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Impact of Evolving Radiation Therapy Techniques on Implant-Based Breast Reconstruction
Muresan, Horatiu; Lam, Gretl; Cooper, Benjamin T; Perez, Carmen A; Hazen, Alexes; Levine, Jamie P; Saadeh, Pierre B; Choi, Mihye; Karp, Nolan S; Ceradini, Daniel J
BACKGROUND: Patients undergoing implant-based reconstruction in the setting of postmastectomy radiation therapy suffer from increased complications and inferior outcomes compared with those not irradiated, but advances in radiation delivery have allowed for more nuanced therapy. The authors investigated whether these advances impact patient outcomes in implant-based breast reconstruction. METHODS: Retrospective chart review identified all implant-based reconstructions performed at a single institution from November of 2010 to November of 2013. These data were cross-referenced with a registry of patients undergoing breast irradiation. Patient demographics, treatment characteristics, and outcomes were analyzed. RESULTS: Three hundred twenty-six patients (533 reconstructions) were not irradiated, whereas 83 patients (125 reconstructions) received radiation therapy; mean follow-up was 24.7 months versus 26.0 months (p = 0.49). Overall complication rates were higher in the irradiated group (35.2 percent versus 14.4 percent; p < 0.01). Increased maximum radiation doses to the skin were associated with complications (maximum dose to skin, p = 0.05; maximum dose to 1 cc of skin, p = 0.01). Different treatment modalities (e.g., three-dimensional conformal, intensity-modulated, field-in-field, and hybrid techniques) did not impact complication rates. Prone versus supine positioning significantly decreased the maximum skin dose (58.5 Gy versus 61.7 Gy; p = 0.05), although this did not translate to significantly decreased complication rates in analysis of prone versus supine positioning. CONCLUSIONS: As radiation techniques evolve, the maximum dose to skin should be given consideration similar to that for heart and lung dosing, to optimize reconstructive outcomes. Prone positioning significantly decreases the maximum skin dose and trends toward significance in reducing reconstructive complications. With continued study, this may become clinically important. Interdepartmental studies such as this one ensure quality of care. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
PMID: 28538549
ISSN: 1529-4242
CID: 2574862
SERI Surgical Scaffold in 2-Stage Breast Reconstruction: 2-Year Data from a Prospective, Multicenter Trial
Karp, Nolan; Choi, Mihye; Kulber, David A; Downey, Susan; Duda, Gloria; Kind, Gabriel M; Jewell, Mark L; Murphy, Diane K; Lehfeldt, Max R; Fine, Neil
BACKGROUND: Soft-tissue support devices are used during breast reconstruction. This study investigated long-term clinical data following SERI Surgical Scaffold (SERI) implantation, a bioresorbable, silk-derived scaffold for soft-tissue support. METHODS: This was a prospective, multicenter study in 103 subjects who received SERI during stage 1 of 2-stage breast reconstruction with subpectoral tissue expander placement (Natrelle Style 133V; Allergan plc, Dublin, Ireland) followed by subpectoral breast implant placement. Investigator satisfaction (11-point scale: 0, very dissatisfied and 10, very satisfied) at 6 months was the primary endpoint. Ease of use, satisfaction, scaffold palpability/visibility, breast anatomy measurements via 3D images, SERI integration, histology, and safety were also assessed through 2 years after stage 1 surgery. RESULTS: Analyses were performed on the per-protocol population (103 subjects; 161 breasts) with no protocol deviations that could affect outcomes. Ease of use and subject and investigator satisfaction with SERI were high throughout 2 years. Breast anatomy measurements with 3D images demonstrated long-term soft-tissue stability of the lower breast mound. Key complication rates per breast were tissue/skin necrosis and wrinkling/rippling (8.1% each) and seroma, wound dehiscence, and breast redness (5.0% each). Over 2 years, 4 breasts in 4 subjects underwent reoperation with explantation of any device; 2 breasts required SERI explantation. SERI was retained in 98.8% of breasts (159/161) at 2 years. CONCLUSIONS: SERI was associated with high and consistent levels of investigator and subject satisfaction and demonstrated soft-tissue stability in the lower breast through 2 years. SERI provides a safe, long-term benefit for soft-tissue support in 2-stage breast reconstruction.
