The Society for Vascular Technology of Great Britain and Ireland PHYSIOLOGICAL MEASUREMENT SERVICE SPECIFICATIONS Vascular Technology Arterial Duplex - lower limb, upper limb, assessment of bypass graft/stent patency This investigation uses ultrasound to image and assess flow in the major arteries of the lower or upper limbs. An ultrasound probe is used to scan the legs or arms to assess the location, extent and type of any occlusive or aneurysmal disease of the major arteries. For the lower limbs, the arteries can be scanned from the aorta in the abdomen down to ankle and where appropriate onto the foot. For the arms, the arteries can be scanned from the neck down to the wrist and where appropriate into the hand. Arterial disease is less common in the arms than in the legs. This test is also used for surveillance following interventions such as a bypass graft or stent. It is used to identify the location, extent and severity of arterial disease in order to facilitate clinical or surgical management decisions. Patients, who experience pain in the legs on walking (claudication), in arms on movement or have pain in the limbs at rest and/or ulceration may require this investigation. Note: For leg assessments the measurement of ankle brachial pressure index (ABPI) is a good indicator of whether disease is present or not and its severity. This is often carried out prior to a duplex examination. Where ABPI have not been already been measured, they will often be done at the same time as the duplex investigation. 1. PATIENT PATHWAY An Arterial Duplex assessment is a major diagnostic test in the pathway of patients with suspected lower or upper limb arterial disease, and particularly where any intervention may be needed. It is used in surveillance programs to follow up patients who have had an intervention such as a bypass graft or stent. Guidance is given to implementation of duplex in the National Institute for Clinical Excellence (NICE) publication’ lower limb peripheral arterial disease diagnosis and management cg147’ 20121 and Vascular Society Great Britain and Ireland document The Provision of Services for Patients with Vascular Disease 20122 2. REFERRAL Clinical Indications Page 1 of 8 These include: Investigation or follow-up of patients with claudication or ischaemic symptoms e.g. rest pain and/or arterial ulceration Assessment of patients with known arterial disease Pre-procedure assessment for planning of intervention Follow-up to determine technical adequacy of intervention i.e. post angioplasty and/or stent placement Follow-up of bypass grafts to detect intrinsic stenosis or progression of disease, which may threaten graft patency Evaluation of aneurysm, pseudoaneurysm, arterial-venous fistula Evaluation of arterial trauma Further guidance is given in the Society for Vascular Ultrasound (SVU) professional performance guidelines for vascular technology ‘Upper extremity arterial duplex evaluation’3 ‘Abdominal aorto-iliac arterial duplex evaluation’4 and ‘Lower extremity arterial duplex evaluation’ 5 Contra indications Scans may be limited due to high body mass index (BMI) and in the presence of ulcers, wounds, bandaging or casts. 3. EQUIPMENT Specification A high resolution imaging ultrasound duplex scanner which has colour, power and pulsed Doppler modalities is required. A midrange (covering nominal frequencies of 4-7MHz) linear array transducer (probe) should be available for scanning the leg below the groin and for scanning the arm. A lower frequency transducer (covering nominal frequencies of 2.5–4MHz) should be available scanning the aorto-iliac segment (above the groin). A highfrequency linear array transducer (covering frequencies above 7MHz) may be useful for scanning the forearm arteries. There should be facilities to record images/measurements6. The Royal College of Radiologists (RCR) has more detailed technical standards for ultrasound equipment7. It should be noted that a range of relatively low cost portable scanners is now available, not all of which will suitable for vascular work. It is important that the duplex scanner is of ergonomic design as explained in the health and safety section to minimise the risk of operator work related musculoskeletal disorders8. Maintenance Equipment should be regularly safety-tested and regularly maintained in accordance with the manufacturer’s recommendations. Further information is available from the British Medical Ultrasound Society (BMUS): ‘Extending the provision of ultrasound services in the UK’9. Quality Assurance (QA) and Calibration QA procedures should be in place to ensure a consistent and acceptable level of performance of all modalities of the duplex scanner. Such procedures are likely to be set up with involvement from Medical Physics Departments or service engineers as they require specialist skills and will require both imaging and flow phantoms. Detailed guidance on the QA of the imaging modality of duplex scanning is contained in the Institute of Physics and Engineering in Medicine (IPEM) Quality Assurance of Ultrasound Imaging Systems report 10210. The IPEM report 70 Testing of Doppler Page 2 of 8 Ultrasound Equipment, contains extensive information relating to performance testing of the pulsed and colour Doppler modalities of duplex scanners11. Further general guidance is available in ‘Guidelines for Professional working standards: Ultrasound practice’12. Set up procedures An appropriate probe should be selected. All duplex control settings should be set to defaults appropriate for peripheral arterial investigation. Equipment