Multiple studies have examined outcomes in implant-based reconstructions using total submuscular coverage versus use of scaffolds, with the majority focusing on acellular dermal matrices.18–23 In a 2011 meta-analysis, 19 studies examining total submuscular coverage were compared to 35 studies examining acellular dermal matrix use.23 Acellular dermal matrix use significantly increased the risk of overall complications, seroma, infection, and reconstructive failure compared with submuscular coverage.23 In a more recent 2016 meta-analysis of 23 studies and over 6100 patients, acellular dermal matrix use was associated with significantly higher rates of infection, seroma, and mastectomy flap necrosis and significantly lower rates of capsular contracture and implant malposition.18 Risk of implant loss, unplanned reoperation, and total complications was equivalent between the groups.18 Meanwhile, conflicting results have emerged regarding pain reduction during expansion and the ability for increased initial expander fill with the use of scaffolds.24
Notably, differences in outcomes reported in these large-scale studies may be influenced by differences in scaffold design.19 , 20 Specifically, many acellular dermal matrix products have undergone an evolution in product design from aseptic to sterile and now fenestrated products, which has been shown to decrease certain complications.19 , 20 Moreover, scaffolds more nascent in the field of breast reconstruction, such as polyglactin 910 mesh, have yet to be studied in large-scale or comparative studies, limiting the conclusions that may be made on their behalf.21 , 22
Both total submuscular and scaffold coverage are the standard of care in implant-based breast reconstruction. However, scaffolds offer distinct advantages, including improved lower pole and inframammary fold control with reduced capsular contracture coupled with a variably increased risk of overall complications. Used judiciously, scaffolds play an important role in alloplastic breast reconstruction, specifically in cases of insufficient muscle coverage or in which the implant pocket must be enlarged to match a larger overlying skin envelope, such as single-stage reconstruction or nipple-sparing mastectomy.
Smooth, Round or Textured, Anatomical Implants?
Permanent implants to be used in one- or two-stage alloplastic breast reconstruction are broadly divided into those that are round with a smooth texture and those that are anatomically, or tear-drop, shaped and textured to mitigate the risk of implant rotation and malposition.25 Multiple studies have examined comparative outcomes with these devices.25–27 In 2013, Macadam et al. demonstrated equivalent patient satisfaction in patients undergoing one- and two-stage reconstruction with smooth, round or textured, anatomical implants.26 Notably, patients with shaped implants noted their implants felt significantly more firm than the round implant cohort.26 In 2017, Khavanin et al. examined outcomes of tissue expander–based reconstructions that were at least 1 year after exchange using either round or shaped implants.27 In unilateral reconstructions, patients with round implants underwent significantly more contralateral symmetry procedures, with no such difference identified in bilateral reconstructions.27 Shaped implants were significantly more likely to experience overall or major complications, including reconstructive failure and infection, with no difference in capsular contracture; malposition; seroma; or implant leakage, failure, or deflation.27 However, patents with round, shaped implants reported equivalent 2-year patient-reported satisfaction rates.27 [See Figure, Supplemental Digital Content 3, which shows a 27-year-old woman (above) preoperatively and (below) postoperatively who underwent bilateral prophylactic nipple-sparing mastectomy with one-stage implant-based reconstruction using 375–ml, smooth, round, extra high-profile silicone implants. The patient had undergone a prior breast reduction, and her previous incisions were used for surgical access for mastectomy and reconstruction, http://links.lww.com/PRS/D271.]
