Clinical Practice Guideline for the Use of Fillers in Non-Surgical Rhinoplasty

Süleyman Taş1 Sofia Santareno2

1 Assoc.Prof.Dr. at TAŞ Aesthetic Surgery Clinic, Istanbul - Turkey 2 Fellow at TAŞ Aesthetic Surgery Clinic, Istanbul - Turkey

Running Head: Non-Surgical Rhinoplasty

Address for correspondence: Süleyman Taş, MD, FEBOPRAS, Assoc.Prof.,

Member of American Society of Plastic Surgeons Member of Turkish Society of Plastic, Reconstructive and Aesthetic Surgery Member of Turkish Society of Aesthetic Surgery Member of ISAPS (International Society of Aesthetic Plastic Surgery) Member of RSE (Rhinoplasty Society of Europe)

TAŞ Aesthetic Surgery Clinic, Hakkı Yeten Cad, No: 11, Terrace Fulya, Center: 1, Apt: 97 Şişli, Istanbul 34349, Turkey Tel: +90-532-0563693; Fax: +90 212 9793000 E-mail: [email protected] Social Media: @drsuleymantas (instagram) (twitter)

Conflict of Interest The authors declare that they have no conflicts of interest, commercial associations, or intent of financial gain regarding this research.

Foot note: This study was prepared from RSE Research Group for RSE (Rhinoplasty Society of Europe).

Abstract The seeking for medically assisted aesthetic procedures is rapidly increas- ing. Patients look for the less invasive ones, with little to no downtime, that cost less, even if the results are not permanent. The correct patient, filler and plan selection by an experienced doctor is fundamental to achieve good results. Rhino- plasty surgeons need to know all treatment options with pretreatment evaluation, the technical details of the applications, possible side effects, and the management of the complications. In this article, simplified but complete guidelines of the so- called “non-surgical rhinoplasty” will be explored.

Introduction Nonsurgical rhinoplasty is not a modern concept: the first reports date back to the beginning of the 20th century and Broeckaert is likely the father of modern medical rhinoplasty, since he started correcting the nasal profile with liquid paraffin in 1901.1 Due to several complications, these permanent fillers were abandoned. Later, new dermal fillers have emerged, with greater longevity and rheo- logical properties and minimal adverse effects. Though the actual fillers in the nose remain an off-label application to the nose, they result in high patient satis- faction.2,3 The actual data regarding non surgical cosmetic procedures in the United States of America confirms it’s a growing trend: it has augmented about 228% from 2000 to 2018. On the other hand, surgical rhinoplasty has dropped about 45% at the same time interval and country4. Another report from the Amer- ican Aesthetic society confirms this: from 2017 to 2018 the injectables procedures raised about 13,9%, and about 38,7% compared to 2014.5 The new fillers offer several advantages: they’re available off-the-shelf, the temporary results may rehearsal a surgical rhinoplasty and manage the anxiety of some patients, they help to address some small contour irregularities after a surgical rhinoplasty, among others.6 The non-surgical rhinoplasty is mainly the aesthetic remodeling of the nose

with temporary fillers; there’s also a subtype known as minimal-invasive that combines the use of botulinum toxin A (BTxA) to manage the dynamic activity of the nose (rotation and dropping tip) from both the depressor septi nasi muscle and the levator labii alaeque nasi muscle.7 In this work, simplified but complete guidelines of the so-called “nonsurgical rhinoplasty” will be explored.

Selection of the appropriate filler

The ideal filler should be safe, cheap, easy to apply, have no sensibility reaction, last long and adapted perfectly to the tissue whatever is the plan. We should also con- sider the filler’s properties (hydrophilicity, elasticity, viscosity and longevity). The best fillers for nonsurgical rhinoplasty have a high n* and G02. Well-known fillers include hyaluronic acids (HA), calcium hydroxyapatite (CaHa), collagen/polymethylmethacrylate (Artecoll®), micro-fat graft, paraffin, liquid silicon and others. The soft tissue injections with HA occupy the second place in the ranking of the top five nonsurgical procedures in 2018 in the USA, making this the most commonly used filler5. It’s a temporary filler (last 6–12 months), reversible with hyaluronidase and so is perfect for beginners.2,8

