More than 300 delegates and 36 speakers, representing Europe, America, the Middle East, Canada, Africa, Asia and Australia, convened in Berlin in March 2015 for Smith & Nephew’s 6th International Negative Pressure Wound Therapy (NPWT) Expert Meeting.
Surgeons are required to make challenging decisions with patients about the most appropriate breast surgery. Dr Maurizio Nava described some of the algorithms available to help choose the most appropriate surgery, considering complications and an array of treatment options.
Professor Michael Sugrue explained the role of NPWT in open wounds. All open wounds can potentially benefit from NPWT, especially in the abdomen, and this is particularly important for breast surgery as it is the ‘gold standard’ donor site for the abdominal perforator flap. NPWT has also been shown to benefit skin graft takes and to be a valuable tool in treating open wounds in the breast, thereby helping to avoid any delay to adjuvant therapy.
Dr Robert Galiano presented the results of a study evaluating PICO◊ NPWT in patients under going reduction mammoplasty. The study revealed that compared with standard care, PICO◊-treated patients showed a trend toward fewer adverse events and a decrease in dehiscence. In addition, Mr John Murphy explained how he found convincing evidence that PICO◊ yielded no wound breakdowns in breast oncology patients, and patient satisfaction with PICO◊ was high.
Fewer healing complications/dehiscence were reported in patients using PICO◊ who had undergone reduction mammoplasty, and these patients also reported better scar quality. Professor René Van der Hulst explained that PICO◊ works by acting on almost all of the elements involved in scar formation.
Breast surgery: Main surgical techniques in breast surgery: type and incidence of complications
Chair: Maurizio Nava
Breast surgery has undergone vast changes since the 1970s, when the only choice was mastectomy. These days, surgeons, in agreement with patients, must make challenging decisions about the most appropriate surgery according to a much wider range of options.
There are several complexities in performing conservative mastectomies. It is vital to thoroughly understand the breast’s anatomy and vascular system, and the microscopic anatomy of the skin flaps, in order to avoid damaging subdermal layers and preserve their vascularity, and reduce the risk of necrosis. Preserving vascularity can be very challenging where the subcutaneous fatty layer is thin.1,2
Mastectomy is still indicated where:
• There are multicentric carcinomas
• There is unifocal and extensive ductal carcinoma in situ
• It is the patient’s wish.
Delayed reconstruction might still be right for some patients. Dr Guiseppe Catanuto detailed the main oncoplastic techniques for breast conservation and surgical techniques for implant-based reconstruction and presented a Table of Elements designed to aid decisions about appropriate oncoplastic procedures.
So what are the complications related to different oncological procedures? One retrospective evaluation of the severity of postoperative complications in 485 women with breast cancer3 found that axillary dissection increased wound infections and seroma rates; oncoplastic surgery increased wound infections and necroses; neoadjuvant chemotherapy had no impact on morbidity. Another study in 20134 of patients under going oncoplastic breast conservation surgery found that the procedure did not delay commencement of adjuvant chemotherapy.
Making specific adaptations to cosmetic techniques in breast reductions and oncoplastic breast surgery is very important: it is crucial not to delay a patient’s adjuvant treatment for cosmetic issues.
An analysis of 12 000 patients to find the risks of surgical morbidity in immediate breast reconstruction used risk factors and weight coefficients to create an Immediate Breast Reconstruction Risk Assessment Score (IBRAS)5 to facilitate decision making. Patients identified as particularly at risk of surgical morbidity are:
• Those with obesity (body mass index >30kg/m2)
• Those with diabetes
• Those with a cardiovascular comorbidity
The IBRAS score – a decisional pathway – is now part of the new Oncoplastic Framework. Those with a very high IBRAS score should be warned about possible complications and smokers should be urged to stop smoking before surgery.
Very accurate preoperative planning is vital, with detailed examination of risk factors, oncological needs and patient expectations.
Breast surgery: Mastectomy, reduction mammoplasty and conservative therapy: challenges and useful tips
There is increasing co-operation and overlap between oncoplastic and aesthetic breast surgery, and there are hard decisions to make.
