Laser-Assisted Removal of Embedded Vena Cava Filters: A 5-Year First-in-Human Study

Abstract

Many patients are subjected to the potential risks and morbidity associated with an indwelling inferior vena cava (IVC) filter when standard methods fail to remove the filter. We evaluated the safety and effectiveness of the excimer laser sheath technique for removing embedded IVC filters. Over a 5-year period, 251 consecutive patients undergoing laser-assisted filter retrieval were prospectively enrolled. There were 103 men and 148 women (mean, 46 years; range, 15-82 years). Indications for retrieval included symptomatic acute IVC thrombosis, chronic IVC occlusion, and/or pain from filter penetration. Retrieval was also performed to prevent risks from prolonged implantation and potentially to eliminate the need for lifelong anticoagulation. After retrieval failed using three times the standard retrieval force (digitally measured), treatment escalation was attempted using a laser sheath powered by a 308-nm XeCl laser. Success was defined as complete filter detachment and removal from the body. Primary safety outcomes were major procedure-related complications. Laser-assisted retrieval was successful in 249 of 251 patients (99.2%) (95%CI, 97.2%-99.9%), with a mean implantation of 979days, range: 37-7,098days (> 19 years), among retrievable-type filters (n= 211) and permanent-type filters (n= 40). Average force during failed attempts without laser was 6.7 vs3.8 lbs during laser-assisted retrievals (P< .0001). The major complication rate was 1.6%(95%CI, 0.4%-4.0%), and all were successfully treated. Successful retrieval allowed cessation of anticoagulation in 45 of 46 patients (98%) (95%CI, 88%-99%) and alleviated filter-related morbidity in 55 of 57 patients (96%) (95%CI, 88%-99%). The excimer laser sheath technique is safe and effective for removing embedded IVC filters refractory to standard retrieval and high force. This technique can be used to alleviate or prevent filter-related morbidity and may allow cessation of filter-related anticoagulation. ClinicalTrials.gov; No.: NCT01158482; URL: www.clinicaltrials.gov.