Role of IVC filters in endovenous therapy for deep venous thrombosis: the FILTER-PEVI (filter implantation to lower thromboembolic risk in percutaneous endovenous intervention) trial.

Sharifi, Mohsen; Bay, Curt; Skrocki, Laura; Lawson, David; Mazdeh, Shahnaz

OBJECTIVES The purpose of this study was to evaluate the necessity of and recommend indications for inferior vena cava (IVC) filter implantation during percutaneous endovenous intervention (PEVI) for deep venous thrombosis (DVT). BACKGROUND PEVI has emerged as a powerful tool in the management of acute proximal DVT. Instrumentation of extensive fresh thrombus is potentially associated with iatrogenic pulmonary embolism (PE). The true frequency of this complication has not been studied in a randomized fashion. We evaluated IVC filter implantation during PEVI for DVT. METHODS A total of 141 patients with symptomatic proximal DVT undergoing PEVI for symptomatic DVT were randomized to receive an IVC filter (70 patients) or no filter (71 patients; control group). The anticoagulation and PEVI regimen were similar between the two groups. Patients with development of symptoms suggestive of PE underwent objective testing for PE. RESULTS PE developed in 1 of the 14 symptomatic patients in the filter group and 8 of the 22 patients in the control group (P = 0.048). There was no mortality in any group. Three patients (4.2%) in the control group had transient hemodynamic instability necessitating resuscitory efforts. Predictors of iatrogenic PE were found to be PE at admission; involvement of two or more adjacent venous segments with acute thrombus; inflammatory form of DVT (severe erythema, edema, pain, and induration); and vein diameter of ≥7 mm with preserved architecture. CONCLUSIONS IVC filter implantation during PEVI reduces the risk of iatrogenic PE by eightfold without a mortality benefit. A selective approach may be exercised in filter implantation during PEVI.