Bilateral reduction mammaplasty with pulsed electron avalanche knife PlasmaBlade™ and conventional electrosurgical surgery: A retrospective, randomised controlled clinical trial

Abstract

Wound‐healing disorders are common complications in bilateral reduction mammaplasty. Traditional electrosurgical devices generate large amounts of thermal energy, often causing extensive thermal‐related collateral tissue damage. This study aimed to retrospectively analyse the operative performance of a novel low‐thermal plasma dissection device (pulsed electron avalanche knife—PEAK PlasmaBlade™) compared with traditional electrosurgery. Twenty patients with breast hypertrophy were randomly treated with PEAK PlasmaBlade™ on one breast and conventional electrosurgery on the other. Primary outcome measures were resection weight, drain duration, total drainage volume, and drain output on the first postoperative day. Breasts treated with PEAK PlasmaBlade™ had significantly higher resection weights (728.0 ± 460.1 g vs 661.6 ± 463.4 g; P = .038), significantly lower drain output on the first postoperative day (15.9 ± 15.2 mL vs 27.6 ± 23.5 mL; P = .023), and significantly lower drain durations (2.8 ± 1.0 days vs 3.3 ± 1.0 days; P = .030). Mean total drainage volume was lower where breast reduction was performed with PEAK PlasmaBlade™, but this difference was not significant. No major complications occurred, but wound‐healing disorders were documented in almost one‐third of the patients (35.0%, n = 7). The PEAK PlasmaBlade™ seems to be superior to conventional electrosurgery for bilateral reduction mammaplasty in terms of tissue damage and wound healing.

1. INTRODUCTION

Bilateral breast reduction surgery (reduction mammaplasty) is one of the most commonly performed plastic surgery procedures and involves surgical removal of excess breast tissue from both female breasts. The combination of removing breast fat, glandular tissue, and skin allows the surgeon to decrease breast weight and restructure the breast to a more pleasing appearance. ¹ The indications for reduction mammaplasty include aesthetic concerns and therapeutic reasons such as decrease of breast weight for treatment of complaints of breast and skeletal pain (mainly back and neck pain), ² , ³ ptosis, intertriginous skin disorders of the inter‐ or sub‐mammary fold, and psychological disorders. ⁴ , ⁵ When performed for therapeutic reasons, bilateral reduction mammaplasty is one of the few plastic surgeries that health insurance providers in many countries will recognise and routinely pay for. ⁶ , ⁷

Over the years, reduction mammaplasty techniques have been continually modified and refined to enhance aesthetic outcomes with minimal scarring and fewer complications. Complication rates for bilateral breast reduction vary between 4% and 54% in the literature, and rates of up to 63% have been described. ⁸ Mostly, complications seem to be minor, with wound‐healing disorders being the most common. ⁸ Factors associated with increased complication rates are an incorrect choice of surgical technique, body mass index ≥30 kg/m², higher resection weight, radiation therapy, smoking, and diabetes. ⁹ , ¹⁰

The choice of dissection technique may also play a role in the incidence of wound‐healing disorders. While traditional electrosurgical devices are considered the standard of care, they also use continuous‐wave, high‐frequency electrical current of alternating polarity, thereby generating considerable amounts of thermal energy. ¹¹ , ¹² Thus, this technique is associated with extensive thermal‐related collateral tissue damage. The pulsed electron avalanche knife (PEAK) PlasmaBlade™ (Medtronic, Minneapolis, Minnesota) is a novel low‐thermal plasma dissection device, which uses very short, high‐frequency pulses of radiofrequency energy to generate electrical plasma at the cutting edge of the instrument. The PEAK PlasmaBlade™ has significantly lower working temperatures than conventional electrosurgery devices but seems to demonstrate both the same level of accuracy as the scalpel and the same amount of bleeding control as traditional electrosurgery technologies. ¹¹ , ¹² The low‐thermal energy dissection technique has produced excellent results and reduced postoperative wound pain and seroma incidence in breast cancer surgery ¹³ , ¹⁴ and is thought to have a preventive effect on seroma in latissimus dorsi breast reconstruction procedures ¹⁵ and reduced drainage volumes in nipple‐sparing mastectomy. ¹⁶ Apart from a manufacturer‐sponsored clinical trial, ¹⁷ we were unable to identify a single study examining the operative performance of PEAK PlasmaBlade™ in breast reduction surgery. The aim of this study was, therefore, to examine the operative performance of PEAK PlasmaBlade™ in patients having bilateral reduction mammaplasty and compare them with traditional electrosurgery.

