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Review of Vascular Services Key Messages from the Literature (Arterial inpatient procedures) Author: Dr P Stevenson Date: 25 January 2012 Version: 1 Publication/ Distribution: Project Board North Wales Clinicians Review Date: Ongoing Purpose and Summary of Document: This working draft document has been prepared to support BCUHB in its review of vascular services. It considers: Background to the current situation; Key aspects of safety, quality, and sustainability by which proposed service model options generated by the review can be assessed; Guidance and recommendations made by national bodies and authorities. Work Plan reference: N/A Public Health Wales 1. Review of vascular services key messages from the Literature Introduction This paper supports the review of Vascular Services in North Wales. It is one of a number of reviews undertaken by BCUHB, including a review of emergency general surgical services. Currently vascular surgery is a subspecialty of general surgery, though plans are well advanced to secure vascular surgery as a speciality in its own right. In addition to the move towards specialty status for vascular surgery, there are a number of other drivers for undertaking a separate and specific review of vascular services, namely: The introduction in 2012 of a Abdominal Aortic Aneurysm screening programme for men aged 65; The need to provide optimum quality care including emergency care for all vascular surgery; To enable and inform workforce planning; To meet the training requirements that are likely to be mandatory for training locations; The meet the European Working Time Directive; To enable workable model(s) of delivery consistent with recommendations from the other major reviews, particularly emergency surgery. To consider the optimal provision of interventional radiology, specialist anaesthesia and support staff as an integral part of vascular services. 1.1 Aim of Review The key strategic question is, “How should vascular services be configured for North Wales to ensure a sustainable service that addresses national and local strategic policies and drivers?” The remit of the review is: From a population perspective, to: Review the needs of North Wales residents for vascular services; Date: 25.01.12 Version: 1 Page: 2 of 21 Public Health Wales Review of vascular services key messages from the Literature To review the existing service profile, consider relevant literature/evidence for models of provision that address safety, quality and sustainability in the short and long term; To recommend a future service configuration to the BCU Board. This review of the literature focuses on the second of these aims, and specifically to consider relevant evidence for models of provision which are safe and of high quality. The focus of this report is arterial inpatient procedures. 1.2 Background The Vascular Society of Great Britain and Ireland has recently produced a document on the Provision of Services for Patients with Vascular disease.1 The main thrust of the document is to recommend an overall model of service provision, and in addition there are recommendations and statements regarding particular patient groups and procedures, eg carotid artery intervention. In summary the model is: Either a network, or a single fully centralised site but in either case all elective and emergency arterial intervention to happen on a single site, thus developing a high volume arterial hospital providing the following: A 24/7 on-site vascular on call rota for vascular emergencies of 1:6 or greater, covered by vascular surgeons and interventional radiologists; A 24/7 critical care facility; A minimum number of AAA procedures (100 over three years); Audit mortality and aim for 3.5% elective AAA mortality; An onsite vascular laboratory; Dedicated wards and at least one endovascular theatre. Whether a centralised service or a network, a range of services (excluding arterial surgery) would be provided in the non-arterial hospitals. The rationale for this model is the assertion of strong volume outcome data emerging with particularly good evidence for aortic aneurysm surgery2, but also for other procedures including carotid endarterectomy3 and aorto-bifemoral bypass4. Date: 25.01.12 Version: 1 Page: 3 of 21 Public Health Wales Review of vascular services key messages from the Literature It is also asserted that specialist vascular teams involving surgeons, interventional radiologists and anaesthetists achieve superior clinical outcomes.5,6 A further key issue in rural areas are access times. Paras 6.21 and 6.22 of the Vascular Society document1 assert that patient survival after a ruptured aneurysm is much higher following arrival in a non-vascular hospital if the patient is then transferred to the vascular service, and this advantage persists even with up to 4 hours of hypotension. (unless a cardiac arrest) Patients diagnosed with a vascular condition requiring emergency intervention should be diagnosed and referred within one hour of arrival and the transfer time should also be less than one hour. In other words the target time for arrival at spoke hospital to vascular unit is under 2 hours. There are therefore three key questions, for which the evidence base needs to be examined in detail, namely: The evidence for high volume/better outcome; The evidence for combined teams/better outcome; The evidence for survivable transfer times to a vascular unit for definitive assessment and treatment. 