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Reprinted from PLASTIC & RECONSTRUCTIVE SURGERY
Vol. 118 No. 1 July 2006
Copyright © 2006 American Society of Plastic and Reconstructive Surgeons
Published by Lippincott Williams & Wilkins Printed in U.S.A.
BREAST
Use of Regenerative Human Acellular Tissue (AlloDerm) to Reconstruct the Abdominal Wall following Pedicle TRAM Flap Breast Reconstruction Surgery
Scot B. Glasberg, M.D.
Richard A. D'Amico, M.D.
New York, N.Y.; and Englewood, N.J.
Background: Harvest of transverse rectus abdominis muse ulocu tan eous (TRAM) flaps for breast reconstsruction leaves a variable defect in the anterior rectus fascia. Inadequate closure of the defect could lead to the development of hernia or abdominal wall bulging. Various techniques have been developed to reduce the incidence of hernia and abdominal wall bulging. The authors describe a novel technique of using a regenerative human acellular matrix (AlloDerm) as a fascial substitute in closing the defect.
Methods: Fifty-four consecutive patients who opted for pedicle TRAJV1 flap procedures for breast reconstruction postmastectomy were scheduled for donor-site repair with the use of AltoDerm. AlloDenn was placed interpositionally as an inlay graft to mimic the anterior rectus fascia.
Results: Hernia or infection did not develop in any of the patients. There was a greater incidence of seroma and bulging among the first 18 patients, with eight seromas (44.4 percent) and six bulges (S3.3 percent). When the technique was ameliorated in the next 36 patients, there was a reduction in the incidence of seromas (16.V percent, p = 0.03) and bulges (16.7 percent, p = 0.17). Of the three patients who experienced wound dehiscence, partial AlloDenn exposure occurred in two, but was resolved without further consequences. Biopsy specimens of AlloDerm, obtained 12 and 14 months after TRAM donor-site repair, showed full tissue integration. The cell density, vasculature, and collagen orientation in the biopsies were consistent with abdominal fascia tissue.
Conclusion: Based on these results, the authors recommend the use of AlloDerm as an alternative option for abdominal fascia closure after TRAM flap haiYest for breast reconstruction. (Plast. Recmistr. Surg. 118: 8, 2006.)
Since the introduction of the pedicle transverse rectus abdominis myocutaneous (TRAM) flap technique in 19821 for breast reconstruction, closure of the abdominal donor site has continued to be a challenge for reconstmc-tive surgeons. Concerns over risks of postoperative lower abdominal wall bulging (or laxity) and hernia and the potential loss of abdominal wall strength remain, despite refinement of TRAM flap harvesting techniques. The incidence of abdominal hernia and bulging, to a large extent, depends on the technique used to close the abdominal wall and on the experience of the surgeon performing the closure. The pioneers of the pedicle TRAM flap technique, Hartrampf etal.1 advocated primary closure of the abdominal wall without the use of prosthe-ses. Ilartrampf,2 in a review of his first 6 years of experience with TRAM flaps, reported a minimal abdominal wall complication rate of 1.5 percent and noted that with experience the complication rate with this technique was decreased. Subsequently, however, other authors have reported abdominal hernia rates of up to 20 percent? and abdominal bulging or weakness of up to 44 percent1 with primary closure. To avoid the development of abdominal herni-ation and bulging, different techniques have been described in the literature. These include a variety of surgical techniques ranging from a two-layered closure of the internal oblique fascia and the an- terior rcctus sheath/' fasciotomy of the external oblique muscle to facilitate closure of the defect/1 and use of the anterior rectus abdominis sheath flap to facilitate closure of the defect.7 Others have advocated the use of synthetic mesh8"10 and autol-ogous dermal graft11 to reinforce the musculofas-cial defect in the abdominal wall. Today, most TRAM donor sites are routinely closed using synthetic mesh prostheses to support the abdominal wall defect.810 Mesh, however, carries a documented risk of infection and could lead to contrac-ttire or encapsulation from long-term host-prosthesis interaction. Thus, despite a reduction in abdominal hernia rates associated with mesh reinforcement,12 the other complications associated with mesh use necessitate the quest for alternative materials or techniques to reconstruct the abdominal wall following TRAM flap surgery. AlloDerm (LifeCell Corp., Branchburg, N.J.), a regenerative human acellular tissue, has been shown to be tolerant to infection,13 to rapidly repopulate and revascularize,141' and to remodel histologically and functionally and therefore serve the function of native tissue.1Silfi AlloDerm has also been proven to successfully incorporate and endure in numerous physiologic sites and body systems with little risk of complications such as infection or hcrniation.17"21 AlloDerm, therefore, would seem a rational choice to improve long-term outcomes and reduce hernia rates following TRAM donor-site repair. We present the use of AlloDerm as an alternative technique for closure of the abdominal donor site after harvest of the pedicle TRAM flap for breast reconstruction. The initial experience with the use of this technique in 54 patients is presented.
