Blood Aspiration Test for Cosmetic Fillers to Prevent Accidental Intravascular Injection in the Face Gabriela Casabona, MD

BACKGROUND Filler injection for cosmetic treatment of the aging face may be complicated by visual impairment, skin necrosis, or anaphylaxis because of accidental intravascular injection. Blood aspiration test (withdrawal of blood by the syringe plunger before injection) may decrease the risk of intravascular injection. OBJECTIVE

To evaluate the reliability of the aspiration test.

METHODS AND MATERIALS A red ink solution was withdrawn from a cup using a syringe containing 0.1 mL filler (17 different filler products); when there was no aspiration, retesting was performed with larger-gauge needles until aspiration was observed. In a white rabbit, aspiration was attempted after puncturing the ear vein and withdrawing the syringe plunger (5 different filler products). RESULTS The aspiration test with an ink solution in vitro was negative with 8 filler products (47%) and positive with 9 filler products (53%); for all products that had a negative aspiration test, the test became positive when a larger-gauge needle was used. All 5 products tested with the rabbit ear aspiration test were positive. CONCLUSION The aspiration test was reliable with 53% syringes and needles tested. Fillers that have a negative aspiration test may be applied when the needle gauge is adjusted. The author has indicated no significant interest with commercial supporters.

I

n recent years, dermatologists have developed a three-dimensional view of the aging process on facial structures. The broad rejuvenation process involves skin, bone structure, muscle contraction, and subcutaneous fat. Changes in bone structure and subcutaneous fat pads during aging cause volume loss of the face. The 2 main goals in correcting volume loss of the aging face include restoring subcutaneous volume and reshaping the bone structure.1–3

A common treatment of the aging face includes the use of fillers in the supraperiosteal plane, subcutaneous fat pad, or in the potential space above the subcutaneous fat pad. In 2012, placement of fillers was the second most common minimally invasive procedure performed by dermatologists and plastic surgeons.4,5 Therefore, adverse events and complications are becoming more frequent after filler placement.

Adverse events, such as ecchymosis, swelling, and erythema, are frequent, self-limited, and have no permanent sequel. Complications may be self-limited (overcorrection, irregularities, filler visibility, Tyndall effect, or granuloma formation) or severe (visual impairment, skin necrosis, or anaphylaxis).6,7 A recent review of 41 articles about severe complications (total, 61 patients) such as skin necrosis and blindness reported 0.0001% incidence of developing a severe complication, estimated from population-based filler data and case reports.6 Today, the most commonly used fillers are made from hyaluronic acid, poly-L-lactic acid (PLLA), and calcium hydroxyapatite. Hyaluronic acid is a transparent viscous gel generated by streptococci and cross-linked with 1,4-butanediol diglycidyl ether stabilized and suspended in phosphate-buffered saline (pH 7;

Cosmetic and Surgical Dermatology and Mohs Surgery, Clinica Vida, Sao Paulo, Brazil © 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. ISSN: 1076-0512 Dermatol Surg 2015;41:841–847 DOI: 10.1097/DSS.0000000000000395

·

·

841

© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

ACCIDENTAL INTRAVASCULAR INJECTION IN THE FACE

concentration, 18–22.5 mg/mL). The polymer PLLA is a resorbable biocompatible powder that is reconstituted with distilled water and lidocaine and used to add volume or as a biostimulator (concentration, 12– 20 mL).8 Calcium hydroxyapatite is a white material with microspheres (45 mm) of calcium hydroxyapatite in a carboxymethyl cellulose gel that may function as a filler, biostimulator, and inducer of new collagen formation within 6 months after injection. Hyaluronic acid is degraded by a naturally occurring enzyme hyaluronidase without any inflammation.9 Degradation of PLLA occurs by enzymatic depolymerization to lactic acid monomers, and carbon dioxide gas is produced and eliminated from the lungs. Calcium hydroxyapatite is degraded by macrophages, and a giant cell reaction may occur.10 These products

may be sterilized and packaged with a specific needle or cannula for safe use (Table 1). However, these products have not been tested for blood aspiration. The gauge of the needle or cannula may regulate the material flow rate and duration when applied with those needles/cannulas because different-gauge needles require different strengths and times to aspirate a determined liquid with a certain density, and the smaller the gauge, the higher will be the strength and the lower will be the speed. Varied brands may have >1 density and viscosity of the available products, and different levels of injections may be addressed at the supraperiosteal level, dermis, or subcutaneous level where large vessels and arteries may be located.11 Tissue necrosis is a severe and feared early complication after filler placement and may occur because of

