Cath Lab Digest

Q. In what clinical cases is CryoPlasty^® Therapy a particularly effective treatment method?

A. I use CryoPlasty Therapy in a variety of complex cases, basically in any scenario where I previously used plain old balloon angioplasty. Typically, I treat either long or severely stenotic lesions – particularly in the femoral and popliteal area – that were traditionally reserved for stenting. This is a perfect scenario for CryoPlasty Therapy because personal experience and registry data have shown that the incidence of dissection with this procedure is dramatically lower than with stenting or balloon angioplasty. In addition, I am very skeptical about long-term outcomes with extensive femoral-popliteal stenting, and I am also concerned about stent fracture and the high incidence of restenosis. I have used CryoPlasty Therapy extensively in the adductor canal. Although many technologies show suboptimal results with severe adductor canal lesions, I have used CryoPlasty Therapy extensively in this area of the femoral artery with excellent outcomes.

Similarly, I have used CryoPlasty Therapy in below-the-knee tibial-peroneal interventions – basically limb-salvage scenarios – with excellent results, when essentially all other treatments, including surgery, have failed. Typically, tibial-peroneal disease is seen in vasculopaths and patients with advanced diabetic atherosclerotic disease. Although balloon angioplasty works well for focal lesions in this group of patients, it is not effective for long-segment disease, particularly in diabetics. Furthermore, even though there has been interest in the off-label use of drug-eluting stents in these patients, the benefits in this particular situation are yet to be determined.

The third group of patients in which I frequently use CryoPlasty are those with restenosis, either after multiple procedures (such as balloon angioplasty) or with restenotic arterial conduits. Regardless of lesion location – the femoral-popliteal or popliteal-tibial regions or even in the renal or subclavian arteries – CryoPlasty Therapy has worked well in these patients when other technologies have not; therefore I’m optimistic that long-term data will be encouraging.

Q. As a physician, why is ease of use so important to you? What does it mean to the success of the procedure?

A. Ease of use is an extremely important aspect of the technology. The PolarCath^TM System is simple and straightforward to use, leading you through each step of the procedure. Additionally, it offers excellent trackability. I frequently use the PolarCath System with a contralateral approach, and it tracks well over the aorta-iliac bifurcation. Furthermore, its low-profile design is particularly beneficial in cases of diffuse disease that involve the femoral-popliteal and tibial-peroneal segments, especially if you have a lot of calcifications.

Q. Can you talk about the cost effectiveness of CryoPlasty^® Therapy compared with other treatment options like ballooning or stenting?

A. At face value, CryoPlasty Therapy is obviously more expensive than plain balloon angioplasty. However, balloon angioplasty alone is associated with flow-limiting dissections that can eventually lead to restenosis or occlusion. To avoid these problems, many interventionalists automatically use stents in certain circumstances, such as femoral popliteal disease. When you combine the cost of the balloon with the multiple stents needed to cover a typical superficial femoral artery (SFA) lesion, the expense is significantly more than CryoPlasty Therapy. Thus, CryoPlasty Therapy can be a cost-saving measure.

Q. What long-term clinical outcomes are available to provide further evidence of the effectiveness of CryoPlasty Therapy? How do these outcomes compare with those for atherectomy devices?

A. There are obviously concerns among interventionalists about long-term clinical outcomes with both types of device. The reason for this concern is the lack of objective, randomized trials with long-term follow-up. Although we have registries such as the CryoPlasty Multicenter IDE registry and Below-the-Knee (BTK) CHILL Study, that provide us with important, meaningful information, these studies are not equivalent to randomized trials. With atherectomy in particular, we need long-term clinical data to further investigate concerns such as perforation, aneurysmal dilatation and the formation of true- and pseudo-aneurysms, concerns that we have not had with CryoPlasty Therapy.

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