RESUMEN
BACKGROUND: Inadvertent intra-arterial injection of sclerosants is an uncommon adverse event of both ultrasound-guided and direct vision sclerotherapy. This complication can result in significant tissue or limb loss and significant long-term morbidity. OBJECTIVES: To provide recommendations for diagnosis and immediate management of an unintentional intra-arterial injection of sclerosing agents. METHODS: An international and multidisciplinary expert panel representing the endorsing societies and relevant specialities reviewed the published biomedical, scientific and legal literature and developed the consensus-based recommendations. RESULTS: Actual and suspected cases of an intra-arterial sclerosant injection should be immediately transferred to a facility with a vascular/interventional unit. Digital Subtraction Angiography (DSA) is the key investigation to confirm the diagnosis and help select the appropriate intra-arterial therapy for tissue ischaemia. Emergency endovascular intervention will be required to manage the risk of major limb ischaemia. This includes intra-arterial administration of vasodilators to reduce vasospasm, and anticoagulants and thrombolytic agents to mitigate thrombosis. Mechanical thrombectomy, other endovascular interventions and even open surgery may be required. Lumbar sympathetic block may be considered but has a high risk of bleeding. Systemic anti-inflammatory agents, anticoagulants, and platelet inhibitors and modifiers would complement the intra-arterial endovascular procedures. For risk of minor ischaemia, systemic oral anti-inflammatory agents, anticoagulants, vasodilators and antiplatelet treatments are recommended. CONCLUSION: Inadvertent intra-arterial injection is an adverse event of both ultrasound-guided and direct vision sclerotherapy. Medical practitioners performing sclerotherapy must ensure completion of a course of formal training (specialty or subspecialty training, or equivalent recognition) in the management of venous and lymphatic disorders (phlebology), and be personally proficient in the use of duplex ultrasound in vascular (both arterial and venous) applications, to diagnose and provide image guidance to venous procedure. Expertise in diagnosis and immediate management of an intra-arterial injection is essential for all practitioners performing sclerotherapy.
RESUMEN
BACKGROUND: A phase 4, prospective, open-label, multicenter study showed that treatment with deoxycholic acid injections (ATX-10) followed by a hyaluronic acid filler (VYC-20L) is safe and effective for reducing submental fullness and improving jawline definition. OBJECTIVE: To quantify changes in the jawline and submental area using 3-dimensional (3D) photogrammetry and conduct an immunohistochemical analysis of submental tissue. Methods: Participants received 1 to 6 ATX-101 treatments (8 weeks apart) followed by VYC-20L (optional touch-up after 14 days). Changes from baseline in jawline and submental volumes, submental major and minor strain events, submental skin displacement, and submental angles were quantified using photogrammetry. Submental skin biopsies (N=13) were excised for histologic analysis. Treatment-emergent adverse events (TEAEs) were monitored. RESULTS: Fifty-three participants were treated. From baseline to the final study visit, the mean volume increased for the jawline and decreased for the submental area. There was a larger percentage change from baseline in the minor versus major strain event, indicating greater skin surface compression than expansion within the submental area. Mean change from baseline in submental skin position indicated superior and posterior movement from a lateral perspective, while the mean submental angle decreased between baseline and exit. Collagen I and III expression significantly increased from baseline (P<0.05). All participants reported at least 1 TEAE; the majority were mild or moderate in severity. CONCLUSIONS: Dual-modality treatment with ATX-101 and VYC-20L reduces submental fat and improves jawline definition with quantifiable changes in jawline volume, submental volume, strain, skin displacement, and angle, as well as collagen expression. J Drugs Dermatol. 2024;23(1):1325-1331. doi:10.36849/JDD.7458.
