Care pathways or guidelines help doctors and patients with complex problems decide what to consider next when there are many different treatment options. Care pathways developers try to sort out which treatments should be included in the pathway and then set them out in a logical order.
In 1996, when we set up the first patient-centred angina clinic for so-called “end-of-line” angina sufferers we weren’t sure where to start. We contacted several of the top UK experts to find out what they thought should be done to help a patient who still had angina despite multiple angioplasty procedures and two bypass operations. One expert suggested it might be worth trying a TENS machine, another suggested a third bypass while another said, “there’s always something you can unblock with a angioplasty balloon.” One suggested a nerve injection and another suggested a heart transplant. A psychologist (Professor Bob Lewin) who specialised in angina, asked if we knew what the patient thought was going on and what they really wanted. This turned out to be the most sensible suggestion.
Each expert suggested the treatment they were personally familiar with. The worrying thing was that the interventional experts didn’t suggest trying something simple and non-invasive first. They didn’t seem to understand that if patient is offered a third bypass he will naturally assume that there couldn’t be a simple low risk alternative. The result was that the same patient could travel around the country and meet half a dozen different experts and receive half a dozen opinions on what should be done, ranging from simple outpatient treatments up to a heart transplant. In practice patients tend to stick with who they know and the result is that patients who go back to their bypass surgeon are very likely to end up with another bypass, even if they would have preferred to try something low risk first.
It was clear to anyone that a care pathway was urgently needed and we persuaded a group of national and internationally renowned experts to come together to agree what should be included in the pathway. In a major innovation, we asked patients to tell the experts what mattered most to them. It won’t surprise patients that the patients told us they wanted a better quality of life for themselves and their families. They also told us they would prefer to hear about low risk, non-invasive treatments before invasive procedures. They also said that if they had to take risks of a complication from an invasive procedure they would prefer to hear about treatments with reversible complications first. This helped the expert panel to sort out the various treatment options into a sensible order with the least invasive options listed before the more invasive ones.
NRAC implemented the care pathway in 1999 and we have modified the pathway to take account of new research and patient preference.
Everyone agrees that the pathway should start with a holistic diagnosis to ensure the doctor understands how the condition affects the patient and their family. Doctors who don’t understand how the condition affects the patient and their family can easily miss simple interventions that could significantly improve things.
After that patients should be educated about the condition and the risks and benefits of the available treatments. This is a time consuming process that is only available at specialist patient-centred angina clinics where patients learn how to work with their doctors to get the best out of life. Getting the best out of life generally involves learning stress management techniques, how to get fit and stay fit, changing to a healthy diet and getting on the right combination of drugs. (Note, optimising drugs doesn’t necessarily mean taking more tablets. In practice patients who follow the programme are able to take fewer drugs). In practice nearly all patients who have complete the education programme say their knew found knowledge has enabled them to take back control. For many, especially patients and carers who wrongly believed angina was damaging their heart and those who were living on a knife edge, angina becomes a “nuisance” that they have learned to manage. Most have a significantly better quality of life and get by on fewer tablets. In our experience, every patient completing the education programme asks, “why doesn’t everyone do this?” or words to that effect.
During the education programme, the pros and cons of the various treatments are discussed. This means that patients are in the best position to work with us to choose what to try next. As more and more patients opt to try the patient-centred approach in an effort to avoid invasive cardiac procedures we have added angioplasty and bypass to the list of options. UPDATE. NICE RECOMMENDS PATIENT CENTRED CARE FROM THE OUTSET AND EMPHASISES THE IMPORTANCE OF PATIENT EDUCATION AND OPTIMISING DRUG THERAPY AT THE OUTSET OF CARE.
