Thursday, 5 July 2018

Nipple-Sparing Mastectomy Incisions for Cancer Extirpation Prospective Cohort Trial: Perfusion, Complications, and Patient Outcomes

by Odom, Elizabeth B.; Parikh, Rajiv P.; Um, Grace; Kantola, Simone W.; Cyr, Amy E.; Margenthaler, Julie A.; Tenenbaum, Marissa M.; Myckatyn, Terence M.  

Plastic and Reconstructive Surgery: July 2018 - Volume 142 - Issue 1 - p 13–26

Background: Nipple-sparing mastectomy offers several advantages for women seeking postmastectomy breast reconstruction, but compromised skin and nipple perfusion may lead to skin and nipple necrosis. It is unclear whether the incisional approach contributes to these complications; therefore, the purpose of this study was to compare the impact of incision type on outcomes in patients undergoing nipple-sparing mastectomy. Methods: This is a prospective cohort study of patients undergoing nipple-sparing mastectomy with prosthetic breast reconstruction through an inframammary fold versus a lateral radial incision. Skin and nipple perfusion as represented by fluorescence intensity, mammometric parameters, patient-reported outcomes, and clinical outcomes were analyzed and compared for the two cohorts, and multivariable logistic regression models were performed to evaluate the effects of covariates on outcomes. Results: Seventy-nine patients were studied: 55 in the inframammary fold cohort and 24 in the lateral radial cohort. The inframammary fold group had significantly less fluorescence intensity to the inferior (21.9 percent versus 36.9 percent; p = 0.001) and lateral portions of breast skin (23.1 percent versus 40.7 percent; p = 0.003) after reconstruction. Decreased fluorescence intensity was associated with smoking, decreased mean arterial pressure, and greater specimen weight. Postreconstruction breast volumes were increased over preoperative volumes in the inframammary fold group (38.3 percent) versus the lateral radial (31.2 percent) group; however, patients with a lateral radial incision had a greater increase in satisfaction with their breasts and psychosocial well-being. Conclusions: There are significant differences in patient-reported outcomes and final breast volumes based on the incisional approach to nipple-sparing mastectomy. These data can be used to guide providers and counsel patients considering nipple-sparing mastectomy with prosthetic reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

IDEAL IMPLANT Structured Breast Implants: Core Study Results at 6 Years

by Nichter, Larry S.; Hardesty, Robert A.; Anigian, Gregg M.  

Plastic and Reconstructive Surgery: July 2018 - Volume 142 - Issue 1 - p 66–75

Background: The structured breast implant uses different technology than saline or silicone gel implants, making it a third type of implant. The U.S. Food and Drug Administration and Health Canada granted approval in November of 2014. This implant is filled with saline but has an internal structure consisting of a series of nested shells that support the upper pole when upright and control fluid movement. It combines certain key features and benefits of saline and silicone gel implants. As with saline, the filler is only saline, which women like for peace of mind in case of rupture/deflation. As with silicone gel, it has a natural feel, but without the risk of silent rupture and U.S. Food and Drug Administration–recommended magnetic resonance imaging scans—women can simply look in the mirror and know their implants are intact. Methods: This U.S. trial enrolled 502 women: 399 primary augmentations and 103 replacements of existing augmentation implants. Investigators were 45 American Board of Plastic Surgery–certified plastic surgeons at 35 sites. Of the 502 women enrolled, 438 (87.3 percent) completed 6-year follow-up visits, a higher percentage than other Core breast implant trials. Results: At 6 years, patient satisfaction was 89.7 percent for primary and 91.6 percent for replacement augmentations; surgeon satisfaction was 92.6 percent for primary and 94.0 percent for replacement augmentation. Kaplan-Meier adverse event rates were as follows: Baker grade III and IV capsular contracture, 5.7 percent for primary and 11.5 percent for replacement augmentation; and rupture/deflation, 1.8 percent for primary and 4.7 percent for replacement augmentation. Conclusion: Six-year results from 438 women show that the structured breast implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Gender Differences in the Professional and Personal Lives of Plastic Surgeons

by Furnas, Heather J.; Garza, Rebecca M.; Li, Alexander Y.; Johnson, Debra J.; Bajaj, Anureet K.; Kalliainen, Loree K.; Weston, Jane S.; Song, David H.; Chung, Kevin C.; Rohrich, Rod J.  

