1444-nm Nd:YAG for Laser-Assisted Lipolysis: A Minimally Invasive Technique for the Treatment of Pseudogynecomastia

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Gynecomastia is a common male problem characterized by breast enlargement that can occur bilaterally or, rarely, unilaterally.^1,2 Breast enlargement is due to an increase in the amount of ductal tissue (glandular gynecomastia), fat (also known as pseudogynecomastia), or both (mixed gynecomastia).^3-5 Patient history and physical examination can help determine the diagnosis. It is commonly seen during puberty and in the elderly and is usually caused by a hormonal imbalance. The incidence varies according to age group. This is typically a unilateral, transient problem in adolescents.⁶ It frequently occurs idiopathically. To exclude potential pathological causes, such as pharmacological causes and inflammatory, degenerative, and neoplastic diseases of the liver, adrenal glands, kidneys, gonads, and central nervous system, it is necessary to identify symptoms.^7,8 In 1973 Simon et al proposed the most used clinical classification for gynecomastia⁹ (Table 1). This is widely utilized and practical; however, it has limits, as evidenced by the fact that the assignment to a particular class strongly depends on the subjective opinion of the examiner. An alternative classification was developed by Rohrich,⁷ standardizing the approach to treatment while also describing the pathology. Typically, gynecomastia doesn't need any kind of treatment. Only a small portion of patients seek treatment because of the psychosocial burden or pain it causes. At an early stage of proliferation, medical treatment may be effective. Three possible approaches are used in the pharmacological treatment of gynecomastia: blocking the effects of estrogens on breast tissue (tamoxifen, raloxifene, clomiphene), controlling androgens (danazol), and inhibiting estrogen production (testolactone, anastrozole).¹⁰

The best results from medical therapy are obtained in cases of recent gynecomastia (up to 2 years). Two years later, the stroma has grown more fibrotic, making conservative therapy useless. The efficacy of pharmaceutical therapy for adolescent gynecomastia is primarily limited to case reports and little case series without a control group, which results in a lower degree of significance due to spontaneous regression.^11,12 In summary, medication treatment for pubertal gynecomastia is more beneficial when administered at the early stage of this condition. Over time, the tissue becomes fibrotic and medical therapy is not able to bring benefits, necessitating surgery if the patient desires a correction.¹³ 

Gynecomastia is typically treated surgically with a sharp excision of the mammary gland through a semicircular incision on the edge of the areola. However, technical difficulties in application and inexperience in mastectomy often lead to poor cosmetic outcomes. There is a possibility of some postoperative complications; the most common ones are a plate-shaped deformity (above resection under areola), residual gynecomastia (under resection), inversion or necrosis of the nipple-areola complex, the persistence of the inframammary fold, irregularities in contour, and asymmetries between the breasts. The technical challenges in performing the acute resection of the currently used conventional surgical approach, as well as the long learning curve, are the fundamental reasons for these problems. Furthermore, the success of gynecomastia surgery is highly dependent on the surgeon's intuition and expertise in removing the gland.¹⁴

Several surgical methods and techniques have been adopted to effectively treat gynecomastia with a lower complication rate. Although there are numerous treatment options available, when there is predominately fatty tissue present during gynecomastia, liposuction is thought to be the best option (suitable for pseudogynecomastia and to treat fat component in mixed gynecomastia) in the absence of cancer suspicion or risk. However, in terms of natural shape and conformation to the pectoral muscle region,⁸ the excess skin is what determines surgical success and cosmetic acceptability. In 1996, Apfelberg¹⁵ introduced laser-assisted liposuction (LAL), with the benefits of high patient acceptance, quick recovery, and the added benefit of dermal tightening. A pilot study describing our experience using a novel Nd:YAG system emitting a 1444 nm wavelength for LAL in gynecomastia with predominant fatty tissue is presented here. The positive aspects of this technique are also reported.