In more experienced hands or for dorsal augmentation CaHA is the filler of choice (moldable but stable and long-lasting up to 9-12months, even 18 months in some reports). 2,8 CaHA is mixed with 0.3 mL of lidocaine with epinephrine, be- coming less and more moldable, injected deeply with a 27G and shaped into the dorsum; after a Denver nasal splint is applied for 2-3 days. Its disadvantages are the absent of an antidote (like hyaluronidase works for HA), the high G’ and h" that may lead to nodules and imperfections that do not resemble native tissue.9,10 Compared to CaHA, Artecoll® (collagen/ polymethylmethacrylate) was consid- ered a superior filler in a study, since its long lasting and offers low rate of side- effects.11 Autologous fat transfer is also an option for nonsurgical rhinoplasty; it’s a great to improve nasal scarring and tight, thin skin.12 Silicone should be avoided since it presents the highest rate of adverse events, despite its high permanence.3

Indications for non surgical rhinoplasty This method may address a deep radix, a saddle nose, a mild hump, some side wall deformities, a mild deviated nose and some asymmetries. We may improve tip projection and/or rotation, columella retraction or the nasolabial angle, lengthen a short nose, perform dorsal augmentation or address contour irregularities even after a surgical rhinoplasty.2,6

Relative Contra-indications A good nasal analysis is important. A patient with an upturned or bulbous nose, a severe hump or nose deviation is not a good candidate, since the expectations are harder to meet. Some previous conditions of the patient must also take our attention, since they augment the risk of vascular compromise and skin irregularities. Among them are a previous rhinoplasty, nasal implant, history of liquid silicon or paraffin injections.6,13

Contra-indications The non-surgical rhinoplasty is absolutely contra-indicated when the patient has unrealistic expectations or a special psychological profile that plastic surgeon should be aware off. There are also some local conditions that don’t meet safety to perform this treatment, like bleeding disorders (or anticoagulants), hipersensibility to lidocaine or any other component, local rosacea or pronounced scars.13

Patient selection The patient’s psychological profile is, of course, a priority like in all other aesthetic procedures. Patients who are good candidates should meet realist expectations, understanding that, though most series report the longer lasting of HA in the nose when compared to other facial areas, this result is not permanent. The nonsurgical nose changes are based on temporary augmentation; and only the surgical procedure can provide reduction or redistribution.2

Physical evaluation After the appropriate patient selection, the study of the nose is important in order to decide the best treatment plan.14-16 All structures must me analyzed, starting with the outer envelope of skin and soft tissue and the framework (size, shape, and strength of the cartilage and bone). Just like in surgical rhinoplasty, thick-oily skin patients represent a challenge, since they have more edema and is harder to address the expected shape; on the other hand, minor irregularities are easily camouflaged.7 The best procedure for aesthetic evaluation is photographic documenta- tion of the patient in different angles: stable (anterior, oblique, profile) and dynamic (smiling) views. The analysis of the nose should be standardized from the radix until the tip regarding both bony and cartilaginous framework. In the anterior view, the harmony between the nose and the nearby structures like the eyes and mouth is important. A central line should be imagined and asymmetries and deviations of the dorsum addressed. Also, symmetry of the nasal change, alar cartilages and tip, can be evaluated. In the profile view, we evaluate the nasofrontal, the dorsal and the nasolabial angles; the nasofacial (normally around 35º) and the nasomental (125º) angles allow us to precisely evaluate the projection of the tip with precision. The non surgical rhinoplasty is specially indicated when the nasofrontal angle is below than 120º and the nasolabial angle is less than 90º. On the profile, the supra-tip breakpoint and columella may also be visualized. The dynamic evaluation of the tip during smiling is very important. This evaluation may star right from the beginning of the consultation, during the conversation with the patient (Figure 1-5).1

Anatomy The nose is composed by different layers, from superficial to deep: skin (rich in sebaceous glands), superficial fatty layer, fibro muscular layer, deep fatty layer and periosteum or perichondrium.17 The skin is thickest at the nasion and thinnest at the rhinion.18