manufacturers will normally provide appropriate default peripheral arterial settings. Infection control There are no nationally agreed standards for vascular ultrasound scanning but local infection control policies should be in place. BMUS13 advises that users should refer to manufacturer’s instructions for the cleaning and disinfection of probes and transducers and general care of equipment. It should be noted that ultrasound probes can be damaged by some cleaning agents and so manufacturer’s specifications should always be followed. Sterile ultrasound gel and sheaths should be available and used in appropriate cases. Accessory equipment Examination couches and scanning stools/chairs must be of an appropriate safety standard and ergonomic design to prevent injury, particular consideration should be given to reducing the risk of operator work related musculoskeletal disorders7. 4. PATIENT Information and consent There is no legal requirement that written patient consent be obtained prior to an extracranial carotid arterial duplex examination. However, patients should be fully informed about the nature and conduct of the examination so that they can give verbal consent. It is desirable that this information is provided in written format and is given prior to their attendance14. This information should also be verbally explained to the patient when they attend for the investigation. Examples of additional patient information to include can be found at the RCR http://www.rcr.ac.uk/docs/patients/worddocs/CRPLG_US.doc The Circulation Foundation produces leaflets which provide further information to patients: www.circulationfoundation.org.uk. Clinical history The written referral for the investigation should contain relevant clinical history. But this information should be verified and clarified for any discrepancies This should include any symptoms or history of lower or upper extremity arterial disease and details of any previous interventions e.g. angioplasty, stent insertion or bypass graft. The nature and duration of symptoms should be established; and relevant risk factors established e.g. hypertension4 5 6. Preparation No specific preparation is required for scanning the leg arteries below the groin6 or for scanning the arteries of the arm4. Access will be required to the patient’s legs or arms. Scanning may be difficult in patients with leg ulcers or open wounds or high BMI. Sterile dressings or cling film will allow imaging over these sites. Bowel gas often makes imaging of the aorta and iliac segment5 (the arteries in the abdomen which supply the legs) difficult. Some centres use advanced preparation, such as fasting for 6 hours prior to the scan, in Page 3 of 8 order to improve imaging of these vessels. Particular care should be taken with any advice given to diabetic patients prior to a scan appointment. 5. ENVIRONMENT A private room (or curtained off area in a larger multiscan bay unit) is required to carry out the scan which should be darkened, with no natural light entry, and preferably dimmer switch lighting. Air conditioning may be required due to heat production from the scanning equipment. The ultrasound manufacturer should supply appropriate guidance on air conditioning requirements. Further general guidance on the environment is given in the BMUS documents: Extending the provision of ultrasound services in the UK and Guidelines for Professional Working Standards Ultrasound Practice8. On occasion, assessment for lower or upper limb arterial disease may also need to be carried out in other localities e.g. in theatre, theatre recovery or at the patient’s bedside. These scans may be somewhat limited due to poor environmental conditions. 6. PROCEDURE The request will specify whether one or both limbs should be scanned. The transducer is positioned on the leg, arm or on the abdomen. The transducer is manipulated to obtain optimal images of the arteries. The major arteries of the limbs, and where appropriate the arteries in the abdomen supplying the legs, should be imaged to visualise any areas of pathology. Flow in these arteries should be assessed using the colour and pulsed Doppler modalities. Further guidance is given in the SVU professional performance guidelines for vascular technology ‘Upper extremity arterial duplex evaluation’4 ‘Abdominal aortoiliac arterial duplex evaluation’5 and ‘Lower extremity arterial duplex evaluation’6. The referral will indicate any specifically required additional investigation, such as thoracic outlet syndrome15 or popliteal entrapment16, where the limbs need to be evaluated in particular positions. Protocol A local protocol should be set up in accordance with professional guidelines4 5 6. It is important to follow the sequence of events outlined in the protocol to avoid missing important information. As a minimum, the leg examination should include assessment of the common femoral, superficial femoral, popliteal and calf arteries. In addition, the aorta-iliac arteries may be examined where the referrer or the local protocol specifies this or where findings or symptoms indicate disease may be present in this segment. For bypass grafts, the entire length of the graft should be scanned paying particular attention to the anastomoses. The inflow and outflow should also be assessed. Similarly, for stent insertions, particular attention should be given to imaging and assessing flow through the stent together with an assessment of the inflow and outflow to the stented area. Ankle brachial pressure indices may also be included in the protocol, particularly