Professional Documents
Culture Documents
Busso, Denkova - 2019 - High-Intensity Focused Electromagnetic (HIFEM) Field Therapy
Busso, Denkova - 2019 - High-Intensity Focused Electromagnetic (HIFEM) Field Therapy
inducing magnetic fields was placed over the buttock to The treatment time of each side of the buttock was 30
stimulate the left and right gluteus maximus muscles. minutes.Weight measurements and digital photographs were
Positioning the applicator above the inferior gluteal nerve was taken immediately after the last treatment, during 1-month
crucial for homogenous stimulation, the intensity was therefore follow-up and 3-month follow-up. In addition, subjects were
initially set to 15% of the device output, and the position of the asked to fill patient satisfaction and comfort questionnaires.
applicator was adjusted for inducing contractions of the entire Clinical efficacy was evaluated using the Global Aesthetic
gluteal area. Once the proper position of the applicator was Improvement Scale (GAIS). It is a photograph-based instrument
found, the intensity was increased up to the patients’ tolerance for grading the overall improvement by comparing the after
threshold and was further adjusted throughout the treatment intervention photographs to the baseline photographs (Table 1).
based on the patient’s feedback.
1 Improved Improvement in the appearance, better compared with the original condition
0 No change The appearance substantially remains the same compared with the original condition
-1 Worse The appearance has worsened compared with the baseline condition
Three independent evaluators were presented pairs of compared to the ones taken immediately after the last
“before–after”, “before-follow - up” photographs which they treatment. For the photo pairs, baseline and 1-month follow-up,
visually examined and graded according to the GAIS. the average score of the three evaluators was 1.51 ± 0.65. The
improvement score at three months was 1.53 ± 0.66 indicating
A visual analog scale (VAS) with a score ranging from 0 to 10
that the improvement seen immediately after the last treatment
(0=absolutely dissatisfied, 10=absolutely satisfied) was used to
was maintained over the course of 3 months. Example of a set of
assess the patient satisfaction with the treatments after the last
patient photographs can be seen in Figure 1.
treatment, and during one-month and three-month follow-ups.
Patients’ comfort with the treatments was assessed after the The figure shows mild improvement in the buttock shape and
last treatment using VAS questionnaire with a score range 0-10, volume immediately post-treatment. The more dramatic change
where 0 stands for unbearable discomfort and 10 for no in comparison to baseline can be seen in the photo taken 1
discomfort. During each treatment and follow up visit patients month post-treatment showing lifted and more toned buttocks
were monitored for any side effects and adverse events. with significantly increased volume. The three month follow-up
photo shows that the lifted buttock shape was preserved and
Ethics the volume continued to increase.
All subjects received oral instructions and information after Evaluation of VAS satisfaction questionnaires resulted in high
which they signed informed consent. patient satisfaction with the treatment outcomes as the average
VAS score was 7.2 ± 1.84 after the last treatment. The
Statistics satisfaction increased during the 1-month follow-up to 7.4 ±
1.79 and was further enhanced to 7.8 ± 1.95 during the 3-month
Fluctuation of the subject’s weight was statistically analyzed follow-up. The histogram representing the distribution of patient
using the paired t-test with significance level set as 5%. satisfaction during the 3-month follow-up is displayed in Figure
2.
Results It shows that there was one dissatisfied patient (score<5),
All recruited subjects completed the 4 treatments with a while 10 patients reported satisfaction higher than 8.
device utilizing HIFEM technology, after treatment follow-up Furthermore, subjects found the treatments comfortable with
visits and phone call evaluation. GAIS score showed that VAS score of 8.3 ± 1.9. None of the patients reported discomfort
patients significantly improved post-treatment. The patients during the treatments (score<5). Average weight change did not
found the treatments comfortable and showed high satisfaction exceed 1 lb during the study and was not statistically significant
which was gradually increasing. (p>0.05). Mild muscle soreness was present on the day after the
Photo evaluation using the GAIS grading system resulted in a treatment session in several subjects but resolved within 24
score of 1.56 ± 0.68 when the baseline photographs were hours. No adverse events or side effects were reported.
Figure 1: Digital photographs of subject ID 6 taken at baseline (left), after the 4th treatment (middle left), during the one-month
follow-up (middle right) and three-month follow-up (right). The photographs illustrate gradual progress in the shape of the
buttocks.
