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Implementing NICE guidance

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1 Implementing NICE guidance
The VeriQ system for assessing graft flow during coronary artery bypass graft surgery Implementing NICE guidance NOTES FOR PRESENTERS: ABOUT THIS PRESENTATION: This presentation has been written to help you raise awareness of the NICE medical technology guidance on VeriQ. This guidance has been written for clinicians who carry out coronary artery bypass graft surgery (CABG) and those who manage and commission CABG procedures. You can add your own organisation’s logo alongside the NICE logo. We have included notes for presenters, broken down into ‘key points to raise’, which you can highlight in your presentation, and ‘additional information’ that you may want to draw on, such as a rationale or an explanation of the evidence for a recommendation. Where necessary, the recommendation will be given in full. This slide set contains a hyperlink to an additional slide containing further details of the studies used in developing the guidance. This link works in slide set mode, by left clicking the mouse when the mouse has turned to a hand (when over the link), or when in editing mode, right click the mouse and select open link. Once you have returned to the main slide set after visiting the reference page continue to move through the slides in the normal manner. DISCLAIMER This slide set is an implementation tool and should be used alongside the published guidance. This information does not supersede or replace the guidance itself. PROMOTING EQUALITY Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. November 2011 NICE medical technology guidance 8

2 What this presentation covers
Background Guidance Using the device Costs and savings Discussion Accessing the guidance and implementation tools NOTES FOR PRESENTERS: In this presentation we will start by providing some background to the guidance and why it is important. We will then present the guidance and provide some detail regarding practical use of the device. This has been taken from the guidance and the manufacturer’s user manual. Next, we will summarise the costs and savings that are likely to result from in implementing the guidance. Then we will open the meeting up with a list of questions to help prompt a discussion on local issues for incorporating the guidance into practice. Finally, we will end the presentation with further information about the support provided by NICE. Image: The VeriQ 19 inch micro-computer mounted on a moveable trolley Additional information: The user manual referred to in this slide set is the manual for Mod. VQ4122 VQ2111 VQ1111 VQ4001 VQ2011 VQ1011 VQ1001 Software ver. 3 series . Manual reference: VQ1990GB_rev.F accessible here All images in this presentation reproduced with kind permission of MediStim ASA

3 Background: medical technologies guidance
NICE medical technology guidance addresses specific technologies notified to NICE by manufacturers The case for adopting the technology is supported if the technology has been found to offer advantages to patients and the NHS The specific recommendations on individual technologies are not intended to limit use of other relevant technologies that may offer similar advantages NOTES FOR PRESENTERS: Key points to raise: The Medical Technologies Evaluation Programme supports the Medical Technologies Advisory Committee and focuses specifically on evaluating innovative medical technologies (including devices and diagnostics). This programme is part of the Centre for Health Technology Evaluation at NICE. This new programme complements the work already undertaken by NICE’s existing technology appraisal programme, which evaluates new pharmaceutical and biotechnology products; the interventional procedures programme, which looks at the safety and efficacy of new surgical procedures; and the diagnostic assessment programme. The medical technologies programme is designed to help the NHS adopt efficient and cost-effective medical technologies more rapidly and consistently. The types of products that might be evaluated are medical devices that deliver treatment - such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. NICE medical technology guidance addresses specific technologies notified to NICE by manufacturers. The ‘case for adoption’ recommendations are based on the claimed advantages of introducing the specific technology compared with current management of the condition. This ‘case’ is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies that may offer similar advantages.

