Reticulated livedoid skin patterns after soft-tissue filler-related vascular adverse events.

BACKGROUND: For the treatment of vascular adverse events caused by filler injections, duplex ultrasound imaging may be used. The findings of duplex ultrasound examination and the clinical features of reticulated livedoid skin patterns were compared with the hemifaces anatomy. OBJECTIVE: The objective of this study was to link the reticulated livedoid skin patterns to the corresponding duplex ultrasound findings and the facial perforasomes. METHODS: Duplex ultrasound imaging was used for the diagnosis and treatment of vascular adverse events. The clinical features and duplex ultrasound findings of 125 patients were investigated. Six cadaver hemifaces were examined to compare the typical livedo skin patterns with the vasculature of the face. RESULTS: Clinically, the affected skin showed a similar reticulated pattern in each facial area corresponding with arterial anatomy and their perforators in the cadaver hemifaces. With duplex ultrasound, a disturbed microvascularization in the superficial fatty layer was visualized. After hyaluronidase injection, clinical improvement of the skin pattern was seen. Normalization of blood flow was noted accompanied by restoration of flow in the corresponding perforator artery. The skin patterns could be linked to the perforators of the superficial fat compartments. CONCLUSION: The livedo skin patterns seen in vascular adverse events may reflect the involvement of the perforators.

Investigating the Anatomic Location of Soft Tissue Fillers in Noninflammatory Nodule Formation: An Ultrasound-Imaging-Based Analysis.

INTRODUCTION: Noninflammatory nodules may be persistent to dissolve. To evaluate the possible reasons, a case series of ultrasound images and medical data of patients who were prospectively referred with noninflammatory nodules were evaluated. MATERIALS AND METHODS: A total of 27 patients with nodules but without signs of inflammation were included. All cases were assessed with an 18-MHz linear ultrasound device. Exact location of the filler material was noted. Relations with clinical data were analyzed using chi-square tests. RESULTS: Early onset of complaints (<2 weeks) was found in 16 patients and late onset (>2 weeks) in 11. All patients had multiple nodules. In all cases, the filler nodule was found to be located inside the fascia. Extension to the subcutaneous tissue was seen in 8 cases and to the deeper planes in 5. In 14 cases, the filler material was completely located inside layers of the fascia, and migration was observed in 5 cases. DISCUSSION: Accumulation of filler material in the superficial musculoaponeurotic system or fascia may be an important cause for the occurrence of persistent noninflammatory nodules, either by initial faulty injection technique or by later accumulation through the pathway generated with a needle or cannula. Ultrasound-guided injections are helpful to dissolve the nodule.

Early ultrasound for diagnosis and treatment of vascular adverse events with hyaluronic acid fillers.

BACKGROUND: Hyaluronic acid fillers are known for a reliable safety profile, but complications do occur, even serious vascular adverse events. OBJECTIVE: To improve the treatment outcome after a vascular adverse event with use of hyaluronic acid filler treatments. METHODS: Duplex ultrasonography is used to detect the hyaluronic acid filler causing the intra-arterial obstruction. RESULTS: If treated in time, 1 single treatment of ultrasonographically guided injections of hyaluronidase into the filler deposit will prevent skin necrosis. CONCLUSION: Because the use of duplex ultrasonography adds extra essential information, its use may become an integral part of the prevention and treatment of injection adverse events.

Bacterial Contamination Is Involved in the Etiology of Soft-Tissue Filler, Late-Onset, Inflammatory Adverse Events.

BACKGROUND: The treatment algorithm in late-onset inflammatory adverse events with soft-tissue fillers depends primarily on the assumed causative factor: immunologic or bacterial. METHODS: The authors included 29 patients, 13 of whom experienced late-onset inflammatory adverse events to fillers (inflammatory group) and 16 who did not (reference group). Biopsies were acquired from both groups with an 18-G needle. Before taking the biopsy, the authors acquired skin swabs for 25 of the 29 patients. The IS-pro method-a new and very sensitive method to detect microbiota-was used. This is a novel broad-range polymerase chain reaction technique based on length and sequence variations of the 16S to 23S ribosomal interspacer region. IS-pro can detect bacteria at low abundances and identify them up to species level. To exclude contamination from skin microbiota, the authors compared the microbiota found on skin swabs with that found in the corresponding biopsies. RESULTS: A high level of Gram-positive bacteria was found in biopsies of soft-tissue fillers, predominantly in patients from the inflammation group. This suggests that these bacteria were introduced during the primary filler injection treatment. The composition of the microbiota on the skin differed markedly from that in the filler, indicating that contamination during the sampling process did not influence results. CONCLUSIONS: Bacteria adherent to soft-tissue fillers or bacteremia probably play a causative role in adverse events. Contamination of samples in the biopsies with skin microbiota was excluded. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Precision of Soft-Tissue Filler Injections: An Ultrasound-Based Verification Study.

