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This report summarises the results of SBU’s systematic review of the literature concerningmethods of diagnosing and treating symptomatic peripheral arterial disease caused by
atherosclerosis or arterial thrombosis in the lower extremities. The project did not include
studies of methods to prevent or affect the development or progress of peripheral arterial
disease. Many of those methods have been assessed by previous SBU reports: Smoking Cessation
Methods (1998), Obesity – Problems and Interventions (2002), Moderately Elevated Blood
Pressure (2004), Interventions to Prevent Obesity (2005) and Methods of Promoting Physical
Activity (2007). PERIPHERAL ARTERIAL DISEASE IS COMMON, PARTICULARLY IN THE ELDERLY, AND POSES A HIGH RISK OF LONG-TERM SUFFERING, AMPUTATION AND PREMATURE DEATH: Peripheral arterial disease is the result of ischaemia (insufficient blood flow) in the
lower extremities. In the great majority of cases, the cause is atherosclerosis – which is
among the most common diseases and one that rarely affects the blood vessels of the lower
extremities alone, but rather the entire cardiovascular system. Thus, all patients who
have symptoms of peripheral arterial disease should be assessed for risk of
atherosclerosis. Peripheral arterial disease in its mild form may be limited to intermittent claudication,
pain in the lower extremities that is triggered by exertion but that ceases during rest.
When ischaemia is chronic, critical or acute – characterised by stenosed or occluded blood
vessels – peripheral arterial disease increases the risk of tissue death (gangrene),
amputation and premature death. Because atherosclerosis – the primary cause of peripheral arterial disease – can progress
for a long time without producing any direct symptoms, the number of people who have the
disease is unknown. The risk increases with age, and peripheral arterial disease occurs
among an estimated 10% of people over 60 years. Half (more than 5,000) of the invasive
procedures that are performed every year at Swedish hospitals for vascular diseases seek
to restore blood flow in patients with various forms of peripheral arterial disease. THE MOST URGENT PRIORITY FOR ALL VASCULAR DISEASES, INCLUDING THOSE IN THE LOWER EXTREMITIES, IS TO PERSUADE AND HELP PATIENTS TO STOP SMOKING: The correlation between smoking and peripheral arterial disease is very strong and has
been documented by a large number of studies. The risk that a smoker will develop
intermittent claudication is almost double that of developing angina pectoris. Smoking
cessation reduces the risk of serious ongoing symptoms, amputation and death due to
vascular complications. All treatment of peripheral arterial disease includes aggressively affecting the general
risk factors for atherosclerosis, such as smoking, physical inactivity, overweight,
hypertension, high lipids and high blood sugar. THE SCIENTIFIC EVIDENCE FOR DIAGNOSIS AND TREATMENT OF PERIPHERAL ARTERIAL DISEASE IS LIMITED: Although a review of the literature identified several thousand articles, close
examination revealed that only a small percentage of the studies met the criteria for
quality and internal validity that have been established by health technology assessment
and SBU in particular. As a result, the scientific evidence for the report’s conclusions
is limited – or moderately strong at best. The benefits and risks of a number of the
treatment methods reviewed by the project could not be assessed due to a lack of studies
characterised by sufficient quality and internal validity. Such methods include
anticoagulant therapy for intermittent claudication, oestrogen and testosterone therapy,
hyperbaric oxygen therapy, spinal cord stimulation, electromagnetic therapy, ultraviolet
light therapy and intermittent pneumatic compression. Scientific evidence is also lacking
to assess the efficacy of vitamin E, vitamin B / folic acid, Omega-3, garlic and the Padma
28 herbal preparation. WHILE THE PATIENT#ENTITYSTARTX02019;S EXPERIENCE OF SYMPTOMS SHOULD ALWAYS FORM THE BASIS OF DIAGNOSING AND TREATING PERIPHERAL ARTERIAL DISEASE, CLINICALLY RELEVANT STUDIES ARE GENERALLY LACKING THAT COMPARE HOW VARIOUS INTERVENTIONS IMPACT QUALITY OF LIFE: Peripheral arterial disease has a decisive – often disabling – impact on quality of life,
the experience of which varies from person to person. Quality of life, which is among the
key goals of all medical treatment, may be defined as an aggregate measure of physical and
mental functioning, along with a sense of wellbeing and satisfaction. But clinical
practice still takes only limited advantage of opportunities to assess quality of
life, i.e., how the patient deals with daily activities and responds to
treatment. DIAGNOSTIC METHODS: The basic method for diagnosis and assessment of patients with symptomatic peripheral
arterial disease includes assessing medical history with walking distance palpation, and a
simple physical examination with a stethoscope, sphygmomanometer cuff and Doppler probe to
compare blood pressure in the arms and legs. Such examinations, which may be performed at
any health centre or hospital, can identify most patients with peripheral arterial
disease. To more precisely locate stenoses and any thrombi requires additional assessment. While
conventional angiography is still the most common approach, technical progress in recent
years has generated a number of new methods for reliably diagnosing peripheral arterial
disease. These methods are just as dependable as conventional angiography for designing a
treatment strategy, but are gentler, easier, faster and less risky.Duplex ultrasonography has the same high reliability as conventional angiography
when it comes to confirming or ruling out vascular disease in the lower abdominal
aorta, as well as the arteries of the pelvis, thigh and knee. The scientific
