13 Cryolipolysis

13.1 Introduction

Cosmetic surgical and nonsurgical procedures are on the rise, according to the Cosmetic Surgery National Data Bank Statistics by The American Society of Aesthetic Plastic Surgery (ASAPS) in 2016.1 Nearly 12.8 million procedures were performed in 2015. More than 1.9 million surgical and 10.8 million nonsurgical procedures were performed in 2015, with nonsurgical cosmetic procedures accounting for 42% of the total expenditures. Liposuction was the number one procedure performed on both men and women, with 396,048 procedures completed. In 2015, non-surgical fat reduction procedures increased by 18.7%.¹

The majority of patients undergoing both surgical and non-surgical fat reduction is between 35 and 50 years of age. Non-surgical techniques in fat reduction offer patients an opportunity to decrease fat deposits without recovery, downtime, pain, or the risks associated with surgery and anesthesia.^1,2

The most popular nonsurgical fat reduction system, which accounts for approximately 99% of nonsurgical body contouring performed at Marina Plastic Surgery, is CoolSculpting® (ZELTIQ Aesthetics, Inc.). We have used 10 other nonsurgical devices, and none of them compare to this system with regard to effectiveness, tolerability, efficient use of staff time, and patient satisfaction.

CoolSculpting employs controlled cooling to reduce fat deposits using a mechanism known as cryolipolysis. Fat cells are uniquely sensitive to cold and crystallize at a warmer temperature than water in surrounding tissues.³ Consequently, cryolipolysis induces apoptosis in fat cells and an inflammatory response in the treated tissue, without damage to overlying skin and surrounding muscles, nerves, and blood vessels. The Cool-Sculpting patented technology protects the skin from freezing while the adipose cells are exposed to therapeutic levels of cooling⁴ ( Fig. 13.1). Over the course of 2 to 4 months, the damaged fat cells are metabolized, resulting in gradual, permanent fat reduction in the treated region. The results have been shown to be long-term⁵ ( Fig. 13.2).

Fat reduction related to cold exposure was first described in 1970, with the observation of inflammatory nodules followed by fat necrosis and change in cheek contour of an infant who had been sucking on a popsicle.⁶ In 1980, the term equestrian cold panniculitis was coined to describe the inflammation of the inner thighs of female equestrians who rode horses in cold temperatures for at least 2 hours a day without insulated pants. A decrease in thigh fat was noted after resolution of the inflammation.⁷ Cryolipolysis was performed on abdominal porcine tissue, showing the clinical reduction of fat 90 days after the treatment⁸ ( Fig. 13.3). Several studies on various areas of the body and its effects on peripheral nerves and lipid levels have validated cryolipolysis as a safe and effective procedure for reducing subcutaneous fat.^3,9,10,11,12

Fig. 13.1 (a) Safety measures to prevent thermal injury include the thermal coupling gel pad. Applied before placement of the applicator, it ensures consistent thermal contact and insulates the skin during the treatment. (b) Freeze Detect® (ZELTIQ Aesthetics, Inc.) sensors and software are patented technology that detect changes in skin temperature and will stop the treatment if a freeze is detected. (Courtesy of ZELTIQ Aesthetics, Inc)

Fig. 13.2 Long-term results of cryolipolysis. (a) Flanks before treatment. (b) Left flank treated after 8 weeks. (c) 2 years after and (d) 6 years after the left flank treatment with weight gain of + 10 pounds. Procedure by Dr. Eric Bernstein. (Reproduced with permission from Bernstein EF. Long-term efficacy follow-up on two cryolipolysis case studies: 6 and 9 years post-treatment. J Cosmet Dermatol. 2016 Dec;15(4):561-564.)

Fig. 13.3 Porcine abdominal specimen showing the effectiveness in fat reduction after cryolipolysis. (a) Ultrasound image showing pretreated subcutaneous fat. (b) Ultrasound at 3 months shows a 0.7-cm, or greater than 40% decrease, in the thickness of the fat layer. (c) Gross pathology from the same treatment side shows the superficial fat layer at the center of the treatment site reduced 1 cm, or 50%, at 90 days posttreatment compared to the untreated region. (Reproduced with permission from Zelickson B, Egbert BM, Preciado J et al. Cryolipolysis for noninvasive fat cell destruction: initial results from a pig model. Dermatol Surg 2009;35:1462–1470, 2009)

CoolSculpting is the only cryolipolysis machine in the United States approved by the Food and Drug Administration (FDA). In 2010, it was approved for use on the abdomen. Since then, the FDA has approved its use on the flanks (2012), thighs (2014), and chin (2015).13 Other areas can be treated at the discretion of physicians and with consent disclosing non-FDA-approved use. These areas include “bra-fat” rolls, inner thighs, knees, arms, axillary fat pads, and the male chest.