4 Background: current clinical practice
Coronary artery disease: atherosclerosis occluding coronary arteries common cause of symptoms, disability and death Coronary artery bypass graft (CABG) surgery uses grafts to bypass narrowed or blocked arteries Graft dysfunction is a major determinant of perioperative morbidity and mortality after CABG Graft flow assessment usually subjective Objective methods (such as transoesophageal echocardiography, ECG, angiography) also used to give indirect information about technical success NOTES FOR PRESENTERS: Key points to raise: Coronary artery disease is a common cause of symptoms, disability and death. It is caused by atherosclerosis, which leads to stenosis or occlusion of the coronary arteries. NICE clinical guideline 126, on the management of stable angina, recommends that that revascularisation of the blocked coronary arteries using CABG or percutaneous coronary interventions should be considered in people whose symptoms are not satisfactorily controlled by medical treatment and NICE clinical guideline 94, on unstable angina and NSTEMI, refers to CABG as a possible revascularisation strategy. (www.nice.org.uk/guidance/CG126 section 1.5 and section 1.5). CABG aims to bypass narrowed or blocked segments of the coronary arteries using grafts. Grafts are usually lengths of the patient’s long saphenous vein from the leg or their internal thoracic artery, although other vessels are also used. Graft dysfunction is a major determinant of perioperative morbidity and mortality after CABG. The majority of graft failures in the perioperative period are a result of technical imperfections that, if recognised, may be corrected at the time of surgery. Cardiac surgeons use a variety of techniques to avoid imperfections during CABG, but assessment of graft flow is usually subjective. Techniques vary according to the graft used, the surgical technique, and the surgeon’s individual preference. They include the surgeon assessing resistance and perfusion beyond a graft by flushing fluid through it before restoring flow; and observing and palpating grafts and coronary arteries for pulsation when blood flow has been re-established. There are also a number of methods of objective assessment that provide indirect information about the technical success of bypass grafts. Transoesophageal echocardiography (ToE) evaluates heart function after bypass by assessing regional left ventricular wall motion abnormalities, which can be compared with preoperative regional left ventricular function. Perioperative graft flow can be visualised in the operating theatre using conventional angiography (usually used postoperatively) or using indocyanine green fluorescence (usually used intraoperatively). NICE interventional procedure guidance 98, ‘Intraoperative fluorescence angiography in coronary artery bypass grafting’, states that ‘current evidence suggests that the procedure is safe enough for routine use in the evaluation of coronary artery bypass graft patency’.

5 Background: VeriQ For non-invasive assessment of graft blood flow during CABG Probe and microcomputer with touch screen, on a moveable trolley Two probe types (PS and PQ); guidance focuses on PS probes (compatible with common NHS sterilisation techniques) Probes deliver bidirectional ultrasound across target vessel; analysis of returning signal gives real time flow curve, mean blood flow, pulsatility index and diastolic filling percentage NOTES FOR PRESENTERS: Key points to raise: The VeriQ system (MediStim ASA) is intended for use in patients with coronary artery disease and uses ultrasound for the non-invasive assessment of graft blood flow during CABG surgery. It measures three parameters (mean blood flow in ml/minute, pulsatility index and diastolic filling percentage) to assess graft blood flow and check patency. The VeriQ system measures transit time volume flow using specially designed probes. A microcomputer with a 19‑inch touch screen mounted on a moveable trolley is used to control the probes and store their outputs. For assessment of blood flow during CABG procedures the VeriQ system uses two types of probes (the PS and PQ), which differ in the number of recommended reuses and the method of sterilisation . This guidance considers only the PS probe, because the PQ probe requires ethylene oxide sterilisation, which is not widely available in the NHS. The probes deliver a bidirectional ultrasound beam across a target vessel and the system analyses the returning signal to calculate the blood flow through the vessel at the default filter setting of 20 Hz. A real-time flow curve is displayed, together with the mean blood flow in ml/minute, pulsatility index and diastolic filling percentage. This information can be used to determine whether flow through the graft and its anastomoses is acceptable. If not, the graft can be explored to detect imperfections and revised as necessary to achieve acceptable  blood flow.