BACKGROUND: Uncontrolled product spread is an important issue to consider in facial filler injections. Lack of precision can result in reduced effectiveness and surface projection, as well as irregularities and product visibility. OBJECTIVES: The authors sought to assess the precision of soft-tissue filler injections in the face by employing a cannula. METHODS: This single-center observational study investigated soft-tissue filler distribution utilizing real-time non-invasive ultrasound imaging. Outcome parameters included (1) the tissue plane of product distribution, (2) the extent of horizontal as well as vertical product spread at the injection site, and (3) the product surface area taking into account the multifactorial influence of several independent variables. Participants were followed up to 30 days post-injection. RESULTS: A total 100 facial injections were performed in 8 patients (2 males, 6 females) with a mean age of 37.20 (±6.34) years and a mean BMI of 22.21 (±1.39) kg/m.2. The plane of product distribution remained constant in approximately 90% of cases at day 0 (d0), d14, and d30. Mean horizontal product spread was higher compared with vertical spread, and both significantly decreased over all time points (P < .001). Mean product surface area was 22.51 ± 16.34 mm2 at d0, 15.97 ± 11.28 mm2 at d14, and 12.9 ± 9.15 mm2 at d30. Analysis employing generalized linear models revealed that injection volume and injection depth significantly influenced product surface area. CONCLUSIONS: Injection of soft-tissue filler employing a cannula allows precise application of the product within the intended tissue plane. Precision can be improved by injecting less product into deeper tissue layers.

Ultrasound-Guided Targeted vs Regional Flooding: A Comparative Study for Improving the Clinical Outcome in Soft Tissue Filler Vascular Adverse Event Management.

BACKGROUND: Adverse vascular event management following hyaluronic acid-based aesthetic injections relies on the administration of hyaluronidase which is capable of enzymatically degrading the injected product and improving clinical symptoms. Two protocols are currently available to manage such complications: "ultrasound-guided targeted" and "flooding". OBJECTIVES: The aim of this study was to compare the 2 protocols in terms of the volume of hyaluronidase utilized, and the onset and degree of clinical improvement. METHODS: A comparative case series of 39 patients was retrospectively evaluated. The patients were initially treated with the "flooding" protocol and then treated with the "ultrasound-guided targeted" protocol due to no or little improvement. RESULTS: The "ultrasound-guided targeted" protocol utilized a mean [standard deviation] total of 122.5 [34] IU of hyaluronidase, whereas the "flooding" protocol utilized 1519.4 [1137] IU, which represents a statistically significant reduced amount of injected hyaluronidase (P = 0.028). There was no clinical improvement in 92.3% and only little improvement in 7.7% of the treated patients following the first applied "flooding" protocol, but there was a 100% immediate improvement when subsequently treated with the "ultrasound-guided targeted" protocol. Ultrasound imaging revealed that the application of hyaluronidase restored normal blood flow both in the perivascular space and in the superficially located subdermal soft tissues. CONCLUSIONS: Despite its limitations in study design, this retrospectively evaluated case series revealed that the "ultrasound-guided targeted" protocol utilized less hyaluronidase and restored clinically visible symptoms faster. The effect of this protocol is best explained by the perforasome concept which will need to be investigated further in future studies.

A Guide to Doppler Ultrasound Analysis of the Face in Cosmetic Medicine. Part 1: Standard Positions.

Interest in Doppler ultrasound (DUS) analysis of the face has grown in cosmetic medicine, in particular for injectable fillers. When dealing with complications, DUS has the advantage of easily visualizing the filler and identifying the problem in relation to the patient's anatomy. When working with hyaluronic acid filler, ultrasound-guided injections with hyaluronidase can precisely target the problem. In addition, DUS can be used to study the anatomy of a patient, specifically to prevent intravascular injections. We predict that in a few years' time DUS will become standard equipment in the offices of cosmetic doctors. We discuss the basics of ultrasound imaging of different tissues with the concomitant terminology. With the use of 7 basic DUS probe positions, key anatomic reference points can be easily found. From these, all relevant anatomic structures in the face can be observed and analyzed. With some practice, physicians will ultimately be able to acquire a complete 3-dimensional mental image of a patient's face.

