Energy-based Devices Research Articles

The culture of entering aesthetic dermatology amongst freshers

The life of a dermatology fresher can be quite confusing and filled with uncertainty about what kind of practice to start and build. The advancement in aesthetic procedures and energy-based devices has helped achieve promising results and, therefore, has increased the number of patients seeking these services. The aesthetic practice offers more money than a clinical dermatology practice, but so does it demand more experience, time, and investment. The pressure of establishing oneself and the rat race of flourishing in no time has forced the freshers to indulge in practicing aesthetic dermatology as soon as possible without growing organically.

The Use of Harmonic Focus and Thunderbeat Open Fine Jaw in Thyroid Surgery: Experience of a High-Volume Center.

Background: In thyroid surgery, achieving accurate haemostasis is fundamental in order to avoid the occurrence of complications. Energy-based devices are currently extensively utilized in this field of surgery. This study aims to compare Harmonic Focus and Thunderbeat Open Fine Jaw with regard to surgical outcomes and complications. Methods: Patients submitted to total thyroidectomy in our center, between January 2017 and June 2020, were retrospectively analysed. Based on the energy-based device utilized, two groups were identified: Group A (Harmonic Focus) and Group B (Thunderbeat Open Fine Jaw). Results: A total of 527 patients were included: 409 in Group A and 118 in Group B. About surgical outcomes, the mean operative time was significantly shorter in Group B than in Group A (p < 0.001), while as regards complications, the occurrence of transient recurrent laryngeal nerve injury was significantly greater in Group B than in Group A (p = 0.019). Conclusions. Both Harmonic Focus and Thunderbeat Open Fine Jaw have proven to be effective devices. Operative times were significantly shorter in thyroidectomies performed with Thunderbeat Open Fine Jaw; however, the occurrence of transient recurrent laryngeal nerve injury was significantly greater in patients operated on with this device.

Electrosurgery and Other Technical Advancements in Minimally Invasive Gynecological Surgery - An Update.

Electrosurgery in gynecology has changed over the past few decades. The use of energy-based devices, especially in minimally invasive procedures, is extremely important for preparation, short reconvalescence and patient safety. Recently, there have been major advances in energy-based surgical devices that have further shortened OR time and increased patient safety. Although bipolar and monopolar electrosurgery is still very important, the introduction of high-frequency ultrasound in gynecologic surgery has improved cutting and coagulation by lowering thermal damage in the surrounding tissue. Furthermore, new technical inventions have fundamentally changed the treatment of specific diseases. The introduction of ablation in the therapy of uterine fibroids, for example, has made conventional myomectomy no longer necessary in some cases, as necrosis of fibroids can be induced by placing very small thermal probes into the fibroids. Robotic surgery will change the face of gynecological surgery in the near future, as the initial studies could show lower surgical morbidity and faster recovery of patients after robotic-assisted laparoscopy. In this article we provide a short overview of current technical advances, review possible indications as well as limitations, and take a look into the future of minimally invasive surgery in gynecology.

Host-Guest Intercalation Chemistry for the Synthesis and Modification of Two-Dimensional Transition Metal Dichalcogenides.

Intercalation chemistry is of great importance in solid-state physics and chemistry for the ability to modulate electronic structures for constructing new materials with exotic properties. This ancient and versatile discipline has recently become prevailing in the synthesis and regulation of 2D transition metal dichalcogenides (TMDs) with atomic thickness due to diverse host-guest configurations and their impact on layered frameworks, which bring in extensive applications in electronics, optoelectronics, and other energy-based devices. In order to prepare 2D TMD materials with desired structure and properties, it is essential to gain in-depth understanding of the key role the intercalation chemistry plays in the preparation process. A focused review on recent advances regarding 2D TMD materials through intercalation exfoliation from the view of host, guest, and solvent interactions is provided. The effect of intercalation chemistry on TMD nanosheets synthesis and modification is comprehensively reviewed. The interactions between host and guest from the aspects of lattice strain, interlayer distance, and carrier density are considered. Finally, a prospectus of the future research opportunities for the intercalation chemistry of 2D materials is provided.