1.3 Methods In view of the short time scales available to produce a summary report of the evidence, a method drawn from an approach known as rapid appraisal was used. The key steps included: A rapid scope and scan of the literature – key NHS/International evidence sources (eg NICE, Royal Colleges, Cochrane Reviews and Health Technology Assessments, NCEPOD reports); A more detailed search carried out by the Library, Knowledge Management service of Public Health Wales focussed on the three questions above; Identification of a group of key clinicians with expertise in vascular services, including vascular surgeons, interventional radiologists, and specialist anaesthetists. (an expert stakeholder group); Date: 25.01.12 Version: 1 Page: 4 of 21 Public Health Wales Review of vascular services key messages from the Literature Key evidence sources discussed with the stakeholder group and other sources of intelligence identified; Triangulation to the check the reliability of information gathered; Feedback of collated findings to the stakeholder group and the project board to allow checking of drafts and correct misinterpretations. This pragmatic approach allows for ongoing review and updating as further evidence becomes available. 2. The Evidence In assessing the evidence of models of vascular care it is imperative to assess which model(s) of service provision provides the safest outcomes for patients, specifically the lowest possible operative mortality following vascular procedures. In addition services should be provided to minimise other adverse outcomes such as stroke and limb amputation. The review is in large part driven by the need to respond to screen detected aneurysms in the new aortic aneurysm screening programme (although AAA work is but a part of the wide range of vascular interventions now possible). In the AAA programme men, who believing themselves to be well are screened, and then invited to surgery. The only way this can be ethically acceptable is to ensure that the surgery offered gives the lowest possible mortality rates which can be achieved with optimal modern techniques, equipment and training. 2.1 Evidence regarding Volume/Outcome There are numerous studies looking at the relationship between volume and outcome for vascular surgical procedures. Three key reports highlighted below attempt to synthesize the evidence for AAA repair (The first also looks at CE). The first paper reviews studies which are now somewhat historical, but it is included as it was a major and thorough review at the time. All three reports refer to open surgical repair rather than endovascular procedures which have become more common in recent years. Date: 25.01.12 Version: 1 Page: 5 of 21 Public Health Wales Review of vascular services key messages from the Literature Report 1 A Health Technology Assessment published in 20007 reviewed 36 papers published between 1986 and 1998 looking at the relationship between volume and outcome. A recurring theme is the need to minimise bias in volume-outcome studies, so that account is taken of any other factors other than volume that are likely to affect patient outcomes. Of the 36 studies identified in the search, 17 were concerned with carotid endarterectomy, 16 concerned AAA repair, and four were concerned with other vascular interventions. When taken together, the CE studies were supportive of a positive volume-outcome relationship existing at the physician level for both mortality and stroke, but the weight of evidence was less conclusive when consideration was restricted to those studies which made a full adjustment for case-mix. Indeed there was no clear support either way. For unruptured AAAs, the evidence supported the existence of a positive volume-outcome relationship at both hospital and physician level. For ruptured aneurysms the weight of evidence was against there being a positive volume relationship at the hospital level, while for physicians there was no clear support either way. For “other vascular interventions” there were insufficient studies to draw conclusions. The authors of the report acknowledge that all but two of the studies considered were based on retrospective data. They point out that the ideal would be randomised trials, but these would be difficult to undertake in this context, so the best pragmatic option may be detailed prospective cohort studies with full adjustment for case-mix. Report 2 A US study published in 2002 looked at the variation in death rate after aortic abdominal aneurysmectomy in the United States.8 Patients undergoing repair of intact or ruptured AAAs in the Nationwide Inpatient Sample for 1996 and 1997 were included in the study (n=13,887). This was a 20% stratified random sample representative of all US hospitals. Unadjusted and case mix adjusted analyses were performed. For repair of intact AAAs, high volume hospitals had a lower death rate than lower volume hospitals. The death rate