PROOF trial: protection from pulmonary embolism with the OptEase filter.
OBJECTIVE
A postmarketing surveillance registry was conducted to monitor the safety and effectiveness of the OptEase vena cava filter when used as a permanent filter.


METHODS
This study was a nonrandomized, multicenter prospective trial with all patients receiving the OptEase vena cava filter for the prevention of pulmonary embolism (PE). A total of 11 clinical sites in the United States enrolled patients. A 1-month postimplantation follow-up examination was performed to determine potential filter migration and the presence of symptomatic thrombosis of the inferior vena cava (IVC) or lower extremities. At 6-month postimplantation follow-up, patients were again assessed for the safety and stability of the filter and any clinical evidence of symptomatic thrombosis.


RESULTS
One hundred fifty patients were enrolled in this study. Fifty-five patients (36.6%) were unable to complete all of the necessary follow-up at 6 months. At 1 month, filter migration and filter-related symptomatic deep vein thrombosis was observed in one patient each (0.9% and 0.8%, respectively). At 6 months, no new cases of filter migration or filter-related symptomatic thrombosis were observed. Filter tilting (> or = 15 degrees off the IVC axis) was observed in one patient at baseline (0.7%), four patients at 1-month follow-up (3.6%), and three patients (11.4%) at 6-month follow-up. Incidental findings on follow-up radiographs included filter fracture in two patients (1.8%) at 1 month and in one additional patient (4.3%) at 6 months. There were no clinical sequelae associated with the filter fracture.


CONCLUSIONS
The co-primary endpoints of filter migration and symptomatic thrombus formation at 1 month had an observed frequency of 0.9% and 0.8%, respectively. These co-primary endpoints were stable and unchanged at 6 months.
Ziegler
J Werner
JW
Department of Radiology, Sunrise Medical Center, 3186 S Maryland Pkwy, Las Vegas, NV 89109, USA. wernerziegler@yahoo.com
Dietrich
Gary J
GJ
Cohen
Sidney A
SA
Sterling
Keith
K
Duncan
James
J
Samotowka
Michael
M
D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D015995:Prevalence; D011655:Pulmonary Embolism / Q000517:prevention & control*; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D016306:Vena Cava Filters / Q000706:statistics & numerical data*