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ADM-assisted prepectoral breast reconstruction and skin reduction mastectomy: Expanding the indications for subcutaneous reconstruction
Journal Pre-proof
ADM-assisted prepectoral breast reconstruction and skin reduction mastectomy: expanding the indications for subcutaneous reconstruction. MG Onesti MD , G Di Taranto MD , D Ribuffo MD , N Scuderi MD PII: DOI: Reference:
S1748-6815(19)30492-9 https://doi.org/10.1016/j.bjps.2019.11.004 PRAS 6308
To appear in:
Journal of Plastic, Reconstructive & Aesthetic Surgery
Received date: Accepted date:
28 November 2018 22 November 2019
Please cite this article as: MG Onesti MD , G Di Taranto MD , D Ribuffo MD , N Scuderi MD , ADMassisted prepectoral breast reconstruction and skin reduction mastectomy: expanding the indications for subcutaneous reconstruction., Journal of Plastic, Reconstructive & Aesthetic Surgery (2019), doi: https://doi.org/10.1016/j.bjps.2019.11.004
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Ltd on behalf of British Association of Plastic, Reconstructive and Aesthetic Surgeons.
ADM-assisted prepectoral breast reconstruction and skin reduction mastectomy:
expanding
the
indications
for
subcutaneous
reconstruction.
Onesti MG1, MD; Di Taranto G1*, MD; Ribuffo D1, MD; Scuderi N1, MD.
1. Plastic Surgery Unit, Department of Surgery "P. Valdoni", Sapienza University, Rome, Italy.
*Send correspondence to Giuseppe Di Taranto Via dei Latini, 33 00185 Rome, Italy Phone: +39 328 3869334 Fax: +39 06 49970205 [email protected]
1
ABSTRACT Backgrounds Recently a flood of new techniques and studies have been released for prepectoral reconstruction, following strict criteria for selection of patients undergoing skin or nipple sparing mastectomy. Nevertheless a big population of patients that would otherwise benefit from prepectoral techniques has been excluded so far. Patients and methods Between January 2016 and February 2017, patients undergoing skin reducing mastectomy (SRM) were enrolled at our Institution. We selected patients with large and ptotic (grade II-III) breasts undergoing SRM, followed by a new technique, which involves placement of the implant, wrapped by acellular dermal matrix, in a prepectoral pocket under a dermal flap. Data of all the surgeries were prospectively collected and contracture grade was assessed by Baker scale. Complication rate and cancer recurrence were reported and health related quality of life (HRQOL) measurement was recorded using BREAST-Q questionnaire. At early follow-up, postoperative pain was assessed through VAS scale. Results 29 patients underwent SRM and 10 patients, meeting inclusions criteria, were enrolled, with a total of 13 operated breasts. Postoperative average pain was assessed as low as 4.1. The median follow-up was 2.6 (range 2.1-3.2) years. Post-operative complications occurred in 1 case of minimal wound dehiscence. No patient reported breast seroma or severe capsular contracture grade. Patient scored high level of satisfaction with breast, psychosocial well-being, sexual wellbeing, physical impact and overall satisfaction with outcome, at BREAST-Q questionnaire.
2
Conclusions In this study we present a modified prepectoral technique for patients undergoing SRM, reporting satisfactory outcomes. These results might support the rationale for expanding the population target of prepectoral reconstruction. KEYWORDS:
ADM;
BRAXON;
subcutaneous
breast
reconstruction; BREAST-Q; direct-to-implant reconstruction.
3
reconstruction;
muscle
sparing
INTRODUCTION
Prosthetic breast reconstruction is the most performed breast reconstructive surgical technique following mastectomy1. In the setting of continuous expanding options for implant-assisted reconstruction, the most recent and successful advancement was prepectoral approach. Although positioning the implant in a subcutaneous pocket is not a novel concept, the technique have been overlooked over the last decades, disqualified by the aggressive ablative surgery and the poor reported outcomes with the release of
1,2
. Nowadays the giant strides made by breast reconstruction, along
innovative devices, allowed plastic surgeons to retrieve subcutaneous
approach, providing excellent outcomes and catering the ongoing greater awareness about aesthetic results. For many years subpectoral implant placement has been the generally accepted method at the cost of acute and chronic post-operative pain and impaired movement of upper limb, as a result of pectoralis major detachment
1–6
. Today the new prostethic techniques, assisted by dermal matrix
(ADM) or synthetic mesh, place the implant in a complete subcutaneous plane, delivering an immediate, muscle-sparing breast reconstruction 1–3,7. Although the first technique was recently described, several variations of this procedure have been already introduced and a number of studies has reported promising preliminary results2–4,8–18. So far, prepectoral reconstruction has been generally performed after nipple-sparing or skin-sparing mastectomy in patients under 30 kg/m2 of body mass index (BMI) and with a breast excision volume not exciding 600g, following the criteria from British Association of Plastic Reconstructive and Aesthetic Surgeons and Association of Breast Surgery associations for prepectoral reconstruction with ADM 19. In the present study, we describe a modified prepectoral technique, which exploits ADM-assisted muscle-sparing breast reconstruction as an alternative to traditional submuscular reconstruction in 4
the context of skin-reduction mastectomy. The results of the study could expand prepectoral reconstruction population target and provide new hint towards the revision of its indications.