after repair of ruptured AAA was also slightly lower at high volume hospitals. In a multi-variate analysis adjusting for case-mix, having surgery at a low volume hospital was associated with a 56% increased risk of in-hospital death. Date: 25.01.12 Version: 1 Page: 6 of 21 Public Health Wales Review of vascular services key messages from the Literature Report 3 A study published in 2007 analysed all of the published literature on the volume-outcome relationship in AAA surgery, using meta-analysis and systematic review.9 They also analysed HES data for 2000. This review considered the volume-outcome relationship only at the institutional level, not at the physician level. For elective aneurysm repair, after exclusions 32 articles and the HES data provided information on volume of elective AAA repair and mortality. The mean mortality rate was 9.5% and the observed mortality rate fell as the operative volume increased. Most articles showed a statistically significant reduction in mortality with increasing volume. For ruptured aneurysms, the mortality rate across all studies was 37.1%. Analysis unequivocally favoured surgery at higher volume hospitals. The authors made reference to the importance of minimising bias in volume-outcome studies and the role of case-mix. They state that although some older studies employed no case-mix adjustment, more recent articles commonly employed the Romano modification of the Charlson co-morbidity score. They were not specific in the paper as to which studies had used adjustment. They state that studies specifically investigating the role of case-mix found no impact on the observed volume-outcome relationships when using adjusted or unadjusted data. They also infer that despite referral bias of high-risk patients to tertiary hospitals, higher-volume hospitals have a lower actual and risk-adjusted in–hospital death rate. Holt also quotes evidence to show that for AAA hospital volume and surgeon volume are independent predictors of mortality with an additive effect, and that higher volume vascular surgeons operating in higher volume hospitals achieve the lowest mortality rates. 2.1.1 Other Studies looking at Volume/Outcome Holt et al published a further study looking at the relationship between hospital volume and outcome after AAA surgery in the UK from 2000 to 2005.10 They concluded that elective AAA repair undertaken at high-volume hospitals showed volume related improvements in mortality. They asserted that the critical threshold was 32 elective AAA repairs per year. Date: 25.01.12 Version: 1 Page: 7 of 21 Public Health Wales Review of vascular services key messages from the Literature This conclusion has been challenged by Troeng11, who pointed out that in the five hospital volume groups Holt looked at, the mortality rate in the intermediate groups was stable and comparable statistically to the highest volume group. His own analysis of contemporary (within last ten years) papers looking at volume and mortality for elective AAA surgery leads him to conclude that 10-15 procedures annually in at a single site may be sufficient to secure safe open repair. However, scrutiny of the Holt paper10 does show that in the highest volume quintile the death rate is 5.9%, compared to 7.7%, 7.2%, and 7.6% in the next three groups by volume in descending order of magnitude. This seems an important difference when we are considering elective surgery (in the future including screen detected). As it is based on all cases over a five year period in the UK, statistical testing is really redundant – we need only eyeball the data. It is also not clear how Troeng reached his conclusions – in scrutinizing one study of HES data from 1997-200212, he states that the average mortality of 7.7% was reached in centres performing only 14 elective repairs or more. However, 7.7% cannot now be regarded as acceptable for elective repair, and certainly not for screen detected aneurysm. Holt et al also carried out a meta-analysis and systematic review of the relationship between hospital volume and outcome following carotid endarterectomy.13 Twenty-five articles were analysed. Overall, the pooled effect estimate was odds ratio 0.78 in favour of surgery at higher volume units, with a critical volume threshold of 79 CEA per annum. The key factors underlying this relationship between volume and outcome related to hospital infrastructure. For CEA, lower volume surgeons achieved results similar to higher volume surgeons when operating in higher volume hospitals, supporting the concept that hospital infrastructure was a major component of the volume-outcome relationship. However, death and stroke rate for CEA are lowest for highvolume vascular specialist surgeons operating in a high volume hospital. A paper looking at surgeon volume and operative mortality in the USA across a range of procedures found that for elective AAA repair, the operative mortality among patients treated by low-volume surgeons at high-volume hospitals was higher than the overall operative mortality at low-volume hospitals. Best results, ie lowest operative mortality were again achieved by high volume surgeons in high volume hospitals14. Some papers have looked at other procedures – for