Research update: cryolipolysis
Aesthetic Dentistry Today explores the evidence base on the non-invasive fat reduction treatment growing in popularity amongst UK dental practices: cryolipolysis.
Cryolipolysis for the treatment of submental fat: review of the literature
Lipner SR (2018) J Cosmet Dermatol 17(2): 145-51
Submental fat accumulation is a common cosmetic concern. Cryolipolysis utilises non-invasive cooling to lyse adipocytes. A cryolipolysis device was recently approved for treatment of submental fat.
This manuscript provides a review of the preclinical work and clinical trials related to cryolipolysis for the treatment of submental fat. Settings, efficacy, and side effects are also discussed.
Materials and methods
A literature search was performed through Pubmed, Embase, Web of Science, and CINAHL, using the search terms ‘cryolipolysis’, ‘submental’, and ‘paradoxical adipose hyperplasia’. Additional sources from the original source bibliographies were used to further supplement this review.
There are four clinical trials and one case series (total 101 patients) that evaluated the use of cryolipolysis for treatment of submental fat. In these studies, there was a statistically
significant reduction in submental fat and patients expressed high satisfaction with the treatment. Adverse effects were mild and transient.
Cryolipolysis is a non-invasive cooling technique that is safe and effective for treatment of submental fat. To date, there are no reports of marginal mandibular nerve injury or paradoxical adipose hyperplasia following treatment with this device.
Effectiveness and safety of contrast cryolipolysis for subcutaneous-fat reduction
Savacini MB, Bueno DT, Molina ACS, Lopes ACA, Silva CN, Moreira RG, Almeida S, Guidi RM, Sant’Ana E, Liebano RE (2018) Dermatol Res Pract 5276528
Cryolipolysis is the non-invasive treatment of localised fat through cold-induced panniculitis.
The purpose of the present study was to evaluate the safety and efficacy of contrast cryolipolysis for subcutaneous fat reduction. Contrast cryolipolysis mixes the principles of conventional cryolipolysis and periods of heating in accordance with the contrast lipocryolysis process.
Twenty-one subjects aged 34 ± nine years were treated with contrast cryolipolysis in the regions of abdomen and flanks through the Polarys device. Anthropometry, standardised photographs, measurements with a skinfold caliper, and diagnostic ultrasounds were performed at the baseline and during follow-ups at 30, 60, and 90 days after the treatment.
The safety assessments included laboratory testing and monitoring of the adverse events.
The level of significance for all tests was set at P < 0.05. No significant differences in weight and body mass index were found.
The waist measurements at the baseline and 30-day follow-up had significant differences, as did the measurements at the 30-day and 60-day follow-ups.
The skinfold and ultrasound measurements were significantly reduced in the treated areas in all the time points compared to the baseline. The laboratory results showed no significant changes from baseline. Temporary adverse effects were resolved spontaneously.
This study confirmed that contrast cryolipolysis is safe and effective in reducing the fat layer and improving body contouring.
Complications of cryolipolysis: paradoxical adipose hyperlasia (PAH) and beyond
Khan M (2019) Aesthet Surg J 39(8): NP334-NP342
Cryolipolysis is a fairly popular procedure performed in North America, Europe, and many other countries. Although it is considered a rather safe procedure, there are underreported side effects such as paradoxical adipose hyperplasia (PAH), contour irregularities, skin and soft tissue atrophy, and asymmetries. Our knowledge regarding the prevalence and treatment of such complications is limited.
The researchers reported on a case series of five patients treated for various complications of cryolipolysis, including PAH, that persisted for more than 12 months after their last treatment.
Five patients with various complications of cryolipolysis (four patients with PAH and one with atrophy and indentations) presented at the researcher’s clinic between 2015 and 2018. Three of the four patients with PAH were treated at other facilities with ultrasonic liposuction, laser lipolysis, and radiofrequency skin tightening devices respectively. The fourth patient developed PAH after liposuction at another facility. The fifth patient developed several areas of indentations and atrophy and received mesotherapy and lymphatic massages at another facility. All five patients were subsequently treated in practice by means of a customised approach specific to their underlying complications.
Near-normal results were achieved in all five patients. None of the researcher’s patients showed any recurrences of their initial complication for which they were treated. All five patients were extremely satisfied with their results.
Cryolipolysis, just like any other form of lipolysis, has certain specific adverse effects associated with it, including but not limited to PAH. Complications of cryolipolysis must be individually recognised and treated accordingly.
A three-dimensional quantitative analysis of volume loss following submental cryolipolysis
Jain M, Savage NE, Spiteri K, Snell BJ (2020) Aesthet Surg J 40(2): 123-32
Cryolipolysis is a proven and effective means of fat reduction; however, there are no standardised means of measuring volume reduction.
This study aims to assess the volume loss using a three-dimensional (3D) analysis following submental cryolipolysis.
A retrospective cohort study between April 2016 and August 2018 was performed. Thirty-five patients underwent a single 45-minute cycle of cryolipolysis to the submental region using the Coolsculpting System. A threefold analysis was performed, employing an independent observer assessment of two-dimensional photographs and 3D volumetric analysis utilising the Vectra XT system, and patient satisfaction was measured with the FACE-Q questionnaire.
