Cryolipolysis: The Importance of Scientific Evaluation of a New Technique.

As of October 8, 2014, the second most viewed publication on the Aesthetic Surgery Journal’s website is an article on cryolipolysis that was published over 14 months ago. To my knowledge, this communication represents the first original article in the Aesthetic Surgery Journal to focus on “commercial experience.” It may be the first article in the Journal to quantitate cross-selling. No measurement data or patient-reported outcome data are provided. The authors report no adverse events and, after 4 initially dissatisfied patients were re-treated, no unhappy patients. No plastic surgery procedure can claim a 100% patient satisfaction rate. This reality is especially true of liposuction, because some patients inevitably have unrealistic expectations and cellulite is usually not eliminated by liposuction. Even after liposuction, reported patient satisfaction is 80%: respectable but certainly not 100%. A claim of skin tightening based on two patients who also lost weight is tenuous. The new verb of “coolsculpting” serves the interests of the manufacturer because both coolsculpting and cryolipolysis (a name that seems generic) are registered trademarks (Zeltiq Aesthetics, Pleasanton, CA). Today, cryolipolysis is one of the most discussed treatments on Realself.com. Experienced plastic surgeons, however, have witnessed these bubbles of interest before (eg, LipoDissolve) and will take a measured view. First, one needs to consider the standard to which the new treatment is compared (Figure 1). Magnetic resonance imaging (Figure 2), the most reliable method for imaging the fat layer, reveals that liposuction reduces the subcutaneous fat thickness by 45%. Liposuction removes, on average, 2420 cc of fat from multiple sites in one treatment. Liposuction permits 3-dimensional fat removal from confluent areas (Figure 1) with subtle, controlled differences in aspirate volumes. The fat does not return or redistribute, and there are favorable changes in circulating triglyceride and leukocyte levels. Outcome studies are supportive. These findings hold up to scientific scrutiny and are powerful selling points to patients, no doubt explaining the enduring popularity of liposuction. Importantly, supportive studies are free of commercial bias. How does cryolipolysis compare to this standard? Shek et al measured skin folds in nonconsecutive patients undergoing one or two treatments. Calipers are unlikely to be sufficiently precise for reliable comparisons. The authors disclosed no financial conflict. However, an erratum published subsequently revealed that one of the authors had received a fee from Zeltiq. Garibyan et al reported a 39.6 cc reduction in treated areas, <2% of the average fat volume removed by liposuction. Distributed over a typical treatment area, this volume represents a 3 mm decrease in thickness. Another study of cryolipolysis, funded by the manufacturer, documented a 25.5% reduction in fat thickness in 6 of 10 treated patients using ultrasound, a technique known to be affected by pressure on the transducer. Some of the authors of all three studies were either employed by or had financial ties to Zeltiq. Although noninvasive, cryolipolysis is not painless or entirely without risk. Redness, bruising, and temporary numbness are common. Nodules can also occur. Like LipoDissolve before it, cryolipolysis revives the old notion of spot treatments. There is no real-time feedback, such as a palpable reduction in thickness of the fat layer, visual cues as the fat fills the tubing and canister, or comparison of aspirate volumes removed from each site. The operator may not be a plastic surgeon. Treatment sites immediately swell from inflammation. How can one truly sculpt body areas when the tissues swell right away? “Cooling” is a euphemism for freezing (ie, the formation of