Aesthetic Surgery Journal http://aes.sagepub.com/
Evidence-Based Evaluation Technique to Assess Augmentation Mammaplasty Results: A Simple Method to Objectively Analyze Mammary Symmetry and Position Marco Mazzocchi, Luca Andrea Dessy, Nefer Fallico, Carmine Alfano and Nicolò Scuderi Aesthetic Surgery Journal 2014 34: 1205 originally published online 30 September 2014 DOI: 10.1177/1090820X14545617 The online version of this article can be found at: http://aes.sagepub.com/content/34/8/1205
Published by: http://www.sagepublications.com
On behalf of:
American Society for Aesthetic Plastic Surgery
Additional services and information for Aesthetic Surgery Journal can be found at: Email Alerts: http://aes.sagepub.com/cgi/alerts Subscriptions: http://aes.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav
>> Version of Record - Oct 29, 2014 OnlineFirst Version of Record - Sep 30, 2014 What is This?
Downloaded from aes.sagepub.com at UCSF LIBRARY & CKM on November 23, 2014
AESXXX10.1177/1090820X14545617Aesthetic Surgery JournalMazzocchi et al
IBUTION TR
AL CON ON
ERN INT ATI
545617
research-article2014
Breast Surgery
Evidence-Based Evaluation Technique to Assess Augmentation Mammaplasty Results: A Simple Method to Objectively Analyze Mammary Symmetry and Position
Aesthetic Surgery Journal 2014, Vol. 34(8) 1205–1220 © 2014 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: http://www. sagepub.com/ journalsPermissions.nav DOI: 10.1177/1090820X14545617 www.aestheticsurgeryjournal.com
Marco Mazzocchi, MD, PhD; Luca Andrea Dessy, MD, PhD; Nefer Fallico, MD; Carmine Alfano, MD; and Nicolò Scuderi, MD
Abstract Background: Despite the great variety of mammaplasty techniques, outcome assessment remains a challenging issue. Objectives: The authors devised an objective method to evaluate mammary symmetry based on statistical analysis of objective manual breast measurements and validated the method by applying it to results of a randomized controlled trial on the correction of breast asymmetry. Methods: Sixty consecutive patients with hypoplastic breasts and small-volume asymmetry were enrolled in the study and randomly assigned to 1 of 2 groups. One group received a fixed-volume implant in 1 breast and an adjustable-volume implant in the other. The other group received 2 fixed-volume implants of different sizes. The differences in specific breast and chest measurements, obtained before surgery and during follow-up, were analyzed statistically with the Wilcoxon signed rank test. Results: Correction of the asymmetry resulted in the reduction of the differences between left and right values for each specific breast measurement. Placement of an adjustable implant on 1 side yielded better symmetry than placement of 2 fixed-volume prostheses of different sizes. Patient and physician satisfaction was high for both groups. Conclusions: This objective analysis of clinical parameters enables comparing results for different patients in large clinical trials and for the same patient at different follow-up periods. Level of Evidence: 3 Keywords mammaplasty results, mammary symmetry and position, evaluation techniques Accepted for publication March 20, 2014. Plastic surgery of the breast has garnered considerable research attention, which has led to a wide variety of augmentation mammaplasty techniques being available for clinical practice. However, the assessment of mammaplasty outcomes remains challenging for plastic surgeons because standard methods are lacking to objectively analyze mammary symmetry, position, and variations throughout follow-up. Although factors such as breast size, shape, and proportion1-4 are generally regarded as important, an objective quantifiable determinant of breast aesthetics has not been universally acknowledged.5 Although several reproducible measurement techniques have been proposed, none has been adopted in clinical practice because they are either very complex or expensive.
Therefore, the evaluation of breast surgery outcomes remains subjective, visual, and not reproducible.6,7
Dr Mazzocchi is an assistant professor and Dr Alfano is head professor in the Department of Plastic and Reconstructive Surgery, University of Perugia, Italy. Dr Dessy is a consultant, Dr Fallico is a resident, and Dr Scuderi is Head Professor in the Department of Plastic and Reconstructive Surgery, “Sapienza” University of Rome, Italy. Corresponding Author: Dr Nefer Fallico, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy. E-mail: [email protected]
Downloaded from aes.sagepub.com at UCSF LIBRARY & CKM on November 23, 2014
1206
Aesthetic Surgery Journal 34(8)
We introduce a simple method to objectively assess breast symmetry and position after augmentation mammaplasty. We applied this method to analyze symmetry results from a prospective randomized controlled trial designed to determine whether patients with small-volume asymmetry had better outcomes from different-sized fixed-volume implants or from an adjustable implant on the smaller side and a fixed-volume device on the contralateral side. Smallvolume asymmetry was defined as a volume difference of 30 mL to 70 mL between the breasts.
