Abstract
To assess the effectiveness and safety of the InThrill Thrombectomy System in treating thrombosed arteriovenous fistulas (AVFs) and grafts (AVGs) via mechanical thrombectomy. Institutional database was retrospectively searched to identify all thrombectomy procedures performed using the study device at our hospital for thrombosis of AVFs or AVGs. Inclusion criteria encompassed patients aged 18 and above who underwent AV access thrombectomy using the study device. Intraprocedural metrics, including procedure time, device time, blood loss, and adjunctive procedures were collected. Technical success was defined as restoration of flow combined with <30% residual diameter stenosis of the treated vascular segment. Clinical success was defined as the resumption of normal hemodialysis for a minimum of at least one session following intervention. Through 3-month follow-up, patency, and adverse events were evaluated. A total of 20 thrombectomies were performed on 2 AVFs and 18 AVGs in 13 patients. Median procedure and device times were 45 and 10 min, respectively. Balloon angioplasty was performed in all cases with additional stenting in 40% (8/20) of cases to address stenosis following thrombus removal. No other mechanical thrombectomy devices were utilized. Intraprocedural thrombolytics were not administered in any case. Average blood loss was 10 mL. The technical success and clinical success rates were 100% (20/20) and 95% (19/20), respectively. There were no intraoperative adverse events. One patient developed a post-operative minor hematoma, and one patient developed a post-operative pseudoaneurysm at the access site. The primary patency rate was 77% (10/13) at 1 month. Both assisted primary and secondary patency rates were 100% at 1 and 3 months. These preliminary results suggest that the InThrill Thrombectomy System is rapid, safe, and effective for thrombolytic-free treatment of AV access thrombosis in hemodialysis patients.
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