Scientific Abstract Presentations: Breast 1 Thursday, October 26 Thu, Oct 26 1:30-2:30 p.m. CDT

Introduction: Despite numerous European reports exploring synthetic alternatives, acellular dermal matrix (ADM) is ubiquitously employed for implant-based breast reconstructions (IBR) within the United States. The direct cost of ADM devices encourages further exploration of synthetic alternatives. No mesh device has gained FDA approval for the specific indication of breast reconstruction.

This study is the first to report experience with Enform® (Gore, USA) mesh in IBR. Enform® is a readily absorbed polyglycolic acid:trimethylene carbonate co-polymer with premarket approval for soft tissue reinforcement in plastic and reconstructive surgery. The authors make comparison with a contemporary institutional cohort of cases employing ADM. We hypothesized that short-term outcomes would be similar between cohorts.

Methods: In a single-institution retrospective study, short-term outcomes at 3-month follow-up were compared between all pre-pectoral and partial sub-pectoral breast reconstructions employing Enform® and a randomly selected cohort of cases using ADM. Demographics, operative details, complications, and failures were analyzed at the 0.05 significance level. Logistic regression models for mesh effect on complication were built by backward selection at the 0.15 significance level. Example intraoperative, histological, and long-term figures are additionally provided. All outcomes were assessed on a per-breast basis.

Results: Synthetic and ADM cohorts included 42 subjects (54 breasts) and 43 subjects (55 breasts) respectively, with similar age, BMI, smoking history, breast cancer status, radiation and chemotherapy history, and operative details (p<0.05). Synthetic and ADM cohorts were not significantly different in rate of complication (26% vs 36%; p=0.24) or explant (14.8% vs 29.1%, p=0.11). In regression, mesh device (Synthetic/ADM) was not a significant predictor of complication (OR=0.77; 95%CI[0.32-1.86]) or tissue necrosis (OR=0.46; 95%CI[0.13-1.44]).

Histology demonstrated Synthetic integration at three-months without evidence of bacteria or inflammation. An estimated ~$175,000 in direct device costs were saved with synthetic mesh employment.

Conclusions: This is the first US report to compare outcomes between synthetic mesh and ADM. Enform® demonstrated cost-effective viability with similarity between cohorts, insignificantly lower major complication and explant rates with synthetic mesh, and no difference in overall complication or tissue necrosis rates in multivariate regression models. Further synthetic mesh breast reconstruction investigations are warranted, particularly within the United States. Reliance on ADM should be reviewed in comparison with alternatives.

Background Periprosthetic infection following tissue expander (TE) breast reconstruction remains a devastating complication, with rates as high as 35%. While prophylactic antibiotic-loaded polymethylmethacrylate (PMMA) cement is routinely used in orthopedic surgery, few reports exist documenting employment in breast reconstruction. This is the first multi-institutional study to report on outcomes following the use of intraoperatively-crafted tobramycin-vancomycin PMMA plates (ABP) for periprosthetic infection prophylaxis in TE-based breast reconstruction.

Methods All patients with >3mo follow-up undergoing breast reconstruction with pre-pectoral or sub-pectoral tissue expansion and concomitant ABP insertion at 3 institutions (2021-2022) were reviewed. Practice patterns among the 3 surgeons are comparable, with all current TE patients receiving ABP. Patient demographics, operative details, and outcomes, including major postoperative complications (necessitating readmission/reoperation), are described by patient. Backward-selection logistic regression modeling of literature-reported confounders on major complication was performed with predetermined alpha set to 0.05.

Results 146 cases (198 breasts) were identified with mean follow-up of 7.4+/-3.1 months. Reconstruction was immediate in 95% of cases. Mean age was 49+/-10 and BMI was 26.5+/-4.7. Comorbidities included smoking (19.2%), and diabetes (8.9%). Patients received neoadjuvant chemotherapy in 24% of cases, neoadjuvant radiation therapy (RT) in 8.2%, and lymph node dissection in 8.2%. Expansion was completed at median day 49 with fill volume of 452+/-138cc, and second stage completed in 35.6% of patients at median month 5.

