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NLN Position Papers: Risk Reduction, Risk Reduction Summary, Diagnosis and Treatment, Exercise, Training, Breast Cancer-Related Lymphedema, Supplement BC-Related LE
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Volume 24, No. 2 April - June, 2012
Surgical Treatment of Lymphedema: A Review of the Literature and a Discussion of the Risks and Benefits of Surgical Treatment
Volume 24, No. 1 January - March, 2012
Exercise for breast cancer survivors: Prevention, treatment, and attenuation of persistent adverse effects of treatment. including lymphedema?
Introduction
The surgical treatment of lymphedema has recently received significant attention in the press as an effective treatment of lymphedema for select groups of patients. Despite advances in a number of different surgical techniques, it is still not clear which lymphedema patients would benefit the most from surgical treatment and which surgical techniques are the most effective.1 Some investigators have suggested that surgery for lymphedema should be considered when there is substantial functional impairment, frequent lymphedema-associated infections, therapy-resistant pain, or considerable cosmetic deformity. Complete decongestive therapy (CDT) is still considered the gold standard lymphedema treatment, and with an aggressive approach and adherent patient, CDT should be able to manage limb swelling in the majority of patients. The approach in the United States is currently to evaluate referral patients for surgical treatment options when nonsurgical treatments have failed. The potential benefits of surgery are to reduce the weight of the lymphedematous region, minimize the frequency of inflammatory episodes, and improve cosmesis and function.
Surgical treatment of lymphedema can be categorized as follows: excisional operations (e.g., debulking, amputation, and liposuction), lymphatic reconstruction, and tissue-transfer procedures (e.g., lymph-node transplantation and tissue transfers). Recently, we conducted a systematic review of peer-reviewed literature to try to identify which lymphedema patients benefit the most from surgical treatment and which surgical techniques are the most effective in treating lymphedema.
Methods
A systematic review of the literature was performed in two phases. First, a reference research librarian searched 11 major medical indices (PubMed-MEDLINE, CINAHL, Cochrane Library databases [Systematic Reviews and Controlled Trials Register], PapersFirst, ProceedingsFirst, Worldcat, PEDro, National Guidelines Clearing House, ACP Journal Club, and Dare) for articles published between 2004 and 2010 using terms to capture all literature related to lymphedema. In the second phase, abstracts were reviewed by experts in the field for confirmation of defined inclusion (lymphedema-related, >8 patients) and exclusion criteria (non-refereed articles). Abstracts were sorted by topic experts. Full original research articles for each of the studies and English translations were requested as needed. In addition, published articles from the archives of the authors were also examined as well as reference lists from related articles. A total of 20 studies met the inclusion criteria. The studies were categorized according to the type of surgical procedure performed: (1) excisional procedures (n=8), (2) lymphatic reconstruction (n=8), and (3) tissue transfer (n=4). All studies referred to in this summary are fully cited in the systematic review article by Cormier et al. 2011.2 Detailed review of each article was performed and the following data were extracted: number of patients, specific surgical procedure, length of follow-up, criteria for defining lymphedema, measurement methods, volume or circumference reduction, and reported complications. A quality analysis of each of the studies was also performed using a 14-item tool (QUADAS).3 An overview of the findings is presented below (Table 1).
Excisional Procedures
We reviewed four published studies that included 50 patients who underwent excisional procedures (debulking) on either the extremities (upper or lower) or the genital region (penile/scrotal). Excisional procedures involve the radical removal (resection) of skin and soft tissue in the lymphedematous area. The area is then covered by a skin graft for healing. Complications associated with this procedure include bleeding (hematoma), death of the grafted skin (necrosis), infection, chronic wounds or delayed healing, blood clots, scarring or poor appearance, destruction of remaining lymphatic vessels, and recurrence of lymphedema. The overall volume reduction reported for the excisional procedures ranged from 18% to 118%, with a weighted average reduction (based on the number of patients in the study) of 91.1%. Mehrara et al4 found that excisional procedures for lymphedema are typically reserved for patients with lymphostatic elephantiasis, whereas liposuction is used in patients for whom conventional treatments have failed.