Methods Statistical Analysis of Objective Measurements Method Differences between breast and chest measurements obtained before surgery and during follow-up can be analyzed statistically by a parametric (eg, t test) or a nonparametric test (eg, Wilcoxon matched pairs signed-rank test), depending on the size of the study group. It is important that statistical significance be set below 5% probability (P < .05) to minimize the likelihood of type I errors (falsepositive findings). Before surgery and during follow-up visits, standard objective measurements are obtained.8 Manual measurements pertain to the breast or the chest. Breast-specific measurements obtained for each breast include the following distances: from the jugular notch to the nipple, from the midclavicular point to the nipple, from the sternum to the nipple, from the midarmpit to the nipple, and from the inframammary fold (IMF) to the nipple (Figure 1). Chestspecific circumferences are measured at the nipple-areola complex (NAC) and the IMF, while the lungs are full as well as empty (Figure 2). To maximize objectivity, 3 consecutive measurements are taken for every chest and breast distance, and the mean of the 3 measurements is calculated and utilized for analysis. Differences in measurements between each breast denote asymmetry. The statistical significance of changes in these differences postsurgery, noted during follow-up visits, permits assessment of the degree of symmetry achieved by the surgery. Chest-specific measurements also are useful for detecting changes in breast size. These measurements are particularly helpful for assessing maintenance of prosthesis volume over time, as noted in a study on breast implants filled with soybean oil.9 In fact, both circumference measurements (NAC and IMF) can change after surgery because of postoperative edema and variations in soft- tissue thickness, and the NAC circumference also can be affected by changes in prosthesis size. Because such measurements are obtained routinely both pre- and postsurgery, this method of analysis is easy
to perform, objective, reproducible, inexpensive, and efficient. (However, a disadvantage of this method is that precision may be compromised somewhat because the measurements are obtained manually.) We recently applied this method to a study involving placement of adjustable-volume breast implants to correct hypoplastic breasts that had small-volume asymmetry.10 The statistical analysis allowed comparison between preand postoperative values, confirming or repudiating the achievement of breast symmetry and, in turn, the utility of the type of implant placed.
Application of the Statistical Analysis of Objective Measurements Method Between January 2009 and January 2012, a total of 60 consecutive women with hypoplastic breasts and small-volume asymmetry presented for augmentation mammaplasty and were enrolled in a prospective randomized controlled trial. In our series, 13 patients had iatrogenic breast asymmetry secondary to benign mass ablation. None of the patients underwent previous breast augmentation. The institutional review board at “Sapienza” University of Rome, Italy, approved the study, and all patients provided written informed consent before study initiation and were treated at Sapienza University of Rome in the Department of Plastic Surgery. Patients with congenital or iatrogenic breast asymmetry were eligible for participation 6 months after the initial surgery, including women who had undergone previous breast surgery if they presented with smallvolume asymmetry. Patients who underwent previous breast surgery were only operated on for benign mass ablation. Preoperatively, all patients underwent mammary ultrasonography; 4 women (aged 36-38 years) also underwent mammography to evaluate the quality of mammary tissue. Patients were randomly assigned to group A (n = 30) or group B (n = 30). The most appropriate implant pocket (subglandular, subpectoral, or dual plane) was selected for each patient after evaluating soft-tissue coverage and the degree of breast ptosis.11,12 In group A, the selected implant pocket was subglandular in 11 cases, subpectoral in 11, and dual plane in 8. In group B, the pocket was subglandular in 12 cases, subpectoral in 10, and dual plane in 8. Group A patients received a textured, fixed-volume, round Siltex Cohesive Gel I implant (size range, 275-375 cc; Mentor Corp, Santa Barbara, California) in the larger breast and an adjustable-volume implant with a textured surface (size range, 250-355 cc; commercially available as Spectrum in the United States and as Spectra in Europe [Mentor Corp]) in the smaller breast. Implant diameter was the same for both breasts. The inner chamber of the adjustable implant was filled with sodium chloride intraoperatively (mean volume, 47 cc; range, 35-50 cc).
