Implant Based Breast Reconstruction
Dikmans, R.E.G.
2019
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citation for published version (APA)
Dikmans, R. E. G. (2019). Implant Based Breast Reconstruction: One step at a time.
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Breast Reconstruction
one step at a time
The printing of this thesis was supported by the Department of Plastic, Reconstruc-tive & Hand Surgery, VUmc, Amsterdam.
Cover image Gumdrops by Jessalyn Brooks, LA, CA, USA Image parts Antidepression by Jessalyn Brooks, LA, CA, USA
Layout Renate Siebes | Proefschrift.nu Printing Proefschriftmaken.nl
ISBN 978-94-6380-622-0 © 2019 Rieky Dikmans
Implant Based Breast Reconstruction;
one step at a time
ACADemiSCH PRoefSCHRifT
ter verkrijging van de graad Doctor aan de Vrije Universiteit Amsterdam,op gezag van de rector magnificus prof.dr. V. Subramaniam, in het openbaar te verdedigen ten overstaan van de promotiecommissie
van de faculteit der Geneeskunde op dinsdag 17 december 2019 om 9.45 uur
in de aula van de universiteit, De Boelelaan 1105
door
Chapter 1 Introduction 9 Part 1: The Surgeon & Implant Based Breast Reconstruction
Chapter 2 Single stage breast reconstruction using Strattice™: A retrospective
study 31
Chapter 3 Two-stage implant-based breast reconstruction vs immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: An open-label, phase IV multicentre randomised controlled trial
47 Chapter 4 Predictors of complications after direct-to-implant breast
reconstruction with an acellular dermal matrix
From a multicentre randomised controlled trial
73 Chapter 5 Discussing sexuality in the field of plastic and reconstructive surgery, a
national survey of current practice in the Netherlands 91
Part 2: The Patient & Implant Based Breast Reconstruction
Chapter 6 The Aesthetic Items Scale: A tool for the evaluation of aesthetic
outcome after breast reconstruction 109
Chapter 7 Patient reported outcomes after ADM-assisted direct-to-implant breast reconstruction: A cross-sectional study 125
Chapter 8 Quality of life and patient satisfaction after one-stage implant-based breast reconstruction with an acellular dermal matrix compared with two-stage breast reconstruction
Primary outcome of the BRIOS study, an open-label, phase IV Multicentre Randomised Controlled Trial
145 Chapter 9 Sexuality, a topic that surgeons should discuss with women before
risk-reducing mastectomy and breast reconstruction 169
Chapter 1
Breast cancer then & now
Through the years the treatment of breast cancer and the survival rate have improved tremendously. In ancient times the Egyptians already described it and Hippocrates also mentioned the existence of tumours in breasts. In the past, much more so than nowadays, there was a taboo on discussing female breasts, which resulted in a later presentation of the illness. Because of a lack of diagnostic methods, breast cancer could easily develop invasively and very often the illness was only recognized when it became visible on the surface of the skin.1
The initial method of treatment was to have an operation. It lasted long into the 20th century before the first real radical breast amputations were performed, which
were subsequently optimised and popularized by Halsted in New York, USA. Not only was the breast removed, but also the breast muscles and the axillar lymph nodes. Despite the sometimes-serious complications of this procedure, radical breast amputation was the golden standard for a long time. During the second half of the 20th century more precise breast operations, known as breast saving surgery,
became in vogue. In the past four decades the modern treatment of breast cancer has really became established.1
A turning point in the treatment of breast cancer in our country occurred in 1989, when women in the Netherlands between 50 and 75 years of age were invited to take part in the National Screening Programme for Breast Cancer. This programme included a standard mammography, a proven effective method for the early detection of breast cancer. Another important development took place at the end of the nineties, namely the sentinel node biopsy for nodal staging, which resulted in a decrease in the necessity for extensive axillar lymph node dissection. In addition, the discovery of the BRCA-gene in 1994 was a major breakthrough for the prophylactic treatment of breast cancer and ever since more related genes have been discovered. With the introduction of advanced diagnostics, systemic therapy and refined surgical techniques, modern breast cancer treatment has taken a huge leap forward and has considerably increased the chances of survival.2
mean age of women who are diagnosed with breast cancer is 61.2 A quarter of the
women with breast cancer diagnosis are younger than 50 years old, which accounts to 3,000 women in the Netherlands each year. Around 10% of these women are younger than 25.3 Moreover, about 130 Dutch men develop breast cancer annually.
In the last 25 years the incidence of mamma carcinoma in the Netherlands has doubled and it is still increasing. Although the incidence of mamma carcinoma is high, mortality from mamma carcinoma is relatively low. Of all the deaths from cancer, 7% are the result of a mamma carcinoma. The 10-year survival rate of a patient after the treatment for breast cancer has significantly improved in the past decades, from 59% in 1989 to 77% in 2004-2007.4
Breast cancer especially occurs in western countries and seems to be a welfare-related disease. Mamma carcinoma is associated with several factors (smoking, certain food consumption, use of alcohol, being overweight, age at the first pregnancy, the number of pregnancies and oral contraception). A strong family history with a close female family member clearly gives a greater chance of breast cancer developing.5
It is suspected that about 5% to 10% of all breast cancer cases in the Netherlands are attributed to hereditary predisposition. Women from families with a BRCA 1/2-mutation have a significantly higher risk of developing breast cancer (39-85%) and ovarian cancer (10-63%) in their lives. At present it is advised that carriers of the BRCA 1/2-mutation are offered prophylactic bilateral salpingo ovariectomy and mastectomy to reduce the risk of developing ovarian carcinoma and mamma carcinoma and to improve the chance of survival for premenopausal carriers of the BRCA 1/2-mutation. Carriers of the BRCA 1-mutation are advised to undergo these operations between the age of 35 and 40. For carriers of the BRCA 2-mutation this is between the age of 40 and 45.4
A better survival also means an increasingly larger group of women who have experience with breast cancer. Campaigns in the Netherlands (e.g. the breast cancer month in October) by the Dutch Breast Cancer Society (since 1979) and Pink Ribbon (since 2003) contribute to an increased awareness in society. The breast cancer movement is a spin-off of a larger feminist movement and health associations for women that came into existence in the late seventies. Their aim was to provide quality certification, collect financial support for breast cancer research and to offer patients support. Through this, specific checklists have been developed for patients to better prepare them for contact with practitioners.6 The modern media also help
in the New York Times in 2016 by a famous American actress who described her preventive breast amputation and direct reconstruction. After this publication the number of women who chose for this radical prophylactic surgery increased, the so-called “Angelina-effect”.7,8
At this moment, researchers work worldwide on the improvement of prevention, detection and therapy for breast cancer. Prevention research focuses, among other things, on all kinds of causes of breast cancer such as lifestyle (the effects of nutrition and exercise), environmental factors and genetic factors. New detection methods focus on a changed elasticity in the breast tissue, 3D mammography and ultrasounds to name but a few. Therapeutic research focuses on such things as hormonal therapies or a better treatment for the so-called ‘triple negative breast cancer’. In recent years there has been enormous progress in life saving treatments for breast cancer, which gives patients new hope. There is a range of treatment options available and every individual mix of cells in a specific tumour demands another treatment. The treatment can consist of a combination of systemic and local (neo) adjuvant therapies such as hormonal therapy, chemotherapy, “targeted” therapy, immunotherapy and/or radiotherapy.