Plastic and Reconstructive Surgery: July 2018 - Volume 142 - Issue 1 - p 252–264

Background: Although the number of women becoming plastic surgeons has increased during the past six decades, in comparison with the current gender parity in medical schools, plastic surgery still attracts disproportionately more men. Previous studies have shown disparities in the professional and personal lives of female and male plastic surgeons. A survey study was conducted to identify current challenges women and men encounter in the pursuit of a plastic surgical career to guide remedial strategies. Methods: An anonymous electronic survey was distributed to American Society of Plastic Surgeons members and candidates for comparison between sexes. Differences were tested by the Fisher’s exact and chi-square tests. Results: Women were more likely than men to have experienced sexism or bias. Women were less likely to be married; be satisfied with work-life balance; or feel recognized for ideas, authorship, promotions, or raises. Women felt that their sex was a disadvantage in career advancement, with one exception: unlike men, women felt many patients chose them because of their sex. Despite these challenges, over 80 percent of all plastic surgeons were satisfied with their choice of career. Conclusions: Traditions and gender bias create disparities in the personal and professional lives of female and male plastic surgeons. Our specialty must make concrete changes to promote all plastic surgeons, both women and men, to thrive personally and professionally.

Location of the Internal Mammary Vessels for Microvascular Autologous Breast Reconstruction: The “1–2–3 Rule”

by Lee, Christina Dami; Butterworth, James; Stephens, Robert E.; Wright, Barth; Surek, Christopher  

Plastic and Reconstructive Surgery: July 2018 - Volume 142 - Issue 1 - p 28–36

Background: Postmastectomy breast reconstruction provides psychosocial benefits in self-esteem, sexuality, and quality of life. Autologous procedures yield the highest overall patient satisfaction compared with implant-based breast reconstruction as the gold standard. The internal mammary vessels are the preferred recipient vessels for free flap breast reconstruction. The purpose of this study is to provide surgeons with a reliable method for locating the vessels intraoperatively. Methods: The internal mammary vessels were dissected bilaterally on 30 cadaveric specimens. Distances from the lateral sternal borders and the costochondral junctions to the internal mammary vessels at the second, third, and fourth costal levels were recorded. Descriptive bifurcation patterns were recorded. Initial dissection practicums were performed using the proposed safer dissection zone according to quantitative data. Results: Sixty internal mammary arteries and 120 internal mammary veins were studied at three costal levels, resulting in 180 sets of measurements. Distances from the lateral sternal border to the medial internal mammary vein were 6.12, 9.04, and 10.45 mm at costal levels 2, 3, and 4, respectively. Mean distances between costochondral junctions and internal mammary arteries were 12.80, 24.78, and 33.28 mm at costal levels 2, 3, and 4, respectively. Most internal mammary vein bifurcated at the third costal level, and the left side bifurcated higher than the right. Dissection practicums revealed that the proposed dissection zone was consistently reliable in locating the vessels. Conclusions: This study provides mean measurements from common bony landmarks to the internal mammary vessels, equipping surgeons with a reliable zone of dissection for recipient vessel exposure. This may decrease morbidity and improve outcomes in autologous breast reconstructions.

Prepectoral Implant-Based Breast Reconstruction with Postmastectomy Radiation Therapy

 by Elswick, Sarah M.; Harless, Christin A.; Bishop, Sarah N.; Schleck, Cathy D.; Mandrekar, Jay; Reusche, Ryan D.; Mutter, Robert W.; Boughey, Judy C.; Jacobson, Steven R.; Lemaine, Valerie  

Plastic and Reconstructive Surgery: July 2018 - Volume 142 - Issue 1 - p 1–12

Background: Two-stage subpectoral implant-based breast reconstruction is the most common method for breast reconstruction. Recent advances in surgical techniques and technology have made prepectoral implant-based breast reconstruction feasible. There are limited data on outcomes after prepectoral implant-based breast reconstruction and postmastectomy radiation therapy. Methods: A retrospective review of consecutive patients undergoing immediate two-stage prepectoral implant-based breast reconstruction with postmastectomy radiation therapy was performed. Outcomes of irradiated breasts were compared with nonirradiated breasts in bilateral cases. Results: Ninety-three cases of prepectoral implant-based breast reconstruction in 54 women who underwent immediate two-stage reconstruction (39 bilateral and 15 unilateral) and unilateral postmastectomy radiation therapy were identified. Mean follow-up was 19 months from mastectomy and tissue expander reconstruction and 9 months from implant placement. Crude complication rates in irradiated versus nonirradiated sides were as follows: surgical-site infection, 18.5 percent versus 7.7 percent; seroma, 5.6 percent versus 5.1 percent; mastectomy skin flap necrosis, 1.9 percent versus 2.6 percent; wound dehiscence, 1.9 percent versus 7.7 percent; capsular contracture, 1.9 percent versus 0 percent; hematoma, 1.9 percent versus 2.6 percent; and extrusion, 1.9 percent versus 0 percent. On univariate analysis, there were no risk factors associated with any complication, including radiation therapy, surgical-site infection, unplanned readmissions, and unplanned return to the operating room. To date, reconstruction has been completed in 96 percent of patients, with successful implant-based breast reconstruction in 81 breasts (45 irradiated breasts and 36 nonirradiated breasts). Conclusions: Early data of prepectoral implant-based breast reconstruction in patients with postmastectomy radiation therapy show promising results. Postmastectomy radiation therapy should not be an absolute contraindication to prepectoral implant-based breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial

 by Gunter von Minckwitz, Marco Colleoni, Hans-Christian Kolberg, Serafin Morales, Patricia Santi, Zorica Tomasevic, Nan Zhang, Vladimir Hanes  

The Lancet Oncology, Vol 19, No. 7, p987-998, July 2018

Although the lower bounds of the 90% CIs for RR and risk difference showed non-inferiority, the upper bounds exceeded the predefined equivalence margins when based on local laboratory review of tumour samples, meaning that non-superiority was non-conclusive. In our sensitivity analyses based on central laboratory evaluation of tumour samples, estimates for the two drugs were contained within the predefined equivalence margins, indicating similar efficacy. ABP 980 and trastuzumab had similar safety outcomes in both the neoadjuvant and adjuvant phases of the study.

Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial

 by Debu Tripathy, Seock-Ah Im, Marco Colleoni, Fabio Franke, Aditya Bardia, Nadia Harbeck, Sara A Hurvitz, Louis Chow, Joohyuk Sohn, Keun Seok Lee, Saul Campos-Gomez, Rafael Villanueva Vazquez, Kyung Hae Jung, K Govind Babu, Paul Wheatley-Price, Michelino De Laurentiis, Young-Hyuck Im, Sherko Kuemmel, Nagi El-Saghir, Mei-Ching Liu, Gary Carlson, Gareth Hughes, Ivan Diaz-Padilla, Caroline Germa, Samit Hirawat, Yen-Shen Lu  

The Lancet Oncology Vol 19, No. 7, p904-915, July 2018

Ribociclib plus endocrine therapy improved progression-free survival compared with placebo plus endocrine therapy, and had a manageable safety profile in patients with premenopausal, HR-positive, HER2-negative, advanced breast cancer. The combination could represent a new first-line treatment option for these patients.

Prospective, Randomized, Controlled Comparison of Bupivacaine versus Liposomal Bupivacaine for Pain Management after Unilateral Delayed Deep Inferior Epigastric Perforator Free Flap Reconstruction

 by Gatherwright, James; Knackstedt, Rebecca W.; Ghaznavi, Amir M.; Bernard, Steven; Schwarz, Graham; Moreira, Andrea; Gurunluoglu, Raffi; Djohan, Risal  

Plastic and Reconstructive Surgery: June 2018 - Volume 141 - Issue 6 - p 1327–1330

Summary: Effective postsurgical analgesia is a critical aspect of patient recovery. The goal of this prospective, randomized, controlled, blinded study was to examine the effect that liposomal bupivacaine delivered by means of a transversus abdominis plane block has on pain control in women undergoing unilateral deep inferior epigastric perforator flap reconstruction. Institutional review board approval was granted for this prospective study. Patients were eligible if they were undergoing unilateral, delayed deep inferior epigastric perforator flap reconstruction. Patients were randomized to one of three groups: liposomal bupivacaine transversus abdominis plane block, or bupivacaine pain pump. Charts were reviewed for demographics, length of stay, and postoperative narcotic use. There were eight patients in the liposomal bupivacaine and bupivacaine transversus abdominis plane block groups and five patients in the pain pump group. A retrospective cohort of six patients who did not receive any intervention was included. Patients who received a liposomal bupivacaine transversus abdominis plane block used statistically significantly less intravenous and total postoperative narcotics in milligrams and milligrams per kilogram per day compared with all other cohorts. They were able to get out of bed at an earlier time point. Overall hospital costs were similar among the groups. This is the first study to investigate liposomal bupivacaine delivered as a transversus abdominis plane block in a prospective, randomized, blinded study in women undergoing unilateral, delayed, abdominally based autologous breast reconstruction. The authors were able to demonstrate a significant reduction in intravenous and total narcotic use when a liposomal bupivacaine transversus abdominis plane block was used. Future studies are needed to prospectively investigate the effect that liposomal bupivacaine would have on immediate and bilateral reconstructions.

