A double-blind comparative study of the safety, tolerability, and efficacy of ioversol and iohexol in peripheral and visceral arteriography.

A randomized, double-blind, parallel-group clinical study was conducted to compare the efficacy, tolerability, and safety of ioversol 320 mg I/mL (Optiray, 320 Mallinckrodt Medical, Inc., St. Louis, MO) and iohexol 300 mg I/mL (Omnipaque 300, Winthrop Pharmaceuticals, New York, NY). The study was conducted in 50 patients undergoing peripheral arteriography and in ten patients undergoing visceral arteriography. In the peripheral group, 92% of the radiographs acquired using Optiray were rated excellent or good. Eighty-eight percent of those acquired with Omnipaque were so rated. In the visceral study all radiographs in both groups were rated excellent or good. Patient tolerance was also impressive. We used a four-point rating scale (1 - none; 4 = severe) to score both heat and pain sensations. For peripheral patients the average heat score was 2.4 in the Optiray group versus 2.3 in the Omnipaque group. The average pain scores were 1.1 in both groups. For visceral patients, the average heat scores were 2.4 in both groups, while the pain scores were 1.7 for the Optiray group versus 1.0 for the Omnipaque group. No clinically significant changes in vital signs were observed in any of the patients. One clinically significant change in the electrocardiogram (ECG) tracing was noted after an Optiray injection, but it was not felt to be drug induced. There were five instances in which laboratory values rose from their normal baseline values, but all changes were minor. There was only one adverse reaction in the entire study. A short episode of coughing occurred in one patient who received Omnipaque for a peripheral study; the coughing resolved spontaneously. Both Optiray and Omnipaque proved to be efficacious, well tolerated, and safe for intra-arterial use in peripheral and visceral vessels.

Arterial occlusive disease below the knee: treatment with percutaneous transluminal angioplasty performed with low-profile catheters and steerable guide wires.

In 98 patients with arterial occlusive disease below the knee who were candidates for limb salvage surgery, percutaneous transluminal angioplasty (PTA) was performed with a low-profile balloon catheter and steerable guide wire system. Sixteen patients had bilateral disease; thus, there were 114 endangered limbs and 145 diseased vessels, including 19 with a single stenosis, 94 with multiple stenoses, and 32 with total occlusions. Primary anatomic success was achieved in all stenosed vessels and in 28 occluded vessels. Initial limb healing without amputation was achieved in 88% of limbs. In four patients occluded vessels could not be recanalized; thus, the four affected limbs were amputated. Two years after PTA, 32 of 37 patients available for follow-up had viable pain-free extremities. Cumulative limb salvage rate at 2 years was 86%. At this time, below-the-knee PTA is still recommended only for limb salvage candidates. However, with this new catheter and guide wire system, success rates have been increased and complication rates decreased. PTA may be useful in selected patients with severe claudication.

Control of renal arterial bleeding after percutaneous biopsy.

Transcatheter arterial embolization is becoming an accepted method of controlling massive acute hemorrhage, including that secondary to blunt and penetrating renal trauma. Two patients with retroperitoneal bleeding postrenal biopsy and angiographically proved pseudoaneurysms at the biopsy sites had successful embolization without sequelae. Experimental and clinical experience with transcatheter embolization is reviewed. It appears that this modality is a safe, effective way of controlling renal hemorrhage.