The vascularization runs along the superficial muscular aponeurotic sys- tem (SMAS) layer or the superficial fatty layer. The upper corner of the nose is irrigated by the angular arteries (intracranial circulation) and by the lateral and columella arteries (superficial branches from the external carotid).1 The nasal tip has double vascularization: superiorly from the dorsal nasal artery superiorly, in- feriorly from the lateral nasal and columellar arteries (Figure 6).19 The nose sensibility is warranted by the external nasal nerve, the infraorbital and the nasolabial nerve (second branch of the trigeminal nerve). The motor innerva- tion derives from the facial nerve (levator, depressor, compressor and dilator muscles of the nostrils). These muscles are important for functional and aesthetics and may be treated with BTxA.1 The ideal plan for the injection of a filler is the deep fatty layer (between the SMAS and the perichondrium or periosteum); this plan minimizes vascular damage. However, the presence of the dorsal nasal artery in this preperiosteal layer may make this plan unsafe for filler injection.20

Technical Guidelines • Approach to muscular hypertonia with botulinum toxin A

The minimal-invasive nonsurgical rhinoplasty addresses the dynamic activity of the nose: rotation and dropping tip (depressor septi nasi and levator labii alaeque nasi muscles) and alar flaring (levator labii alaeque nasi muscles). If the nasal ala is too wide, dilator naris muscle may also be paralyzed. 7 When treating the levator labii alaeque nasi muscle its important to be careful, since it creases the upper lip length and may cause ptosis. The risk is bigger with age over 60 years old and long lips (>1,8 cm) than in younger patients with short lips (<1,5 cm) and gummy smile. 1 To treat the depressor septi nasi muscle, the injection should be along both its insertion above the columella and in the nasal spine. The levator labii alaeque nasi muscle should be pinched when there’s a clear lift of the nasal sides and rotation of the tip downwards at the sides of the nose (2U Vistabel/Bocouture or 10U

Azzalure). After 14 days we can perform a retouch. 14, 21, 22 Another detail in consideration is the glabella area. If this area is planned to be injected with HA, a good strategy is to paralyze 2 weeks before the procedure muscle so it doesn’t contract so intensely and moves the filler. 6

• Approach to nose reshaping with fillers

1. Anestesia a. Topical anesthesia • Apply topic Benzocaine 20%, tetracaíne 4% and lidocaine 6% with plastic dressing for 30 minutes; • If tip or columellar work is planed, xylocain may be applied to the oral mucosa around the frenulum.

b. Local anesthesia (1% lidocaine with 1:100,000 of epinephrine) • Infra-trochlear nerve block and infraorbital nerves block (this last one can be made with the infiltration of the medial branches along the frontal process of the maxilla, approximately where a low lateral osteotomy would be performed ). • If tip or columellar work is planned, anterior superior alveolar nerve block should also be performed (intraoral approach to the anterior nasal spine).

2. Injection Guidelines A detailed explanation for injection guideline which included the nasal filler application from the beginning to to the end was demonstrated in Video 1, please see it. There are 3 techniques to perform injectables to the nose: small static bolus (0.1 mL or less), retrograde moving bolus and retrograde thread deposition.2 This last is the most commonly used, especially for reshaping the dorsum3. For smaller areas, such as the tip or columella, smaller bolus are preferred (serial or single puncture).23, 24 Whatever the chosen technique, there are

some common concepts: 1. Treatment area should be cleaned with 70% alcohol or combination of 0.1% octenidine dihydrochloride and 2% 2-phenoxyethanol (Octenisept®) and aseptic conditions maintained during the injection. 2. To minimize the vascular damage risk, blunt cannulas (25G or wider) are preferred in the sub-cutis (specially for beginners), and sharp needles (29G) supraperiostally and intradermally; it’s harder to achieve precise results with cannula; knowledge of vascular anatomy is important to avoid such complications, especially in patients who have had previous nasal surgeries.25 3. Entry points should be far from the target site to fill. 4. Preferred planed is sub-SMAS / supra-perichondrial to prevent the risk of skin necrosis. 5. Needle tip is monitored by the non-dominant index finger. 6. Injection should be made in small quantities and slowly, always monitored for color change in the skin. 7. Continuous reevaluation and small massage is performed until the desired shape is acquired.

