Vibrational angioplasty

Percutaneous angioplasty is a first line choice in the treatment of peripheral arteriopathy. Major advantages of the method compared to the traditional surgery are the lower rates of mortality and morbidity, especially for patients with many risk factors. Furthermore, the method of percutaneous angioplasty (PTA) can be repeated and does not prevent a by pass surgery in the future. The last decades percutaneous angioplasty has been more effective and safe by the use of low profile balloons and hydrophilic guidewires and has been widely, well accepted by the medical community. This medical progress has been successfully applied in the treatment of peripheral arteries with limb salvage rates similar to the femoral-peripheral by pass. Conventional angioplasty has better results in the treatment of ostial stenoses, than in long length chronic total occlusions. The main cause of failure is the inability of the guidewire to cross the total occlusion, or to re-entry to the distal true lumen after a subintimal course. 133 PURPOSE There is need of new techniques in combination with the conventional angioplasty, in order to optimize the recanalization rates and long term vessel patency in the treatment of chronic total occlusions. Furthermore, the new technique has to be less traumatic to the arterial wall. Minimal arterial wall injury results in less intimal hyperplasia and low rate of restenosis. The purpose of this study is: a. To evaluate the efficacy and the safety of vibrational angioplasty method in the treatment of chronic total occlusions in the peripheral arteries. b. To estimate the prognostic value of anatomical, technical and clinical characteristics on the technical and clinical success and outcomes. c. To evaluate the complications of the procedure. 134 METHOD The procedures have been performed in the angiographic suite. Vibrational angioplasty is performed by a hand–held device, that is designed to provide vibrational motion to a guide wire, in order to cross the chronic total occlusion. The vibrational device accommodates guide wires of up to 0.018 inch in diameter and generates a combined reciprocal and lateral movement at the wire with a range of frequencies from 16 to 100 Hz. The duration of each activation lasts from 1 to 2 minutes. The vibration movement facilitates the intraluminal navigation of the guide wire through the lesion. The procedure is completed with a conventional balloon angioplasty. Technical success was defined as the absence of residual stenosis, or the presence of residual stenosis less than 30% after balloon angioplasty. Clinical success was defined as free amputation salvage, ulcer healing, amputation stump healing and rest pain relief. 135 MATERIALS Fifty seven (57) patients with severe restrictive intermittent claudication, or critical limb ischemia (rest pain, ulcer and gangrene) and duration more than three months. Patients with acute arterial thrombosis, or coagulation disorders and high risk of hemorrhage were excluded from the study. RESULTS The method was technically successful in fifty one (51) cases (89,5%). Technical failure was noticed in six (6) cases (10,5%). The free amputation survival rate was 71,4% at twelve 12 months and 51,8% at 36 months. The mean time of fluoroscopy was 9,0 minutes. Additional angioplasty in order to optimize the inflow, or the outflow was performed in five patients (9,8%). There were no complications, that needed further intervention, or hospitalization. 136 DISCUSSION One of the most challenging fields in endovascular procedures is the recanalization of chronic total occlusions in patients with critical limb ischemia, or severe restrictive intermittent claudication. Vibrational angioplasty is a reliable technique, that can be applied in the recanalization of difficult chronic total occlusions. The benefit of the method in comparison with other techniques such as subintimal angioplasty is the intraluminal course of the guidewire. Subintimal angioplasty is a well established and accepted method, but there are studies, that suggest a major trauma on the arterial wall, as a result from the extraluminal course. The major arterial wall trauma is considered as a factor for higher rates of restenoses. The damage of the arterial wall is minimal with vibrational angioplasty and furthermore, there is a minimal risk for the collateral vessels. Vibrational angioplasty is an effective and safe method for the recanalization of difficult chronic total occlusions in patients with peripheral arteriopathy