PATIENTS AND METHODS PATIENTS Between January 2016 and February 2017, patients undergoing mastectomy were enrolled at our Institution, Policlinico Umberto I, Sapienza University of Rome. We selected patients diagnosed for breast cancer or genetic predisposition to breast cancer, undergoing skin reduction mastectomy (SRM), followed by direct-to-implant (DTI) breast reconstruction. Among these patients, we enrolled selected women diagnosed for a localized breast carcinoma or with BRCA1/2 mutation and undergoing prophylactic mastectomy. Inclusion criteria were body mass index (BMI) > 30 kg/m2, ptotic breast (grade II-III according to Regnault scale), an estimated mastectomy weight > 600g, a subcutaneous layer >1cm (measured by the pinch test on the upper and medial quadrants), and mastectomies leaving well-vascularized subcutaneous layer. All the patients were informed that necessary condition for prepectoral implant placement was a well vascularised and healthy subcutaneous layer after mastectomy, evaluated clinically during the surgery. The thickness of the flaps was measured intraoperatively with a ruler. In case of not healthy and adequate mastectomy flaps, the reconstruction was conducted in the submuscular plane. Our study was performed with respect to the ethical standards of the Declaration of Helsinki and the entire protocol was approved by the Ethics Committee of Sapienza, University of Rome. All patients provided written informed consent preoperatively and were evaluated twice a week for the month after surgery. Then they were followed up at one month, three months, six months after surgery, and then yearly. OPERATIVE TECHNIQUE
5
Patients underwent a modified version of the “wrap around technique”, which involves placement of the implant in the subcutaneous layer, wrapped by Braxon® noncross-linked ADM (DecomedSrl, Marcon, Venice, Italy). Patients were preoperatively evaluated and drawings were made according to Wise-pattern fashion, either with sparing or graft of the nipple. The patients were marked while standing: we first marked the position of the new nipple along the midclavicular line. The marking then followed the steps used for a normal Wise pattern breast reduction. When the distance between nipple-areolar complex and hemiclavear point was more than 40 cm, the nipple was grafted. Furthermore, the design included a rectangular area based on the inframammary fold, extending upward up to the inferior border of the areola (Video 1). The length of the flap was evaluated for each patient according to the oncological and breast characteristics of the patient. After skin incision, the dermal flap from the inferior pole of the breast was deepithelialized and then preserved (Video 1 and Figure 2). The wide incision was used as surgical opening for both mastectomy and the eventual axillary surgery. The implant was carefully chosen basing on the weight and diameter of the resected glandular breast. After rehydration in sterile solution of the ADM for 5 minutes, the matrix edges were sutured together around the breast implant (Video 2). The ADM containing the implant was then placed in a prepectoral pocket, under the dermal flap, and sutured with apical, medial and lateral absorbable stitches directly onto the fascia of the pectoralis major muscle (Figure 1 and Video 1). Likewise, the dermal flap was sutured laterally to the pectoralis major and the anterior serratus muscles and to the ADM by its superior edge, mimicking a natural bra. When opportune for the oncological characteristics of the cancer, the nipple-areola complex was preserved and grafted in the new position, following preoperative design. Skin was closed in layer, according to the inverted T-pattern and one vacuum drain was placed in the inframammary fold. Right after the operation, the patients were asked to wear a postsurgical mammary bra and to keep it for one month. Patients received oral antibiotics (Amoxicillin 1g, twice a day) from the surgery until the removal of the drain. The drain was removed when the fluid collected was below 30 cc in 24 hours. OUTCOMES AND MEASURES 6
Data of all the surgeries were prospectively collected in a digital data base, accounting for demographics characteristic, medical history, family history, complications and oncologic outcome. For each patient, photographic documentation was taken pre and after surgery at each follow-up point. Capsular contracture grade was yearly assessed by Baker scale independently by the two senior authors (OMG, NS). To address potential cases of disagreement, a third plastic surgeon, not involved in the protocol, was asked for external evaluation. Any cancer recurrence was named as oncological outcome and health related quality of life (HROQL) measurement was recorded using BREAST-Q questionnaire. Aesthetic complication requiring a reoperation (implant rippling, migration or severe capsular contracture grade) were considered separately in the statistical analysis. Complications were described by Clavien-Dindo Classification. Postoperative pain was evaluated by patients 1 month after surgery using a visual analogue scale (VAS), giving a score from 1 to 10 (1 = no pain, 10= severe pain)20–22. All patients underwent ultrasound examination at 1, 3, 6, and 12 months postoperatively to exclude any possible fluid collection8. HRQOL OUTCOME BREAST-Q was developed for assessing HRQOL among patients undergoing breast surgery and has been extensively validated for breast reconstruction23,24. Postoperative BREAST-Q module for reconstructive surgery was administered 1 year after mastectomy during a follow-up visit, according to our protocol9,10,16,25. Following developers’ instructions, patients who failed to answer more than half the items within each domain were excluded from the analysis for that particular domain. STATISTICAL ANALYSIS Descriptive statistics accounted for patient characteristics, complications and capsular contracture grade. Using the QScore Scoring Software, BREAST-Q scores for each matrix were converted
7
from raw scores (1 through 4 or 5) to a continuous range from 0 to 100, with a higher score representing greater satisfaction or better HRQOL. RESULTS Between January 2016 and February 2017, 29 patients underwent SRM at our Institution. Among them 11 patients met the inclusion criteria of our study (see CONSORT diagram, Figure 1). One patient denied consent to join the study, due to unavailability to adhere to the follow-up schedule. Ten patients were enrolled in the study. Average age of patients was 50±9.1 years. The mean BMI was 36.6±2.7 kg/m2. 8 patients showed a grade III of ptosis, and 2 a grade II. One patient was diagnosed for BRCA1 mutation. 2 patients had given neoadjuvant chemotherapy and one had history of previous conservative breast surgery without radiotherapy. Table 1 reports the characteristic of patients and surgeries. Table 1. Characteristic of patients and surgeries Patients characteristics Number
10
Age [years, mean (SD)]
50±9.1
BMI [kg/m2, mean (SD)]
36.6±2.7
BRCA Mutation carriers (n)
1
Surgeries (n)
13
Unilateral (n)
7
Bilateral (n)
3
Lymphadenectomy (n)
2
Sentinel lymph node biopsy (n)
7
Prophylactic mastectomies (n)
3
8
7 unilateral and 3 bilateral mastectomies were performed, accounting for a total of 13 operated breasts. In unilateral cases, a breast reduction was performed in the contralateral breast, if required by the patient. 9 patients underwent also axillary surgeries: 2 underwent axillary lymphadenectomy and 7 a sentinel lymph node biopsy (SLNB). A total of 3 prophylactic mastectomies were performed. The mean weight of mastectomy was 829±205 g. In all the cases the mastectomy left well vascularized and healthy flaps with a mean thickness of 2.1±0.5 cm. Two patients had their nipple grafted and 8 spared. The mean hospital stay was 2.3±1.2 days. The drains were removed between the fifth and the ninth postoperative day (mean: 6.3±1.6 days). 3 patients underwent adjuvant radiotherapy and 8 patients adjuvant chemotherapy. At one month acute postoperative pain was assessed through a VAS scale, and patients reported acceptable scores, with an average pain of 4.1±0.8. None of the patients was lost to follow-up. The median follow-up period after mastectomy was 31 (range 24-39) months that is 2.6 (range 2-3.1) years. Post-operative complications occurred in 1 case of minimal wound dehiscence and the patient healed uneventfully (Clavien-Dindo grade I). We did not report any nipple-areola or skin necrosis. No patient reported breast seroma or severe capsular contracture grade. Ultrasound examination showed a progressive host integration of the dermal matrix with the subcutaneous tissue and detected no fluid collection. In no case, a disagreement was encountered during the evaluations of capsular contracture. A Baker grade II and a Baker grade I was assessed in 3 and 10 breasts respectively. In our series, we assessed no Baker grade III or IV over a median follow-up of 2.6 years. No cancer recurrence was identified during oncological surveillance. After one year, no implant rippling was reported. One patient required a revision of the scar for dog ears and a scar revision was performed after one year. MEASURE OF HRQOL 9
All the patients properly filled the five domains of the questionnaire and were included in the analysis. Table 1 accounts for the self-reported measures of HRQOL, evaluated with BREAST-Q questionnaire. Patient scored high level of satisfaction with breast, psychosocial well-being, sexual well-being, physical impact and overall satisfaction with outcome.
