and scarring in one case (3%). Recurrence was not correlated with the malformation site or number of sessions. All patients with sleep apnea underwent a polysomnography prior to ELT and 6 monthse1 year after the last satisfactory procedure. The AHI, although not always measurable (due to CPAP treatment during the test for some patients), was significantly lower after the laser treatment (Table 3). The proportion of OSA patients requiring CPAP was also significantly reduced after treatment (Table 4). Of the 16 patients requiring CPAP treatment for OSA before ELT, seven (44%) did not need CPAP anymore afterward. Three patients (19%) still used CPAP but had a better AHI, and six (38%) had to continue CPAP without any evolution of their OSA. MRI results were found to be quite subtle and disappointing (Fig. 2). Intralesional or perilesional post-laser inflammatory reaction remain months after treatment, and the complex three-dimensional size of the remaining VM tend to make accurate measurements difficult.

4. Discussion Our study results show that diode endovascular laser treatment is effective in treating patients with VM of the upper aerodigestive tract, with an overall high patient satisfaction rate. Significant results were obtained for reducing dysphagia, measured with the EAT-10 score. Moreover, significant results were obtained for reducing OSA, using different methods of comparison. First, the Epworth Sleepiness Scale score was reduced as well as the AHI. However, these statistics only show a trend and are difficult to interpret, as some patients had to continue CPAP, thus interfering with the results. More importantly, significant reduction in the proportion of OSA patients requiring CPAP was achieved, which had a high impact on the quality of life of the patients. In our series, almost half (44%) of the patients initially requiring CPAP were able to discontinue the treatment after ELT. Four patients describing the laser as a game-changer were in this category. It must be noted that patients also reported better diction after ELT, although this was not specifically measured in our study. In the literature, a range of other treatments are available for VM of the head and neck, such as surgery (Hontanilla et al., 2013;

Table 3 Score comparison before and after endovascular diode laser treatment.

Number of patients Mean before laser Mean after laser p Value

ESS scorea

EAT-10 scorea

AHIb

9 17.3 10.4 0.015

13 8.2 3.5 0.002

10 47.5 24.7 0.01

AHI ¼ apneaehypopnea index; EAT-10 ¼ Eating Assessment Tool; ESS ¼ Epworth Sleepiness Scale. a Patients with pathological score before treatment (ESS >11 and EAT-10 >3). b Obstructive sleep apnea patients with measurable AHI (recording available without continuous positive pressure ventilation).

Table 4 Proportion of patients with obstructive sleep apnea (OSA) requiring continuous positive pressure ventilation (CPAP) before and after laser treatment.

Number of patients Percentage a

OSA patients

Before lasera

After lasera

p Value

18 100

16 89

9 50

0.016

Patients requiring CPAP treatment according to their apneaehypopnea index.

Kobayashi et al., 2013) and sclerotherapy (Su et al., 2010; Stimpson et al., 2012; Kamijo et al., 2013; Leung et al., 2014; Garg et al., 2015). Also, Nd:YAG laser (Scherer and Waner, 2007; Vesnaver and Dovsak, 2009; Eivazi et al., 2010; AlcantaraGonzalez et al., 2013; Crockett et al., 2013; Wiegand et al., 2014) and KTP laser (Kishimoto et al., 2008; Miyazaki et al., 2009) have been studied, with great success in limit bleeding risks during the procedure, especially on mucosal VM. Other studies have examined the use of diode laser (Lapidoth et al., 2005; Angiero et al., 2009; Alvarez-Camino et al., 2013; Liu et al., 2014), with promising results and minimal side effects. However, management of VM of the aerodigestive tract is subtler, due to access difficulty and the proximity of functional structures, with an increased risk of side effects. Some authors have published series of cases of the upper airways treated by sclerotherapy (Stimpson et al., 2012; Kamijo et al., 2013; Leung et al., 2014), KTP laser (Kishimoto et al., 2008; Miyazaki et al., 2009), Nd:YAG laser (Eivazi et al., 2010; Wiegand et al., 2014), and in one case diode laser (Alvarez-Camino et al., 2013). In most cases, laser treatments have fewer side effects (especially on the nerves), and the authors all conclude that there is a good response for small (<2 cm) and superficial VM, although there can be some degree of recurrence in the follow-up. In this study, we preferred the 980-nm diode laser, as it can treat deeper lesions and has excellent absorption in water and hemoglobin (Fan and Rox-Anderson, 2008; Vuylsteke and Mordon, 2012). Indeed, we were able to treat the superficial mucosal lesions but also submucosal lesions, especially in the tongue, by inserting the laser tip as far as 4 cm deep. Nd:YAG laser can only be used for superficial lesions and does not allow endovascular treatment, as opposed to diode laser. Also, the diode laser fiber can be introduced through a guiding catheter or through direct puncture of the venous pouch, and allows direct VM lesion shrinkage. Further research should also be done using the 1470-nm radial fiber diode laser, which has shown excellent results in lower limb ELT (von Hodenberg et al., 2015). We do not recommend ELT for deep lesions of the neck (deep tissue or intramuscular lesions) because of the danger to the carotid and internal jugular vein, and our team (like most authors) prefers sclerotherapy. Although oropharyngeal VM are considered as deep lesions, they are clinically visible during endoscopy and allow direct controlled puncture and safe ELT of venous pouches. VM is a very complex and rare disease, and the objective is seldom to cure but rather to control and improve the symptoms or stop VM evolution. Due to the variety of VM presentations and patient expectations, is it difficult to establish a diode laser protocol. From our experience, there is no correlation between the locations of the malformation, the number of ELT sessions, or MRI with the clinical results. Most patients have required two sessions, but many patients have had very good results after one session. The best indicator is the size of the malformation and the satisfaction of the operator during the laser procedure itself (efficacy of photocoagulation, Fig. 1). Each treatment must be tailored to the patient's demands and to the characteristics of the malformation. Also, as in our study, a multimodal approach is often necessary for each patient with, for example, ELT in the pharynx associated with sclerotherapy or even surgery for lesions in the neck and face