Downloaded from aes.sagepub.com at UCSF LIBRARY & CKM on November 23, 2014
Mazzocchi et al 1207
Figure 1. Standard objective measurements of the breast: (A) jugular notch to nipple, (B) midclavicular point to nipple, (C) sternum to nipple, (D) midarmpit to nipple, and (E) inframammary fold to nipple.
Group B patients received a textured, fixed-volume, round, Cohesive Gel I implant (size range, 275-375 cc; Mentor Corp) in each breast; the prostheses differed in volume and diameter. One of 2 surgeons performed all procedures and assessments (L.A.D. or M.M.). Before surgery and during all follow-up visits (scheduled at 1, 4, and 12 months postsurgery), standard digital photographs were obtained (frontal, oblique, and lateral views, with arms down and up), along with standard objective measurements of the breast and chest (Figures 1
and 2). Differences in values between the breasts were calculated for each patient to evaluate the degree of symmetry attained. Differences in specific breast and chest measurements taken before surgery and during follow-up visits were analyzed statistically with the Wilcoxon signed-rank test. Statistical significance was defined as P < .05, and all confidence intervals were 95% values. Statistical analyses were performed with SPSS (SPSS, Inc, an IBM Company, Chicago, Illinois).
Downloaded from aes.sagepub.com at UCSF LIBRARY & CKM on November 23, 2014
1208
Aesthetic Surgery Journal 34(8)
Figure 2. Measurement of chest-specific circumferences at (A) the nipple-areola complex and (B) the inframammary fold, with the lungs both full and empty (C and D, respectively).
Patient satisfaction was assessed by responses to a questionnaire administered in person by a nurse at the 1-year follow-up visit (Appendix A; A VAS scale ranging from 0 [no improvement] to [10 maximum improvement] was provided for answering question 11 in the Patient Satisfaction Questionnaire. Available online at www.aestheticsurgeryjournal.com). Breast appearance was evaluated subjectively by the patient at the same time point. The patient’s global impression of clinical improvement was rated on a visual analog scale (VAS) of 1 to 10 (1 = no improvement, 10 = maximum improvement). Breast symmetry was assessed by an external panel of physicians 1 year postsurgery, based on subjective impression of differences between preoperative and postoperative photographs, and was scored on the same VAS. We chose not to consider implant pocket in the evaluations because the aim of the study was to assess a method to evaluate breast asymmetry rather than the best surgical technique to correct the asymmetry. However, no meaningful differences were noted with respect to implant location.
Results The mean age of the 60 patients was 30 years, 4 months (range, 19-38 years; median, 29 years). Each study group
(A, B) comprised 30 patients. Mean body mass index (BMI) was 19.03 kg/m2 in group A (range, 16.96-24.71 kg/m2; median, 19.62 kg/m2) and 19.57 kg/m2 in group B (range, 17.08-25.04 kg/m2; median, 20.02 kg/m2). Thirty-two patients (53% of 60), 15 from group A and 17 from group B, presented with bilateral developmental hypoplasia and small-volume asymmetry. Fifteen patients (25% of 60), 8 from group A and 7 from group B, presented with small-volume breast asymmetry and moderate ptosis. Thirteen patients (21.7% of 60), 7 from group A and 6 from group B, presented with unilateral iatrogenic hypoplasia as a result of previous surgical intervention (benign mass ablation). All patients in both groups presented with at least a grade I breast ptosis, but 15 actually had a moderate (grade II) ptosis.13 The duration of follow-up was 12 months for all patients in both groups. No patients were lost during follow-up. Interim postoperative measurements also were obtained at 1 and 4 months. The mean length of hospitalization was 1.75 days (range, 1-3 days). Early complications that occurred in group A (30 patients) were delayed wound healing on the side with the adjustable implant (n = 1; 3.33%) and 1 case each of hematoma (3.33%) and seroma (3.33%) on the side with
Downloaded from aes.sagepub.com at UCSF LIBRARY & CKM on November 23, 2014
Mazzocchi et al 1209 Table 1. Group A: Mean Differences in Breast Measurements Between Left and Right Breasts and Statistical Significance of the Differencesa Mean Difference in Breast Measurement (cm) ± Standard Deviation Time
