The Use of Hemostatic Agents to Decrease Bleeding Complications in Breast Cancer Surgery PDF

Article The American Surgeon 2021, Vol. 0(0) 1–6 The Use of Hemostatic Agents to...

Article The American Surgeon 2021, Vol. 0(0) 1–6 The Use of Hemostatic Agents to © The Author(s) 2021 Decrease Bleeding Complications in Article reuse guidelines: sagepub.com/journals-permissions Breast Cancer Surgery DOI: 10.1177/00031348211029866 journals.sagepub.com/home/asu Joshua A. Bloom, MD1, Sina Foroutanjazi, BS2, Zachary Erlichman, BS2, Zhaneta Beqiraj, MA1, Michael M. Jonczyk, MD, MSCTS1, Sarah M. Persing, MD, MPH3, and Abhishek Chatterjee, MD, MBA, FACS4 Abstract Introduction: Following breast cancer surgery, patients often require adjuvant radiation and chemotherapy for lo- coregional and systemic disease control. These procedures may result in postoperative complications, which may delay adjuvant therapy. To potentially decrease these complications, hemostatic agents may be used. This study evaluated the rate of postoperative bleeding complications and duration of Jackson-Pratt (JP) drain use in oncologic breast surgery with and without hemostatic agents. Methods: After obtaining institutional review board approval, a retrospective chart review was performed. Patients who underwent oncoplastic breast surgery, mastectomy with or without expander/implant-based reconstruction, and subsequent reconstruction with expander to implant exchange were included. Data collected included indication for surgery, type of operation, use of hemostatic agent, specifically fibrin sealant (FS, EVICEL®, Ethicon, USA) or combination powder (CP, HEMOBLASTÔ Bellows, biom’up, France), length of follow-up, time to JP drain removal, and post-operative complications (seroma, hematoma, or operating room (OR) takeback). This was a consecutive experience where initially no hemostatic agent was used, followed by use of FS, and then CP. Results: The use of a hemostatic agent resulted in fewer bleeding complications and significantly decreased time until JP drain removal. Although not significant, subgroup analysis demonstrated that this was more pronounced in the CP group. JP drain duration was decreased among all procedures for CP compared to FS. Conclusions: The use of hemostatic agents in oncologic breast surgery may result in decreased postoperative complications and significantly reduce time to JP drain removal. Keywords oncoplastics, mastectomy, seroma, hematoma, hemostatic agent Key Takeaways surgical subspecialities including breast surgery that in- 1. The use of hemostatic agents in breast cancer cludes breast conservation in addition to mastectomy and surgery results in an overall decreased incidence of reconstruction.1-3 Post-operative complications in major bleeding complications. 2. The duration of time until JP drain removal is 1 decreased with the use of hemostatic agents in Department of Surgery, Tufts Medical Center, Boston, MA, USA 2 breast cancer surgery. Tufts University School of Medicine, Boston, MA, USA 3 Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Southern California, Los Angeles, CA, USA 4 Introduction Division of Plastic and Reconstructive Surgery, Department of Surgery, Tufts Medical Center, Boston, MA, USA Improvements in surgical technique as well as the de- Corresponding Author: velopment of modern hemostatic agents have increased Joshua A. Bloom, MD, Department of Surgery, Tufts Medical Center, our ability in achieving surgical hemostasis. However, 800 Washington Street, Boston, MA 02111, USA. hematoma and seroma formation continue to occur in all Email: [email protected] 2 The American Surgeon 0(0) breast surgery operations such as mastectomy with or follow-up, duration of time to JP drain removal, and post- without reconstruction include seroma and hematoma operative complications (seroma, hematoma, or operating with rates of 8.2% and 3.3%, respectively.4 Major tissue room (OR) takeback). rearrangement in breast surgery also includes onco- This was a consecutive experience where initially no plastic surgery (OPS), which is a broad surgical field in hemostatic agent was used, followed by use of FS (be- which oncological breast surgery and plastic surgery ginning June 2017), and then CP (beginning August techniques have been combined for optimal patient 2019). All patients were consecutively treated within each outcomes.5,6 Some of the common OPS techniques in- time period. These changes were motivated by an ob- clude local tissue rearrangement, reduction mamma- served increase in bleeding