2. METHODS

2.1. Patients

We conducted a retrospective study of 20 patients who underwent bilateral breast reduction surgery as part of treatment for breast hypertrophy using Robbins inferior pedicled reduction mammaplasty technique. The surgeries took place between November 2018 and December 2019 at the Department for Plastic and Aesthetic, Reconstructive and Hand Surgery at the AGAPLESION Markus Hospital in Frankfurt am Main, Germany. Prior to surgery, we prospectively randomised patients’ operative sites. One breast was reduced using PEAK PlasmaBlade™, while the other breast was reduced using a traditional monopolar electrosurgical handpiece (Erbe VIO‐HF‐Surgery System, Tübingen; Germany). Thus, each patient served as her own control. Patients were unaware of which device was used on which breast.

From patients’ records, we collected

1. baseline data: age, body mass index, and preoperative haemoglobin levels

2. surgery‐related parameters: duration of surgery, length of hospital stay, subjective pain levels on the first day post‐surgery, and postoperative haemoglobin levels

3. information on possible complications: haematoma, seroma, wound‐healing disorders, and need for surgical revision

4. outcome measure‐related data: resection weight, drain output on the first postoperative day, total drainage volume, and duration of wound drain.

Patients’ subjective pain levels on the first day after surgery were measured by the operating surgeon using a visual analogue scale ranging from 0 (no pain at all) to 10 (extreme pain).

2.2. Surgical procedures

Bilateral breast reduction surgery was performed in all patients according to the inferior pedicle reduction pattern first described by Robbins. ¹⁸ First, preoperative markings, including bilateral breast meridians and intended inframammary fold, were drawn in while the patient was standing. The new nipple level was marked approximately 21 cm from the suprasternal notch. Finally, the proposed position of the areola and outlines of the inferior pedicle were marked.

Prior to surgery, adrenaline in saline (1:200 000) was injected subcutaneously along the incision lines. The inferior pedicle was first deepithelialised and then prepared until the fascia of the chest wall. Resection of skin, glandular tissue, and breast fat was performed according to the preoperative markings. The nipple‐areola complexes were brought to their new positions, after which the medial and lateral flap portions were brought together with stitches. Skin closure was performed after the placement of drains.

In each patient, the PEAK PlasmaBlade™ was used for skin incision, incision of subcutaneous tissue, and preparation until fascia on one breast. In contrast, the same incisions were performed with a standard monopolar electrosurgical device on the other breast. The PEAK PlasmaBlade™ device was used in combination with the PULSAR® II generator as its radiofrequency power source at either Cut level 5 or 6 (Cut modes: Low Cut Or Medium Cut) or Coag level 7 (Coag mode: High Coag). The device settings for the standard of care with Erbe VIO‐HF‐Surgery System for conventional electrosurgery were set to Cut: Auto Cut/Classic Coag (Forced Coag: Effect 2, max. 80 W; Dry Cut: Effect 4, max. 180 W) and Bipolar: Bipolar Soft Coag.

2.3. Ethical considerations

We informed all patients of the risks and benefits surrounding the procedures and obtained written informed consent for breast reduction surgery. We obtained ethics approval for this study from the institutional ethics committee before commencing. The study protocol followed the STROBE guidelines for observational studies and adheres to the ethical standards laid down in the Declaration of Helsinki.

2.4. Data analysis

Descriptive statistics were mainly used for data analysis. Clinical data are reported as means ± SD. Complications are presented as the number of cases and corresponding percentages. For comparative analyses, the Shapiro‐Wilk test was first used to test for normality. Differences in normally distributed data (P ≥ .01) were analysed using the t‐test, whereas not normally distributed data (P < .01) were evaluated with the Wilcoxon signed‐rank test. A P‐value of <.05 was defined as being statistically significant.

3. RESULTS

Mean patient age was 46.1 ± 12.6 years, and the average body mass index prior to surgery was 29.2 ± 6.1. The surgical procedures took 190.9 ± 38.0 minutes on average, with patients being discharged from the hospital after 3.4 ± 0.9 days. Baseline data and surgery‐related parameters are presented in Table 1.

TABLE 1.