This study included 9 male patients diagnosed with pseudogynecomastia, aged 18 to 32 years (mean age 24.4 ± 5.0 years), who underwent laser procedure with a Nd:YAG laser (LipoAi, DEKA) emitting at 1444 nm. The study was carried out in accordance with the Helsinki Declaration. For both the study and the surgery, each participant gave their free and informed consent. The breast tissue growth was bilateral and asymptomatic. As a result of their gynecomastia, every single patient, without exception, reported experiencing psychological distress.

During the study, patients were asked not to modify their eating or physical activity. All patients completed an anamnestic questionnaire and had a medical interview. Anamnesis was ordinary. The exclusion criteria were: BMI >30; cardiovascular disease; diabetes; cancer; use of therapies or medications that may interfere with the protocol (antiplatelets, anticoagulants, thrombolytics, or anti-inflammatories); and levels of estradiol, luteinizing hormone/follicle-stimulating hormone, testosterone, and human chorionic gonadotropin higher than normal limits.. 

Furthermore, hepatic, renal, and thyroid laboratory tests for all patients revealed no unusual findings, and chest plain radiographs and mammograms were normal. Following the evaluation of the glandular and fatty components of gynecomastia in each participant, LAL surgery to reduce breast volume was suggested. Our patients were classified using the Simon et al system⁹ for gynecomastia reported in Table 1. Physical examination identified 4 of the 9 patients (44%) with a BMI >25 (overweight) as shown in Table 2.

Flaccidity was present in all study participants. An accurate marking with photographic documentation was carried out before surgery. With the patient standing, the proportions and rough limits of fat and glandular tissue were delineated, considering any asymmetry that may exist for correction during the LAL procedure. The upper and lower breast poles' borders were drawn, and the inferior breast fold was marked 3 cm below its usual location. The areola/nipple complex was also labeled for preservation during surgery. Patients were prepped and draped after surgical marking. The intervention was performed under sedoanalgesia. The supervising anesthesiologist usually requires midazolam for this purpose. In all patients, the sketched areas were infiltrated with a tumescence solution (Klein formula; 0.1% lidocaine and 1:1,000,000 epinephrine).¹² Two 2-mm incisions were made with a no. 11 scalpel 15 minutes after the anesthetic injection. Tunneling maneuvers were performed using a 1 mm in diameter, 9-cm-long blunt 16G cannula. A Toledo cannula was first used to break down fibrotic bridges in case the breast had a conical shape and hard tissue consistency. The 600-µm fiber, passing through the laser handpiece and cannula (Figure 1), was then introduced. The fiber was adjusted to protrude approximately 2 to 3 mm from the tip of the cannula. A very helpful clip blockage that passes through both the laser handpiece and cannula is a feature of the handpiece. A fiber-protecting option that is activated by adjusting the clamp position safeguards the fiber insertion. Finally, the handpiece and cannula can be equipped with a thermal sensor. The following setting was adopted: 100 µs pulse duration, 40 Hz frequency, 300 mJ pulse energy, and 12 W power. The total exposure time was determined by the extent of gynecomastia. The total energy delivered per patient bilaterally varied from 800 to 1500 J. The cannula position was easily identified thanks to the red guide beam trans-illumination. 

Figure 1. Laser handpiece and cannula.

The fiber's tip was placed on the hypodermis or subcutaneous fat layer, and the cannula moved to fan forward and backwards. When the laser was turned on, the cannula was moved back and forth in two fat tissue planes: the deeper plane first, followed by a faster movement through the more superficial skin layer. The goal was to produce the most homogeneous heat propagation and thermal action in the dermis.

It was important not to halt the movement of the cannula, always keeping coordination between laser emission and arm movement back and forth. There was a risk of skin surface burns in case the cannula slowed too much or stopped and the irradiation continued. Hand movements in the areola-nipple complex area were quick and careful to avoid damage to the vascular pedicle. Indeed, vascularized fat tissue must remain in the subareolar and pre-pectoral regions to avoid subsequent retractions and possible adhesions of the cutis with deeper layers. Normally, intraoperative hemostasis is unnecessary as long as the fascia of the pectoralis major muscle is protected. For patients with asymmetric gynecomastia, additional passes of the laser cannula were made in the contralateral breast.