Both the nasal analyses and treatment should be divided in two big areas (dorsum and tip) and 4 sections (radix, rhinion, supratip and tip). The radix and the supratip regions have thicker soft tissue, and the underlying structure (bone and cartilage, respectively) is concave. This 2 regions then need large filler volume to avoid depressions, mainly in the nasion.6 The best order to achieve a standart analysis and injection technique is the up to down approach. First the dorsum, then the tip and at last the supratip area.2

3. Injection Sides 1. Dorsum - accurately marking should be performed (Figure 7, 8): a. The midline — important to prevent imbalance or intravascular injection (most of the blood vessels are out of the center line of the nose)

b. The ideal radix position — depends on the height of the forehead and length of the nose; in Asians, is in the supra-tarsal crease or slightly below from the ciliary margin of the upper lid.2, 6 c. The dorsal aesthetic lines — dorsum should be 1-2 mm below a line drawn from the nasion to the nasal tip.8, 26

The objective is to create about 135º angle of the nasal dorsum to the forehead and distinct pleasing dorsal aesthetic lines with the narrowest por- tion at the level of the nasion and supratip area. Femininity or masculinity should also be reflected.26

- Hump correction: 1. Entry point is lateral, below the dorsolateral junction; 2. Inject bolus around <0.1 mL first above the hump; 3. Continue upwards to the nasofrontal angle and radix and reaccess (avoid overfilling the nasofrontal angle); 4. Then address the area inferior to the hump.

- Dorsal augmentation: 1. Same principles for hump correction, but starting the augmentation from the radix in a downwards manner;

- Nose width 1. If the dorsum is wide, the midline projection along both the dorsum and tip will make it thinner; 2. If the dorsum is narrow, the needle should advance beyond the midline to create a pocket that allows the expansion of the filler; start from the rhinion and then progress over the upper lateral cartilages.

2. Tip - with the right technique the injection of the nasal tip has a low complication rate. The areas usually injected to augment the tip are the nasal spine, columellar space, interdomal area and alar margin.26

- Increase tip projection/rotation 1. Entry point is below the tip. 2. The medial crura can be pulled forward and down to subluxate the alar cartilage and stretch the fibrous septum, injection is performed by passing the needle back and forward to create a pocket and then filler is injected into the lower third of the space created.27 3. Inject into the midline, at the tip defining point (unless asymmetric). 4. A supplemental sub-dermal injection with a thin needle helps to achieve a better tip definition; deep injection (directly on the cartilages) usually requires larger volumes of product and may widen the lower lateral cartilages.13 In Asian, filler injection should increase tip projection (hard do obtain due to the weak supporting structures) with less cranial rotation; the ratio between the dorsum length-to- columella should be around 1 to 0.6. 28

- Increase tip rotation 1. The illusion of cephalic tip rotation can be obtained with the injection to the tip area (may also lengthen of the nose). 2. Injection at the nasolabial angle can also be performed, right anterior to the anterior nasal spine, so nasolabial angle becomes more obtuse. (90º to 110º). 6,29

- Lengthening of the columella (collumellar retraction or nasolabial angle insufficiency) 1. Entry point is superior or inferior to the target. 2. The columellar space is injected between the medial crus to prevent vascular compromise; so it works like a column to increase nasal tip support and may correct a retracted columella.30

- Alar retraction or collapse (lengthening of the ala) 1. Transfer a low reticulate filler into a 1 ml insulin syringe with a small needle allows better control of micro bolus. 2. Along the rim, injection is done superficially in the intradermal

plane; to widen the alar sill, more subcutaneous placement of the gel is needed.13 3. Injection to the ala under pressure should be discouraged; if re- sistance is felt, needle should be repositioned or injection discontin- ued; 4. This technique is contra-indicated to patients that had a previous surgical rhinoplasty with alar scaring, since the risk of dermal necrosis is high.6

- Supratip 1. “Cherry on top of the cake” concept only after the projection of the tip is defined, the supra-tip may be injected; this is the last step in the correction of the midline. In Asians, the tip support is so weak, so first preview the projection should be achieved. If supratip area is injected before the tip it may result in a polybeak deformity. 2. Some authors don’t perform this injection because of the likelihood of complications.31

