PURPOSE

To evaluate (i) the appropriateness, safety, and patient outcomes after placement of the VenaTech LP caval filter and (ii) the success of filter insertion through various venous access routes.

MATERIALS AND METHODS

An open multicenter prospective observational study was conducted in 12 European centers, including an initial part limited to four centers. Patients with common indications were eligible for inclusion after approval by an independent ethics committee. Over a 42-month period, 106 patients (46 men [43.4%], 60 women [56.6%]), 72.2 years +/- 13.3 of age (range, 37-97 y), with poor prognoses were included. Patients were examined 2-5 days after the procedure, then at 30 days +/- 5 and 90 days +/- 15 for clinical follow-up and filter assessment. Evaluation criteria were based on occurrence of pulmonary embolism (PE), adverse events, death, filter position, and caval patency. Data were available in 101 case report forms at days 2-5, in 75 at day 30 +/- 5, and in 60 at day 90 +/- 15. Two patients (1.9%) were lost to follow-up.

RESULTS

The overall mortality rate was 20.8%. PE was present in 71 patients (67.0%). History of venous thromboembolic disease (VTED) was noted in 32 patients (30.2%), and recently diagnosed VTED was present in 101 patients (95.3%). Partial caval thrombosis was present before the procedure. Filter tilting of 10-45 degrees was seen in 3.9% of cases at days 2-5, 4.3% of cases at day 30 +/- 5, and 1.9% of cases at day 90 +/- 15. Follow-up evidenced neither clinical signs of PE nor significant device-related events.

CONCLUSIONS

In a prospective patient cohort with a projected 3-month mortality rate of nearly 21.0% as a result of severe prognoses, the success of insertion via various venous access routes and the appropriateness and safety of the VenaTech LP caval filter were assessed. Findings at 90-day follow-up were free of symptomatic PE and device-related adverse effects.