evidence is, however, weaker with respect to the certainty of the method for
diagnosing changes in the lower leg and foot. Magnetic resonance angiography (MRA) using an injected contrast agent has the same
high reliability as conventional angiography when it comes to confirming or ruling
out vascular disease in the abdominal aorta below the kidneys, as well as the
arteries of the pelvis and thigh. The scientific evidence is not as strong in terms
of identifying stenoses in the arteries of the lower leg. MRA that does not use an injected contrast agent has the same high reliability as
conventional angiography when it comes to confirming or ruling out vascular disease
in the arteries of the thigh and lower leg. MRA is not as reliable for identifying
changes in the abdominal aorta below the kidneys and in the pelvic arteries. Computed tomographic angiography (CTA) has the same high reliability as
conventional angiography when it comes to confirming or ruling out vascular disease
in all blood vessels, from the abdominal aorta to the arteries of the foot. TREATING INTERMITTENT CLAUDICATION: No drug has been approved in Sweden for specifically treating peripheral arterial
disease, and there is no therapy that can be said to cure the condition. Nevertheless, the following has been established:Physical training, walking or Nordic walking – particularly when organised or
supervised – improves walking distance. Revascularisation, which is an intervention intended to restore or improve blood
flow, should generally be avoided. But there is limited scientific evidence that
open revascularisation in claudication patients with disabling symptoms may be
somewhat more effective than walking training. Percutaneous transluminal angioplasty (PTA) with selective placement of a stent is
cost-effective in comparison with other revascularisation methods that were
reviewed. There is limited scientific evidence that Ginkgo biloba, a natural
remedy, and levocarnitine can improve walking distance. There is limited scientific evidence that intravenous prostaglandin E1 increases
walking distance. TREATING CHRONIC CRITICAL LIMB ISCHAEMIA: Patients who have symptoms of critical limb ischaemia must receive prompt treatment to
relieve the pain and minimise or eliminate the risk of deterioration leading to ulcers and
tissue death (gangrene).Open or endovascular revascularisation using thrombolysis therapy or PTA should be
offered when critical limb ischaemia may lead to amputation. Adjunctive therapy using a platelet inhibitor or vitamin K antagonist whose
(warfarin) improves results after revascularisation therapy. Adjunctive therapy using a vitamin K antagonist causes more bleeding complications
than platelet inhibitor. TREATING ACUTE LIMB ISCHAEMIA: Acute limb ischaemia is caused by abrupt occlusion of a major artery. The patient often
experiences severe pain. Treatment must start immediately. The leg may have to be
amputated.Immediate invasive treatment normally permits amputation-free survival for many
years. There is no decisive difference between open surgical intervention and endovascular
revascularisation through the blood vessels (thrombolysis therapy) in terms of
amputation-free survival. Acute limb ischaemia often occurs at the end of life. In such cases, lower limb
ischaemia results from a gradual slowdown in the functioning of the organs. Surgery
is not indicated, and pain relief may be the proper treatment from a medical and
compassionate point of view. ETHICAL ASPECTS: Following are some of the ethical issues that must be taken into consideration when
diagnosing and treating peripheral arterial disease:Reconstructive procedures for critical and acute limb ischaemia are often
associated with the risk of serious complications, as well as death in some cases.
Such risks must be weighed against the opportunity to improve health and quality of
life. One problem in particular is that caregivers may have difficulty refraining from
the use of new methods even when the documentation is substandard or incomplete. A patient’s lifestyle, such as continued smoking, must not lead to discriminatory
treatment. While attempts to avoid amputation are a worthy goal, they must be weighed against
risks and suffering in patients for whom it may turn out to be necessary after all.
Resource utilisation is also an ethical issue in such cases. SURVEY OF CLINICAL PRACTICE: Diagnosis, medical treatment and referral procedures for peripheral arterial disease
patients in primary care can be improved. The disease is an uncommon diagnosis in Swedish
primary care. Many patients are referred for diagnosis and assessment prior to possible
intervention, but only a few undergo invasive treatment. SBU’s survey of clinical practice
also reveals major regional differences in the number of patients who are referred for
such diagnosis and assessment. Educational efforts, as well as guidelines for diagnosis and treatment of peripheral
arterial disease in primary care, would raise awareness about patients with vascular
disease who are at high risk of cardiovascular disease and death. ASSESSMENT AND REPORTING: Major inadequacies remain when it comes to assessing new technologies. Systematic efforts
in that area should be given high priority. The results of treatment should be reported to, and compiled in, a central registry. For
the past 20 years, most vascular surgery – including radiological interventions such as
throm- bolysis therapy and PTA – has been reported to the Swedish Vascular Registry
(Swedvasc). Amputation due to peripheral arterial disease is however not systematically
reported to the registry. RESEARCH NEEDS: Multicentre randomised trials could be arranged in Sweden to address two key
questions:Which therapy is better for intermittent claudication – intervention or walking
training and best medical treatment? Which therapy is better for critical limb ischaemia – surgical/endovascular
intervention or best medical treatment?