This study is the most comprehensive meta-analysis to date of RCTs for breast cancer surgeries comparing Harmonic technology to conventional techniques and evaluating a wide range of breast surgery complications. Overall, the randomized trials included in this study were deemed to be of high quality with a fairly low risk of bias. The results of this analysis remained robust to a variety of sensitivity analyses excluding studies that were less methodologically rigorous and using different statistical measures for rare events. Specifically, we used the relative risk measure for all dichotomous outcomes in the primary analysis to enhance interpretability of the study results. In a secondary analysis, all dichotomous outcomes were analyzed using ORs, with the Peto ORs being calculated for outcomes reporting rare events. This method was considered the least biased and most powerful method providing the best CI coverage for rare events.43
This study has some limitations. First, high heterogeneity was observed for some continuous outcome measures such as intraoperative blood loss and operating time. This may, in part, be due to the variability in surgeon technique and operating methods used during the surgical procedure and was addressed through the use of a random-effects model. Conversely, statistical heterogeneity was found to be very low for dichotomous, complication-related outcomes. Second, data were not sufficient to be statistically combined in this meta-analysis for the outcome of postoperative pain in the few studies that assessed this outcome given some missing variance measures. In the two studies that reported visual analog scale pain scores,30,33 results appeared favorable for Harmonic technology compared with conventional techniques in mastectomy; however, in one study, the P-value was not reported. Furthermore, methodological limitations precluded analysis of the outcome of mean number of lymph nodes dissected. Two studies noted a numerically greater number of lymph nodes dissected with Harmonic technology compared with conventional care in breast surgery.6,7 Although these two studies could not be statistically pooled, other clinical studies using Harmonic technology support this observation.44–46 For example, one study in gastric surgery reported that approximately five more lymph nodes were dissected with Harmonic technology compared with conventional care (P<0.05).44 Harmonic technology is reported to facilitate lymph node dissection based on the generation of an “empty” effect, whereby adipose tissue is vaporized and a three-dimensional operation space is created, which facilitates the separation of the lymph nodes and lymphatic tissue from the large blood vessels.47 Harmonic technology can thereby coagulate the small lymph node hilar vasculature more easily, resulting in a smooth dissection.47 Finally, data were not available to evaluate the important outcome of lymphedema in breast cancer surgery patients. This is due to the limited follow-up time of the included studies, as additional years of data would be required in order to accurately assess this outcome or other sequelae such as cancer recurrence or mortality.
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CONCLUSION
The current meta-analysis demonstrates that Harmonic technology can significantly reduce the risk of surgical complications, such as overall seroma, blood loss, and necrosis in breast cancer surgery patients compared with conventional methods. Furthermore, Harmonic technology demonstrates significant reductions in postoperative drainage of the chest wall and hospital length of stay, which may be attributed to reduced complications. These demonstrated that reductions in surgical complications with Harmonic technology may ultimately assist in reducing associated downstream health care costs, while offering several clinical advantages in breast cancer surgery.
Acknowledgment
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.
Hang Cheng,1 Jeffrey W. Clymer,1 Nicole C. Ferko,2 Leena Patel,2 Ireena M. Soleas,2 Chris G. Cameron,2 Piet Hinoul1
1Ethicon Inc., Cincinnati, OH, USA; 2Cornerstone Research Group, Burlington, ON, Canada
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