Supplier
Product name
Energy source
Energy/power/frequency
Spot size
Depth of penetration
Cooling method
Ablation
BTL Aesthetics
Exilis
Dynamic monopolar RF
2 W/cm2
Internal cooling
Non-ablative
Ellman International
Pellevé
Monopolar RF
4 MHz
7.5 mm, 10 mm, 15 mm, 20 mm diameter
None required
Non-ablative
Invasix
Fractora
Bipolar RF
10–60 mJ/pin
10 × 2 pins, 10 × 6 pins
500–600 μM
Air cooling optional
Sublative
Lumiere Medical and Pollogen Ltd.
Apollo
Monopolar and bipolar RF
18 W/cm2
4 × 4 mm, 17 × 17 mm, 87 × 87 mm
Up to 20 mm
None required
Non-ablative
Lutronic
INFINI Microneedle Fractional RF
Bipolar RF
50 W
10 × 10 mm, 5 × 5 mm
None required
Sublative
INFINI Superficial Fractional RF
Bipolar RF
50 W
20 × 20 mm, 10 × 10 mm
None required
Ablative
Solta
Thermage CPT
Monopolar RF
Up to 225 J/cm2
2.5 × 2.5 mm, 15 × 15 mm, 30 × 30 mm
Internal cryogen cooling spray
Non-ablative
Syneron and Candela
eMatrix
Diode/bipolar RF
eMax/eLaser WRA
Diode/bipolar RF
Up to 50 J/cm2/up to 100 J/cm3
12 × 8 mm
Internal cooling
Sublative
eMax/eLight SR
Optical energy/bipolar RF
Up to 45 J/cm2/up to 25 J/cm3
12 × 25 mm
Internal cooling
Sublative
eMax/eLight SRA
Optical energy/bipolar RF
Up to 45 J/cm2/up to 25 J/cm3
12 × 25 mm
Internal cooling
Sublative
ePrime
Bipolar RF
Up to 84 VRMS
1–2 mm
Internal cooling
Sublative
Viora
V-touch
Bipolar RF
Up to 25 J
13.2 × 13.2 mm, 8 × 8 mm
3.9–18.6 mm
Internal cooling
Non-ablative
Ultrasound entered the market in the 1970s with ultrasound-assisted liposuction (UAL) but fell out of favor with various entities, including the American Society for Dermatologic Surgery (ASDS), who issued statements of concern regarding the risk of burns and seromas. While external ultrasound-assisted liposuction was available as early as 2000, this procedure didn’t become popular and isn’t a widespread technology currently in use.
In 2009, the FDA approved Ultherapy (Ulthera, Inc., Mesa, AZ) as the first external ultrasound device for non-ablative skin tightening of the face and neck areas [20]. This procedure has become very common and is installed in about 1,170 practices worldwide at present [21]. Although use began on the face, the technology is now being used on additional body areas.
This chapter will focus on the Thermage CPT system for radiofrequency and the Ultherapy system for ultrasound. The two other RF technologies with a significant market share, Pellevé (Ellman International, Oceanside, NY) and Exilis (BTL, Boston, MA), will be discussed briefly as well.
Patient Selection for Noninvasive Tissue Tightening of the Periorbital Forehead and Cheek Areas
Patient selection for these noninvasive tissue tightening of the face and periorbital areas remains the most important indicator of patient outcome. While no hard-and-fast rules are present, generally speaking, patients must be screened for their emotional and physical appropriateness for these procedures. This section will attempt to define the best practices for patient selection.
The best patients for noninvasive procedures such as RF and ultrasound rejuvenation are those who are not ready for surgery medically, emotionally, or financially. In other words, they may have insufficient skin laxity to warrant surgery, have fears of more invasive procedures, or be unable to afford the cost of a large surgery (which often includes operating room and anesthesiology costs in addition to the price of the procedure). Most good candidates are in their thirties to forties and have mild to moderate skin laxity. Older patients who have already had a surgical lifting procedure, have excellent skin quality, or who cannot or will not undergo surgery may also be treated. (Anecdotally the oldest patient one author has treated with radiofrequency tissue tightening was in her early eighties.) Clinically, good candidates for treatment present with periorbital, forehead, jawline, or cheek laxity, marionette lines, pronounced nasolabial folds, and early submental bulging [14].