Despite all these innovations, surgery and reconstruction remain an important part of the breast cancer treatment. As a result of the improved survival rate after breast cancer, the aesthetics of the breast after treatment has begun to play a more important role. Accordingly, much attention is currently paid to the improvement in the quality of life. This has resulted in a greater demand for breast reconstructive surgery from patients. In general, reconstructive surgery advanced significantly after the First and Second World Wars by the development of specialized techniques for transplanting tissue. In 1961 the first silicone breast implant was placed; initially, for cosmetic breast augmentation, but its use in breast reconstructive operations quickly followed. According to the current guidelines, reconstructive breast operations form an integral part of the breast cancer treatment plans in the Netherlands and a reconstruction option has to be discussed with and offered to the patients.9
Alexander Monro Breast Cancer Centre in Bilthoven, strive to make this process proceed as efficiently and as fast as possible and with more comfort and service for the patient.
The reconstruction of the breast
Surgery
As stated before, surgery is still a very important part of the treatment of patients with breast cancer. Nearly all in situ tumours are removed surgically. In 46% of all therapeutic cases a mastectomy is performed.9 In the Netherlands, the oncologic
surgeon almost always performs a therapeutic mastectomy, but in some countries the gynaecologist carries out all operations on the breast. In the case of a skin saving breast amputation or preventive ablation surgery, a plastic surgeon is most likely to be involved during this operation or in some centres he or she actually does the mastectomy him/herself. One of the most commonly used techniques for amputation is the skin saving breast amputation, introduced in 1991, which is used for preventive amputations as well as for therapeutic breast amputations. This procedure leaves the majority of the skin and possibly the nipple of the breast intact for reconstruction.
the possible conflicting planning of radiotherapy. Women can in addition choose for extra aesthetic adjustments and a nipple reconstruction to complete the breast reconstruction process. In some cases, the nipple can be saved, for example using the skin saving mastectomy technique.
Techniques
Nowadays many different breast reconstruction techniques are available. These can be divided into two main techniques: the autologous (own tissue) breast reconstruction, and reconstruction with implants. In the case of an autologous reconstruction, also known as “flap” reconstruction, tissue is transplanted from one part of the body (like the tummy, buttock, thigh or back) to the breast. Autologous reconstruction can also be combined with the use of an implant. The tissue can be completely separated from the supplying and draining vessels and is transplanted to a new location. This is called a “free lap” reconstruction and is the most advanced and difficult form of reconstruction. The tissue can also remain attached to the vessels, which is called a “pedicled flap” reconstruction. In both types the supplying tissue is formed into a breast and stitched into position. The free lap reconstruction demands a microsurgeon with special skills, which is not available everywhere. However, the sustainability of autologous reconstructions, without the use of foreign body material, is seen as the main advantage of these techniques. Other advantages are the fact that the reconstructed breast changes along with the changes in body weight and the fact that the flap reconstruction can endure radiotherapy therapy reasonably well.
implants. Normally, implants ought to be replaced after 10 or 20 years. Recently, the implant reconstruction method came under scrutiny because of the PIP-affair10 and
the relationship with the breast implant associated anaplastic large cell lymphoma.11
In the Netherlands this resulted (once again) in a national registration for breast implants.12 At this moment in time around 5 to 10 million women have breast
implants worldwide.
A rather new technique is lipofilling. This is where the breast is reconstructed with autologous body fat. Using only a fat transplant, some breasts can be fully reconstructed. This technique has gained in popularity and at present long-term studies are being carried out on the result and sustainability of this method.
One versus two steps
Within the implant-based breast reconstructions, two important techniques can be described. Both methods are a direct reconstruction after a skin saving mastectomy; 1. the reconstruction in one step with direct placing of a definite breast implant and 2. the reconstruction in two steps with the implant of a tissue expander during the first operation. The expander is placed under the breast muscle that covers the median and superior breast border. During a number of successive sessions at the outpatients’ clinic, the expander is gradually inflated to create space and to stretch the skin and muscle. After about three to six months the expander is replaced by a permanent implant during a second operation.13,14 Theoretically, the advantage
of the one phase technique is that only one operation is needed, which in turn means a reduction in the costs, risk of complications and morbidity.15 Nonetheless,
the technique in one phase has several limitations. There are indeed a higher number of complications described in the direct one step method, like capsule contraction16 and explantations of the prosthesis.17 The successful outcome of the
muscled pocket needs time to stretch, the skin loses its original elasticity. Moreover, an extra surgical procedure is necessary, as well as the tissue expander being filled several times at the outpatients’ clinic and the patient is without a reconstructed breast for a number of months. It also means pain after each surgical procedure, discomfort, time off work and health risks for the patient and apart from that higher costs. There is no consensus on a preferred technique. Surgeons often have a personal preference for one of the two techniques for several reasons. In order to come to a well-considered decision, it is necessary to have extensive knowledge of the outcome of both procedures.