Table 2. BREAST-Q scores. Domain
Postoperativ e mean (±SD)
Satisfaction-breasts
60.10 (±7.9)
Psychosocial wellness
62.1 (±16.4)
Sexual well-being
48.5 (±21)
Physical impact (chest)
66.9 (±14.6)
Overall satisfaction with outcome
94.1 (±10.6)
DISCUSSION Recently, prepectoral reconstruction has established as an effective development in prosthetic reconstruction, after the release of new devices, either biological or synthetic, which completely envelope the implant, composing an additional layer between the prosthesis and the subcutaneous tissue. As plastic surgeons have revived the use of prepectoral breast reconstruction, a flood of new techniques and studies have been released 3,4,8–17. So far in these studies, patients have been strictly selected following the criteria from British Association of Plastic Reconstructive and Aesthetic Surgeons and Association of Breast Surgery associations for prepectoral reconstruction with ADM: body mass index (BMI) of < 30 kg/m2, no history of radiotherapy, an estimated mastectomy weight not exciding 600g, a subcutaneous layer 10
>1cm (measured by the pinch test on the upper and medial quadrants) and sparing mastectomies leaving well-vascularized subcutaneous layer 19. At our Institution we routinely apply the prepectoral reconstruction to selected patients undergoing mastectomy and DTI, reporting great results in term of outcomes and patient-satisfaction8,15,16. Nevertheless, we felt in our experience that those criteria, although valid and suitable for sparing mastectomy, would exclude a big population of patients that would otherwise benefit from prepectoral techniques. Following these concerns, we decided to apply the prepectoral approach protocol also to patients with large and ptotic breast and a BMI>30 kg/m2, undergoing skin reducing mastectomy. In this pilot study we report the outcomes of a series of 10 patients undergoing SRM and prepectoral DTI breast reconstruction with a modified wrap-around technique. Surgical complications can frequently occur in Wise-pattern skin-reduction mastectomy, owing to the stress and tension applied to surgical sutures that could severely affect flaps vascularization20,21,26. In this case series, we placed the implant wrapped-around with ADM in the prepectoral plane, under a dermal flap which braces the prosthesis as a natural bra, reducing the burden on the skin flaps. Furthermore, the flap could decrease the likelihood of implant palpability and exposure in case of wound dehiscence, a frequent inconvenience after skin reducing mastectomy26. We designed a rectangular-shaped flap based on the inframammary fold, extending upward up to the inferior border of the areola. The wide base of the rectangular design ensures a good vascularization of the flap, reducing the likelihood of necrosis. The vertical sides of the rectangular flap are detached from the lateral skin flap, allowing an easy closure of the skin in layers. Furthermore, the posterior aspect of the dermal flap lay over the implant, while the anterior aspect is behind the vertical suture of the skin. This design is based on a single flap and do not show any break on its surfaces: the rectangle act like a shield over the implant, avoiding a direct contact between the implant and the joint point of the suture of the inverted T pattern, where wound dehiscence is reported to occur the most26. 11
We reported acceptable results in term of surgical and patient-reported outcomes as well as capsular contracture rate over a follow-up of 2 years and half. Minor complications occurred in 1 case: a minimal wound dehiscence of the T-scar, which healed uneventfully. Interestingly, we did not report any case of seroma. A possible explanation to this issue could rely on our modified wrap-around technique. Indeed, unlike the first description and more recent reports of the technique, we preferred to secure also the anterior surface of the dermal matrix to the subcutaneous tissue, aming to reduce the possibility of any dead space. One of the main concerns about traditional submuscular reconstruction is the disinsertion of the pectoralis major muscle, which can increase postoperative pain and shoulder impairment, requiring long recovery and physiotherapy rehabilitation 2–4,9,16. The subcutaneous approach avoids the need of detaching the muscle, reducing operative time along with patients’ pain and discomfort 16,18. At one month follow-up, we evaluated post-operative pain using a visual analogue scale (VAS), assessing a low grade of pain (mean 4.1±0.8)
27
. This data is notably relevant, as the low level of
acute pain has been reported to allow a fast recovery, reducing the hospital stay and increasing the cost effectiveness of breast reconstruction28. We assessed pain and functional impairment was well at one-year follow-up with BREAST-Q. Patients reported a good score at the fifth domain of the questionnaire “Physical Well-being”, which measures several physical problems such as pain and activity limitations, due to discomfort. Furthermore we assessed the impact of subcutaneous reconstruction on HRQOL. In our analysis, 1-years outcomes of quality of life, measured by BREAST-Q questionnaire, confirmed high patient satisfaction. Indeed few studies have examined the impact of prepectoral approach on HRQOL and postoperative pain and we believe that is fundamental to assess patients reported outcomes through objective measurement by means of validated instruments16. Over the past years, history of radiotherapy precluded radiated patients from prepectoral approach. Recently, evidence showed that direct-to-implant or two-stages prepectoral breast reconstruction is a safe and effective alternative and that the morbidity profile is similar to that 12
encountered with submuscular reconstruction in the setting of postmastectomy radiation therapy 3,9,10,29–33
. On the other hand, given the lack of evidence on correlation between preoperative
radiation therapy dose, field, and duration and success of reconstruction, prepectoral breast reconstruction has not normally been offered to patients who had history of conservative surgery and radiation. Nevertheless, in a recent retrospective review on 521 prepectoral reconstructions, history of previous breast surgery and radiotherapy did not affect the surgical outcomes 25. In our series, only one patient had already undergone conservative breast surgery without radiotherapy. We are now currently applying prepectoral breast reconstruction also to patients with history of conservative surgery and radiotherapy, reporting promising results at short-term follow-up. Despite of these finding, we firmly believe that a longer follow-up and stronger evidence are needed to properly address the issue. Anyway, as far as we are concerned, postoperative radiation or history of radiotherapy should not be an absolute contraindication to prepectoral reconstruction. We feel that every patient could be a good candidate, unless an adequate skin coverage is provided and adequate thickness and vascularisation of the mastectomy flaps are assessed intraoperatively. We suggest to carefully choose candidates for prepectoral breast reconstruction, weighing the characteristic of patients and the intraoperative findings. The preservation of a large dermal flap may seem a challenge for the oncological safety of this technique. A 2-years and half follow-up is not enough to properly provide strong evidence about oncological safety of the dermal flap in the context of skin-reduction mastectomy.