A major advantage of these therapies is that patients of all skin types can be treated safely even during periods when sun exposure is expected. Although lasers can cause discoloration in patients of Fitzpatrick skin type IV–VI, neither RF nor ultrasound treatments deliver light energy or significant heat to the epidermis and therefore are unlikely to disrupt melanin. Multiple studies have demonstrated the safety of these two treatment modalities for patients with skin of color [5, 15, 22, 23]. The importance of having “color-blind” options can’t be understated. Individuals with skin of color are at greater risk of prolonged or even permanent hyper- or hypo-pigmentation after procedures that impact melanocytes. Heat absorption by pigmentation can also lead to secondary blister and scar formation. Because the risk of keloid formation is generally higher in skin of color, surgery is not always a good option.
While treatment is generally safe, there are patients who should not undergo monopolar RF procedures like Thermage. Contraindications for monopolar RF include a pacemaker or any implanted defibrillating device, because the patient must be grounded and becomes part of the circuit. Contraindications for all RF include predisposition to hypertrophic scarring; koebnerization; oral isotretinoin within one year prior; pregnancy; and metallic implants, previously radiation, medical, or cosmetic tattoo (including permanent makeup) in the treatment area. Heating dermal “implants” like tattoo ink can lead to a burn and even scarring. Patients with a history of herpes virus in the area of treatment should be given oral prophylaxis to prevent outbreak [14, 24–26]. It should be noted that RF has been shown to be safe over dermal fillers like hyaluronic acid, calcium hydroxyapatite, or poly-l-lactic acid [27–29]. In the opinion of the authors, care should be taken to avoid edematous, ecchymotic, or non-intact skin because fluence output is based on the device’s measurement of skin impedance, so soft tissue augmentation is best performed immediately after, not before, Thermage. However, Dr. Waldorf has treated patients with mild to moderate acne, including cysts, without adverse events (and anecdotally often with improvement). Cysts are treated with intralesional dilute corticosteroids at the time of treatment.
For the Thermage Eyes procedure, metallic ocular eyeshields like those used for laser procedures must be avoided because heated metal can cause ocular injury. Instead plastic ocular eyeshields must be used whenever treatment immediately over the eye itself (rather than over the brow) is planned. No eyeshield should be inserted (and eyes should accordingly not be treated) if a patient has had a recent corneal shield, ocular surgery, or a corneal abrasion, without surgical clearance from that treating physician. Indeed it is generally recommended that patients wait to two or three months to have the eyelids treated with RF after having LASIK surgery [30] unless cleared by their surgeon in advance.
Contraindications for ultrasound include a predisposition to hypertrophic scarring or problems with wound healing. While prior cosmetic or surgical treatments (laser, RF, surgical lifting, or filler injections) are nearly inevitable in the population seeking this form of treatment, as with RF, it is best to wait until any edema or purpura is gone before performing the procedure. Similarly, active skin wounds, severe or cystic acne on the face and/or neck, and infections should be treated in advance. Pregnancy is a contraindication [15, 31, 32]. While any of the above stated issues can be concerning for treatment, many patients are acceptable even with the aforementioned relative contraindications if there is appropriate discussion and consent prior to the procedure. Additionally, the use of fillers such as Restylane, Perlane, or Juvederm prior to the procedure generally isn’t a problem if the Ultherapy is being done in other areas. One theoretical risk to the patient is that the fillers may degrade quicker, yet there is no particular harm otherwise.