Acellular matrices
In recent years a series of products has been introduced for breast reconstruction with an implant; surgical meshes, also commonly called “mesh”. The most frequently used meshes are Acellular Dermal Matrices (ADM). ADM are collagen matrices that are made from human or animal tissue. The most important aim of the use of these meshes is to give the prosthesis extra cover. They are mainly used to provide inferolateral implant coverage. The use of an ADM also enhances the sub pectoral pocket, which makes the placement of an implant or tissue expander with a bigger volume possible. Furthermore, it has been suggested that the use of ADM improves the cosmetic outcome by giving a better definition of the inframammary fold. In the United States this technique has been used for a longer period of time. In the past decade, the use of ADM there has seemed to be an important step in direct breast reconstructions with an implant. Worldwide the direct implant technique has also received more interest because of the increased availability of ADM. In the Netherlands, insurance companies do not pay the extra cost of these rather expensive collagen matrices. Although skin saving breast amputation followed by a direct reconstruction with an implant is a common procedure worldwide for the therapy of patients with breast cancer or hereditary breast cancer, the tissue expander followed by a permanent implant, that is the two-step procedure, is still the standard reconstruction technique in the Netherlands.
the body. The characteristics of the original matrices are altered in the production process and, if necessary, are removed by various biochemical processes. The deletion of all cells is also called decellularization. Another process that often is seen is the stabilisation of collagen, called cross-linking, which gives mechanical strength to the matrix to prevent rapid degeneration. The prevention of infections can be achieved by using sterilisation techniques like gamma radiotherapy. The combination of biochemical characteristics makes every type of matrix unique with individual characteristics. Through the process of neovascularization and neocellularization, the matrices are partly replaced by host fibroblasts and macrophages with the same design. Rejection of host cells because of the foreign origin of the matrix is a process that has to be avoided.18 That is why the ADM also vary in the operating
characteristics such as stiffness and flexibility. ADM are also produced in several forms and sizes.
Surgical techniques, peri-operative measures and after care differ considerably among hospitals. All these factors may possibly affect the outcome of the surgery. The technique using ADM seems simple, but the detailed preparation and placement technique are very sensitive. Possible complications with ADM reconstructions are seroma formation, flap necrosis, infection, explantation of the implant and/ or the acellular dermal matrix. In addition, several, more aesthetic, complications are described, such as surface irregularities and wrong positioning or the implant becoming deformed over time. Although the first articles on this subject were predominantly promising, the proof of the safety of AMD in breast reconstructive surgery still has not been completely confirmed. Five systematic reviews on ADM and breast reconstruction were found.19-23 The meta analyses showed significant
The patients’ perspective
Decision making
Nowadays breast cancer treatment is fortunately more patient-centred and the patient is more involved in the treatment. “Shared decision making” is an important general development within health care, where the patient and the practitioner together come to a well-considered choice for a particular treatment. The choice for breast reconstruction can be difficult. Not every patient is suitable for every type of reconstruction. The choice depends on many factors: tumour related (size, necessity for radiotherapy, prophylactic or curative, single/double sided, etc.), surgeon related (experience, preference, etc.), directly patient related (timing, physical factors, co-morbidity, etc.), but also indirect patient related factors about the expectations of the outcome of the procedure, like the aesthetics and sensibility. Informing the patient well about a realistic outcome of the breast reconstruction and the possible complications is an important task for the plastic surgeon. The appointment for receiving this information is often only once and of limited duration. It is very well possible that not all subjects are discussed during this visit. What does not seem to be a problem pre-operatively, may become so after the operation. Besides, in a short period of time many choices have to be made, also with respect to the treatment of the breast cancer itself.
Programmes have been developed that make taking these decisions easier, like BRECONDA. This appears to be a promising tool to help patients decide about their specific reconstructive treatment.24 Electronic health programmes have shown
to be effective in cancer care,25 as does digital information provision in addition to
verbal information.26 For example, patients can be shown realistic pictures of the
outcome of the breast reconstructions before the surgery.
But what can we tell patients about the experience of other patients after breast reconstruction? This will have to be based on well conducted comparative studies. And how do we measure a patient’s experience after breast reconstruction in a standardized way?
Patient reported outcomes
by standardized questionnaires and expressed by outcome measures reported by patients (Patient Reported Outcome Measures, PROMs).27 The importance of PROs
and PROMs is increasingly recognized in health care, because they illustrate the patient’s opinion and experience directly.28-30 The use of PROMs in research and
in the clinical practice can bring physical and psychological problems to light that could otherwise be overseen.28 PROMs can have different functions. Healthcare
providers can use PROMs to screen an individual patient for problems, to follow the patients’ health in time, to evaluate the effectiveness of a treatment and if necessary to adjust the treatment, to promote communication between doctors and patients, and to encourage shared decision making.31 In this way PROMs simplify
personalized health care and they help in adjusting the diagnosis, the management and the treatment of each patient to his or her individual needs.32
Health related quality of life
Health Related Quality of Life (HRQoL) is about the physical, psychological and social functioning and wellbeing of patients. This well-known PRO is more and more a standard result in health care and clinical studies. Measuring the quality of life has also become more popular in the last few years in breast reconstructive surgery. For patients, the improvement of HRQoL is an important treatment goal. With the increasing incidence and survival percentages, it is crucial to take a look at the quality of life in the long term. A wide range of instruments is used in clinical research in breast cancer patients, as, for instance, the EORTC-questionnaire (QLQ-BR23).
The BREAST-Q study, led by Andrea Pusic at the Memorial Sloan-Kettering Institute for Cancer Research, was established to develop a new patient-reported outcome measure (PROM) that would give essential information on the impact and effectivity of breast reconstructive operations.33 The BREAST-Q has a modular,
Body image
In breast reconstructions the concept of the body image is very important and it is known that a positive body image can be considered to be a favourable factor. To answer the question what a body image is exactly, it is important to understand its role as a connector between physical characteristics, psychosocial outcome (sexuality, mental health) and quality of life. Body image can be influenced by several factors, such as social norms with regard to body representations.34,35 Psychological aspects
of the body image can be distinguished as sentiments (sensibility of the body, pain, discomfort), behaviour (for example sports and ways of dieting) and cognition (ideals and satisfaction with the body).35 Important factors in forming a body image
are the aesthetic results of breast reconstruction and the sexuality of the patient.36
Aesthetics
The aim of breast reconstructive surgery is to restore the form of the breast and in doing so to restore the aesthetic appearance, and thereby improving the self-image of the patient. The aesthetic outcome, therefore, is a primary outcome measure for breast reconstructive surgery. Reliable tools for the assessment of aesthetic results after plastic reconstructive surgery are scarce. Several studies report aesthetic results in the form of an assessment by the patient, by the surgeon and/or by an independent professional. Some authors use questionnaires, while others use pictures to assess the aesthetic results. Scales for the assessment of the aesthetic results of breast reconstructions differ strongly from one another and are often unclear. To make a comparison between outcomes possible, for instance between individual surgeons or between different surgical techniques, it is important to have a valid, scoring system.