PMCID:5459638
PMID: 28607855
ISSN: 2169-7574
CID: 2593602
Analysis of Flap Weight and Postoperative Complications Based on Flap Weight in Patients Undergoing Microsurgical Breast Reconstruction
Lam, Gretl; Weichman, Katie E; Reavey, Patrick L; Wilson, Stelios C; Levine, Jamie P; Saadeh, Pierre B; Allen, Robert J; Choi, Mihye; Karp, Nolan S; Thanik, Vishal D
Background Higher body mass index (BMI) has been shown to increase postoperative complications in autologous breast reconstruction. However, the correlation with flap weight is unknown. Here, we explore the relationship of flap weights and complication rates in patients undergoing microvascular breast reconstruction. Methods Retrospective chart review identified all patients undergoing microvascular breast reconstruction with abdominally based flaps at a single institution between November 2007 and April 2013. Breasts with documented flap weight and 1-year follow-up were included. Patients undergoing stacked deep inferior epigastric perforator flaps were excluded. Breasts were divided into quartiles based on flap weight and examined by demographics, surgical characteristics, complications, and revisions. Results A total of 130 patients undergoing 225 flaps were identified. Patients had a mean age of 50.4 years, mean BMI of 27.1 kg/m2, and mean flap weight of 638.4 g (range: 70-1640 g). Flap weight and BMI were directly correlated. Flaps were divided into weight-based quartiles: first (70-396 g), second (397-615 g), third (616-870 g), and fourth (871-1640 g). There were no associations between flap weight and incidences of venous thrombosis, arterial thrombosis, hematoma, flap loss, fat necrosis, or donor site hernia. However, increased flap weight was associated with increased rate of donor site wound healing problems in both univariate and multivariate analysis. Conclusions Increased flap weight is not associated with added flap complications among patients undergoing microvascular breast reconstruction, however, patients with flaps of 667.5 g or more are more likely to have donor site healing problems. The success and evidence contrary to previous studies may be attributed to surgeon intraoperative flap choice.
PMID: 27919113
ISSN: 1098-8947
CID: 2354242
The Impact of Two Operating Surgeons on Microsurgical Breast Reconstruction
Weichman, Katie E; Lam, Gretl; Wilson, Stelios C; Levine, Jamie P; Allen, Robert J; Karp, Nolan S; Choi, Mihye; Thanik, Vishal D
BACKGROUND: Given the complexity of microsurgical breast reconstruction, there are many opportunities to improve both surgical efficiency and outcomes. The use of two operating surgeons has been employed, but the outcomes are unproven. In this study, the authors compare the outcomes of patients undergoing microsurgical breast reconstruction with one operating surgeon to those with two surgeons. METHODS: A retrospective review of all patients undergoing microsurgical breast reconstruction between July of 2011 and January of 2014 at a single academic institution was conducted. Patients were divided into two cohorts: those undergoing reconstruction with one surgeon and those having reconstruction with two surgeons. Once identified, patients were analyzed and outcomes were compared. RESULTS: A total of 157 patients underwent 248 microsurgical breast reconstructions during the study period. One hundred three patients (170 flaps) had two surgeons and 54 patients (78 flaps) had one surgeon. Patients undergoing unilateral and bilateral reconstructions with two surgeons had decreased mean operating room time by 60.1 minutes and 134 minutes (p < 0.001) and length of stay by 1.8 days and 1.3 days (p < 0.05), when compared to a single surgeon. Additionally, patients with one surgeon were more likely to have postoperative donor-site breakdown at 5.1 percent (n = 4) versus 0.6 percent (n = 1) (p = 0.0351). CONCLUSIONS: The use of two operating surgeons has demonstrable effects on the outcomes of microsurgical breast reconstruction. The addition of a second surgeon significantly decreases operating room time and shortens hospital length of stay in both unilateral and bilateral reconstruction. It also significantly decreases donor-site wound healing complications. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
