Background
Breast cancer is still the most common malignant tumor in women worldwide [
1]. About every eighth woman will develop breast cancer in the course of her life [
2]. Surgical intervention, systemic therapy and radiation therapy and are the three pillars of breast cancer treatment. Today, in almost 80% of patients the tumor can be removed by breast-conserving surgery. However, a mastectomy, in which the entire mammary gland is removed, may still be unavoidable for certain indications [
3,
4].
This intervention can have significant consequences for the women concerned. In addition to physical impairments, psychosocial consequences, such as the feeling of a lack of femininity, can also be stressful. Breast reconstruction is therefore of essential importance in today’s oncoplastic breast surgery [
5,
6]. Breast reconstruction can be done with the help of the body’s own tissue or an artificial implant. When it comes to implant reconstruction, the selection of the right implant is crucial with regard to the functional and cosmetic result. In addition to standardized distance measurements, impression procedures or radiological imaging procedures, tissue-based planning can be used for implant selection [
7,
8]. Here, the observed dimensions and measurements guides the appropriate choice of the breast implant [
8]. Since objective selection criteria for optimal implant selection have not yet been sufficiently evaluated, many surgeons rely on their knowledge and subjective experience [
9].
The aim of our retrospective study is to identify objective parameters that can positively influence decision-making in favor of the optimal implant selection. To answer this question, we analyzed the correlation between the weight of the removed mammary tissue and the used implant volume. Moreover, the weight of the resected tissue and the volume of the implant were compared with the breast gland density measured by radiological imaging. Based on this data, we would like to provide breast surgeons with a new kind of calculation tool that could facilitate the selection of the implant and improve the functional and cosmetic result.
Materials and methods
Data acquisition
The data collection was based on the oncological documentation program ODSeasy® (Asthenis® GmbH, Aschheim, Germany) of the clinic and polyclinic for gynecology and obstetrics at the University of Cologne. Patient that received both a mastectomy and subsequently a breast implant between Jan 1, 2006, and Jan 31, 2018, were included in this retrospective study. Clinical parameters including TNM classification, hormone receptor status, tumor grading, indication and type of ablation were collected from patient’s files. The weight of the resected breast tissue was taken from the pathology report. The implant volume and breast density in mammography and MRI were found in the surgical and radiology report, accordingly. The resected weight contains the sum of the main operation and all documented surgical specimens of reoperations for incomplete tumor excision.
Inclusion and exclusion criteria
All patients had to have received a mastectomy followed by an implant reconstruction between Jan 1, 2006, and Jan 31, 2018, were included in the study. Breast-conserving therapy that had previously taken place did not lead to exclusion. Pre- or postoperative measures such as chemotherapy, radiation or endocrine therapies, as well as missing MRI or mammography findings did not constitute an exclusion criterion. The exclusion criteria were defined as information on the weight of the resected breast specimen, no information on the implants used, missing written pathological reports and patients who had undergone radical mastectomy without breast reconstruction or expander insertion.
Statistical procedure
The data collected were evaluated using the SPSS version 25 statistical software (IBM Corp., Armonk, NY, USA). Here, the breast densities (ACR) measured in mammography and MRI were compared on the basis of their four-stage division, both with the removed resected weight and with the volume of the implants used. In addition, the weight of the resected breast tissue was compared directly with the implant volume.
The Spearman rank correlation coefficient was calculated. This correlation coefficient gives a measure of the (monotonous) relationship between two variables. Its absolute values can vary between − 1 and + 1. Positive values correspond with positive correlations and vice versa values close to 1 indicating a high correlation and values close to zero pointing to a nonexistent correlation. All analyses are essentially explorative with p values ≤ 0.05 (*) indicating moderate evidence, p values ≤ 0.01 (**) intermediate evidence and p values ≤ 0.001 (***) strong evidence against the null hypothesis (e.g., zero correlation). The number of patients (Valid N), the mean value (Mean), the median, the standard deviation, the minimum and maximum as well as the 25th and 75th percentile were given in each comparison that we carried out.
The comparison between resected weight and implant volume was also shown in a potential function. The course of the function shows both disproportionate and disproportionate increases between the two variables, as well as the extent to which individual values deviate from the curve.