TABLE 1. Cosmetic Fillers and Ink Aspiration Test With Needles Recommended by Manufacturers

Filler Hyaluronic acid

Brand Name

Density (mg/mL)

Syringe Needle Volume Gauge (mL)

Ink Reflux

Time to Reflux (seconds)

Juvederm ultra XC

24

30

0.8

2

2

Juvederm Ultra Plus XC*

24

27

0.8

2

2

Voluma 1 mL

20

27

1

+

2

Voluma 2 mL*

20

23

2

+

1

Volift†

17.5

30

1

+

1

Volbella*†

15

30

1

+

1

Perlane Restylane

20 20

29 29

1 1

2 +

2 3

Restylane Vital

12

30

1

+

2

Emervel Classic†

20

30

1

2

2

Emervel Lips†

20

30

1

2

2

Esthelis/Belotero

22.5

30

1

+

2

Esthelis/Belotero

22.5

27

1

+

4

Rennova Lift†

23

27

1

+

3

Poly-L-lactic acid Sculptra (mixed with 10 mL saline and 2 mL lidocaine—final solution, 12 mL)*

2

27

+

3

Calcium Radiesse 1.5 mL (mixed with 0.25 mL hydroxyapatite lidocaine)

2

27

1.5

2

2

2

27

1.5

2

2

Radiesse 1.5 mL (mixed with 0.5 mL lidocaine)*

1 (silicone Luerlock)

All the needles were tested to determine whether or not they were obstructed before aspiration by pulling the plunge until a drop of product could be seen. The results regarding positivity and time for reflux in vitro and in vivo did not change and were the same among syringes of the same product. *Brands and types of products that were also chosen to test blood aspiration in vivo. †Some products used in this study have no Food and Drug Administration approval for regular use in the United States, such as Emervel, Volift, Volbella, and Rennova.

842

DERMATOLOGIC SURGERY

© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

CASABONA

interruption of the vascular supply to the area by direct vascular canalization, compression of blood vessels, or obstruction of vessels by fillers.12 Compression of vessels using the products used in this study was never proved in any study; nevertheless, the amount used in each bolus was limited to 0.1 mL to minimize the possible risk of compression. Familiarity with dangerous injection zones and normal facial anatomy may potentially prevent these complications (Appendix; Figures 1 and 2).13–19 The use of cannulas may help prevent tissue necrosis, after intravascular injection, but the use of needles is more common and riskier. Vascular obstruction after filler injection is most frequently observed at the glabellar area (32%), nasolabial fold (26%), and nasal area (26%).6 The exact mechanism involved in vascular accidents after filler injection is not completely understood but may include intravascular injection, vasospasm, or vascular compression. The symptoms usually appear immediately but may be delayed until the day after injection.20 The most catastrophic complications include blindness and brain injury.21 Iatrogenic retinal artery obstruction may occur when pressure is applied to the plunger of a syringe and the needle is embedded in the arterial lumen, forcing a bolus of the syringe contents into the artery. When pressure on the plunger is released, the injected material may be forced by systolic blood pressure into the distal circulation, toward an anastomosis, and by retrograde reflux from the glabellar, zygomatic, infraorbital, temporal, or nasal dorsal area. Intravascular injection is accompanied by immediate pain, and visual impairment may occur on the obstructed side.21 Rapid treatment may be effective including embolectomy, transdermal nitroglycerin, anticoagulants (aspirin or heparin), hyaluronidase injection, local heat, intravenous steroids, and prostaglandins (Figure 3).22–26 The purpose of this study was to evaluate the reliability of the aspiration test in confirming intravascular needle placement with different brands and densities of hyaluronic acid, PLLA, and calcium hydroxyapatite used as cosmetic filler in the treatment of facial aging.

Figure 1. External carotid system—A, external carotid; B, temporal artery; C, facial artery; D, inferior labial artery; E, superior labial artery; F, angular artery; G, alar branches of angular artery; H, infraorbital artery; I, zygomatic artery; J, transverse artery of the face; K, orbital artery; L, frontal branch of temporal artery internal carotid system; M, supraorbital artery; N, supratroclear artery; O, dorsal nasal artery.

Materials and Methods The authors tested 17 different filler products that contained hyaluronic acid, PLLA, or calcium hydroxyapatite (Table 1). Reflux Test With an Ink Solution In Vitro After a filler injection procedure in clinic using the needle that had been packaged with the filler or recommended by the manufacturer, 0.1 mL filler remained in the syringe. The remaining filler was used to test aspiration of an ink solution. The ink was diluted with saline (10 mL) and water-based gouache red ink (5 mL) (Faber-Castell, Sao Paulo, Brazil) to change the density and fluidity qualitatively similar to that of venous blood.

