The removal of breast tissue during a mastectomy can often leave behind a very thin flap that provides inadequate soft-tissue coverage for IBR. For this reason, submuscular implant placement became the standard of care. Placing the implant behind the pectoralis major muscle (PMM) reduces implant visibility, palpability, rippling, and the risk of capsular contracture. However, pectoral muscle detachment has been associated with a number of complications including pain and functional impairment of PMM.1–3 This is often unacceptable to women who require PMM function for occupational or sporting requirements and activities of daily living. Patients may also complain of breast animation on contraction of the pectoral muscle.3 In addition, early techniques involving complete submuscular placement often resulted in unnatural appearing breast, as the muscle limited lower pole expansion and ptosis.
Acellular dermal matrices (ADMs) are increasingly used as an adjunct in IBR following mastectomy.4 ADMs are decellularized soft-tissue matrix grafts that behave as a collagen scaffold, allowing repopulation, revascularization and integration of the host’s cells into the implanted tissue.5 These matrices can be made from human cadaveric skin or xenogenic materials such as porcine skin or bovine pericardium. Techniques have evolved from 2-stage complete submuscular placement of tissue expander (TE),6,7 to single-stage direct to implant (DTI) reconstruction using partial submuscular coverage and an ADM to cover the lower part of the implant.8–10 Excellent cosmetic outcomes can be achieved as the ADM facilitates natural ptosis and definition of the inframammary fold. Despite this, there are problems with subpectoral implant placement. Although the prevalence of animation is unclear in the literature, it is apparent in over 60% of subpectoral breast augmentations and presumed to be more problematic in reconstruction patients with less soft-tissue cover.3 Additionally, over a period of time the natural ptosis can be blunted by the continuous “pull” on the ADM by the still partially functional PMM.
We hypothesize that the prepectoral placement of an implant with total ADM coverage can provide an excellent cosmetic result by camouflaging upper pole irregularities and creating a well-defined pocket to avoid implant malposition, while avoiding the complications associated with detachment of the pectoral muscle. This technique has not been extensively described in the literature to date. We report the initial results of a prospective cohort study of prepectoral implant placement with total ADM cover.
A prospective database was maintained for all patients undergoing prepectoral reconstruction at our institution since 2013. All patients provided informed consent for inclusion in the study, after a detailed description of the technique as well as all the potential risks and benefits. The data collected included patient demographics, baseline characteristics, indication for surgery, oncological data, surgical technique, and follow-up visits. Outcome data included length of hospital stay, complications, delay to adjuvant treatment, and the need for revisional surgery. Early complications were classified as “major” if the patients required a readmission to hospital and “minor” if they responded to nonoperative management. Specific complications included unplanned return to theatre, skin or nipple necrosis, implant loss, hematoma or seroma, infection requiring antibiotics, and delayed wound healing. Late complications of animation, rippling, or capsular contracture (graded using the Baker classification11) were documented.
Prepectoral implant placement with total ADM cover is indicated for women undergoing immediate IBR and revision of existing IBR. We used the porcine ADM StratticeTM or ArtiaTM (LifeCellTM Corporation, Bridgewater, N.J.).
Immediate Prepectoral Implant-Based Reconstruction
Reconstruction is performed following skin-sparing, nipple-sparing (NSM), or skin-reducing mastectomy (SRM). The mastectomy pattern selected depended on the oncological status and/or the patient’s wish to retain the nipple and the degree of breast ptosis present. In all cases, great care was taken to maintain a well-vascularized subcutaneous tissue layer to ensure adequate blood supply to promote wound healing and ADM integration through neovascularization.
Two sheets of Strattice or Artia (generally Contour 2 and 8 × 16 cm products) are prepared and sutured together on the bench using undyed 3/0 polydioxanone (Ethicon, N.J.). The superior edge of the ADM sheet is sutured to the upper mastectomy flap close to the chest wall interface. The cavity is irrigated and gloves changed before inserting the implant. An appropriately sized cohesive silicone gel implant is placed in the prepectoral position, beneath the ADM. The ADM is draped over the implant and sutures placed medially and laterally to create a snug pocket ensuring accurate implant positioning and good medial projection. Finally, sutures are placed to secure the ADM to fascia and periosteum, defining the inframammary fold. In total, 10–15 interrupted undyed 3/0 PDS (Ethicon) sutures are used to secure the ADM.