PMID: 28121853
ISSN: 1529-4242
CID: 2418512
The Effect of Neoadjuvant Chemotherapy Compared to Adjuvant Chemotherapy in Healing after Nipple-Sparing Mastectomy
Frey, Jordan D; Choi, Mihye; Karp, Nolan S
BACKGROUND: Nipple-sparing mastectomy is the latest advancement in the treatment of breast cancer. The authors aimed to investigate the effects of neoadjuvant and adjuvant chemotherapy in nipple-sparing mastectomy. METHODS: Patients undergoing nipple-sparing mastectomy from 2006 to June of 2015 were identified. Results were stratified by presence of neoadjuvant or adjuvant chemotherapy. RESULTS: A total of 840 nipple-sparing mastectomies were performed. Twenty-eight were in those who received neoadjuvant chemotherapy and 93 were in patients receiving adjuvant chemotherapy. Patients receiving both neoadjuvant and adjuvant chemotherapy were included in the neoadjuvant group. Nipple-sparing mastectomies that received neoadjuvant (with or without adjuvant) chemotherapy were compared to those in patients who received adjuvant chemotherapy. Those with neoadjuvant (with or without adjuvant) chemotherapy were more likely to have explantation (p = 0.0239) and complete nipple-areola complex necrosis (p = 0.0021). Those with neoadjuvant (with or without adjuvant) chemotherapy were more likely to have implant explantation (p = 0.0015) and complete nipple-areola complex necrosis (p = 0.0004) compared to those with no chemotherapy. Compared to nipple-sparing mastectomies in patients with no chemotherapy, those with adjuvant chemotherapy were more likely to have a hematoma (p = 0.0021). Those that received both neoadjuvant and adjuvant chemotherapy were more likely to have complete nipple-areola complex necrosis compared with both the neoadjuvant chemotherapy-only and adjuvant chemotherapy-only groups (p < 0.0001). CONCLUSIONS: Nipple-sparing mastectomy is safe to perform in the setting of neoadjuvant and adjuvant chemotherapy. As a whole, neoadjuvant (with or without adjuvant) chemotherapy increases risk of complications. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
PMID: 28027222
ISSN: 1529-4242
CID: 2383272
Subcutaneous Implant-based Breast Reconstruction with Acellular Dermal Matrix/Mesh: A Systematic Review
Salibian, Ara A; Frey, Jordan D; Choi, Mihye; Karp, Nolan S
BACKGROUND: The availability of acellular dermal matrix (ADM) and synthetic mesh products has prompted plastic surgeons to revisit subcutaneous implant-based breast reconstruction. The literature is limited, however, with regards to evidence on patient selection, techniques, and outcomes. METHODS: A systematic review of the Medline and Cochrane databases was performed for original studies reporting breast reconstruction with ADM or mesh, and subcutaneous implant placement. Studies were analyzed for level of evidence, inclusion/exclusion criteria for subcutaneous reconstruction, reconstruction characteristics, and outcomes. RESULTS: Six studies (186 reconstructions) were identified for review. The majority of studies (66.7%) were level IV evidence case series. Eighty percent of studies had contraindications for subcutaneous reconstruction, most commonly preoperative radiation, high body mass index, and active smoking. Forty percent of studies commenting on patient selection assessed mastectomy flap perfusion for subcutaneous reconstruction. Forty-five percent of reconstructions were direct-to-implant, 33.3% 2-stage, and 21.5% single-stage adjustable implant, with ADM utilized in 60.2% of reconstructions versus mesh. Pooled complication rates included: major infection 1.2%, seroma 2.9%, hematoma 2.3%, full nipple-areola complex necrosis 1.1%, partial nipple-areola complex necrosis 4.5%, major flap necrosis 1.8%, wound healing complication 2.3%, explantation 4.1%, and grade III/IV capsular contracture 1.2%. CONCLUSIONS: Pooled short-term complication rates in subcutaneous alloplastic breast reconstruction with ADM or mesh are low in preliminary studies with selective patient populations, though techniques and outcomes are variable across studies. Larger comparative studies and better-defined selection criteria and outcomes reporting are needed to develop appropriate indications for performing subcutaneous implant-based reconstruction.
