Interventional treatments for acute iliofemoral deep vein thrombosis (DVT) remain controversial following publication of the ATTRACT study. Interventions have been shown to reduce post-thrombotic syndrome (PTS) severity and improve quality of life in DVT patients but have been accompanied by risk of major bleeding from thrombolytics. We describe thrombus removal using a novel combined basket-rotational thrombectomy device that minimizes the need for thrombolytics or repeat procedures.
The aim of this prospective, nonrandomized, multicenter, first-in-human study of 19 subjects with acute iliofemoral DVT was to evaluate the safety and performance of the Pounce Venous Thrombectomy System (Pounce) up to 12 months following treatment. The primary performance endpoint was defined as procedural success through achievement of Society of Interventional Radiology (SIR) Grade II Lysis in treated vessels with freedom from procedural adverse events. Secondary endpoints included venous disease severity assessments using the Villalta scale and the Venous Clinical Severity Score (VCSS), patient quality-of-life measurement using the Venous Insufficiency Epidemiological and Economic Study-Quality of Life questionnaire (VEINES QOL/Sym), and calf circumference measurements taken at baseline, 24 hours, and 1 month.
The primary endpoint of complete or near-complete thrombus removal (SIR Grade II or III) was achieved in all subjects. All study device-related safety endpoints were met, with no major bleeding or device-related adverse events. Of the 19 subjects treated, 16 (84.2%) did not receive thrombolytics during the procedure. PTS (Villalta scale >4) was identified in 17 of 19 (89.5%) of subjects at baseline, 4 of 13 (30.8%) subjects available for follow-up at 6 months, and 2 of 11 (18.2%) subjects at 12 months. Median VCSS decreased (P < .001) from 8.5 (interquartile range [IQR], 7-10) at baseline to 4 (IQR, 2-4) at 1 month post-procedure and was similar at 6 months (2; IQR, 2-5) and 12 months (2; IQR, 1.5-3) post-procedure. Median VEINES QOL/Sym score improved (P < .001) by 39 from baseline (57; IQR, 53.5-74) to 1 month (96; IQR, 86-101) post-procedure, and remained high at 6 months (99; IQR, 75-103) and 12 months (98; IQR, 94.5-100). Median calf circumference decreased (P=0.089) from 39 cm (IQR, 35-47.8) at baseline to 36 cm (IQR, 32.5-40.5) at 24 hours post-procedure and was 34.5 cm (IQR, 33.2-38.5) at 1 month.
The Pounce device is safe and effective for removal of thrombus in acute iliofemoral DVT patients. Initial results demonstrate improvements in venous disease severity and patient quality of life.

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