Given their more recent development and widespread use, examining large-scale and long-term outcomes with textured, anatomical devices is paramount. In one study of over 17,000 subjects, McGuire et al. found rates of capsular contracture and implant malposition ranging from 3 to 4 percent and 1 to 3 percent in reconstruction cohorts, respectively.28 Importantly, 14 cases of late seroma and two cases of breast implant–associated large cell lymphoma (four overall identified) were identified in reconstruction patients.28 Breast implant–associated large cell lymphoma has been associated with textured implants as described by Doren et al. in their 2017 landmark study. One hundred cases in the United States were identified from 1999 to 2015, for an incidence of 2.03 per 1 million person-years.29 All cases were in patients with a known history of textured implants or with an unknown history of implant type.29 In cases without extracapsular spread or clinical lymphadenopathy, the recommended treatment is implant removal and complete capsulectomy. Radiation therapy and chemotherapy are reserved for more advanced cases with extracapsular spread.29
Overall, smooth, round implants remain the most commonly used in alloplastic breast reconstruction. They offer advantages such as a more natural feel with less risk of complications, compared with the infectious risk seen with their textured counterparts.26 , 27 (See Video, Supplemental Digital Content 4, which displays insertion of smooth, round silicone implants in a partial submuscular pocket with human acellular dermal matrix in a patient undergoing nipple-sparing mastectomy with one-stage implant-based breast reconstruction. This video is available in the “Related Videos” section of the full-text article on PRSJournal.com or at http://links.lww.com/PRS/D272.) However, textured, anatomical implants may offer a superiorly visualized breast aesthetic, especially in unilateral reconstructions.27 These unique advantages and disadvantages of smooth, round and textured, anatomical implants, including breast implant–associated large cell lymphoma among others, must be discussed with all patients undergoing implant-based breast reconstruction so that an informed decision can be made.29
Which Device Should Be Irradiated?
Radiation therapy improves rates of locoregional recurrence in patients with breast cancer.30 However, radiation therapy can impart significant risk in implant-based breast reconstruction.31 , 32 In one meta-analysis of 1105 patients, radiotherapy after alloplastic breast reconstruction was found to be associated with a greater than fourfold higher risk of complications compared with reconstructions without radiotherapy, with the most common complications being infection, capsular contracture, and mastectomy flap necrosis.33 Strategies to minimize risk in patients requiring postmastectomy radiation therapy undergoing implant-based reconstruction are therefore critical. In two-stage tissue expander–based reconstruction, significant debate has persisted regarding the timing of postmastectomy radiation therapy delivery. [See Figure, Supplemental Digital Content 5, which displays a 37-year-old woman (above) preoperatively and (below) postoperatively who underwent bilateral prophylactic nipple-sparing mastectomy with one-stage implant-based reconstruction using 290-ml textured, anatomical silicone implants through an inframammary fold incision. Human acellular dermal matrix was used for inferolateral implant support and coverage (M.C.), http://links.lww.com/PRS/D273.]
In a 2014 study, Cordeiro et al. described their protocol, which consisted of placing a tissue expander, expanding during chemotherapy, with exchange for a permanent implant 4 weeks after completion of chemotherapy.34 Radiation therapy then commenced 4 weeks after the exchange procedure. Using the protocol, patients with radiation therapy had significantly greater rates of reconstructive failure compared with those without radiation therapy.34 However, the authors conclude that most patients (82.5 percent) retain their reconstruction long term and have good satisfaction.34 The rise of neoadjuvant chemotherapy with earlier initiation of adjuvant radiotherapy, however, limits the utility of this approach.
Also in 2014, Ho et al. presented their differing approach to patients undergoing tissue expander–based reconstruction requiring postmastectomy radiation therapy.35 Their group performed tissue expander placement followed by delivery of radiation therapy to the fully expanded device.35 The exchange procedure was then performed after a 6-month waiting period. This study found that, again, reconstructions undergoing radiation therapy had significantly higher rates of reconstructive failure, with an acceptable rate of capsular contracture.35 Potential advantages of this approach include perhaps less delay to adjuvant radiation therapy and ability to address any injurious effects of radiation therapy on the reconstruction during the exchange procedure.