Jugular Notch to Nipple
Midclavicle to Nipple
Sternum to Nipple
Midarmpit to Nipple
IMF to Nipple
T0
0.533 ± 0.2005
0.593 ± 0.0572
0.470 ± 0.2193
0.210 ± 0.1184
0.930 ± 0.8251
T1
0.046 ± 0.0730
0.050 ± 0.0572
0.466 ± 0.0498
0.030 ± 0.0534
0.123 ± 0.1612
T2
0.053 ± 0.0681
0.063 ± 0.0718
0.0533 ± 0.0499
0.036 ± 0.0668
0.124 ± 0.1568
T3
0.063 ± 0.0649
0.063 ± 0.0719
0.0633 ± 0.0481
0.043 ± 0.0504
0.126 ± 0.1617
P Values (Wilcoxon Signed-Rank Test)
T0-T1
.05
Abbreviations: IMF, inframammary fold; T0, presurgery; T1, 1 month postsurgery; T2, 4 months postsurgery; T3, 1 year postsurgery. a The bold P values denote statistically significant differences. Data in the top section of the table are mean differences between the left and the right breasts before surgery and at various followup points. In the bottom section, the statistical significance between pre- and postoperative values is shown.
the fixed-volume prosthesis. In group B (30 patients), we observed 1 case (3.33%) of hematoma and 1 case (3.33%) of seroma. None of these complications (in either group) had a negative effect on the ultimate achievement of breast symmetry. No major late complications occurred during the 1-year follow-up.
The mean differences and standard deviations in specific breast measurements, as well as their statistical significance, are summarized in Table 1 (group A) and Table 2 (group B). Data for specific chest circumferences are summarized in Table 3 (group A) and Table 4 (group B). Group A had better symmetry postoperatively (Tables 1
Table 2. Group B: Mean Differences in Breast Measurements Between Left and Right Breasts and Statistical Significance of the Differencesa Mean Difference in Breast Measurement (cm) ± Standard Deviation Time
Jugular Notch to Nipple
Midclavicle to Nipple
Sternum to Nipple
Midarmpit to Nipple
IMF to Nipple
T0
0.346 ± 0.3471
0.390 ± 0.4037
0.430 ± 0.3064
0.533 ± 0.2523
0.606 ± 0.4463
T1
0.193 ± 0.2839
0.173 ± 0.2911
0.236 ± 0.3285
0.366 ± 0.2684
0.056 ± 0.0678
T2
0.166 ± 0.2669
0.183 ± 0.2972
0.190 ± 0.3166
0.240 ± 0.2268
0.063 ± 0.0764
T3
0.173 ± 0.2651
0.166 ± 0.2733
0.193 ± 0.3150
0.246 ± 0.2208
0.070 ± 0.0836
P Values (Wilcoxon Signed-Rank Test)
T0-T1
.05
Abbreviations: IMF, inframammary fold; T0, presurgery; T1, 1 month postsurgery; T2, 4 months postsurgery; T3, 1 year postsurgery. The bold P values denote statistically significant differences. Data in the top section of the table are mean differences between the left and the right breasts before surgery and at various followup points. In the bottom section, the statistical significance between pre- and postoperative values is shown. a
Downloaded from aes.sagepub.com at UCSF LIBRARY & CKM on November 23, 2014
1210
Aesthetic Surgery Journal 34(8)
Table 3. Group A: Mean Differences in Chest Measurements at Maximum and Minimum Inspiration and Statistical Significance of Differencesa Mean Difference in Chest Measurement (cm) ± Standard Deviation At Nipple-Areola Complex
At Inframammary Fold
Maximum Inspiration
Maximum Expiration
Maximum Inspiration
Maximum Expiration
T0
84.48 ± 2.251
80.84 ± 1.771
77.54 ± 1.519
72.52 ± 1.783
T1
91.79 ± 2.649
88.43 ± 1.852
77.88 ± 1.529
73.15 ± 1.812
T2
91.36 ± 2.665
87.91 ± 1.882
77.47 ± 1.467
72.22 ± 1.684
T3
91.33 ± 2.657
87.92 ± 1.870
77.57 ± 1.513
72.45 ± 1.703
Time
P Values (Wilcoxon Signed-Rank Test)
T0-T1
Evidence-Based Evaluation Technique to Assess Augmentation Mammaplasty Results: A Simple Method to Objectively Analyze Mammary Symmetry and Position Marco Mazzocchi, Luca Andrea Dessy, Nefer Fallico, Carmine Alfano and Nicolò Scuderi Aesthetic Surgery Journal 2014 34: 1205 originally published online 30 September 2014 DOI: 10.1177/1090820X14545617 The online version of this article can be found at: http://aes.sagepub.com/content/34/8/1205
Published by: http://www.sagepublications.com
On behalf of:
American Society for Aesthetic Plastic Surgery
Additional services and information for Aesthetic Surgery Journal can be found at: Email Alerts: http://aes.sagepub.com/cgi/alerts Subscriptions: http://aes.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav
>> Version of Record - Oct 29, 2014 OnlineFirst Version of Record - Sep 30, 2014 What is This?