From a psychological standpoint, a few guidelines have been suggested for patients desiring to undergo tissue tightening. Patients should have realistic expectations about the outcomes, risks, pain levels, and benefits of the procedure. While patients may see some improvement immediately, it should be noted that the most significant results are noticeable 3–6 months after RF or ultrasound treatment. Finally, patients should be completely informed of other options for treatment prior to having surgery [33, 34].
It should be emphasized that the most important contraindication for both of these procedures is that of unrealistic patient expectations. Many patients wish to have a procedure performed that is easy, quick, relatively painless, and has the same or better results than surgery, fillers, or neurotoxins. As part of informed consent, patients must be told clearly that results will not be the same as those achieved by surgery. However, improvements can result with the advantage of gradual natural rejuvenation without downtime, a significant advantage for a large percentage of patients. One of the authors, Dr. Waldorf, specifically avoids calling it a “nonsurgical facelift or eyelift” as a way to stress that results will not be the same degree as those resulting from a facelift or blepharoplasty. She also discusses the treatment as part of a 3-dimensional rejuvenation plan that will also include some combination of neuromodulators, soft tissue augmentation, laser resurfacing, and a good cosmeceutical regimen to maximize results. It is important to show prospective patients not only your best before and after photographs but also more typical examples. If the physician or staff suspects that an individual’s expectations cannot be met, it is the physician’s responsibility to dissuade the patient and even to refuse to perform the procedure. In the extreme, body dysmorphic syndrome sufferers will rarely, if ever, be pleased by results. Making sure there is sufficient time for both staff and the physician to interact with a new prospective patient is critical for screening. Dissuading someone from a treatment without causing insult can be difficult and can be addressed gently by saying that the procedure is unlikely to fulfill the patients needs.
Pain tolerance and control can also help determine ultimate patient satisfaction. One of the authors, Dr. Schlessinger, gives all Ulthera patients a combination of ibuprofen, Vicodin, and Ativan one-half hour pretreatment. In his experience, Dr. Schlessinger has found injectable anesthetics to be of little or no use because anesthesia is uneven, leading to greater discomfort when painful areas are encountered. He has similar feelings regarding topical anesthetics, since their depth of anesthetization (the superficial aspect of the epidermis and dermis) is not as deep as the ultrasound’s depth of penetration (deeper aspect of the dermis and subcutaneous area). On the other hand, the combination of vibration, chilling, and oral pain medications has provided a superior effect with less overall discomfort resulting from injectable or topical anesthetics. Those patients who refuse this combination are dissuaded from undergoing the procedure. In Dr. Waldorf’s practice, since the addition of the CPT (comfort pulse technology), Thermage patients no longer require analgesic or amnestic medications, which has resulted in increased patient satisfaction. It was always recommended that topical and injectable anesthetics be avoided with Thermage because of the risk of the hydration and edema altering impedance measurements.
How Radiofrequency and Ultrasound Technology Play a Role in Eyelid and Facial Rejuvenation
One of many ways to characterize aging is by the loss of collagen, which comprises more than 90 % of the skin’s protein. Photodamage is characterized by the accumulation of abnormal elastin (solar elastosis). Occurring at the boundary between the dermis and epidermis, these two processes result in several clinical changes, including skin laxity and the development of fine lines and deeper rhytides [14, 35, 36].
Ablative resurfacing, which includes dermabrasion, Er:YAG and CO2 lasers, and chemical peels, works by causing a controlled zone of damage to the epidermis and dermis and then allowing it to regrow/heal with minimal scarring. Reduction of rhytides and an overall tightening is seen immediately after healing, but additional improvement is noted up to 6 months later. The explanation has been that in addition to the manual resurfacing renewing the epidermis, heat extending to the deeper dermis stimulates new collagen formation. Limitations to ablative resurfacing include a prolonged downtime requiring extensive wound care, the risk of bleeding, infections, unexpected scarring, pigmentary changes, and the need for extended vigilant sun protection [35]. Additionally, Fitzpatrick skin types IV–VI generally cannot be properly treated with laser-assisted ablative resurfacing because of the potential of resulting discoloration and scarring from the light source [5]. These problems led to a goal by physicians and scientists to develop procedures to heat the dermis without affecting the epidermis, including the ones outlined in this chapter.