Sexuality
Sexology is the scientific study of human sexuality, including human sexual interests, behaviour and functions.37 In general, sexuality has not yet acquired an
important position within health care. The taboo around this subject is real and therefore still not often mentioned. In fields such as urology and gynaecology, sexology increasingly becomes part of the care. It is known that breasts and nipples can play an important role in women’s sexual experience and that of their partners. In breast cancer patients the (partial) removal of their natural erogenous body parts may lead to problems with sexuality.37 Data suggest that undergoing
reported by patients) studies in this field have objectified that breast satisfaction after a reconstruction has improved.38 Many women report that having a breast
reconstruction is a better solution than no reconstruction at all or the wearing of external prostheses.39 The fact that breasts can look “normal” or “female” again is
an important aim of breast reconstruction.40 Breast satisfaction does not, however,
necessarily translate into improved sexuality. Given that reasons for undergoing a breast reconstruction may be associated with the female body image, partner relationships and sexual satisfaction, sexuality should be one of the decisive factors in surgical decision making, counselling and outcome studies on this subject.41 The
subject of sexuality during (and after) breast cancer is widely acknowledged, but a lot still has to be done to improve knowledge on this subject.42 At present, women
experience considerable limitations in discussing sexuality with their doctors, and vice versa.43 The vast majority of available knowledge on sexuality in women with
breast cancer concerns the effects of oncological surgery and medicinal treatment, while breast reconstructive surgery to a large extent remains unstudied.42,44,45
It is not only important to understand how the subject can be integrated into the current treatment, but also when and by whom.46 The literature on sexual
outcome of surgery is restricted and there is even less known about the impact of breast reconstruction in particular. Sexual problems, which can play a part, are the loss of desire, orgasm disorder and pain during intercourse by the reconstructed breast being touched. Other factors that affect sexual functioning, among others, are characteristics of the patient (for instance, basic psychosocial wellbeing47 and
anxiety41), type of reconstruction,48 and whether a salpingo ovariectomy was
performed (e.g. in the case of prophylactic surgery for carriers of BRCA). This last operation also has an effect on sexuality by the removal of endogenous hormone production.44
Content of this thesis
Study questions
cancer, a large group of “survivors” has emerged. As a result of this the emphasis in breast cancer care has also been put on the improvement of the quality of life after breast cancer. Fortunately, the patient has received a more central role in healthcare and the patient’s opinion and experience has become the most important outcome measure of the treatment.
This thesis focusses on the breast reconstruction with an implant and in particular the additional use of an ADM in a one phase reconstruction. The aim is to investigate the added value of ADM assisted breast reconstruction with an implant. On the one hand, it is about the clinical outcome and in the first part of the thesis we will focus on the technical aspects of ADM assisted breast reconstruction. On the other hand, it is about the outcome and impact of breast reconstruction as it is experienced by the patient. The Aesthetic Items Scale is evaluated and we explore to what extend breast reconstruction affects the sexual wellbeing of the woman and to what extend plastic surgeons discuss sexuality with a patient in the consultation room.
The chapters
Part 1 the surgeon
• Chapter 2: At the start of this study there was little experience with the use of Acellular Dermal Matrices in the Netherlands. In this chapter we describe a retrospective cohort study on the clinical outcome of breast reconstructions with ADMs in some Dutch centres that were at the cutting edge with the use of this technique.
• Chapter 3: This chapter reports on the outcome regarding the safety of the used methods in the prospective, randomized multicentre trial Breast Reconstruction In One Stage (BRIOS). It concerns a comparison between the direct breast reconstruction in one step with an implant and an Acellular Dermal Matrix versus the breast reconstruction in two steps with a tissue expander followed by an implant.
• Chapter 4: This chapter is a deepening of the study described in Chapter 3. In this chapter it is examined whether factors can be indicated that can play a part in the occurrence of complications in ADM-assisted breast reconstruction with an implant.
• Chapter 5: In this chapter plastic surgeons in the Netherlands are asked by means of a national questionnaire what the role of sexuality is in their field.
Part 2 the patient
• Chapter 6: In this chapter attention is paid to the measurement of aesthetics
after breast reconstruction. The Aesthetic Items Scale is re-introduced and validated through aesthetic results of a controlled case study. The aim is to validate a new method for aesthetic evaluation that can eventually be used in breast reconstructive surgery.
• Chapter 7: In this chapter quality of life outcome for patients who had undergone
a breast reconstruction with an implant and an Acellular Dermal Matrix is reported. It concerns a cohort study in cooperation with the Mount Sinai Hospital in New York, NY, USA.
• Chapter 8: In this chapter quality of life and cosmetic outcome of the prospective
randomized multicentre BRIOS (Breast Reconstruction In One Stage) study is reported.
• Chapter 9: In this chapter patients with a breast reconstruction are asked through
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38. Berlin NL, Momoh AO, Qi J, Hamill JB, Kim HM, Pusic AL, et al. Racial and ethnic variations in one-year clinical and patient-reported outcomes following breast reconstruction. Am J Surg. 2017;214(2):312-7.
39. Gopie JP, ter Kuile MM, Timman R, Mureau MA, Tibben A. Impact of delayed implant and DIEP flap breast reconstruction on body image and sexual satisfaction: a prospective follow-up study. Psychooncology. 2014;23(1):100-7.
40. Crompvoets S. Comfort, control, or conformity: women who choose breast reconstruction following mastectomy. Health Care Women Int. 2006;27(1):75-93.
41. Flitcroft K, Brennan M, Spillane A. Making decisions about breast reconstruction: A systematic review of patient-reported factors influencing choice. Qual Life Res. 2017;26:2287–319. 42. Cornell LF, Mussallem DM, Gibson TC, Diehl NN, Bagaria SP, McLaughlin SA. Trends in
43. McWilliam CL, Brown JB, Stewart M. Breast cancer patients’ experiences of patient-doctor communication: a working relationship. Patient Educ Couns. 2000;39:191-204.
44. Slob K. Geslachtshormonen en seksueel functioneren bij de vrouw: een beperkt overzicht. Tijdschrift voor Seksuologie. 2003;27:70-7.
45. Cuzick J. Preventive therapy for cancer. Lancet Oncol. 2017;18(8):e472-e82.
46. Schneider LF, Mehrara BJ. De-mythifying breast reconstruction: a review of common misconceptions about breast reconstruction. J Am Coll Surg. 2015;220(3):353-61.