Three steps in oncoplastic decision-making can be defined:
• Assessment of the disease’s biological properties and the risk of local recurrence
• Assessment of surgical techniques
• Informing patients of choices and risks, and assessing their wishes so they make a shared informed decision.
A series of algorithms were reported to help in navigating the complex pathway to an appropriate surgical decision. These involve, for instance, complications such as previously irradiated breasts and capsular contracture, and a wide range of treatment options, including autologous flaps and nipple-sparing mastectomy.
Adjuvant chemotherapy seems not to create problems in surgical procedures.6 Problems arise if the surgery is below par, and poor wound healing can delay adjuvant radiotherapy or chemotherapy.
Some papers have outlined factors influencing the incidence of complications following tissue expander/implant reconstruction.7,8 The main risks are age, obesity and active smoking, and not the surgical procedure itself.
An Oncoplastic Workflow diagram was presented that provides a good tool to select patients and reduce trade-offs and complications. Very fast healing is vital in order not to delay radiotherapy. Extra caution is needed when performing a reduction mammoplasty on previously irradiated breasts.9
An outcome analysis of more than 2000 breast-reduction procedures concluded that the important factors impacting on outcomes were:
• Tobacco use
• Cardiac history
• Secondary surgery.9
Obesity and resection weight, and smoking are among the highest risk factors in breast-reconstruction surgery.10
One retrospective evaluation of the severity of postoperative complications in 485 women with breast cancer3 found that axillary dissection increased wound infections and seroma rates; oncoplastic surgery increased wound infections and necroses.
Dr Guiseppe Catanuto
Adjuvant chemotherapy seems not to create problems in surgical procedures.6 Problems arise if the surgery is below par, and poor wound healing can delay adjuvant radiotherapy or chemotherapy.
Dr Maurizio Nava
Very fast healing is vital for breast cancer patients in order not to delay radiotherapy.
Dr Maurizio Nava
Breast surgery: Evidence-based medicine: thinking critically, reading critically – how to evaluate the evidence from a scientific paper
Surgeons should practice evidence-based surgery, and properly evaluate the efficacy of diagnostic and therapeutic interventions before accepting them as standard surgical practice. The audience was asked, ‘How do you read a scientific paper?’ and Dr Nicola Rocco set about providing an intellectual scalpel for his audience to dissect the huge body of evidence they receive.
The Centre for Evidence Based Medicine at Oxford University grades medical evidence from 1 (the best) to 5 (the poorest). Randomised controlled trials (RCTs) are at the top, with expert opinion and case reports at the bottom. Levels of evidence, however, are not enough; evidence quality is what matters. Describing a study as ‘randomised’ does not allow inference of its validity. There are three main questions to ask when judging a study: what are the results; are the results valid; and are the results applicable to my patients?
Surgical trials, unlike medical trials, are affected by unique methodological problems. Standardisation is difficult and an RCT should only be considered when participating surgeons are equally capable of performing both interventions. Groups should be randomised off-site and handled independently. Any prognostic factors known to be strongly associated with outcome should be evenly distributed prior to randomisation (stratified randomisation).
Surgical skills can have a major effect on surgical outcomes, therefore stratification by surgeon should be considered whenever possible. Patients’ data should be analysed in the surgical groups to which they were randomised. Surgical investigators can corrupt randomisation if all patients do not receive their assigned surgery. ‘Intention-to-treat analysis’ avoids this potential bias.
Failure to account for all patients when the study ends is a major threat to the study’s validity. Did investigators take the learning curve (accumulated experience of a new procedure) into account? If an RCT is methodologically poorly executed or poorly reported, there may be bias in the effect of interventions. The statistics need to be understood. Help in writing an RCT is available free online: www.consort-statement.org
Breast reconstruction: Single-patient use NPWT (PICO◊) in breast reduction: a prospective, randomised clinical trial11
Chairs: Rene Van der Hulst and Maurizio Nava
Dr Robert Galiano presented results from a recently completed (not yet published) multinational, prospective, randomised, intra-patient, comparative, open study to evaluate the efficacy of PICO◊ on prevention of post-surgical incision healing complications in 200 patients undergoing reduction mammoplasty.