Downloaded from aes.sagepub.com at UCSF LIBRARY & CKM on November 23, 2014
AESXXX10.1177/1090820X14545617Aesthetic Surgery JournalMazzocchi et al
IBUTION TR
AL CON ON
ERN INT ATI
545617
research-article2014
Breast Surgery
Evidence-Based Evaluation Technique to Assess Augmentation Mammaplasty Results: A Simple Method to Objectively Analyze Mammary Symmetry and Position
Aesthetic Surgery Journal 2014, Vol. 34(8) 1205–1220 © 2014 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: http://www. sagepub.com/ journalsPermissions.nav DOI: 10.1177/1090820X14545617 www.aestheticsurgeryjournal.com
Marco Mazzocchi, MD, PhD; Luca Andrea Dessy, MD, PhD; Nefer Fallico, MD; Carmine Alfano, MD; and Nicolò Scuderi, MD
Abstract Background: Despite the great variety of mammaplasty techniques, outcome assessment remains a challenging issue. Objectives: The authors devised an objective method to evaluate mammary symmetry based on statistical analysis of objective manual breast measurements and validated the method by applying it to results of a randomized controlled trial on the correction of breast asymmetry. Methods: Sixty consecutive patients with hypoplastic breasts and small-volume asymmetry were enrolled in the study and randomly assigned to 1 of 2 groups. One group received a fixed-volume implant in 1 breast and an adjustable-volume implant in the other. The other group received 2 fixed-volume implants of different sizes. The differences in specific breast and chest measurements, obtained before surgery and during follow-up, were analyzed statistically with the Wilcoxon signed rank test. Results: Correction of the asymmetry resulted in the reduction of the differences between left and right values for each specific breast measurement. Placement of an adjustable implant on 1 side yielded better symmetry than placement of 2 fixed-volume prostheses of different sizes. Patient and physician satisfaction was high for both groups. Conclusions: This objective analysis of clinical parameters enables comparing results for different patients in large clinical trials and for the same patient at different follow-up periods. Level of Evidence: 3 Keywords mammaplasty results, mammary symmetry and position, evaluation techniques Accepted for publication March 20, 2014. Plastic surgery of the breast has garnered considerable research attention, which has led to a wide variety of augmentation mammaplasty techniques being available for clinical practice. However, the assessment of mammaplasty outcomes remains challenging for plastic surgeons because standard methods are lacking to objectively analyze mammary symmetry, position, and variations throughout follow-up. Although factors such as breast size, shape, and proportion1-4 are generally regarded as important, an objective quantifiable determinant of breast aesthetics has not been universally acknowledged.5 Although several reproducible measurement techniques have been proposed, none has been adopted in clinical practice because they are either very complex or expensive.
Therefore, the evaluation of breast surgery outcomes remains subjective, visual, and not reproducible.6,7
Dr Mazzocchi is an assistant professor and Dr Alfano is head professor in the Department of Plastic and Reconstructive Surgery, University of Perugia, Italy. Dr Dessy is a consultant, Dr Fallico is a resident, and Dr Scuderi is Head Professor in the Department of Plastic and Reconstructive Surgery, “Sapienza” University of Rome, Italy. Corresponding Author: Dr Nefer Fallico, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy. E-mail: [email protected]
Downloaded from aes.sagepub.com at UCSF LIBRARY & CKM on November 23, 2014
1206
Aesthetic Surgery Journal 34(8)
We introduce a simple method to objectively assess breast symmetry and position after augmentation mammaplasty. We applied this method to analyze symmetry results from a prospective randomized controlled trial designed to determine whether patients with small-volume asymmetry had better outcomes from different-sized fixed-volume implants or from an adjustable implant on the smaller side and a fixed-volume device on the contralateral side. Smallvolume asymmetry was defined as a volume difference of 30 mL to 70 mL between the breasts.