Discussion
Oncoplastic breast reconstruction is now generally accepted as an important part of the operative treatment of breast cancer patients. The goal here is to restore an aesthetic breast shape and symmetry. There is no recognized standard method for the selection of the appropriate implant [
10,
11]. The numerous techniques for pre- and intraoperative estimation of the implant size are often imprecise and prone to errors [
9,
12]. The preoperative estimation procedures include anthropometric volume estimation and volumetric analysis using ultrasound, mammography, computer tomography, magnetic resonance imaging and three-dimensional scanners. In addition, the thickness of the residual skin covering after mastectomy cannot be correctly estimated using this method [
9,
11].
One of the intraoperative estimation techniques is the “implant size method”, in which implant prostheses of different sizes are used one after another on a trial basis and thus gradually approach the ideal. This method is easy to implement, but costly because many implant sizes have to be stored in the operation room. In the “gauze swab implant estimation method”, the required volume is estimated using gauze swabs soaked in sodium chloride and also inserted into the implant pocket on a trial basis. Deviations in size and properties between the different manufacturers of the gauze can falsify this inexpensive method [
9,
12].
In addition, the final decision in favor of an implant is subjectively influenced in many cases by the experience, personal preferences and surgical skills of the surgeon [
9].
All of the methods mentioned for determining the breast volume are based on the same principle of determining the volume as accurately as possible by means of measurement technology directly on the individual, pre- or intraoperatively.
Our approach is based on the assumption that the ideal implant size can be derived from the ratio between the resected weight and the implant volume. In practice, it is obvious that the selected implants became larger as the amount of resected tissue increased. Our study confirms this observation. We were able to show that there is a significant correlation between the resected breast tissue and the implant volume. From this, we were able to derive a potential function. With this function, the appropriate implant volume can be calculated for any resected tissue directly in the OR, making it easier for the surgeon to select an optimal fitting implant.
We also examined whether breast density has an impact on the weight of the resected tissue and the volume of the implant. The idea is that higher densities in the tissue might result in higher weights. Thus, a breast with a higher percentage of parenchyma with the same volume should be heavier than one with a high percentage of fat. With breast reconstructions, however, it is assumed that the weight of the breast tissue corresponds to the volume of the breast tissue. Applied to reconstructive breast surgery, it would therefore be expected that a lower breast density is associated with a relatively smaller resected tissue weight, but must be compensated for with more implant volume. We were able to confirm this relationship on the basis of our data. It was shown here that with increasing ACR, i.e., higher breast density, a smaller implant was chosen. This observation is supported by a recent South Korean study. Here the actual volume was measured using the Archimedes principle based on the water displacement of resected breast tissue in saline solution. The study was able to show that the displaced volume decreases with increasing breast density [
13]. This correlation appears to be independent of the weight of the resected tissue since we could not find any significant connection between the ACR value and the weight of the resected tissue. Presumably, this could be explained by the observation that dense breasts contain less fat tissue and therefore might be smaller.
Using the newly generated formula, a more precise assessment of the implant size can then be made intraoperatively. Thus, the surgeon has a new tool for an objective pre- and intraoperative implant selection. The advantage compared to already established methods is the simple and quick implementation. There are hardly any costs because fewer implant sizes have to be kept available. In addition, subjective and therefore error-prone factors such as the surgeon's aesthetic preference based on a mathematical calculation of the implant selection have less influence.
This study has some limitations and further studies with higher numbers of cases are necessary to evaluate the clinical benefit in the routine. In particular patients with hypo- and macromastia were underrepresented in this study. For this subgroup, the formula might be inaccurate due to the fact that some patients with small breasts request a larger implant or a breast reduction surgery in case of macromastia. The formula might not be useful for the reconstruction of ptotic breasts since many patients might need a bigger implant than the volume to achieve a satisfactory cosmetic outcome. Furthermore, the informative value for patients with a low breast density is limited, since the group ACR I was underrepresented in this evaluation. Due to the retrospective nature of the study, no data on the postoperative aesthetic outcome could be collected. In this regard, further studies should check whether the result obtained with this formula for surgery achieves the same patient satisfaction compared to established methods and, if necessary, could even improve it for inexperienced surgeons. A practical application of our approach would be the future integration of the formula into software that could be used at any time on-site using a smartphone or computer.
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