Demographic and descriptive data of the patients (n = 20)

	Mean ± SD
Age (y)	46.1 ± 12.6
BMI (kg/m2)	29.2 ± 6.1
Duration of surgery (min)	190.9 ± 38.0
Length of in‐patient stay (d)	3.4 ± 0.9
Pain on first day after surgery	1.6 ± 0.9
Preoperative haemoglobin levels (g/dL)	13.3 ± 1.3
Postoperative haemoglobin levels (g/dL)	9.2 ± 0.7

The PEAK PlasmaBlade™ was used for breast reduction of the right breast in 10 patients and breast reduction of the left breast in the other 10 patients. Average resection weight was found to be significantly higher in breasts operated on with the PEAK PlasmaBlade™ (PEAK PlasmaBlade™: 728.0 ± 460.1 g vs traditional electrosurgery: 661.6 ± 463.4 g; P = .038, t‐test) (Figure 1). Drain output on the first postoperative day was significantly lower than when conventional electrosurgery was used (PEAK PlasmaBlade™: 15.9 ± 15.2 mL vs traditional electrosurgery: 27.6 ± 23.5 mL; P = .023, t‐test) (Figure 2). Total drainage volume was lower on average, where breast reduction had been performed with the PEAK PlasmaBlade™ (PEAK PlasmaBlade™: 51.2 ± 74.4 mL vs traditional electrosurgery: 70.6 ± 59.3 mL), but this difference was not significant (P = .186, t‐test). The duration of drainage was significantly shorter in breasts wherever the low‐thermal energy dissection device had been applied (PEAK PlasmaBlade™: 2.8 ± 1.0 days vs traditional electrosurgery: 3.3 ± 1.0 days; P = .030, Wilcoxon signed‐rank test) (Figure 3).

FIGURE 1.

Average resection weight for the PEAK PlasmaBlade™ and traditional electrosurgery

FIGURE 2.

Drainage volume on first day after surgery

FIGURE 3.

Duration of drainage

Because of the small sample size, analysis of complication rates was performed for the entire study cohort rather than according to dissection technique (PEAK PlasmaBlade™ or standard of care). All complications were minor, and no patient required revision surgery. Haematoma occurred in one patient (5%), whereas seroma was not observed in a single patient. Approximately one‐third of the patients (35.0%, n = 7) experienced some form of wound‐healing disorder. In contrast, two‐thirds of the patients (65.0%, n = 13) recovered from surgery without wound‐healing disorders. The distribution of minor wound‐healing disorders was equal in both groups, with no difference between the devices (Figures 4, 5 and 6).

FIGURE 4.

A‐C, Preoperative views of a 29‐year‐old female patient with breast hypertrophy

FIGURE 5.

Intraoperative view of the right breast performing deepithelisation with PlasmaBlade™

FIGURE 6.

A‐C, Postoperative views of the same patient 12 months following inferior dermal‐pyramidal‐pedicled breast reduction of 900 g in each breast

4. DISCUSSION

Bilateral reduction mammaplasty has evolved over the years from mere tissue removal to achieve highly aesthetic outcomes with minimal scarring. Uncomplicated postoperative healing is of great importance to both the patient and the surgeons as wound‐healing disorders often result in unfavourable outcomes, longer in‐patient hospital stay, and prolonged pain and discomfort. Although conventional electrosurgical instruments are valued for their efficacy in bleeding control and dissection ability, they have also been linked to extensive thermal‐related collateral tissue damage. ¹² Infrared analyses have shown that the PEAK PlasmaBlade™ cutting surface operates at temperatures between 40°C and 100°C, in contrast to the 250°C to 350°C measured in conventional electrosurgical instruments. ¹¹

While the use of traditional electrosurgical devices may be acceptable for many operations, we hypothesised that patients undergoing breast reduction surgery might benefit from the use of a low‐thermal energy dissection device, namely, PEAK PlasmaBlade™. In this study, we found that, while resection weight was approximately 10% higher in breasts when using the PEAK PlasmaBlade™, drainage volume on the first postoperative day was reduced by 32% compared with conventional electrosurgery.

In this study, we found the resection weight to be approximately 10% higher in breasts when using the PEAK PlasmaBlade™. The significant difference in resection weight between the two devices can most likely be attributed to the small patient cohort in this study as there were no notable breast asymmetries. According to our data, the difference in resection weight came to approximately 66 g, or 5% to 9% of the total resection weight. Although significant in this study, from a surgical standpoint, 66 g is a very small difference with little to no clinical relevance. Indeed, a difference in breast weight of 5% to 9% represents a difference that would most likely not be visible to the viewer pre‐ or postoperatively.