Albeit we
believe that a longer follow-up is crucial for assessing the oncological safety, we are confident to report comparable results to those reported with similar techniques involving reduction pattern mastectomy and dermal flaps, which are now considered standard of treatment33–37. Recently, Gabriel et al reported their experience with prepectoral breast reconstruction in challenging patients32. In this case series, 39 overweight or obese patients underwent skinreducing mastectomy and subcutaneous reconstruction with expander or implant, with complications occurring in 12 out of 73 breasts. Similarly, in another study, Caputo et al described 13
their personal prepectoral technique, positioning the implant into a composed dermal flap–ADM pocket, reporting successful outcomes and complications in 3 out of 33 breasts
26
. In this case, the
ADM was used as a patch to cover the upper pole of the implant. Conversely, in our experience we prefer to entirely wrap around the implant with the ADM, as in recent reports the use of ADMs was associated with a low capsular contracture rates, similar to those of total submuscular reconstruction12,15,16,18,38. The ADMs seem to act like a sieve layer between the prosthesis and the subcutaneous tissue, reducing inflammatory response along with the likelihood of capsular contracture
15,16,39–42
. We firmly believe that the implant should be completely enveloped by the
matrix, in order to entirely exploit its modulating effect, as the direct exposure of the prosthesis could probably act as in an inflammatory trigger, vanishing this effect. Although no significant capsular contracture (grade III or IV) was detected in our three-years experience with the modified wrap around-technique16 , the present study does not have a long follow-up, limiting possible considerations about capsular contracture. Thus we believe that a longer evaluation period is necessary. Although, our study pilot study shows promising results we believe that larger studies should be welcome to properly assess the complications rate and the outcomes of prepectoral approach in the context of skin-reduction mastectomy. CONCLUSIONS In this study we present a modified prepectoral wrap-around technique for patients undergoing skin reduction mastectomy. We place the implant in the subcutaneous plane under a dermal flap and applied the prepectoral approach to a group of patients with ptotic and large breast and high BMI. We reported satisfactory patient-reported results and complications rate, with high patient comfort and low postoperative pain. These results might support the rationale for expanding the population target of prepectoral reconstruction and provide new data towards a future revision of its indications. AKNOWLEGDEMENT 14
None of the authors has any conflict of interest or financial interest in any of the products, devices, or drugs mentioned in this manuscript. The study followed the ethical standards of human experimentation, according to the Declaration of Helsinki.
15
FIGURE LEGENDS FIGURE 1. Consort Diagram.
FIGURE 2. Surgical technique: modified wrap-around technique. Above left) Dermal flap is preserved from the inferior pole of the breast. Above right) Skin reduction mastectomy is performed, leaving well vascularized skin flaps and dermal flap. Below left) The wrapped around implant is placed in the prepectoral pocket under the dermal flap. Below right) The dermal flap is sutured over the implant. 16
FIGURE 3. Unilateral case. Preoperative (left) and postoperative pictures (one moth and two years follow-up, center and right respectively). The patient did not rquire contralateral reduction.
17
FIGURE 4. Bilateral case. Preoperative (left) and postoperative pictures (one moth and two years follow-up, center and right respectively).
SUPPLEMENTAL DIGITAL CONTENT VIDEO 1. Surgical technique Drawings were made according to Wise-pattern fashion. The design included a rectangular area based on the inframammary fold extending upward, up to the inferior border of the areola. After skin incision, the dermal flap from the inferior pole of the breast was deepithelialized and then preserved. The ADM containing the implant was then placed in a prepectoral pocket, under the dermal flap, and sutured with apical, medial and lateral absorbable stitches directly onto the fascia of the pectoralis major muscle. Likewise, the dermal flap was sutured laterally to the pectoralis major and the anterior serratus muscles and to the ADM by its superior edge, mimicking a natural bra. Skin was closed in layer, according to the inverted T-pattern. VIDEO 2. Preparation and wrapping of ADM The implant was carefully chosen basing on the weight and diameter of the resected glandular breast. After rehydration in sterile solution of the ADM for 5 minutes, the matrix edges were sutured together around the breast implant.
18
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25. Casella D, Di Taranto G, Onesti MG, Greco M, Ribuffo D. A retrospective comparative analysis of risk factors and outcomes in direct-to-implant and two-stages prepectoral breast reconstruction: BMI and radiotherapy as new selection criteria of patients. Eur J Surg Oncol J Eur Soc Surg Oncol Br Assoc Surg Oncol. 2019 Feb 10; 26. Caputo GG, Marchetti A, Dalla Pozza E, Vigato E, Domenici L, Cigna E, et al. Skin-Reduction Breast Reconstructions with Prepectoral Implant. Plast Reconstr Surg. 2016 Jun;137(6):1702–5. 27. Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain. - PubMed - NCBI [Internet]. [cited 2019 Aug 3]. Available from: https://www-ncbi-nlm-nihgov.ezproxy.uniroma1.it/pubmed/?term=Boonstra+AM%2C+Schiphorst+Preuper+HR%2C+B alk+GA%2C+Stewart+RE.+Cutoff+points+for+mild%2C+moderate%2C+and+severe+pain+on+the+visual+analogue+scale+f or+pain+in+patients+with+chronic+musculoskeletal+pain. 28. Glasberg SB. The Economics of Prepectoral Breast Reconstruction. Plast Reconstr Surg. 2017 Dec;140(6S Prepectoral Breast Reconstruction):49S-52S. 29. Sinnott CJ, Persing SM, Pronovost M, Hodyl C, McConnell D, Ott Young A. Impact of Postmastectomy Radiation Therapy in Prepectoral Versus Subpectoral Implant-Based Breast Reconstruction. Ann Surg Oncol. 2018 Oct;25(10):2899–908. 