PATIENTS AND METHODS
Patient Population
Between March of 2002 and February of 2004, all patients who opted for pedicle TRAM flap procedures for breast reconstruction post-mastectomy were scheduled for donor-site repair with the use of AlloDerm. All procedures were performed at either Lenox Hill Hospital in New York, New York, or at Englewood Hospital in Englewood, New Jersey.
Surgical Procedure
After elevating the TRAM flap and tunneling it through to the mastectomy site, closure of the abdominal wall fascia at the TRAM donor site was addressed. The abdominal wound in this fasciasparing dissection, extending above and below the arcuate line, usually consists of a defect in the anterior rectus fascia where an area of the fascia was removed with the TRAM flap. The superior portion of the anterior rectus fascia has a split, up to the level of the xiphoid, made to rotate the muscle to the chest without, constriction. This superior portion is closed primarily with interrupted figure of eight sutures. This, then, leaves a rectangular deficit, in the anterior rectus fascia. Just below the deficit, where the muscle has been taken out, there is some redundancy to the fascia. This area is plicated with figure of eight sutures to avoid the development of postoperative bulging. To repair the residual rectangular defect, a 4 X 12-cm piece of rehydrated AlloDerm (1 nun average thickness; range, 0,79 to 1.78 mm thickness) is placed interpositionally, as an inlay graft, to mimic the anterior rectus fascia. This thickness of AlloDerm has been successfully used in abdominal hernia repairs.13 Rchydration of the AlloDerm is accomplished in saline baths according to the manufacturer's instructions. The rehydrated AlloDerm is placed with the dermal side down in the defect area and attached to the rectus and/or external oblique fascia, initially, with four simple tacking sutures at. the corners of the AlloDerm. The AlloDerm is then trimmed such that its total area is about 25 to 30 percent less than the total defect area. This is important because AlloDerm yields about 30 percent over time. These "give" properties of Alloderm appear to be analogous to the properties of a full-thickness skin graft. The trimmed AlloDerm is then contoured and sutured (Fig. 1) with running 2-0 Prolene sutures under a moderate amount of tension such thai a bulge would not develop postoperatively. For bilateral TRAM procedures, two pieces of AlloDerm were sutured at the midline and then contoured into place.
The elevated abdominal flap is then replaced over the TRAM donor site alter placement of closed suction drains in a standard multilayer technique re-approximating Scarpa's fascia and skin.
Follow-Up
All patients were followed weekly for the first month and then as needed. At each visit, the patient, was examined in both the supine and standing positions, and the Valsalva maneuver was performed to assess for hernia occurrence, bulging, and the presence of subcutaneous seroina. Bulges were differentiated from hernias by the absence of sacs. Hernias have sacs with an acute angle between the sac and the abdominal wall. Bulges do not have sacs, and the angle between the protruding area and the abdominal wall is obtuse.
RESULTS
AlloDerm was used in a total of 54 consecutive patients with an average age of 48.7 years (range, 32 to 62), who underwent pedicle TRAM flap reconstructions over a period of 24 months (Table 1), At the time of this report, patients had been followed for an average of 18.5 months (range, 9 to 30).
The surgical technique for the closure of the TRAM donor site was well tolerated by all patients without any major complications. Patients were discharged after an average of 2.6 days. No postoperative wound infections occurred, and the TRAM donor sites exhibited normal wound healing within 1 month of the procedure. Importantly, hernia did not. develop in any of the patients up to an average follow-up period of 18.5 months (Table 2).
Total no. of patients 54
Age, years
Average 48.7
Range S2-62
Risk factors
Smoking,* no. (%) 12 (22.2)
Non-insulm-dependent diabetes
mcllitus, no. (%) 6(11.1)
Reconstructions
Immediate, no. (%) 45 (88,3)
Delayed, no. (%) 9 (16.7)
No. of breasts
Unilateral, no. (%) 49 (90.7)
Bilateral, no. (%) 5 (9.3)
*A11 smokers stopped smoking I month before surgery. 1 A
Plastic and Reconstructive Surgery • July 2006
Table 2. Rate of Abdominal Complications
Patients with Complications, no. (%)
Subset 1 Subset 2 Total
Complications (n = 18) (n = 36) (n = 54)
Wound infection 0 0 0
Hernia 0 0 0
Seroina 8 (44.4) 6 (16.7)* 14 (25.9)
Bulging 6 (33.3) 6 (16.7)t 12 (22.2)
Wound dchisccncc — 3 (5.5)
AlloDerm exposed — — 2(1.4)
Differences between groups were analyzed by the chi-square test. *p = 0.03, subset 2 versus subset 1. \p = 0.17, subset 2 versus subset 1.