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(Glade et al., 2010; Richter and Braswell, 2012; Aboelatta et al., 2014; Colletti et al., 2014; Judith et al., 2014; Wiegand et al., 2014). This emphasizes the importance of a multidisciplinary clinic to decide the best tailored treatment for each patient (Angiero et al., 2009; Zheng et al., 2013; Wiegand et al., 2014). The treatment must be discussed and planned in advance to prevent intravascular coagulation (Mazoyer et al., 2008; Martin et al., 2009) with heparin. Laryngeal edema must also be prevented, but tracheotomy was required only in extremely extensive laryngeal VM (and no emergency tracheotomy was performed). This is an important point because, in our experience, preventive tracheotomy was almost always associated with lesions in these locations before the use of ELT and thus limited the treatment indications. ELT seems to induce less inflammatory reaction, enabling us to reduce the indications for tracheotomy. Indeed, in our own experience with traditional ethanol sclerotherapy in oropharyngeal VM locations, we observed that the inflammatory post-sclerotherapy reaction was much more painful and lasted longer than with ELT, often requiring nasogastric tubes for at least 2 weeks. The main limitation of this study is the fact that it is retrospective and partially based on patient memory for the initial Epworth Sleepiness Scale and EAT-10 scores. The rarity of this pathology makes prospective studies difficult, and, to our knowledge this is the largest series of patients with venous malformations of the upper aerodigestive tract. We are starting in our department a prospective study comparing ELT to sclerotherapy using bleomycin. Another limitation is the long-term follow-up, as VM are known to sometimes grow back over time. However, our team has 15 years of experience with ELT in other locations, such as VM (<3 cm) of the mouth, tongue, or lips, with long-term patient satisfaction and without recurrence. This needs to be confirmed for larger VM of the upper airways. 5. Conclusion Our results demonstrate that the 980-nm diode endovascular laser treatment is effective in treating venous malformations of the upper aerodigestive tract and greatly reduces dysphagia and especially sleep apnea symptoms. The results are very promising, with few side effects and early clinical recovery, although other prospective studies are needed to specify the long-term efficacy and to establish a treatment protocol. A multimodal approach must be discussed in a specialized multidisciplinary clinic to best tailor treatments for each patient. Conflict of interest None. The authors did not have any financial support to write this paper. All authors have materially participated in the research and/or article preparation. All authors have approved the final article. References Aboelatta YA, Nagy E, Shaker M, Massoud KS: Venous malformations of the head and neck: a diagnostic approach and a proposed management approach based on clinical, radiological, and histopathology findings. Head Neck 36: 1052e1057, 2014 Alcantara-Gonzalez J, Boixeda P, Perez-Garcia B, Truchuelo-Diez MT, GonzalezMunoz P, Jaen-Olasolo P: Venous malformations treated with dual wavelength 595 and 1064 nm laser system. J Eur Acad Dermatol Venereol 27: 727e733, 2013 Alvarez-Camino JC, Espana-Tost AJ, Gay-Escoda C: Endoluminal sclerosis with diode laser in the treatment of orofacial venous malformations. Med Oral Patol Oral Cir Bucal 18: e486e490, 2013 Angiero F, Benedicenti S, Benedicenti A, Arcieri K, Berne E: Head and neck hemangiomas in pediatric patients treated with endolesional 980-nm diode laser. Photomed Laser Surg 27: 553e559, 2009

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