Representatives from multiple specialties highlight a pressing need to drive up the quality of research and care for patients who require the “life-changing” intervention that is an amputation of the leg.
The UK government’s National Institute for Health and Care Research (NIHR) recently announced it has commissioned a trial in through-knee amputation—a move that has brought into sharp focus the need for research in this area and, it is hoped, will act as a catalyst for change.
According to Robert Hinchliffe, professor of vascular surgery at the University of Bristol in Bristol, UK, and chair of the Vascular Society of Great Britain and Ireland (VSGBI)’s Amputation Special Interest Group (SIG), amputation research has not been a high priority for vascular surgeons in recent years.
Dan Carradice, vascular surgical specialty lead for the Royal College of Surgeons of England based at Hull University Teaching Hospitals NHS Trust in Hull, UK, agrees, stating that, while amputation “does not receive the same attention or investment as revascularisation or limb salvage,” it is “absolutely no less important”. In fact, “in some patients, attempted limb revascularisation is either futile or not associated with salvage of a functional limb and amputation surgery can yield better patient outcomes,” he points out. “I think there is a tendency for surgeons to feel that when they reach the point of an amputation, it is almost a surgical failure,” Carradice explains. “The interest seems to get lost.”
This point of “failure,” however, marks the start of the next significant part of someone’s life following amputation, vascular surgeon George Smith (Hull University Teaching Hospitals) highlights, marking the stage at which a patient’s lifestyle will be “completely turned on its head”. Carradice underlines the crux of the issue: “We struggle to move past the paradigm that success looks like a patient who survives with two legs, and for many patients this is the case. However, we must accept for others successful treatment looks very different.”
Shigong Guo, a consultant in rehabilitation medicine at the North Bristol NHS Trust in Bristol, UK, notes that this failure “mindset” has changed “significantly” in recent years and is continuing to do so. “Many vascular surgeons I work with today would see (unavoidable) amputation surgery as a pivotal first step in a patient’s successful rehabilitation journey,” he tells Vascular News.
While Smith believes clinicians’ focus should be on avoiding having to do an amputation where possible, stressing that anything they can do to preserve a functional limb “should be the first choice,” this principle should not get in the way of providing good care for the patients who do require an amputation.
“I think regardless of how good we get, certainly for the foreseeable future there will be a need for amputations,” he believes, highlighting a clinical need to minimise the impact of an amputation, which is going to be a “hugely life-changing event” for the patient. This is a message Smith is keen to pass on to the next generation of vascular surgeons. “If you have done everything you can, you have used the best evidence base that you possibly can to treat the patient up to the point where, despite your best efforts, they do require an amputation, that is not the point to lose interest. You still have a significant role to play in the future of that patient by getting the amputation right and giving them the best possible future.”
“There shall always be some amputations that are unavoidable,” he précises.
Carradice notes that it is not uncommon for a patient to express their wish that they had agreed to amputation much sooner, pointing out that “different patients require different solutions”. He opines that clinicians are doing themselves and a significant group of patients a “disservice” in not accepting that amputation surgery may lead to the best outcomes in some situations. A focus on research and clinical improvement in this area, he says, “need not detract from our mission to prevent limb loss in other circumstances”.
Saving limbs is rightly an “essential” focus of research, physiotherapist Hayley Crane (Hull University Teaching Hospitals NHS Trust) adds, noting that in fact it was recently ranked as the top research priority for amputation surgery by the James Lind Alliance priority research setting project. However, she stresses that it is still the case that thousands of people in the UK require major lower limb amputation every year. “The priority for physiotherapists and prosthetists is improving the lives of our patients after amputation,” Crane emphasises, reiterating that while reducing amputations where possible is important, there is a need to stop thinking of amputation as “the end of the line”.
Another issue is that opinion-based care is often the best available, according to Smith. “If [a patient] asks me a question about which of [above-knee or through-knee amputation] is better, at the moment I can give them an opinion, I cannot give them any evidence whatsoever to base that on,” he says. Crane concurs, noting that clinicians’ opinions, which “vary hugely” across the UK, are the basis of current clinical practice.
“There are many clinical decisions that we have to make without any evidence,” consultant clinical academic physiotherapist Chantel Ostler (Portsmouth Hospitals University NHS Trust, Portsmouth, UK) adds, noting that the evidence base around understanding amputation, as well as prosthetic rehabilitation following amputation, is “really poor”. As a result, she comments, it is “difficult” for clinicians to be able to use that evidence base to help them make decisions.
According to Carradice, the NIHR announcement is “excellent news” for the care of patients in need of lower limb amputation surgery. “We owe it to our patients and our specialty to leave no stone unturned in understanding how to deliver better care and better outcomes.”
The hope is that the research will have an international element, with Guo noting that the NIHR are currently considering collaboration and joint funding with the Australian National Health and Medical Research Council (NHMRC). “Having this level of international support elevates the profile of amputation research within the UK and abroad, and hopefully it will spur other trials within this important and challenging field,” he states.
Crane is positive about the impact research will have on the whole care pathway. The greater the evidence, guidance, and consideration given to the amputation at the start of the patient’s journey, she believes, the easier the recovery for the patient.