3. Deviations - With this powerfull tool, some iatrogenical or post-traumatic rhinoplasty deformities may also be approached:

A. Crooked Nose (side wall deformity) 1. Approach angle should be closed to the midline the majority of the vessels exit in the lateral sides. 2. Straighten the nose by filling the concavity on one side. 3. Evaluate if a convexity is or not present in the contralateral side and ad- just in necessary. B. Saddle Nose Deformity 1. Evaluate the septum, since the filler will only work with the support of an intact septum. If there’s a perforation, since the filler could not provide a structural support, surgical septorhinoplasty should be offered. 2. CaHA is preferred.

C. Pollybeak deformity 1. The order of approach is slightly different, starting from the superior aspect of the supratip over-projection, then the center of dorsum and at last the tip projection. 2. The infradomal area is then injected if needed to provide the illusion of cephalic rotation. 3. Columellar retraction or nasolabial angle insufficiency can also be approached.

• The non-surgical rhinoplasty may also help to correct some functional problem, like the internal nasal collapse (middle reticulated HA is preferred).1,2 • Non–cross-linked HA may also be used for revitalization in cases of nasal mucosa atrophy and in chronic or atrophic rhinitis.1

Aftercare and Follow-up

The patients are advised not to wear glasses and to avoid heavy exercise for a week after the non-surgical rhinoplasty.32 There’s no need for a special dressing or antibiotics. Just in case of dorsal augmentation with CaHA, a cast for 2-3 days is advisable.2 Follow-up visits times should be scheduled: for touch-up after 2 weeks and reevaluation at 6 weeks and 6 months.

Complications

Thought the rate of complications with the new generation of fillers de- creased, they are still some that are possible and transversal to all fillers. Recently, Signorini et al.33 classified the filler complications as early and late reactions. Early reactions include pain, ecchymosis, erythema, bruising, bleeding, soft tissue necrosis, vascular infarction34–38, ocular ischemia39, vision loss40-42, discolora- tion/Tyndall effect43, infection, hypersensitivity, inappropriate placement, or dis- tant spread32. Late reactions include inflammatory reactions such as granuloma,

nodules, depigmentation, and displacement of fillers33. The potential for nodular- ity with CaHA is also known.44 The use of permanent fillers in the nose like silicone should be avoided, because of association with granuloma formation45,46 and complications that are difficult to manage.47 Knowing how to manage these complications is a must for the plastic surgeons perform these procedures: 1. Hypersensitivity → usually leads to erythema and pain, pruritus or even fever. These symptoms usually fade when causative substance disappears. Severe cases justify the use of oral corticosteroid (methylprednisolone) and warm compression. Intralesional triamcinolone is not advisable to avoid tissue atrophy. The persistent erythema may be managed with Pulsed dye laser. Care must be taken to accurately distinct these reactions from a bacterial reaction. 2, 28 2. Tyndall Effect → avoid intradermal injection; the most effective management is through the aspiration of HA and hyaluronidase injection.2,13 3. Bruising → to avoid this complication, blood thinners (aspirin and other NSAID’s) aren’t advisable for the previous week. Injection should be performed with adequate lighting and piercing of muscular layers should be mini- mized. Local compression and ice packs should be applied on the injection site immediately after the procedure.7,13 4. Infection Cellulitis → may need oral antibiotics or topical mupirocin2 Herpetic eruption →may be confused with skin necrosis (though herpetic eruption starts 3-4 days after the injection); the management is made with Valacyclovir (1 g, 3 times per day), oral prednisone (60 mg daily, 5 days) and tapering. The prescription of herpes prophylaxis is suggested for all patients with previous personal history. 2 5. Degree of correction Cases of under-correction are more easily remedied. In case of overcorrection, as a first approach, massage and warm compresses may fade away part of the product; if HA was applied, hyaluronidase is also an option. On the other hand, CaHA isn’t reversible. 6. Asymmetry → To prevent an asymmetric correction, the needle tip should be

placed precisely in the midline, and beveled toward the median plane.7 7. Implant visibility → To avoid implant visibility, the appropriate plan of injection must be chosen according to the filler properties.49 8. Granuloma (foreign body immune-mediated response) → Corticosteroid injection or surgical removal. 9. Inflammatory (after days or even years) or noninflammatory nodules (immediately after, due to wrong placement of the filler) → hyaluronidase, corticosteroid, or surgical removal.50 10. Vascular compromise