47. Matthews H, Carroll N, Renshaw D, Turner A, Park A, Skillman J, et al. Predictors of satisfaction and quality of life following post-mastectomy breast reconstruction. Psychooncology. 2017. 48. Duraes EF, Durand P, Duraes LC, Orra S, Moreira-Gonzalez A, Sousa JB, et al. Comparison
R.E.G. Dikmans, F. El Morabit, M.J. Ottenhof, S.M.H. Tuinder, J.W.R. Twisk, C. Moues, M.B. Bouman, M.G. Mullender
Chapter 2
J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):227-33.
Single stage breast reconstruction
using Strattice™:
Summary
Introduction: Strattice, a porcine acellular dermal matrix, has emerged as a product to augment implant-based breast reconstruction. It is supposed to resolve problems related to poor tissue coverage of the implant. Presently, evidence justifying the use of Strattice in breast reconstruction is lacking. The objective of this study is to assess the clinical outcomes of a patient cohort who underwent single-stage implant-based breast reconstruction with the additional use of Strattice.
Methods: We conducted a retrospective chart review of patients who underwent single-stage breast reconstruction with the use of Strattice. All cases of breast reconstruction after oncologic or prophylactic mastectomy between 2010 and 2014 in one of eight different centres in the Netherlands were included. Patient demographics, treatment characteristics and clinical outcome data were collected. Outcomes are presented using descriptive statistics and associations were evaluated using the Fisher’s exact test.
Results: Eighty-eight patients were identified who underwent either unilateral (60 patients) or bilateral (25 patients) (n=110 breasts) single-stage breast reconstruction with the use of Strattice. The indication for mastectomy was therapeutic for 69.1% (76) of cases and prophylactic for 30.9% (34) of cases. Reported minor complications included seroma (20.9%), skin necrosis (20.0%), wound dehiscence (11.8%), erythema/inflammation (14.5%) and infection (11.8%). In 22 breasts (22.7%), reoperation was necessary, with explantation of the implant in 11 breasts (11.8%).
Conclusions: In this cohort, the total complication rate was quite high (78%). Although most complications were minor, reoperation was performed in 22.7%, with explantation of the implant in 11.8% of breasts. We suggest that patient selection, experience of the surgeon, and handling of early complications are factors that play a crucial role in the success of the operation. The use of a Strattice sheet in one-stage implant based breast reconstruction may be a promising technique, but more evidence from prospective, randomized studies is necessary to warrant its use.
Level of evidence: IV
Introduction
The use of acellular dermal matrices (ADMs) to augment implant based breast reconstruction increases rapidly all over the world. According to a national survey among members of the American Society of Plastic Surgeons, more than 50% of the surgeons use ADMs in breast reconstruction.1 Different types of ADMs are
available for breast reconstruction, varying between human, porcine and bovine derived products, which are all processed differently and have different material characteristics. One of these products is Strattice™, a porcine-derived acellular dermal matrix.2 Strattice was commercially launched in December 2008 and is utilized
similarly in implant based breast reconstruction to provide implant coverage.19
Porcine dermis has important similarities to human dermis in terms of collagen arrangement and structure. Due to the limited availability of cadaver skin and the cost of purchasing human ADM, porcine ADM has potential advantages over human ADM.3,4 Most studies regarding the use of ADM in breast reconstruction
describe the outcome of breast reconstruction with human ADM, which is not available in Europe.7-16
Some of the supposed benefits of using ADM in breast reconstruction are that it enables direct breast reconstruction by allowing more lower-pole expansion and that it yields better aesthetic outcomes due to better inferolateral implant coverage.2,17,18 Although it has already been used for several years in implant-based
breast reconstructions, only a few studies are available on the clinical outcomes after Strattice-assisted single-stage breast reconstruction.2,5,6 It is not yet clear whether
the results of direct breast reconstruction with the use of Strattice are comparable to those with the use of human ADM.
While human ADM is not approved in the Netherlands for application in breast reconstruction, Strattice was introduced in 2009. Because the use of ADM to augment implant-based breast reconstruction is not reimbursed by health care insurance in the Netherlands, its use has gained popularity less rapidly in the Netherlands compared to the USA. Still, in a number of Dutch centres, Strattice has now been used for several years.
Methods
Study design
A retrospective chart review was conducted of all consecutive patients who underwent Strattice-assisted single-stage implant-based breast reconstruction between 2010 and 2014 in one of the eight centres in the Netherlands. Cases of breast reconstruction after oncologic or prophylactic mastectomy were included. Two-stage implant-based breast reconstruction with the use of Strattice was excluded. Data were independently extracted from the patient records by two researchers.
Outcome measures
The follow-up period was documented as the time of the first breast reconstructive surgery using the strattice until the moment of data-collection. Subject data included indication for mastectomy, patient’s age during operation, body mass index (BMI), co-morbidities, smoking status, and neoadjuvant/adjuvant therapy. All registered complications were recorded, whether treated with a medical intervention or therapy or without active treatment. Early complications included infection, skin necrosis, wound dehiscence, seroma and erythema/inflammation. In addition, re-operations, and secondary corrections were assessed from the patient records. A complication requiring any form of reoperation was considered a major complication. All other complications were considered minor complications.
Operative technique
After the oncology surgeon performed the skin-sparing mastectomy, the plastic surgeon performed the single-stage breast reconstruction. The plastic surgeon created a pocket by elevating the musculus pectoralis major. A sheet of Strattice was placed between the lower border of the muscle and the inframammary fold. At the end of the surgery, two Redon drains were placed at each side of the Strattice in the majority of cases. One drain was placed between the skin and the Strattice, and the second drain was placed in the implant pocket.
Postoperative management
Statistical analysis
Demographic data and clinical outcomes are reported using descriptive statistics. Average values and standard deviations or median values and ranges are given for numeric variables and percentages for categorical and nominal variables. Odds ratios and 95% confidence intervals were used to assess the association between a risk factor (neoadjuvant/adjuvant therapy, smoking) and the occurrence of a complication. The Fisher exact test was used to assess the corresponding p-values. Statistical analyses were performed using SPSS (IBM SPSSS statistics 20).
