“The Hunterian approach: Cordis Smart Stent safe and effective, but what about its use in long or severely calcified chronically occluded lesions… Let's get it done the first time”

In the past femoropopliteal disease was always difficult to treat. In the late 18th century John Hunter was the first to devise a less invasive way to treat “the Coachmen's knee. ” In the textbook “The Knife Man: Extraordinary Life and Times of John Hunter, Father of Modern Surgery” author Wendy Moore describes many extraordinary techniques that John Hunter pioneered as a surgeon in London, England. In 1785, he got sick and tired of amputating the legs of coach drivers who suffered an occupational hazard. These hard‐ working men would occasionally develop popliteal aneurysms from working all day crouched down in their bumpy horse drawn coach. He came up with the extraordinary idea of tying off the distal femoral artery upstream from the popliteal artery thereby recruiting the collateral circulation to bypass the swelling to prevent the popliteal aneurysm rupture necessitating either amputation and/or death from this catastrophic event. In the early days of intervention for leg stenosis we were really not very successful with standard PTA. With the introduction of the Palmaz stent for iliac disease eventually we began to place these stents in diseased femoral arteries. In early 1990, I replaced Dr Richard Schatz, as the Director of Research and Education at The Arizona Heart Institute. At that time, Dr Edward B. Dietrich and myself put on courses for cardiovascular surgeons, vascular surgeons, interventional radiologists and as well as interventional cardiologists. We hosted these meetings frequently to demonstrate placement of the Palmaz stent. At that time, we were the highest volume stenting operators worldwide, with excellent results however when we started to place the stents in the femoral arteries, we found a couple of problems. There were fractures and the restenosis rates were fairly high; however, we could treat many of femoropopliteal lesions with excellent acute results. It took many years, until 2006, that the first trials showed the superiority over PTA with the self‐expanding stent. The self‐expanding stent quickly became the gold standard for femoropopliteal disease. The Smart stent has been around for a number of years and has been very efficacious in treating SFA lesions; however, there are limitations. The excellent report on the OPEN study by Gray et al. suggested that the overall results are certainly acceptable with this self‐expanding stent. This study included, basically, all comers, but this was a population of patients that had fairly focal short lesions (mean lesion length 71 ± 46mm.) with severe calcification in just over one half of the subjects. We still have many patients requiring multiple interventions for femoropopliteal disease. It would be nice to have a treatment that can be done one time with low risk and high degree of success with long term patency. The Smart stent results from the OPEN study look acceptable with the procedure success rate high at 93.4%, absence of major complication at 100% and 93.4% of patients had residual stenosis of less than 30%. Primary efficacy at 12 month was very high at 68.4% and fracture rate was rare (2.3%); however, these were fairly short lesions that were treated. Total occlusion lesions were treated but only a third of the patients had occlusions and about half the cases had severe calcification. What about much longer lesions? Do we have nonsurgical reasonable results? The recently published DETOUR 2‐year results on greater than 20 cm lesions had an average length of 371 ± 51mm in length with 96% with chronic total inclusions and 67% of these lesions were severely calcified. There was a mean occlusion rate at 159 ± 88mm and 96% could be successfully treated. The secondary patency rates by the Kaplan–Meier analysis was 86 ± 4%. These were very long lesions, much longer than any interventional study is ever reported, or for that matter, any percutaneous treated study.