Liposuction
We reviewed four published studies that included 105 patients who underwent liposuction for upper extremity lymphedema. Liposuction has been introduced as a technique to remove subcutaneous fat to reduce a limb's overall size. Liposuction is considered to have less morbidity than radical excision; complications from liposuction include bleeding, infection, skin loss, numbness, and recurrence of swelling.
Lymphatic Reconstructive Procedures
We also reviewed eight studies that reported on the use of microvascular lymphovenous anastomoses procedures to treat lymphedema in a total of 2,058 patients. These procedures create microscopic connections between lymphatic channels and adjacent veins to allow for a type of "bypass" of lymphatic obstruction. An advantage of microvascular lymphovenous anastomoses procedures is the minimal tissue dissection and destruction; however, these procedures are only performed by highly skilled plastic surgeons who have received extensive training in microvascular surgery, which is performed using a microscope. In addition, a high number of early-failure rates (e.g., narrowing and scarring of the connections) has been reported. The overall weighted volume reduction reported for lymphatic reconstructive procedures was 54.9%.
Tissue Transfer Procedures
We reviewed four studies on tissue transfer procedures (upper and lower extremity) in which included 61 lymphedema patients. These procedures included lymph node transplantation and/or transfer and tissue transfer and involved transplanting distant lymph nodes or lymphatic tissue into the area of obstructed lymphatics. Complications that were associated with tissue transfer procedures include skin-flap failure and lymph node or tissue donor-site complications. Particularly in lymph node transfer procedures, the remaining lymph nodes at the donor site may be damaged, resulting in lymphedema at the site of lymph node or tissue collection. The overall weighted average for studies that reported a volume reduction was 47.6%.
Discussion
Findings from our systematic review of the published literature on the surgical treatment of lymphedema indicate that, overall, excisional procedures are associated with the greatest volume reduction, followed by lymphatic reconstruction procedures and then tissue transfer. However, it was not possible to identify one surgical technique as more effective than another because the patient characteristics and selection criteria varied substantially among the studies. For example, it is likely that the most dramatic volume reductions were related to excisional procedures performed on limbs with massive lymphedema. Patients with elephantiasis and fibrosis would not likely be candidates for lymphatic reconstruction procedures. In addition, the studies presented in this review were all observational studies, largely without comparison groups, and were not randomized controlled trials. A randomized clinical trial offers the opportunity to evaluate new procedures against the current standard of care. The process of randomization within a clinical trial is designed to create groups with similar characteristics. The primary advantage of randomized controlled clinical trials is to eliminate patient selection bias, which ensures that the findings and outcomes of the study can be attributed to the procedure or treatment itself rather than to the more favorable characteristics in a particular group of patients.
An important component of determining whether surgical treatment is indicated is to examine the risk-benefit ratio. The risk-benefit ratio considers the surgical risks or morbidity associated with an individual procedure in terms of the likelihood or frequency of a complication (such as postoperative infection) versus a rarely occurring complication that may be life threatening (such as a stroke). The individual goals of the patient, the extent of the surgical procedure, and the level of expertise and experience required to perform the surgery should also be carefully considered. As discussed above, significant complications have been reported with each of the surgical procedures, and in almost all of the studies, patients were required to wear postoperative compression garments.
