Are there two populations of patients considered for EVAR, those fit for open repair and those unfit? Is there ever more evidence that the fitness of the patient is of crucial importance in the decision-making? Are trial results pointing toward EVAR being of poor or even no benefit in the very sick patients?
IIP > read on here > http://cxnx.affinoworld.com…
…In those circumstances, EVAR has a tough task to score any benefit. All over the world, on second thoughts, there are many instances now reported in which experts are saying that they find a small but recognizable group of patients with aneurysm, so ill that intervention simply is unlikely to alter the date of expected death…
It is clear now that some centers have demanded more of a device than others and, again, there is a gradation of anatomical suitability such that the most conservative clinicians can expect perhaps less reinterventions. Is this really so? We do not know for sure but if the same center is performing and reporting, there are no quality checks. Thus, a core laboratory of three-dimensional measurements is desirable so as to be able to examine range of anatomical characteristics and how outcomes relate to them, if they do…
Is this important? It is at about this time that the regulatory bodies of various countries will start to examine evidence for safety and efficacy on behalf of the patient. The best data that are available and the longest running in terms of followup are these trials. The problem is that the trials covered an important early stage and we need to model the future with newer devices and more knowledge on patient fitness and anatomical suitability…
Modelling is the way to assess cost effectiveness. This is because cost effectiveness is a function of cost and of clinical benefit. Time must elapse to measure the benefit and regulatory bodies rely on a ‘model’ to point them in the right direction. This places a great responsibility upon the team of clinicians and health economists who are charged with doing this task. Various ‘assumptions’ are made as ‘best estimates’ for the model and it is important to get this right. From the above, it is clear that cost effectiveness will be influenced by a number of factors and EVAR will not be as cost effective to the same extent for every situation…
However, endovascular specialists cannot relax at this critical time and must be aware that EVAR is under minute scrutiny. Just look what happened when the National Institute of Clinical Excellence (NICE) released its findings on drug-eluting stents in the coronary circulation. Drug elution was conferring benefit but NICE did not like the price the taxpayer was expected to pay for this accepted benefit. So there you have it. If the clinical benefit is small and the cost is high, one body chooses not to buy. Does this affect just that country? No way. These bodies speak to each other. These decisions affect markets throughout the world and as a result of the NICE report on the drug-eluting stent, one really major company, is putting its non-cardiovascular business up for sale! There are three main companies manufacturing EVAR stent graft systems: Cook, Medtronic and Gore with other important groups contributing a small share. The “big three” are putting much research funding into EVAR. Clinicians are using EVAR for their patients because they see the possibility of a relatively minor procedure, possible under local anaesthetic with little post operative pain. It is clearly important to assess formally what is the patient benefit. In the opinion of the patient not the doctor! It is not a case of which is the procedure the surgeon likes to do most or which earns him more money…
The assessment procedure must be “whiter than white”. Of necessity, there is distance between the assessors and those assessed viz, companies and products and clinicians and techniques. However, it is clear that companies would be wise not to chose this time to hike the selling price upwards. They can also adopt a plan to prioritize the need to reduce the need for reintervention as this is disturbing for the patient and costly. Routine CT follow-up needs to go and clinicians need to be sensitive to ranges in terms of patient fitness and anatomy and to attempt to “pick winners” much more in the future than we have at the beginning of our experience…