Major complications occurred in 13.8% of cases including tissue necrosis in 7.3%, infection in 5.5%, seroma/hematoma in 3.4%, and dehiscence in 2.1%. Expander explant without salvage, indicating reconstructive failure, occurred in 6.2% of cases. Logistic regression modeling demonstrated neoadjuvant chemotherapy and neoadjuvant RT to have significant effect on odds of major complication (Chemotherapy; OR 1.16[1-1.3], p=0.02, RT; OR 1.22[1-1.5], p=0.05).

Conclusion This multi-institutional study demonstrates potential in employing antibiotic-loaded PMMA plates for prophylaxis in TE breast reconstruction with overall major complication and infection rates well-below the most reported. Odds of major complication were significantly greater with neoadjuvant chemotherapy and RT. Previous experience indicates that >75% of complications occur within the minimum follow-up of included cases. Further study will include comparison with a non-ABP cohort and extended follow-up encompassing more subjects having completed second stage.

PURPOSE: Textured implants were developed to reduce rates of capsular contracture and prevent implant malposition (e.g., malrotation). Recent evidence has questioned whether textured implants are as resistant to malrotation as previously reported.

METHODS: Women presenting to a single healthcare system for removal of textured implants were prospectively enrolled in the study from September 2019 to July 2022. Patients who underwent removal of an anatomic, textured implant in the operating room were included in the study, while those who did not undergo implant removal or were found to have a smooth implant, or a round, textured implant were excluded. The degree of implant rotation upon removal of the implant was measured intra-operatively. Implant-specific factors, patient demographics, clinical factors, and operative characteristics were collected.

RESULTS: A total of 51 patients (80 implants) were included in the study. 45% of implants were malrotated (rotated >30 degrees) and the median degree of rotation was 30. More than one previous revision of the breast pocket was predictive of implant rotation (42 degrees) on multivariate linear regression analysis. Patients who presented with a complaint of "Aesthetic Dissatisfaction" had 2.89 increased odds of having an implant rotated > 30 degrees.

CONCLUSION: Our study found an alarmingly high rate of malrotation of textured, shaped implants upon explantation. We do not see a role for textured implant placement, particularly for patients undergoing breast reconstruction.

Purpose: Opioids are routinely prescribed for pain management following breast reconstruction procedures; however, there is an associated risk of abuse, addiction, and overdose that ultimately contributes to the ongoing opioid epidemic and public health crisis in the US. Overprescribing of opioids after surgery is common and results in excess opioid pills that are available for potential misuse. The lack of procedure-specific postoperative opioid prescription protocols contributes to the wide variation in prescribing practices, emphasizing the critical need for evidence-based guidelines. In this study, we propose evidence-based prescription guidelines for postoperative opioid use based upon analysis of our quality improvement (QI) initiative, which standardized opioid use in patients who underwent outpatient reconstructive surgeries at the Memorial Sloan Kettering Cancer Center ambulatory oncology facility.

Methods: Between August 2019 to December 2019, women who underwent outpatient procedures including exchange of tissue expander to permanent implant, removal and replacement of breast implant, revision of reconstructed breast including autologous fat grafting, and reduction mammoplasty or mastopexy were surveyed via telephone 7–10 days after surgery, before (n=97) and after (n =101) implementing a standardized opioid prescription reduction initiative. We compared postoperative opioid use, pain control, and refills in both groups of patients. Patient-reported outcomes were compared using the BREAST-Q Physical Wellbeing of the Chest domain and a novel symptom Recovery Tracker.