30. Elswick SM, Harless CA, Bishop SN, Schleck CD, Mandrekar J, Reusche RD, et al. Prepectoral Implant-Based Breast Reconstruction with Postmastectomy Radiation Therapy. Plast Reconstr Surg. 2018 Jul;142(1):1–12. 31. Sbitany H, Gomez-Sanchez C, Piper M, Lentz R. Prepectoral Breast Reconstruction in the Setting of Postmastectomy Radiation Therapy: An Assessment of Clinical Outcomes and Benefits. Plast Reconstr Surg. 2019 Jan;143(1):10–20. 32. Gabriel A, Maxwell GP. Prepectoral Breast Reconstruction in Challenging Patients. Plast Reconstr Surg. 2017 Dec;140(6S Prepectoral Breast Reconstruction):14S-21S. 33. Lo Torto F, Parisi P, Casella D, Di Taranto G, Cigna E, Ribuffo D. Impact of Evolving Radiation Therapy Techniques on Implant-Based Breast Reconstruction. Plast Reconstr Surg. 2018;141(1):182e–3e. 34. Nava MB, Ottolenghi J, Pennati A, Spano A, Bruno N, Catanuto G, et al. Skin/nipple sparing mastectomies and implant-based breast reconstruction in patients with large and ptotic breast: oncological and reconstructive results. Breast Edinb Scotl. 2012 Jun;21(3):267–71. 35. Veronesi U, Stafyla V, Petit J-Y, Veronesi P. Conservative mastectomy: extending the idea of breast conservation. Lancet Oncol. 2012 Jul;13(7):e311-317. 36. Jepsen C, Hallberg H, Pivodic A, Elander A, Hansson E. Complications, patient-reported outcomes, and aesthetic results in immediate breast reconstruction with a dermal sling: A systematic review and meta-analysis. J Plast Reconstr Aesthetic Surg JPRAS. 2019 Mar;72(3):369–80. 37. Calabrese C, Casella D, Di Taranto G, Marcasciano M, Kothari A, Sordi S, et al. Oncoplastic conservative surgery for breast cancer: long-term outcomes of our first ten years experience. Eur Rev Med Pharmacol Sci. 2018 Nov;22(21):7333–42. 21
38. Jafferbhoy S, Chandarana M, Houlihan M, Parmeshwar R, Narayanan S, Soumian S, et al. Early multicentre experience of pre-pectoral implant based immediate breast reconstruction using Braxon®. Gland Surg. 2017 Dec;6(6):682–8. 39. Inserra I, Martelli C, Cipollina M, Cicione C, Iavarone F, Taranto GD, et al. Lipoaspirate fluid proteome: A preliminary investigation by LC-MS top-down/bottom-up integrated platform of a high potential biofluid in regenerative medicine. Electrophoresis. 2016 Apr;37(7–8):1015–26. 40. Stump A, Holton LH, Connor J, Harper JR, Slezak S, Silverman RP. The use of acellular dermal matrix to prevent capsule formation around implants in a primate model. Plast Reconstr Surg. 2009 Jul;124(1):82–91. 41. Schmitz M, Bertram M, Kneser U, Keller AK, Horch RE. Experimental total wrapping of breast implants with acellular dermal matrix: a preventive tool against capsular contracture in breast surgery? J Plast Reconstr Aesthetic Surg JPRAS. 2013 Oct;66(10):1382–9. 42. Iqbal FM, Bhatnagar A, Vidya R. Host Integration of an Acellular Dermal Matrix: Braxon Mesh in Breast Reconstruction. Clin Breast Cancer. 2016;16(6):e209–11.
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ADM-assisted prepectoral breast reconstruction and skin reduction mastectomy: expanding the indications for subcutaneous reconstruction. MG Onesti MD , G Di Taranto MD , D Ribuffo MD , N Scuderi MD PII: DOI: Reference:
S1748-6815(19)30492-9 https://doi.org/10.1016/j.bjps.2019.11.004 PRAS 6308
To appear in:
Journal of Plastic, Reconstructive & Aesthetic Surgery
Received date: Accepted date:
28 November 2018 22 November 2019
Please cite this article as: MG Onesti MD , G Di Taranto MD , D Ribuffo MD , N Scuderi MD , ADMassisted prepectoral breast reconstruction and skin reduction mastectomy: expanding the indications for subcutaneous reconstruction., Journal of Plastic, Reconstructive & Aesthetic Surgery (2019), doi: https://doi.org/10.1016/j.bjps.2019.11.004
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Ltd on behalf of British Association of Plastic, Reconstructive and Aesthetic Surgeons.
ADM-assisted prepectoral breast reconstruction and skin reduction mastectomy:
expanding
the
indications
for
subcutaneous
reconstruction.
Onesti MG1, MD; Di Taranto G1*, MD; Ribuffo D1, MD; Scuderi N1, MD.
1. Plastic Surgery Unit, Department of Surgery "P. Valdoni", Sapienza University, Rome, Italy.
*Send correspondence to Giuseppe Di Taranto Via dei Latini, 33 00185 Rome, Italy Phone: +39 328 3869334 Fax: +39 06 49970205 [email protected]
1
ABSTRACT Backgrounds Recently a flood of new techniques and studies have been released for prepectoral reconstruction, following strict criteria for selection of patients undergoing skin or nipple sparing mastectomy. Nevertheless a big population of patients that would otherwise benefit from prepectoral techniques has been excluded so far. Patients and methods Between January 2016 and February 2017, patients undergoing skin reducing mastectomy (SRM) were enrolled at our Institution. We selected patients with large and ptotic (grade II-III) breasts undergoing SRM, followed by a new technique, which involves placement of the implant, wrapped by acellular dermal matrix, in a prepectoral pocket under a dermal flap. Data of all the surgeries were prospectively collected and contracture grade was assessed by Baker scale. Complication rate and cancer recurrence were reported and health related quality of life (HRQOL) measurement was recorded using BREAST-Q questionnaire. At early follow-up, postoperative pain was assessed through VAS scale. Results 29 patients underwent SRM and 10 patients, meeting inclusions criteria, were enrolled, with a total of 13 operated breasts. Postoperative average pain was assessed as low as 4.1. The median follow-up was 2.6 (range 2.1-3.2) years. Post-operative complications occurred in 1 case of minimal wound dehiscence. No patient reported breast seroma or severe capsular contracture grade. Patient scored high level of satisfaction with breast, psychosocial well-being, sexual wellbeing, physical impact and overall satisfaction with outcome, at BREAST-Q questionnaire.
2
Conclusions In this study we present a modified prepectoral technique for patients undergoing SRM, reporting satisfactory outcomes. These results might support the rationale for expanding the population target of prepectoral reconstruction. KEYWORDS:
ADM;
BRAXON;
subcutaneous
breast
reconstruction; BREAST-Q; direct-to-implant reconstruction.