Drainage volume on the first postoperative day was reduced by 32% compared with conventional electrosurgery. Total drain output was also reduced by 27% when reduction mammaplasty was performed with PEAK PlasmaBlade™, but this difference was not significant. Our findings are consistent with some of the results in the literature in that they suggest improved wound‐healing dynamics for the PEAK PlasmaBlade™ device compared with standard of care. In bilateral breast reduction surgery, the PEAK PlasmaBlade™ displayed significantly shorter operating times, superior dissection performance (defined as the amount of tissue removal per minute), and higher resection weights. There was less blood loss in the PEAK PlasmaBlade™ group, but this difference was not significant (P = .147). ¹⁷ A secondary surgery for haematoma was required for one patient in the PEAK PlasmaBlade™ group, and the minor complication rate was 7.0% versus 9.3% for conventional electrosurgery. ¹⁷ The relatively high percentage of patients with complications in our study compared with the manufacturer‐funded research cited above may be attributed to differences in reporting complications, which included only serious adverse events, wound dehiscence, haematoma, and seroma. When used for breast cancer surgery, there was a significant reduction in seroma incidence in the PEAK PlasmaBlade™ group but no significant difference in surgical duration, length of hospital stay, and the number of postoperative medications. ¹⁴ That study was most likely limited by its small sample size of only 20 subjects, which could explain why many of the results did not reach statistical difference. In particular, a study published only a few months later with 44 subjects who underwent latissimus dorsi breast reconstruction was able to show significantly lower total drainage volumes, shorter hospital stay, and rate of seroma formation. ¹⁵

Similar results have been found for other types of operations as well. The use of PEAK PlasmaBlade™ for tonsillectomy in adults led to shorter time to pain‐free swallowing and patient satisfaction compared with monopolar electrocautery. ¹⁹ Adult patients treated with the PEAK PlasmaBlade™ had lower blood loss and needed fewer sutures versus cold dissection for tonsillectomy in a different study. ²⁰ Neither study observed any significant differences in duration of surgery, wound‐healing status, amount of postoperative pain, and postoperative complications. Tonsillectomy with the PEAK PlasmaBlade™ in children was associated with less postoperative bleeding and fewer visits to the emergency department. ²¹ In comparison, a retrospective chart analysis of 1280 paediatric patients with adenotonsillectomy showed the significantly faster surgical time for monopolar electrocautery versus the PEAK PlasmaBlade™ and radiofrequency ablation and insignificant differences in postoperative haemorrhaging. ²²

However, the same study found average overall procedural costs for the PEAK PlasmaBlade™ to be more than eight times as high as for monopolar electrocautery ($30.04 vs $246.95). ²² A randomised controlled trial comparing four different energy‐based tissue dissection techniques for abdominoplasty calculated much higher costs for the PEAK PlasmaBlade™, with no significant differences in wound‐healing complications and drainage quantity. ²³ In contrast, Kypta et al found significantly reduced procedure times and hospital stays for the PEAK PlasmaBlade™, as well as a cost savings of approximately €120 per patient in a retrospective analysis of techniques used for cardiovascular device replacement. ²⁴ A review suggested that these results may be largely dependent on the nature of the operation and inconsistencies in evidence. ²⁵ Longer operating times may also be attributed to the learning curve associated with transitioning from conventional electrosurgery devices to low‐thermal energy dissection devices. The within‐subject design of our study did not allow for cost analyses, so future research in the form of prospective clinical trials should include economic aspects.

This study has several limitations. First, the sample size with only 20 patients was rather small. Future studies should include larger sample sizes and be prospective in nature. Owing to the small sample size, we were unable to perform statistical analyses of complication rates for PEAK PlasmaBlade™ versus electrosurgery. Next, although the within‐patient study design has its advantages, it also limits the generalisability of study results. In addition, it only allowed for the comparison of breast‐related factors rather than patient‐related factors such as length of hospital stay or use of antibiotics. Finally, the study focussed only on immediate outcomes post‐surgery (during in‐patient stay), so more long‐term follow up is needed in order to evaluate outcomes such as differences in the amount of scarring, aesthetics, etc. Future studies will also have to address the aspect of procedural costs as, ideally, surgical instruments should be both cost‐ and time‐efficient, as well as have low complication rates.

5. CONCLUSION

The PEAK PlasmaBlade™ seems to be superior to conventional electrosurgery for bilateral reduction mammaplasty in terms of tissue damage and wound healing.

CONFLICT OF INTEREST

The authors declare no potential conflict of interest.

Schlosshauer T, Kiehlmann M, Rothenberger J, Sader R, Rieger UM. Bilateral reduction mammaplasty with pulsed electron avalanche knife PlasmaBlade™ and conventional electrosurgical surgery: A retrospective, randomised controlled clinical trial. Int Wound J. 2020;17:1695–1701. 10.1111/iwj.13452