complications. plasty, mastopexy.7-10 A recent literature review of level Of note, before operative closure of any incision site, 2 OPS techniques in the United States, which includes lidocaine with epinephrine was injected for postoperative reduction mammaplasty and mastopexy designs, has found analgesia, and the surgeon made sure that the patient was the rate of hematoma and seroma to be 2.26% and 1.35%, not hypotensive so as to minimize the chances of missing respectively.11 vessels that would potentially bleed when the patient Over the past several decades, the development and use became normotensive post-operatively. No tumescent of ancillary hemostatic techniques have become more fluid was used. available, as they assist the surgeon in achieving durable JP drains were removed in the clinic when drain output hemostasis and reducing the incidence of hematoma and was less than 30 cc/day for 2 consecutive days. JP drain seroma formation.12 One such product is EVICEL®, output was compared between groups using Welch’s a fibrin sealant that consists of BAC2 (human fibrinogen) t-test. Post-operative complications were compared using and thrombin, that is FDA approved for surgical hemo- Fisher’s exact test. Statistical significance was defined as stasis.13 An additional product is the combination powder P <.05. (CP) by HEMOBLASTÔ Bellows, which is made up of Institutional review board approval was obtained. This porcine-derived collagen, bovine-derived chondroitin study was done in accordance with the principles outlined sulfate, human-derived thrombin, and fibrinogen.14 The in the Declaration of Helsinki. HEMOBLASTÔ Bellows CP has been shown to play a superior role in immediate hemostasis in several surgical subspecialities, including cardiothoracic, abdominal, and Results orthopedic surgery, as compared to the traditional he- The use of a hemostatic agent resulted in reduced time mostatic matrix.14-16 However, to the authors’ knowledge, duration for JP drain use and overall fewer recorded the role of these two products in oncoplastic and onco- bleeding complications as compared to the non- logic breast surgery has not yet been studied and their hemostatic agent group (Table 1). effectiveness in these procedures are not validated. Compared to no hemostatic agent, the use of CP was Given that the role of hemostatic agents in oncoplastic resulted in decreased incidence of seroma, hematoma, and surgery and breast surgery has had limited study, the aim return to OR, especially in the mastectomy group, with an of this study was to (1) evaluate the frequency of post- 8.7% seroma and 0% return to OR rate in the CP group operative bleeding complications, and (2) the duration of (n = 23), as compared to 17.4% seroma and 13% return to Jackson-Pratt (JP) drain use in oncoplastic and oncologic OR rate in the non-hemostatic agent group (n = 23). These breast surgery procedures with and without the use of were without statistical significance. Additionally, JP either EVICEL® or HEMOBLASTÔ Bellows. drain duration was statistically significantly decreased in the CP group as compared to the non-hemostatic agent group among oncoplastic (5 vs 11.4 days, P <.01), Methods mastectomy (12.7 vs 30.4 days, P <.01), and expander A retrospective chart review was performed from a single exchange (2 vs 14.8 days, P <.01) operations. surgeon’s case database from January 2015 to September Subgroup analysis demonstrated that the CP group 2020. Patients were included who underwent surgery for experienced no hematomas, seromas, or return to OR for breast cancer, including oncoplastic breast surgery, the oncoplastic (n = 29) and expander exchange (n = 7) mastectomy with or without expander/implant-based re- procedures as compared to the FS group with a 5.5% construction, and subsequent reconstruction with ex- seroma rate in oncoplastic (n = 73) and 20% seroma rate in pander to implant exchange. Those not meeting these expander exchange operations (n = 5). The seroma rate criteria were excluded from the analysis. after mastectomy was 8.7% with CP (n = 23) compared to Data was collected including the indication for surgery, 14.3% with FS (n = 28). The OR takeback rate after type of operation, use of hemostatic agent, specifically mastectomy was 0% with CP (n = 23) compared to 8.7% fibrin sealant (FS, EVICEL®, Ethicon, USA) or CP (n = 28) with FS. These differences in post-operative (HEMOBLASTÔ Bellows, biom’up, France), length of complications were without statistical significance. Lastly, Bloom et al 3 Table 1. Rates of