Patients were treated with PICO◊ on one breast and Steri-stripsTM (standard care) on the other incision, and were followed up for local wound complications three weeks after the operation. Secondary objectives were to assess post-surgical complications (such as skin necrosis, haematoma, dehiscence), to assess scar quality and the ease of application of PICO◊ versus standard care.
The results showed a trend toward fewer complications and fewer adverse events in the PICO◊ group compared to standard care and a 38% decrease in dehiscence, which was statistically significant. The splinting effect provided by the PICO◊ dressing, under negative pressure, seems to be what drives the major potential benefit for the patient.
Patients and clinicians both found the dressing easy to apply and 95.5% of patients found it acceptable to wear. Scar quality was analysed using the Patient and Observer Scar Assessment Scale (POSAS) and the Visual Analogue Scale (VAS) at 42 and 90 days postoperatively between treatments. It was shown to be significantly better with PICO◊ versus standard care by both systems at both time points.
Known as the ‘scarring cascade’, small changes early in the healing process can result in significant differences in later scar appearance. NPWT can help reduce adverse scarring by decreasing the contributors to poor scar formation: by lowering tension and increasing hydration and pressure at an early stage. More research is needed, but this study gives a good basis for it.
Breast reconstruction: Main surgical techniques in breast reconstruction: type and incidence of complications
Most of the problems relating to treating breast cancer patients arise from the radiation effect: when the tumour is removed, a void is created in the tissue and when this is irradiated, the tissue shrinks. Early complications include dehiscence and cellulitis, while late-onset complications include nipple-areola sensory loss and scar hypertrophy. Dr Risal Djohan outlined advances in breast conservation techniques and oncoplastic strategies to avoid these problems: for instance, by using intra-operative ultrasound to make sure the incisions, resections and skin flap are in the right place.
If the breast reduction is performed at the same time as the lumpectomy (trying to contain the tumour within the lumpectomy itself), there are much more generous margins, with much lower rates of recurrence and better outcome. An intra-operational radiotherapy machine can be used in the cavity and the reduction technique can be performed, making sure the cavity and the radiation are deep, to ensure minimal damage to the skin that will be used for closure.
A good post-mastectomy breast reconstruction depends directly on vascularisation and the quality of the skin flap. Indocyanine green can be used intra-operatively to evaluate flap perfusions and assess vascularity.
Surgeons face increasing challenges in managing patients’ expectations, while delivering oncological safety and aesthetic restorations. They need to choose the right surgery for the patient and assess their suitability for skin-saving mastectomy or nipple-saving mastectomy (NSM). It is important to stress that it is not cosmetic surgery: patients need to understand that, depending on the biopsy, while trying for NSM there is a risk that the nipple might still have to be removed, and there will be no sensation in the nipple. High BMI is a risk factor and getting patients to lose weight pre-operatively might improve outcomes for aesthetic surgery patients: those with cancer need to have the surgery first, then the reconstruction.
Breast reconstruction: The abdominal incision: challenges and useful tips
The autologous tissue options available for breast reconstruction following a mastectomy and the complications associated with them were described and illustrated at the meeting. A variety of donor sites to create perforator flaps were suggested and their use outlined. Although the abdominal perforator flap is still considered the ‘gold standard’, the surgeon must assess the patient’s body shape to find where they have excess tissue. The donor site must be treated with as much care as the reconstruction.
A key point in successful perforator flaps is good preoperative planning and to identify the dominant perforator. Help is at hand in the use of the multidetector-row CT Era machine,12 which allows surgeons access to a ‘road map’ of the deep system to study abdominal perforator flaps. The deep inferior epigastric artery perforator (DIEAP) flap is probably best for autologous breast reconstruction. The superior inferior epigastric artery (SIEA) flap is only suitable for around one-third of women and is technically demanding, but is exactly the same as an aesthetic abdominoplasty and offers the patient the least possible morbidity.
Where no abdominal fat is available for the DIEAP or SIEA flap, a gluteal artery perforator (GAP) flap is an option. These sites mostly need scar revision and fat grafting, but PICO◊ might improve the outcome for these donor sites. Other possible donor sites include the inner thigh and the lumbar area.