Radiofrequency
In ablative resurfacing, the skin’s natural resistance (impedance) is a barrier to treatment, as most energy delivered is scattered, reflected, or diffracted, insofar that there is significant energy depletion at the dermis. In contrast, in RF tissue tightening, impedance creates energy by resisting the flow of electrons generated by the device’s electric current. Hence, it targets the collagen in the dermis without harming the epidermis. To avoid overheating of the epidermis by the current, a cooling mechanism is usually used at the same time, creating a reverse thermal gradient [14, 19, 20].
Different layers of the soft tissue (dermis, epidermis, fat, fibrous tissue) have different values of impedance [37]. Ohm’s Law states that Energy = I 2 × R × T, where I is current (amperes), R is impedance (ohms), and T is time (seconds). Consequently, more impedance means more energy, heating, and contraction. It also means more potential for wounding [35].
Further, RF energy will follow the path of least resistance. When faced with the choice between adipose tissue and fibrous septae, current will travel through the fibrous septae, which has very similar properties to the dermis. Although fat’s resistivity to current is not known, lipids that make up fat are nonconductive. Therefore, current will primarily heat the fibrous septae, which is the reigning explanation for the volumetric heating in the z-dimension that is observed with RF devices. As a general rule, fibrous septae heats somewhere between 1.4 and 3 times more than adipose tissue [38]. Additionally, in Thermage CPT, a coupling fluid is used to create a dielectric, which distributes the RF current to create a regional impact rather than a local one [39].
The mechanism of neocollagenesis via RF has been studied in bovine models and seems to be twofold. Analysis by light and electron microscopes demonstrates an initial, immediate collagen denaturation (melting and breaking of its triple-helix) and tissue contraction followed by a lengthier, thermally induced dermal wounding process. The latter process also is thought to stimulate neocollagenesis [18]. It is well documented that neocollagenesis occurs around 65–75 °C [40–44].
RF devices send an electric current between two poles. Some devices, termed monopolar, have one pole on the device and a grounding pole that is placed on the patient’s body. Unipolar devices deliver energy in all directions from only one pole, similarly to how a cellular tower sends out a cell signal [14]. Bipolar devices, on the other hand, deliver energy between two poles which are next to one another on the device [24].
Several studies have demonstrated the efficacy of radiofrequency in treating periorbital rhytides and the cheek area. Fitzpatrick et al. treated 86 patients age 35–70 with a single pass of ThermaCool TC in the periorbital area, with energy ranging from 52 to 220 J. Side effects included erythema (36.0 % incidence immediately and 16.7 % within 72 h) and edema (13.9 % immediately and 6.4 % within 72 h). No third-degree burns were observed, and the overall second-degree burn rate was 0.36 %. At 6 months posttreatment, blinded raters determined at least 0.5 mm brow-lifting in 60.5 % of eyebrows and at least a 1-point facial wrinkle scale improvement in 83.2 % of participants [45].
Narins and Narins treated 17 patients age 42–60 with two passes of ThermaCool TC for the full face, with energy ranging from 125 to 144 J/cm2. Side effects included mild erythema which lasted for a few hours. No objective improvement metrics were employed, but gradual improvement was observed in before and after photographs. The low AE incidence rate was attributed to decreasing the energy with any patient discomfort [46].
Abraham et al. treated 35 patients (28 women, 7 men, mean age 51) with a single pass of ThermaCool TC in the periorbital, forehead, and neck areas with energy ranging from 115 to 144 J/cm2. Side effects included immediate mild erythema in most patients, edema in about one-third of patients, discreet, firm, subdermal areas on the neck in 14 % of patients, and transient numbness in 14 % of patients. All side effects subsided within a few weeks of treatment.
