Purpose: Currently, endovascular techniques require monitoring by radiographic imaging for accurate catheter placement. The aim of this study was first to determine the feasibility of angioplasty under ultrasound guidance using a special catheter system. Based on this outcome, the second goal was to investigate the prevalence of lesions amenable to ultrasound-guided angioplasty.
Methods: A balloon catheter system (Echomark) has been developed, which allows accurate catheter guidance by ultrasound imaging. An ultrasound-sensitive piezoelectric sensor positioned in the middle of the balloon portion of the angioplasty catheter is interfaced to an external duplex scanner via the catheter system. The exact position of the balloon relative to the transducer is calculated and reproduced on the screen of the duplex scanner to guide balloon positioning. In the feasibility assessment of the procedure, 16 patients with disabling claudication and rest pain were selected for balloon angioplasty under ultrasound guidance based on arteriographic and hemodynamic lesion criteria of > 50% stenosis with a peak systolic velocity ration > 2.5 in a lesion < 4 cm long that could be imaged by duplex ultrasonography. A fall in the peak systolic velocity ratio below 2.0 was selected for a procedural endpoint corresponding to < 30% residual stenosis on the completion angiogram. In the second part of the study, the prevalence of stenoses amenable to ultrasound-guided angioplasty was studied in 80 patients presenting with symptoms of peripheral arterial disease.
Results: In the feasibility study, 20 stenoses (5 common iliac, 6 external iliac, and 8 superficial femoral arteries and 1 graft) meeting the inclusion criteria were subjected to ultrasound-guided angioplasty with confirmation by completion angiography. The procedure was possible in 18 (90%) of the 20 stenoses. The two failures occurred in iliac arteries that could not be imaged by duplex scanning due to obesity, bowel gas, and/or vessel wall calcification. In one case, the peak systolic velocity ratio exceeded 2.5 despite a satisfactory control arteriogram; redilation was performed, and the ratio fell below 2.0. In the second part of the study, 21 (26.2%) of the 80 patients had 29 stenoses that were amenable to angioplasty according to angiographic criteria (> 50% stenosis and < 4 cm length). All these stenoses were evaluated with duplex scanning to determine their suitability for angioplasty under ultrasound guidance. Twenty-three (79%) of the 29 lesions selected for angioplasty were well visualized by duplex, and angioplasty would have been possible based on our initial clinical experience.
Conclusions: Angioplasty under ultrasound control is a feasible technique for peripheral lesions. Ultrasound allows monitoring of both anatomical and hemodynamic parameters during angioplasty and thus provides a procedural endpoint that correlates to the control angiogram. A large proportion (79%) of stenoses deemed suitable for angioplasty can be well visualized by ultrasound, but obesity, vessel wall calcification, and bowel gas may limit the ability to obtain a satisfactory ultrasound image. Ultrasound-guided angioplasty is a potentially useful procedure that warrants further investigation.