The most feared complication can lead to skin necrosis or even blindness; the assumed mechanisms are arterial embolization/occlusion, external arterial compression that leads to vascular compromise, and/or dermo-epi- dermal congestion.2 Some authors advice the restriction of the use of fillers to the nasal dorsum and sidewalls to minimize these complications, since more adverse events are known to occur after injection the tip and alae.9 The supply of enough oxygen to the area of ischemia is a priority. Though the lack on an unified consensus for treatment of these events;51-53 1. Immediately discontinue injection if whitening of the skin distal to the cannula tip or intense pain occurs 2. Topical 2% nitropaste as early as possible (twice a day, one week)2,9 3. Injection of Hyaluronidase (15 to 50 units; three separate injections each separated by two days).2,9 There is no consensus on optimal doses; some authors advocate the use of at least 100 U for every 1 mL of filler used.13 Hyaluronidase is known to decrease the interstitial pressure, so it should be used whatever the filler applied.6 To obtain 1 mL of solution, 150 U of hyaluronidase is mixed with 10 mL of 1% lidocaine.2 The importance of performing a good anamnesis is very important, since a personal history of bee bite hyperalergic reaction offers a great risk for an allergic reaction (hyaluronidase is ones of the bee venom’s components).2 4. Injection of prostaglandin E1 (10 mg /day, 5 days)54 5. Start with cool (not cold) compresses for the first 24–48 hours to slow the metabolic rate, then convert to warm compresses for vasodilatation, though

they also increase the metabolic demand.2 6. Anticoagulants: low–molecular weight heparin13 or aspirin (80 mg, once/twice day)2 decrease the risk for thrombosis and embolism.6 7. Oral antibiotics to avoid a secondary infection.20-23 8. Hyperbaric oxygen therapy is helpful.6 9. If crusting develops, perform good wound care; conservative debridement may also be necessary.2 10. If visual impairment occurs, immediately refer the patient to an ophthal- mologist/oculoplastic surgeon for further treatment (eg, injection of hyaluronidase in a retrobulbar location or into the ophthalmic artery [possibly by radiology-assisted catheterization or periocular arterial catheterization] and reduction of intraocular pressure).55,56

Conclusions

Nowadays, the seeking for medically assisted aesthetic procedures is in- creasing. Patients look for the less invasive ones, with little to no downtime, that cost less, even if the results are not permanent. The actual techniques and filler properties offer a reduced risk. The correct patient, filler and plan selection by an experienced doctor is fundamental to achieve good results. The perfect candidate for a non surgical rhinoplasty is a patient that needs a minimal dorsal or sidewall correction, who is not amenable to surgical intervention. Even so, surgical rhinoplasty remains the most definitive way to improve the nose. So, plastic surgeons need to know and dominate these treatment options and should offer them to selected patients. Rhinoplasty surgeons need to maintain their continuous effort and motivation for the conquest of the perfect nose in the surgery, since fillers still can’t substitute excellent surgical outcomes.

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Figure Legends Figure 1-5: A 28 year-old female is demonstrated before and after nasal filler application from frontal, oblique, profile, bottom, and top views respectively. The clinical practice of the filler application is presented in Video 1. Figure 6: The vascular anatomy of the nose is demonstrated, as seen in the pic- ture, due to the anastomosis between the dorsal nasal artery and ophthalmic artery, the filler material may reverse the in the artery and arrive to the retinal artery and cause blindness, if the needle penetrates the artery and pressure is applied to the piston. That knowledge is very crucial for whom would like to apply nasal filler application. Figure 7-8: Lateral walls of the nose has a very rich vascular network. To decrease vascular complication rate due to the needle penetration and consequent filler embolisation, application side should be in the central part of the nose.