where these measurements have not been carried out prior to this investigation. As a minimum, the arm examination should include assessment of the subclavian, axillary, brachial, radial and ulnar arteries. For both leg and arm examinations, any areas where the colour flow Doppler appears disturbed should always be interrogated with pulsed Doppler. The highest peak systolic velocity should be measured at the site of the disturbance or narrowing (Vs) and in a normal area of the artery just proximal to the narrowing (Vp). Care should be taken to 0 ensure that the Doppler angle is 60 or less when recording velocity measurements. Page 4 of 8 Documentation It is recognised that ultrasound scanning is operator dependent and recording of images may not fully represent the entire examination. Recording of images should be done in accordance with a locally agreed protocol. Images that document the findings of the investigation are appropriate. Any stored images should have patient identification, examination date, organisation and department identification. Further explanation and guidance is given in section 4 of the UKAS Guidelines and SVT image storage guidelines11 5. The extent, location and morphology of any areas of plaque together with an indication of the degree of any stenosis should be documented. The diameters of any areas where the vessel appears dilated should be documented. A description of the shape of the Doppler waveforms at different locations should be included. 7. INTERPRETATION & REPORT Criteria The main criterion used to grade the degree of narrowing in a lower limb artery is the ratio of Vs to Vp, known as the peak systolic velocity (PSV) ratio. The PSV ratio is used to grade the severity of the narrowing. A PSV ratio of greater than 2 is used to define a stenosis (narrowing) that is causing a greater than 50% reduction in the diameter of the 1. artery1718 Changes in the shape of Doppler waveforms are important criteria in determining the presence of disease. Multiphasic waveforms are representative of normal flow, whereas monophasic/damped waveforms usually represent diseased flow. Criteria for arm arteries are less well established, but it is widely acknowledged that the same increased PSV ratios used for legs can be applied. Providers should take into consideration the criteria used by other local organisations when agreeing upon criteria to be used. This will help reduce the repeat testing that often occurs when a patient is referred to another organisation. Minimum report content There are no specific recommendations for the structure and content of reports for upper and lower arterial scans, but many referrers find a pictorial report with written conclusions helpful. However, any evidence of plaque formation within the vessel lumen, wall calcification or dilatation should be documented in the report together with severity and location. Comments on the shape of the Doppler waveform at different locations should be included in the report. Where the investigation was a surveillance or follow up scan of an intervention, the report should give details of the intervention and should specifically comment on the patency and flow in the region of the intervention. The report should note the timing of the next surveillance scan. The report should be signed by the operator carrying out the test. Where a computer generated reporting system is used, the verification and authorisation procedure should be followed. The report should be made available to the referring clinician on the day of the test. Any urgent findings, , should be brought to the attention of the referring clinician immediately. 8. WORKFORCE It is well recognised that ultrasound diagnosis is highly operator-dependent, and it is essential that the workforce has the appropriate competencies and underpinning knowledge. This is achieved by ensuring the workforce has followed recognised education and training routes. This applies to both medically and non-medically qualified individuals. Education and training requirements Page 5 of 8 All staff carrying out and reporting investigations should have successfully completed one of the following education and training routes: (i) Full SVT accreditation (Accredited Vascular Scientist) http://www.svtgbi.org.uk/assets/Uploads/Education/EdComm-Accreditation-2012v1.pdf (ii) Post graduate qualification in ultrasound imaging from a Consortium for Accreditation of Sonographic Education (CASE) accredited course with successful completion of a vascular module which has included clinical competency in venous duplex scanning. A list of CASE accredited courses can be found at www.caseuk.org (iii) Radiologists, medical and surgical staff should have successfully followed the RCR recommendations for training in vascular scanning to level 2 competencies in peripheral extremity veins (Ultrasound training recommendations for medical and surgical specialties. BFCR(05)2 www.rcr.ac.uk/docs/radiology/pdf/ultrasound.pdf (iv) Completion of the NHS Scientist Training Programme specialising in Vascular Science and statutory registration as a Clinical Scientist with the Healthcare Professions Council (HCPC). http://www.nshcs.org.uk/assessment/learning-guides-2/ Regulation It is important that both employees and employers are aware that although ultrasonography is not currently a regulated profession, there is a move towards statutory regulation of all healthcare science groups in the future. Current statutory or voluntary registration includes: (i) Registered on the SVT Voluntary Register (ii) UK Registered