Results
Patient characteristics
Eighty-eight patients (110 breasts) were included in the study. These patients were treated by one of six different surgeons working at eight different hospitals. Indications for the use of Strattice were mixed; most were used to improve coverage of the lower pole or with expectations to achieve a better cosmetic outcome. Subject data are summarized in Table 2.1. Mastectomy was therapeutic in approximately two-thirds (76/110) of cases and prophylactic in the remainder (34/110) of cases. Seven patients were BRCA I mutation carriers, and seven patients were BRCA II mutation carriers. Reported comorbidities are diabetes mellitus 2.3% (two patients)
Table 2.1. Patient demographics (n=88, 110 breasts)
Age, mean (SD) 50.0 (10.8)
BMI, mean (SD) 24.3 (4.1)
Smoking, n (% of patients) 17 (19.3)
Breast carcinoma, n (% of breasts) 76 (69.1)
Prophylactic mastectomy, n (% of breasts) 34 (3p=0.9)
Chemo/hormonal therapy Preoperative, n (% of patients) Postoperative, n (% of patients) 35 2 33 (39.8) (2.3) (37.5) Radiotherapy Preoperative, n (% of patients) Postoperative, n (% of patients) 23 8 15 (26.1) (9.1) (17.05) Previous operation affected breast,n (% of breasts)
and hypertension 9.1% (eight patients). Seventeen patients (19.3%) were active tobacco smokers during the perioperative period.
Sixty patients received unilateral treatment, and 25 patients received bilateral treatment. Of the three patients who received bilateral breast reconstruction, only one breast was included in the study because the other breast was reconstructed using a different procedure. The one-breast lumpectomy was followed by partial breast reconstruction with the use of Strattice. Skin-sparing mastectomy was performed in the other 109 breasts, of which three (in two patients) were also nipple-sparing. Eight patients (eight breasts) underwent previous breast-conserving surgery and received radiation therapy before breast reconstruction. Fifteen patients had an indication for postoperative radiotherapy (Table 2.1). None of the patients had previous lymph node dissection. The mean implant size was 429 g (SD=137). Preoperative Cefazolin was administered to every patient. Registration of postoperative antibiotic use was deficient for the majority of the patients. The patients were hospitalized for an average of 2.9 (SD=1.1) days. The average follow-up period was 23.1 (SD=16.2) months.
Complications and re-interventions
Of the 88 patients in this cohort, 69 patients (78.4%) developed one or more complications, and 78 of the 110 breasts (67.3%) developed one or more complications (Table 2.2). Seroma (20.9% of breasts) and skin necrosis (20.0% of breasts) were the most frequently occurring complications. Other complications included erythema/inflammation (14.5% of breasts), wound dehiscence (11.8% of breasts) and infection (11.8% of breasts). Antibiotic treatment was reported in six of the 13 infected breasts.
Medical reintervention without narcosis was performed in 39 cases for the treatment of seroma, skin necrosis, or wound dehiscence. Reoperation was performed in 25 (22.7%) breasts, with removal of the implant in 13 (11.8%) breasts. Infection was the main reason for explantation of the implant (seven of 13 cases), of which two infections developed after radiotherapeutic treatment. Two implants were removed due to late complications (one recurrence of mammacarcinoma, one capsular contraction). Not all explanted implants were replaced; five were replaced with a tissue expander, two were replaced by another implant, three were not replaced, and in three cases, no further details after explantation were described.
(p=0.011, Odds ratio=6.1, 95% CI: 1.7-22.7). The association of radiotherapy with infection was just below the significance level (p=0.06). Systemic therapy was not significantly associated with complications. Smoking was significantly associated with reoperation (p=0.024, Odds ratio=5.1, 95% CI: 1.3-20.2) and showed a nearly significant association with necrosis (p=0.059). All other factors were not significantly associated with reported outcomes (Table 2.3).
Discussion
In this study, we describe the clinical outcomes of single-stage implant-based breast reconstruction with the additional use of Strattice. We found that most of the patients undergoing Strattice-assisted breast reconstruction developed one or more complications. Seroma formation (20.9%) was the most frequently occurring complication. Other complications were skin necrosis (20.0%), erythema (14.5%), wound dehiscence (11.8%) and infection (11.8%). Most complications were minor and were resolved without treatment after conservative treatment or after a minor intervention. However, 22.7% of the breasts were reoperated on, and 11.8% of the reconstructed breasts required implant removal. Reoperation and implant removal are major events. Implant loss implies a complete failure of the reconstruction and has a significant impact on the patient.
Table 2.2. Early complications and treatments
Complications Outcome Total interventions
Breasts n
(%) Resolved Implant loss
Con-servative treatment
Intervention without
anesthesia Reopera-tions
Seroma 23 (20.9) 23 0 5 18 0 Skin necrosis 22 (20.0) 21 1 12 10 6 Infection 13 (11.8) 6 7 13 0 10 Wound dehiscence 13 (11.8) 10 3 2 11 3 Erythema/ inflammation 16 (14.5) 16 0 16 0 0 Hematoma 3 (2.7) 3 0 0 0 3
* One breast was intraoperatively inspected for pain complaints of the patient.
Table 2.3. O
utcomes of the F
isher
’s exact test (FET) to assess the association betw
een risk factors and complications
Skin necr oses Infection Ser oma W ound dehicense Er ythema/ inflamation H ematoma Explantation Re-operation Adjuv ant radiotherapy O dds ratio 95% CI P 7.81 (2.35-25.95) 0.01 3.87 (1.01-14.88) 0.06 1.04 (0.26-4.1) 1.00 0.54 (0.065-4.50) 1.00 0.90 (0.18-4.44) 1.00 2.11 (0.51-8.74) 0.33 2.35 (0.56-9.85) 0.37 6.11 (1.65-22.67) 0.01 Systemic therapy O dds ratio 95% CI P 1.079 (0.69-4.63) 0.32 0.53 (0.14-2.10) 0.54 0.79 (0.29-2.13) 0.81 1.74 (0.54-5.61) 0.36 1.40 (0.49-4.03) 0.58 1.50 (0.48-4.70) 0.55 0.53 (0.14-2.10) 0.54 2.48 (0.77-8.01) 0.13 Smoking* O dds ratio 95% CI P 2.87 (0.95-8.68) 0.06 0.78 (0.16-3.94) 1.00 0.87 (0.26-2.97) 1.00 2.02 (0.55-7.42) 0.28 0.64 (0.13-3.12) 0.73 2.70 (0.79-9.28) 0.14 0.79 (1.58-3.94) 1.00 5.14 (1.31-20.15) 0.02 * Analyses of 96 br
easts, due to missing data.
