Descriptive Analysis of 213 Positive Blood Aspiration Cases When Injecting Facial Soft Tissue Fillers.

BACKGROUND: Pre-injection aspiration procedures could increase safety during soft tissue filler injections. However, various influencing factors have been detected in vitro that could result in false negative aspiration results. OBJECTIVE: A case series was retrospectively investigated to identify factors contributing to positive blood aspiration procedures in vivo. METHODS: This study evaluated 213 clinical cases positive for blood aspiration documented in an Asian population: 208 females (43.8 ±â€…7.2 years old) and 5 males (46.8 ±â€…7.8 years old) during soft tissue filler injections. Injection location, layer (depth) of injection, product injected, size of utilized needle (gauge), length of needle (inch), priming of needle (yes/no), injection angle (degree), and time until blood was visible in the needle hub (seconds) were evaluated. RESULTS: The most frequent location where a positive aspiration was observed was the pyriform fossa (n = 56; 26.3%), the most frequent plane was the supra-periosteal plane (n = 195; 91.5%), and the most frequent needle utilized was a 27G needle (n = 125; 58.7%). Statistically significantly more positive cases were identified when the needle was primed compared with an unprimed needle (P < 0.001, which was independent of the product). The estimated incidence rate was 0.04% to 0.9% for having positive aspiration procedures per total performed injection procedures. CONCLUSIONS: Pre-injection aspiration could be a valuable tool to prevent accidental intravascular injection of soft tissue filler. The results of the present investigation show that aspiration can be performed with an acceptable aspiration time, that is, less than 2 seconds, if a suitable product/needle combination is chosen.

New High Dose Pulsed Hyaluronidase Protocol for Hyaluronic Acid Filler Vascular Adverse Events.

The purpose of this article is to update the changes to the author's protocols used to manage acute filler related vascular events from those previously published in this journal. For lack of a better term, this new protocol has been called the High Dose Pulsed Hyaluronidase (HDPH) protocol for vascular embolic events with hyaluronic acid (HA) fillers. The initial protocol used involved many different modalities of treatment. The current protocol is exceedingly simple and involves solely the use of hyaluronidase in repeated high doses. Despite the simplicity of the treatment, it has proven itself to be very successful over the past two years of clinical use. There has been no partial or complete skin loss associated with this protocol since its implementation if the protocol was implemented within 2 days of the ischemic event onset. The protocol involves diagnosis and repeated administration of relatively high doses hyaluronidase (HYAL) into the ischemic tissue repeated hourly until resolution (as detected clinically through capillary refill, skin color, and absence of pain). The dosage of HYAL varies as the amount of ischemic tissue, consistent with the new underlying hypothesis that we must flood the occluded vessels with a sufficient concentration of HYAL for a sufficient period of time in order to dissolve the HA obstruction to the point where the products of hydrolysis can pass through the capillary beds. Although vascular embolic events are rare, it is important to note that the face has higher risk and lower risk areas for filler treatment, but there are no "zero risk" areas with respect to filler treatments. Even with good anatomic knowledge and correct technique, there is still some nonzero risk of vascular embolic events (including highly skilled, experienced injectors). However, with careful low pressure, low volume injection technique, and adequate preparation for treatment of acute vascular events, the risk is quite manageable and the vast majority of adverse events are very treatable with an excellent prognosis, with a few exceptions. This new protocol offers excellent results, but requires further research to determine optimal parameters for various HA fillers.

An Anatomical Analysis of the Supratrochlear Artery: Considerations in Facial Filler Injections and Preventing Vision Loss.

BACKGROUND: Embolia cutis medicamentosa (ECM) is a rare phenomenon attributed to intra-arterial drug injection. Glabellar filler injections can result in potentially devastating visual loss from inadvertent retrograde arteriolar embolization due to the extensive vasculature within the upper face. The minimum amount of filler necessary to potentiate this complication has not yet been reported. OBJECTIVES: We aim to determine the volume of filler necessary to occupy the supratrochlear artery from the glabella to the bifurcation of the ophthalmic and central retinal arteries. We specifically examine the volume of the supratrochlear artery from the glabella to orbital apex. METHODS: The study was approved by Duke University Institutional Review Board and involved surgical dissection of six fresh tissue cadaver heads (12 hemifaces). The arterial system in each cadaver head was injected with latex for visualization. The supratrochlear arteries were isolated anteriorly from the glabella to the orbital apex posteriorly. Intra-orbital vessel radius and length were measured. The vessel volume was calculated by water displacement of the intra-arterial latex. RESULTS: The vessel volumes ranged from 0.04 to 0.12 mL. The average vessel volume was calculated as 0.085 mL, the average length as 51.75 mm, and the average radius as 0.72 mm. CONCLUSIONS: Vascular occlusion from filler injections can lead to devastating visual consequences due to inadvertent retrograde intra-arterial embolization. Our findings indicate that the average entire volume of the supratrochlear artery from the glabella to the orbital apex is 0.085 mL. Injectors should be aware that a bolus of this critical volume may lead to a significant adverse outcome.