Asunto(s)
Colágeno , Mandíbula , Humanos , Estudios Prospectivos , Biopsia , Ácido DesoxicólicoRESUMEN
BACKGROUND: Hyaluronic acids (HAs) continue to be the fillers of choice worldwide and their popularity is growing. Adverse events (AEs) are able to be resolved through the use of hyaluronidase (HYAL). However, routine HYAL use has been at issue due to perceived safety issues. OBJECTIVES: There are currently no guidelines on the use of HYAL in aesthetic practice, leading to variability in storage, preparation, skin testing, and beliefs concerning AEs. This manuscript interrogated the use of this agent in daily practice. METHODS: A 39-question survey concerning HYAL practice was completed by 264 healthcare practitioners: 244 from interrogated databases and 20 from the consensus panel. Answers from those in the database were compared to those of the consensus panel. RESULTS: Compared to the database group, the consensus group was more confident in the preparation of HYAL, kept reconstituted HYAL for longer, and was less likely to skin test for HYAL sensitivity and more likely to treat with HYAL in an emergency, even in those with a wasp or bee sting anaphylactic history. Ninety-two percent of all respondents had never observed an acute reaction to HYAL. Just over 1% of respondents had ever observed anaphylaxis. Five percent of practitioners reported longer-term adverse effects, including 3 respondents who reported loss of deep tissues. Consent before injecting HA for the possible requirement of HYAL was always obtained by 74% of practitioners. CONCLUSIONS: Hyaluronidase would appear to be an essential agent for anyone injecting hyaluronic acid filler. However, there is an absence of evidence-based recommendations with respect to the concentration, dosing, and treatment intervals of HYAL, and these should ideally be available.
Asunto(s)
Técnicas Cosméticas , Rellenos Dérmicos , Ácido Hialurónico , Hialuronoglucosaminidasa , Pautas de la Práctica en Medicina , Hialuronoglucosaminidasa/administración & dosificación , Humanos , Ácido Hialurónico/administración & dosificación , Ácido Hialurónico/efectos adversos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Técnicas Cosméticas/efectos adversos , Rellenos Dérmicos/administración & dosificación , Rellenos Dérmicos/efectos adversos , Encuestas y Cuestionarios/estadística & datos numéricos , Anafilaxia/inducido químicamenteRESUMEN
BACKGROUND: The pathogenesis of delayed-onset tissue nodules (DTNs) due to hyaluronic acid (HA) injections is uncertain. OBJECTIVES: To formulate a rational theory for DTN development and their avoidance and treatment. METHODS: A multidisciplinary and multicountry DTN consensus panel was established, with 20 questions posed and consensus sought. Consensus was set at 75% agreement. RESULTS: Consensus was reached in 16 of 20 questions regarding the pathogenesis of DTNs, forming the basis for a classification and treatment guide. CONCLUSIONS: The group believes that filler, pathogens, and inflammation are all involved in DTNs and that DTNs most likely are infection initiated with a variable immune response. Injected filler may incorporate surface bacteria, either a commensal or a true pathogen, if the skin barrier is altered. The initially high molecular weight HA filler is degraded to low molecular weight HA (LMWHA) at the edge of the filler. Commensals positioned within the filler bolus may be well tolerated until the filler is degraded and the commensal becomes visible to the immune system. LMWHA is particularly inflammatory in the presence of any local bacteria. Commensals may still be tolerated unless the immune system is generally heightened by viremia or vaccination. Systemic pathogenic bacteremia may also interact with the filler peripheral LMWHA, activating Toll-like receptors that induce DTN formation. Given this scenario, attention to practitioner and patient hygiene and early systemic infection treatment deserve attention. Classification and treatment systems were devised by considering each of the 3 factors-filler, inflammation, and infection-separately.
Asunto(s)
Técnicas Cosméticas , Rellenos Dérmicos , Humanos , Ácido Hialurónico/efectos adversos , Inyecciones , Técnicas Cosméticas/efectos adversos , Inflamación/etiología , Rellenos Dérmicos/efectos adversosRESUMEN
We present a case report of hyaluronic acid (HA) injected in the subcutaneous fat of the lateral face, deep fat compartments of the mid-face, and a combination of deep and superficial injection of HA in the chin. MRI demonstrates longevity of HA in the lateral face and deep fat compartments of the mid-face versus almost complete degradation of HA in the chin 19 months from injection. The MRI signal demonstrated no migration of HA and persistence of HA at 27 months in the lateral face and mid-face.
RESUMEN
BACKGROUND: Aspiration prior to hyaluronic acid filler injection is often taught as a safety maneuver to minimize the risk of intravascular injection; however, the validity of this technique in aesthetic practice is being increasingly challenged. One key assumption underpinning the validity of the aspiration test is that the needle tip does not move during the aspiration and subsequent injection of filler. OBJECTIVES: The aim of this study was to visualize and measure needle tip movement in real time during aspiration and injection of filler. Secondary objectives were to assess the impact of injector experience and double-handed versus single-handed aspiration technique in maintaining stability of the syringe. METHODS: Under real-time ultrasound visualization, 3 injectors with different levels of experience injected hyaluronic acid filler into pork belly tissue utilizing both double-handed and single-handed aspiration techniques. Needle tip movements were recorded and measured by means of ultrasound and video. RESULTS: The aspiration maneuver is in all cases associated with retrograde movement of the needle tip, ranging from 1.1 to 5.3 mm (mean, 2.9 mm), whereas injection leads to anterograde movement ranging from 0.6 to 4.1 mm (mean, 1.9 mm). Double-handed aspiration is associated with less needle tip movement than single-handed aspiration (Pâ =â 0.037). Greater experience is also associated less movement of the needle tip (Pâ <â 0.0001). CONCLUSIONS: In all cases, the aspiration and injecting maneuver is associated with micromovements of the needle tip, of a magnitude consistently significant relative to the typical size of facial vessels. Although needle tip movement is only a single factor limiting the usefulness of the aspiration test, the results of this study suggest that it is not advisable to rely only on aspiration as a method to prevent intravascular injection.