Pancreatic Fistula and Biochemical Leak after Splenectomy: Incidence and Risk Factors—A Retrospective Single-Center Analysis

PurposePostoperative pancreatic fistula (POPF) is a complication discussed in the context of pancreatic surgery, but may also result from splenectomy; a relationship that has not been investigated extensively yet.MethodsThis retrospective single-center study aimed to analyze incidence of and risk factors for POPF after splenectomy. Patient characteristics included demographic data, surgical procedure, and intra- and postoperative complications. POPF was defined according to the International Study Group on Pancreatic Surgery as POPF of grade B and C or biochemical leak (BL).ResultsOver ten years, 247 patients were identified, of whom 163 underwent primary (spleen-associated pathologies) and 84 secondary (extrasplenic oncological or technical reasons) splenectomy. Thirty-six patients (14.6%) developed POPF of grade B/C or BL, of which 13 occurred after primary (7.9%) and 23 after secondary splenectomy (27.3%). Of these, 25 (69.4%) were BL, 7 (19.4%) POPF of grade B and 4 (11.1%) POPF of grade C. BL were treated conservatively while three patients with POPF of grade B required interventional procedures and 4 with POPF of grade C required surgery. POPF and BL was noted significantly more often after secondary splenectomy and longer procedures. Multivariate analysis confirmed secondary splenectomy and use of energy-based devices as independent risk factors for development of POPF/BL after splenectomy.ConclusionWith an incidence of 4.5%, POPF is a relevant complication after splenectomy. The main risk factor identified was secondary splenectomy. Although POPF and BL can usually be treated conservatively, it should be emphasized when obtaining patients’ informed consent and treated at centers with experience in pancreatic surgery.

A rare epidermal naevus: naevus comedonicus case repot

&lt;p&gt;Naevus comedonicus (NC) is a rare epidermal naevus characterized by a honeycomb-like dilated follicular opening filled with black or brown keratinous plug. Diagnosis is based mainly on clinical examination and histopathology. It is also a part of NC syndrome (a neurocutaneous syndrome) with ophthalmological (congenital cataract), skeletal (scoliosis, fused vertebra, spina bifida, absence of the fifth finger, polysyndactyly, clinodactyly, rudimentary toe, bone hypertrophy, bone cyst, kyphosis and vitamin D resistant rickets), neurological (mental retardation, corpus callosum dysgenesis, seizures, paresis, electrocochleographic abnormalities). The physician should be aware of the extracutaneous manifestations involving the skeletal system, ophthalmological, neurological, and other skin manifestations. Several topical creams and energy-based devices treat with an unsatisfactory or moderate response. Surgical excision offers good aesthetic results.&lt;/p&gt;

Effectiveness of partially and fully submerged triangular cross-sectional metal hollow-fins and wool cloth wick-fins on triangular pyramid solar still.

Rapid growth in population and industrialization causes the worldwide crisis for potable water, which is emphasizing on researchers to find an alternative way. Solar still is a solar energy-based device facing the problem of low productivity. The motive of the present investigation is to improve the productivity of triangular pyramid solar still by incorporating triangular cross-sectional aluminium hollow-fins and wool cloth wick-fins. In two sets of experiments, the performance of the triangular pyramid solar still with hollow-fins, wick-fins, and without fins has been compared for the case of partially and fully submerged fins. The total distillate outputs per day (including nocturnal duration) from stills for the case of partially submerged fins were: 2.5674 L/m2 (12.36% higher) with hollow-fins, 2.5481 L/m2 (11.51% higher) with wick-fins, and 2.2850 L/m2 for without fins. For the case of partially submerged fins, the productivity was observed higher for the still with wick-fins during morning hours (9:00h to 13:00h), whereas for the still with hollow-fins during afternoon hours (14:00h to 17:00h). For the case of fully submerged fins, total distillate outputs per day (including nocturnal duration) from stills were: 2.2529 L/m2 (9.00% higher) with hollow-fins, 2.3042 L/m2 (11.49% higher) with wick-fins, and 2.0668 L/m2 for without fins. For the still with hollow-fins and wick-fins, efficiency was improved by 13.22% and 15.70% in the case of partially submerged fins, and 17.36% and 29.34% in the case of fully submerged fins. The enhancement in the efficiency of the still with wick-fins and hollow-fins was observed higher for the case of fully submerged fins than the case of partially submerged fins.