6 Click here for further information about evidence reviewed
Guidance The case for adopting the VeriQ system in the NHS for assessing graft flow during CABG is supported by the evidence Intraoperative transit time flow measurement detects imperfections that may be corrected by graft revision May reduce graft occlusion, perioperative morbidity and mortality NOTES FOR PRESENTERS: Recommendations in full: The case for adopting the VeriQ system in the NHS for assessing graft flow during coronary artery bypass graft (CABG) surgery is supported by the evidence. The evidence suggests that transit time flow measurement is effective in detecting imperfections that may be corrected by intra-operative graft revision. This may reduce the incidence of graft occlusion and may reduce perioperative morbidity and mortality. [1.1] Related recommendation: The VeriQ system is associated with a cost saving of £115 per patient compared with clinical assessment, when it is used routinely for assessing coronary artery bypass grafts during surgery. [1.2] Overview of the evidence: Evidence for clinical effectiveness for VeriQ was based on two retrospective observational studies and one comparator study. The Committee recognised limitations in the available evidence. The main studies were observational, with potential for bias. The study by Kieser et al. (2010) investigated the VeriQ system on arterial grafts only, whereas in the NHS the majority of CABGs are vein grafts. Nevertheless, the Committee judged that there was sufficient additional evidence relating to predecessor devices and sufficient expert advice to support the expectation that routinely revising all appropriate grafts on the basis of VeriQ measurements would result in reduced perioperative graft occlusions and consequent complications. The Committee noted from the study by Nordgaard et al. (2010) that pulsatility index values from the VeriQ system may differ from those of other machines and are influenced by filter settings. However, these differences are systematic and expected to be predictable.  Additional information: Please note the overall cost quoted in 1.2 above is slightly different from the costs in the costing template and slides 9,10 and 11 because of a slight difference in the aims and methods of the cost modeling. Image: Flow graph image Click here for further information about evidence reviewed

7 Committee considerations
Perioperative adverse cardiac events resulting from graft failure cause serious complications which require subsequent interventions prolonged intensive care stays readmission VeriQ, added to other methods of assessment, is likely to detect technical graft problems and has the potential to reduce graft occlusion rates The ESC and EACTS revascularisation guidelines (2010) recommend graft evaluation by objective methods NOTES FOR PRESENTERS: Key points to raise: The Committee noted the following points: Perioperative myocardial infarction resulting from graft failure may cause serious complications such as left ventricular dysfunction, ventricular arrhythmias and haemodynamic instability. These complications may: necessitate a prolonged stay in an intensive therapy unit need interventions such as intra-aortic balloon pumping, coronary angiography and early reoperative CABG surgery lead to readmission to hospital. The available evidence supported the claim that transit time flow measured by the VeriQ system can identify grafts that have reduced flow as a result of technical imperfections. Cardiac surgeons use a variety of methods to minimise and detect technical imperfections during CABG surgery but these may have limitations. On the basis of the evidence, the Committee judged that the routine use of VeriQ, as an adjunct to other methods of assessment such as trans-oesophageal echocardiography, electrocardiography and clinical assessment  would be likely to detect technical problems in some grafts that appear to be satisfactory on clinical assessment alone. The available clinical and cost evidence supported the case for adopting the VeriQ system in the NHS for routine intraoperative graft flow assessment in patients having CABG surgery. Clinical outcomes of CABG surgery have improved in the UK in the past 20 years and complication rates are now very low. However, the Committee was advised that there is still a perioperative graft occlusion rate of 1–3%. The Committee considered that the VeriQ system has potential to reduce this graft occlusion rate and so further reduce morbidity and mortality after CABG. The recent joint guidelines on myocardial revascularisation issued by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) (2010) recommended graft evaluation by objective methods before leaving the operating theatre after CABG surgery. These guidelines refer to flow less than 20 ml/minute and a pulsatility index greater than 5 as predicting technically inadequate grafts that need revision before leaving the operating theatre. For more information see page S30, paragraph and table 32