Post-Operative Complications and Time to JP Drain Removal Within Oncologic Breast Surgery using no Hemostatic Agent vs EVICEL® (FS) and HEMOBLASTÔ Bellows (CP). No hemostatic agent HEMOBLASTÔ bellows (CP) Oncoplastic Mastectomy Expander exchange Oncoplastic Mastectomy Expander exchange N 87 23 40 29 23 7 Average follow-up (weeks) 7.9 15.3 6 4.8 6.3 3.9 Average time with JP (days) 11.4 30.4 14.8 5 12.7 2 Standard deviation 4.5 16.5 12.6 4.1 7.2 3.4 P <.01 P <.01 P <.01 Seroma (%) 2 (2.3) 4 (17.4) 2 (5) 0 (0) 2 (8.7) 0 (0) P=1 P =.665 P=1 Hematoma (%) 3 (3.4) 1 (4.3) 0 (0) 0 (0) 1 (4.3) 0 (0) P =.329 P=1 P=1 OR takeback (%) 1 (1.1) 3 (13) 1 (2.5) 0 (0) 0 (0) 0 (0) P=1 P =.233 P=1 EVICEL® (FS) HEMOBLASTÔ bellows (CP) Oncoplastic Mastectomy Expander exchange Oncoplastic Mastectomy Expander exchange N 73 28 5 29 23 7 Average follow-up (weeks) 7.4 8.5 5.4 4.8 6.3 3.9 Average time with JP (days) 11 17.6 17.3 5 12.7 2 Standard deviation 5.3 14.4 10.7 4.1 7.2 3.4 P <.01 P =.138 P =.124 Seroma (%) 4 (5.5) 4 (14.3) 1 (20) 0 (0) 2 (8.7) 0 (0) P =.576 P =.678 P =.417 Hematoma (%) 0 (0) 1 (3.6) 0 (0) 0 (0) 1 (4.3) 0 (0) P=1 P=1 P=1 OR takeback (%) 0 (0) 2 (8.7) 0 (0) 0 (0) 0 (0) 0 (0) P=1 P =.495 P=1 Abbrevation: JP, Jackson-Pratt. JP drain duration was statistically significantly decreased rearrangement to reconstruct the breast. OPS can be further among oncoplastic (5 vs 11 days with P <.01), but not categorized into level 1 volume displacement, level 2 mastectomy (12.7 vs 17.6 days with P =.138), and ex- volume displacement, and volume replacement based on pander exchange (2 vs 17.3 days with P =.124) for CP as the American Society of Breast Surgeons definitions.20 compared to FS (Figure 1). However, similar to all procedures, OPS and other oncologic breast surgery, including mastectomy and expander/implant-based reconstruction, is not without Discussion associated complications. Seromas and hematomas are Oncoplastic surgery is an innovative reconstructive ap- a relatively common complication due to increased dead proach that has continued to gain in popularity for certain space created from the surgical process. Surgical com- patient populations. Women with large tumors and plications can result in delays of adjuvant radiation and moderate to large ptosis can benefit from a partial mas- chemotherapy leading to worsened outcomes.21 There- tectomy while utilizing local tissue for rearrangement in fore, the use of hemostatic agents can possibly reduce order to reconstruct the breast. The large partial mas- these complications. Our results noted decreased hema- tectomy allows for decreased positive margins while the toma and seroma formation when hemostatic agents were implementation of autologous tissue creates an optimal used in addition to statistically significantly lower drain aesthetic outcome.17,18 Oncoplastic surgery showed the duration times. The latter decreases patient discomfort most favorable PROMs when compared to other re- and theoretically prevents the chances of drain infections. constructive modalities.19 Its oncologic utility lies in the It is interesting to note that even with statistically de- ability to perform a large partial mastectomy, resulting in creased drain times, the hemostatic agent groups showed a decreased positive margin rate, while utilizing local tissue a decreased incidence of seromas supporting a mechanism 4 The American Surgeon 0(0) Figure 1. Duration of time to Jackson-Pratt drain removal ( = statistically significant as compared to no hemostatic agent, # = statistically significant as compared to EVICEL® (FS)). for decreased post-operative seroma complications other which could potentially introduce bias. However, it is not than the presence of a drain. This could be due to the feasible to blind the surgeon to which product is being used ability of the hemostatic agents to collapse deadspace, due to the differences in product preparation. Furthermore, something that is seen in the abdominoplasty/plastic while promising post-operative outcomes were noted, the surgery literature.22 lack of statistical significance favoring hemostatic agents This is the first study to examine these agents in on- could be related to sample size with larger samples possibly cologic breast surgery and evaluate their efficacy. Ex- showing statistical significance with avoidance of a potential amining postoperative outcomes from hundreds of Type II statistical error. It should also be mentioned that the patients, the use of CP and FS resulted in a decreased cost of the hemostatic