Visualization of energy-based device-induced thermal tissue alterations using bimodal ex-vivo confocal microscopy with digital staining. A proof-of-concept study.

Ex-vivo confocal microscopy (EVCM) enables examination of tissue alterations immediately after treatment with energy-based devices (EBDs). This proof-of-concept study aimed to describe EBD-induced tissue effects in ex-vivo porcine skin after treatment with microneedle radiofrequency (MNRF) and ablative fractional CO2 -laser (AFL) using EVCM. Ex-vivo porcine skin was treated with MNRF and AFL. Three cryosections from each intervention were stained with acridine orange (AO) and scanned with EVCM. Reflectance confocal microscopy (RCM, 638nm) and fluorescence confocal microscopy (FCM, 488nm) images were captured and evaluated individually, after image fusion, and after digital hematoxylin and eosin (H&E) staining. Bimodal EVCM was able to visualize EBD-induced thermal alterations in porcine skin. In RCM mode, the full width and depth of the vertically aligned microscopic treatment zones (MTZs) were displayed with clear demarcation to surrounding intact skin. In FCM mode, the ablation of the epidermis after AFL was prominent in contrast with the almost intact epidermis observed in MNRF treated skin. In fusion mode, fluorescence signal from AO marked the surrounding coagulation zone (CZ) from both interventions, with enhanced discrimination between ablation and coagulation. Digitally H&E-stained images closely resembled conventional histopathology but proved superior in terms of visualization of the CZ. Bimodal EVCM with digital H&E-staining facilitates the identification and qualitative evaluation of thermal alterations induced by treatment with EBD. By providing high-resolution images comparable to standard histology, EVCM is a useful tool in the research and development of EBD to visualize and evaluate device-tissue interactions.

The use of self-assembling peptides (PuraStat) for hemostasis in cervical endocrine surgery. A real-life case series of 353 patients.

IntroductionCervical endocrine surgery is frequent and carries the risk of rare but potentially life-threatening bleeding complications. Energy-based devices for stopping bleeding are not always usable in contact with nerves or parathyroid glands. Topical hemostatic agents may be an additional resource. PuraStat™, made of the self-assembling peptide RADA16, forms a new category of topical hemostatic agents.ObjectiveTo assess the performance and safety of PuraStat to achieve hemostasis in cervical endocrine surgery.MethodsA retrospective chart review over four years was performed on 353 patients undergoing thyroidectomy and/or parathyroidectomy by a single senior surgeon, using PuraStat at the end of surgery in contact with recurrent nerves and parathyroid glands.Results353 patients (79.06% female, mean age 54 years) underwent surgery with six weeks follow-up visit. Three patients had revision surgery for hematoma within the first 4 h (0.84%), which is within the low ranges reported in the literature. There was no delayed bleeding after 24 h, and dysphonia was observed in 15 patients, more severe for 2 patients (one unilateral and one bilateral palsy), and transient for the other 13 patients suggesting no product-related damage to the recurrent nerves. Hypocalcemia with clinical signs were reported in 8 cases. There were no unexpected adverse events.ConclusionThis is the first report of the use of PuraStat in patients undergoing cervical endocrine surgery, showing high performance and safety in achieving hemostasis and in preventing delayed bleeding without damage to the recurrent nerves. Further randomized controlled studies are needed to confirm the results.

Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or with Estriol or Moisturizers in Postmenopausal Women with Vulvovaginal Atrophy

Among treatments for vulvo-vaginal atrophy (VVA), there is a new kind of energy-based device, the non-ablative CO2 laser. This study aimed to assess the efficacy and safety of the non-ablative CO2 laser in menopausal women with VVA as a monotherapy or in association with vaginal estriol or moisturizer. Seventy-five women with VVA received laser treatment (Laser group), laser plus estriol gel (Laser+E) or laser plus moisturizers (Laser+M). The study protocol consisted of 3 monthly laser sessions (t0, t1, t2) and a gynecological examination at baseline and 1 month after last laser treatment (t3). Objective measures included VHI (Vaginal Health Index) and VuHI (Vulvar Health Index); subjective symptoms of VVA (Dryness, Burning, Itching, Dysuria) evaluated via visual analog scales, sexual function evaluated by FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Score) and MENQOL (Mopause-specific Quality Of Life). Adverse events and discomfort encountered during the procedure were also assessed. Primary outcomes were the evaluation of VHI and VuHI and secondary outcomes were changes in VVA symptoms (VAS), sexual function (MENQOL, FSFI, FSDS) and discomfort during the procedure. Seventy-five women (25 in Laser, 25 in Laser+E and 25 in Laser+M group) completed the study. At t3, mean VHI, VuHI, dryness, burning and itching VAS scores improved significantly with no differences between the groups. The lubrication domain of FSFI improved significantly only in the Laser+M group, while the pain domain improved significantly in all women with no differences between the groups. FSFI and FSDS overall scores and MENQOL sexual domain improved in all women with no significant difference between the groups. The mean score of the pain during the procedure was low at t0 and did not change throughout the study. This study extends knowledge concerning the effectiveness of a new non-ablative CO2 laser in post-menopausal women with VVA. This is one of the first studies on this kind of laser and is the first to compare the effectiveness of laser treatment alone or in combination with vaginal estriol or moisturizers. Parameters of VVA and sexual function were evaluated using validated tools. Study limitations include short follow-up time, the limited number of participants and the absence of a sham-controlled group. Non-ablative CO2 laser seems to be an effective treatment for VVA in menopausal women. Our preliminary data shows that it can be effective as monotherapy or with adjuvant treatments.

Impact of energy-based devices in pediatric thyroid surgery

BackgroundEnergy-based devices are surgical devices increasingly utilized for thyroid surgery, owing to a reduction of operative time and surgical related complications. The aim of the study is to evaluate whether the use of energy-based devices could improve the complication rate in pediatric thyroid surgery. MethodsThis is a retrospective observational study. We identified 177 consecutive pediatric patients (Group A) with thyroid diseases, surgically treated by energy-based devices and 237 patients (Group B) treated by conventional clamp and tie technique and matched for sex, age and indication for surgery. Transient and permanent complications rate, operative time and length of hospital stay were compared between the two groups. ResultsPatients of Group A experienced a lower complication rate compared to Group B. Particularly, transient (11.3 vs. 19% p < 0.05) and permanent post operative hypoparathyroidism (1.7 vs. 5.5%, p < 0.05) were lower in Group A. Moreover, operative time was also shorter in Group A compared to Group B and this difference was statistically significant in patients who performed total thyroidectomy alone and total thyroidectomy associated with central compartment neck dissection (p < 0.05). Length of hospital stay was lower in Group A than in Group B, but this difference was statistically significant only for microfollicular lesion (p < 0.05). ConclusionThe use of energy-based devices has a key role in reducing surgical related complications, particularly transient and permanent hypoparathyroidism, operative time and length of hospital stay in pediatric patients treated with thyroid surgery. Level of evidenceLevel III. Type of studyRetrospective comparative study.

Racial and ethnic diversity in clinical trials of laser treatments for scars

Patients with skin of color are prone to dyspigmentation and excessive scar cosmesis after laser surgery.1 This poses challenges when using energy-based devices in this cohort, highlighting the need for their representation in clinical trials.2 It remains unclear if trials evaluating laser-treated scar cosmesis equitably represent a diverse population. This study aimed to characterize the racial composition and Fitzpatrick skin types (FSTs) of patients in trials evaluating scar cosmesis after laser surgery.

