Chi-Kong Or, MD, Plastic Surgeon, Sphere Medical Aesthetic Centre, Hong Kong, China
email: dror@spheremedical.com.hk

Chi-Kong Or discusses using a new combined infrared, bipolar radiofrequency, and mechanical tissue manipulation device to improve skin laxity

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ABSTRACT 

Background and objectives: Skin laxity can be emotionally frustrating for women after pregnancy. The excessively stretched abdominal tissue loses its collagen and elastin, resulting in unpleasant sagging looking skin. Major surgical correction, such as liposuction and abdominoplasty have surgical and anaesthetic risks and a long recovery period. This article reviews the safety and efficacy of a combined infrared light (IR), bipolar radio-frequency (RF), and mechanical tissue manipulation device (VelaShape® III, Wayland, MA, USA) for abdominal circumference reduction and improvement of skin laxity in a post-partum Asian patient. 

Methods: One female patient, aged 36 years old, with severe post-partum abdominal skin laxity received treatment with a combined IR, bipolar RF, and mechanical tissue manipulation device (VelaShape® III) in two stages over eight months. In Stage 1, the patient received a total of nine weekly treatments then a follow-up review 1-month post-treatment. In Stage 2, the patient received a total of four fortnightly treatments, then another follow-up review 1-month after the last treatment received. The abdominal circumference measurements and clinical photographs were recorded before and after each treatment and at both 1-month follow-up. The outcome was assessed using circumference measurements, digital photography, and patient satisfaction. Safety was evaluated by a survey of patient comfort, side-effects, and adverse events.

Results: The patient received a total of 13 treatments. The average abdominal circumference reduction from baseline to first and second stage follow-up were 9.9% (9.0cm) and 12.6% (11.4cm), respectively.  Both patient and physician noted a significant improvement in skin laxity and tightening. At the second stage 1-month follow-up (end of treatment programme), the patient expressed she was highly satisfied with the treatment outcomes. Treatments were well-tolerated with mild treatment-related erythema and oedema, and no safety concerns reported.

Conclusions: The results demonstrated that the combined IR, bipolar RF and mechanical tissue manipulation device (VelaShape® III) could deliver safe and promising outcomes with significant circumference reduction and skin laxity improvement through a systematic treatment programme.

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The market for body shaping treatments has been increasing with 91% of women wanting to change some aspects of their bodies, 72% of women are not satisfied with their bellies, and 81% are concerned about maintaining their body shape1. Due to the reduced procedure costs, risks, and downtime, the demand for non-invasive treatments for body contouring has been increasing rapidly over other invasive treatments in Asia. Non-invasive treatments with a combination of IR, bipolar RF, vacuum, and mechanical massage have been shown to be safe and effective for reshaping and contouring body areas including the abdomen, buttocks, and thighs in Caucasian patients2,3. As there are limited data and clinical studies in Asian patients, this case report provides an opportunity to evaluate the safety and efficacy of the latest enhanced VelaShape III System with VContour applicator (Candela, Wayland, MA, USA) for abdominal circumference reduction and improvement of skin laxity in post-partum Asian women.

Material and methods
Device description 

VelaShape III is the third generation of the VelaShape System with higher power and modified guided-mode technology. It is FDA-cleared for the temporary reduction in the appearance of cellulite and reduction of thigh circumferences4. The VelaShape III System combines bipolar RF for deep and sustained heating and IR for superficial heating in cellulite treatment and temporary reduction of thigh circumferences in conjunction with vacuum and mechanical massage. 

Treatment parameter 

All treatments were performed with the VContour medium applicator using RF energy of 150W and IR energy of up to 3.2W. Throughout each treatment, the settings were IR — 0, RF — II, Vacuum — 1 with a target temperature set at 42°C.

Patient

The female patient was 36 years old, Fitzpatrick skin type IV, with clinically apparent skin laxity and abdominal subcutaneous fat deposits. The patient agreed to receive the first treatment with combined IR, bipolar RF, and mechanical tissue manipulation device 1-year post-pregnancy. 

Clinical evaluation

The patient was treated for circumferential reduction and improvement in skin laxity on the abdominal area in two stages. In Stage 1, the patient received a total of 9 weekly treatments then a follow-up review 1-month post-treatment. In Stage 2, the patient received a total of four fortnightly treatments, then another follow-up review 1-month after the last treatment received (Table 1). Each treatment session was 60 minutes.

Treatments were performed using the modified Guided Mode, which is a step-by-step guided process. For taking consistent photographs, the patient was standing in the same position, as marked by a footprint placed on the floor. All clinical photographs were taken with a Canon EOS 550D camera. 

The primary efficacy endpoint was the percentage of abdominal circumference reduction. Measurements were recorded each time before and after treatments. For each pre-, post-treatment, and follow-up measurements, the average of three circumferences at the level of the navel (84 cm distance from the ground), 2 cm above and 2 cm below navel were recorded. Each abdominal circumferential measurement was measured no matter the contour changes after treatments. Baseline results were 90.8 cm at the navel, 88.7 cm above and 92 cm below the navel.