Treatment of Hyaluronic Acid Filler-Induced Impending Necrosis With Hyaluronidase: Consensus Recommendations.

Injection-induced necrosis is a rare but dreaded consequence of soft tissue augmentation with filler agents. It usually occurs as a result of injection of filler directly into an artery, but can also result from compression or injury. We provide recommendations on the use of hyaluronidase when vascular compromise is suspected. Consensus recommendations were developed by thorough discussion and debate amongst the authors at a roundtable meeting on Wednesday June 18, 2014 in Las Vegas, NV as well as significant ongoing written and verbal communications amongst the authors in the months prior to journal submission. All authors are experienced tertiary care providers. A prompt diagnosis and immediate treatment with high doses of hyaluronidase (at least 200 U) are critically important. It is not felt necessary to do a skin test in cases of impending necrosis. Some experts recommend dilution with saline to increase dispersion or lidocaine to aid vasodilation. Additional hyaluronidase should be injected if improvement is not seen within 60 minutes. A warm compress also aids vasodilation, and massage has been shown to help. Some experts advocate the use of nitroglycerin paste, although this area is controversial. Introducing an oral aspirin regimen should help prevent further clot formation due to vascular compromise. In our experience, patients who are diagnosed promptly and treated within 24 hours will usually have the best outcomes.

Transarterial degradation of hyaluronic acid filler by hyaluronidase.

BACKGROUND: Hyaluronidase (HYAL) has been recommended in the emergency treatment of ischemia caused by accidental intra-arterial injection of hyaluronic acid (HA) dermal fillers. To date, there have been no published studies showing that HYAL can pass through intact arterial wall to hydrolyze HA emboli. OBJECTIVE: The goal of this study was to study whether or not HYAL could cross intact human facial arterial wall to hydrolyze HA filler. MATERIALS AND METHODS: Short tied-off segments of fresh human cadaver-sourced facial artery specimens, overfilled with a monophasic dermal filler (dermal filler "sausages"), were immersed in either HYAL or normal saline as controls. At 4 and 24 hours, the vessels were removed from the preparations, and one end of each vessel was cut open. RESULTS: Only the HYAL-immersed specimens showed degradation of filler gel. CONCLUSION: In conclusion, cross-linked HA is susceptible to hydrolysis by HYAL when contained within the intact facial artery in a cadaver model, indicating that direct intra-arterial injection of HYAL is likely not necessary to help restore the circulation of ischemic tissues. This bench study provides support for the current recommended treatment of accidental intra-arterial injection with HYAL injection diffusely into ischemic tissues.

Complications of injectable fillers, part 2: vascular complications.

Accidental intra-arterial filler injection may cause significant tissue injury and necrosis. Hyaluronic acid (HA) fillers, currently the most popular, are the focus of this article, which highlights complications and their symptoms, risk factors, and possible treatment strategies. Although ischemic events do happen and are therefore important to discuss, they seem to be exceptionally rare and represent a small percentage of complications in individual clinical practices. However, the true incidence of this complication is unknown because of underreporting by clinicians. Typical clinical findings include skin blanching, livedo reticularis, slow capillary refill, and dusky blue-red discoloration, followed a few days later by blister formation and finally tissue slough. Mainstays of treatment (apart from avoidance by meticulous technique) are prompt recognition, immediate treatment with hyaluronidase, topical nitropaste under occlusion, oral acetylsalicylic acid (aspirin), warm compresses, and vigorous massage. Secondary lines of treatment may involve intra-arterial hyaluronidase, hyperbaric oxygen therapy, and ancillary vasodilating agents such as prostaglandin E1. Emergency preparedness (a "filler crash cart") is emphasized, since early intervention is likely to significantly reduce morbidity. A clinical summary chart is provided, organized by complication presentation.