Twelve patients (22.2 percent) did develop lower abdominal bulging. Six of the patients were among the first 18 patients (subset 1) who had received AlloDerm (Table 2). In this patient subset, the AlloDerm was probably not sutured taut enough to take into consideration AlloDerm's propensity to yield over time. When this was corrected in the second subset of 36 patients (subset 2), a lower incidence of abdominal bulging (six of 36) was seen; 16.7 percent in subset 2 versus 33.3 percent in subset 1. However, there was no statistical difference in the incidence of bulging among the two subsets of patients (p — 0.17). It should be noted, however, that patients in subset 2 might not have been followed for a long enough period for bulges to appear. Eight of the 12 patients were eventually plicated as part of their two-stage breast reconstruction procedure.
A greater incidence of seroma formation was also observed among patients in subset 1, with eight seromas (44.4 percent), compared with six (16.7 percent) in subset 2 (Table 2). Suction drains were left for a longer period of time in the second subset of patients (average of 12.6 days) compared with the first subset of patients (average of 7.3 days), and this led to a statistically significant reduction in the incidence of seroma in the second group of patients (p = 0.03). All seromas were resolved by single or multiple aspirations without any further consequences.
Three patients experienced abdominal wound dehiscence (5.5 percent) with partial exposure of the AlloDerm occurring in two patients (Table 2). In all three patients, the wound was healed by placing a VAC sponge system over it, without the need for surgical intervention. Two of the three patients, one of those with the AlloDerm exposure, experienced eventual fascial weakening (bulging).
Two patients underwent subsequent abdominal surgery involving the TRAM donor area for indications unrelated to donor-site repair. Per the recommendation of their oncologists, both patients required bilateral salpingo-oophorectomy, one at 12 months and the other at. 14 months after abdominal wall repair. The oophorectomies were performed in conjunction with the two-stage breast reconstructions, and the plastic surgeon was responsible for opening and closing of the abdominal wall.
Clinically, both patients had no fascial weakening. On opening the abdomen at. the previous TRAM donor' site, gross integration and revascu-larization of the graft were observed (Fig. 2). The boundaries between the AlloDerm and the endogenous abdominal fascia were difficult to discern, if not for the suture lines. Grossly, there appeared to be extensive tissue integration, yielding a well-incorporated and functional abdominal fascial layer.
Biopsy samples were obtained and stained using hematoxylin and eosin stain and Verhoeffs van Gieson stain for elastin. Elastin is a valuable marker for tracking AlloDerm because it turns over very slowly compared with collagen and other matrix proteins. The biopsy results confirmed the complete viability of AlloDerm. Hematoxylin and eosin staining revealed vascular ingrowth, recel-lularization, and reorganization of collagen fibers (Fig. 3). The cell density, vascularization, orientation of die collagen, and the removal of elastin in AlloDerm were more consistent with abdominal fascia-like tissue than dermal tissue (Fig. 4). No evidence of scarring or inflammation was seen in anv of the sections.
DISCUSSION
Abdominal wall competence is a major concern of all plastic surgeons using the TRAM flap procedure for breast reconstruction. Low hernia and abdominal laxity rates and adequate abdominal stability are current, standard expectations in abdominal wall closure. Harvest of TRAM flaps for breast reconstruction inevitably leaves at least a segmental defect in the abdominal rectus muscle, in addition to a variable defect in the anterior rectus fascia. There is, therefore, an inherent risk of incisional herniation or abdominal bulging associated with the TRAM flap technique unless adequate closure of the anterior rectus fascia is achieved.
Closure of the abdominal fascial defect is usually performed by direct closure, by using synthetic materials, or by using a combination of direct closure and synthetic materials. If the defect is too large, as in bilateral TRAM flaps, or if the fascia is of poor quality, direct closure is precluded. Moreover, a high rate of hernia (12.5 to 20 percent)3-2 and abdominal bulging or weakness (20 to 44 percent)3*423 have been attributed to direct closure. In addition, oil-centering of the umbilicus is also an inevitable consequence of the direct closure approach.