The patient evaluated treatment outcome satisfaction was based on a scale consisting of: not satisfied, slightly satisfied, satisfied, very satisfied, and extremely satisfied. The survey also reported the patient’s comfort during treatments, side-effects, and adverse events.

Results

The patient completed nine treatments in Stage 1 and four treatments in Stage 2. Reduction in the abdominal area was observed after all treatments. The average reduction in the circumference of the abdomen from baseline to Stage 1 follow-up was 9.9% (9.0cm). At Stage 2 follow-up, the average abdominal circumference measurements further reduced to an average reduction of 12.6% (11.4 cm) (Figure 1). Navel measurements alone had an overall circumference change of 13% (11.8cm). The patient did not have any significant weight change during the study.

The degree of skin laxity had also improved. The skin tightening effect was most visible from the substantial reduction of the skin apron. Both patient and doctor were very satisfied with the results. The patient tolerated the treatments well and rated the treatment as very comfortable. Treatment-related side-effects included transient erythema and oedema. No safety concern was reported.

Discussion

At baseline, the patient’s skin laxity was evident and severe (Figure 2a). After receiving intensive nine weekly treatments in Stage 1, the circumferential reduction and skin laxity improvement was significant at 1-month post-treatment follow-up (Figure 2b). After Stage 1, fortnightly treatments were arranged instead of weekly treatments and further circumferential reduction and skin laxity improvement were observed at the follow-up (Figure 2c).

Theoretically, in order to achieve circumference reduction and improvement in skin laxity, a heating of connective tissue for the growth of new and healthier collagen and elastin is required. Thermal connective tissue injury is based on reaching a ‘thermal dose’ threshold. It is a combination of elevated temperature and exposure time. In order to achieve progressive skin tightening and circumference reduction, it is critical to achieve a target temperature and to maintain it for a duration.

With more power, the latest generation of combined IR, bipolar RF, and mechanical tissue manipulation device can reach a target temperature of 45°C in a shorter time of one minute. Therefore, the effective therapeutic duration and endpoint temperatures are maintained for longer in the same treatment session time. The real-time temperature monitoring system maximises patient comfort and avoids adverse events, such as skin burns, while achieving optimal treatment outcomes. In general, the patient reported a high degree of comfort during the treatment, even falling asleep during treatment sessions.

The VContour applicator includes a pulsed vacuum to improve blood circulation and lymphatic drainage. When blood vessels are compressed at normal atmospheric pressure, the negative pressure will cause vessel dilation and increase blood flow. The pulsed vacuum also enables targeted penetration of RF resulting in fibroblastic stimulation.

The combined IR, bipolar RF, and mechanical tissue manipulation device is very user-friendly. The Guided Mode Technology is an operator-independent step-by-step guided process for each treatment session. An operator does not need to count the pulses, which simplifies operation and minimises technique sensitivity, further improving patient comfort and delivering more reliable and effective treatment outcomes. A previous clinical study also reported high patient satisfaction for VelaShape treatments5. 

Treatment intervals are critical to managing patient expectation and compliance for further sessions, especially for patients with tight schedules or living remotely from the treatment centre. Due to the positive experience obtained in the first few sessions, the patient would be eager to continue until the full treatment programme is completed. The recommended treatment plan is a minimum of 10 sessions, including 2–4 weekly treatments, followed by fortnightly, then monthly treatment sessions. An individualised patient treatment plan should be based on the severity of the treatment area and the desired outcomes. In conjunction with all body contouring treatments, it is advised that patients continue a proper diet and exercise regime to achieve the best and sustainable outcomes.

Conclusion

The Asian post-partum patient had both measured and visible results in her abdominal area after each VelaShape III treatment session. This case report was able to demonstrate that the non-invasive combined IR, bipolar RF, and mechanical tissue manipulation device can deliver safe and promising outcomes with significant circumference reduction and skin laxity improvement through a systematic treatment programme. The combination of optical energy and bipolar RF tissue heating provide a synergistic effect, which is suitable for skin type IV patients. RF-generated tissue heating does not depend on the chromophore; however, treatment providers should be cautious when treating skin type V and VI.

  Declaration of interest Funding for submission of this paper was provided by Candela

  Figures 1-2 © Dr Or

  Tables 1  © Dr Or

 

References

  1. Syneron Proprietary Consumer Survey 2012 and 2015
  2. Winter LW. Post-pregnancy body contouring using a combined radiofrequency, infrared light and tissue manipulation device, J Cosmet Laser Ther 2009;11(4):229-235.
  3. Brightman L, et al. Improvement in arm and postpartum abdominal and flank subcutaneous fat deposits and skin laxity using a bipolar radiofrequency, infrared, vacuum and mechanical massage device. Lasers Surg Med 2009;41:791-798
  4. 510 (K) clearance (K122579), Aug 2012
  5. Maurice AA. Reduction in adipose tissue volume using a new high-power radiofrequency technology combined with infrared light and mechanical manipulation for body contouring. Lasers Med Sci 2013;29(5):1627–1631