Palpable softness, a sign of the liquefaction of fat cells, represented the clinical endpoint. Following the procedure, the 4-mm cannula previously used for tunneling was used for lysate removal at 1 bar negative pressure. Following aspiration, additional laser treatment (40 Hz frequency, 150 mJ pulse energy, 6 W power, and total energy of 1,000 J) was performed to tighten the skin and close lymphatic and blood vessels to reduce edema and ecchymosis. After that, a manual examination was performed to find any possible irregularities in breast shape. A single 4-0 nylon stitch was used to close the incisions. The incision site was then bandaged with a small piece of gauze. Patients were instructed to wrap elastic bandages around both of their breasts for 7 days to provide compression. In the following 6 weeks, all patients received manual lymphatic drainage sessions once a week. Patients were advised to supplement their recovery with light exercises to keep their pectoral muscles toned. On postoperative days 3, 4, and 6, paracetamol (650 mg every 6 hours), prednisolone (30 mg per day), and amoxicillin/clavulanic acid (500 mg 3 times daily) were prescribed.

A medical photographer took gross breast images at baseline and after 4 months. The subjects were photographed in the same position, lighting, and camera setup, by the same photographer and with the same digital camera (LifeViz 3D imaging system - Quantificare). Clinical symptoms as well as adverse events were also recorded.

Clinical Assessment

The results were clinically evaluated by comparing pictures at baseline and 4 months later. Independent physician evaluators were presented with photographs taken before and 4 months after surgery to compare them. A 5-point Global Aesthetic Improvement Scale (GAIS) (0 points = no change; 1 point = 1%-25%, mild improvement; 2 points = 25%-50%, moderate improvement; 3 points = 51%-75%, good improvement; 4 points = 76%-100%, excellent improvement)¹⁶ was used to assess the treatment response. 

LAL was performed on all 9 patients, with no follow-up loss. After 4 months, patients' weights and waist sizes did not change statistically significantly (Table 2).

An independent comparison of baseline and post-treatment pictures by a physician evaluator 4 months after treatment revealed significant improvement in all patients. Three subjects (33%) showed excellent improvement; 4 (44%) showed good improvement, and 2 (22%) showed moderate improvement (Figures 2 and 3). Patients’ breast sizes decreased in all patients 4 months after 1444-nm LAL.

Figure 2. Patient with grade IIa gynecomastia (according to the classification of Simon et al⁹) before laser-assisted liposuction (A; C) and 4 months after laser-assisted liposuction (B; D).

Figure 3. Lateral view of patient with grade IIa gynecomastia before laser-assisted liposuction (A; C) and 4 months after laser-assisted liposuction (B; D).

All patients experienced an incident-free postoperative period. The most common early side effects during and after the LAL procedure were mild pain and swelling, numbness, and bruising. Paracetamol provided effective pain relief. 

The movement of the arms, especially when lifting relatively light weights, caused the most discomfort. Ischemia, areola congestion, skin burning, or nipple sensation loss were not present. Within 1 to 2 weeks after LAL, all patients had recovered from a slight bruising-related darkening.

Seven days following surgery, sutures were removed, and no signs of infection, seroma, or scarring were found.

Gynecomastia can occur due to an increased sensitivity of the breast tissue to estrogen or an imbalance of the hormones androgen and estrogen in the body. Commonly this condition does not need any treatment but, when it does not regress significantly, can necessitate surgical intervention.^17,18

Pseudogynecomastia, lipomastia, and lipomatous gynecomastia are all terms used to describe the condition with excessive subareolar fat deposition without glandular proliferation. In contrast to true gynecomastia, pseudogynecomastia, as well as mixed gynecomastia, are more common in obese men.¹⁹ 

