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J Vasc Interv Radiol · Jul 2009
Multicenter Study Clinical TrialLong-term retrieval success rate profile for the Günther Tulip vena cava filter.
- H Bob Smouse, David Rosenthal, Van Ha Thuong, Michael F Knox, Robert G Dixon, William D Voorhees, and Jennifer A McCann-Brown.
- Department of Vascular and Interventional Radiology, OSF St. Francis Medical Center, Peoria, Illinois, USA.
- J Vasc Interv Radiol. 2009 Jul 1; 20 (7): 871-7; quiz 878.
PurposeTo evaluate the likelihood of successful retrieval of the Günther Tulip vena cava filter after various implant durations (up to 494 days).Materials And MethodsRetrievable Günther Tulip filters were placed in 554 patients. All patients satisfied requirements for filter placement; the primary indication for placement was specified for 394 patients (71%), as follows: unspecified trauma (n = 164), bariatric procedures (n = 128), orthopedic procedures (n = 36), and other (n = 66). Filter tilt and vena cava injury were assessed at implantation. Filters were not repositioned after placement. At retrieval, filter orientation, vena cava injury, other device-related incidents, and the degree of difficulty associated with retrieval were reported.ResultsFilter retrieval was attempted in 275 patients and successful in 248 (90.2%). The mean filter indwell time was 58.9 days (range, 3-494 days). Unsuccessful retrievals (n = 27) were attributed primarily to improper hook orientation (n = 10) or excessive tissue in-growth at the filter legs (n = 16). Of the remaining 279 patients, 223 withdrew from the study, 41 were associated with a decision to keep the filter as a permanent device, 13 died for reasons unrelated to the study, and two had no reported endpoint data. A Kaplan-Meier product-limit survival estimate revealed that the probability of successful device retrieval remained greater than 94% at 12 weeks and greater than 67% at 26 weeks.ConclusionsThis study contributes to the body of clinical data related to retrievable filters, demonstrating reliable retrieval rates at 12 weeks, with successful retrievals up to 17 months after implantation.
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