When nipple-sparing mastectomy was performed through an inframammary incision, the superior sutures were placed; then, the ADM construct was parachuted into the cavity (Figs. 1, 2). Other incisions in nonptotic breasts included periareolar (Fig. 3) and skin ellipse, depending on whether the nipple was to be retained or excised, respectively. In patients with significant breast ptosis, SRM was performed through a Wise pattern incision (Figs. 4–6). In these cases, an inferior dermal flap was developed and used sutured to a superior sheet of ADM to provide full prepectoral implant coverage (Fig. 4).
Revision of Existing Submuscular Implant-Based Reconstruction
The technique has also been used for revision of existing submuscular IBR due to animation, disruption of pectoral muscle function, implant malposition, or capsular contracture. In these cases, the mastectomy plane is reentered through existing scars. Following implant removal, the pectoral muscle fibers are detached from the skin flap, replaced to their anatomical position, and sutured to the chest wall with 2/0 prolene (Ethicon). The technique then continues as described above.
A single-suction drain is inserted between the ADM and the skin flap and remains in situ for 7 days to minimize seroma. Antibiotic prophylaxis is teicoplanin and coamoxiclav on induction, followed by oral coamoxiclav for 5 days. Patients are discharged either on the same day or 1 day postoperatively.
Between June 2013 and February 2017, prepectoral implant-based breast reconstruction was performed for 166 breasts in 106 patients (Table 1). One hundred thirteen immediate reconstructions (68.1%) were performed following therapeutic (34 breasts) or risk-reducing (79 breasts) mastectomy. Fifty-three prepectoral reconstructions (31.9%) were performed for revision of existing submuscular implant-based reconstruction. In total, 27.7% of patients underwent unilateral procedures and 72.3% bilateral surgery.
The mean patient age was 44 years (range, 20–78), and the mean body mass index was 25.4 (range, 17.3–36.6). Among the cohort, 7 patients were smokers (6.6%) and 2 patients diabetic (1.9%).
In total, 73.5% of prepectoral reconstructions had full implant coverage with 2 sheets of StratticeTM or StratticeTM/ArtiaTM combination, and 26.5% of breast had significant ptosis to allow prepectoral reconstruction with upper pole ADM and inferior dermal flap supporting the lower pole of the implant (Fig. 4; Table 2).
For patients having immediate reconstruction, the mean mastectomy weight was 527 g (range, 69–3,720 g; SD, 532). Reconstruction was DTI in 92.8.2% of breasts and 2 stage with initial TE placement in 7.2% of breasts. The mean implant volume was 423 cc (range, 120–620 cc; SD, 113) in the patients undergoing DTI reconstruction. A nipple-sparing approach was used in 51 breasts (45.1% immediate IBR). Immediate nipple areolar complex reconstruction with free areolar graft was performed in 28 breasts (24.7%), and a free nipple graft was used in 4 breasts (3.5%).
Revisional prepectoral reconstruction was performed on 53 breasts with existing submuscular implant-based reconstruction. In these cases, previous implant placement had been total submuscular in 39 breasts (73.5%) and partial subpectoral with lower ADM pole cover in 14 breasts (26.4%). Revision was required due to breast animation in 39 breasts (74%), implant malposition in 8 breasts (15%), intractable pain in 4 breasts (8%), and Baker grade IV capsular contracture in 2 breasts (4%). Some patients presented with more than 1 problem.
Neoadjuvant chemotherapy was given to 5 (14.7%) therapeutic cases and adjuvant chemotherapy to 6 (17.6%) therapeutic cases. Ten breasts had received prior radiotherapy (whole breast or mantle; 6%), and 4 therapeutic cases required adjuvant radiotherapy (11.8%).