3
reconstruction;
muscle
sparing
INTRODUCTION
Prosthetic breast reconstruction is the most performed breast reconstructive surgical technique following mastectomy1. In the setting of continuous expanding options for implant-assisted reconstruction, the most recent and successful advancement was prepectoral approach. Although positioning the implant in a subcutaneous pocket is not a novel concept, the technique have been overlooked over the last decades, disqualified by the aggressive ablative surgery and the poor reported outcomes with the release of
1,2
. Nowadays the giant strides made by breast reconstruction, along
innovative devices, allowed plastic surgeons to retrieve subcutaneous
approach, providing excellent outcomes and catering the ongoing greater awareness about aesthetic results. For many years subpectoral implant placement has been the generally accepted method at the cost of acute and chronic post-operative pain and impaired movement of upper limb, as a result of pectoralis major detachment
1–6
. Today the new prostethic techniques, assisted by dermal matrix
(ADM) or synthetic mesh, place the implant in a complete subcutaneous plane, delivering an immediate, muscle-sparing breast reconstruction 1–3,7. Although the first technique was recently described, several variations of this procedure have been already introduced and a number of studies has reported promising preliminary results2–4,8–18. So far, prepectoral reconstruction has been generally performed after nipple-sparing or skin-sparing mastectomy in patients under 30 kg/m2 of body mass index (BMI) and with a breast excision volume not exciding 600g, following the criteria from British Association of Plastic Reconstructive and Aesthetic Surgeons and Association of Breast Surgery associations for prepectoral reconstruction with ADM 19. In the present study, we describe a modified prepectoral technique, which exploits ADM-assisted muscle-sparing breast reconstruction as an alternative to traditional submuscular reconstruction in 4
the context of skin-reduction mastectomy. The results of the study could expand prepectoral reconstruction population target and provide new hint towards the revision of its indications.
PATIENTS AND METHODS PATIENTS Between January 2016 and February 2017, patients undergoing mastectomy were enrolled at our Institution, Policlinico Umberto I, Sapienza University of Rome. We selected patients diagnosed for breast cancer or genetic predisposition to breast cancer, undergoing skin reduction mastectomy (SRM), followed by direct-to-implant (DTI) breast reconstruction. Among these patients, we enrolled selected women diagnosed for a localized breast carcinoma or with BRCA1/2 mutation and undergoing prophylactic mastectomy. Inclusion criteria were body mass index (BMI) > 30 kg/m2, ptotic breast (grade II-III according to Regnault scale), an estimated mastectomy weight > 600g, a subcutaneous layer >1cm (measured by the pinch test on the upper and medial quadrants), and mastectomies leaving well-vascularized subcutaneous layer. All the patients were informed that necessary condition for prepectoral implant placement was a well vascularised and healthy subcutaneous layer after mastectomy, evaluated clinically during the surgery. The thickness of the flaps was measured intraoperatively with a ruler. In case of not healthy and adequate mastectomy flaps, the reconstruction was conducted in the submuscular plane. Our study was performed with respect to the ethical standards of the Declaration of Helsinki and the entire protocol was approved by the Ethics Committee of Sapienza, University of Rome. All patients provided written informed consent preoperatively and were evaluated twice a week for the month after surgery. Then they were followed up at one month, three months, six months after surgery, and then yearly. OPERATIVE TECHNIQUE
5
Patients underwent a modified version of the “wrap around technique”, which involves placement of the implant in the subcutaneous layer, wrapped by Braxon® noncross-linked ADM (DecomedSrl, Marcon, Venice, Italy). Patients were preoperatively evaluated and drawings were made according to Wise-pattern fashion, either with sparing or graft of the nipple. The patients were marked while standing: we first marked the position of the new nipple along the midclavicular line. The marking then followed the steps used for a normal Wise pattern breast reduction. When the distance between nipple-areolar complex and hemiclavear point was more than 40 cm, the nipple was grafted. Furthermore, the design included a rectangular area based on the inframammary fold, extending upward up to the inferior border of the areola (Video 1). The length of the flap was evaluated for each patient according to the oncological and breast characteristics of the patient. After skin incision, the dermal flap from the inferior pole of the breast was deepithelialized and then preserved (Video 1 and Figure 2). The wide incision was used as surgical opening for both mastectomy and the eventual axillary surgery. The implant was carefully chosen basing on the weight and diameter of the resected glandular breast. After rehydration in sterile solution of the ADM for 5 minutes, the matrix edges were sutured together around the breast implant (Video 2). The ADM containing the implant was then placed in a prepectoral pocket, under the dermal flap, and sutured with apical, medial and lateral absorbable stitches directly onto the fascia of the pectoralis major muscle (Figure 1 and Video 1). Likewise, the dermal flap was sutured laterally to the pectoralis major and the anterior serratus muscles and to the ADM by its superior edge, mimicking a natural bra. When opportune for the oncological characteristics of the cancer, the nipple-areola complex was preserved and grafted in the new position, following preoperative design. Skin was closed in layer, according to the inverted T-pattern and one vacuum drain was placed in the inframammary fold. Right after the operation, the patients were asked to wear a postsurgical mammary bra and to keep it for one month. Patients received oral antibiotics (Amoxicillin 1g, twice a day) from the surgery until the removal of the drain. The drain was removed when the fluid collected was below 30 cc in 24 hours. OUTCOMES AND MEASURES 6
Data of all the surgeries were prospectively collected in a digital data base, accounting for demographics characteristic, medical history, family history, complications and oncologic outcome. For each patient, photographic documentation was taken pre and after surgery at each follow-up point. Capsular contracture grade was yearly assessed by Baker scale independently by the two senior authors (OMG, NS). To address potential cases of disagreement, a third plastic surgeon, not involved in the protocol, was asked for external evaluation. Any cancer recurrence was named as oncological outcome and health related quality of life (HROQL) measurement was recorded using BREAST-Q questionnaire. Aesthetic complication requiring a reoperation (implant rippling, migration or severe capsular contracture grade) were considered separately in the statistical analysis. Complications were described by Clavien-Dindo Classification. Postoperative pain was evaluated by patients 1 month after surgery using a visual analogue scale (VAS), giving a score from 1 to 10 (1 = no pain, 10= severe pain)20–22. All patients underwent ultrasound examination at 1, 3, 6, and 12 months postoperatively to exclude any possible fluid collection8. HRQOL OUTCOME BREAST-Q was developed for assessing HRQOL among patients undergoing breast surgery and has been extensively validated for breast reconstruction23,24. Postoperative BREAST-Q module for reconstructive surgery was administered 1 year after mastectomy during a follow-up visit, according to our protocol9,10,16,25. Following developers’ instructions, patients who failed to answer more than half the items within each domain were excluded from the analysis for that particular domain. STATISTICAL ANALYSIS Descriptive statistics accounted for patient characteristics, complications and capsular contracture grade. Using the QScore Scoring Software, BREAST-Q scores for each matrix were converted