Accumulation of Experience and Newly Developed Devices Can Improve the Safety and Voice Outcome of Total Thyroidectomy for Graves’ Disease

Total thyroidectomy (TT) in patients with Graves’ disease is challenging even for an experienced thyroid surgeon. This study aimed to investigate the accumulation of experience and applying newly developed devices on major complications and voice outcomes after surgery of a single surgeon over 30 years. This study retrospectively reviewed 90 patients with Graves’ disease who received TT. Forty-six patients received surgery during 1990–1999 (Group A), and 44 patients received surgery during 2010–2019 (Group B). Major complications rates were compared between Group A/B, and objective voice parameters were compared between the usage of energy-based devices (EBDs) within Group B. Compared to Group B, Group A patients had higher rates of recurrent laryngeal nerve palsy (13.0%/1.1%, p = 0.001), postoperative hypocalcemia (47.8%/18.2%, p = 0.002), and postoperative hematoma (10.9%/2.3%, p = 0.108). Additionally, Group A had one permanent vocal cord palsy, four permanent hypocalcemia, and one thyroid storm, whereas none of Group B had these complications. Group B patients with EBDs had a significantly better pitch range (p = 0.015) and jitter (p = 0.035) than those without EBDs. To reduce the major complications rate, inexperienced thyroid surgeons should remain vigilant when performing TT for Graves’ disease. Updates on surgical concepts and the effective use of operative adjuncts are necessary to improve patient safety and voice outcome.

Efficacy of partially and fully submerged circular cross-section metal hollow-fins and black cotton cloth wick-segments on a single-basin dual-slope solar still

The rapid growth of industrialization and population has led to a worldwide crisis for potable water, which has stimulated researchers to discover an alternative solution to fulfill the need for potable water. Solar still is a solar energy-based device that can fulfill the requirement of potable water but facing the problem of low productivity. The current study aims to improve the productivity of single-basin dual-slope solar stills by incorporating hollow-fins and wick-segments. In two sets of experiments, the performance of solar still for the partially and fully submerged hollow-fins and wick-segments was compared with solar still without augmentation. An enhancement of 4.05% and 8.61% in distillate output and 5.20% and 9.39% in efficiency was obtained from the solar stills with partially submerged hollow-fins and wick-segments. Whereas an increment of 9.44% and 6.11% in distillate output and 10.08% and 6.54% in efficiency was obtained from the solar stills with fully submerged hollow-fins and wick-segments. Wick-segments improve the performance of solar still by increasing the evaporation surface and rate of evaporation by capillary action. Whereas hollow-fins improve the performance of solar still by increasing the heat storage capacity, the contact area with saline water, and reducing the thermal resistance for the heat transfer. The performance of solar still was maximum with wick-segments for the partially submerged case, whereas with hollow-fins for the fully submerged case. The solar still with wick-segments was found economical in both partially and fully submerged cases.

Cellulite: Presentation and management.

Cellulite is a common dermatological condition with a female preponderance, affecting up to 90% post-pubertal females. It is characterized with dimpling and denting of the skin surface, giving it a Peau d'orange appearance. Once considered to be a benign physiological isolated skin condition of only an esthetic concern, cellulite is now considered a pathological entity with systemic associations and a negative psychological impact on patients. The objective of this article was to discuss etiology, pathophysiology, and treatment of cellulite. Literature was screened to retrieve articles from PubMed/Medline and Google Scholar and related websites. Cross-references from the relevant articles were also considered for review. Review articles, clinical studies, systematic reviews, meta-analysis, and relevant information from selected websites were included. Several treatment options from lifestyle modifications and topical cosmetic therapies to energy-based devices have been studied for its treatment. However, treatment remains a challenge despite many new modalities in the armamentarium. Laser and light therapies along with radiofrequency are useful treatment options with good safety profile. Acoustic wave therapy, subcision, and 1440-nm Nd:YAG minimally invasive laser are beneficial in cellulite reduction. Methodological differences in the trials conducted make it difficult to compare different treatment modalities. Overall, treatment needs to be individualized based on the patient characteristics and severity of the condition. A combination of treatments is often required in most patients for reducing cellulite.