PMCID:5142500
PMID: 27975034
ISSN: 2169-7574
CID: 2363572
"Breast in a Day": Examining Single-Stage Immediate, Permanent Implant Reconstruction in Nipple-Sparing Mastectomy
Choi, Mihye; Frey, Jordan D; Alperovich, Michael; Levine, Jamie P; Karp, Nolan S
BACKGROUND: Nipple-sparing mastectomy with immediate, permanent implant reconstruction offers patients a prosthetic "breast in a day" compared to tissue expander techniques requiring multiple procedures. METHODS: Patients undergoing nipple-sparing mastectomy with immediate, permanent implant reconstruction were reviewed with patient demographics and outcomes analyzed. RESULTS: Of 842 nipple-sparing mastectomies from 2006 to June of 2015, 160 (19.0 percent) underwent immediate, permanent implant reconstruction. The average age and body mass index were 46.5 years and 23.3 kg/m. The majority of implants were either Allergan Style 20 (48.1 percent) or Style 15 (22.5 percent). The average implant size was 376.2 ml, and 91.3 percent of reconstructions used acellular dermal matrix. The average number of reconstructive operations was 1.3. Follow-up was 21.9 months. The most common major complication was major mastectomy flap necrosis (8.1 percent). The rate of reconstructive failure was 5.6 percent and implant loss was 4.4 percent. The most common minor complication was minor mastectomy flap necrosis (14.4 percent). The rates of full-thickness and partial-thickness nipple necrosis were 4.4 and 7.5 percent, respectively. Age older than 50 years (p = 0.0276) and implant size greater than 400 ml (p = 0.0467) emerged as independent predictors of overall complications. Obesity (p = 0.4073), tobacco use (p = 0.2749), prior radiation therapy (p = 0.4613), and acellular dermal matrix (p = 0.5305) were not associated with greater complication rates. CONCLUSION: Immediate, permanent implant reconstruction in nipple-sparing mastectomy provides patients with a breast in a day in less than two procedures, with a low complication rate. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
PMID: 27465178
ISSN: 1529-4242
CID: 2191202
Cost Analysis of Intraoperative Subareolar Frozen Section During Nipple-Sparing Mastectomy
Alperovich, Michael; Reis, Scott M; Choi, Mihye; Karp, Nolan S; Frey, Jordan D; Chang, Jessica B; Axelrod, Deborah M; Shapiro, Richard L; Guth, Amber A
BACKGROUND: Permanent paraffin subareolar biopsy during nipple-sparing mastectomy (NSM) tests for occult cancer at the nipple-areolar complex. Intraoperative subareolar frozen section can provide earlier detection intraoperatively. Cost analysis for intraoperative subareolar frozen section has never been performed. METHODS: NSM cases from 2006-2013 were reviewed. Patient records including financial charges were analyzed. RESULTS: Of 480 subareolar biopsies for NSM from 2006-2013, 21 were abnormal (4.4 %). A total of 307 of the subareolar biopsies included intraoperative frozen section. Of the 307, 12 (3.9 %) were abnormal with 7 of 12 detected on intraoperative frozen section. The median baseline charge for an intraoperative subareolar frozen section was $309 for an estimated total cost of $94,863 in 307 breasts. The median baseline charge for interval operative resection of a nipple-areolar complex following an abnormal subareolar pathology result was $11,021. Intraoperative subareolar biopsy avoided an estimated six return trips to the operating room for savings of $66,126. At our institution, routine use of intraoperative frozen section resulted in an additional $28,737 in healthcare charges or $95 per breast. CONCLUSIONS: We present the first cost analysis to evaluate intraoperative subareolar frozen section in NSM. This practice obviated an estimated six return trips to the operating room. With our institutional frequency of abnormal subareolar pathology, intraoperative frozen sections resulted in a marginal increased charge per mastectomy.
