Remodeling of facial soft tissue induced by simultaneous application of HIFES and synchronized radiofrequency provides nonsurgical lift of facial soft tissues.

BACKGROUND: The application of radiofrequency (RF) and HIFES on the body provides improvement in skeletal muscle tissue, reduction in fatty tissue, reorganization of connective tissue, and skin texture improvement. However, overall facial appearance relies on both skin and underlying structures, specifically muscles and connective tissue which have to be treated as one unit to achieve proper care while preserving fatty layers that define youth facial appearance. AIMS: The aim of this study is to find whether the effect of novel RF + HIFES is safe and can induce the lifting of soft tissue and overall improvement in facial appearance. METHODS: In this study, 21 subjects were enrolled. The therapy was administered in four 20-min treatments on the forehead and cheeks. Photographs were evaluated by a Global Aesthetic Improvement Score (GAIS) and linear measurements of facial tissue lifting at 1- and 3-month follow-ups. Volumetric changes in the cheek area were investigated as well. The patients' satisfaction, safety, and comfort were documented throughout the study. RESULTS: The data indicated improvement in overall facial appearance, and 23% of average lifting was found in brows (p = 3.14 × 10-12 ) and cheeks (p = 6.00 × 10-15 ). The assessment of digital photographs showed an improvement in 100% of patients at 3-month follow-up. The treatments were safe, accompanied by high therapy comfort and subject satisfaction of 98%. CONCLUSIONS: The treatment by simultaneous RF and HIFES technology produces significant changes to the overall facial appearance, characterized by the lifting of facial tissues.

Artificial Intelligence: Singularity Approaches.

SUMMARY: Artificial intelligence (AI) has been a disruptive technology within health care, from the development of simple care algorithms to complex deep-learning models. AI has the potential to reduce the burden of administrative tasks, advance clinical decision-making, and improve patient outcomes. Unlocking the full potential of AI requires the analysis of vast quantities of clinical information. Although AI holds tremendous promise, widespread adoption within plastic surgery remains limited. Understanding the basics is essential for plastic surgeons to evaluate the potential uses of AI. This review provides an introduction of AI, including the history of AI, key concepts, applications of AI in plastic surgery, and future implications.

Technology Innovation and Disruption in Plastic Surgery: Intelligence Quotient, Emotional Quotient, and Technology Quotient.

SUMMARY: This article is an introduction to the new PRS Tech Disruptor Series, the culmination of work originating from the Technology Innovation and Disruption Presidential Task Force. Our technology quotient is important to our success as individuals and as a specialty society. The goal of this new series is to address the broader concepts in technology as they relate to plastic surgery and thus enhance the technology quotient of readers and, in turn, of the specialty and specialty society. Critical topics related to technology, their current and future impact on plastic surgery, and the opportunities and barriers in research, education, and advocacy will be addressed. The intent is for readers to engage in dialogue and think outside the box about the current and future impact of technology.

Robotics in Plastic Surgery: It's Here.

SUMMARY: Although robotic surgery has been routinely established in other surgical disciplines, robotic technologies have been less readily adopted in plastic surgery. Despite a strong demand for innovation and cutting-edge technology in plastic surgery, most reconstructive procedures, including microsurgery, have continued to necessitate an open approach. Recent advances in robotics and artificial intelligence, however, are gaining momentum and have shown significant promise to improve patient care in plastic surgery. These next-generation surgical robots have the potential to enable surgeons to perform complex procedures with greater precision, flexibility, and control than previously possible with conventional techniques. Successful integration of robotic technologies into clinical practice in plastic surgery requires achieving key milestones, including implementing appropriate surgical education and garnering patient trust.

Cybersecurity and Technical Patient Privacy Protection.