The Impact of Mastectomy Weight on Reconstructive Trends and Outcomes in Nipple-Sparing Mastectomy: Progressively Greater Complications with Larger Breast Size

 by Frey, Jordan D.; Salibian, Ara A.; Karp, Nolan S.; Choi, Mihye  

Plastic and Reconstructive Surgery: June 2018 - Volume 141 - Issue 6 - p 795e–804e

Background: Reconstructive trends and outcomes for nipple-sparing mastectomy continue to be defined. The graduated impact of breast size and mastectomy weight remains incompletely evaluated. Methods: All patients undergoing nipple-sparing mastectomy from 2006 to June of 2016 were identified. Demographics and outcomes were analyzed and stratified by mastectomy weight of 800 g or higher (large group), between 799 and 400 g (intermediate group), and less than 400 g (small group). Results: Of 809 nipple-sparing mastectomies, 66 (8.2 percent) had mastectomy weights of 800 g or higher, 328 (40.5 percent) had mastectomy weights between 799 and 400 g, and 415 nipple-sparing mastectomies (51.3 percent) had mastectomy weights less than 400 g. Nipple-sparing mastectomies in the large group were significantly more likely to be associated with major mastectomy flap necrosis (p = 0.0005), complete nipple-areola complex necrosis (p < 0.0001), explantation (p < 0.0001), cellulitis treated with oral (p = 0.0008) and intravenous (p = 0.0126) antibiotics, abscess (p = 0.0254), and seroma (p = 0.0126) compared with those in the intermediate group. Compared with small nipple-sparing mastectomies, patients in the large group had greater major mastectomy flap necrosis (p < 0.0001), complete (p < 0.0001) and partial (p = 0.0409) nipple-areola complex necrosis, explantation (p < 0.0001), cellulitis treated with oral (p < 0.0001) and intravenous (p < 0.0001) antibiotics, abscess (p = 0.0119), and seroma (p < 0.0001). Patients in the intermediate group were more likely to experience major (p < 0.0001) and minor (p < 0.0001) mastectomy flap necrosis, complete (p = 0.0015) and partial (p < 0.0001) nipple-areola complex necrosis, cellulitis treated with oral antibiotics (p = 0.0062), and seroma (p = 0.0248) compared with those undergoing small nipple-sparing mastectomies. Larger mastectomy weights were significant predictors of complications on logistic regression analysis. Conclusion: Reconstructive and ischemic complications in nipple-sparing mastectomy are progressively greater as mastectomy weight and breast size increase. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Toradol following Breast Surgery: Is There an Increased Risk of Hematoma?

by Nguyen, Brittany N.; Barta, Ruth J.; Stewart, Christine E.; Heinrich, Cherrie A.  

Plastic and Reconstructive Surgery: June 2018 - Volume 141 - Issue 6 - p 814e–817e

Background: Ketorolac tromethamine (Toradol), a nonsteroidal antiinflammatory drug, is used with increased frequency given its success in postoperative pain control and the subsequent decreased need for narcotics. Its use has been limited in plastic surgery for fear of postoperative bleeding and hematoma formation. In this study of breast surgery patients, the authors investigated whether ketorolac increased the risk of postoperative hematoma formation. Methods: After obtaining institutional review board approval, the authors retrospectively reviewed the records of patients undergoing breast surgery from January of 2012 through December of 2014. The authors compared the incidence of postoperative hematomas in patients who did, versus those who did not, receive ketorolac postoperatively. Results: For the entire cohort, the overall hematoma rate was 2.8 percent. Of the patients who received ketorolac, the rate was 3.5 percent; of those who did not, the rate was 2.5 percent. Of the breast reduction patients, the rate was 4 percent in those who received ketorolac versus 3.2 percent in those who did not. Of the breast reconstruction patients, the rate was 4 percent in those who received ketorolac versus 3.2 percent in those who did not. Conclusions: Recently, the high rates of prescribing postoperative narcotics have received increased attention. Aside from the risk of increased availability of narcotics in the community, the side effects can delay patient recovery. Ketorolac is controversial for postoperative pain control because of the potential risk of bleeding, but in the authors’ 3-year retrospective study, it was not associated with an increased risk of hematoma formation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.