example Dimick et al looked at hospital-volume related differences in aorto-bifemoral bypass operative mortality in the United States.15 The AFB operative mortality was significantly lower at high-volume hospitals. Date: 25.01.12 Version: 1 Page: 8 of 21 Public Health Wales Review of vascular services key messages from the Literature Awopetu et al conducted a systematic review and meta-analysis of the relationship between hospital volume and outcome for lower limb arterial surgery16. The systematic review included 452,093 patients form 10 studies, and five studies were included in meta-analyses. They concluded that higher-volume hospitals were associated with reduced amputation and mortality rates after lower limb vascular surgery, with OR of 0.81 for mortality and OR of O.88 for amputation in favour of higher volume hospitals. 2.1.2 Conclusion Studies on the volume-mortality relationship for vascular surgical procedures have a number of methodological problems. Studies use different definitions of high and low volume, variable groupings by volume or volume as a continuous variable. Adjustment for case-mix or riskadjustment and referrals is also problematic and variable. Studies often look at retrospective data – there are no randomised trials. Most studies use in-hospital death rates, but for some comparisons 30 day mortality may be a better outcome to use. Many studies are from the USA, and the conclusions of such trials may not be completely applicable to UK practice. Nevertheless the accumulated weight of evidence taken as a whole is in favour of higher volume hospitals for arterial surgery. Although it is clear that units doing very low numbers of procedures do not generally produce good results, it is more difficult though to give a precise figure as to thresholds for a minimum number of procedures per hospital per annum. “Reasonable” results may be obtained from say 15 procedures/per unit/per annum, but Holt does provide persuasive evidence that a threshold around 30 cases per annum gives optimal results10, and the aim must surely be to achieve optimal results, not “reasonable”. With regard to the provision of a model of service for the repair of screen detected aortic aneurysm it is difficult to disagree with the conclusions of the National Screening Committee below: Before a screening programme could be set up, the local NHS would need to agree a suitable network of screening and vascular units…….the vascular units providing treatment for AAA would need to agree to conform to the clinical and service standards agreed for UK wide implementation,. These standards will incorporate the requirements put forward by the VSGBI for the treatment of AAA. The evidence is not so clear cut for emergency repair. Holt points out that there was no reduction in mortality rate with increasing annual volume for ruptured AAA in their epidemiological study10 in contrast to a recent metaDate: 25.01.12 Version: 1 Page: 9 of 21 Public Health Wales Review of vascular services key messages from the Literature analysis9. The data for the meta-analysis came from the USA where travel times may be longer than a UK average. Patients reaching hospital in the USA may have been a selected group who had a contained rupture and sufficient physiological reserve to survive the transfer. Of course travel times in North Wale can also be lengthy, this issue will be considered further later. (see section 2.3) There is a significant body of evidence in favour of higher volume units for other procedures such as carotid endarterectomy. In addition to higher volume hospitals with the advantages of a better infrastructure, optimal outcomes are most likely to occur with high volume surgeons operating within those hospitals. 2.1.3 National Standards The NCEPOD report of 200517 on AAA stated that there was little to support surgeons continuing to treat single figure numbers of elective cases on a regular annual basis. It also recommended that clinicians, purchasers, Trusts and Strategic Health Authorities should review whether elective aortic aneurysm surgery should be concentrated in fewer hospitals. 2.2 Evidence working and recommendations regarding team In 2002 the RCR produced guidance on the provision of vascular radiology services.18 This document supports the recommendation of the NCEPOD 2000 report, which stated that vascular radiologists and surgeons should work as a team both in the decision as to what procedures to undertake and in the management of any complications. With the development of both vascular surgical and radiological services, the RCR document noted the significant development of team working, with many elective and emergency vascular procedures managed jointly by surgeons and vascular radiologists, that often worked effectively during the normal working day, but out of hours is often less effective and less efficient. The RCR recommended that vascular radiologists and surgeons should attend regular joint meetings, at which all vascular cases could be discussed. Date: 25.01.12 Version: 1 Page: 10 of 21 Public Health Wales Review of vascular services key messages from the Literature In a draft report, The Provision of Emergency Vascular Services 2007, the RCR recommends