The overall incidence of complications, including infection, hematoma, seroma, mastectomy flap necrosis, implant exposure, and capsular contracture, was 12 percent (n = 7) for dual-plane and 2 percent (n = 1) for prepectoral (p = 0.07). There were no cases of complete device loss, although three implants (dual-plane, n = 2; prepectoral, n = 1) required removal and downsizing to placement of a tissue expander (Table 4). In the case of the two dual-plane reconstructions, a patient undergoing bilateral reconstruction experienced an anaphylactic reaction to the isosulfan blue dye, received intraoperative epinephrine, and subsequently had bilateral partial mastectomy flap necrosis with unilateral exposure, necessitating excision of the demarcated flaps and downsizing to a tissue expander. In the case of the prepectoral reconstruction, a patient undergoing bilateral reconstruction, with a history of augmentation and cardiac surgery with subpectoral pacemaker leads, experienced a 2-mm area of persistent poor wound healing of her mastectomy flap with concern for exposure. The patient was returned to the operating room, her implant was removed, and downsizing to a tissue expander with placement of a latissimus dorsi flap to reinforce the thin mastectomy flap was carried out. Both patients have completed exchange operations and have stable implant constructs.
One case (1.7 percent) of capsular contracture was identified in the dual-plane cohort that required operative revision and implant exchange. Thus far, there have been no cases of capsular contracture among prepectoral reconstructions.
Mean pain scores for the first 24 hours postoperatively were low for both cohorts (dual-plane, 3.62; prepectoral, 3.55; p = 0.86) and length of stay was similar (dual-plane, 1.77 days; prepectoral, 1.79 days; p = 0.90). Dual-plane and prepectoral reconstructions were equally likely to undergo reoperation for aesthetic revision [dual-plane, n = 10 (18 percent); prepectoral, n = 9 (19 percent); p = 0.42), including lipofilling, implant exchange, and mastopexy of the reconstructed breast(s). Pectoralis animation deformity was completely eliminated in the prepectoral cohort.
Blinded panel evaluation determined that overall reconstruction scores were highest for prepectoral reconstruction compared with dual-plane reconstructions independent of laterality (bilateral prepectoral, 8.1; unilateral prepectoral, 6.3; bilateral dual-plane, 6.1; and unilateral dual-plane, 5.3). The panel also favored prepectoral with regard to lack of rippling (prepectoral, 8.2; dual-plane, 6.9) and lack of visibility of the implant (prepectoral, 7.6; dual-plane, 6.2).
Direct-to-implant breast reconstruction is at the forefront of advancements in postmastectomy breast reconstruction and presents distinct advantages compared with tissue expander and implant reconstruction through a shorter, more efficient reconstructive process and potential for reduced cost, improved patient satisfaction, and quality of life.3–5,24 Although some authors have demonstrated similar rates of complications between direct-to-implant and tissue expander/implant reconstructions,4,25 other studies highlight the technical challenges and potential pitfalls of the direct-to-implant approach. A recent meta-analysis in 2014 found direct-to-implant reconstruction to result in a higher incidence of flap necrosis, reoperation, and implant loss compared to tissue expander/implant reconstruction, and a large National Surgical Quality Improvement Program study corroborated these findings with higher rates of implant loss.26,27 There is additional evidence to suggest that direct-to-implant reconstructions may be more likely to require operative revision, as high as 87 percent3; however, early outcomes may be related to the steep learning curve, as Colwell et al. demonstrated that complication rates were reduced by half after the initial year performing the direct-to-implant technique.2
Prepectoral implant placement represents another step toward advancing postmastectomy reconstruction and has been described with both tissue expander and direct-to-implant methods, although studies are only now emerging. Prepectoral breast reconstruction eliminates dynamic deformity of the implant and has the potential to reduce postoperative pain and narcotic use, expediting recovery for postmastectomy patients compared to submuscular implant placement.8,9 In addition, prepectoral reconstruction, although associated with increased additional cost of the acellular dermal matrix, may ultimately prove cost-effective through avoidance of secondary operations, decreased use of health care resources (e.g., physical therapy, decreased narcotic use, and length of stay), and faster return to work.24 Prepectoral implant placement may also confer aesthetic benefits, resulting in a natural appearance to the reconstructed breast.7,17 When combined with a direct-to-implant operation, prepectoral reconstruction capitalizes on the advantages of both methods and may amplify benefits to the patient. Historically high complication rates, concern regarding the cosmetic results, and a steep learning curve have resulted in relatively few reconstructive surgeons who routinely use this technique.28 However, the advent of acellular dermal matrix, improved implant designs, and the evolution of mastectomy operations with greater conservation of the breast envelope have all contributed to renewed interest in prepectoral reconstruction.7–10,14–22
In our prepectoral patients, we experienced a low incidence of complications, with only one case (2.1 percent) of persistent delayed wound healing requiring excision and downsizing to a tissue expander. Aggressive management is recommended for any mastectomy flap necrosis to avoid loss of the reconstructive domain. Complication rate in the dual-plane reconstruction cohort was also low at 12.3 percent, although this difference approached significance (p = 0.07), despite similar patient demographics and oncologic history. We feel that both techniques are viable and that this difference may be attributable to acceleration along the learning curve, as the majority of the dual-plane cohort precedes the prepectoral cohort temporally. It is notable, however, that the incidence of complications was not increased in the prepectoral cohort even though the implant is placed in the more vulnerable, superficial position.
