Patient satisfaction of microfocused ultrasound treatments on the face and neck laxity: A narrative review

Background: Microfocused ultrasound with visualization (MFU-V) delivers focused ultrasound energy to heat tissue and has emerged as a fast and effective noninvasive method for treating skin laxity. After obtaining approval in 2009 by the Food and Drug Administration, satisfactory feedback was recorded using several scoring systems for MFU-V treatment for facial and neck laxity. Aim: To evaluate the efficacy and satisfaction rates of MFU-V for facial and neck laxity treatment by providing a basis for developing a validated scoring system for MFU-V treatment. Method: A constrictive survey was carried out by selecting relevant publications on MFU-V treatment of facial and neck laxity using PubMed, Medline, and Embase electronic databases from January 2017 to March 2022

skin tightening has been increasing in popularity.Over the years, multiple new devices have been proposed to treat facial and neck skin laxity. 2 Microfocused ultrasound with visualization (MFU-V) has emerged as an effective noninvasive method for skin tightening.This procedure was approved by the Food and Drug Administration (FDA) in 2009.Its efficacy and validation have been proven in several studies. 3U-V delivers focused ultrasound energy to heat the tissue at a temperature greater than 60°C, creating multiple micro thermal subcutaneous coagulation zones (approximately 1 mm) with tissue depth from mid-to-deep dermis up to the musculoaponeurotic system, sparing the papillary dermis and overlying epidermis. 4e satisfaction rate for MFU-V in the literature was recorded using several scoring systems, such as the subjective global aesthetic improvement scale (SGAIS) and a 5-point scale rating global aesthetic improvement in appearance compared to pretreatment, as judged by the investigator. 3Other self-developed scoring systems, such as the Patient Satisfaction Questionnaire (PSQ) or self-developed scoring, are based on non-anonymous data, which are subject to physician influence and gratitude bias. 5is review aims to establish data regarding satisfaction with MFU-V for skin laxity, particularly for the face and neck regions, providing a basis for developing a validating scoring system for MFU-V treatment for skin laxity.
To our knowledge, no previous reviews have described the clinical satisfaction of MFU-V using several studies.For this reason, we set up a retrospective narrative literature review to evaluate these issues.

| MATERIAL S AND ME THODS
The electronic database was searched through PubMed, Medline, Exclusion criteria were as follows: method of treatment applied outside the head and neck area, multiple sessions of MFU-V at different times, mean follow-up time of fewer than 90 days, and number of patients less than 10.
All the data collected were stored in Microsoft Excel 365 updated version.GraphPad Prism v.9 (GraphPad Software) was used for data analysis.Data were checked by the normality test before deciding which statistical tests to use.We used the paired t-test and measured the covariance.
The search measures revealed that the satisfaction rate for MFU-V for face and neck laxity treatments was used in 11 original articles.Herein, we summarize the findings in the literature, from the most recent to the oldest.A summary of the clinical data from each study is presented in Table 1.

| RE SULTS
Fusano et al. reported on 54 vegan and omnivore patients with MFU-V at 4.0 MHz-4.5 mm and 7.0 MHz-3.0 mm depth parameters, using three points scale scoring 74% of the omnivorous patients were very satisfied, and 26% were satisfied 6 months post-treatment. 6 2020, Yalici-Armagan and Elcin treated 24 patients with lower facial and submental laxity, using the original parameter of 7.5 MHz with a focal depth of 3.0 mm and 4 MHz with a focal depth of 4.5 mm.
Of the patients who self-reported using the 5-point SAIGS, 45.9% reported an improvement, whereas 37.5% reported no change in lower face skin laxity, with average follow-up results after 4.3 months. 3In the same year, another single-center study conducted by Friedman et al. in 2020 on 43 patients with a single session of MFU-V, using the patient SAIGS scale, demonstrated that at 6 months, 52.9% of patients did not respond to the treatment and 47.1% felt the effects of the treatment. 7aco et al. reported that 50 patients with moderate skin laxity and ptosis of the face and neck, using the self-developed PSQ and patient pain scale rate (PPSR), which had not previously been validated on the scoring of subjective satisfaction.After 6 months of follow-up, the patients scored 7.28 out of 10 on the PSQ scale and only 3.32 on the PPSR scale. 8Fabi et al. reported that 20 patients developed wrinkles along the décolletage area.A single session of MFU-V was applied; subjective satisfaction scores increased from 2.9 on Day 180 to 3.9 on Day 360, based on a 7-point scale (0-6).
None of the studies reported severe side effects. 9 2019, Shome et al. reported a study of 50 patients treated with a single session of MFU-V; the upper face was treated with a frequency of 7.5 MHz, while the lower face was treated with 4.4 MHz.
The pulse spacing within each exposure line was set at 1.5 mm.The patients noticed an increasing subjective improvement at 2 and 6 months, which reduced at 1 year. 10ang et al. reported another study in the same year including 83 patients, who had been treated initially with MFU-V with dualdepth (4.5 and 3 mm) transducers and had on average 2-3 sessions, subjective satisfaction scoring, using anonymous online surveys after 4 months of treatment indicated 57.5% reported none or mild improvement, 27.7% reported moderate improvement, and 14.5% of the patients reported dramatic or significant improvement. 5 the same year, Alhaddad et al. reported that 20 patients used a single session of both MFU-V and monopolar capacitive-coupled radiofrequency (MRF) in two separate areas of the face and neck.
Six months post-treatment, using SGAIS, the mean of improvement was 2.43 ± 0.81 for the MFU-V-treated side, and 3.3% of the MFU-V rated themselves as much improved or improved. 11 a study published by Montes and Santos in 2019, 52 patients were treated with MFU-V with a minimum follow-up of  Among the patients, 42.8% were extremely satisfied, 28.6% were satisfied, and 28.6% were somewhat satisfied.
No reported serious AE Forty percent of patients treated were noted to have edema on Day 30.Ten percent were noted to have erythema, two patients had contour irregularity, and none had bruising.
All adverse events in MFU-V-treated patients were resolved by Day 180.
post-treatment outcomes, the results were highly influential: 48% of the patients were very satisfied or satisfied, 23% were very dissatisfied or dissatisfied, and 61% of the patients indicated that the treatment met their expectations, or exceeded their expectations. 12 et al. reported in 2017 on 25 patients who received a single session of MFU along the forehead, temple area, cheeks, neck, and infraorbital area.Satisfaction was calculated using the SGAIS scale, 16% of patients reported much improvement or very much improvement on Day 90, while 0% reported much or very much improvement on Day 180.Furthermore, 68% and 80% of patients reported improvement on Days 90 and 180, respectively, while 16% and 20% reported no change on Days 90 and 180, respectively, with no reports of worsening. 13In the same year, Jones et al. conducted a study on ten patients with moderate skin laxity along the neck, a single session of MFU-V was applied using the standard technique; transducers were used: first, a 4 MHz with a 4.5-mm focal depth set to 0.90 J, and second, a 7 MHz with a 3.0-mm focal depth set to 0.30 J, satisfaction was scored using the 5-point scale scored on Day 180 of follow-up, patient satisfaction was rated at a mean of 2.1 ± 1.88, 42.8% were extremely satisfied and 57.2% were satisfied or somewhat satisfied. 14