- Transcutaneous electrical nerve stimulation (TENS). Involves four small pads placed on the skin around the angina area and they are attached by thin wires to a small box the size of a kitchen matchbox which creates a tingling sensation. TENS is safe, simple and reversible. Provides long term benefit in around 20% of properly selected patients. It is not advisable to use TENS in patients who have not had the benefit of a comprehensive education programme. UPDATE NICE HAVE RULED TENS SHOULD NOT BE USED IN ANGINA
- Nerve blocks. Involves the injection of local aneasthetic in the neck or the back using a thin needle. Patients say it is less uncomfortable than having a cannula placed in a vein in the back of the hand. Short term complications are common, but it has an excellent safety record. Nerve blocks are only temporary and some patients find them so helpful they come back for regular blocks. A year after starting treatments, around 25% of patients feel nerve blocks are worth going through regular injections. UPDATE NICE HAVE CONSIDERED NERVE BLOCKS BUT HAVE NOT COMMENTED ONE WAY OR THE OTHER
- Spinal cord stimulation (SCS) for nerve damage pain, but is no longer used for angina in the NHS because NICE found insufficient evidence for its cost effectiveness. SCS is quite invasive and therefore more risky than nerve blocks and TENS. It involves the placement of a wire about the size and consistency of cooked spaghetti next to the spinal cord which is tunnelled under the skin and attached to a metal box the size of a tin of shoe polish under the skin over the stomach. It provides good levels of pain relief in around 40% of patients who try it.UPDATE NICE HAVE RULED SCS SHOULD NOT BE USED IN ANGINA
- Strong pain killers. Most useful for controlling occasional severe episodes in well informed patients. Anxieties about the risk of addiction are misplaced, but patients who regularly take strong painkillers over a prolonged period are liable to develop complications. For this reason we advise that strong painkillers are reserved for patients who have been fully counselled. UPDATE NICE HAVE CONSIDERED STRONG PAINKILLERS BUT HAVE NOT COMMENTED ONE WAY OR THE OTHER
- Enhanced External CounterPulsation (EECP). This is a safe, non invasive treatment that is only available in certain specialist centres. It involves large cuffs like the ones used to measure blood pressure, wrapped around the calves, thighs and buttocks, which are inflated to high pressure and deflated in time with each heart beat. It requires 35 separate treatments each one lasting about an hour and the course of treatment usually takes five to seven weeks to complete. A year after completing a full course, around 50% say they are pleased with the treatment. It is possible to have top up treatments if/when the angina returns. UPDATE NICE HAVE RULED EECP SHOULD NOT BE USED IN ANGINA
- Angioplasty. An invasive procedure that involves passing tubes along the inside of the coronary arteries and then blowing up a balloon at the point where the narrowing is thought to be causing angina. Usually a wire cage like internal scaffolding (stent) is placed at the same time. The procedure involves significant risks of permanent damage. A third of patients suffer heart muscle damage sufficient to increase mortality by 33%, but cardiologists usually quote a much lower complication rate. After a year there is very little difference in quality of life between patients who have angioplasty and those who do not.
- Bypass surgery. The most invasive and most risky option. Of all treatments it is the most effective at reducing angina, but complications make it an unattractive early option except in certain situations where it has been shown to increase life expectancy.
- There is very little research on acupuncture. We know it is safe in well informed angina patients, but we do not know how effective it is and until we know more we are reluctant to recommend it. However, when the alternative is a risky palliative operation or nothing, many patients opt give it a try. UPDATE NICE HAVE RULED ACUPUNCTURE SHOULD NOT BE USED IN ANGINA
We recommend that the following invasive therapies should only be undertaken as part of a formal clinical trial.
Nerve destruction; Laser (via blood vessels, a bit like an angiogram, or via an operation through the chest); Gene therapy.
Angina alone is not an indication for cardiac transplantation.
NOTE Patients should be monitored carefully and taught to recognise the signs that indicate new “dangerous” narrowings have developed, so they get the right treatment at the right time.
What follows is the current consensus evidence-linked treatment algorithm that has been commissioned by the United Kingdom Pain Society. The guideline has been endorsed by the British Cardiovascular Interventional Society and reflects the current state of the art (National Health Service, National Service Framework Document for Cardiology, March 2000, chapter 4, p6, paras 16-17, Hansard 15 Oct 2008 : Column 322WH http://www.publications.parliament.uk/pa/cm200708/cmhansrd/cm081015/halltext/81015h0011.htm).
1998 Working guideline
This document was written in 1998 to open the debate to a wide audience on the “best management stepwise algorithm” for patients suffering with chronic refractory angina. At that time the treatment options were only available to angina sufferers when their consultants had decided that invasive treatments (bypass and angioplasty) were no longer possible. Since then consent law has evolved and current EU legislation requires health professionals to ensure patients are able to choose from all legitimate (evidence-based) options. This has created a conflict between those of us who believe that patients are entitled to know that low risk options are available before undergoing a none life prolonging and potentially dangerous procedure and those who feel that it is right to withhold information about low risk options until after the invasive option has been tried and failed. The logic underpinning the latter argument is hard to understand, especially in the case of angioplasty, whose temporary benefits might be explained by the placebo effect. In our experience patients who have undergone palliative revascularization express bewilderment that the information about non-invasive alternatives was withheld from them.