Methods Statistical Analysis of Objective Measurements Method Differences between breast and chest measurements obtained before surgery and during follow-up can be analyzed statistically by a parametric (eg, t test) or a nonparametric test (eg, Wilcoxon matched pairs signed-rank test), depending on the size of the study group. It is important that statistical significance be set below 5% probability (P < .05) to minimize the likelihood of type I errors (falsepositive findings). Before surgery and during follow-up visits, standard objective measurements are obtained.8 Manual measurements pertain to the breast or the chest. Breast-specific measurements obtained for each breast include the following distances: from the jugular notch to the nipple, from the midclavicular point to the nipple, from the sternum to the nipple, from the midarmpit to the nipple, and from the inframammary fold (IMF) to the nipple (Figure 1). Chestspecific circumferences are measured at the nipple-areola complex (NAC) and the IMF, while the lungs are full as well as empty (Figure 2). To maximize objectivity, 3 consecutive measurements are taken for every chest and breast distance, and the mean of the 3 measurements is calculated and utilized for analysis. Differences in measurements between each breast denote asymmetry. The statistical significance of changes in these differences postsurgery, noted during follow-up visits, permits assessment of the degree of symmetry achieved by the surgery. Chest-specific measurements also are useful for detecting changes in breast size. These measurements are particularly helpful for assessing maintenance of prosthesis volume over time, as noted in a study on breast implants filled with soybean oil.9 In fact, both circumference measurements (NAC and IMF) can change after surgery because of postoperative edema and variations in soft- tissue thickness, and the NAC circumference also can be affected by changes in prosthesis size. Because such measurements are obtained routinely both pre- and postsurgery, this method of analysis is easy
to perform, objective, reproducible, inexpensive, and efficient. (However, a disadvantage of this method is that precision may be compromised somewhat because the measurements are obtained manually.) We recently applied this method to a study involving placement of adjustable-volume breast implants to correct hypoplastic breasts that had small-volume asymmetry.10 The statistical analysis allowed comparison between preand postoperative values, confirming or repudiating the achievement of breast symmetry and, in turn, the utility of the type of implant placed.
Application of the Statistical Analysis of Objective Measurements Method Between January 2009 and January 2012, a total of 60 consecutive women with hypoplastic breasts and small-volume asymmetry presented for augmentation mammaplasty and were enrolled in a prospective randomized controlled trial. In our series, 13 patients had iatrogenic breast asymmetry secondary to benign mass ablation. None of the patients underwent previous breast augmentation. The institutional review board at “Sapienza” University of Rome, Italy, approved the study, and all patients provided written informed consent before study initiation and were treated at Sapienza University of Rome in the Department of Plastic Surgery. Patients with congenital or iatrogenic breast asymmetry were eligible for participation 6 months after the initial surgery, including women who had undergone previous breast surgery if they presented with smallvolume asymmetry. Patients who underwent previous breast surgery were only operated on for benign mass ablation. Preoperatively, all patients underwent mammary ultrasonography; 4 women (aged 36-38 years) also underwent mammography to evaluate the quality of mammary tissue. Patients were randomly assigned to group A (n = 30) or group B (n = 30). The most appropriate implant pocket (subglandular, subpectoral, or dual plane) was selected for each patient after evaluating soft-tissue coverage and the degree of breast ptosis.11,12 In group A, the selected implant pocket was subglandular in 11 cases, subpectoral in 11, and dual plane in 8. In group B, the pocket was subglandular in 12 cases, subpectoral in 10, and dual plane in 8. Group A patients received a textured, fixed-volume, round Siltex Cohesive Gel I implant (size range, 275-375 cc; Mentor Corp, Santa Barbara, California) in the larger breast and an adjustable-volume implant with a textured surface (size range, 250-355 cc; commercially available as Spectrum in the United States and as Spectra in Europe [Mentor Corp]) in the smaller breast. Implant diameter was the same for both breasts. The inner chamber of the adjustable implant was filled with sodium chloride intraoperatively (mean volume, 47 cc; range, 35-50 cc).