A Guide to Doppler Ultrasound Analysis of the Face in Cosmetic Medicine. Part 2: Vascular Mapping.

Duplex mode ultrasound imaging can detect the course of the main vascular structures in the face, which are known to be subject to variation. Once duplex mapping has been performed, measures can be taken to prevent injection into an artery, thereby avoiding skin necrosis or, worse, vision loss. For this reason, in particular, we predict that in the coming years sonography will become standard equipment in the offices of cosmetic doctors. We discuss the basics of vascular imaging by Doppler ultrasound, both in normal and pathologic situations. Starting from the 7 basic positions for the ultrasound probe, all facial arteries relevant in cosmetic medicine can be found.

Increased risk of late-onset, immune-mediated, adverse reactions related to dermal fillers in patients bearing HLA-B*08 and DRB1*03 haplotypes.

Even though manufacturers claim that the dermal fillers are nontoxic and nonimmunogenic, adverse events may occur. Clinically and histologically, most of the late onset adverse events present as an inflammatory response. To assess whether HLA polymorphisms are associated with late-onset inflammatory adverse events related to dermal fillers. A total of 211 patients were included, of whom 129 experienced late-onset inflammatory adverse events to different fillers (Inflammation group) and 82 who did not (Reference group). Patients completed a standardized questionnaire and provided a blood sample or oral swap for HLA testing. The study population consisted of 188 (89%) women and 23 (11%) men. The two study groups were similar in the distributions of filler type, location of injecting, allergy, autoimmune disease, gender, age, ethnicity, and smoking status. Of the 211 patients in the sample, 25 had the combination of HLA subtype-B*08 and HLA subtype-DRB1*03. This was 16.3% of the inflammatory group and 4.9% of the reference group. This combination of HLA subtypes was associated with an almost 4-fold increase in the odds of developing immune mediated adverse events (odds ratio = 3.79, 95% CI 1.25-11.48). Genetic polymorphisms such as HLA combinations may identify patients at risk of developing late onset immune mediated adverse events to dermal fillers.

Ultrasound to Improve the Safety and Efficacy of Lipofilling of the Temples.

BACKGROUND: Autologous fat is known for a reliable and natural safety profile, but complications do occur-even serious vascular adverse events. OBJECTIVES: The authors sought to examine doppler-ultrasound (DUS) imaging for the harvesting and subsequent facial implantation of autologous fat tissue. METHODS: All patients underwent lipofilling treatment of the temporal fosse of the face. DUS examination was performed for preprocedural vascular mapping and imaging of previously injected (permanent) fillers. In addition, the injection of autologous fat was performed DUS-guided. RESULTS: Twenty patients (all female; mean age, 57.9 years; range, 35-64 years). DUS examination showed that 16 of the 20 patients (80%) had been injected with resorbable or nonresorbable fillers elsewhere in the past. The temporal artery could be visualized and avoided in all cases. An average of 1.1 cc of autologous fat was injected in the temporal fossa per side. One case of edema and nodules was described, but no other adverse events were reported. CONCLUSIONS: The utilization of DUS can add valuable information to a lipofilling procedure and should be considered an integral part of a safe lipofilling treatment.

Nomenclature proposal for the sonographic description and reporting of soft tissue fillers.

BACKGROUND: There is a steady increase in publications about the use of ultrasound and filler treatments, written by physicians from different specialties. The terminology used to describe the ultrasound images of fillers is not uniform, making the different articles difficult to compare. Standardization of the descriptions based on their basic sonographic parameters is recommendable. AIMS: The purpose of this study is to propose a nomenclature for the sonographic description and reporting of cosmetic fillers. METHODS: An assessment of articles indexed for MEDLINE/PubMed and Embed electronic database was conducted; in total of 39 articles could be included. RESULTS: All articles were investigated for their sonographic descriptions of soft tissue fillers. Ten parameters used for describing and monitoring soft tissue fillers were distinguished. CONCLUSION: The proposed sonographic descriptions for cosmetic fillers may contribute to a better standardization and understanding fillers ultrasound images in the reports or literature.

Ultrasound to improve the safety of hyaluronic acid filler treatments.