Following these studies, Cordeiro et al. directly compared tissue expander–based reconstructions receiving postmastectomy radiation therapy to the tissue expander to the permanent implant after an exchange procedure.36 Ultimately, the authors demonstrated that reconstructions receiving radiation therapy to the tissue expander had greater rates of reconstructive failure but higher surgeon-rated scores of aesthetic outcomes compared to those receiving radiation therapy to the permanent implant.36 Patient-reported outcomes were similar between the two groups.36 In contrast, Santosa et al. recently demonstrated that there were no significant differences in reconstructive failure rates between reconstructions receiving radiation therapy to the tissue expander or to the permanent implant using the Mastectomy Reconstruction Outcomes Consortium database.37
Overall, postmastectomy radiation therapy universally appears to increase complications after alloplastic breast reconstruction.31–37 Unique advantages and disadvantages regarding timing of device radiation therapy should be considered and discussed with patients undergoing two-stage reconstruction techniques. Notably, patients undergoing single-stage reconstruction may be advised that their outcomes may mirror those of patients undergoing radiation therapy of the permanent implant after two-stage reconstruction.32 Promisingly, emerging techniques in radiation therapy delivery, such as prone patient positioning, may help limit collateral damage and mitigate adverse effects of radiation therapy in the setting of alloplastic breast reconstruction.7 [See Figure, Supplemental Digital Content 6, which displays a patient who underwent bilateral skin-sparing mastectomy for right breast cancer with two-stage implant-based reconstruction. The patient underwent adjuvant radiation therapy to the right breast with the tissue expander in place, which was complicated by radiation-induced mastectomy flap necrosis and device exposure requiring device removal (M.C.). Radiation-induced skin changes are especially noted on the inferior skin flap of the right breast, http://links.lww.com/PRS/D274.]
Antibiotic prophylaxis has certainly become a controversial issues with regard to implant-based breast reconstruction. In establishing evidence-based best practices with regard to antibiotic prophylaxis, a series of pertinent questions must be addressed. First, is preoperative antibiotic prophylaxis warranted? In 1995, Amland et al. performed a prospective, double-blind, placebo-controlled, randomized clinical trial examining preoperative antibiotic prophylaxis in plastic surgery patients, including a small number undergoing alloplastic breast reconstruction (5.1 percent).38 Patients were randomized to receive a single preoperative dose of azithromycin or a placebo. Significantly lower levels of postoperative infection were found in those receiving preoperative antibiotics, supporting this practice.38
Is postoperative antibiotic prophylaxis necessary in implant-based breast reconstruction? In 2012, Clayton et al. examined patients undergoing breast reconstruction who received a single dose of preoperative antibiotics without postoperative antibiotics compared to those receiving postoperative prophylaxis until drains were removed.39 Implant-based reconstruction patients who did not receive postoperative antibiotics were 3.77 times more likely to experience an infection requiring reoperation.39 Although this study supports the need for postoperative antibiotic prophylaxis, the more pressing question becomes, for how long should antibiotics be given postoperatively?
A myriad of studies have sought to answer this question. In 2016, Phillips and Halvorson summarized the most pertinent of these to offer an evidence-based answer.5 Avashia et al. examined their single-surgeon experience divided into three periods: the first and third cohorts received postoperative antibiotics for more than 48 hours, whereas the second cohort received prophylaxis for less than 24 hours.40 The change back to greater than 48 hours in the third cohort was attributable to significantly higher rates in the second cohort, leading the authors to recommend greater than 48 hours of postoperative antibiotic prophylaxis.40 Contrastingly, a retrospective review by McCullough et al. of patients receiving antibiotics preoperatively and during their hospital stay compared to those receiving additional postoperative antibiotics found equivalent rates of postoperative infection.41 Separate systematic reviews by Phillips et al. demonstrated similar or lower levels of postoperative infection in patients receiving less than 24 hours of postoperative antibiotics compared with those receiving prophylaxis for greater than 24 hours.42 , 43 An additional randomized controlled trial by Phillips et al. found that antibiotics for less than 24 hours was not inferior to administering antibiotics until drains were removed in implant-based breast reconstruction.44 Moreover, patients receiving less antibiotic prophylaxis were found to generally have earlier infections treated with oral antibiotics compared with those in the group with prolonged administration of antibiotics that tended to have later infections complicated by device loss.44
Ultimately, in their review, Phillips and Halvorson conclude that 24 hours of postoperative antibiotic prophylaxis is supported by the literature.5 However, an individualized approach to this question is perhaps more appropriate. Certain patients with risk factors such as diabetes mellitus, obesity, and poor mastectomy flap quality, among others, may benefit from prolonged antibiotics postoperatively. Risk assessment models supporting this patient-centered antibiotic strategy remain to be evaluated.
