Laser‐Assisted Removal of Embedded Vena Cava Filters: A First‐In‐Human Escalation Trial in 500 Patients Refractory to High‐Force Retrieval

BACKGROUND: Many patients are subject to potential risks and filter‐related morbidity when standard retrieval methods fail. We evaluated the safety and efficacy of the laser sheath technique for removing embedded inferior vena cava filters. METHODS AND RESULTS: Over an 8.5‐year period, 500 patients were prospectively enrolled in an institutional review board–approved study. There were 225 men and 275 women (mean age, 49 years; range, 15–90 years). Indications for retrieval included symptomatic acute inferior vena cava thrombosis, chronic inferior vena cava occlusion, and/or pain from filter penetration. Retrieval was also offered to prevent risks from prolonged implantation and potentially to eliminate need for lifelong anticoagulation. After retrieval failed using 3X standard retrieval force (6–7 lb via digital gauge), treatment escalation was attempted using laser sheath powered by 308‐nm XeCl excimer laser system (CVX‐300; Spectranetics). We hypothesized that the laser‐assisted technique would allow retrieval of >95% of embedded filters with <5% risk of major complications and with lower force. Primary outcome was successful retrieval. Primary safety outcome was any major procedure‐related complication. Laser‐assisted retrieval was successful in 99.4% of cases (497/500) (95% CI, 98.3%–99.9%) and significantly >95% (P<0.0001). The mean filter dwell time was 1528 days (range, 37–10 047; >27.5 years]), among retrievable‐type (n=414) and permanent‐type (n=86) filters. The average force during failed attempts without laser was 6.4 versus 3.6 lb during laser‐assisted retrievals (P<0.0001). The major complication rate was 2.0% (10/500) (95% CI, 1.0%–3.6%), significantly <5% (P<0.0005), 0.6% (3/500) (95% CI, 0%–1.3%) from laser, and all were successfully treated. Successful retrieval allowed cessation of anticoagulation in 98.7% (77/78) (95% CI, 93.1%–100.0%) and alleviated filter‐related morbidity in 98.5% (138/140) (95% CI, 96.5%–100.0%). CONCLUSIONS: The excimer laser sheath technique is safe and effective for removing embedded inferior vena cava filters refractory to high‐force retrieval. This technique may allow cessation of filter‐related anticoagulation and can be used to prevent and alleviate filter‐related morbidity. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01158482.