In comparing different techniques to close the abdominal defect, Kroll and Marchi2:i reported a decrease in hernia or bulge rates from 35 percent with single-layer fascial closures following single- or double-pedicle TRAM flaps to 6 percent with Marlex mesh and two-layered fascial closures. In another study, a review of 346 patients over a 9-year period, a reduction of abdominal wall complications from 16 percent to 4 percent was again attributed to the liberal use of polypropylene mesh and to greater surreal experience.24 Others have reported hernia rates as low as 1.5 percent with polypropylene mesh8 or 0 percent with Gore-Tex.9 With this successful demonstration of the reduction of hernia and bulge rates with synthetic materials, these are now liberally used to close the abdominal fascial defect at TRAM donor sites.
Synthetic materials, however, have their own set of complications. These include infection, foreign body reaction, extrusion, and intestinal fis-tulation. In the Kroll and Marchi study,23 Marlex mesh use was associated with an 11.8 percent abdominal infection rate. Gore-Tcx and polypropylene mesh have been associated with infection rates of 5.8 percent9 and 1.5 percent,8 respectively. In all three studies, all patients who developed abdominal infections had to undergo a second procedure to remove the synthetic material.
Because of these issues with synthetic prosthe-ses, the use of AlloDerm, a human acellular tissue to reconstruct the fascial defect after removal of TRAM flaps, was examined. Previous experience with AlloDerm in a variety of surgical settings has shown that this acellular tissue integrates well into the surrounding host tissue and has a minimal risk af infection, extrusion, hematoma, or seroma. In :he present series of 54 patients, there was no incidence of infection or hernia formation, and :here were no major complications associated with \lloDerm use (Fig. 5). In two patients, partial \lloDerm exposure occurred because of wound iehiscencc. However, this did not necessitate fur-:her surgery to remove the AlloDerm as would :iave been the case with an exposed synthetic 3rosthesis.2r'"27 In both cases, the wound healed -vithout further consequences.
There was a greater incidence of seroma and bulging with the use of AlloDerm within the first 18 patients (subset I), with eight seromas (44.4 percent) and six bulges (33.3 percent). As with any new technique, there is a learning curve in which perfecting the technique by experience needs to be overcome. Here, too, in the second subset of patients, there were lower incidences of seroma (16.7 percent) and bulging (16.7 percent) after leaving the suction drains in place for a longer period and after taking into consideration the inherent give in AlloDerm, respectively.
The 16.7 percent bulge rate in subset 2 in this series, however, lower than that encountered with primary closure without the aid of prostheses, is at die higher end of the range (2.3 to 20.6 percent)3'1'2 obtained with mesh closure. The rate of bulging, however, is correlated with body mass index, with overweight patients having a higher incidence of abdominal bulging.28 Likewise, the rates of other abdominal complications such as hernia, seroma, and infection are also higher in overweight and obese patients.28 Although we have not made a correlation between body mass index and the rates of abdominal complications in our scries of patients (and also our patient population was not large enough to make any meaningful correlations), nonetheless, we can safely conclude that irrespective of the body mass index of our patients, the use of AJloDerm for abdominal repair lowered the rate of occurrence of hernia and infection.
Insertion of prosthesis, either biologic or synthetic, always raises concerns over the fate of the material within the repair site over time. A significant Finding in this study is that biopsy samples of AlloDerm, 12 and 14 months alter placement at TRAM donor site, showed that the acellular tissue had revascularized and recellulari/ed and its collagen network had reoriented. The cell density, vasculature, and collagen orientation were consistent with abdominal fascial tissue. Tt appeared as though AlloDerm placed at the abdominal defect site was actually transitioning into fascia-like tissue, an indication that functionality of the repair site might be restored. In fact, all patients at follow-up ascertained that they were able to perform all routine and daily activities as before the procedure.
CONCLUSIONS
This report presents an alternative means of repairing the TRAM donor site following pedicle TRAM flap reconstruction. AlloDerm, a regenerative human acellular tissue, was used as a rectos fascial substitute to close the abdominal defect at TRAM donor sites. The principal advantages of using AlloDerm in this technique include the benefit of using a biologic tissue that integrates into the surrounding host tissue without being rejected or causing inflammation and minimizing scarring and fibrosis, potential elimination of hernia and infection, and the ease of use of AlloDerm. The results obtained from this series support a role for AlloDerm in abdominal fascial defect closure following TRAM flap surgery. A formal randomized prospective clinical trial is warranted to further establish the advantages of AlloDerm compared with mesh in TRAM donor-site closure.
Scot Bradley Glasberg, M.D.
Cosmetic and Reconstructive Plastic Surgery
42A East 74th Street
New York, New York 10021
scotbg@jnno.com
DISCLOSURE
Scot B. Glasberg, M.D., is a consultant for Life.CeU Corporation.
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