Thursday, 10 November 2011

Endoscopic Vein Harvesting and the Disingenuity of NICE.

In the coronary artery bypass (CABG) operation, saphenous vein is harvested from the leg for use as a conduit to bypass stenoses in coronary arteries. This harvesting can be done in 2 ways - open harvest i.e. using an incision that is as long as the length of vein required or endoscopic harvest using a 3cm incision above the knee to harvest any length of vein.

Endoscopic vein harvest or EVH is standard of care in the USA. If enough patients in the UK knew about it, it would be standard of care here. The evidence for its superiority as far as cosmesis, healing and wound infection is strong - a summary of the evidence from 2004 can be read here. After many months of effort on my part, NICE agreed to perform an interventional procedure assessment.  As expected, their initial assesment was favourable - the evidence was strong.
In 2009, a paper was published in that compared cardiac outcomes between the 2 methods of harvesting vein. The data was taken in a posthoc fashion from a randomised trial called Prevent IV. The initial study compared outcomes in patients undergoing CABG whose conduits were transfected with an antiproliferative gene, with those patients with control conduits. Both groups of patients therefore had received veins that had been harvested in both ways. This therefore was not a RCT comparing open with endoscopic vein harvesting. This study suggested that cardiac outcomes in that subgroup of patients who had undergone EVH, were worse. Within weeks of publication, NICE reissued advice about EVH suggesting surgeons should use this technique with extreme caution and suggested patients sign a special consent form. The anticipated expansion of the technique in the UK was stopped dead in its tracks.
In the USA, surgeons have heeded possible lessons from this last paper and have adopted best practice of EVH. They recognise that patients will always prefer a short incision that is less likely to get infected than a disfiguring long one.

I was very pleased therefore to see the publication of this paper in a recent issue of the Heart Journal. It represents real world data from a number of British Cardiac surgical centres. Although not a RCT, it complements the robust evidence that has been around for a while in favour of EVH. Will NICE re-issue further guidance? I am not holding my breath. The procedure itself costs money and in the NHS cost always trumps clinical governance - despite some evidence suggesting EVH may be cost effective if one takes the treatment (usually in the community) of treating infected leg wounds! 
Maybe a bit of competition between cardiac surgical centres in the new NHS may get the ball rolling!