Asunto(s)
Ácido Hialurónico , Jeringas , Cara , Humanos , Inyecciones , AgujasRESUMEN
BACKGROUND: Aesthetic physicians rely on certain anecdotal beliefs regarding the safe practice of filler injections. These include a presumed safety advantage of bolus injection after a negative aspiration. OBJECTIVES: The authors sought to review and summarize the published literature on inadvertent intravascular injection of hyaluronic acid and to investigate whether the technique of aspiration confers any safety to the practitioner and the patient. METHODS: Pertinent literature was analyzed and the current understanding of the safety of negative and positive aspiration outlined. RESULTS: The available studies demonstrate that aspiration cannot be relied on and should not be employed as a safety measure. It is safer to adopt injection techniques that avoid injecting an intravascular volume with embolic potential than utilize an unreliable test to permit a risky injection. CONCLUSIONS: To prevent intravascular injection, understanding "injection anatomy" and injection plane and techniques such as slow, low-pressure injection are important safety measures. Assurance of safety when delivering a bolus after negative aspiration does not appear to be borne out by the available literature. If there is any doubt about the sensitivity or reliability of a negative aspiration, there is no role for its utilization. Achieving a positive aspiration would just defer the risk to the next injection location where a negative aspiration would then be relied on.
Asunto(s)
Técnicas Cosméticas , Rellenos Dérmicos , Técnicas Cosméticas/efectos adversos , Rellenos Dérmicos/efectos adversos , Humanos , Ácido Hialurónico/efectos adversos , Inyecciones , Inutilidad Médica , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: It is believed that combination treatment with both neuromodulators (NM) and hyaluronic acid soft-tissue fillers (HA) results in superior aesthetic results and increased patient satisfaction compared to either treatment alone. AIMS: To determine whether combined treatment with NM and HA leads to greater patient retention than treatment with NM or HA alone. PATIENTS/METHODS: This is a large, multi-center, retrospective review of patient retention rates from 7 aesthetic practices across 5 continents, incorporating over 2600 patients. Patient retention is interpreted as a surrogate marker for overall patient satisfaction. Retention rates were compared at 1, 3, and 5 years for patients who received NM only, HA only, or combination treatment with both NM and HA. RESULTS: Combination therapy significantly increased the probability of retention for each time point (1, 3, and 5 years) compared with NM alone (P < .0001) and HA alone (P < .0001). CONCLUSION: This large multicenter, global retrospective review demonstrates that patients who received combined HA and NM were more likely to be retained in the same practice over many years than those who received either treatment alone.
Asunto(s)
Técnicas Cosméticas , Rellenos Dérmicos , Envejecimiento de la Piel , Humanos , Ácido Hialurónico , Neurotransmisores , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
The coronavirus disease 2019 (COVID-19) global pandemic has resulted in diversion of healthcare resources to the management of patients infected with SARS-CoV-2 virus. Elective interventions and surgical procedures in most countries have been postponed and operating room resources have been diverted to manage the pandemic. The Venous and Lymphatic Triage and Acuity Scale was developed to provide an international standard to rationalise and harmonise the management of patients with venous and lymphatic disorders or vascular anomalies. Triage urgency was determined based on clinical assessment of urgency with which a patient would require medical treatment or surgical intervention. Clinical conditions were classified into six categories of: (1) venous thromboembolism (VTE), (2) chronic venous disease, (3) vascular anomalies, (4) venous trauma, (5) venous compression and (6) lymphatic disease. Triage urgency was categorised into four groups and individual conditions were allocated to each class of triage. These included (1) medical emergencies (requiring immediate attendance), example massive pulmonary embolism; (2) urgent (to be seen as soon as possible), example deep vein thrombosis; (3) semi-urgent (to be attended to within 30-90 days), example highly symptomatic chronic venous disease, and (4) discretionary/non-urgent- (to be seen within 6-12 months), example chronic lymphoedema. Venous and Lymphatic Triage and Acuity Scale aims to standardise the triage of patients with venous and lymphatic disease or vascular anomalies by providing an international consensus-based classification of clinical categories and triage urgency. The scale may be used during pandemics such as the current COVID-19 crisis but may also be used as a general framework to classify urgency of the listed conditions.