| DISCUSS ION
Ultrasound is an energy modality that can be focused on an area of the body to penetrate deeper into the tissue and cause thermal coagulation and improved skin remolding, emphasizing its therapeutic use.This device can be used to avoid the undesirable postprocedural effects observed with other methods such as carbon-dioxide laser resurfacing of the superficial layers. 15e studies reviewed in this article demonstrate the efficacy of MFU-V for the treatment of face and neck laxity, especially for the first 6 months of treatment.In several studies, adjuvant therapy such as CaHA was used; however, treatment results can differ from the results of using MFU-V alone, as CaHA is approved for treating face and neck laxity as a monotherapy. 16terestingly, combination treatment with CaHA and MFU-V led to higher satisfaction rates, as reported by Casabona and Teixeira; 66% were very satisfied with the treatment result, which is higher than the average for using MFU-V as monotherapy.However, further studies are needed to confirm and compare the two methods. 17cording to Yalici-Armagan and Elcin, after a median 4-month follow-up period evaluated by pre-and post-treatment photographs on a 5-point scale, subjective and objective assessments vary.As described using the Investigator Global Aesthetic Improvement Scale, which is an objective scoring system reviewed by two blinded dermatologists assessed paired before and after photographs, four patients (16.7%) were assessed as mildly improved, and one patient (4.2%) was assessed as moderately improved.In contrast, according to SGAIS, 11 patients (45.9%) described themselves improved. 3e subjective assessments of MFU-V devices present many limitations.First, the subjective scoring method, which can be interpreted differently among patients, presents a non-anonymous platform, which can affect the outcome owing to a biased result.
To date, there is no anonymous validating subjective scoring for the treatment of face and neck laxity, in contrast to the objective scoring that uses the IBSA Photographic Scale to assess neck laxity. 18ta on subjective scoring systems for patients with face and neck laxity that have been treated with MFU-V have been well established and validated, such as PSQ, SGAIS, the three-point scoring system, and self-developed scoring.However, all of the aforementioned scoring systems encompass non-anonymous data, which can influence patients and render their subjective results liable to physician bias.
The most significant limitations to evaluating subjective assessments for face and neck laxity treatment with MFU-V are not having a standardized device technique, follow-up time, and a validated subjective scoring method.

| CON CLUS ION
To date, MFU-V, which is FDA-approved, has proven to be an effective and safe method for treating skin laxity along the face and neck.
With excellent and promising responses, a few mild events were observed, such as erythema, pain, edema, and injection-site induration, all of which resolved on an average of 2-3 days.A burn occurred in one case because of improper application of the probe; this was the only serious adverse event that was reported.
Based on the variation of responses, we sought to propose a new scoring method, using the validated SGAIS technique at different times, namely on Day 30, Day 90, Day 180, and Day 360, during which all patients will score their assessments using an online platform to avoid physician bias.

and
Embase from January 2017 to March 2022 using the following search terms: "Micro focused Ultrasound Treatments [All Fields] Face and neck laxity [All Fields].Satisfaction rate [All Fields]."Published articles on MFU-V treatment of head and neck laxity, post-MFU-V treatment subjective satisfaction scoring, clear technique about the MFU-V application, and MFU-V side effects were included.
Day 180, subject satisfaction was rated at a mean of 2.1 ± 1.88 in MFU-Vtreated patients.
Summary of the clinical data.
TA B L E 1