Results: 198 patients were included in the analysis. Pre-standardization (n=97), patients were prescribed a median of 30 pills and consumed 3 pills [IQR:1,9]. After standardization, the median number of pills prescribed was 8. Post-standardization, the median number of pills consumed (3 pills [IQR:1,6]) did not significantly differ between the groups, however, post-standardization patients had significantly fewer excess pills than pre-standardization patients (5 vs. 23 excess pills; p<0.001), lowering the risk for diversion and misuse. Additionally, a statistically significant smaller proportion of post-standardization patients had excess pills (81% vs. 99%, p<0.001). Pre-standardization 78% of the pills prescribed were in excess, and post-standardization, 50% of prescribed pills were in excess. Data from the Recovery Tracker demonstrated that after adjusting for postoperative day, there was no evidence of an association between study period and experiencing moderate or greater pain across the 10 postoperative days (p=0.8). The BREAST-Q Physical Wellbeing of the Chest scores were not significantly different between pre- and post-standardization (median 64 [IQR 55, 80] versus median 68 [IQR 55, 85]) at the two-week time point (p=0.3).

Conclusions: This QI initiative demonstrated that patients were prescribed more opioids than they required after ambulatory plastic surgery procedures. Standardizing and reducing opioid prescriptions for patients undergoing ambulatory reconstructive breast surgery is feasible and can significantly decrease the number of excess pills prescribed. Prior studies have revealed the prevalence of opioid over-prescription and excess pills; however, our current initiative is strengthened by feedback coming directly from patients. The opioid reduction guidelines implemented in this study promote safety and reduce the potential for diversion, addiction, and fatalities from opioid misuse.

Introduction: The nipple-sparing approach has become an oncologically sound and desirable choice for women choosing mastectomy. Indocyanine green (ICG) perfusion imaging has been shown to reduce ischemic complications in mastectomy skin flaps. Direct-to-implant reconstruction requires a well-vascularized skin flap capable of tolerating full expansion. Identification of the perforating subcutaneous vessels to the skin envelope may allow for better and more consistent blood vessel preservation and flap perfusion.

Methods: The authors conducted an institutional review board-approved prospective study with 41 patients to assess the feasibility of using ICG perfusion imaging to visualize, cutaneously map, and preserve the vessels that supply the skin flap and nipple-areolar complex. For each patient, the number of vessels initially mapped, the number of vessels preserved, the extent to which each vessel was preserved, and the proportion of the flap with adequate perfusion (as defined by the SPY-Q >20% threshold) were recorded and analyzed.

Results: Vessels were able to be identified and marked in a high majority of patients (90%). There was a moderate linear relationship between the number of vessels marked and the number preserved. Successful mapping of vessels was associated with lower rates of wound breakdown (p=0.036). Mapping and preserving at least one vessel led to excellent flap perfusion (>90%). No increase in complications was observed from utilizing ICG angiography preoperatively.

Conclusion: This prospective study using preoperative ICG perfusion mapping demonstrated safety, feasibility, and good prognostic outcomes.

Background: Secondary reduction mammaplasty (SRM) is a challenging procedure that may be performed for patients who present with recurrent macromastia, breast asymmetry, poor contour, or inadequate prior reduction. Due to low incidence, there is limited data on SRM outcomes and technical guidelines – especially in cases for which the vascular pedicle of the prior breast reduction is unknown. This study seeks to assess clinical and aesthetic outcomes with respect to operative factors in SRM.

Methods: All reduction mammaplasties performed by 6 surgeons across 2017-2021 at a single institution were included. SRM patients, defined by an additional reduction with a pedicled nipple-areolar-complex (NAC), were compared to a randomized unmatched control group of primary mammaplasty (PRM) patients (1:3 cases to controls). Clinical data was extracted via retrospective chart review. Clinical photographs obtained 2-12 months postoperatively were graded by five non-experts (research assistants) in blinded surveys using the 13-item Validated Breast Aesthetic Scale developed by Duraes et al.1 Univariate analyses were performed.