In addition to safety and efficacy, cryolipolysis has high tolerability, excellent patient satisfaction, and offers the potential for tremendous growth of a plastic surgery practice. From a business perspective, offering an alternative to surgical fat reduction with CoolSculpting has increased the number of new patients to the practice by attracting people who are interested in body contouring but who are reluctant to undergo invasive procedures. CoolSculpting has increased the number of male patients in our practice more than any other technology. Of the 66% new patients seen within 2 years, 62% had never had any aesthetic procedure. Forty percent of those who underwent CoolSculpting became established patients, undergoing additional aesthetic procedures within the next 3 years.¹⁴ Multiple concomitant procedures can be performed while a patient is undergoing cryolipolysis, such as hair transplantation, neuromodulator injections, filler injections, laser treatments and so on (see Video 1.1).¹⁴

Cryolipolysis has been successfully integrated into the Marina Plastic Surgery practice. Unique to this system is the potential to use multiple devices simultaneously, a term called Dual-Sculpting® (Seattle Aesthetics), to reduce overall treatment times ( Fig. 13.4) Currently, there are nine devices available at the main office in Marina del Rey, California, and eight devices at the satellite offices in the Orange County offices. An average of 80 cycles are delivered each week in Marina Del Rey and 70 cycles in Orange County, totaling over 240,000 CoolSculpting procedures. Patients can reduce overall treatment time if multiple machines are being used simultaneously. Also, it is possible for multiple concomitant procedures to be performed while a patient is undergoing cryolipolysis, such as hair transplantation, neuromodulator injections, filler injections, laser treatments, and so on ( Fig. 13.5). CoolSculpting is convenient and efficient for both the patient and the clinician.¹⁴

Dr. W. Grant Stevens (author) has been a pioneer in unlocking the potential of this technology. The treatment plans have ranged from one to two cycles per treatment area, with optimal results attained after at least two cycles per area. Comprehensive contouring is a term coined by Dr. Stevens that describes a strategy to debulk fat and sculpt the body.

Comprehensive contouring can produce liposuction-like results and has even proved useful in softening contour irregularities from previous liposuction procedures¹⁴ ( Fig. 13.6). This technique utilizes multiple, varying applicators, a variable number of cycles depending on the treatment area, and overlapping treatment sites. With the addition of the nonsuction flat panel and the mini-cupped applicators, clinicians are able to target nearly any desired area. As the technology continues to advance, more applicator variations will assist the clinician and patient in achieving the desired nonsurgical fat reduction in more regions.

Fig. 13.4 DualSculpting. Multiple cycles can be performed, saving time and money for both the patient and clinician.

Fig. 13.5 Multiple procedures can be done concomitantly. This patient is undergoing cryolipolysis of the right flank and left abdomen as well as hair transplantation. Procedure by Dr. W. Grant Stevens.

Fig. 13.6 Cryolipolysis can be used to smooth the contour irregularities. CoolSmoothPro used circumferentially around thighs in (a) a 66-year-old woman, who presented for treatment of her anterior thighs. (b) 2 years after circumferential treatment of the thighs with CoolSmooth Pro. Procedure by Dr. W. Grant Stevens. (Reproduced with permission from Stevens WG, Pietrzak LK, Spring MA. Broad overview of a clinical and commercial experience with CoolSculpting®. Aesthet Surg J. 2013 Aug 1;33(6):835-46.)

Consequently, cryolipolysis can freeze fat cells without inducing damage to overlying skin and surrounding muscles, nerves, and blood vessels. The exposure to cold induces apoptosis in the fat cells and an inflammatory response in the treated tissue. Over the course of 2 to 4 months, the damaged fat cells are cleared by the body, resulting in gradual, permanent fat reduction in the treated region. Several studies on various areas of the body, cholesterol, and peripheral nerve effects have shown cryolipolysis to be a very safe and effective procedure for the nonsurgical reduction of subcutaneous fat.3,9,10,11,12

In addition to safety and efficacy, cryolipolysis has high tolerability, excellent patient satisfaction, and brings potential for tremendous business growth to a plastic surgery practice. Cryolipolysis has been successfully integrated into the Marina Plastic Surgery practice, attracting new patients who are interested in body contouring but not yet ready for invasive procedures. Of the 66% new patients, 62% had never had any aesthetic procedure. Forty percent of those who underwent CoolSculpting became established patients, undergoing other aesthetic procedures. CoolSculpting has increased the number of male patients to the practice greater than any other technology.¹⁴ Unique to this practice is the multiple machines available for each patient to improve treatment times.