Alster and Tanzi treated 50 patients, mean age 53.3, with a single pass of ThermaCool TC with energy ranging from 97 to 144 J/cm2 on the cheek area and 74 to 134 J/cm2 on the neck area. Side effects included immediate mild erythema (average duration of 2.3 h) in most patients, soreness or sensation in 56 % of patients, and erythematous papules in 6 % of patients. All side effects subsided within a few days of treatment. Blinded investigators determined clinical improvement in the cheek area in 28 of 30 patients and improvement in the neck area in 17 of 20 patients [47] (Fig. 5.1).
Fig. 5.1
53 years old, 5 months posttreatment, no other cosmetic treatment in between ((a) Front, (b) angled left, (c) left side, (d) angled right, (e) right side)
Bassichis et al. treated 24 patients with a single pass of ThermaCool TC on the upper one-third of the face. These patients were compared to a control group of 12 subjects. No side effects were noted. Objective brow analysis showed at least 0.5 mm improvement in more than 87.5 % of patients, and posttreatment improvement was statistically significant over the control (P < 0.05). Patients’ subjective self-evaluation and satisfaction levels, however, did not correlate with the objective measurements. Additionally, asymmetry in brow improvement was noted in many patients [48].
Fritz et al. treated 11 patients with a single treatment and 9 patients with two treatments of ThermaCool TC spaced 1 month apart, on the middle and lower face areas, with energy ranging from 85 to 135 J/cm2. Side effects included mild edema and mild to moderate erythema. All side effects subsided within a few days of treatment. Blinded investigators determined statistically significant better improvements in the treatment group receiving two treatments in the following categories: nasolabial folds (P = 0.03), patient self-assessment (P = 0.04), and physician photographic assessment at both 1 and 4 months (P = 0.05). 75 % of subjects indicated they would consider paying for more treatments [49]. With the newest generation of Thermage CPT, posttreatment erythema, edema, and nodularity are no longer expected. With appropriate skin cleansing, liberal use of coupling fluid, and use of multiple passes at medium heats without pulse stacking, blisters and burns should not occur.
Ultrasound
Ultrasound can propagate energy into the body in such a way that the lower the frequency, the deeper the penetration and vice versa. It is widely accepted as an extremely safe method of fetal imaging. When the same machine is used at a much higher energy, its waves are able to focus to target a very confined region (about 1 mm3). This is the basis for intensive ultrasound (IUS). It has long been known that at these settings, ultrasound can cause coagulative necrosis. It is believed that the intense focus of the ultrasound beam causes vibration of molecules at the target, heating the tissue. Using this knowledge, scientists have begun using ultrasound technology to treat tumors of the liver, breast, and uterus [40, 50, 51].
Other cosmetic applications of ultrasound have been developed harnessing the controllable depth and geometry of IUS. Recently, a high-intensity focused ultrasound (HIFU) device for treatment of subcutaneous adipose tissue (SAT) was developed (Liposonix; Solta, Hayward, CA) and approved by the FDA. In clinical trials, it was proven to be safe and effective for treatment of SAT, reducing waist circumference by 4–5 cm and exhibiting an adverse event (AE) profile similar to sham treatment [52–56]. The same science is the basis for Ultherapy, but Ultherapy is focused deep to the SAT.
In ablative resurfacing, the aim is to create thermal injury zones (TIZs), which then generate new collagen during their repair process. This is a relatively superficial process, aiding the uppermost layers of the skin but not inducing larger structural changes. In contrast, in ultrasound skin tightening, the aim is to create TIZs in the skin’s deeper structural layers, inducing greater textural changes. The target of Ultherapy is a layer of the skin called the superficial musculoaponeurotic system (SMAS). Located below the dermis, the SMAS is a fibrous envelope composed of collagen and elastin that communicates muscle movements so that facial expressions are seen in the skin. It is believed that creating TIZs in the SMAS leads to its contraction and shrinkage, as well as collagen denaturation [51].