The researchers’ results suggested the mean (standard deviation) pretreatment volume (n = 35) was 104.12cm3 (28.78). The six-week mean post-treatment volume (n = 26) was 81.55cm3 (21.29). The mean volume reduction found at six weeks post-treatment showed a reduction of 22.46cm3 (19.10) (95% CI 14.74 to 30.17, P < 0.0001). The 12-week mean post-treatment volume (n = 24) was 82.24cm3 (23.97). The 12-week post-treatment demonstrated a reduction of 22.30cm3 (14.04) (95% CI 16.37 to 28.23, P < 0.0001). The mean percentage correct for each reviewer correctly identifying the pre-treatment and post-treatment photograph was 76.33% (7.14). Patient satisfaction showed a mean FACE-Q score of 54.10 (20.41).
The study further affirms that though a rather safe procedure, there are underreported side effects such as paradoxical adipose hyperplasia (PAH), contour irregularities, skin and soft tissue atrophy, and asymmetries. Our knowledge regarding the prevalence and treatment of such complications is limited.
Adverse events associated with cryolipolysis: a systematic review of the literature
Hedayati B, Juhász M, Chu S, Mesinkovska NA (2020) Dermatol Surg 46 Suppl 1: S8-S13
Cryolipolysis is a popular procedure for people seeking non-invasive body contouring. As with any novel therapy, it is critical for providers to familiarise themselves with related adverse events (AEs), to provide appropriate information to patients before treatment.
To describe reported complications and AEs associated with cryolipolysis.
Materials and methods
A systematic review was completed using the Pubmed database and following search terms: ‘cryolipolysis’ or ‘lipocryolysis’ or ‘coolsculpting’. Only randomised clinical trials, prospective cohort studies, retrospective studies, case series, and case reports describing AEs related to cryolipolysis as well as studies written in English were included for review.
Fifty-three articles were included in this review. The most common AEs associated with cryolipolysis were treatment site erythema, numbness/paresthesia, bruising, and edema. More serious complications of cryolipolysis include severe/persistent pain, dysesthesia, skin hyperpigmentation, motor neuropathy, and paradoxical adipose hyperplasia.
Cryolipolysis is a safe option for patients seeking non-invasive body contouring. Most reported AEs are minimal and resolve quickly. It is important that physicians are aware of serious, irreversible AEs and are prepared to counsel patients appropriately before treatment.
Cryolipolysis (CLL) for reduction of localised subcutaneous fat: review of the literature and an evidence based analysis
Atiyeh BS, Fadul R Jr, Chahine F (2020) Aesthetic Plast Surg doi: 10.1007/s00266-020-01869-x. Epub ahead of print
In recent years, cryolipolysis (CLL), a non-invasive approach based upon the inherent sensitivity of adipocytes to cold injury, has emerged. However, it is not clear whether available evidence to date about its efficacy justifies aggressive marketing and extensive widespread application by many practitioners without well-defined indications or objectives of treatment. The current review is intended to evaluate available evidence regarding CLL mechanisms of action and its efficacy not only in fat reducing but also in its ability to result in an aesthetically optimal outcome.
Materials and methods
A systematic search of Pubmed and Scopus computerised medical bibliographic database was conducted with the search terms ‘cryolipolysis’, ‘lipocryolysis’, and ‘coolsculpting’. Selection criteria included all matched reports with the search terms in their titles.
Thirty-two reports matched the inclusion criteria of this review. Five experimental studies were identified and included to further supplement the discussion.
Most reports about CLL included in this review lacked rigorous scientific methodology in study design or in outcome measurement. Serious concerns about integrity of many of these reports, particularly with respect to validity of photographic outcome documentation in addition to objectivity, conflict of interest issues, and commercial bias, have been expressed. Further research should be encouraged to prove with methodological rigour positive effects of this treatment modality and to determine categories of patients in whom most favourable outcomes might be expected.
Histopathological features of tissue alterations induced by cryolipolysis on human adipose tissue
Pugliese D, Melfa F, Guarino E, Cascardi E, Maggi M, Ferrari E, Maiorano E (2020) Aesthet Surg J 40(7): 761-6
Adipose tissue cooling, under controlled conditions, induces physical effects on subcutaneous tissue called cryolipolysis (CLL), which has been proposed as a method to reduce non-invasively the amount of adipose tissue. Although CLL has been widely utilised in clinical practice and many favourable results have been reported in clinical studies, very few published studies have dealt with the effects of such therapies on human adipose tissue.
The aim of this study was to evaluate, through histopathological examination, the in vivo effects of CLL on human adipose tissue.
Six patients to be submitted to abdominoplasty were enrolled in the study. Samples were taken from the surgical patch, respectively, 15 days (two patients), 45 days (two patients), and 60 days (two patients) after a single standard session of CLL. Control samples were derived from the non-treated areas of the surgical patch.
Disruption of the adipocytic membranes was evident in all treated areas, with a reduction of cell dissolution in the 60-day samples. Focal dissolution and homogenisation of the collagen fibres was evident, resulting in the dissolution of the interlobular fibrous septa. A mild inflammatory response was observed in the 15- and 45-day samples. Neocapillarisation was observed in the 45- and 60-day samples.
The lesions demonstrated in adipocytes confirm the theoretical premises of a usefulness of CLL in the treatment of localised adiposis. The alterations in the connective stroma could lead to a structural reorganisation and consequently to the in vivo external appearance of the treated areas.
These abstracts were compiled from a search on Pubmed using the keywords fat reduction, cryoliposis, complications, and cryolipolysis efficacy.