B
old
The complication rate in this study is considerably higher than the complication rates reported in the few cohorts of single-stage breast reconstructions with the use of Strattice published previously (Table 2.4).2-20 With regard to explantation
rate, the results vary between studies. Two studies report lower rates, and one study reports higher explantation rates compared to our study.2,25,26 The disparities in
outcomes could be due to the dissimilar study characteristics. The population in our study was mostly composed of women diagnosed with breast cancer (69%), of which many received adjuvant therapy and several also underwent radiotherapy, whereas in the study of Salzberg et al., 77% of reconstructions were prophylactic.2
Additionally, the proportion of smokers differed between studies. In our cohort and in the studies of Barber et al. and Glasberg et al., the percentage of smoking women was higher compared to the populations described by Salzberg et al. In the study of Salzberg et al., patients were operated on by a single surgeon with ample experience with the use of ADMs in a single centre. In contrast, the present study represents a cross-section of daily practice in breast surgery, with several participating surgeons working in various hospitals. The surgeons, although experienced in breast reconstructive surgery, had limited experience with the use of ADMs due to the limited availability in the Netherlands. Hence, these studies can be seen as two extremes with regard to the control of possible adverse covariables, and the differences in results may be interpreted accordingly.
Although it is not possible to directly identify the causes of complications that occurred in the present cohort, it is of interest to discuss the differences between these studies as possible factors that should be taken into account. One of the obvious factors that influences outcomes is patient selection. Breast reconstruction performed after prophylactic mastectomy in a healthy, young female has a better prognosis than reconstruction in an oncological patient who received adjuvant therapy. Adjuvant radiotherapy in particular has been found to adversely affect the outcomes. In this study, we found radiotherapy to be associated with higher rates of necrosis and a higher number of reoperations. Smoking was also associated with a higher number of reoperations. The direct effects of smoking on complications were not significant, but this may be due to an insufficient number of patients to statistically analyse such a relationship.
Table 2.4. Comparing studies on br
east r
econstr
uction with the use of S
trattice™ Author Reconstr uction type (n) Br easts (n) Smokers n (%) Radio -therapy n (%) Systemic therapy n (%) Complications Total n (%) Implant loss n (%) Infection n (%) Ser oma n (%) H ematoma n (%) Skin necr osis n (%) Salzberg ( 2) one-stage (101) two-stage (4) 105 5(9.3) 6(5.7) 4 (7.4) 9 (8.6) 4 (3.8) 4 (3.8) 2 (1.9) * 3 (2.9) G lasberg ( 26) two-stage 144 15 (16.6) 43 (29.9) 60 (66.7) 9 (6.3) 2 (1.4 3 (2.1) 2 (1.4) 0 (0.0) * Barber ( 25) one-stage 155 15 (16.6)* * 26 (14.5)* * 24 (13.8)* * * 24 (15.5) * * * * This cohor t one-stage 110 17 (19.3) 23 (26.1) 35 (39.8) 78 (67.3%) 13 (11.8) 13 (11.8) 23 (20.9) 3 (2.7) 22 (20.0) * N o data av ailable. ** Calculated fr
om total population (also cases included wher
e P
should not be underestimated.20 Details of the surgical technique can be very
specific, where surgeons tend to develop their own “best practice” without the existence of a clear guideline. This is true for the surgical technique and also applies to patient selection, post-operative care and the way in which early complications are being handled. Ganske et al.15 suggested that improved technique and peri- and
post-operative care can reduce the complication rate, including intraoperatively bacitracin use, drain placement in submastectomy skin flap pocket and the sub-ADM pocket, continued oral antibiotic use until last drain removal, and drain removal only after drain production is less than 20 ml in 24 hours. Such adaptations and measures might be particularly important for reducing seroma production and the chances of infection.
The complication rate of Strattice-assisted breast reconstruction was fairly high. However, it is not clear whether this can be attributed to the use of Strattice per se. In general, reported complication rates vary considerably between studies on implant based breast reconstruction. The complication rate in this study is no exception when compared to that of direct one-stage implant-based reconstruction, but reported complication rates for two-stage procedures are typically lower.21-24 The
impact of the additional use of ADMs on complication rate, and more specifically on infections in breast reconstruction, is still unclear. Very few studies directly compared ADM-assisted breast reconstruction with traditional 2-stage submuscular coverage or direct-to-implant reconstructions. In a comparative retrospective study of 75 patients (expander based reconstructions 44 without ADM and 31 with ADM), there were fewer minor complications (respectively 19.4 versus 29.5%), while major complications were more frequent in the ADM group (22.6 versus 9%). However, these numbers are too small to draw any definite conclusions.13,20
The high costs of ADM are still a drawback of ADM application in breast reconstruction. Rodriquez-Unda et al. recently published a systematic review of three articles (concerning a total of 112 patients) on results with a cheaper alternative: a polygalactin 910 mesh. They reported a reconstruction failure of 3.2%.27 A future
study in which the performance of ADM and vicryl meshes in breast reconstruction are compared could be valuable.
of drain removal, pain score, prescription of antibiotics, and duration of antibiotic use. Additionally, definition of complications was not always clear. In addition, follow-up time varied between patients. This means that the measurement of late complications is biased. Our study focused on safety (complications) only; however, the primary aim of an additional use of Strattice (or other ADM) is to improve the cosmetic appearance and thereby improve the quality of life. We did not assess whether this goal was achieved. Yet, we think that it is important to convey the outcomes of a study that represents “general practice” because it provides a starting point for future studies.
Presently, there is still a lack of prospective controlled studies on AMD-assisted breast reconstruction. Prospective comparative studies could provide more information about the safety and efficacy of Strattice-assisted breast reconstruction. Additional research is needed to establish which specific factors attribute to the occurrence of complications and what interventions are most effective to prevent or treat complications. Additionally, the impact of risk factors, such as radiotherapy, need to be better determined in the future. For this, we need to have better definitions of complications and standardized outcome measures.
Conclusion
References
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2. Salzberg CA, Dunavant C, Nocera N. Immediate breast reconstruction using porcine acellular
dermal matrix (Strattice): long-term outcomes and complications. J Plast Reconstr Aesthet Surg. 2013;66:323-8.
3. Ge L, Zheng S, Wei H. Comparison of histological structure and biocompatibility between human acellular dermal matrix (ADM) and porcine ADM. Burns 2009;35:46-50.
4. Campbell KT, Burns NK, Rios CN, et al. Human versus non-cross-linked porcine acellular dermal matrix used for ventral hernia repair: comparison of in vivo fibrovascular remodeling and mechanical repair strength. Plast Reconstr Surg. 2011;127:2321-32.