Review of Lasers and Energy-Based Devices for Skin Rejuvenation and Scar Treatment With Histologic Correlations.

Lasers and energy-based devices (EBD) are popular treatments for skin rejuvenation and resurfacing. Achieving desired outcomes and avoiding complications require understanding the effects of these devices at a histologic level. Currently, no comprehensive review summarizing the histologic effects of laser and energy-based treatments exists. To describe how lasers and EBD alter skin histology and improve the overall understanding of these devices. A PubMed search was conducted for studies with histologic analysis of fractional picosecond laser, fractional radiofrequency microneedling, nonablative lasers, and ablative lasers. Fractional picosecond lasers induce intraepidermal and/or dermal vacuoles from laser-induced optical breakdown. Fractional radiofrequency microneedling delivers thermal energy to the dermis while sparing the epidermis, making it safer for patients with darker skin phototypes. Fractional nonablative lasers induce conical zones of coagulation of the epidermis and upper dermis. Ablative lasers vaporize the stratum corneum down to the dermis. Traditional ablative lasers cause diffuse vaporization while fractional ablative lasers generate columns of tissue ablation. Lasers and EBD are effective for skin resurfacing and rejuvenation and have different mechanisms with disparate targets in the skin. Safe and effective use of devices requires understanding the histologic laser-tissue interaction.

An experimental investigation of the effectiveness of partially and fully submerged metal hollow-fins and jute cloth wick-fins on the performance of a dual-basin single-slope solar still

The rapid growth of the population and industrialization have caused a global crisis for potable water, which has triggered researchers to propose an alternative solution to the problem. Solar still is a solar energy-based device confronting the problem of low productivity. The prime objective of the present study is to investigate the effectiveness of hollow-fins and wick-fins on the performance of dual-basin single-slope solar still. The performance of solar still with hollow-fins, wick-fins, and without fins has been compared in two sets of experiments for partially and fully submerged cases. The distillate outputs from stills for partially submerged fins were 4.2313 L/m2 (8.96% higher) with wick-fins, 4.0733 L/m2 (4.89% higher) without fins, and 3.8833 L/m2 with hollow-fins. The wick-fins improve the performance of the solar still by increasing the evaporation surface and rate of evaporation through capillary action. The distillate outputs from stills for fully submerged fins were 3.6554 L/m2 (3.91% higher) with wick-fins, 3.8534 L/m2 (9.54% higher) without fins, and 3.5179 L/m2 with hollow-fins. The reason for the higher performance of still without fins are the highest temperature of the lower basin; reduced heat loss due to increased heat storage capacity of brackish water; a lower temperature difference between the lower basin and saline water that increases evaporation of brackish water in the lower basin; the highest temperature difference between saline water and the upper basin glass cover that enhances the condensation rate of water vapour in the upper basin. The still with wick-fins proved to be the most efficient from the performance and economic point of view for partially submerged fins, while the still without fins proved to be the most efficient for fully submerged fins.

Changes of Functional, Morphological, and Inflammatory Reactions in Spontaneous Peripheral Nerve Reinnervation after Thermal Injury.

In recent decades, the use of energy-based devices has substantially increased the incidence of iatrogenic thermal injury to nerves (cauterization, etc.). While recovery of the nerve after thermal injury is important, the changes in neural structure, function, and peripheral inflammatory reactions postinjury remain unclear. This study is aimed at demonstrating the changes mentioned above during the acute, subacute, and chronic stages of nerve reinnervation after thermal injury. Spontaneous reinnervation was evaluated, including the neural structures, nerve conduction abilities, and muscle regeneration. These effects vary depending on the severity of thermal injury (slight, moderate, and severe). Peripheral inflammatory reactions, as impediments to reinnervation, were found in significant numbers 3 days after thermal injury, exhibiting high expression of IL-1β and TNF-α, but low expression of IL-10. Our findings reveal the pathogenesis of peripheral nerve reinnervation after thermal injury, which will assist in selecting appropriate treatments in further research.