Plastic surgery offices are subject to a wide variety of cybersecurity threats, including ransomware attacks that encrypt the plastic surgeon's information and make it unusable, as well as data theft and disclosure attacks that threaten to disclose confidential patient information. Cloud-based office systems increase the attack surface and do not mitigate the effects of breaches that can result in theft of credentials. Although employee education is often recommended to avoid the threats, a single error by a single employee has often led to security breaches, and it is not reasonable to expect that no employee will ever make an error. A recognition of the two most common vectors of these breaches, compromised email attachments and surfing to compromised websites, allows the use of technical networking tools to both prevent email attachments from being received and to prevent employee use of unsanctioned and potentially compromised websites. Further, once compromised code is allowed to run within the office network, that code must necessarily make outbound connections to exploit the breach. Preventing that outbound traffic can mitigate the effects of a breach. However, most small office network consultants design firewalls to only limit incoming network traffic and fail to implement technical measures to stop the unauthorized outbound traffic that is necessary for most network attacks. Detailed techniques are provided which can be used to direct IT consultants to properly limit outbound network traffic as well as incoming email attachments, with more information at https://officenetworksecurity.com.

Retrospective analysis of high-intensity focused electromagnetic procedure synchronized with radiofrequency energy for visceral fat reduction.

BACKGROUND: Visceral adipose tissue (VAT), present in the abdominal cavity, oftentimes contributes to an unpleasant aesthetic appearance and can be correlated with serious health issues. High-intensity focused electromagnetic field (HIFEM) technology with synchronized radiofrequency (RF) was recently used for abdominal body shaping through subcutaneous fat reduction and muscle growth. AIM: This study aimed to assess the effect of HIFEM + RF technology on VAT tissue. METHODS: Data of 16 men and 24 women (22-62 years, 21.2-34.3 kg/cm2 ) from the original study were retrospectively reviewed. All subjects received three 30-min HIFEM + RF abdominal treatments once weekly for three consecutive weeks. The VAT area was measured in the axial plane of MRI scans at two levels: L4-L5 vertebrae and 5 cm above this level. The VAT was identified, segmented, and calculated, yielding total area in square centimeters per scan at both specified levels. RESULTS: By thoughtful review of the subject's post-treatment MRI scans, no other changes in the abdominal cavity were found except for VAT. The evaluation showed a VAT reduction of 17.8% (p < 0.001) on average at 3-month follow-up, maintaining the results up to 6 months (-17.3%). Averaging the values obtained from both measured levels, the VAT, occupied an area of 100.2 ± 73.3 cm2 at the baseline. At the 3-month follow-up, the subjects achieved an average reduction of 17.9 cm2 , preserving the results at 6 months (-17.6 ± 17.3 cm). CONCLUSION: This retrospective analysis of MRI images objectively documented the effect of HIFEM + RF abdominal therapy on VAT. The data indicates considerable VAT reduction without serious adverse events following the HIFEM + RF procedure.

Novel Technology for Facial Muscle Stimulation Combined With Synchronized Radiofrequency Induces Structural Changes in Muscle Tissue: Porcine Histology Study.

BACKGROUND: With age, facial muscles lose the ability to complete contractions properly, resulting in limitation of facial expressions and fat shifting, and leading to skin creases and wrinkling. OBJECTIVES: The aim of this study was to determine the effects of the novel high intensity facial electromagnetic stimulation (HIFES) technology combined with synchronized radiofrequency on delicate facial muscles, using an animal porcine model. METHODS: Eight (n = 8, 60-80 kg) sows were divided into the active group (n = 6) and the control group (n = 2). The active group underwent four 20-minute treatments with radiofrequency (RF) and HIFES energies. The control group was not treated. Histology samples of muscle tissue were collected by a punch biopsy (6 mm in diameter) from the treatment area of each animal at baseline, 1-month, and 2-month follow-up. The evaluation included staining of the obtained tissue slices with hematoxylin and eosin and Masson's trichrome to determine the changes in muscle mass density, number of myonuclei, and muscle fibers. RESULTS: The active group showed muscle mass density increase (by 19.2%, P < .001), together with elevated numbers of myonuclei (by 21.2%, P < .05) and individual muscle fibers, which increased from 56.8 ± 7.1 to 68.0 ± 8.6 (P < .001). In the control group, no significant changes were seen in any of the studied parameters throughout the study (P > .05). Finally, no adverse events or side effects were observed in the treated animals. CONCLUSIONS: The results document favorable changes after the HIFES + RF procedure at the level of the muscle tissue, which may be of great importance in terms of maintenance of facial appearance in human patients.