Since the first mention of combined treatment for gynecomastia,²⁰ advances in techniques for surgery, predictability, and esthetic results have been made.^21,22 Since its invention, liposuction has become one of the most popular and successful surgical procedures.¹³ However, new minimally invasive therapies have been developed^7,23 because patients prefer less invasive techniques that cause minimal discomfort. Because of the small caliber of the fiber-optic tip, which makes it useful in delicate body areas, LAL has been extensively utilized since its introduction¹⁴ and is now one of the most widely used laser lipoplasty techniques worldwide. Furthermore, less bleeding and a quicker recovery time are associated with the capacity of LAL to induce coagulation of small vessels in fat tissues. Through increased collagen synthesis and direct lipolysis, it also enhances aesthetic results. Heating the deep dermis denatures collagen and increases the production of heat shock proteins, which are then followed by vascular growth and collagen synthesis.²⁴

According to some authors, using Nd:YAG lasers significantly accelerates collagen synthesis while inhibiting collagen degradation.²³ It has been observed that the development of new collagen fibers after conventional laser skin rejuvenation and tightening takes approximately 6 to 8 weeks. Fibers can then be seen running parallel to the epidermal junction, where they are involved in tissue reshaping and skin laxity resolution.²⁵ As a result, skin tightening occurs.

There are currently several LAL devices available, delivering wavelengths ranging from 920 to 1444 nm.²⁶ There has been much discussion regarding the ideal wavelength for reducing skin laxity and melting fat tissue. An innovative Nd:YAG system emitting a 1444-nm wavelength was recently developed, which could be crucial in fixing these issues. 

The 1444-nm wavelength has a significantly higher duality of absorption in both water and fat than the 1064-nm and 1320-nm wavelengths.²⁷ To treat the same volume, 1064-nm and 1320-nm lasers require 3 times or twice the energy of 1444-nm lasers, respectively.²⁸ The same research also found that, even though water absorption in the tissue is much higher, selective photothermolysis occurred at 1444 nm because this wavelength corresponds to a fat peak absorption, ensuring effective lipolysis, even though fat is the primary target of action (Figure 4). The thermal reaction is contained with little diffusion to surrounding tissue due to the high water absorption. Furthermore, this wavelength ensures maximum ablation efficiency while causing the least amount of heat localization throughout the depth.²⁹

Figure 4. Graphical representation of absorption coefficient versus wavelength for water and human fat. The 1444-nm wavelength shows high selectivity characteristics, and it is highly absorbed by the human fat.

Clinical advantages of LAL using a 1444-nm laser³⁰ include increased thermal confinement and reduced unintended collateral thermal injury. This may allow for safer contouring while also lowering the risk of damaging nearby tissue. In recent years the 1444 nm wavelength has been widely used for laserlipolysis and/or LAL, not only for body remodeling purposes.^31,32 LAL with a 1444-nm laser may provide greater thermal confinement and less accidental collateral thermal damage. This could result in much safer contouring with a lower risk of surrounding tissue damage. The 600-m optical fiber and small diameter cannula used in the present investigation also contributed to the LAL being minimally invasive. 

We found that 1444-nm Nd:YAG LAL reduces breast size in patients with pseudogynecomastia without causing significant side effects. The only adverse reactions were pain, swelling, numbness, and bruising, which were all temporary and resolved soon after they appeared. This technique is a good response to the growing demand from patients for less invasive and highly effective procedures.

Study limitations include a lack of proper control groups, small sample size, and a lack of extended follow-up evaluations to demonstrate the long-term beneficial effects of the subject device/technique. The absence of a patient satisfaction assessment is a further limitation of the study. A future goal is to investigate the patient satisfaction index to better validate these scientific findings. 

The LAL procedure performed in this study using 1444-nm Nd:YAG laser appears to be a very effective and comfortable outpatient solution. It has proven to be a safe procedure, and all subjects in the study experienced a significant clinical improvement in pseudogynecomastia, with a reduction in breast volume and visible skin contraction. When performed by a skilled doctor, this modality, also thanks to its minimally invasive approach, might be one of the best options with significant and consistent results and improvement in quality of life.