under models for emergency vascular services that vascular units should include both radiological and surgical expertise. The same report also highlights that colleagues in anaesthesia and intensive care are vital members of the multidisciplinary team. Another RCR report, Standards for providing a 24 hour interventional radiology service, published in 2008 recommends that out of hours provision must be subject to a formal rota, stating that it is not sustainable, safe or timely to rely on ad hoc methods of trying to find a suitable radiologist who is not officially on call. The NCEPOD report17 on ruptured AAA showed a 30 day mortality of 27% for anaesthetists who undertook a higher than median volume of aneurysm repairs, compared to 40% for those who took a lower than median volume. NCEPOD have recommended that anaesthetic departments should reduce the number of anaesthetists caring for very small numbers of elective and emergency aortic surgery care. Another paper, a retrospective cohort study, identified patients undergoing major vascular surgery (lower limb revascularisation, elective and ruptured AAA, endovascular aneurysm repair and carotid endarterectomy) over a five year period 2003-719. For the overall cohort, care from vascular anaesthetists was independently associated with reduced 30-day and medium–term mortality. For elective patients vascular anaesthesia was associated with reduced 2 year mortality though not 30 day mortality, and for emergency surgery no effect was shown. Some of the negative findings could be due to under-powering of the study. Clearly more work and analysis is needed in the areas of specialist vascular anaesthesia, but it is likely there could be some benefits, and certainly for elective AAA work on screen detected aneurysm there could be a case for securing anaesthetists with reasonable experience of vascular work as an adjunct to driving down post-operative mortality rates to the lowest possible. There was complete consensus of our North Wales expert stakeholder group that vascular surgery and interventional radiology should work closely together, fitting the recommendations of the RCR. With regards to anaesthetics, the evidence supports those with greater experience of vascular procedures giving better outcomes – there will be some problems in achieving this on rotas, but the aspiration should be that any anaesthetist providing anaesthesia for vascular procedures at least has reasonable experience of that type of work. Date: 25.01.12 Version: 1 Page: 11 of 21 Public Health Wales Review of vascular services key messages from the Literature Further issues include the necessity for other staff to be available at all time wherever arterial surgery is provided, for example nursing staff and radiographers. A RCR/RCN document20 advises that departments of clinical radiology carrying out interventional procedures should have and adequate number of appropriately registered nurses to provide effective in-hours and out of hours cover. Departments with a large interventional radiology workload should have sufficient wte registered radiology nurses to provide at least one in five on call rota. 2.2.1 Issues regarding treatment of AAA There are two techniques available to treat unruptured aneurysms., conventional open surgery repair (OSR) and endovascular aneurysm repair (EVAR). EVAR is a minimally invasive procedure commonly done by interventional radiologists in collaboration with a vascular surgeon21. EVAR has become a more common intervention in recent years. Two randomised studies in the UK, the EVAR122 and EVAR223 trials have investigated the outcomes of AAAs treated electively by EVAR. The EVAR1 trial compared the outcome of EVAR against OSR in patients who were suitable for OSR and had suitable morphology for the stent-graft (around 50% of patients). The EVAR1 trial showed a near three-fold reduction in 30 day mortality with the use of EVAR when compared to OSR. The EVAR2 trial indicated that for patients unsuitable for OSR there was no overall benefit in those treated with EVAR compared with no intervention. There may be some benefit of EVAR over OSR in treating ruptured AAA, but without randomised data it is unclear whether this is due to real benefit, publication bias or case selection21. What does seem clear though that in case selection and collaborative working, and using the developing evidence to guide decision making, it is essential that vascular surgeons and interventional radiology work closely together in determining and carrying out optimal treatment for each and every patient. Of course the increased use of EVAR has lead to the same questions being asked regarding volume and outcome as for open repair. A recent study aimed to quantify the relationship between the volume and outcome from elective endovascular or open repair of AAAs in England between 2005 and 200724. Date: 25.01.12 Version: 1 Page: 12 of 21 Public Health Wales Review of vascular services key messages from the Literature This study had many of the same limitations as previous work, but the authors concluded that EVAR did demonstrate an independent volume effect, that total aneurysm experience (open and endovascular) appeared to be important in determining outcome, and that the uptake of EVAR in England is insufficient contributing to operative deaths. There is a further complicating factor to be considered. The EVAR trial investigators have recently reported25 that although EVAR is associated with significantly lower operative mortality than open repair, no differences were seen in total mortality or aneurysm related mortality in the long term. The rates converged at 2 years for any cause mortality, and 6 years for aneurysm related mortality. EVAR was associated with increased rates of graft-related complications and re-interventions and was more costly. This clearly has implications for case selection for EVAR, patient choice, ongoing surveillance after repair and cost-effectiveness. 