Spot Reduction of Localized Fat Deposits on the Lateral Thighs by Simultaneous Emission of Synchronized Radiofrequency and High-Intensity Focused Electromagnetic Energy: Magnetic Resonance Multicenter Study.

BACKGROUND: Unwanted lateral fat most prominently affects the female population and may cause self-esteem issues. OBJECTIVE: To investigate the effectiveness and safety of synchronized high-intensity focused electromagnetic (HIFEM) + radiofrequency (RF) for the treatment of lateral thigh adipose tissue. MATERIALS AND METHODS: Ninety-three subjects (21-70 year old) received 4, 30-minute HIFEM + RF treatments of the lateral thighs. Magnetic resonance imaging (MRI) of the treated area was obtained at baseline, 1, 3, and 6 months post-treatment to document the changes in fat layer thickness. Furthermore, digital photographs, circumference measurements of the lateral thighs, subjects' satisfaction questionnaires, and therapy safety and comfort were documented. RESULTS: Magnetic resonance imaging revealed a significant reduction of fat tissue in the saddlebag region peaking at 3 months (-18 ± 5.5 mm; N = 51). The thigh circumference measured at 3 predefined levels decreased on average by 2.3 cm, with the greatest change at the level of 10 cm below the infragluteal fold (-3.5 cm, 3-month follow-up). Results were maintained at 6 months. No adverse events were recorded. The therapy was found comfortable with a high satisfaction rate. CONCLUSION: High-intensity focused electromagnetic + RF treatment to the lateral thigh area demonstrated effectiveness in long-term fat thickness reduction by MRI imaging. Secondary endpoint showed simultaneous effectiveness and safety.

The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans.

Silicone is widely used in chronic implants and is generally perceived to be safe. However, textured breast implants have been associated with immune-related complications, including malignancies. Here, by examining for up to one year the foreign body response and capsular fibrosis triggered by miniaturized or full-scale clinically approved breast implants with different surface topography (average roughness, 0-90 µm) placed in the mammary fat pads of mice or rabbits, respectively, we show that surface topography mediates immune responses to the implants. We also show that the surface surrounding human breast implants collected during revision surgeries also differentially alters the individual's immune responses to the implant. Moreover, miniaturized implants with an average roughness of 4 µm can largely suppress the foreign body response and fibrosis (but not in T-cell-deficient mice), and that tissue surrounding these implants displayed higher levels of immunosuppressive FOXP3+ regulatory T cells. Our findings suggest that, amongst the topographies investigated, implants with an average roughness of 4 µm provoke the least amount of inflammation and foreign body response.

Comparison of 2.5% agarose gel vs hyaluronic acid filler, for the correction of moderate to severe nasolabial folds.

