A systematic review and meta-analysis of Harmonic technology compared with conventional techniques in mastectomy and breast-conserving surgery with lymphadenectomy for breast cancer

Abstract

Background

Mastectomy and breast-conserving surgery (BCS) are important treatment options for breast cancer patients. A previous meta-analysis demonstrated that the risk of certain complications can be reduced with the Harmonic technology compared with conventional methods in mastectomy. However, the meta-analysis did not include studies of BCS patients and focused on a subset of surgical complications. The objective of this study was to compare Harmonic technology and conventional techniques for a range of clinical outcomes and complications in both mastectomy and BCS patients, including axillary lymph node dissection.

Methods

A comprehensive literature search was performed for randomized controlled trials comparing Harmonic technology and conventional methods in breast cancer surgery. Outcome measures included blood loss, drainage volume, total complications, seroma, necrosis, wound infections, ecchymosis, hematoma, hospital length of stay, and operating time. Risk of bias was analyzed for all studies. Meta-analysis was performed using random-effects models for mean differences of continuous variables and a fixed-effects model for risk ratios of dichotomous variables.

Results

Twelve studies met the inclusion criteria. Across surgery types, compared to conventional techniques, Harmonic technology reduced total complications by 52% (P=0.002), seroma by 46% (P<0.0001), necrosis by 49% (P=0.04), postoperative chest wall drainage by 46% (P=0.0005), blood loss by 38% (P=0.0005), and length of stay by 22% (P=0.007). Although benefits generally appeared greatest in mastectomy patients with lymph node dissection, Harmonic technology showed significant reductions in complications in the BCS study subgroup.

Conclusion

In this meta-analysis of both mastectomy and BCS procedures, the use of Harmonic technology reduced the risk of most complications by about half across breast cancer surgery patients. These benefits may be due to superior hemostatic capabilities of Harmonic technology and better dissection, particularly lymph node dissection. Reduction in complications and other resource outcomes may engender lower downstream health care costs.

Keywords:

• dissection
• complications
• ultrasonic

Supplementary materials

Literature search strategy

The following search strategy was used in MEDLINE, where “MeSH” indicates Medical subject headings:

1. “harmonic scalpel” OR ultracision OR “ultrasonic scalpel” OR “ultrasonically activated scalpel” OR “ultrasound scalpel” OR “harmonic shears” OR “ultrasonic shears” OR “ultrasonic scissors” OR “laparosonic” OR “coagulating shears” OR “ultrasound shears” OR “ultrasonically activated shears” OR “harmonic blade” OR “ultrasonic blade” OR “harmonic hook” OR “ultrasonic hook” OR “Harmonic Focus” OR “Harmonic ACE” OR “Harmonic Wave” OR “Harmonic Synergy” [Title/Abstract]

2. “Comparative Study” OR “Controlled Clinical Trial” OR “Randomized Controlled Trial” [Publication Type]

3. Humans [MeSH]

4. #1 AND #2 AND #3

Table S1 Secondary analysis of dichotomous outcomes using the OR, Mantel–Haenszel method with a fixed-effects model

Acknowledgments

This study was supported by Ethicon, Inc.

Disclosure

HC, JWC, and PH are employees of Ethicon Inc., manufacturer of Harmonic devices. NCC, LP, IMS, and CGC are employees of Cornerstone Research Group, Inc., which conducts research on behalf of pharmaceutical and medical devices companies, including Ethicon, Inc.