7
from raw scores (1 through 4 or 5) to a continuous range from 0 to 100, with a higher score representing greater satisfaction or better HRQOL. RESULTS Between January 2016 and February 2017, 29 patients underwent SRM at our Institution. Among them 11 patients met the inclusion criteria of our study (see CONSORT diagram, Figure 1). One patient denied consent to join the study, due to unavailability to adhere to the follow-up schedule. Ten patients were enrolled in the study. Average age of patients was 50±9.1 years. The mean BMI was 36.6±2.7 kg/m2. 8 patients showed a grade III of ptosis, and 2 a grade II. One patient was diagnosed for BRCA1 mutation. 2 patients had given neoadjuvant chemotherapy and one had history of previous conservative breast surgery without radiotherapy. Table 1 reports the characteristic of patients and surgeries. Table 1. Characteristic of patients and surgeries Patients characteristics Number
10
Age [years, mean (SD)]
50±9.1
BMI [kg/m2, mean (SD)]
36.6±2.7
BRCA Mutation carriers (n)
1
Surgeries (n)
13
Unilateral (n)
7
Bilateral (n)
3
Lymphadenectomy (n)
2
Sentinel lymph node biopsy (n)
7
Prophylactic mastectomies (n)
3
8
7 unilateral and 3 bilateral mastectomies were performed, accounting for a total of 13 operated breasts. In unilateral cases, a breast reduction was performed in the contralateral breast, if required by the patient. 9 patients underwent also axillary surgeries: 2 underwent axillary lymphadenectomy and 7 a sentinel lymph node biopsy (SLNB). A total of 3 prophylactic mastectomies were performed. The mean weight of mastectomy was 829±205 g. In all the cases the mastectomy left well vascularized and healthy flaps with a mean thickness of 2.1±0.5 cm. Two patients had their nipple grafted and 8 spared. The mean hospital stay was 2.3±1.2 days. The drains were removed between the fifth and the ninth postoperative day (mean: 6.3±1.6 days). 3 patients underwent adjuvant radiotherapy and 8 patients adjuvant chemotherapy. At one month acute postoperative pain was assessed through a VAS scale, and patients reported acceptable scores, with an average pain of 4.1±0.8. None of the patients was lost to follow-up. The median follow-up period after mastectomy was 31 (range 24-39) months that is 2.6 (range 2-3.1) years. Post-operative complications occurred in 1 case of minimal wound dehiscence and the patient healed uneventfully (Clavien-Dindo grade I). We did not report any nipple-areola or skin necrosis. No patient reported breast seroma or severe capsular contracture grade. Ultrasound examination showed a progressive host integration of the dermal matrix with the subcutaneous tissue and detected no fluid collection. In no case, a disagreement was encountered during the evaluations of capsular contracture. A Baker grade II and a Baker grade I was assessed in 3 and 10 breasts respectively. In our series, we assessed no Baker grade III or IV over a median follow-up of 2.6 years. No cancer recurrence was identified during oncological surveillance. After one year, no implant rippling was reported. One patient required a revision of the scar for dog ears and a scar revision was performed after one year. MEASURE OF HRQOL 9
All the patients properly filled the five domains of the questionnaire and were included in the analysis. Table 1 accounts for the self-reported measures of HRQOL, evaluated with BREAST-Q questionnaire. Patient scored high level of satisfaction with breast, psychosocial well-being, sexual well-being, physical impact and overall satisfaction with outcome.
Table 2. BREAST-Q scores. Domain
Postoperativ e mean (±SD)
Satisfaction-breasts
60.10 (±7.9)
Psychosocial wellness
62.1 (±16.4)
Sexual well-being
48.5 (±21)
Physical impact (chest)
66.9 (±14.6)
Overall satisfaction with outcome
94.1 (±10.6)
DISCUSSION Recently, prepectoral reconstruction has established as an effective development in prosthetic reconstruction, after the release of new devices, either biological or synthetic, which completely envelope the implant, composing an additional layer between the prosthesis and the subcutaneous tissue. As plastic surgeons have revived the use of prepectoral breast reconstruction, a flood of new techniques and studies have been released 3,4,8–17. So far in these studies, patients have been strictly selected following the criteria from British Association of Plastic Reconstructive and Aesthetic Surgeons and Association of Breast Surgery associations for prepectoral reconstruction with ADM: body mass index (BMI) of < 30 kg/m2, no history of radiotherapy, an estimated mastectomy weight not exciding 600g, a subcutaneous layer 10
>1cm (measured by the pinch test on the upper and medial quadrants) and sparing mastectomies leaving well-vascularized subcutaneous layer 19. At our Institution we routinely apply the prepectoral reconstruction to selected patients undergoing mastectomy and DTI, reporting great results in term of outcomes and patient-satisfaction8,15,16. Nevertheless, we felt in our experience that those criteria, although valid and suitable for sparing mastectomy, would exclude a big population of patients that would otherwise benefit from prepectoral techniques. Following these concerns, we decided to apply the prepectoral approach protocol also to patients with large and ptotic breast and a BMI>30 kg/m2, undergoing skin reducing mastectomy. In this pilot study we report the outcomes of a series of 10 patients undergoing SRM and prepectoral DTI breast reconstruction with a modified wrap-around technique. Surgical complications can frequently occur in Wise-pattern skin-reduction mastectomy, owing to the stress and tension applied to surgical sutures that could severely affect flaps vascularization20,21,26. In this case series, we placed the implant wrapped-around with ADM in the prepectoral plane, under a dermal flap which braces the prosthesis as a natural bra, reducing the burden on the skin flaps. Furthermore, the flap could decrease the likelihood of implant palpability and exposure in case of wound dehiscence, a frequent inconvenience after skin reducing mastectomy26. We designed a rectangular-shaped flap based on the inframammary fold, extending upward up to the inferior border of the areola. The wide base of the rectangular design ensures a good vascularization of the flap, reducing the likelihood of necrosis. The vertical sides of the rectangular flap are detached from the lateral skin flap, allowing an easy closure of the skin in layers. Furthermore, the posterior aspect of the dermal flap lay over the implant, while the anterior aspect is behind the vertical suture of the skin. This design is based on a single flap and do not show any break on its surfaces: the rectangle act like a shield over the implant, avoiding a direct contact between the implant and the joint point of the suture of the inverted T pattern, where wound dehiscence is reported to occur the most26. 11
We reported acceptable results in term of surgical and patient-reported outcomes as well as capsular contracture rate over a follow-up of 2 years and half. Minor complications occurred in 1 case: a minimal wound dehiscence of the T-scar, which healed uneventfully. Interestingly, we did not report any case of seroma. A possible explanation to this issue could rely on our modified wrap-around technique. Indeed, unlike the first description and more recent reports of the technique, we preferred to secure also the anterior surface of the dermal matrix to the subcutaneous tissue, aming to reduce the possibility of any dead space. One of the main concerns about traditional submuscular reconstruction is the disinsertion of the pectoralis major muscle, which can increase postoperative pain and shoulder impairment, requiring long recovery and physiotherapy rehabilitation 2–4,9,16. The subcutaneous approach avoids the need of detaching the muscle, reducing operative time along with patients’ pain and discomfort 16,18. At one month follow-up, we evaluated post-operative pain using a visual analogue scale (VAS), assessing a low grade of pain (mean 4.1±0.8)