8 Using the device Easy to use Does not increase operative time
Two people to operate: cardiac surgeon and another (can be a member of the surgical team) Probe must be sterilised according to manufacturer’s instructions to achieve maximum repeat uses NOTES FOR PRESENTERS: Key points to raise: The Committee was informed that the VeriQ system is easy to use and does not significantly increase operative time. In the costing model it was estimated that additional time for measuring flow in three grafts was 2.35 minutes The system boot-up time is 35 seconds before it becomes fully functional (page 12 of user manual). The manufacturers manual and NICE costing template assumes that the CABG team consists of two cardiothoracic surgeons, one anaesthetist, once cardiac perfusionist and two cardiac nurses. At least two people are needed operate the VeriQ system (one operator and one surgeon). It is anticipated that the second person will be a member of the surgical team. During the procedure it is important that the surgeon and operator maintain good communication to work effectively and get the best possible results. The main task for the operator is to prepare the system before use, adjust the system during operation and to save essential findings (page 15 of user manual). Pages of the manufacturers user manual explain preparations by the system operator, preparation by the surgeon, tasks during the procedure by the operator, tasks during the operation by the surgeon and postoperative procedures for the VeriQ system. The QuickFit probes are used following completion of the bypass graft, to verify patency and measure the graft function (page 8 of user manual). The (QuickFit) PS probes are the focus of this guidance because they are compatible with NHS sterilisation techniques. PS probes are available in different sizes. See section , page 50 of user manual It is essential that the probes are sterilised in accordance with the manufacturer’s instructions (pages 59 and 60 of user manual). PS probes are limited to 30 uses. Probes are deactivated automatically after they have reached their recommended number of reuses (page 29 of user manual). Additional information The link to the manufacturer’s user manual (VQ1990GB_rev.F) was correct at time of publication of the slide set (November 2011). Image: system overview

9 Costs and savings for the NHS
Net cost of implementation for England (population 51.2 million) Recurrent annual  cost/−saving (£) Additional cost of equipment and surgery time from using VeriQ 1,203,723 Savings from reduction in adverse events −2,578,270 Total annual cost/-saving −1,374,547 Total annual cost/-savings per procedure −147 ADAPTING THIS SLIDE FOR LOCAL USE: We are aware that local factors such as incidence and baseline can vary considerably when compared with the national average. NICE has provided a costing template and report for you to calculate the financial impact this guidance will have locally. We encourage you to calculate the local impact of this guidance by amending the local variations in the template, such as incidence, baseline and uptake. You can then remove the national figures from the table and replace them with local figures to present to your colleagues. NOTES FOR PRESENTERS: NICE has worked closely with people within and outside the NHS to look at the major costs and savings related to implementing this guidance. The estimated national annual changes in costs and savings arising from implementing the guidance on VeriQ is an annual saving of £1.4 million for the total population of England. NICE has produced a costing report that provides detailed estimates of the national costs and savings associated with implementing this guidance. NICE has also developed a costing template to calculate the local costs associated with implementing this guidance. The costs and savings per 1,000,000 population are discussed in subsequent slides. The average cost saving per procedure calculated in this template is £147; this is higher than the £115 calculated in the clinical and economic external assessment centre report. The calculations in the costing template use more recent figures for hospital activity and, where available, national tariff rather than reference costs for the unit costs of adverse events. Users are advised to check the assumptions made against the latest local information available when using the costing template. Key assumptions in the costing template: It is assumed that currently VeriQ is used for assessment of graft flow in 5% of CABG procedures and that clinical graft assessment only is used in the remaining 95% of CABG procedures. Following publication of the guidance, the costing template assumes that nationally, VeriQ will be used in 50% of CABG procedures and clinical assessment only in the remaining 50%. The costing template can be adapted for local use and the sensitivity analysis section can be used to explore rations on the cost model assumptions The eligible population for VeriQ is all those undergoing CABG, which is estimated to be 0.04% of the population.