BACKGROUND: Agarose gel filler is a natural hydrocolloid with a three-dimensional structure similar to the extracellular matrix, with gel formed by hydrogen bonds and electrostatic interactions rather than through chemical cross-linking or polymerization. OBJECTIVE: To determine efficacy and safety of 2.5% agarose gel filler for the correction of nasolabial folds. METHODS: In this split-face study, efficacy, safety, and usability of 2.5% agarose gel were compared to those of NASHA-L. Assessments included the nasolabial fold (NLF) Wrinkle Severity Rating Scale (WSRS), Global Aesthetic Improvement Scale (GAIS [blinded investigator]), subject satisfaction, safety (adverse events), and usability. RESULTS: Sixty-six subjects were treated, and 46/66 (66.7%) were available for evaluation at 3 months, when mean change in WSRS was identical for both products (-1.1 ± 0.4 for 2.5% agarose; -1.1 ± 0.4 for NASHA-L). Scores for each product remained similar across all time points and began to return to baseline between 7 and 8 months. GAIS score followed a similar pattern, rising between months 7 and 8 (2.7 ± 0.6 for 2.5% agarose at month 7-3.3 ± 0.5 at month 8 and 2.7 ± 0.6 for NASHA-L at month 7-3.3 ± 0.5 at month 8). Ultrasound confirmed the longevity of both fillers between 7 and 8 months. All adverse events were transient in nature and resolved within 15 days. Most events were mild in nature, and the number of events was similar between the two fillers. CONCLUSION: Treatment with 2.5% agarose gel resulted in improvement that persisted for between 7 and 8 months. The treatment effect was equivalent to NASHA-L.

The effect of high-intensity focused electromagnetic procedure on visceral adipose tissue: Retrospective assessment of computed tomography scans.

BACKGROUND: High levels of visceral adipose tissue (VAT) are associated with abdominal obesity and increased risk of metabolic deterioration. Recent studies showed that intensive physical exercise results in the reduction of subcutaneous and visceral fat. AIMS: This study investigates the effect of supramaximal muscle contractions induced by a HIFEM procedure for abdominal VAT changes. METHODS: Computed tomography (CT) scans of 22 subjects (47.3 ± 8.4 years, BMI of 23.5 ± 3.5 kg/m2 ) who received 8 HIFEM treatments of the abdomen (2-3 days apart) were retrospectively evaluated for the changes in VAT. The CT scans were obtained at baseline and 1 month after the last treatment. The transverse slices at umbilical, infraumbilical, and supraumbilical levels were used to determine the cross-sectional area (CSA) of VAT through a semi-automated segmentation method. RESULTS: Analysis of the CSA revealed a significant (P = .004) and uniform reduction of the abdominal VAT area by 14.3% (-16.7 cm2 ) from 110.6 ± 69.0 cm2 to 93.9 ± 54.6 cm2 . In general, a higher relative improvement was seen infraumbilically (17.1%), followed by supraumbilical (15.5%) and umbilical (10.7%) levels. The reduction of VAT was strongly correlated to the reduction of subcutaneous fat (r(17) = 0.66; P = .002). A decrease in VAT volume contributed to the overall aesthetic enhancement visible on digital photographs. CONCLUSIONS: The outcomes indicate that HIFEM technology has a positive effect on VAT. However, further studies are necessary to validate these outcomes and to clarify the exact mechanism of a VAT reduction. Based on our results, the HIFEM procedure may be a beneficial treatment option for patients with high VAT deposits.

A multi-center, open-label, pilot study of allograft adipose matrix for the correction of atrophic temples.

BACKGROUND: Autologous fat grafting (AFG) and synthetic fillers are currently used in esthetic and reconstructive surgery. Challenges in AFG include inconsistent graft retention, donor site morbidities, insufficient harvest, and excessive harvesting times. An allograft adipose matrix (AAM) has been developed as an off-the-shelf alternative to AFG and synthetic fillers. AIMS: To evaluate the clinical safety and retention of an AAM over 24 weeks after treatment of bilateral atrophic temples. PATIENTS/METHODS: Ten subjects (nine females, one male, aged 47-69 years) with temple atrophy were enrolled in the IRB-approved study. AAM (Renuva® , MTF Biologics, Edison, NJ) was injected (<3 mL) bilaterally into the atrophic temples of each subject. Volume retention, global improvement, and safety were evaluated at 1, 4, 8, 12, 16, 20, and 24 weeks. Biopsy specimens were obtained for adipogenic and angiogenic histological evaluation. RESULTS: The mean temple volume improved over the baseline and was retained throughout the study period. Fullness (measure of volume) increased immediately from 0 pretreatment to 2.8 post-treatment (scale 0-4 = none-maximum). Fullness varied from 0.8 to 2.2 from weeks 1 through 12 and was 2.7-3.0 from weeks 16-24, around 75% increase from baseline. Furthermore, skin tone, smoothness, texture, and overall appearance also improved with 71% of subjects being satisfied to very satisfied with the results. Adverse events were minimal and histology revealed native tissue incorporation and remodeling. CONCLUSION: AAM is safe and well tolerated, provides at least 6-month volume retention, improves skin quality, and supports adipose tissue remodeling after treatment into temples.