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11. Brooke S, Mesa J, Uluer M, et al. Complications in tissue expander breast reconstruction: a comparison of AlloDerm, DermaMatrix, and FlexHD acellular inferior pole dermal slings. Ann Plast Surg. 2012;69:347-9.
12. JoAnna NT, Carey JN, Wong AK. Use of human acellular dermal matrix in implant- based breast reconstruction: evaluating the evidence. J Plast Reconstr Aesthet Surg. 2011;64:1553-61. 13. Hanna KR, DeGeorge BR Jr, Mericli AF, et al. Comparison study of two types of expander-based breast reconstruction: acellular dermal matrix-assisted versus total submuscular placement. Ann Plast Surg. 2013;70:10-5.
14. Salzberg CA, Ashikari AY, Koch RM, et al. An 8-year experience of direct-to-implant immediate breast reconstruction using human acellular dermal matrix (AlloDerm). Plast Reconstr Surg. 2011;127:514-24.
15. Ganske I, Verma K, Rosen H, et al. Minimizing Complications With the Use of Acellular Dermal Matrix for Immediate Implant-Based Breast Reconstruction. Ann Plast Surg. 2013;71:464-70. 16. Chun YS, Verma K, Rosen H, et al. Implant-based breast reconstruction using acellular dermal matrix and the risk of postoperative complications. Plast Reconstr Surg. 2010;125:429-36. 17. Ho G, Nguyen TJ, Shahabi A, et al. A systematic review and meta-analysis of complications
associated with acellular dermal matrix-assisted breast reconstruction. Ann Plast Surg. 2012;68:346-56.
18. Hill JL, Wong L, Kemper P, et al. Infectious complications associated with the use of acellular dermal matrix in implant-based bilateral breast reconstruction. Ann Plast Surg. 2012;68:432-4. 19. Salzberg CA. Direct-to-implant breast reconstruction. Clin Plast Surg. 2012;39:119-26. 20. Sbitany H, Langstein HN. Acellular dermal matrix in primary breast reconstruction. Aesthet
21. Woerdeman LA. Skin-sparing mastectomy and immediate breast reconstruction by use of implants: an assessment of risk factors for complications and cancer control in 120 patients. Plast Reconstr Surg. 2006 Aug;118(2):321-30; discussion 331-2.
22. Nava MB, Ottolenghi J, Pennati A, et al. Skin/nipple sparing mastectomies and implant-based breast reconstruction in patients with large and ptotic breast: oncological and reconstructive results. Breast. 2012 Jun;21(3):267-71.
23. Davila AA, Mioton LM, Chow G, et al. Immediate two-stage tissue expander breast reconstruction compared with one-stage permanent implant breast reconstruction: A multi-institutional comparison of short-term complications. J Plast Surg Hand Surg. 2013 Oct;47(5):344-9.
24. Strock LL. Two-stage expander implant reconstruction: recent experience. Plast Reconstr Surg. 2009 Nov;124(5):1429-36.
25. Barber MD, Williams L, Anderson ED, et al. Outcome of the use of acellular-dermal matrix to assist implant-based breast reconstruction in a single centre. Eur J Surg Oncol. 2015 Jan;41(1):100-5.
26. Glasberg SB, Light D. Alloderm and Strattice in breast reconstruction: a comparison and techniques for optimizing outcomes. Plast Reconstr Surg. 2012 Jun;129(6):1223-33. 27. Rodriguez-Unda N, Leiva S, Cheng HT, et al. Low incidence of complications using polyglactin
R.E.G. Dikmans, V.L. Negenborn, M.B. Bouman, H.A.H. Winters, J.W.R. Twisk, P.Q. Ruhé, M.A.M. Mureau, J.M. Smit, S. Tuinder, Y. Eltahir, N.A. Posch, J.M. van Steveninck-Barends, M.A.
Meesters-Caberg, R.R.W.J. van der Hulst, M.J.P.F. Ritt, M.G. Mullender
Chapter 3
Lancet Oncol. 2017 Feb;18(2):251-8.
Two-stage implant-based breast
reconstruction vs immediate
one-stage implant-based breast
reconstruction augmented with an
acellular dermal matrix:
Abstract
Background: The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. The aim of this prospective randomised trial was to compare the outcomes of immediate IBBR augmented with an ADM (Strattice™, LifeCell Cooperation) with those of two-stage IBBR. We report on the first results on the safety outcomes of the two procedures.
Methods: A non-blinded randomised controlled trial was conducted at eight hospitals in the Netherlands. Patients older than 18 years, diagnosed with breast carcinoma or gene mutation and who intended to undergo skin-sparing mastectomy and immediate IBBR were electronically randomised to one of two procedures for IBBR: one-stage ADM-assisted IBBR or two-stage IBBR. Randomisation was carried out electronically, stratified per centre and divided into fixed blocks of ten to achieve roughly balanced groups. The primary endpoint was quality of life. In the present article, we assessed the effect of the procedure on the occurrence of adverse outcomes. Analyses were performed per protocol, using logistic regression and the general linear model. The inclusion of patients is completed. This study is registered at http://www.TrialRegister. nl, number NTR5446.
Findings: Between April 14, 2013, and May 29, 2015, 142 patients were enrolled in the study. Eventually, 59 patients (91 breasts) in the one-stage IBBR group and 62 (92 breasts) in the two-stage IBBR group were included for analyses. The overall surgical complication rates per breast (38.5% vs 14.1%, OR=3.81, p<0.001), the surgical re-operation rates (31.9% vs 12.0%, OR=3.38, p<0.001) and the implant explantation rates (26.6% vs 4.4%, OR=8.80, p<0.001) were significantly higher in the one-stage group. This was also true after controlling for multiple confounding factors. Severe (grade 3) adverse events occurred in 28.6% (n=26 of 91) of breasts the one stage group and in 6.5% (n=6 of 92) in the two-stage group. Mild to moderate adverse events (grade 1-2) were noted in 9.9% (n=8 of 91) and 6.5% (n=6 of 92) of the breasts in the one and two stage groups, respectively.
Conclusions: Immediate one-stage ADM-assisted IBBR was associated with a significantly higher rate of wound healing problems compared with two-stage IBBR. There was no evidence of adverse tissue reactions to the ADM itself. These results indicate that immediate one-stage ADM-assisted IBBR should be considered very carefully. We need a better understanding of the right patient selection, the risk factors involved in one stage IBBR, and the requirements for surgical and post surgical procedures involved in ADM assisted IBBR.
Funding: Grant support was received from Pink Ribbon, Nuts-Ohra and Life Cell Corporation.