The reported success of many of these procedures was likely strongly influenced by the selection of patients. The majority of the studies were performed overseas, and performed by clinicians with significant experience with these procedures. Patients were often selected patients who had recent-onset secondary lymphedema with no previous history of cellulitis or venous hypertension, and these patients were more likely to have good outcomes. Given the lack of randomized clinical trials and the overall quality of the studies reported to date, insurance companies in the United States consider these surgical procedures for the treatment of lymphedema "investigational," resulting in a lack of insurance coverage for the majority of procedures. Medicare, which is the US government's insurance for people over the age of 65, does not currently cover lymphatic venous bypass or transplantation.5 Many private insurance companies use Medicare as a guide for their own reimbursement policies. In a few reported cases, individual insurance companies have approved reimbursements after an extensive petition process. Without insurance coverage, surgical procedures for the treatment of lymphedema are often limited to wealthy individuals who can afford to pay the costs out of pocket, which range from $20,000 to $40,000 for the procedure itself and this does not include the costs of postoperative hospitalization and rehabilitation if needed.
Despite the promising results from surgical treatment of lymphedema, complete decongestive therapy and compression garments should continue to be considered the primary treatment for lymphedema. Potential risks are associated with all surgical procedures, including general risks and stressors related to anesthesia. No prospective randomized controlled clinical trials have been conducted to date to compare the nonsurgical and surgical treatments of lymphedema. Additional studies are required to select appropriate lymphedema patient populations who would derive the greatest benefit from surgery. Only when these results are available will it be possible to advocate for wider insurance coverage.
Exercise is good for breast cancer survivors, for many reasons. Multiple large, methodologically strong observational studies consistently find that three hours a week or more of walking reduces risk for breast cancer recurrence or mortality. There have been over 50 high quality randomized controlled trials which have demonstrated the safety and benefits of exercise during and after breast cancer treatment. The demonstrated benefits include physiologic improvements in physical function, cardiorespiratory fitness, strength, body weight, and body composition. Additional benefits include improvements in cancer-related symptoms and side effects, fatigue, and body image. Based on these findings, last year the American College of Sports Medicine published a set of recommendations for exercise among cancer survivors, including breast cancer survivors. The advice from the ACSM begins with 2 words 'Avoid Inactivity', and continues with guidance to return to normal daily activities as soon as possible after surgery and during non-surgical treatments. The specific recommendation for aerobic activity is to build to 150 minutes per week over the course of a month. Advice for cancer survivors to do flexibility activities on a daily basis mirrors long-held advice from physical therapists and certified lymphedema therapists. Resistance training is recommended 2-3 times weekly. These ACSM recommendations are similar to exercise advice from the National Lymphedema Network, the MacMillan Report from the U.K., and guidelines from Canada and Australia.
The ACSM expert roundtable advised that breast cancer survivors start with a supervised upper body resistance training program and that if a woman notices a change in symptoms that lasts a week or longer, she should seek an evaluation from a medical professional with training in lymphedema. The roundtable noted that the fitness professionals leading programs for cancer survivors should be familiar with common toxicities of cancer treatment (including lymphedema). The ACSM offers such training through the Cancer Exercise Trainer webinars. There is also a specialty certification for personal trainers through ACSM called 'Cancer Exercise Trainer'. Pre-exercise evaluation was advised only for those women with upper body symptoms. Those who had diagnosed upper body issues, including but not limited to lymphedema, were advised to seek treatment for those issues prior to starting upper body exercise. Those who developed new upper body symptoms, including but not limited to lymphedema symptoms, were advised to reduce upper body exercise and seek evaluation and treatment for those issues prior to restarting.
The advice from the ACSM is much more specific than any prior published advice on this topic, yet many elements of translating this advice to safe, effective, easily available, low cost exercise programs remain to be clarified and prepared. A group of us are undertaking that work, revising the PAL trial intervention so that it will remain safe and efficacious but will be more feasible to implement within a wide variety of settings, including large cancer centers, community oncology clinics, free-standing private physical therapy clinics, as well as community fitness facilities with adequately trained fitness personnel. The barriers to getting this program into the hands of as many of survivors as possible are formidable. There is no existing infrastructure for providing the program. Oncology clinicians are generally enthusiastic about the program and hope their patients will participate. However, getting oncology clinicians to refer women into the program is challenging, given that they are already so overburdened with other important clinical issues with their patients and how little time they get with patients.