2.3 Evidence regarding Travel Times It is sometimes argued that North Wales has unique geographical and travel problems but as recent report pointed out this is not the case26. There are similar travel times in Scotland, West Wales, Cumbria and many rural communities. For patients requiring elective vascular surgery the question of travel times may be felt to be less important – that if a higher quality and safer service is best delivered from a higher volume single unit then the accessing such a service is worth the additional travel and inconvenience incurred. Interestingly a study in Sheffield27 using a mailed questionnaire found that patients who responded had a preference for local treatment to the extent they were willing to incur increased risks of perioperative mortality and amputation to receive treatment at their local hospital. However, it must be debatable how ethical it would be to implement a less safe service even with informed patient/public opinion. It is for emergency vascular problems that the real issue of access times arises. Such problems include acutely ischaemic limbs and vascular trauma, but leaking AAAs are perhaps the major area of debate. For patients with a ruptured AAA there is good evidence that patient outcomes are not related to the distance travelled if they reach a centre where vascular expertise is available28. Date: 25.01.12 Version: 1 Page: 13 of 21 Public Health Wales Review of vascular services key messages from the Literature This study in a sparsely populated region of Scotland found that the death rate from ruptured AAA was almost identical for those living more than or less than 50 miles away from the operating hospital in Inverness. The overall mortality from ruptured AAA and the operative mortality rates in this rural area, where a significant proportion of the patients live more than 25 miles away from the main hospital, were similar to those in urban areas reported in the literature. Another study in West Sussex29 failed to find any association between travel time and survival after ruptured AAA, though the travel times were short, with a mean potential travel time to nearest hospital 14.2 minutes. Many studies have suggested lower mortality for those who had to travel further to get to the hospital carrying out the operative intervention. This is likely to be due to selection bias, as they do not include those who died in the community or pre-operatively29. The diagnosis of acute limb ischaemia is usually obvious in the community, and the onset of permanent damage is delayed for several hours, so there is a window of opportunity for safe transfer30. 3. Overall Conclusions Despite a range of methodological weaknesses, the evidence as a whole tends to support the view that better outcomes result from delivering open arterial surgery, particularly elective AAA procedures and CE, in higher volume units. The evidence is perhaps less persuasive with regard to ruptured AAA. It is difficult to be precise regarding exactly what higher volume means, but certainly with regard to AAA elective surgery, although there is some evidence that units performing around 15 procedures per annum may produce reasonable outcomes the aim must be to aspire to a model which produces optimum outcomes. This is even more necessary when developing services for screen detected aneurysm. A strong case can be made for the recommendation in the VSGBI paper namely 100 procedures over 3 years and it would seem that this standard will in any case be mandatory for screen detected aneurysm. However, a recent editorial31, from the St George’s Vascular Institute (same authors as many of the often quoted papers on volume/outcome) takes a very measured view on the setting of threshold volumes for safety in arterial surgery. Date: 25.01.12 Version: 1 Page: 14 of 21 Public Health Wales Review of vascular services key messages from the Literature They state – “...the use of these data determine a discrete threshold numbers of cases at which optimal outcomes are obtained is debatable. Most studies use historical data based on primarily on open aneurysm repair; any consideration of threshold volumes for implementation by health care providers should take into account the improvements in outcome seen with endovascular aneurysm repair (EVAR)” They also point out that studies attempting to define a threshold have heterogeneous results, and that more recent studies including EVAR have found that mortality