The menu of treatment options below includes those currently available to patients for whom revascularization is not technically possible. The order reflects patient preference for low risk reversible options before high risk invasive procedure. Not all options will be available outside the small number of specialist clinics and individual practitioners will have to take account of local resource provision when discussing options. The big challenge for cardiologists is when patients should be allowed to know about the low risk options. Presently some consultants recognise they have a duty to allow patients the opportunity to fully participate in decisions that effect their health and inform patients about all the options, while others think they should decide when patients should allowed to choose. For patients it is a matter of luck whether they are referred to a paternalistic or a patient-centred consultant.
Importantly the July 2011 NICE stable angina guidelines recommend the patient-centred approach formerly restricted to end-of-line angina patients should be instituted at the outset and continue throughout care.
Comprehensive biopsychosocial diagnosis.
- This should include a diagnosis of the physical problem and the emotional and social consequences for the patients and their family and friends. A significant minority of “angina” patients are incorrectly diagnosed and have other pain conditions that confuse the clinical picture. This is common in, but not limited to, post bypass patients. A joint assessment with a specialist pain is invaluable. Anxiety promoting misconceptions are the norm among patients and carers (and health professionals) and frequently lead to harmful behaviours. Identifying health misconceptions is a time consuming but necessary part of optimal medical care. We recommend established questionnaires such as the Hospital Anxiety and Depression inventory (HAD), the Angina Plan questionnaire or the simple 5 point Liverpool Angina Questionnaire to quickly identify problems.
- It is essential that realistic and achievable objectives and a working strategy is agreed at the outset and at each subsequent interaction.
Rehabilitation. Education to enable self management and covers: angina and coronary heart disease, relaxation and stress management, optimal health promoting lifestyle, optimising medication, evaluating evidence and assertiveness training. This is most effectively delivered through individual and group cognitive behavioural therapy techniques.
A formal psychological assessment can be of value especially in determining whether formal psychotherapy may be of value. In practice formal psychotherapy input is only required for a small minority of patients.
It is essential that patients should be educated sufficiently to enable them to give valid consent to the following interventions. In our experience patients who complete the comprehensive education programme are so satisfied with their progress that only a minority even consider a non-invasive option like Transcutaneous electrical nerve stimulation (TENS).
In July 2011, NICE have ruled that TENS, EECP and acupuncture should not be used. This was inevitable in view of the weak evidence-base, lack of evidence of cost effectiveness, coupled with the lack of awareness of the difficulty in managing end-stage angina sufferers.
Angioplasty and stent, which is only less cost ineffective than angioplasty alone continues to be included in the range of NICE authorised palliative treatment options.
- Transcutaneous electrical nerve stimulation (TENS). This appears to provide useful long term benefit in around 1:5 patients.
- Temporary sympathectomy. Stellate ganglion block, T3/4 paravertebral block in stages. High thoracic epidural. Based on the Liverpool protocol. These provide temporary relief and require repeated treatments. Around 1:4 patients find the intervention sufficiently beneficial that they are willing to undergo repeated blocks.
- Spinal cord stimulation (SCS). There is no doubt among authorities that SCS is an effective treatment in some patients, however in 2009 NICE decided that there was insufficient evidence for cost effectiveness to justify the continued use of SCS for angina. NICE concluded SCS is appropriate in nerve damage related pain (neuropathic pain) that commonly complicates bypass surgery.
- Opioids. Should only be prescribed by specialist opioid clinics after extensive counselling and in close communication with the GP.
- Enhanced External CounterPulsation (EECP). This low risk, non-invasive outpatient treatment is relatively expensive and is only available in a very limited number of specialist centres. It involves over 35 hours of treatment delivered on average for an hour and a half a day. A standard course of treatment requires daily hospital visits for five to seven weeks. In practice, simpler interventions are so effective that EECP is only needed for a small minority of patients.
- Acupuncture. There is very limited research evidence for acupuncture in the treatment of angina, but it is simple, low risk and ameliorates symptoms in some patients. It is unlikely that any patient would decline a trial of acupuncture, if the alternative was a complex risky palliative intervention, such as repeat bypass surgery. However, in practice patients being offered palliative redo bypass are rarely told of any of these options.
Destructive sympathectomy (thoracoscopic, surgical or phenol); Intrathecal opioids; Myocardial laser (percutaneous or transmyocardial); Gene therapy.
Angina alone is not an indication for cardiac transplantation.
For more information, queries or comments please contact Prof. M Chester.