Although autologous reconstruction with perforator flaps seems to be the optimal procedure, it is not risk-free. Complications related to the flap include:13
• Flap failure, 0.6%
• Partial flap necrosis, 5.3%
• Fat necrosis, 10.3% (associated with smoking, radiotherapy and surgeon-related).
Complications related to the donor site:
• Wound dehiscence
• Infection, haematoma
• Bulging or hernia (mostly associated with smoking).
Breast reconstruction is always an optional procedure and must be a consensus decision.
Breast reconstruction: Clinical experience with a single-patient use NPWT (PICO◊) in complex breast reconstructions
Mastectomy wound complication rates of almost 11% at Mr John Murphy’s hospital prompted him to see if the use of PICO◊ would result in an improvement. He had found convincing evidence of NPWT advantages in wound breakdown, but as yet none in breast oncology patients.14 To address this, he and his colleagues designed a study to compare high-risk wound healing in patients undergoing mammoplasty or breast reconstruction with complex wounds using NPWT PICO◊, and symmetrising breast reduction using conventional dressings.
Breast oncology patients are often older, may be smokers, may be diabetic, may have had previous radiotherapy or chemotherapy, and are therefore high-risk patients, said Mr Murphy. Simple wounds thus become complex wounds.
All patients at Mr Murphy’s hospital who were undergoing these procedures between April 2013 and December 2014 were offered the option of joining the case study. Twenty-four patients aged 42 to 70 (including one smoker and one ex-smoker) accepted and were counselled prior to surgery. PICO◊ was applied on the therapeutic side immediately postoperatively in the theatre. Conventional dressings were applied on the contralateral reduction side. All patients went home the day after surgery.
There were no wound breakdowns at day 12 in the PICO◊ side compared with four on the other side and no delays in adjuvant therapy related to wound breakdown. One patient had fat necrosis, which led to a 10-day delay in adjuvant therapy. There was a 16.7% minor T-junction breakdown and 4.8% superficial nipple necrosis in the breast with standard dressings. Patient satisfaction was high and there were no complaints postoperatively about difficulties in PICO◊ use.
One dressing costs £144 (single use) and the cost of wound breakdown would be £840 to £1260. When the wound breakdown includes loss of implant with acellular dermal matrix, plus the redoing of reconstruction, it can be £15 000–£20 000, in addition to the psychological and cosmetic impact on the patient and financial cost to institution, patient and healthcare team – a very high cost in every sense.
‘One dressing costs £144. When the wound breakdown includes loss of implant with acellular dermal matrix, plus the redoing of a reconstruction, it can be
£15 000–£20 000, in addition to the psychological and cosmetic impact on the patient… a very high cost in every sense.
Mr John Murphy
Aesthetic breast surgery: Main surgical techniques in aesthetic breast surgery: type and incidence of complications
Chair: Maurizio Nava
The quality and location of scars are patients’ main concern in aesthetic breast surgery. Breast augmentation, followed by breast reduction, are the most requested aesthetic procedures in Spain. Patients are also increasingly asking for ‘mummy makeovers’ following childbirth and breastfeeding, when they have lost breast volume and have excessive tissue on the abdomen; another group wants to have previous breast implants removed to recover a more natural result, which could often be achieved with fat grafting from the abdomen.
Dr Gemma Pons said she had been spurred to use microsurgery to improve outcomes for these patients. It is not the solution for everyone; the technique must be mastered and there must be careful planning, but it is feasible in aesthetic breast surgery, she said. Patients must be carefully selected – excluding smokers and obese patients – and they must be given information about possible complications for the breast and donor site, which sometimes needs scar revision.
Aesthetic breast surgery: Mastoplasty reduction and pexy: challenges and useful tips
The basic techniques and challenges of mastoplasty and mastopexy reduction surgery were outlined, which are increasingly common in America. Many women with high BMI have large breasts, but not all have what insurance companies would consider symptoms. The American Society of Plastic Surgeons guidelines are based on symptomology so it is difficult to get funding by insurance companies.
Other demands that are associated with the surgery are common to all areas of breast surgery: avoiding complications, reducing symptoms and comorbidities, while delivering aesthetic improvements in line with patient desires. The benefits of using PICO◊ in reduction mammoplasty were emphasised: fewer healing complications/dehiscence and significantly better scar quality.11
The quality and location of scars are patients’ main concern in aesthetic breast surgery.