continues to improve as operative caseload increases. They further conclude that both ruptured AAA and urgent AAA repair were associated with a lower mortality in hospitals performing a greater number of elective OAR and EVAR. This relationship was again continuous rather than dichotomous. In the United Kingdom, improvements in outcome at high-volume centres of excellence are also conferred by nonsurgical factors such as specialist anaesthetists and intensive care in addition to increase uptake of EVAR24. The editorial31 concludes that the quality of vascular surgery cannot be studied or improved by solely reporting volume-dependent outcomes such as mortality, but that there must also be a focus on process and structure. Deficiencies in process include the lack of a specialist vascular and endovascular training programme for surgeons32. A further paper33 summarises the volume-outcome relationships in vascular surgery. Once again the main message is that increased volumes are likely to give improved outcomes. For some procedures at least eg elective OAR, incremental improvement may be more modest at very high volumes. There is strong clinical support in North Wales for multi-disciplinary working, and there is evidence from the literature as well as standards from professional bodies which provide further support. A population needs assessment, and analysis of current service provision put alongside this evidence review will further inform optimal best quality model(s) of service provision for North Wales. Any proposed model will have to take account not only of the evidence around volume and outcome, but be safe and of high quality, ensure reasonable access times, workable rotas in line with EWTD, enable joint working and rotas between vascular surgery, interventional radiology and preferably anaesthetics, meet the training requirements of the Royal Colleges, provide the necessary infrastructure, be able to recruit to consultant posts following retirements, be compatible with the general needs and requirements of emergency and trauma surgery, and be costeffective and affordable. Date: 25.01.12 Version: 1 Page: 15 of 21 Public Health Wales Review of vascular services key messages from the Literature Importantly consultation and involvement of the local population is also needed. Date: 25.01.12 Version: 1 Page: 16 of 21 Public Health Wales Review of vascular services key messages from the Literature 3.1 Summary of Key Messages Practice within vascular services is changing and developing rapidly, for example greater use of EVAR for aneurysm repair. This means the evidence base is constantly evolving. However, balanced judgements on service provision need to be made now on the current best available evidence. Overall the available evidence indicates that higher volume units and operators are associated with lower mortality, but the methodology for most studies is weak and often analyses have used data which is now more than a decade old, and which predates the introduction of new practices/techniques notably EVAR. However the volume/outcome relationship still holds in the latest studies. It is not possible to set an absolute threshold for safe practice with regard to case numbers for vascular procedures. It seems indisputable that very low numbers of particular vascular procedures (eg AAA repair) per unit per annum do give a worse outcome (mortality). In general mortality rates decrease continuously with increased volume, though for some procedures at least the incremental decrease may be much less at higher volumes. Structure and process are important. Teams should be multidisciplinary, and include vascular surgeons, interventional radiologists, specialist anaesthetists and support staff. Facilities need to be high quality and comprehensive. Both the team and the facilities need to be available 24/7, with proper rotas for out of hours cover. There is no evidence that increased travel time increase mortality for ruptured AAA. This catastrophic event will be unsurvivable for many patients no matter how close operative facilities are. Travel times may need further consideration within the broader category of trauma involving vascular damage, for example road traffic accidents and limb threatening disease. Overall the evidence from the literature would support a move to a fewer number of units performing vascular procedures in North Wales. This would facilitate efficient provision of high quality, modern comprehensive facilities, workable staffing and rotas, reasonable volumes of activity, compliance with national guidance, optimal treatment for screen detected AAA, and compliance with likely future training requirements. Date: 25.01.12 Version: 1 Page: 17 of 21 Public Health Wales Review of vascular services key messages from the Literature References 1. The Provision of Services for Patients with Vascular Disease, VSGBI, 2012. 2. Holt PJ, Polonieki JD, Gerrard et al. Meta-analysis and systematic review of the relationship between volume and outcome in abdominal aortic aneurysm surgery, Br J Surg 2007;94:395-403. 3. Holt PJ, Polonieki JD, Loftus IM et al. Meta –analysis and systematic review of the relationship between hospital volume and outcome following carotid endarterectomy. Eur J Vasc Endovasc Surg 2007;33:645-51. 