27
. This data is notably relevant, as the low level of
acute pain has been reported to allow a fast recovery, reducing the hospital stay and increasing the cost effectiveness of breast reconstruction28. We assessed pain and functional impairment was well at one-year follow-up with BREAST-Q. Patients reported a good score at the fifth domain of the questionnaire “Physical Well-being”, which measures several physical problems such as pain and activity limitations, due to discomfort. Furthermore we assessed the impact of subcutaneous reconstruction on HRQOL. In our analysis, 1-years outcomes of quality of life, measured by BREAST-Q questionnaire, confirmed high patient satisfaction. Indeed few studies have examined the impact of prepectoral approach on HRQOL and postoperative pain and we believe that is fundamental to assess patients reported outcomes through objective measurement by means of validated instruments16. Over the past years, history of radiotherapy precluded radiated patients from prepectoral approach. Recently, evidence showed that direct-to-implant or two-stages prepectoral breast reconstruction is a safe and effective alternative and that the morbidity profile is similar to that 12
encountered with submuscular reconstruction in the setting of postmastectomy radiation therapy 3,9,10,29–33
. On the other hand, given the lack of evidence on correlation between preoperative
radiation therapy dose, field, and duration and success of reconstruction, prepectoral breast reconstruction has not normally been offered to patients who had history of conservative surgery and radiation. Nevertheless, in a recent retrospective review on 521 prepectoral reconstructions, history of previous breast surgery and radiotherapy did not affect the surgical outcomes 25. In our series, only one patient had already undergone conservative breast surgery without radiotherapy. We are now currently applying prepectoral breast reconstruction also to patients with history of conservative surgery and radiotherapy, reporting promising results at short-term follow-up. Despite of these finding, we firmly believe that a longer follow-up and stronger evidence are needed to properly address the issue. Anyway, as far as we are concerned, postoperative radiation or history of radiotherapy should not be an absolute contraindication to prepectoral reconstruction. We feel that every patient could be a good candidate, unless an adequate skin coverage is provided and adequate thickness and vascularisation of the mastectomy flaps are assessed intraoperatively. We suggest to carefully choose candidates for prepectoral breast reconstruction, weighing the characteristic of patients and the intraoperative findings. The preservation of a large dermal flap may seem a challenge for the oncological safety of this technique. A 2-years and half follow-up is not enough to properly provide strong evidence about oncological safety of the dermal flap in the context of skin-reduction mastectomy.
Albeit we
believe that a longer follow-up is crucial for assessing the oncological safety, we are confident to report comparable results to those reported with similar techniques involving reduction pattern mastectomy and dermal flaps, which are now considered standard of treatment33–37. Recently, Gabriel et al reported their experience with prepectoral breast reconstruction in challenging patients32. In this case series, 39 overweight or obese patients underwent skinreducing mastectomy and subcutaneous reconstruction with expander or implant, with complications occurring in 12 out of 73 breasts. Similarly, in another study, Caputo et al described 13
their personal prepectoral technique, positioning the implant into a composed dermal flap–ADM pocket, reporting successful outcomes and complications in 3 out of 33 breasts
26
. In this case, the
ADM was used as a patch to cover the upper pole of the implant. Conversely, in our experience we prefer to entirely wrap around the implant with the ADM, as in recent reports the use of ADMs was associated with a low capsular contracture rates, similar to those of total submuscular reconstruction12,15,16,18,38. The ADMs seem to act like a sieve layer between the prosthesis and the subcutaneous tissue, reducing inflammatory response along with the likelihood of capsular contracture
15,16,39–42
. We firmly believe that the implant should be completely enveloped by the
matrix, in order to entirely exploit its modulating effect, as the direct exposure of the prosthesis could probably act as in an inflammatory trigger, vanishing this effect. Although no significant capsular contracture (grade III or IV) was detected in our three-years experience with the modified wrap around-technique16 , the present study does not have a long follow-up, limiting possible considerations about capsular contracture. Thus we believe that a longer evaluation period is necessary. Although, our study pilot study shows promising results we believe that larger studies should be welcome to properly assess the complications rate and the outcomes of prepectoral approach in the context of skin-reduction mastectomy. CONCLUSIONS In this study we present a modified prepectoral wrap-around technique for patients undergoing skin reduction mastectomy. We place the implant in the subcutaneous plane under a dermal flap and applied the prepectoral approach to a group of patients with ptotic and large breast and high BMI. We reported satisfactory patient-reported results and complications rate, with high patient comfort and low postoperative pain. These results might support the rationale for expanding the population target of prepectoral reconstruction and provide new data towards a future revision of its indications. AKNOWLEGDEMENT 14
None of the authors has any conflict of interest or financial interest in any of the products, devices, or drugs mentioned in this manuscript. The study followed the ethical standards of human experimentation, according to the Declaration of Helsinki.
15
FIGURE LEGENDS FIGURE 1. Consort Diagram.
FIGURE 2. Surgical technique: modified wrap-around technique. Above left) Dermal flap is preserved from the inferior pole of the breast. Above right) Skin reduction mastectomy is performed, leaving well vascularized skin flaps and dermal flap. Below left) The wrapped around implant is placed in the prepectoral pocket under the dermal flap. Below right) The dermal flap is sutured over the implant. 16
FIGURE 3. Unilateral case. Preoperative (left) and postoperative pictures (one moth and two years follow-up, center and right respectively). The patient did not rquire contralateral reduction.
17
FIGURE 4. Bilateral case. Preoperative (left) and postoperative pictures (one moth and two years follow-up, center and right respectively).
SUPPLEMENTAL DIGITAL CONTENT VIDEO 1. Surgical technique Drawings were made according to Wise-pattern fashion. The design included a rectangular area based on the inframammary fold extending upward, up to the inferior border of the areola. After skin incision, the dermal flap from the inferior pole of the breast was deepithelialized and then preserved. The ADM containing the implant was then placed in a prepectoral pocket, under the dermal flap, and sutured with apical, medial and lateral absorbable stitches directly onto the fascia of the pectoralis major muscle. Likewise, the dermal flap was sutured laterally to the pectoralis major and the anterior serratus muscles and to the ADM by its superior edge, mimicking a natural bra. Skin was closed in layer, according to the inverted T-pattern. VIDEO 2. Preparation and wrapping of ADM The implant was carefully chosen basing on the weight and diameter of the resected glandular breast. After rehydration in sterile solution of the ADM for 5 minutes, the matrix edges were sutured together around the breast implant.
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