Figure 3: Photographs of a 25-year-old female (Subject ID 7) taken at baseline (left), after the 4th treatment (middle) and after 3
months (right).
Photographs demonstrate the firming effect of the treatments the positive GAIS ratings given by three independent evaluators
as the gluteal fold is lifted in the after intervention photograph. and high patient satisfaction. Marked improvements observed in
Previous abdominal studies [3,4,7] documented reduction in the digital photographs suggest the HIFEM treatments for
subcutaneous fat thickness after treatments by HIFEM buttocks as a suitable alternative to current procedures. Further
technology device. This effect, however, may be an undesirable research including quantitative assessment is necessary.
outcome of the buttock treatments for most of the patients, as
fat deposits on buttocks may contribute to its fuller look. We did Acknowledgments
not measure the fat deposits, but it has been documented
before, that the fat tissue of buttocks is much less metabolically None. No funding to declare.
active when compared to fat tissue of the abdomen. It can,
therefore, be assumed that the fat layer of buttocks is not Conflict of Interest
significantly affected during the treatments [9,10].
Mariano Busso MD is a speaker for BTL. Radina Denkova MD
We thus link the observed aesthetic improvement solely to
has no relevant conflicts to declare.
the HIFEM effect on muscles as previous studies [3,4] report
approximately 16% increase in muscle thickness. Since the
muscle laxity plays crucial role in the sagging look of buttock the References
correction of muscle laxity is the key for improving the buttock
1. Barker AT (1991) An introduction to the basic principles of
appearance and creating the desired sporty look. The HIFEM magnetic nerve stimulation. J Clin Neurophysiol Off Publ Am
technology allows treatment of muscle laxity through induction Electroencephalogr Soc 8: 26-37.
of supramaximal muscle contractions.
2. Jones DA, Bigland-Ritchie B, Edwards RHT (1979) Excitation
Even though the used evaluation methodologies give frequency and muscle fatigue: Mechanical responses during
promising results of the HIFEM technology for the buttock voluntary and stimulated contractions. Exp Neurol 64: 401-13.
shaping, a quantitative evaluation is missing. Future studies 3. Kinney BM, Lozanova P (2018) High intensity focused
should bring a quantitative and more objective evaluation of the electromagnetic therapy evaluated by magnetic resonance
buttock treatments e.g., MRI measurements of muscle imaging: Safety and efficacy study of a dual tissue effect based
thickness, MRI muscle volume assessment or 3D photograph non-invasive abdominal body shaping. Lasers Surg Med.
volumetric assessment. Extended protocol with an increased 4. Kent DE, Jacob CI (2018) Computed tomography (CT) based
number of treatments including long-term monitoring of the evidence of simultaneous changes in human adipose and muscle
patient should also be considered for future research. tissues following a high intensity focused electro-magnetic
(HIFEM) application: a new method for non-invasive body
sculpting.
Conclusion
5. Weiss R, Bernardy J (2018) Induction of fat apoptosis by a non-
The HIFEM technology showed its capability in improving thermal device: safety and mechanism of action of non-invasive
aesthetic improvement of buttocks which was demonstrated by HIFEM technology evaluated in a histological porcine model.
Present Annu Meet Am Soc Lasers Surg Med.
6. Jacob CI, Paskova K (2018) Safety and efficacy of a novel 9. Brouwers B, Hesselink MKC, Schrauwen P, Schrauwen-Hinderling
highintensity focused electromagnetic technology device for VB (2016) Effects of exercise training on intrahepatic lipid content
noninvasive abdominal body shaping. J Cosmet Dermatol. in humans. Diabetologia 59: 2068-79.
7. Katz BE, Bard RL, Goldfarb R, Shiloh A, Kenolova D (2018) Changes 10. Bjørndal B, Burri L, Staalesen V, Skorve J, Berge RK (2011) Different
in subcutaneous abdominal fat thickness following high-intensity adipose depots: their role in the development of metabolic
focused electro-magnetic HIFEM field treatments: a multi-center syndrome and mitochondrial response to hypolipidemic agents. J
ultrasound study. In Dallas TX, USA: Lasers Surg Med P: 360-61. Obes 490650.
8. The American Society for Aesthetic Plastic Surgery (2016)
Procedural Statistics.