Physicians on the General Medical Council (GMC) Specialist Register (iii) Registered Clinical Scientist with Health Care and Professions Council (HCPC) (iv) Registered on the National Voluntary Register for Sonographers held by the Society & College of Radiographers (SCoR) Maintaining competence It is important that scanning competence is maintained by all personnel performing this investigation either by performing a minimum number of scans each year or through a CPD scheme. Criteria for ensuring continuing competence are set by the professional bodies. Continuing Professional Development (CPD) Staff must undertake continuing professional development, to keep abreast of current techniques and developments, and to renew and extend their skills. I. SVT accredited staff must maintain their accreditation by meeting the CPD requirements of the SVT: http://www.svtgbi.org.uk/assets/Uploads/Education/EdComm-Accreditation2012-v1.pdf II. Staff with a post graduate qualification in ultrasound imaging should meet the CPD requirements of SCoR registration: http://www.sor.org/learning/document-library/continuing-professionaldevelopment-professional-and-regulatory-requirements III. Medical and surgical staff should follow the requirements outlined for maintenance of skills as well as the need to include ultrasound in their ongoing CME: www.rcr.ac.uk/docs/radiology/pdf/ultrasound.pdf IV. For Clinical Scientists maintain registration with CPD through the HCPC Page 6 of 8 9. AUDIT, SAFETY & QA Safety The provider should be aware of the guidelines for the safe use of ultrasound equipment produced by the Safety Group of BMUS. In particular, they should be aware of ultrasound safety precautions related to vascular scanning. All staff should be aware of local safety rules and resuscitation procedures. Sonographers are at risk of work related musculoskeletal disorders. To minimise this risk the scanner and its control panel, the examination couch and scanning stool must be of appropriate safety standard and ergonomic design. The published document by the Society of Radiographers (SCoR) ‘Prevention of Work Related Musculoskeletal Disorders in Sonography’7 gives clear guidance on this issue as well as ’Guidelines for Professional Working Standards Ultrasound Practice’11 QA and Audit There are no specific requirements, but a mechanism of audit/quality control to ensure patients continue to receive high level of diagnostic accuracy should be in place. QA and audit programs should cover: The BMUS document8 and UKAS Guidelines11 also give guidance. Equipment QA is covered in section 3 of this document. Websites: www.rcr.ac.uk www.bmus.org www.svtgbi.org.uk www.svunet.org www.case-uk.org www.ipem.ac.uk www.hpc-uk.org www.rcplondon.ac.uk www.vascularsociety.org.uk www.circulationfoundation.org.uk www.sor.org www.nice.org.uk References: 1 NICE guideline Lower Limb Arterial Disease Diagnosis and Management: http://publications.nice.org.uk/lower-limb-peripheral-arterial-disease-diagnosis-and-management-cg147 2 Vascular Society Great Britain and Ireland The Provision of Services for Patients with Vascular Disease 2012 http://www.vascularsociety.org.uk/library/vascular-society-publications.html 3 Society for Vascular Ultrasound Professional Performance Guidelines; Upper extremity arterial duplex evaluation www.svunet.org/files/positions/UE-Arterial-Duplex-2011.pdf 4 Society for Vascular Ultrasound Professional Performance Guidelines; Abdominal aortoiliac arterial duplex evaluation. www.svunet.org/files/positions/Abdominal-AortoIliac-Duplex-2011.pdf 5Society for Vascular Ultrasound Professional Guidelines; Lower extremity arterial duplex evaluation. www.svunet.org/files/positions/0809-LowerExtremArterialD.pdf 6SVT Guidance on Image Storage and use, for the vascular ultrasound scans 2012 www.svtgbi.org.uk/assets/Uploads/Resources/Final-SVT-Image-Storage-Guidelines-April-2012-PDF.pdf 7Standards for Ultrasound Equipment’ Royal College of Radiologists 2005 www.rcr.ac.uk/docs/radiology/pdf/StandardsforUltrasoundEquipmentJan2005.pdf pages 15-17 Page 7 of 8 ‘Prevention of Work Related Musculoskeletal Disorders in Sonography - Society of Radiographers 2007 Extending the provision of ultrasound services in the UK’ BMUS 2003 http://www.bmus.org/policiesguides/pg-protocol01.asp 10 Quality Assurance of Ultrasound Imaging Systems’ IPEM report 102 2010 11 Testing of Doppler Ultrasound Equipment’ IPEM report 70 1994 12 Guidelines for Professional Working Standards Ultrasound Practice. www.bmus.org/policies-guides/SoRProfessional-Working-Standards-guidelines.pdf 13 www.bmus.org/policies-guides/pg-clinprotocols.asp 14 Improving Quality in Physiological Sciences (IQIPS) Standards and Criteria http://www.iqips.org.uk/documents/new/IQIPS%20Standards%20and%20Criteria.pdf 15 Vascular Ultrasound How, Why and When Thrush Hartshorne Third Edition 2010 Chapter 10 Duplex Assessment of upper-limb arterial disease 16 Vascular Ultrasound How, Why and When Thrush Hartshorne Third Edition 2010 Chapter 9 Duplex Assessment of lower-limb arterial disease 17 Cossman D, Ellison J E, Wagner W H et al 1989 Comparison of contrast arteriography to arterial mapping with colour-flow duplex imaging in the lower extremities. Journal of Vascular Surgery 10: 522-529 18 Sensier Y., Hartshorne T, Thrush A et al 1996 A prospective comparison of lower limb colour-coded duplex scanning with arteriography.’ European Journal of Vascular and Endovascular Surgery 11:170-175’ 8 9 th Final Version 6 August 2010 Version I.I SVT Professional Standards Committee November 2012 Page 8 of 8