AI Article Synopsis
- The study evaluated the safety and effectiveness of the Atlas Gold balloon during iliofemoral vein procedures across a group of 77 patients over a 1-year period.
- There were no major device-related adverse events reported, achieving over 95% intraprocedural safety, with significant symptom improvement noted in 89% of patients after the procedure.
- At the one-year mark, all stents maintained patency with no instances of stent thrombosis or complications, confirming the balloon's reliability in venous interventions.
Article Abstract
Background: We report on intraprocedural and up to 1-year outcomes on the safety of the Atlas Gold balloon (Bard) in iliofemoral venous interventions.
Methods: All patients who underwent iliofemoral vein compression treatment in our laboratory from September 1, 2013 to May 30, 2017 were identified and medical records were reviewed. The primary safety endpoint was the intraprocedural freedom from major device-related serious adverse events (≥95%) for the Atlas Gold balloon in iliofemoral venous treatment.
Results: Seventy-seven patients with iliac vein compression underwent intervention. Predilation was performed in 20 patients with the Atlas Gold balloon (mean diameter, 12.1 mm). The mean pressure was 5.2 atm (range, 3.0-14.0 atm). Post-stent dilation was performed in 61 patients treated with the Atlas Gold balloon (mean diameter: 17.0 mm; range: 12 to 22 mm), with a mean pressure of 6.8 atm (range, 2.0-20.0 atm). There was no stent thrombosis, target-lesion revascularization (TLR), or target-vessel revascularization (TVR) at 1 month. Symptom improvement was reported in 89% of patients. There were 58 patients assessed for patency in the total cohort at 262.7 days, of which 48 patients were postdilated with the Atlas Gold balloon. All stents were patent at 1 year, and there was no stent thrombosis, TLR, or TVR in the cohort treated with the Atlas Gold balloon. Symptom improvement continued at 1 year (37/45 Atlas Gold cohort).
Conclusion: All patients postdilated with the Atlas Gold balloon exceeded the 95% safety benchmark set in this study. No balloon perforation, vessel laceration, or balloon-related intravascular events occurred.
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