A Systematic Review of Subsurface Radiofrequency Treatments in Plastic Surgery.

BackgroundSubsurface radiofrequency (RF) treatments produce skin contraction by causing coagulation of the underlying subcutaneous fat. This method is marketed to fill a treatment gap for patients who do not wish to have surgery. A systematic review of this subject has not been previously published.MethodsAn electronic search was performed using PubMed to identify the literature describing subsurface RF treatments.ResultsThirty articles were evaluated. An InMode device was used in 23 studies, and a Thermi device was used in 6 studies, with or without liposuction. Treatment areas included the face, neck, body, breasts, and labia. Most studies relied on patient satisfaction scores and physician review of photographs. The most frequent complications were induration and nodules. Most patients experienced prolonged swelling and numbness. Several studies reported marginal mandibular neuropraxias. The skin response after treatment of the abdomen was poor, and seromas were common. The incidence of burns improved after modification of the InMode device. Breast treatment did not appear to be effective in treating ptosis. Patient satisfaction scores were modest. Most studies (77%) were published by authors with a known conflict of interest. In some studies, the photographs did not accurately depict the treatment result. Institutional review board approval and disclosure of off-label regulatory status were often missing.DiscussionThermal treatment of the subcutaneous tissue introduces extra risks without a compensatory benefit. Comparisons in terms of safety, cost, recovery time, results, and complications do not favor energy-based devices. A treatment gap may be fictitious; properly informed patients may be treated with existing surgical procedures at all ages.ConclusionsLittle evidence supports the efficacy and safety of subcutaneous RF treatments as an improvement over results that may be obtained using traditional surgical methods such as submental lipectomy, liposuction, and abdominoplasty. Photographic integrity is often lacking. Financial conflict of interest is pervasive. Marketing precedes the science. Plastic surgeons need to be aware of these serious limitations and the off-label regulatory status of these devices, before purchasing expensive equipment and recommending subsurface RF treatments to patients.

Microfocused ultrasound with visualization: Consensus on safety and review of energy-based devices.

BackgroundMicrofocused ultrasound with visualization (MFU‐V; Ultherapy®, Merz North America) is US Food and Drug Administration‐cleared as a non‐invasive procedure that lifts the soft tissue of the neck, submentum and brow, and improves lines and wrinkles on the upper chest. Several other energy‐based devices are in use in countries outside the USA where they are marketed for indications similar to those of MFU‐V, although published studies supporting these indications are limited and none of the other devices provides visualization or verification they reach the superficial musculoaponeurotic system.MethodsDue to the evolving landscape of ultrasound technology as more devices enter the market, seven global thought leaders who are qualified experts on the use of various high‐intensity focused ultrasound (HIFU)/MFU‐V technologies convened to review data from an independent evaluation of the software, thermal characteristics, transducer acoustics and ultrasound therapy of MFU‐V and three other ultrasound‐based devices.ResultsThe independent testing demonstrated the devices have key differences in several parameters that play a role in safety and effectiveness. Specifically, MFU‐V has visualization capability but the other devices lack that feature. Other differences include the retention of patient history, consistent size and uniformity of thermal coagulation points (TCPs), precise localization of energy concentration at the focal point, and reliable thermal regulation during use. The expert panel established a consensus on the types of preventable complications associated with ultrasound‐based energy devices and techniques for preventing and treating complications.ConclusionsThe independent test results of MFU‐V/HIFU devices and the consensus panel conclusions provide strong support that real‐time visualization and the capability to detect coupling, features found only in MFU‐V, help prevent complications and enhance the safety and effectiveness of energy‐based devices. The independent evaluation also revealed that MFU‐V has several additional features that play key roles in safety and clinical effectiveness, including uniformity of TCPs, tight thermal regulation, large focal gain, and short beam length, that were not found collectively in any of the HIFU devices.