Asunto(s)
Infecciones por Coronavirus/terapia , Sistemas de Apoyo a Decisiones Clínicas/normas , Técnicas de Apoyo para la Decisión , Servicio de Urgencia en Hospital/normas , Enfermedades Linfáticas/terapia , Neumonía Viral/terapia , Triaje/normas , Enfermedades Vasculares/terapia , COVID-19 , Toma de Decisiones Clínicas , Consenso , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/transmisión , Necesidades y Demandas de Servicios de Salud/normas , Humanos , Enfermedades Linfáticas/diagnóstico , Enfermedades Linfáticas/epidemiología , Pandemias , Selección de Paciente , Neumonía Viral/diagnóstico , Neumonía Viral/epidemiología , Neumonía Viral/transmisión , Enfermedades Vasculares/diagnóstico , Enfermedades Vasculares/epidemiologíaRESUMEN
The coronavirus disease 2019 (COVID-19) global pandemic has resulted in diversion of healthcare resources to the management of patients infected with SARS-CoV-2 virus. Elective interventions and surgical procedures in most countries have been postponed and operating room resources have been diverted to manage the pandemic. The Venous and Lymphatic Triage and Acuity Scale was developed to provide an international standard to rationalise and harmonise the management of patients with venous and lymphatic disorders or vascular anomalies. Triage urgency was determined based on clinical assessment of urgency with which a patient would require medical treatment or surgical intervention. Clinical conditions were classified into six categories of: (1) venous thromboembolism (VTE), (2) chronic venous disease, (3) vascular anomalies, (4) venous trauma, (5) venous compression and (6) lymphatic disease. Triage urgency was categorised into four groups and individual conditions were allocated to each class of triage. These included (1) medical emergencies (requiring immediate attendance), example massive pulmonary embolism; (2) urgent (to be seen as soon as possible), example deep vein thrombosis; (3) semiurgent (to be attended to within 30-90 days), example highly symptomatic chronic venous disease, and (4) discretionary/nonurgent- (to be seen within 6-12 months), example chronic lymphoedema. Venous and Lymphatic Triage and Acuity Scale aims to standardise the triage of patients with venous and lymphatic disease or vascular anomalies by providing an international consensus-based classification of clinical categories and triage urgency. The scale may be used during pandemics such as the current COVID-19 crisis but may also be used as a general framework to classify urgency of the listed conditions.
Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/epidemiología , Enfermedades Linfáticas/terapia , Neumonía Viral/epidemiología , Triaje/organización & administración , Enfermedades Vasculares/terapia , Venas , COVID-19 , Consenso , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/prevención & control , Humanos , Cooperación Internacional , Enfermedades Linfáticas/diagnóstico , Pandemias/prevención & control , Selección de Paciente , Neumonía Viral/diagnóstico , Neumonía Viral/prevención & control , Reproducibilidad de los Resultados , SARS-CoV-2 , Índice de Severidad de la Enfermedad , Sociedades Médicas , Enfermedades Vasculares/diagnóstico , Procedimientos Quirúrgicos VascularesRESUMEN
BACKGROUND: Hyaluronic acid fillers have a satisfactory safety profile. However, adverse reactions do occur, and rarely intravascular injection may lead to blindness. Currently there is no internationally recognized consensus on the prevention or management of blindness from hyaluronic acid filler. OBJECTIVES: The authors sought to give guidance on how to minimize the risk and optimize the management of this rare but catastrophic adverse reaction. METHODS: A multinational group of experts in cosmetic injectables from multiple disciplines convened to review current best practice and develop updated consensus recommendations for prevention and bedside intervention if visual loss occurs after cosmetic injection of hyaluronic acid filler. RESULTS: The consensus group provided specific recommendations focusing on the consenting process, prevention, and early management of visual impairment related to intravascular hyaluronic acid filler injection. CONCLUSIONS: Although visual loss due to filler injections is rare, it is important that both patient and physician be aware of this risk. In this paper the authors describe methods and techniques available to reduce the risk and also document suggested initial management should a clinician find themselves in this situation.