Dr Maurizio Nava
Aesthetic breast surgery: Breast augmentation: review of main techniques and specific challenges with surgical incisions
Putting in an implant is easy, but thinking of the bio-dimensional approach (matching implants and surgical techniques to individual soft-tissue characteristics) and deciding which of 15 shapes to use from the 250/300 anatomical implants available makes it a complex choice. The patient asks for a natural breast, but that is without an implant or scar, so it is not possible.
Every choice in augmentation has risks and trade-offs, but these can be reduced by shared decision-making between a well-informed patient and a surgeon who listens and is technically prepared.
Dr Nava presented algorithms to help provide a roadmap through the options for selecting an implant based on factors such as patient wishes, soft-tissue characteristics, breast size and breast shape. Most patients are concerned with shape not volume, and want the breasts to feel and move like natural breasts. Surgeons must understand the different implants’ properties before choosing, and plan exhaustively from the beginning.
Postoperatively, paper tape should remain on the scar for two months and the patient should not exercise for three months. Possible complications include wound infection, dehiscence, fibrosis, haematoma, necrosis and pain. Problems in breast augmentation are few, however, and most relate to capsular contracture or malpositioning.15
When deciding to perform a mastopexy with an implant or without, the key question for the patient is: is the size of your breast filling your bra as you wish? If yes, she needs a reshape, not an implant; but if no, she needs an implant to satisfy her wishes.
Mastopexy and augmentation, when performed simultaneously,16 led to a higher complication rate than for either performed separately in one five-year retrospective review, but the authors suggested that with careful patient selection and carefully planned operation, it could be performed in one stage safely.16 Sometimes it is better to delay.
To minimise contamination, Dr Nava requires patients to take a shower with an antibacterial gel and remove axillary hair before surgery. He advises covering the nipple to avoid secretion and recommends using a steri-drape. He says not to cut the glandular tissue, but use a submammary fold skin incision and to make sure the proper tools are at hand to avoid bleeding.
Aesthetic breast surgery: Can the application of NPWT provide a better cosmetic result?11
Professor René Van der Hulst reported the results of his 90-day extension of the prospective RCT into the single-patient use NPWT PICO◊ in breast reduction were reported.
Patients’ main postoperative concern was the scar. Scar formation can be minimised by reducing tension, dead space, tissue injury from infection, friction or allergic reaction to a dressing, and suture damage. PICO◊ works by acting on almost all of these different aspects.
The primary outcome of the original study on bilateral breast was wound complications at 21 days, while the secondary outcome considered aesthetic appearance and scar quality, using the VAS (Global and Total) scores and POSAS at 42 and 90 days. Professor Van der Hulst included 32 patients to see how the scar developed after a further 180 and 360 days and to add a more objective scar assessment via the CutometerTM MPA 580, which measures viscoelasticity, skin surface hydration and transepidermal water loss.
The study concluded that there had been significant improvement using VAS and POSAS in the original study after 90 days and with VAS after 180 days in the prolonged study. No consistent significant improvement was shown in the prolonged study with the CutometerTM MPA 580. The cohort was too small to provide statistically significant results and it was suggested that one week of therapy may not be enough.
There are a number of complexities in performing mastectomies and certain patients are identified as being at a higher risk of surgical comorbidity, including those with high BMI, those with diabetes, those with a cardiovascular comorbidity and smokers. PICO◊ has been evaluated in the prevention of postsurgical incision healing complications, showing a trend toward fewer complications and adverse events than in those not using PICO◊. Using intra-operative ultrasound could ensure that incisions, resections and the skin flap are in the correct place; this should reduce dehiscence and cellulitis, among other problems. PICO◊ might improve the outcome for other donor sites that mostly need scar revision and fat grafting. Evidence of NPWT advantages in wound breakdown has been observed. Scarring is a major cause of concern for patients undergoing aesthetic breast surgery. Scar formation can be decreased by reducing tension, dead space, tissue injury from infection, friction or allergic reaction to a dressing, and suture damage. PICO◊ works on almost all of these aspects. Significant improvement was reported with PICO◊, although the cohort was small.
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