5.1 Introduction

According to the American Society of Plastic Surgeons statistics for 2018, while procedures like upper arm lifts and lower body lifts have shown substantial growth, for the first time since at least 2000, facelifts slipped out of the top 5 most-performed procedures last year, giving way to abdominoplasty (2018 plastic surgery procedural statistics from the American Society of Plastic Surgeons). Over the last few years the trend is growing toward noninvasive procedures. More patients are looking for a less invasive procedure that is effective in improving the body and face with minimal downtime. Under this context, cryolipolysis fulfills those requirements and is gradually becoming a favorite treatment for noninvasive body sculpting. According to Stevens et al the procedural growth was 823% from Jan 2010–2012 [n = 201 (2010), 671 (2011), 1857 (2012)] whereas Sasaki et al are stating that in 2014 more than 450,000 procedures were performed and cryolipolysis is becoming one of the most popular alternatives to liposuction for spot reduction of adipose tissue with high patient satisfaction rates. ¹

There are a number of other technologies available and their comparison of mechanism, pain level, side effects, and number of treatments needed are presented in (▶Table 5.1).

In 1970, Epstein and Oren coined the term “popsicle panniculitis” in their report, concerning the presence of a red indurated nodule followed by transient necrosis in the cheek of an infant who had been sucking on a popsicle, and concluding that lipid-rich tissues are more susceptible to cold injury than the surrounding water-rich tissues. ² But it was almost 40 years later that those observations were introduced by Manstein et al as a novel noninvasive method for fat reduction using freezing and given the new term cryolipolysis. ³ Although the exact mechanism of cryolipolysis is not completely proved as yet there are a few explanations of its function, like the induction of adipocytes crystallization, due to the vacuum suction with regulated heat extraction that impedes their blood flow. This cold ischemic injury to the targeted adipose tissue is further compounded by the ischemia reperfusion injury leading to the apoptosis of the adipose cells as well as to an intense inflammatory response, while the macrophages are executing the evacuation of the damaged cells and debris from the treated area within 3 months period. ⁴ However, multiple clinical studies showed no abnormality in serum lipid levels and liver function during and after cryolipolysis. ^{5 , 6 , 7} Also there is a transient decrease to the cutaneous sensation that returns to normal by 7 weeks after treatment with no permanent damage to nerves and skin of the treated area. ⁸ Moreover, there are studies that confirm its safety and efficacy over multiple treatments and in darker skin types. ⁹

5.2 Patient Selection

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  Women and men with BMI <30.

  
  
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  Over 18 years of age.

  
  
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  Presence of fat layers of thickness >20 (measurement using The FatTrack PRO DIGITAL Body Fat skinfold caliper) in body areas as neck, abdomen, hip rolls/flanks, brassiere rolls, arms, inner thighs, peritrochanteric areas, inner knees, ankles, male breasts, double chin, lateral neck.

  
  
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  No weight change exceeding 5% of body weight in the preceding month.

  
  
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  Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the conclusion of the treatment.

  
  
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  May be candidates for liposuction but wish to try a noninvasive method.

5.3 Exclusion Criteria

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  BMI <19.

  
  
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  Under 18 years of age.

  
  
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  Fat layers of thickness <20.

  
  
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  Intra-abdominal fat or very fibrous fat.

  
  
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  History of a fat reduction procedure (e.g., liposuction or other body contouring surgery, injection with fat dissolving agents, or other noninvasive procedure etc., the last year).

  
  
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  Hernia or previous surgery on the intended treatment area.

  
  
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  Any dermatological conditions or scars in the location of the treatment area that may interfere with the treatment or evaluation.

  
  
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  Known history of autoimmune disease and/or malignancy.

  
  
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  Known history of Raynaud’s disease, or cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria or any other known condition with a response to cold exposure that limits blood flow to the skin.

  
  
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  History of bleeding disorder or if she/he is taking any medication that may increase the patient’s risk of bruising significantly.

  
  
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  Currently taking or has taken diet pills or weight control supplements within the past month.

  
  
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  Active implanted device such as a pacemaker, defibrillator, titanium plates, or drug delivery system.

  
  
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  Pregnancy or intention to pregnancy in the next 6 months.

  
  
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  Lactation in the past 6 months.

  
  
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  Unable or unwilling to comply with the requirements.

5.4 Technique

Our treatment protocol has been standardized following meticulous literature review as well as our experience with the, EC (European Conformity) marked as medical device, CLATUU (Classys Inc-Korea) on more than 550 patients and 3,500 hours/sessions of treatment the last 4 years with satisfactory results for more than 87% of patients following GAIS 5-point scale evaluation. This device comes with two pairs of wing shaped and flat applicators functioning with a particular, patented protected technology, which introduces a 360° surround cooling effect, contributing to a more natural and aesthetically pleasing result, avoiding irregularities. The amount of cooling (selected energy extraction rate) is controlled by the thermoelectric cooling cells powered by DC current and controlled by thermistors that monitor the skin temperature. Moreover, the latest model Clatuu Alpha is even more advanced and with multiple shape and size pairs of handpieces.

5.5 Evaluation-Consultation

Following a detailed patient history, the patient is examined in standing position and her/his intended treatment areas are evaluated for fat thickness/quality (fibrous or not), distribution and “geography” of the fatty areas, skin sagginess or existence of intra-abdominal fat. A first evaluation it can be done clinically using the “pinch test” and following that, using a skin fold fat caliper, with recorded precise measurements taken for future comparison between the same landmarked points according to the area treated (for example on the abdominal area: umbilicus-pubis, umbilicus-anterior superior iliac spine). According to the findings, the evaluation is explained to the patient including: the probable response percentage (it could be up to 40% with a mean of 25%), the time frame for the result to be achieved (approximately 3 months), the number of sessions that may be required, as well as the procedure itself and a plan organized in priority of the areas of more significance/problem. An approximate prediction for the number of sessions needed on the same area may be assessed. It has been noticed that if the fat caliper measurements are ranging between 49–59 the patient may need more than 2 sessions to achieve an optimum outcome, whereas if the results are in the range of 38 and 49 the patient may need 1–2 sessions. Usually one session is enough to treat fatty areas with less than 38.