Complications of injectable fillers, part I.

Dermal filling has rapidly become one of the most common procedures performed by clinicians worldwide. The vast majority of treatments are successful and patient satisfaction is high. However, complications, both mild and severe, have been reported and result from injection of many different types of dermal fillers. In this Continuing Medical Education review article, the author describes common technical errors, the signs and symptoms of both common and rare complications, and management of sequelae in clear, easily adaptable treatment algorithms.

Global Approaches to the Prevention and Management of Delayed-onset Adverse Reactions with Hyaluronic Acid-based Fillers.

BACKGROUND: Delayed-onset adverse reactions to hyaluronic acid (HA) fillers are uncommon but have received increased attention, particularly with regard to late-onset nodules. Globally, there is a need for comprehensive prevention and management strategies. METHODS: Experts with clinical practices in diverse regions of the world and extensive experience in managing complications related to HA fillers convened to propose and evaluate approaches to prevent delayed-onset adverse reactions after HA filler administration and manage late-onset nodules. RESULTS: The expert panel agreed to define delayed-onset adverse reactions as those presenting more than 4 weeks posttreatment, with swelling, induration, and nodulation being the most common clinical signs. The panel recommended 5 general key approaches for the prevention of delayed-onset reactions (patient selection, anatomic location of injection/product selection, aseptic technique, injection procedure/filler, and posttreatment care). Strategies recommended for managing late-onset nodules included oral antibiotics, oral steroids, nonsteroidal anti-inflammatory drugs if needed, hyaluronidase for noninflammatory nodules (recognizing the limitations and regional availability of this treatment), intralesional antibiotics, intralesional immunosuppressive drugs such as steroids and fluorouracil, and surgical excision as a last resort. The panel noted that late-onset nodules may vary in both clinical presentation and etiology, making them challenging to address or prevent, and stressed individualized treatment based on clinical presentation. Regional differences in aseptic protocols, antibiotic selection, and steroid formulations were described. CONCLUSION: Insights from global experts on approaches to prevent and manage delayed-onset adverse reactions following HA filler administration, including late-onset nodules, support clinicians worldwide in optimizing patient outcomes and safety.

The long-term efficacy and safety of a subcutaneously injected large-particle stabilized hyaluronic acid-based gel of nonanimal origin in esthetic facial contouring.

BACKGROUND: Nonanimal stabilized hyaluronic acid (NASHA) offers longer-lasting correction than many other injectable products and is associated with low risk of immunogenic and hypersensitivity reactions. A new large-particle stabilized hyaluronic acid-based gel has been developed to restore facial volume and define facial contours. OBJECTIVE: This study was conducted to assess the long-term efficacy and safety of a large-particle stabilized hyaluronic acid-based gel in patients seeking facial contouring. METHODS: Fifty-seven adult patients seeking esthetic cheek or chin augmentation or both received subcutaneous or supraperiosteal injections or both of large-particle stabilized hyaluronic acid-based gel (20 mg/mL). Efficacy was assessed subjectively using the Global Aesthetic Improvement Scale at intervals up to 12 months after treatment. RESULTS: After treatment, patients and investigators independently considered treatment sites to be at least somewhat improved in 91% and 96% (6 months), 68% and 77% (9 months), and 58% and 52% (12 months) of cases, respectively. Patient- and investigator-assessed treatment response rates (the proportion of patients showing at least moderate improvement) were 72% and 81% (6 months), 42% and 40% (9 months), and 21% and 15% (12 months), respectively. Most commonly reported adverse events were local injection-site reactions, skin induration, and implant mobility. CONCLUSION: This large-particle stabilized hyaluronic acid-based gel is well tolerated and provides relatively long-lasting esthetic correction of the cheeks and chin after subcutaneous or supraperiosteal injection.

Understanding, Avoiding, and Managing Severe Filler Complications.

Any injectable filler may elicit moderate-to-severe adverse events, ranging from nodules to abscesses to vascular occlusion. Fortunately, severe adverse events are uncommon for the majority of fillers currently on the market. Because these are rare events, it is difficult to identify the relevant risk factors and to design the most efficacious treatment strategies. Poor aesthetic outcomes are far more common than severe adverse events. These in contrast should be easily avoidable by ensuring that colleagues receive proper training and follow best practices.