CryoPlasty provides a ‘valuable alternative’ to amputation

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Dr David Kessel, at the 2007 Charing cross meeting in London, looked at the evidence and reviewed the 2004 report of Fava et al (JVIR) which concluded that cryoplasty had a 93% success in terms of patency and that the technique “represents a potential advance in the field of endovascular medicine.”

Further, Laird (JVIR 2005) found a high degree of angiographic success and a low frequency of target lesion revascularisation.

Kessel’s own group in Leeds (Karthic et al EJVES 2007) reported a prospective follow- up of patients with arterial restenosis undergoing cryoplasty. All ten patients had angiographical success immediately but 50% restenosis was evident within six months. Only two out of ten patients were symptom free after a follow-up of one to 12 months.

Results from the Below-The-Knee (BTK) CHILL study, which evaluated the performance of the PolarCath Peripheral Dilatation System (Boston Scientific) for the dilatation of stenotic lesions in infrapopliteal arteries when treating the whole leg, claimed the procedure offered a valuable alternative to amputation or invasive surgical bypass procedures.

The BTK CHILL study is a prospective, multi-centre trial with 111 limbs treated in 108 patients at 16 sites in the US. The one-year results, presented by principal investigator

Dr Tony Das, Director of Peripheral Interventions at Presbyterian Heart Institute of Dallas, TX, showed an 85% freedom from amputation rate and a 97% procedural success rate (a decrease in vessel narrowing to less than 50%), resulting in improved blood flow. These outcomes are particularly encouraging in light of the severity of disease in these patients. The majority of patients in this study exhibited tissue loss at baseline with non-healing ulcers or focal tissue loss reported in 66% of the limbs and gangrene reported in 37% of the limbs (some patients reported both focal tissue loss and gangrene). In total, 69% of the treated limbs were categorised as either Rutherford Class 5 or 6 at the time of study enrollment.

In comparing cryoplasty with percutaneous transluminal angioplasty (PTA), Kessel’s group found that cryoplasty is more expensive by far and not better than PTA and thus not justified in many cases. It can be concluded that there is a wide spectrum of opinion on the place of this technique at the present time and there are those that swear by the technique. However, at Charing Cross this time the usefulness of the technique was seriously questioned.

Thomas McNamara, at Charing Cross, 2007 pronounced cryoplasty safe and associated with a 97% technical success rate and 93% limb salvage at six months and 85% at 12 months. He found it a valuable option especially for rest pain and non-healing ulcers.

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