In the small body of literature on prepectoral direct-to-implant reconstruction, reported rates of partial or total mastectomy flap necrosis range from 0 to 28 percent and implant loss ranges from 0 to 18 percent, with higher rates occurring in smokers and women with previous radiation therapy, highlighting the need for judicious patient selection when considering a prepectoral direct-to-implant reconstruction.7–10,13–15,26 We corroborate the need for careful patient selection and consider smoking and poorly controlled medical comorbidities to be absolute contraindications.
In our practice, typical candidates for prepectoral direct-to-implant reconstruction are women with small or medium-size breasts who desire a reconstruction similar to the size of their native breast. We have expanded our indications and found that patients with mild ptosis or postpregnancy volume loss can achieve a lifted appearance to the reconstructed breast with conservative implant upsizing in the pliable envelope. Patients with previous breast irradiation require careful evaluation, and the breast tissue and skin must exhibit minimal radiation-induced changes to accommodate the implant in a prepectoral direct-to-implant reconstruction. Radiation therapy is not an absolute contraindication. We have found that in the properly selected patient, prepectoral direct-to-implant reconstruction may provide a reasonable alternative, as it avoids expansion of the previously irradiated mastectomy flaps and donor-site morbidity of autologous tissue. Similarly, we do not consider previous breast surgery to be a contraindication; however, increased vigilance is necessary, as prior augmentation may lead to thinner and vascularly compromised mastectomy flaps and may contribute to an increased risk of flap complications.
Other considerations, highlighted by Sigalove et al. and others, include oncologic features.18,19,29 For example, patients with tumors located in close proximity to the chest wall may be better served by a submuscular reconstruction, to allow for enhanced surveillance for recurrence in the pectoralis muscle. Other factors, such as inflammatory breast cancer or the need for axillary lymph node dissections, should also be considered.18,19 Some surgeons prefer to limit prepectoral reconstruction to patients undergoing nipple-sparing mastectomies; however, in our practice, we have used this technique after skin-sparing and modified radical mastectomies as well. Further studies and longer follow-up are necessary to determine any long-term oncologic ramifications of this approach given the recent reemergence of the prepectoral approach although, arguably, logic for alloplastic reconstruction in the native breast space might be derived from the robust data on free flap reconstruction performed in the prepectoral space.
Reconstructive surgeons may be hesitant to use prepectoral direct-to-implant reconstruction because of concern for jeopardizing cosmetic outcomes in the form of rippling or visibility of the implant. At our institution, direct-to-implant reconstruction constitutes nearly half of our current device-based breast reconstruction practice and is now performed preferentially in the prepectoral space, as we have observed favorable aesthetics with this approach. Contrary to prior studies, results from this study indicate that prepectoral direct-to-implant reconstructions are not more likely to undergo reoperation for aesthetic reasons, including lipofilling, implant exchange, and mastopexy of the reconstructed breast [dual-plane, n = 10 (18 percent); prepectoral, n = 9 (19 percent); p = 0.42]. Enhanced aesthetics in the prepectoral cohort were corroborated through objective panel evaluation by blinded physicians, with higher overall reconstruction scores for prepectoral (bilateral, 8.1; unilateral, 6.25) compared to dual-plane cases (bilateral, 6.1; unilateral, 5.25). A series of representative outcomes are demonstrated with preoperative and postoperative photographs in Figures 1 through 4. (See Video, Supplemental Digital Content 1, which demonstrates postoperative results with absence of dynamic deformity with pectoralis muscle contraction, http://links.lww.com/PRS/D457.)