The revised program, firmly grounded in the PAL trial intervention, is currently being called 'Strength After Breast Cancer' or 'Strength ABCs'. We renamed it because of concerns that women without lymphedema would see the name 'Physical Activity and Lymphedema' and decide, 'that's not for me'. The revised program starts with a physical therapy evaluation in which a certified lymphedema therapist (CLT) determines whether the survivor can safely proceed to doing a group weight training class or needs one-on-one therapy to reduce lymphedema, rotator cuff impingements and the myriad of other issues present in breast cancer survivors. It is hoped that most can proceed to the group exercise sessions eventually, even if one-on-one therapy is needed first. Regardless of the outcome of the evaluation, all survivors are invited to attend a 1-hour educational lecture in a group setting based on NLN's widely available patient education materials (training of certified lymphedema therapists, exercise, risk reduction guidelines, air travel).
For those cleared for group exercise, Strength ABCs then proceeds with four group exercise sessions to teach the PAL weight training protocol. At the end of the program, women are given a kitchen magnet that reminds them of key factors that will influence the long term effectiveness of the program, including that if they have a change in symptoms that lasts a week or longer, they should call to set up an evaluation for possible onset or flare-up. The educational lecture and group exercise sessions could be led by physical therapists, lymphedema therapists, or fitness professionals with specialty training in cancer and exercise. Program reimbursement and out-of-pocket cost issues differ across PTs versus CLT versus fitness professionals. Scheduling challenges also vary across PTs and CLTs versus fitness professionals. The breast cancer survivors who participate choose in advance whether they will exercise at home with adjustable dumbbells or at a local gym near their homes. The exercises taught vary according to this choice. In our ongoing research study, we are recruiting 120 women participants to evaluate whether this revised program is as safe and effective as the PAL trial intervention. We are seeking funding to create an online marketing and tracking tool for breast cancer survivors who participate.
Many of us share the goal of making it possible for as many of the 2.6 million breast cancer survivors in the U.S. as possible to have easy access to safe, effective exercise interventions that will improve their health and well-being. Lymphedema is only one of multiple reasons these women need to exercise but it may be a significant motivator. The barriers to getting any group of people exercising regularly are numerous. Breast cancer survivors may be particularly wary of exercise because for decades, oncology clinicians advised breast cancer patients to 'rest, take it easy, don't push yourself'. Advice to avoid overuse, injury, or trauma to the upper body on the side that received treatment is still prevalent and often still interpreted as avoiding use of the upper body on the side that received treatment. This is an excuse women use to avoid any kind of exercise. How many women do you know who would happily conclude that advice to avoid one specific type of exercise is advice to be sedentary? But we know exercise is good for survivors, so how do we get them moving? Do we think that telling them it might reduce risk for breast cancer specific mortality will make more women willing to pay for exercise programs, good walking shoes, and actually take the time for the recommended 3 hours a week of walking? Unfortunately, we know from four decades of efforts to motivate people to exercise because it will reduce likelihood of a disease that might happen years or decades from now results in little to no behavior change. We know that short term goals are more effective than long term goals for behavior change. Most of us are familiar with the idea of 'SMART' goals: specific, measurable, attainable, relevant, and time bound. This has relevance for breast cancer survivors with and at risk for lymphedema because if women have a specific goal to limit lymphedema onset or worsening and can be educated to understand their risk for lymphedema onset and progression, they may be motivated to do something about it through measurable, attainable, relevant, and time-bound exercise programs. If there is an intervention which can control lymphedema onset or progression, they might be particularly motivated to engage in that activity.
As we undertake the arduous work of translating the results of upper body exercise research trials into programs that are available to as many of the 2.6 million breast cancer survivors in the U.S. as possible, there will be questions to answer and decisions to make. As we do so, I urge all of us to weigh carefully the risks of remaining inactive and the resulting de-conditioning against the risks of slowly progressive weight-lifting.
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