Using this technique, no patients required more than a 1-night stay in the hospital, with many patients allowed home on a day case basis. There were no delays to adjuvant treatment.
To date, patients have been followed up for a mean of 485 days (range, 81–1,446 days; SD, 279 days). They were reviewed in the clinic at 1, 2, and 6 weeks postoperatively and at 3-monthly intervals thereafter. Information about the outcome of the surgery was collected and recorded in the prospective database at each visit.
Complications occurred in 19 breasts (11.4%; Table 3). Minor complications occurred in 14 breasts (8.4%) including red breast, seroma, or minor wound issues (Table 4).
Major complications of skin or nipple necrosis or major wound healing delay occurred in 5 breasts in 3 patients and resulted in implant loss (Table 5; Fig. 7). All major complications were seen in the group undergoing immediate prepectoral DTI reconstruction, giving an implant loss rate of 4.4% in this cohort and 0% in the revisional group.
In patients followed up for longer than 12 months, the complications usually associated with submuscular implant placement such as breast animation, implant malposition, restriction in shoulder mobility, and postoperative pain have not been reported. Four patients have had reoperation for rippling (Fig. 8), which included fat grafting and exchanging to a cohesive gel polyurethane-coated implant, which objectively improved the appearance of rippling. No patients have developed Baker grade 3 or 4 capsular contracture to date.
The use of ADM in IBR is a technique that has gained increasing popularity and acceptance in the field of reconstructive breast surgery over the last decade. Prepectoral implant placement with total ADM coverage avoids disruption of PMM function, animation deformity, and implant malposition. Using this technique, postoperative pain appears to be reduced and recovery is faster. Results are promising, with a complication rate comparable, if not superior to published series of subpectoral implant reconstruction with lower pole ADM coverage8–10,12–14 and good aesthetic outcomes. The limited number of complications observed, despite adopting a new technique, may be explained by our previous extensive experience with the use of ADMs. In addition, patients are closely monitored for complications in the postoperative phase, and these are managed aggressively. This includes ultrasound aspiration of seroma and the application of topical negative pressure and/or wound debridement and closure if dehiscence occurs.
Given the small cohort, no association can be made between radiotherapy and outcomes. We generally advocate autologous reconstruction for patients requiring radiotherapy. The cohort who underwent radiotherapy developed no major complications, and it remains to be seen whether ADM provides any protection against the deleterious effects of radiotherapy on IBR.
Although a substantial body of literature exists describing the use of ADMs for primary and revision breast reconstruction, this has not extended to total implant coverage. Reitsamer and Peintinger15 have described a similar technique of prepectoral implant placement and complete coverage with porcine ADM (StratticeTM) for IBR. They used the technique in a total of 22 breasts in 13 patients following NSM. After a mean follow-up of 6 months, the results were extremely promising with a low rate of complications and excellent patient satisfaction regarding the cosmetic outcome. Berna et al.16 also reported a technique of prepectoral muscle-sparing breast reconstruction using a preshaped ADM (Braxon®) in 15 breasts. Using this technique, they reported no major complications, no long-term complications including capsular contracture and a satisfying aesthetic result. Similar results have been achieved with prepectoral implant placement and implant coverage with the synthetic mesh TiLoop®.17
Sigalove et al.18 published the largest series to date of 350 immediate prepectoral breast reconstructions using AllodermTM, coupled with routine delayed lipofilling to augment the soft-tissue coverage of the implant. The rate of complications was < 5%, and there were no cases of capsular contracture.
Capsular contracture is a well-known complication of implant-based breast reconstruction and is one of the most common reasons for revision surgery. The immunologically inert nature of ADMs has been suggested to confer a protective effect against capsule formation, fibrosis, and contraction by minimizing this inflammatory cascade.19–21 To date in our series, capsular contracture has not been problematic. A low incidence of capsular contracture was also reported in the other recent studies of prepectoral implant-based reconstruction with total ADM coverage.15,16,18
Other studies of prepectoral reconstruction have excluded patients with large size or ptotic breasts. By using an inferior dermal flap in conjunction with an ADM, we have been able to offer prepectoral reconstruction to a wider range of patients.