MRI and CT Assessment of Abdominal Tissue Composition in Patients After High-Intensity Focused Electromagnetic Therapy Treatments: One-Year Follow-Up.

BACKGROUND: Several studies investigating high-intensity focused electromagnetic (HIFEM) treatments have recently been published. However, due to the novelty of the procedure, long-term data are still missing. OBJECTIVES: The aim of this study was to evaluate changes in abdominal tissues on average 1 year after a series of HIFEM treatments, to determine the long-term durability of patients' original body responses. METHODS: Magnetic resonance imaging (MRI) or computed tomography (CT) scanning were performed on 21 patients a mean of 332.6 [88.5] days after their original HIFEM treatment series. The scans were evaluated by a blinded radiologist for abdominal muscle thickness, subcutaneous fat changes, and abdominal separation. The results were compared with the MRI/CT-assisted measurements taken at baseline and 6-week follow-up. Correlations between collected data sets were calculated and tested. The incidence of any adverse events related to earlier treatments was monitored. RESULTS: When comparing the 1-year follow-up measurements with the baseline, the MRI/CT-assisted calculations revealed mean reductions of 14.63% (2.97 [2.11] mm) in fat, 19.05% (1.89 [0.88] mm) in muscle thickening, and 10.46% (1.96 [1.71] mm) in diastasis recti. All changes were significant (P < 0.05) and not related to weight fluctuations (P > 0.05). The baseline width of diastasis positively correlated with the degree of improvement at follow-up. No adverse events were reported. CONCLUSION: The HIFEM-induced muscle hypertrophy, fat reduction, and reduction in abdominal separation were maintained 1-year posttreatment. This suggests long-term durability of the original bodily response, which needs to be verified by continuing follow-up of this group and by further studies.

Histological examination of skin tissue in the porcine animal model after simultaneous and consecutive application of monopolar radiofrequency and targeted pressure energy.

BACKGROUND: The cosmetic appearance of skin is substantially influenced by the organization of connective fibers and underlying subcutaneous tissue. It has been previously documented that radiofrequency and pressure energies alone are able to improve skin appearance; however, detailed histological evaluation should be done to determine their synergistic effect. AIMS: This histological study investigates the difference between simultaneous and consecutive application of monopolar radiofrequency with targeted pressure energy on porcine skin. METHODS: In a total of four weekly abdominal treatments, simultaneous emission of the energies was applied to two pigs (12 minutes per session); additionally, two pigs were treated consecutively (12 + 12 minutes per session). The 5th pig served as a control subject. Biopsies were obtained at baseline, after the 4th treatment, and at 1-month follow-up. Primary outcomes were to document changes of dermal and hypodermal tissues. RESULTS: In the treated subjects, the amount of collagen and elastin fibers increased significantly (P < .001). At follow-up, simultaneous application showed a significantly higher increase in collagen and elastin fibers (by 59% and 64%, respectively), when compared to consecutive. Thickness of the dermis increased more in the pigs treated simultaneously (+848.8 µm/50.17%; P < .001). Treated tissue also showed the upper part of dermis to be rich in blood vessels and better organized interlobular septa in hypodermis. No significant change was observed in the control subject. CONCLUSION: Simultaneous application produces significantly more profound changes, when compared to consecutive treatment. Further research is needed but our findings represent a new potential treatment of various skin conditions like cellulite or laxity.