agent is an important consideration incidence of postoperative complications, including se- that contributes to the overall cost of the operation. A cost- roma, hematoma, and OR takeback, with a more pro- effectiveness analysis examining the use of these two he- nounced effect in the CP group when examining time mostatic agents compared to no hemostatic agent would be prior to JP drain removal. Therefore, the use of the agents worthwhile to rationalize the routine use of hemostatic could potentially decrease delays in further therapies and agents in breast surgery. improve outcomes. In general, decreased post-operative Future studies should be performed to evaluate long- complications leads to improved patient satisfaction term outcomes to greater assess the utility of hemostatic outcomes and decreased cost burden further underscoring agents in this population, especially with regard to the importance in the study of technologies that can aid mitigating delays in adjuvant therapy. In the end, we hope surgical technique.23,24 to provide a more detailed and standardized data set in- While this study is novel, it is not without limitations. corporating many institutions in order to analyze out- Although this study incorporated many patients, all onco- comes more precisely and accurately. logic breast surgery procedures were performed at a single institution, by a single surgeon. Therefore, larger studies at Conclusion multiple sites will better address whether this data is re- producible and generalizable. In addition, it is important to The use of hemostatic agents in oncologic breast surgery mention that this study was retrospective and not blinded, significantly shortens time to JP drain removal and may Bloom et al 5 decrease postoperative complications, including seroma, 6. Losken A and Chatterjee A. Improving results in oncoplastic hematoma, and OR takeback. Subgroup analysis of the surgery. Plast Reconstr Surg. 2021;147(1):123e-134e. individual hemostatic agents demonstrated a statistically 7. Franceschini G, Magno S, Fabbri C, Chiesa F, Di Leone A, significant decreased duration of time prior to JP drain Moschella F, et al. Conservative and radical oncoplastic removal in the oncoplastic group. in the CP group as approches in the surgical treatment of breast cancer. Eur Rev compared to FS. Med Pharmacol Sci. 2008;12(6):387-396. 8. Bertozzi N, Pesce M, Santi PL, and Raposio E. Oncoplastic breast surgery: comprehensive review. Eur Rev Med Data Availability Statement Pharmacol Sci. 2017;21(11):2572-2585. The data that support the findings of this study are 9. Patel K, Bloom J, Nardello S, Cohen S, Reiland J, and available on request from the corresponding author. The Chatterjee A. An Oncoplastic surgery primer: common data are not publicly available due to privacy or ethical indications, techniques, and complications in level 1 and 2 restrictions. volume displacement oncoplastic surgery. Ann Surg Oncol. 2019;26(10):3063-3070. 10. Losken A and Chatterjee A. Improving results in oncoplastic Acknowledgments surgery. Plast Reconstr Surg. 2021;147(1):123e-134e. Thank you to all who helped make this project possible. 11. Erlichman Z, Bloom J, Char S, Foroutanjazi S, Nardello S, and Chatterjee A. Trends in outcomes of level 2 volume Declaration of Conflicting Interests displacement in oncoplastic breast surgery between the The author(s) declared no potential conflicts of interest with United States and Western Europe. Am Surg. 2020;23: respect to the research, authorship, and/or publication of this 3134820954859. article. 12. Bullocks J, Basu C, Hsu P, and Singer R. Prevention of hematomas and seromas. Semin Plast Surg. 2006;20(4): Funding 233-240. 13. Dhillon S. Fibrin sealant (evicel® [quixil®/crossealÔ]): The author(s) disclosed receipt of the following financial support a review of its use as supportive treatment for haemostasis in for the research, authorship, and/or publication of this article: surgery. Drugs. 2011;71(14):1893-1915. This project was supported in part by an Investigator Initiated 14. Bruckner BA, Ngo U, Ramchandani M, Suarez E, Awad S, Study grant from Biom’Up. Dr Chatterjee is a consultant for and Reardon M. Application techniques of a novel hemostat Biom’Up. in cardiac operations: HEMOBLAST. J Card Surg. 2019; 34(9):849-853. References 15. Dang NC, Ardehali A, Bruckner BA, Parrino PE, Gillen 1. Seth AK, Hirsch EM, Kim JY, Dumanian GA, Mustoe TA, DL, Hoffman RW, et al. Prospective, multicenter, ran- Galiano RD, et al. 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