We believe several factors contribute to the favorable cosmetic results of prepectoral reconstructions. Placement of the implant in the submuscular position is often limited by the medial insertion of the pectoralis fibers. With the implant superficial to the muscle, the reconstructive surgeon is not restricted and is able to properly position the implant to attain medial cleavage of the reconstructed breasts. In addition, we have found that in the subcutaneous position, the implant settles into the mastectomy envelope to create a subtle and natural ptosis, and the contour of the implant is allowed to transmit more readily through the mastectomy flap without the overlying pectoralis muscle. In this regard, the prepectoral technique capitalizes on the perceived benefits of a subglandular augmentation with correction of mild ptosis, the appearance of natural contours, and absence of animation deformity. In addition, the prosthesis is placed into the same anatomical space from which the native breast tissue was removed, contributing to a more natural appearance; this opinion is shared by other authors who perform prepectoral tissue expander and implant reconstruction.15,16,18–20
In prepectoral reconstruction, proper implant selection is critical. Both round and anatomical implants have been used in our practice with good cosmetic outcome. We have found high-fill “Extra-full profile” cohesive gel implants (SCX, SSX, SRX; Allergan) are useful to counteract rippling potential when performing a prepectoral direct-to-implant reconstruction, and as such, there is a higher proportion of this implant type in the prepectoral cohort. The equivalent low revision rate in the prepectoral cohort (follow-up ≥1 year) reinforces the reduced need for significant subsequent lipofilling, as the implant shell characteristics are less visible. The natural appearance is further enhanced by the absence of pectoralis animation deformity; which was completely eliminated in the prepectoral cohort in this study. Although the differing length of follow-up is a consideration, both cohorts had follow-up of at least 1 year, with mean follow-up of 30.4 and 16.5 months. Furthermore, blinded panel evaluation also demonstrated higher scores among the prepectoral reconstructions with regard to lack of rippling (dual-plane, 6.9; prepectoral, 8.2) and lack of implant visibility (dual-plane, 6.2; prepectoral, 7.6).
Although this is the largest direct-to-implant–only comparative study to date (using acellular dermal matrix overlay tent), Casella et al. and Bernini et al. have published their early and late results with retropectoral and subcutaneous direct-to-implant reconstruction using titanium-coated polypropylene mesh. These authors similarly experienced no difference in implant rippling or visibility between prepectoral and dual-plane reconstruction and found objective cosmetic evaluation to favor prepectoral reconstruction.14,15 Another recent article by Cattelani et al. demonstrated increased patient satisfaction following prepectoral direct-to-implant reconstructions compared to dual-plane direct-to-implant and tissue expander/implant reconstructions (using acellular dermal matrix wrap).9 Patient satisfaction is an important consideration and will be a critical component of future directions.
Proponents of the prepectoral approach have described techniques to reduce the incidence of implant rippling and visibility. For example, Sigalove et al. routinely perform fat grafting anterior to the implant to thicken the mastectomy flap and enhance gliding movement within the subcutaneous pocket.18 In our practice, we do not perform fat grafting to the fresh mastectomy flaps but will consider subsequent grafting. Some surgeons feel that prepectoral reconstruction results in increased visibility of the superior implant border. To mitigate this in prepectoral tissue expander reconstructions, Sbitany et al. perform lipofilling to the upper pole at the time of exchange to permanent implant.19 Pittman et al. describe the P1 method, which uses a partial-thickness slip of pectoralis muscle to mask the upper pole.17 In our experience, we find that use of an initial tight construction of the acellular dermal matrix pocket and the aforementioned use of high-fill cohesive gel implants reduce the potential for rippling and upper pole visibility. Lipofilling remains an available option as a revision procedure if needed. We have more recently used higher cohesivity implants as an additional preventative measure. We did note that the lipofilling performed secondarily for prepectoral direct-to-implant reconstruction appeared to be for more minor defects.
Advocates of the prepectoral technique are encouraged by the potential to reduce postoperative pain and shorten recovery by avoiding dissection and expansion of the pectoralis muscle. Some surgeons report an observation of reduced narcotic requirements and decreased postoperative pain with prepectoral reconstruction, in addition to superior upper limb function.8–10 In our study, no significant difference was seen between the dual-plane and prepectoral cohorts with regard to pain scores (dual-plane, 3.62; prepectoral, 3.55; p = 0.86) or length of stay (dual-plane, 1.77 days; prepectoral, 1.79 days; p = 0.90); however, standardized postoperative management and recent implementation of an enhanced recovery after surgery protocol at our institution may better delineate differences.
Prepectoral direct-to-implant reconstruction is an innovative approach that offers several unique advantages, including the benefits of a single-stage operation and elimination of breast animation deformity. Transition from dual-plane to prepectoral direct-to-implant reconstruction has not resulted in increased complications or degradation of aesthetic results; interestingly, prepectoral reconstructions did not require an increased number of revision procedures and achieved higher aesthetic scores from our blinded panel. We have found the evolution from dual-plane to prepectoral direct-to-implant reconstruction to be a natural progression toward advancing the field of postmastectomy breast reconstruction, amalgamating the advantages of both prepectoral and direct-to-implant techniques to achieve enhanced aesthetic outcomes and a shortened reconstructive process.
The authors give special thanks to Vicky Kang, M.D., Andrea McNab, M.D., Gene R. Solmos, M.D., Norman L. Wool, M.D., Melody A. Cobleigh, M.D., and Mark A. Grevious, M.D.
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