PMID: 26438436
ISSN: 1534-4681
CID: 1794552
To Resect or Not to Resect: The Effects of Rib-Sparing Harvest of the Internal Mammary Vessels in Microsurgical Breast Reconstruction
Wilson, Stelios; Weichman, Katie; Broer, P Niclas; Ahn, Christina Y; Allen, Robert J; Saadeh, Pierre B; Karp, Nolan S; Choi, Mihye; Levine, Jamie P; Thanik, Vishal D
Background The internal mammary vessels are the most commonly used recipients for microsurgical breast reconstructions. Often, the costal cartilage is sacrificed to obtain improved vessel exposure. In an effort to reduce adverse effects associated with traditional rib sacrifice, recent studies have described less-invasive, rib-sparing strategies. Methods After obtaining institutional review board's approval, a retrospective review of all patients undergoing microsurgical breast reconstruction at a single institution between November 2007 and December 2013 was conducted. Patients were divided into two cohorts for comparison: rib-sacrificing and rib-sparing internal mammary vessel harvests. Results A total of 547 reconstructions (344 patients) met inclusion criteria for this study. A total of 64.9% (n = 355) underwent rib-sacrificing internal mammary vessel harvest. Cohorts were similar in baseline patient characteristics, indications for surgery, and cancer therapies. However, patients undergoing rib-sparing reconstructions had significantly shorter operative times (440 vs. 476 minutes; p < 0.01), and significantly less postoperative pain on postoperative day (POD) 1 (2.8/10 vs. 3.4/10; p = 0.033) and POD2 (2.4/10 vs. 3.0/10; p = 0.037). Furthermore, patients undergoing rib-sparing techniques had greater incidence of fat necrosis requiring excision (12.5 vs. 2.8%; p < 0.01) and a trend toward higher incidence of hematoma, venous thrombosis, and arterial thrombosis when compared with rib-sacrificing patients. Conclusions Rib-sparing harvest of internal mammary vessels is a feasible technique in microsurgical breast reconstruction. However, given the significant increase in fat necrosis requiring surgical excision, the trend toward increased postoperative complications, and no significant difference in postoperative revision rates, the purported benefits of this technique may fail to outweigh the possible risks.
PMID: 26258918
ISSN: 1098-8947
CID: 2061682
Nipple-sparing Mastectomy and Sub-areolar Biopsy: To Freeze or not to Freeze? Evaluating the Role of Sub-areolar Intraoperative Frozen Section
Alperovich, Michael; Choi, Mihye; Karp, Nolan S; Singh, Baljit; Ayo, Diego; Frey, Jordan D; Roses, Daniel F; Schnabel, Freya R; Axelrod, Deborah M; Shapiro, Richard L; Guth, Amber A
Use of nipple-sparing mastectomy (NSM) for risk-reduction and therapeutic breast cancer resection is growing. The role for intraoperative frozen section of the nipple-areolar complex remains controversial. Records of patients undergoing NSM at our institution from 2006 to 2013 were reviewed. Records from 501 nipple-sparing mastectomies were reviewed (216 therapeutic, 285 prophylactic). Of the 480 breasts with sub-areolar biopsies, 307 had intraoperative frozen sections and 173 were evaluated with permanent paraffin section only. Among the 307 intraoperative frozen sections, 12 biopsies were positive on permanent paraffin section (3.9% or 12/307). Of the 12 positive permanent biopsies, five were false negative and the remaining seven concordant intraoperatively. Sensitivity and specificity of sub-areolar frozen section were 0.58 and 1, respectively. Positive sub-areolar biopsies consisted primarily of ductal carcinoma in situ (62% or 13/21). The nipples or nipple-areolar complex were resected in a separate procedure following mastectomy (10/21), intraoperatively following frozen section results (7/21) or during second-stage breast reconstruction (3/21; 1 additional scheduled). Only 30% (6/20) of resected specimens had abnormal residual pathology. Intraoperative frozen section is highly specific and moderately sensitive for the detection of positive sub-areolar biopsies in NSM. Its use can help guide intraoperative reconstructive planning. The presence of positive sub-areolar biopsies in both contralateral and high-risk prophylactic mastectomy specimens emphasizes the need to perform sub-areolar biopsies in all nipple-sparing mastectomies.
PMID: 26510917
ISSN: 1524-4741
CID: 1817532