The idea of cryolipolysis stems from two papers that describe fat reduction related to cold temperatures.^6,7 The first was fat reduction of the cheeks in infants after prolonged sucking on popsicles.⁶ There was an altered cheek structure noted after the resolution of the inflammation. The second study referred to a group of female equestrians who were noted to ride horses in the near freezing temperatures for at least 2 hours without insulated pants. Beacham, et al.⁷ described the resulting inflammation of the inner thighs as “equestrian cold panniculitis.” A decrease in fat was noted in these areas. The technology of controlled-cooling therapy to reduce fat was a huge undertaking. The most difficult part was to freeze the fat without affecting the skin.

With the addition of the nonsuction, flat-panel, and mini applicators, clinicians are able to target nearly any desired area. Comprehensive contouring results in liposuction-like results ( Fig. 13.6).

From a business perspective, offering an alternative to surgical fat reduction with CoolSculpting has increased the number of new patients to the practice, specifically men who are normally averse to cosmetic treatments, and neophytes reluctant to undergo invasive procedures. These patients often will undergo other procedures, because they have seen good results with CoolSculpting. Multiple procedures can also be done while the patient is undergoing cryolipolysis, such as hair transplantation, neuromodulator injections, filler injections, laser treatments, and so on.¹⁴ Cryolipolysis is an excellent nonsurgical body contouring procedure because of its high safety, tolerability, efficacy, and business growth potential.

This chapter will cover the patient selection, technique, postprocedural care, typical results, and possible complications related to cryolipolysis.

13.2 Patient Selection

All patients should be counseled for a treatment-to-transformation. Comprehensive contouring is the ideal treatment plan for total body contouring ( Fig. 13.7). The patient should be aware of the optimal number of cycles required for desired fat reduction. Patients who elect to undergo suboptimal treatment, whether because of personal desire or financial constraints, should be informed of the likely suboptimal results. One should consider avoiding treatment in such a scenario, because both the patient and the clinician may be disappointed with the fat-reduction outcome.

Two crucial factors to assess during the patient examination are (1) local skin laxity and (2) thickness of adipose tissue. Gender and ethnic background do not affect outcomes. To use the vacuum-assisted application heads, tissue laxity should allow for adequate draw into the applicator. Areas with dense cutaneous attachments near bony prominences, such as the iliac crest and ribs, may have less mobility. For areas with less skin laxity, the nonsuction, flat-panel applicators are suitable. The nonsuction applicators can also be used to help smooth severe liposuction irregularities, because the prominent fat peaks are cooled more than the depressions. This management, however, is only attempting to improve irregular contours.

Patients with moderate to severe skin laxity often demonstrate the phenomenon of cryodermadstringo, or skin tightening^14,15,16 ( Fig. 13.8).

Patients with thick adipose tissue will require debulking in addition to sculpting, and patients should be made aware that debulking necessitates more than one treatment cycle. Furthermore, treatment of one area may give the illusion of increased adiposity in an adjacent, untreated area; therefore, the comprehensive plan should include treatment of an entire region to avoid deformities or irregularities.¹⁷ For patients who only want or only can afford less than ideal treatment, it may be best to avoid treatment altogether, because both the patient and the clinician will be unsatisfied with the results.

Potential treatment areas should be examined for the presence of open wounds or infection. These areas should be avoided, because tissue injury with cooling can worsen the condition. Patients with prior abdominal surgeries should be evaluated for abdominal hernias, which would present a contraindication to treatment in that area. Any large skin incisions or scars should be noted, because they can draw into the vacuum-assisted device, or they can cause diffusion of the cooling through the flat-panel applicators, which may enhance scar depression. Treatment should be altogether avoided in patients with cryoglobulinemia or paroxysmal cold hemoglubinuria; although the effects of CoolSculpting in patients with these disorders has not been studied or reported, it is reasonable to assume that induced cooling will exacerbate these conditions. Also, when using the CoolMini® (ZELTIQ Aesthetics, Inc.) to treat the submental region, an enlarged thyroid should be avoided.

13.3 Technique

The CoolSculpting system is an FDA-approved device for cryolipolysis on the abdomen, flank, thighs, submental area, and other flexible treatment parameters4 ( Fig. 13.9) . The control console contains a thermoelectric cooling element that modulates the temperature of two cooling plates, which are housed within a cup-shaped applicator of variable size and configuration attached to the console by an umbilical¹⁸ ( Table 13.1). The control unit also regulates the rate of energy extraction (mW/cm²), which is expressed as the cooling intensity factor (CIF). In most clinical studies, the CIF falls between 0 and 5 °Celsius. The vacuum applicators apply negative pressure when applied across the specified treatment area. The adipose tissue is drawn between the cooling plates, which maintain a variable, preset temperature between -10 and -13 °Celsius.¹⁹ The negative pressure of the applicator limits local cutaneous blood flow; this, in conjunction with selective energy extraction from the adipose tissue, eliminates convective heat exchange and leads to therapeutic cooling and cryolipolysis. The nonvacuumed applicators lack draw into the applicator and utilize cooling alone for fat reduction; thus, they require slightly longer treatment times.

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