4. Dimick JB, Cowan JA Jr, Henke PK et al. Hospital volume related differences in aorto-bifemoral bypass operative mortality in the United States, J Vasc Surg. 2003;37:970-975. 5. Department of Health. High Quality Care for All. NHS next stage review final report. London 2008. 6. Michaelis JA, Browse DJ, McWhinnie DL et al. Provision of vascular surgical services in the Oxford Region. Br J Surg, 1994;81:337-381. 7. Health Technology Assessment 2000;Vol.4:No.11. 8. Dimick JB et al. Variation in Death Rate after Abdominal Aortic Aneurysmectomy in the United States. Annals of Surgery, 2002;Vol 235, No 4,579-585. 9. Holt PJE, Polonieki JD, Gerrard D et al. Meta-analysis and systematic review of the relationship between volume and outcome in abdominal aortic aneurysm surgery. Br J Surg 2007;94:395-403. 10. Holt PJ, Polonieki JD, Loftus IM, et al. Epidemiological study of the relationship between volume and outcome after abdominal aortic aneurysm surgery in the UK from 2000-2005. Br J Surg 2007; 94(4)441-448. 11. Troeng T. Volume versus outcome when treating abdominal aortic aneurysm electively – is there evidence to centralise? Scandinavian Journal of Surgery 2008;97:154-60. 12. Jibawi A, HanafyM, Guy A: Is there a minimum caseload that achieves acceptable operative mortality in abdominal aortic aneurysm operations? Eur J Vasc Surg 2006;32(3):273-276. Date: 25.01.12 Version: 1 Page: 18 of 21 Public Health Wales Review of vascular services key messages from the Literature 13. Holt PJE, Polonieki JD, Loftus IM et al. Meta-analysis and systematic review of the relationship between Hospital volume and outcome following carotid endarderectomy. Eur J Vasc Endovasc Surg 33, 645-651. 14. Birkmeyer JD, Stukel TA, Siewers AE et al. Surgeon volume and operative mortality in the United States. N Engl J Med 2003; 349(22):2117-2127. 15. Dimick JB, Cowan JA, Henke PK et al. Hospital Volume related differences in aorto-bifemoral bypass operative mortality in the United States. J Vasc Surg 2003;37:970-75. 16. Awopetu AI, Moxey P, Hinchcliffe RJ et al. Systematic review of the relationship between hospital volume and outcome for lower limb arterial surgery. Br J Surg 2010;97(6):797-803. 17. National Confidential Enquiry into patient outcome and death. The NCEPOD 2005 report, Abdominal Aortic Aneurysm: a service in need of surgery? 18. Provision of Vascular Radiology Services. Ref No:BFCR(03)1 Royal College of Radiologists 2002. 19. Walsh SR, Bhutta H, Tang TY et al. Anaesthetic specialisation leads to improved early and medium term survival following major vascular surgery. Eur J Vasc Endovasc Sug 2010;39:719-25. 20. Guidelines for Nursing Care in interventional radiology, RCR/RCN 2006. 21. Interventional Radiology: Guidance for Service Delivery. A Report of the National Imaging Board DH, 2010. 22. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1):randomised controlled trial. Lancet 2005;365(9478):2179-86. 23. Endovascular aneurysm repair and outcome in patients unfit for open repair of abdominal aortic aneurysm (EVAR trial 2). Lancet 2005;365(9478):2187-92. 24. Holt PE, Poloniecki JD, Khalid U et al. Effect of Endovascular Aneurysm Repair on the Volume-Outcome relationship in Aneurysm repair. Circ Cardiovasc Qual Outcomes 2009;2:624-632. 25. The United Kingdom EVAR trial investigator. New England Journal of Medicine 2010;362:1863-1871. Date: 25.01.12 Version: 1 Page: 19 of 21 Public Health Wales Review of vascular services key messages from the Literature 26. Royal College of Surgeons of England Professional Affairs Board in Wales. Report to Betsi Cadwaladr University Health Board, Reconfiguration of General Surgical Services, 2011. 27. Shackley P, Slack R, Michaels J. Vascular patients’ preferences for local treatment: an application of conjoint analysis. 28. Caesar K, Godden DJ, Duncan JL. Community mortality after ruptured abdominal aortic aneurysm is unrelated to the distance from the surgical centre. Br J Surg 2001;88:1341-3. 29. De Souza VC, Strachan D, Relationship between travel time to the nearest hospital and survival from ruptured abdominal aortic aneurysms:record linkage study. Journal of Public Health 2005; 27(2):165-170. 30. Campbell B, Chester J. 2002;324(7347)1167-68. Emergency Vascular Surgery. BMJ 31. Kathikesalingam MA, Hinchcliffe MD, Poloniecki JD. Centralisation Harnessing Volume-Outcome Relationships in Vascular Surgery and Aortic Aneurysm Care Should not focus Solely on Threshold Operative Caseload. Vasc and Endovasc Surg 2010;44(7):556-559. 32. Hamilton G, Shearman C. Vascular surgical training. Ann R Coll Surg Engl. 2008;90(2):95-96. 33. Kathikesalingam MA, Hinchcliffe RJ, Loftus IM. Volume-outcome relationships in vascular surgery:the current status. Journ Endovasc Ther 2010;17(3):356-365. Date: 25.01.12 Version: 1 Page: 20 of 21 Public Health Wales Review of vascular services key messages from the Literature Abbreviations AAA Aortic Abdominal Aneurysm AFB Aorto-femoral bypass CEA Carotid endarterectomy EVAR Endovascular aneurysm repair EWTD European working time directive OSR Open surgical repair RCR Royal College of Radiologists Date: 25.01.12 Version: 1 Page: 21 of 21