Briefly, there is a paucity of evidence specifically examining the type of antibiotics to provide for preoperative prophylaxis in alloplastic breast reconstruction. Infectious disease guidelines generally dictate that first-generation cephalosporins active against Gram-positive organisms are appropriate for nonallergic, low to moderate risk patients.45 High-risk or allergic patients may be provided an agent with similar activity based on that hospital antibiotic-resistance profile. In the face of postoperative infection, the practice of administering oral or intravenous antibiotics active against methicillin- and cephalosporin-resistant organisms until culture-specific data are available is supported by multiple studies.41 , 46
Nipple-sparing mastectomy is the latest advancement in the surgical treatment of breast cancer, allowing for complete preservation of the nipple-areola complex and improved rates of patient satisfaction and quality of life compared with traditional mastectomy techniques.47 Importantly, oncologic outcomes, including locoregional recurrence, appear equivalent in nipple-sparing mastectomy compared to skin-sparing and total mastectomy techniques as demonstrated in multiple studies.48–51 Although traditional oncologic contraindications for nipple-sparing mastectomy included large tumors and tumors within 2 cm of the nipple-areola complex, more recent studies have demonstrated oncologic safety in patients with tumors within 1 cm of the nipple-areola complex.52 Absence of clinical nipple-areola complex tumor involvement has been proposed as the most important oncologic consideration in patient selection for nipple-sparing mastectomy.52
Overall reconstructive outcomes in nipple-sparing mastectomy continue to be established.2 Multiple risk factors have been variably identified in the literature as increasing the risk of reconstructive complications in this patient cohort.2 , 53–55 These risk factors include elevated body mass index, preoperative radiation therapy and chemotherapy, periareolar mastectomy incisions, smoking, and others.2 , 53–55 Although data are conflicting regarding the hazard posed by each individual risk factor, candidates for nipple-sparing mastectomy possessing multiple such factors should be approached cautiously and counseled regarding their increased potential for complications, including reconstructive failure. In the senior authors’ (M.C. and N.S.K.) practice, patients with nipple-to–sternal notch distances of greater than 28 cm and severe grade II or grade III breast ptosis are at higher risk of reconstructive complications and poor aesthetic outcome, representing relative contraindications for nipple-sparing mastectomy.