Results: Of the total 723 reduction mammaplasties identified, 27 (3.7%) were secondary. Among SRM patients, 7 (26.0%) had unknown prior pedicles. Patients on average underwent SRM 15.3±9.2 years after prior reduction. Compared to PRM patients, SRM patients were significantly older (p<0.0004) and more likely to have hyperlipidemia (p=0.0495) and hypertension (p=0.0767). SRM patients trended toward lower resection volumes (p=0.0608) and were less likely to undergo inferior and superomedial pedicle-based reductions (p<0.0001). Wise-pattern incisions were used in nearly all SRM patients. Rates of complications, readmission, revision, and hypertrophic/keloid scarring between SRM and PRM patients were equivocal. Breast symmetry, naturalness of breast shape and contour, naturalness of inframammary fold, NAC position, NAC projection, and NAC size were rated significantly lower on aesthetic assessment of breasts following SRM. On subset analysis of SRM cases, patients with unknown initial pedicles were more likely to undergo inferior pedicle reduction, vertical bipedicle reduction, or liposuction with skin resection, and less likely to undergo superior/superomedial pedicle-based reduction. Patients with known initial pedicles were more likely than not to undergo SRM using the same pedicles. Based on these operative factors, complication rates, need for readmission or revision, incidence of hypertrophic/keloid scarring, and aesthetic ratings across all measures were equivocal between patients with known and unknown initial pedicles.

Conclusion: SRM patients were found to have poorer aesthetic outcomes on photographic analysis than PRM patients despite equivocal complication rates, demonstrating the consequence of achieving a non-satisfactory result during PRM. Importantly, we found that successful SRM can be safely achieved even without knowledge of the initial pedicle; patients with unknown initial pedicles who subsequently underwent reduction with a vertical bipedicle or inferior pedicle technique were not found to be at higher risk for complications or poorer aesthetic outcomes than those in which the previous pedicle was known.

References: Duraes EFR, Durand P, Morisada M, et al. A Novel Validated Breast Aesthetic Scale. Plast Reconstr Surg. 2022;149(6):1297-1308. doi:10.1097/PRS.0000000000009156

Purpose: Since its introduction, ADM has transformed two-stage breast reconstruction with proponents of its use citing superior aesthetic outcomes, accelerated tissue expansion, and fewer complications as a rational for its use. Enthusiasm for submuscular prosthesis placement dampened and has led to a shift towards the prepectoral approach. Our previous work demonstrated little difference in three-month postoperative complications after prepectoral tissue expander placement with and without ADM. As prepectoral implant placement becomes more widely adopted, conflicting data exists whether the inclusion of ADM at the time of placement of a tissue expander confers any additional benefit in regard to implant rippling, capsular contracture, or long-term aesthetic outcomes. We sought to evaluate outcomes of after tissue expander exchange for implants comparing those who had undergone placement of a tissue expander with and without the use of ADM.

Methods: A single institution retrospective chart review was performed to identify consecutive patients undergoing prepectoral tissue-expander based breast reconstruction from August 2020 to January 2022. Our institution stopped utilizing ADM for prepectoral reconstruction in May 2021. Patients were then followed for 9 months after their tissue expander exchange for implants. Second-stage outcomes of interest after tissue expander exchange for implant including the number and type of revision surgeries performed, implant rippling, capsular contracture, implant exchange, and explantation were collected and compared between the ADM and no ADM cohort.

Results: Of the 239 patients originally enrolled, 74 (108 breasts) received ADM and 74 (131 breasts) did not receive ADM. Of this original cohort, 44 patients (68 breasts) in the ADM cohort and 32 patients (61 breasts) in the no ADM cohort underwent a tissue expander exchange for implant. Demographics, oncologic characteristics (including adjuvant chemo/radiotherapy) and first stage surgical characteristics were similar between the two groups, The median final implant size was 450 in the ADM cohort and 425 in the no ADM cohort (p=0.35). When compared to the ADM cohort, the no ADM cohort underwent fat grafting at the time of implant exchange more often (44.3% v 28.8%, p=0.07). 18.2% of the ADM cohort and 14.8% of the no ADM underwent additional fat grafting at a later date, (p=0.6). Second-stage outcomes of interest were similar between the ADM and no ADM cohort with no statistically significant differences identified in regard to incidence of rippling (22.7% v 13.1%, p=0.16), capsular contracture (4.5% v 3.3%, p=1.00), implant exchange (7.6% v 6.6%), explanation (7.6% v 1.6%, p=0.21), or average number of subsequent surgeries after IBR (0.5 v 0.3%, p=0.44) between the two cohorts.