Looking to the future of amputation surgery considering the NIHR news, Smith notes that he and his team are applying for funding to conduct a trial that will compare through-knee with above-knee amputation for people who are not suitable for a below-knee amputation, examining quality of life in particular. “The trial is about the fact that there is a perception that through-knee amputations may not heal as well as an above-knee amputation, and that is why a lot of people have traditionally shied away from them,” he explains. In registry data, however, he notes that there is no real signal towards this negative outcome. “If anything,” he continues, “the healing is equivalent.” In addition, Smith notes that the researchers want to look further into some positive benefits of through-knee amputation signalled to in the registry data, including fewer medical complications, shorter length of hospital stay, and a shorter rehabilitation period.
The trial, dubbed HAMLET (Through knee or not through knee, that is the question), involves multiple stakeholders and multiple centres, Carradice continues, specifying for example that the Amputation SIG and UK Vascular Clinical Trials Network are all behind the work. “To date in the UK through-knee amputation has made up a very small proportion of procedures and it is therefore important to establish whether these potential benefits are seen in a prospective randomised study and can be translated into a wide-scale change in practice and clinical benefits for this important group of patients.”
With regard to life after amputation surgery, Ostler notes that clinicians are now able to provide some high-tech prosthetic equipment. In 2016, she reveals, NHS England allowed for the prescription of microprocessor knees on the NHS. These prosthetics, Guo also refers to several advancements in prosthetics in recent years, while pointing out that some further research is still needed. One of these developments is osseointegration (OI) prosthetic limbs, also known as direct skeletal fixation. He explains how they work: “In transfemoral amputees for example, instead of having a conventional socket attached to a prosthetic limb, OI involves surgically inserting an intramedullary nail-like stem into the medullary canal of the femur. The stem protrudes through the skin and attaches to a prosthetic limb.”
Guo reports that initial studies focusing on younger, fitter patients with trauma or combat injury amputations have been “promising” in terms of potentially avoiding the problems of a traditional socket interface—such as skin issues, sweating, socket discomfort and fitting issues, as well as reduced control of the prosthetic limb.
However, he also notes that complications have been reported such as peri-prosthetic fractures, implant loosening and breakage, as well as infection. “Currently, the NHS in England does not recommend OI as a treatment for transfemoral amputation, especially for vascular patients. As time progresses, it will be interesting to see the long-term outcomes of OI.”
Carradice acknowledges that while advanced prosthetics “come at a cost,” if they do improve function, this could have a “dramatic” impact on patient outcomes and the social care budget.
“A team sport”
There is consensus that, in conjunction with research, multidisciplinary collaboration will be key to improving amputation care going forward.
Carradice stresses that the multidisciplinary approach, while important across medicine, is especially crucial when it comes to amputation care. “Resources for highly visible and well-promoted areas within surgery are in short supply, much less is often available for less visible and less celebrated treatment such as amputation,” he says. “We must ensure that our patients receive the correct balance of evidence-based clinical, operative, psychological and pain management, as well as physical therapy, prosthetics, physical adaptations and social care so that they can realise the best possible outcomes from their and from societal perspectives.” This, he believes, will require “passionate multidisciplinary academic and clinical leaders working nationally and locally to drive positive change”.
Ostler underscores the importance of including all members of a multidisciplinary team in considering what level of amputation might allow a patient to have the best outcome. She mentions, for example, the significance of thinking about the different types of residual limbs that are created and the impact that they might have on how comfortable the team can get patients in their prosthetic socket, but also about the processes that happen during the inpatient stay that can speed up patient recovery.
While multidisciplinary care is the goal, it is not always the reality, Guo tells Vascular News. A discussion between the operating surgeon and the amputee rehabilitation team with regards to the level of amputation, and even whether to amputate or not, can be a “pivotal step” in managing the patient’s clinical sequelae, he says. Often, however, Guo notes that amputee rehabilitation centres are located off-site, away from the acute (or non-acute) hospital where the amputation surgery is being performed, and that hospitals’ surgical departments may not have access to an amputee rehabilitation centre within close proximity.
According to Guo, he and colleagues are “very fortunate” in Bristol to have an “ingrained and embedded” interdisciplinary and inter-specialty framework, between the rehabilitation team and surgical colleagues. “Despite the Bristol Centre for Enablement (BCE) being off-site to Southmead Hospital, there is a regular weekly in-reach review of selected pre-, peri- and post-amputation inpatients by the amputation rehabilitation team (including the consultant in rehabilitation medicine [i.e. myself], and amputee psychological counsellor),” he explains.
“We are continuing to build up our links with major trauma, vascular and plastic surgery and the limb reconstruction team in order to provide a more holistic approach to this complex and life-changing condition.”
Ostler agrees, noting that “better links” with prosthetic rehabilitation are needed. In parallel to this, she believes it is important to link data. For example, she asks how data collected through the National Vascular Registry could be integrated with data that could be collected in prosthetic settings. “This could give a good idea about the longer-term outcome of amputation, particularly for those who may be prosthetic users, and whether that information then might help us to make better decisions about patients who have an amputation, the information that we provide to them and how we manage their expectations and their adjustment following amputation.”
Amputee care is “very much a team sport,” Smith summarises. “There is no single individual that can make this pathway work.”
For more information on the HAMLET trial, please contact George Smith at [email protected]