Downloaded from aes.sagepub.com at UCSF LIBRARY & CKM on November 23, 2014
Mazzocchi et al 1207
Figure 1. Standard objective measurements of the breast: (A) jugular notch to nipple, (B) midclavicular point to nipple, (C) sternum to nipple, (D) midarmpit to nipple, and (E) inframammary fold to nipple.
Group B patients received a textured, fixed-volume, round, Cohesive Gel I implant (size range, 275-375 cc; Mentor Corp) in each breast; the prostheses differed in volume and diameter. One of 2 surgeons performed all procedures and assessments (L.A.D. or M.M.). Before surgery and during all follow-up visits (scheduled at 1, 4, and 12 months postsurgery), standard digital photographs were obtained (frontal, oblique, and lateral views, with arms down and up), along with standard objective measurements of the breast and chest (Figures 1
and 2). Differences in values between the breasts were calculated for each patient to evaluate the degree of symmetry attained. Differences in specific breast and chest measurements taken before surgery and during follow-up visits were analyzed statistically with the Wilcoxon signed-rank test. Statistical significance was defined as P < .05, and all confidence intervals were 95% values. Statistical analyses were performed with SPSS (SPSS, Inc, an IBM Company, Chicago, Illinois).
Downloaded from aes.sagepub.com at UCSF LIBRARY & CKM on November 23, 2014
1208
Aesthetic Surgery Journal 34(8)
Figure 2. Measurement of chest-specific circumferences at (A) the nipple-areola complex and (B) the inframammary fold, with the lungs both full and empty (C and D, respectively).
Patient satisfaction was assessed by responses to a questionnaire administered in person by a nurse at the 1-year follow-up visit (Appendix A; A VAS scale ranging from 0 [no improvement] to [10 maximum improvement] was provided for answering question 11 in the Patient Satisfaction Questionnaire. Available online at www.aestheticsurgeryjournal.com). Breast appearance was evaluated subjectively by the patient at the same time point. The patient’s global impression of clinical improvement was rated on a visual analog scale (VAS) of 1 to 10 (1 = no improvement, 10 = maximum improvement). Breast symmetry was assessed by an external panel of physicians 1 year postsurgery, based on subjective impression of differences between preoperative and postoperative photographs, and was scored on the same VAS. We chose not to consider implant pocket in the evaluations because the aim of the study was to assess a method to evaluate breast asymmetry rather than the best surgical technique to correct the asymmetry. However, no meaningful differences were noted with respect to implant location.
Results The mean age of the 60 patients was 30 years, 4 months (range, 19-38 years; median, 29 years). Each study group
(A, B) comprised 30 patients. Mean body mass index (BMI) was 19.03 kg/m2 in group A (range, 16.96-24.71 kg/m2; median, 19.62 kg/m2) and 19.57 kg/m2 in group B (range, 17.08-25.04 kg/m2; median, 20.02 kg/m2). Thirty-two patients (53% of 60), 15 from group A and 17 from group B, presented with bilateral developmental hypoplasia and small-volume asymmetry. Fifteen patients (25% of 60), 8 from group A and 7 from group B, presented with small-volume breast asymmetry and moderate ptosis. Thirteen patients (21.7% of 60), 7 from group A and 6 from group B, presented with unilateral iatrogenic hypoplasia as a result of previous surgical intervention (benign mass ablation). All patients in both groups presented with at least a grade I breast ptosis, but 15 actually had a moderate (grade II) ptosis.13 The duration of follow-up was 12 months for all patients in both groups. No patients were lost during follow-up. Interim postoperative measurements also were obtained at 1 and 4 months. The mean length of hospitalization was 1.75 days (range, 1-3 days). Early complications that occurred in group A (30 patients) were delayed wound healing on the side with the adjustable implant (n = 1; 3.33%) and 1 case each of hematoma (3.33%) and seroma (3.33%) on the side with
Downloaded from aes.sagepub.com at UCSF LIBRARY & CKM on November 23, 2014
Mazzocchi et al 1209 Table 1. Group A: Mean Differences in Breast Measurements Between Left and Right Breasts and Statistical Significance of the Differencesa Mean Difference in Breast Measurement (cm) ± Standard Deviation Time
Jugular Notch to Nipple
Midclavicle to Nipple
Sternum to Nipple
Midarmpit to Nipple
IMF to Nipple
T0
0.533 ± 0.2005
0.593 ± 0.0572
0.470 ± 0.2193
0.210 ± 0.1184
0.930 ± 0.8251
T1
0.046 ± 0.0730
0.050 ± 0.0572
0.466 ± 0.0498
0.030 ± 0.0534
0.123 ± 0.1612
T2
0.053 ± 0.0681
0.063 ± 0.0718
0.0533 ± 0.0499
0.036 ± 0.0668
0.124 ± 0.1568
T3
0.063 ± 0.0649
0.063 ± 0.0719
0.0633 ± 0.0481
0.043 ± 0.0504
0.126 ± 0.1617
P Values (Wilcoxon Signed-Rank Test)
T0-T1
.05
Abbreviations: IMF, inframammary fold; T0, presurgery; T1, 1 month postsurgery; T2, 4 months postsurgery; T3, 1 year postsurgery. a The bold P values denote statistically significant differences. Data in the top section of the table are mean differences between the left and the right breasts before surgery and at various followup points. In the bottom section, the statistical significance between pre- and postoperative values is shown.
