Commentary on: Identification of Predictive Factors for Patient-Reported Outcomes in the Prospective Australian Breast Device Registry Free

See the Original Article here.

I appreciate the opportunity to comment on the article “Identification of Factors Predictive for Patient Reported Outcomes in the Prospective Australian Breast Device Registry.” ¹ The authors are to be commended, once again, for implementation of the BREAST-Q Implant Surveillance (BREAST-IS) module—this time on a large scale within the Australian Breast Device Registry (ABDR). The IS module was developed from the pioneering BREAST-Q outcome measure.² The pilot study on the ABDR provided proof of concept.³ The stated goal of this report is to “…develop appropriate risk-adjustment models for the benchmarking of PROMs (Patient-Reported Outcomes Measures) data to accurately identify outliers in an equitable manner.”¹

Both surgeons and regulatory bodies seek to optimize patient outcomes and minimize complications and reoperations. The ability to measure and recognize results both in terms of the surgical procedure itself and with the utilization of implants has historically relied on visual and tactile assessment of the outcome as well as the statistical incidence of reoperation for revision, capsular contracture, and implant replacement.

The BREAST-Q is a validated means of assessing outcomes and, as has been previously demonstrated, can provide an early indication of possible issues with breast implants. By benchmarking the various outcomes, the possibility exists of identifying specific contributing factors to both good and inferior procedures and devices, and possibly surgeons and institutions as well.

Although specifics were not given in this report, the authors utilized a rather innovative method to obtain follow-up at 1 year, with a combination of text messaging, phone calls, and emails. This resulted in an acceptable follow-up of 70%.⁴ They are to be commended for seeking current, innovative, and cost-effective methods to achieve sufficient follow-up. It remains to be seen what the percentages will be at 2, 5, and 10 years.

The current study was expanded to 2221 reconstructive and 12,045 cosmetic primary breast implant cases with 1-year follow-up patient-reported outcomes measures. Going forward, the ABDR will assess these patients at 2, 5, and 10 years. In terms of methodology, there are acknowledged limitations in that only data recorded initially by the ABDR are available. For example, postoperative radiation therapy was not recorded and therefore cannot be assessed. As noted by the authors, potentially confounding factors such as smoking, BMI, postoperative radiation therapy, and preoperative breast size are not included; thus, their possible impact cannot be evaluated.

Utilization of acellular dermal matrix is mentioned; however, specifics of coverage—anterior, partial, or complete—do not appear to be included. Specific utilization of synthetic mesh is not noted despite the fact that its utilization appears to be growing rapidly in prepectoral, direct-to-implant reconstructions worldwide.

Additionally, no mention is made of autologous fat grafting, which has expanded significantly in the past few years as both a primary and secondary procedure. This is particularly significant in that the results from the utilization of BREAST-IS in the ABDR tend to show that those cases with minimal or impaired soft tissue cover have a higher incidence of dissatisfaction. In particular, surgical plane of insertion was the most significant factor in the univariate analysis for aesthetic implant feel. Site type, acellular dermal matrix utilization, and nipple-sparing procedures were all associated with rippling. Radiation therapy and surgical plane were associated with tightness. In many of these cases, the utilization of autologous fat grafting is known to correct or minimize the issue. It is important to sort out these soft tissue factors such that we do not blame the implant for a problem more likely related to thin soft tissue cover or radiation effect.

The above critique should not take away from the significance of the development of this tool and the fact that the stated intent was to provide risk-adjustment to assure fair comparison of PROs. This marks a huge improvement in data analysis for implants and breast surgery in general but also provides the potential for being the “canary in the coal mine” regarding possible issues with breast implants and new procedures or combinations of both. Additionally, we should be able to isolate instances where the “x-factor” is the surgeon—including the oncologic surgeon in mastectomy cases. Most seasoned reconstructive plastic surgeons state that the most important contributor to optimal breast reconstruction results is who is performing the mastectomy in terms of flap thickness, over-dissection, removal of fascia, etc.

We previously relied on experience and opinion. The utilization of the BREAST-IS to obtain meaningful data should allow us to pinpoint and treat the causation of many of the issues related to these increasingly complex procedures and make the necessary changes to optimize patient outcomes.

Disclosures

The author declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.

Funding

The author received no financial support for the research, authorship, and publication of this article.

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