Asunto(s)
Técnicas Cosméticas , Rellenos Dérmicos , Ceguera/inducido químicamente , Ceguera/prevención & control , Consenso , Técnicas Cosméticas/efectos adversos , Rellenos Dérmicos/efectos adversos , Humanos , Ácido Hialurónico/efectos adversosRESUMEN
BACKGROUND: Intravascular injection leading to skin necrosis or blindness is the most serious complication of facial injection with fillers. It may be underreported and the outcome of cases are unclear. Early recognitions of the symptoms and signs may facilitate prompt treatment if it does occur avoiding the potential sequelae of intravascular injection. OBJECTIVES: To determine the frequency of intravascular injection among experienced injectors, the outcomes of these intravascular events, and the management strategies. METHODS: An internet-based survey was sent to 127 injectors worldwide who act as trainers for dermal fillers globally. RESULTS: Of the 52 respondents from 16 countries, 71 % had ≥11 years of injection experience, and 62 % reported one or more intravascular injections. The most frequent initial signs were minor livedo (63 % of cases), pallor (41 %), and symptoms of pain (37 %). Mildness/absence of pain was a feature of 47 % of events. Hyaluronidase (5 to >500 U) was used immediately on diagnosis to treat 86 % of cases. The most commonly affected areas were the nasolabial fold and nose (39 % each). Of all the cases, only 7 % suffered moderate scarring requiring surface treatments. Uneventful healing was the usual outcome, with 86 % being resolved within 14 days. CONCLUSION: Intravascular injection with fillers can occur even at the hands of experienced injectors. It may not be always associated with immediate pain or other classical symptoms and signs. Prompt effective management leads to favorable outcomes, and will prevent catastrophic consequences such as skin necrosis. Intravascular injection leading to blindness may not be salvageable and needs further study. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
Asunto(s)
Competencia Clínica , Rellenos Dérmicos/administración & dosificación , Ácido Hialurónico/administración & dosificación , Surco Nasolabial , Encuestas y Cuestionarios , Australia , Técnicas Cosméticas , Estudios Transversales , Rellenos Dérmicos/efectos adversos , Estética , Femenino , Humanos , Inyecciones Subcutáneas , Rejuvenecimiento/fisiología , Resultado del TratamientoRESUMEN
BACKGROUND: Objective and subjective scales estimating improvement in both clinical studies and clinical practice are becoming more mainstream. However, the use of a system to analyze improvement in aging with a multiplicity of treatments would be useful. The purpose of this study was to use a recently developed educative and patient self-assessment program ("Home of Younger Skin", HOYS) for assessment of the effect of facial treatment with neurotoxins and filling agents in terms of decreasing apparent age. METHODS: Four patients underwent facial treatments with neurotoxins and dermal fillers by an experienced blinded physician and were assessed twice utilizing an age analysis program (HOYS), once before and then 6 weeks after completion of treatment. RESULTS: The four patients showed an average reduction in apparent facial age of 7.5 years. The individual "regions" differed in their reductions. The upper face showed a decline of 13.5 years, the periorbital region 9.25 years, the mid face 4.5 years, and the lower face 12.25 years. CONCLUSION: Use of this previously validated self-assessment program may prove to be a useful measure of patient-reported improvement with treatment.
RESUMEN
Utilization of a 1-10 msec vascular laser to treat facial vessels to limit purpura has become available in recent years. Its efficacy and morbidity in the treatment of common vascular lesions require exploration. We have assessed the relative outcomes and morbidity from a single treatment session of two patterns of 'difficult to treat' facial telangiectasia - perialar vessels and spider naevi - with such a system. Two prospective clinical studies with long pulse 532 nm potassium tritanyl phosphate (KTP) laser were performed with subjective and independent objective assessment at 3 days, 1 week and 4 weeks in both studies. Perialar vessels showed good to excellent improvement subjectively at 4 weeks in 53% (8/15), spider naevi in 83% (20/24). Pain of treatment was substantially greater treating perialar telangiectasia than when treating spider naevi (P < 0.01). Morbidity was low in both groups with no long-term complications. Despite the clinical end-point of vessel disappearance at time of treatment and good early improvement in the appearance of perialar vessels, the failure rate was significant at 1 month follow up. It would appear that spider naevi behave more predictably, with vessel disappearance at time of treatment most often forecasting a successful outcome. Although not statistically significant, spider naevi probably respond better than perialar vessels to a single treatment with this laser.