We also report this as a valuable technique that can also be applied to challenging cases requiring revision of previous subpectoral implant-based breast reconstructions presenting to our tertiary oncoplastic unit. The repositioning of the pectoral muscles fibers to their anatomical position and the change of pocket plane to prepectoral with total ADM cover has been successful in treating breast animation. Furthermore, we are accumulating data to demonstrate that this technique is beneficial for patients experiencing functional difficulties and chronic pain due to existing subpectoral reconstruction.
Although early results with prepectoral ADM implant-based reconstruction are promising, there is a need for larger cohort studies directly comparing the outcomes of pre- and subpectoral, including outcome measures for animation and rippling. An unpublished pilot study conducted in our department compared 20 prepectoral and 20 subpectoral/lower pole ADM breast reconstructions. There was no significant difference in pain scores between the prepectoral group (mean, 1.45) and the subpectoral group (mean, 1.51) during the first 7 days (P = 0.45). Thirty-one BREAST-Qs™ were returned at 3 months postoperatively; mean Q scores were similar for both prepectoral (72) and subpectoral (71) groups (P = 0.81). There was no significant difference in length of stay (median 1 day in both groups; P = 0.53) or early morbidity. These early results suggest at least noninferiority to subpectoral and ADM IBR.
A significant concern with prepectoral reconstruction is the development of traction rippling, particularly for individuals in whom the mastectomy skin flaps are naturally thin. It is important to emphasize that we do not alter mastectomy skin flap thickness to avoid this potential issue, and mastectomy is always performed along the correct anatomical plane. Indeed, leaving “thicker” mastectomy skin flaps puts patients at unnecessary and unacceptable risk, both in the therapeutic and risk-reducing setting. In patients in whom the mastectomy skin thickness is naturally thin (< 5 mm), the risk of rippling is apparent. However, this can be minimized using firm, highly cohesive gel implants, for example, Mentor CPGTM Gel Breast Implants Cohesive III, Polyurethane-coated implants (POLYTECH Health and Aesthetics GmbH), or dual gel anatomical implants (Allergan NatrelleTM 510), and also by ensuring a very snug pocket for the implant to sit in encouraging close implant/ADM adhesion and thereby minimizing the risk of rippling. We have used lipofilling to effectively address this problem in a small group of patients, although do not advocate routine lipofilling as suggested by Sigalove et al.18
ADMs are expensive materials and there are cost implications to using 2 sheets in place of 1 for complete implant coverage. Although an economic analysis was not the primary aim of this study, this additional expense may be offset by reductions in length of stay; patient recovery is faster and postoperative pain is reduced when the pectoral muscle is not detached. Long-term savings in the form of a reduction in incidence of capsular contracture and the need for revision surgery may also be areas for future cost savings. Companies are now tailoring the manufacture of these matrices to meet the demand of surgeons with the development of single large sheets and ready made “envelopes.” Several studies have compared the cost-effectiveness of breast reconstruction with autologous and nonautologous tissue, including ADMs and reported no significant differences.22–25
Prepectoral implant placement with full ADM cover is emerging as a technique for breast reconstruction. This method facilitates immediate IBR with a good cosmetic outcome for patients who want a quick recovery, without the potential compromise of pectoral muscle disruption. By using Wise pattern incisions and an inferior dermal flap when available, this approach can be offered to a wider range of patients. Furthermore, it is a useful technique for revision of existing submuscular IBR in patients complaining of animation or functional disturbance. Although this cohort study has shown promising initial results, there is a need for further cohort studies comparing pre- and subpectoral IBR and an economic analysis.
The authors thank Ben Baker, Specialty Registrar in Plastic Surgery, James Harvey, Consultant Breast Surgeon, and Siobhan O’Ceallaigh, Consultant Plastic Surgeon.
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Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons. All rights reserved.
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