Options for implant-based breast reconstruction after nipple-sparing mastectomy include two-stage tissue expander–based reconstruction or single-stage immediate implant-based reconstruction.56 Similar to breast reconstruction after total or skin-sparing mastectomy, tissue expander–based breast reconstruction has remained the conventional reconstructive approach after nipple-sparing mastectomy, consistently demonstrating safe and favorable results.56 Meanwhile, immediate implant-based reconstruction after nipple-sparing mastectomy has been shown to provide a complete, reconstructed breast in an average of less than two procedures, with acceptable rates of reconstructive complications.57 One comparative study of both methods of alloplastic reconstruction after nipple-sparing mastectomy demonstrated that each technique is safe in appropriately selected patients, with absolute complication rates generally less than 7 percent.56 However, higher complete nipple necrosis and major/minor mastectomy flap necrosis were identified in the immediate implant reconstruction cohort, and higher rates of minor infection were found in the tissue expander cohort, likely related to frequent skin breaks required for device inflation.56
Prepectoral Breast Reconstruction
Commonly cited disadvantages of submuscular breast reconstruction techniques include increased postoperative pain secondary to muscle dissection, animation deformity, and inferior aesthetic outcomes given submuscular implant positioning.3 , 58 Implant placement in the subcutaneous or prepectoral plane has been described in both one- and two-stage breast reconstructions to mitigate negative sequelae of pectoralis disinsertion and submuscular implant positioning, with purported superior aesthetic results.3 , 59–61 Capsular contracture, infection, implant exposure, and reconstructive failure limited early experiences with subcutaneous reconstruction. Advances in mastectomy techniques and use of biological and prosthetic scaffolds may decrease the risk of these complications in the more recently described methods of prepectoral reconstruction3 , 59 , 61 (Fig. 5). However, superior pole rippling and edge artifacts remain as issues with prepectoral reconstruction, mandating fat grafting in many cases.3
In one systematic review of studies examining prepectoral breast reconstruction with scaffolds, pooled complications range from 1 to 5 percent.59 Higher complications were identified in one-stage compared to two-stage reconstructions, with the exception of partial nipple necrosis and minor infection, which were demonstrated to be greater in two-stage reconstructions.59 Meanwhile, similar complication profiles were found in reconstructions using acellular dermal matrices versus those with mesh.59 Aesthetic outcomes were rated favorably.59
Importantly, 80 percent of included studies in this review listed any exclusion criteria.59 The most commonly cited exclusion criteria were preoperative radiation therapy, smoking, and elevated body mass index.59 Although difficult to define, poorly vascularized mastectomy flaps are frequently identified as a significant consideration.3 , 59 , 60 Notably, although some may consider elevated body mass index as a contraindication, patients with larger breasts may undergo successful reconstruction in a prepectoral plane using a skin-reduction mastectomy pattern with an inferior dermal flap supplemented with superior implant coverage using scaffolds.59 , 60 , 62 Oncologic contraindications to prepectoral reconstruction include chest wall involvement or high-stage tumors such that postoperative surveillance is not impacted with the implant placed over the deep margin of the pectoralis major muscle.3 , 60 Notably, outcomes in patients undergoing radiotherapy after prepectoral reconstruction appear promising, and this does not need to be considered an absolute contraindication.63 Overall, the safety, cost, operational profiles, and long-term outcomes (both aesthetic and oncologic) of prepectoral implant-based breast reconstruction remain to be fully defined.
Patient-Controlled Tissue Expansion
Shortcomings of traditional tissue expansion devices include the need for frequent office visits, inherent risk of infection with percutaneous needle introduction for device filling, and a lack of patient autonomy.4 Various devices, such as osmotic tissue expanders and patient-controlled externalized tissue expanders, have been designed with an aim of circumventing these issues.64 , 65 However, each has distinct disadvantages, including lack of control over expansion forces and infection, respectively.64 , 65
More recently, patient-controlled remote carbon dioxide tissue expanders, specifically designed for use in breast reconstruction, have been introduced.4 Preliminary results with these devices have been encouraging. In one recent comparative study of 98 women with patient-controlled carbon dioxide expanders and 52 women with saline expanders, treatment success rates were equivalent between the two groups, whereas time to full expansion and complete reconstruction was significantly less in the carbon dioxide expander group.4 Patient satisfaction was greater than 75 percent, whereas both patient and surgeon rated ease of device use at greater than 90 percent.4 The devices are substantially more expensive than traditional tissue expanders, and although the time to full expansion is much quicker, the time to the second operation is not that much shorter compared with conventional expansion cases. Additional trials are ongoing to further define safety and outcomes with patient-controlled carbon dioxide tissue expanders.
Implant-based techniques are the most common methods of breast reconstruction and their use continues to rise. Many new innovations in oncologic and reconstructive techniques and device design work to improve patient outcomes and experience. With this in mind, plastic surgeons must be aware of the unique advantages and risks inherent in each technique, device, adjunctive tool, and oncologic strategy to help guide their patients to a successful and fulfilling reconstruction.
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