BACKGROUND: Hyaluronic acid fillers are known for a reliable safety profile, but complications do occur, even serious vascular adverse events. OBJECTIVE: To improve the safety of hyaluronic acid filler treatments. METHODS: Ultrasound is used to image hyaluronic acid fillers. RESULTS: Before a filler treatment is performed with ultrasound, previous filler treatments can be brought in to sight and vascular mapping can be performed. In case of adverse events, the filler and the surrounding tissues are visible. Dislocation, abscesses, and vascular adverse events can be seen. Under ultrasound guidance, hyaluronidase can be injected directly into the filler deposit. CONCLUSION: Ultrasound examination can be an important tool to improve the safety of hyaluronic acid filler treatments.

Intralesional Laser Treatment for Dermal Filler Complications.

BACKGROUND: For complications caused by filler treatments, in general, two treatment regimens are advised: systemic drugs and surgical removal of the material. Another possible treatment option would be removal of the material by intralesional laser treatment. METHODS: Two hundred forty-two patients with complications caused by fillers were treated with intralesional laser treatment. RESULTS: In the majority of patients, an improvement was achieved (92 percent), in 9 percent the complication was resolved, and in 3 percent it was not improved (unknown in the rest). CONCLUSION: Considering the large number of patients treated until now and the efficacy and good safety profile of this treatment, the authors plead that intralesional laser treatment may be considered as a treatment option before surgery. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Polyalkylimide: A Nonstable Filler Over Time.

BACKGROUND: Polyalkylimide hydrogel is supposed to be a permanent, biocompatible implant. However, years after subcutaneous implantation clinical complications are seen. OBJECTIVE: To increase the understanding of the changes that occur over time in this subdermal implanted filler. MATERIALS AND METHODS: The extruded filler material of 34 patients was evaluated by histologic examination. RESULTS: In most patients who had cosmetic disturbances but no complaints, histology showed no immune cells in or around the filler material. In patients with an acute inflammatory response, giant cell invasion was seen in and around the filler material. Patients with chronic complaints showed a neutrophilic cell influx in the extruded filler. In all patients, degeneration and calcification of the material was noted. The polyalkylimide hydrogel changed over time, both macroscopically and microscopically. As in most of the patients no immune response was seen around the filler material, this may indicate that the material is biocompatible. CONCLUSION: The authors conclude that a dermal filler should not be judged solely on its biocompatible characteristics but also on the degradation process over time in the human body.

Use of ultrasound to provide overall information on facial fillers and surrounding tissue.

BACKGROUND: Information on fillers and their behavior over time in the different layers of tissue is limited. Ultrasound may be used to visualize these fillers and their surrounding tissue to broaden knowledge. OBJECTIVE: To evaluate the use of ultrasound as a diagnostic and research tool to obtain information on facial fillers and their behavior in human tissue. METHODS AND MATERIALS: Patients with a history of facial filler treatment were examined using ultrasound in an outpatient setting. RESULTS: Seventy-two patients were examined. Hydrophilic fillers were echo visible, whereas tissue-generating fillers, permanent and resorbable, could be detected according to their tissue-generating reaction within the tissue. Filler characteristics such as longevity and reaction within the tissue and complications such as migration and granulomas could be visualized. CONCLUSION: The use of ultrasound may provide information to broaden our knowledge of facial fillers and may improve the performance and safety of filler treatments. The authors have indicated no significant interest with commercial supporters.

Complications after treatment with polyalkylimide.

BACKGROUND: Polyalkylimide is a nonresorbable, biocompatible polymeric filler that has been used for several years to treat soft tissue deficits. The literature has shown a minor complication rate. We noticed that complications typically appear several years after injection. OBJECTIVE: To evaluate the complications reported after treatment with polyalkylimide. METHODS AND MATERIALS: We describe a retrospective evaluation, reported by members and candidate members of the Dutch Society of Cosmetic Medicine, of complications after use of polyalkylimide. RESULTS: In total, 3,196 patients were treated, and 4,738 treatments were performed, from which 154 complications (patient complication rate 4.8%, treatment complication rate 3.3%) were reported. The most common complication was inflammation; other complications were hardening, migration, and accumulation of the product. In some patients, skin biopsy followed by histologic examination was performed. CONCLUSION: Treatments with polyalkylimide have been reported to give rise to complications years after treatment. Even though the study described is a retrospective evaluation, we consider an overall complication rate of 4.8%, the severity of the complications, and the difficulty in treating them too high a risk for a cosmetic treatment. The Dutch Society of Cosmetic Medicine advises against the use of polyalkylimide.