10 Savings from reduction in adverse events
Costs and savings due to reduction in adverse events Costs/−savings per 1,000,000 population (£) Current cost of perioperative myocardial infarction and associated rehabilitation 33,901 Current cost of intra-aortic balloon pumping 84,081 Current costs 117,982 Future cost of perioperative myocardial infarction and associated rehabilitation 17,843 Future cost of intra-aortic balloon pumping 50,198 Future costs 68,041 Net savings from reduced adverse events from guidance implementation −49,941 NOTES FOR PRESENTERS: Key points to raise: It is assumed that the rate of perioperative myocardial infarction following use of clinical assessment alone is 5%, whereas the rate following use of VeriQ is 0%. It is assumed that the rate of intra-aortic balloon pumping following use of clinical assessment alone is 7%, whereas following use of VeriQ it is 1%. Additional information: The costing model does not include potential cost savings from reductions in the length of intensive therapy unit stay, readmission rates or emergency repeated CABG procedures. This is because of the difficulty of quantifying the savings associated with use of VeriQ. The cost savings in these parameters associated with the VeriQ system may therefore have been underestimated. Further savings may be seen from a reduction in the number of excess bed days incurred by CABG patients. These have not been quantified in the costing template because the exact effect of VeriQ on excess bed days is not known. The Committee noted that sensitivity analysis showed that even if VeriQ led to a small change in intra-aortic balloon pump rates it remained cost effective compared with clinical assessment alone – resulting in savings to the NHS.

11 Additional costs of equipment and surgery time
Costs/-savings per 1,000,000 population (£) Total current costs of equipment and surgery time including cost of performing revisions 2,591 Total future costs of equipment and surgery time including costs of performing revisions 25,907 Net additional equipment and surgery time costs from guidance implementation 23,316 Net resource impact from guidance implementation [net additional costs – net savings (slide 10)] -26,625 NOTES FOR PRESENTERS: Key points to raise: Equipment costs The model assumes 220 procedures per device per year, which is a conservative estimate of use. Depending on local set ups, this may be a significant underestimate so the additional costs per procedure of using VeriQ may have been overestimated. PS probes have a 30-use lifespan and the VeriQ device is assumed to have a lifetime of 10 years. Purchase of VeriQ would require a capital investment that is not quantified in this template; however, given the price of £32,000 this is simple to calculate. There is also the option to lease the equipment. The costing template equipment costs include the costs of the device, console, probes and maintenance. Additional time To calculate the cost of the additional time needed to use VeriQ, NICE assumed that it will take 2.35 minutes. This has been considered in relation to the combined salaries of the surgery team, which is composed of two cardiac surgeons, two cardiac nurses, one anaesthetist and one cardiac perfusionist. Additional revisions To calculate the additional costs of revisions, NICE estimated that minor revisions will take 2.5 minutes and major revisions will take 42 minutes. These times have been considered in relation to the combined salaries of the surgery team. It is assumed that using VeriQ will lead to additional minor and major revisions compared with using clinical assessment alone. The costing template estimates that when VeriQ is used there will be 2.3% more minor revisions and 4.3% more major revisions. Net resource impact The savings detailed on slide 10 offset the additional costs of using the device identified in this slide. The net resource impact (of implementing the guidance) for the population of England was detailed on slide 9. The net resource impact per 1,000,000 is a saving to the NHS of £26,625.

12 Discussion What is our current approach to quality assuring graft patency? How can we encourage our colleagues to use this technology? What can we do to facilitate use of VeriQ in our organisation? NOTES FOR PRESENTERS: These questions are suggestions that have been developed to help provide a prompt for a discussion at the end of your presentation – please edit and adapt these to suit your local situation. Contact the manufacturer for information on training.