the fixed-volume prosthesis. In group B (30 patients), we observed 1 case (3.33%) of hematoma and 1 case (3.33%) of seroma. None of these complications (in either group) had a negative effect on the ultimate achievement of breast symmetry. No major late complications occurred during the 1-year follow-up.
The mean differences and standard deviations in specific breast measurements, as well as their statistical significance, are summarized in Table 1 (group A) and Table 2 (group B). Data for specific chest circumferences are summarized in Table 3 (group A) and Table 4 (group B). Group A had better symmetry postoperatively (Tables 1
Table 2. Group B: Mean Differences in Breast Measurements Between Left and Right Breasts and Statistical Significance of the Differencesa Mean Difference in Breast Measurement (cm) ± Standard Deviation Time
Jugular Notch to Nipple
Midclavicle to Nipple
Sternum to Nipple
Midarmpit to Nipple
IMF to Nipple
T0
0.346 ± 0.3471
0.390 ± 0.4037
0.430 ± 0.3064
0.533 ± 0.2523
0.606 ± 0.4463
T1
0.193 ± 0.2839
0.173 ± 0.2911
0.236 ± 0.3285
0.366 ± 0.2684
0.056 ± 0.0678
T2
0.166 ± 0.2669
0.183 ± 0.2972
0.190 ± 0.3166
0.240 ± 0.2268
0.063 ± 0.0764
T3
0.173 ± 0.2651
0.166 ± 0.2733
0.193 ± 0.3150
0.246 ± 0.2208
0.070 ± 0.0836
P Values (Wilcoxon Signed-Rank Test)
T0-T1
.05
Abbreviations: IMF, inframammary fold; T0, presurgery; T1, 1 month postsurgery; T2, 4 months postsurgery; T3, 1 year postsurgery. The bold P values denote statistically significant differences. Data in the top section of the table are mean differences between the left and the right breasts before surgery and at various followup points. In the bottom section, the statistical significance between pre- and postoperative values is shown. a
Downloaded from aes.sagepub.com at UCSF LIBRARY & CKM on November 23, 2014
1210
Aesthetic Surgery Journal 34(8)
Table 3. Group A: Mean Differences in Chest Measurements at Maximum and Minimum Inspiration and Statistical Significance of Differencesa Mean Difference in Chest Measurement (cm) ± Standard Deviation At Nipple-Areola Complex
At Inframammary Fold
Maximum Inspiration
Maximum Expiration
Maximum Inspiration
Maximum Expiration
T0
84.48 ± 2.251
80.84 ± 1.771
77.54 ± 1.519
72.52 ± 1.783
T1
91.79 ± 2.649
88.43 ± 1.852
77.88 ± 1.529
73.15 ± 1.812
T2
91.36 ± 2.665
87.91 ± 1.882
77.47 ± 1.467
72.22 ± 1.684
T3
91.33 ± 2.657
87.92 ± 1.870
77.57 ± 1.513
72.45 ± 1.703
Time
P Values (Wilcoxon Signed-Rank Test)
T0-T1
