Optimizing Patient Outcomes by Customizing Treatment With Microfocused Ultrasound With Visualization: Gold Standard Consensus Guidelines from an Expert Panel

May 2019 | Volume 18 | Issue 5 | Original Article | 426 | Copyright © May 2019

Sabrina G. Fabi MD,a John Joseph MD,b Julia Sevi MD,c Jeremy B. Green MD,d Jennifer Deaver Peterson MDe

aGoldman Fitzpatrick Butterwick Groff & Fabi, San Diego, CA bClinical Testing Center of Beverly Hills, Beverly Hills, CA cAesthetic Health, Leeds, UK dSkin Associates of South Florida, Coral Gables, FL eThe Pearl Dermatology, Houston, TX

results in immediate contraction of denatured collagen and initiation of neocollagenesis and collagen remodeling.1,15 Thisleads to clinically significant tissue lifting in the face and neck16 and improvement of lines and wrinkles of the décolleté.17EfficacyIn the United States, the MFU-V device is cleared for lifting the brow,3,18 submental and neck tissue,19 and improving lines and wrinkles of the décolleté.20 It has also been cleared in the 28 countries of the European Union where it is indicated for sculpting and lifting the upper face, lower face, neck, and décolleté. Additional independent studies have shown MFU-V to be effective for treating lax skin on the knees,21-22 thighs,22 buttocks,23 elbows,24 upper arms,22 and lower eyelids.25Although MFU-V has proven efficacy for lifting and tightening lax skin on the face and neck when focused ultrasound energy is delivered at a single focal depth, the customized application of MFU-V at two focal depths may produce superior clinical results.19 The use of MFU-V has also been shown to enhance the effectiveness of other treatments when combined for improving the appearance of atrophic acne scars,4 stretch marks,26 and cellulite.27SafetyA unique feature of the MFU-V device is the ability to perform real-time ultrasound imaging, which ensures the device is properly coupled to the skin surface for the safe transfer of energy and permits the user to visualize planned treatment areas and to avoid treating non-target tissues, such as bone and large blood vessels (DeepSEE®; Ulthera, Inc., Mesa, AZ).28 Use of the MFU-V system is contraindicated in patients with open wounds or lesions, severe or cystic acne, active implants, or metallic implants in the planned treatment area.Normal effects associated with treatment include mildto- moderate discomfort during treatment and transient post-treatment erythema and edema. Among patients enrolled in MFU-V clinical trials (N=769), reported adverse events included tenderness or soreness (n=12; 1.6%), welts or lines (n=9; 1.2%), and bruising (n=3; 0.4%).29 There have been a few post-marketing reports of transient welts30 and nerve injury31; however, these may be related to poor treatment technique and are not permanent.32 MFU-V is also safe and effective for use in patients with darker skin types.30As mentioned above, the use of MFU-V can enhance the effectiveness of other aesthetic treatments and several studies have demonstrated the safety of combining MFU-V with toxins and temporary, semi-permanent, and permanent fillers.7,33 Expert consensus supports the combined use of multiple techniques for the safe and effective treatment of the aging face.34Expert OpinionDespite similarities in age-related changes in the skin and connective tissue, the clinical presentation of each patient is unique and MFU-V treatment must be customized for each patient. To accomplish this, the MFU-V device utilizes a computer-driven platform that enables the user to visualize the proposed treatment with ultrasound-imaging transducers and form a customized treatment plan prior to applying MFU energy. The objective of the following consensus guidelines is to provide a framework for clinicians to develop a customized treatment plan informed by key patient characteristics and proper use of ultrasound visualization to assess skin anatomical features.

METHODS

A panel of five expert aesthetic physicians convened during the 2018 American Academy of Dermatology Annual Meeting in San Diego, CA to discuss recommendations on the use of MFU-V. Key topics for discussion included: patient factors that contributed to favorable or poor outcomes; customization of the number of treatment lines, energy settings, and treatment depths; distinguishing approaches for restorative vs preventative vs maintenance treatments; and important safety considerations.

RESULTS

Factors that Contribute to Satisfying OutcomesIt was agreed that MFU-V is currently the gold standard treatment for nonsurgical skin lifting. This conclusion is supported by thelargest body of scientific and clinical data available among current noninvasive skin-lifting technologies. It was further agreed that the best clinical outcomes are achieved when the treatment plan is customized to each patient. The proper use of ultrasound imaging, which is a unique feature of MFU-V, is a key factor for customizing treatment.MFU-V is effective for lifting tissue, treating skin laxity, and promoting collagen production for skin rejuvenation. Although MFU-V cannot treat bone loss, muscle atrophy, or shifting fat, most patients present with some combination of such underlying issues. It is therefore critical that clinicians accurately diagnose patient needs and understand what MFU-V can and cannot do.It is also extremely important to properly manage patient expectations. Even poor candidates for facial rejuvenation can be satisfied with their results when expectations are properly managed. With proper expectations, overall patient satisfaction can approach 100%.Factors that Contribute to Poor OutcomesSeveral patient factors can lead to poor clinical outcomes, such as actinic damage and smoking.35 The effects of oxidative damresults