Conclusion: Our study demonstrates similar proportions of implant rippling, capsular contracture, implant exchange, explantation, and need for additional revision surgeries between those with and without ADM. Though the no ADM cohort received fat grafting at the time of implant placement more often, which may reduce implant rippling, the occurrence of rippling remained low in both cohorts and this did not reach significance. Further study is needed to demonstrate long-term outcomes of interest including ptosis and long-term aesthetic outcomes.

BACKGROUND: Two-stage implant-based reconstruction using tissue expanders (TE) is a commonly performed technique for immediate post-mastectomy breast reconstruction.1 Multiple skin-sparing incisions are utilized, however the Wise pattern incision (WPI) with a de-epithelialized inferior mastectomy flap may have superior cosmetic outcomes for large ptotic breasts.2,3 Some surgeons are reluctant to perform WPI due to its historically unfavorable complication profile when compared to other non-Wise pattern incision (NWPI) types.4 We evaluated patient demographics and surgical outcomes in breast reconstruction with WPI compared to NWPI with the goal of aiding physician incision selection for breast reconstruction.

METHODS: An electronic medical record search was performed for all patients at a single institution from 2019 to 2021 with ICD-10-CM diagnosis code "Z42.1: encounter for breast reconstruction following mastectomy." A retrospective chart review was performed evaluating patient demographics, incision type, ptosis grade, intraoperative factors, and 90-day post-operative complications. Results were analyzed using Wilcoxon-Mann-Whitney tests for continuous variables and Chi-Square tests for categorical variables. Significance level was determined using α= 0.05.

RESULTS: 236 patients had immediate reconstruction; 40 had WPI (29%) and 196 had NWPI (71%). There was a significant difference in median BMI between WPI (28.6) and NWPI (26.5) (p=0.0097). Mean preoperative ptosis grade significantly differed between WPI (L:2.21, R:2.23) and NWPI (L:1.66, R:1.65) (L: p=0.0015, R: p=0.0007). Left and right mastectomy weight significantly differed between groups (L: p=0.0008, R: p=0.0006). There were no significant differences in age, medical comorbidities, or cancer treatment before or after mastectomy. While no significant difference was found in median operative times (WPI: 205 minutes, NWPI: 201 minutes, p=0.4989), there was a significant difference found in use of acellular dermal matrix (WPI: 43%, NWPI: 68%, p=0.0024). Rate of postoperative complications did not significantly differ between WPI (55%) and NWPI (45%) (p=0.2431). Median total charge for surgery did not significantly differ between WPI ($32,038) and NWPI ($31,048) patients (p=0.3539).

CONCLUSION: Compared to the NWPI cohort, WPI was performed in patients with significantly higher average BMI, ptosis grades, and mastectomy weights and less frequently involved the use of acellular dermal matrix. There was no significant difference in OR time, complications, or charge between NWPI and WPI patients. Surgeons should consider WPI in patients with higher BMI and ptosis grade without concern for longer operative times or higher complication rates.

1. American Society of Plastic Surgeons. 2020 Plastic Surgery Statistics Report: ASPS National Clearinghouse of Plastic Surgery Statistics [ASPS], 2020. Available at: https://www.plasticsurgery.org/documents/News/Statistics/2020/plastic-surgery-statistics-full-report-2020.pdf. Accessed April 30, 2022.
2. Inbal A, Gur E, Lemelman BT, et al. Optimizing patient selection for direct-to-implant immediate breast reconstruction using wise-pattern skin-reducing mastectomy in large and ptotic breasts. Aesthetic Plast Surg. 2017;41:1058–1067.
3. Calderon T, Skibba KE, Hansen T, Amalfi A, Chen E. Safety of breast reconstruction using inferiorly based dermal flap for the ptotic breast. Ann Plast Surg. 2022;88:156–162.
4. Lin IC, Bergey M, Sonnad SS, Serletti JM, Wu LC. Management of the ptotic or hypertrophic breast in immediate autologous breast reconstruction: a comparison between the wise and vertical reduction patterns for mastectomy. Ann Plast Surg. 2013;70:264–27.