13 Accessing the guidance and implementation tools online
Visit for guidance costing tools podcast NOTES FOR PRESENTERS: Guidance The guidance is available online from the NICE website. Implementation tools NICE has developed tools to help organisations implement this guidance, which can be found on the NICE website. Costing report and costing template to estimate the savings and costs associated with implementation. Podcast with Mr Peter O’Keefe (Expert Adviser for the Medical Technologies Advisory Committee) and Dr Peter Groves (Vice Chair of the Medical Technologies Advisory Committee) discussing implementing the guidance in practice. Image: QuickFit probe surrounding vessel. The QuickFit probes are used following completion of the bypass graft, to verify patency and the measure the graft function (page 8 of user manual).

14 What do you think? Did the implementation tool you accessed today meet your requirements, and will it help you to put the NICE guidance into practice? We value your opinion and are looking for ways to improve our tools. Please complete a short evaluation form. If you have problems accessing or using this tool, please NOTES FOR PRESENTERS: Additional information: The final slide is not intended to be part of the presentation; it asks for feedback on whether this implementation tool meets your requirements and whether it will help you to put this NICE guidance into practice - your opinion would be appreciated. To open the links in this slide set right click over the link and choose ‘open link’ To open the links in this slide set right click over the link and choose ‘open link’

15 References – additional slide
The following slide is an additional slide containing references and details of the studies reviewed in this guidance. If you used the hyperlinks on slide 6 during the presentation you will have already visited this slide

16 Return to slide 6 containing recommendation
Evidence Keiser et al. (2010) Major adverse cardiac events occurred significantly more often in patients with pulsatility index grater than 5 Becit et al. (2007) Lower incidence of intra-aortic balloon pump insertion and myocardial infarction in the study group (those who had transient time flow measurement during surgery and graft revision if needed based on measurement) Nordgaard et al. (2010) The VeriQ system provided systematically higher pulsatility index values than the transonic device NICE’s external assessment centre reviewed 26 studies on predecessor devices of the VeriQ; the predecessor devices predicted short-term graft failure following CABG surgery and were easier to carry out than other methods NOTES FOR PRESENTERS: Kieser TM, Rose S, Kowalewski R et al. (2010) Transit-time flow predicts outcomes in coronary artery bypass graft patients: a series of 1000 consecutive arterial grafts. European Journal of Cardiothoracic Surgery 38: 155–62. This study looked at 1000 arterial grafts in 336 consecutive patients. Patients were split into 2 groups; those with at least one graft with a pulsatility index less than 5 and those with at least one graft with a pulsatility index greater than 5. Major adverse cardiac events occurred significantly more often in patients with a pulsatility index greater than 5. Becit N, Erkut B, Ceviz M et al. (2007) The impact of intra-operative transit time flow measurements on the results of on-pump coronary surgery. European Journal of Cardiothoracic Surgery 32: 313–8. A study group of 100 patients had transient time flow measurement during surgery. The control group of 100 patients did not. Grafts in 9% of the study group had revisions on the basis of abnormal transient time flow measurement . Incidence of intra-aortic balloon pump insertion for low cardiac output and myocardial infarction was significantly lower in the study group. Nordgaard H, Nordhaug D, Kirkeby-Garstad I et al. (2009) Different graft flow patterns due to competitive flow or stenosis in the coronary anastomosis assessed by transit-time flowmetry in a porcine model. European Journal of Cardiothoracic Surgery 36: 137–42. This study investigated variation in pulsatility index measurement between VeriQ (default filter setting 20Hz) and Transonic (default filter setting (10 Hz). VeriQ system provided systematically higher pulsatility index values than the transonic device. NICE’s external assessment centre reviewed a further 26 studies on predecessor devices of the VeriQ. On balance, the studies showed that transit time flow measurements by the VeriQ system predecessor devices predicted short-term graft failure following CABG surgery and were easier to carry out than other methods. However, assessing graft flow with transit time flow measurement alone may prompt unnecessary graft revision in some cases and there is inadequate evidence about whether transit time flow measurement predicts long-term patient survival.    Return to slide 6 containing recommendation


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