41:7:JULY 2015

843

© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

ACCIDENTAL INTRAVASCULAR INJECTION IN THE FACE

The syringe was placed with the needle at 45 to 60 degrees relative to a small plastic cup, and the plunger was pulled to determine whether any aspiration could be observed. The test for aspiration was negative when there was no reflux observed after 10 seconds. The authors tested three syringes for each product and measured the time(s) required for the aspiration to occur (Table 1). Needle Gauge Test for Needles With Negative Aspiration and Bigger Gauges Figure 2. Anatomy, distribution, and connections between the ophthalmic and facial arterial systems.13,14 (7) The supratrochlear artery is the terminal branch of the ophthalmic artery (5) and exits at the superior and medial corners of the bony orbit, with the supratrochlear nerve (4), by piercing the orbital septum. It runs superiorly into the forehead and supplies the integument, muscles, and pericranium, and it maintains numerous anastomoses with the supraorbital artery and contralateral vessels. The supratrochlear artery is the vessel most likely to be involved when embolization occurs from intra-arterial injection of fat and foreign material at the glabella and the forehead. (6) The supraorbital artery occasionally may be the route of embolization of injected material. It arises from the ophthalmic artery and divides into superficial and deep branches that supply the integument, muscles, and pericranium of the forehead. Its terminal branches anastomose with the supratrochlear artery (7), the frontal branch of the superficial temporal artery and the contralateral supraorbital artery. (11) The dorsal nasal artery is the second terminal branch of the ophthalmic artery (5), and it may be responsible for transmission of emboli after injections low in the glabella or proximal to the nasal root. It anastomoses with the angular artery, the contralateral dorsal nasal artery, and the lateral nasal branch of the facial artery. (8) The facial artery arises from the external carotid artery and supplies structures of the face. The facial artery passes forward and upward across the cheek to the angle of the mouth, where it branches and gives rise to the labial systems and lateral nasal artery that supplies the ala and dorsum of the nose. The facial artery also anastomoses with the contralateral facial artery, septal and alar branches, dorsal nasal branch of the ophthalmic artery, and infraorbital branch of the internal maxillary artery. The facial artery ascends along the side of the nose, ending at the medial canthus, where it is named the angular artery (8, 9, 10). After supplying the lacrimal sac and orbicularis oculi, it ends by anastomosing with the dorsal nasal branch (11) of the ophthalmic artery. (9) The angular artery on the cheek distributes branches that anastomose with the infraorbital artery (2). The facial artery is a possible site of embolization from injections of the cheek, nasolabial folds, and lips. (1) The zygomatic facial artery arises from the foramen in the zygomatic arch and is a branch of the superficial temporal artery and can anastomose with the palpebral arch branch of the supratrochlear artery (7). A small branch of the lacrimal artery (15) can emerge from the same foramen and can anastomose with the transverse artery branch of the superficial temporal artery (12). The same lacrimal artery can send a branch (14) through the zygomatic–temporal foramen toward the temporal area that can anastomose with the deep temporal arteries (13).

844

All filler products that had a negative in vitro aspiration test were retested with progressively larger-gauge needles until a positive reflux test was observed. Filler products that were initially positive with a large-gauge needle, such as a 23-gauge needle, were tested with smaller needles to determine whether a smaller and more comfortable needle could be used safely (Table 2). Aspiration Test With a Rabbit Ear Vessel In Vivo In products that had a positive reflux test in vitro, the authors randomly selected 5 products (3 hyaluronic acid, 1 PLLA, and 1 calcium hydroxyapatite) for an aspiration test in vessels (1.0–1.5 mm) of the ear of a white rabbit. This was performed to determine whether the positive in vitro result gave similar results when used in vivo. At 40 minutes after an anesthetic cream was applied (lidocaine 2.5% and prilocaine 2.5%) (EMLA; Oak Pharmaceuticals, Lake Forest, IL), the ear was shaved with a razor blade. For each filler product tested, 1 vessel was punctured (angle, 30 degrees) and the plunger was pulled. The aspiration test was considered positive when blood was aspirated in the syringe in

Blood Aspiration Test for Cosmetic Fillers to Prevent Accidental Intravascular Injection in the Face.

Filler injection for cosmetic treatment of the aging face may be complicated by visual impairment, skin necrosis, or anaphylaxis because of accidental...
340KB Sizes 0 Downloads 11 Views