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Cryoplasty is one form of treatment for peripheral arterial disease (PAD). It combines the dilatation force of conventional angioplasty with cold energy applied to vascular smooth muscle cells provoking apoptosis and reducing myointimal hyperplasia. The first inflation breaks calcium. The second prevents matrix recoil. This study compares the six month results of single versus double cryoplasty inflations.
This is a retrospective cohort. 101 patients were enrolled. Their charts were reviewed to determine age, gender, Rutherford Class, lesion number, location, severity, number of cryoplasty inflations, and immediate results. Symptoms, ankle brachial indices (ABI), arterial Doppler and repeat angiography were reviewed at 6 months. Angiographic success was defined as <30% residual stenosis. Any atherectomy was an exclusion criterion.
Of the 101, thirty seven were excluded after use of a debulking device or were lost to follow up. The baseline characteristics of those receiving single versus double inflations were evaluated. All patients were Rutherford class III to V. 21 had baseline tissue loss. Above knee PAD was noted in 69% and below knee in 31%. All treated lesions had >70% stenosis and 31% were chronic total occlusions. Double inflations were used in 56% and single in 44%. Double inflations were used more than single in above knee PAD compared to below knee. Immediate angiographic success was achieved in 100% of cases with both single and double inflations. Stenting was performed in 8 patients (all above knee) of which 6 had single inflations. Symptoms, ABI, and arterial Dopplers showed improvement at 6 months in both groups. At six months, all patients had healed ulcers except 2 who underwent amputation due to below knee disease. Both had single inflations. Repeat angiography was performed in 67% within 6 months. Ninety percent of those were planned interventions of another vessel. Restenosis was detected in 14% (6 single and 3 double inflations). Of those, six were below knee.
Single and double inflations showed similar success rates in treating above and below knee PAD. Restenosis was more frequent with below knee single inflations. A larger study is necessary to detect differences between single versus double inflations both below and above knee.
- 2013 American College of Cardiology Foundation