The safety and effectiveness of the retrievable option inferior vena cava filter: A United States prospective multicenter clinical study

Matthew S. Johnson, Albert A. Nemcek, James F. Benenati, Dirk S. Baumann, Bart L. Dolmatch, John A. Kaufman, Mark J. Garcia, Michael S. Stecker, Anthony C. Venbrux, Ziv J. Haskal, Rui L. Avelar

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

PURPOSE: To evaluate the safety and effectiveness of the retrievable Option inferior vena cava (IVC) filter in patients at risk for pulmonary embolism (PE). MATERIALS AND METHODS: This was a prospective, multicenter, single-arm clinical trial. Subjects (N = 100) underwent implantation of the IVC filter and were followed for 180 days; subjects whose filters were later removed were followed for 30 days thereafter. The primary objective was to determine whether the one-sided lower limit of the 95% CI for the observed clinical success rate was at least 80%. Clinical success was defined as technical success (deployment of the filter such that it was judged suitable for mechanical protection from PE) without subsequent PE, significant filter migration or embolization, symptomatic caval thrombosis, or other complications. RESULTS: Technical success was achieved in 100% of subjects. There were eight cases of recurrent PE, two cases of filter migration (23 mm), and three cases of symptomatic caval occlusion/thrombosis (one in a subject who also experienced filter migration). No filter embolization or fracture occurred. Clinical success was achieved in 88% of subjects; the one-sided lower limit of the 95% CI was 81%. Retrieval was successful at a mean of 67.1 days after implantation (range, 1175 d) for 36 of 39 subjects (92.3%). All deaths (n = 17) and deep vein thromboses (n = 18) were judged to have resulted from preexisting or intercurrent illnesses or interventions and unrelated to the filter device; all deaths were judged to be unrelated to PE. CONCLUSIONS: Placement and retrieval of the Option IVC filter were performed safely and with high rates of clinical success.

Original languageEnglish (US)
Pages (from-to)1153-1163
Number of pages11
JournalJournal of Vascular and Interventional Radiology
Volume21
Issue number8
DOIs
StatePublished - 2010

Fingerprint

Vena Cava Filters
Pulmonary Embolism
Multicenter Studies
Safety
Venae Cavae
Thrombosis
Venous Thrombosis
Clinical Studies
Clinical Trials
Equipment and Supplies

Keywords

  • DVT
  • IVC
  • PE
  • deep vein thrombosis
  • inferior vena cava
  • pulmonary embolism

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Johnson, Matthew S. ; Nemcek, Albert A. ; Benenati, James F. ; Baumann, Dirk S. ; Dolmatch, Bart L. ; Kaufman, John A. ; Garcia, Mark J. ; Stecker, Michael S. ; Venbrux, Anthony C. ; Haskal, Ziv J. ; Avelar, Rui L. / The safety and effectiveness of the retrievable option inferior vena cava filter : A United States prospective multicenter clinical study. In: Journal of Vascular and Interventional Radiology. 2010 ; Vol. 21, No. 8. pp. 1153-1163.
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title = "The safety and effectiveness of the retrievable option inferior vena cava filter: A United States prospective multicenter clinical study",
abstract = "PURPOSE: To evaluate the safety and effectiveness of the retrievable Option inferior vena cava (IVC) filter in patients at risk for pulmonary embolism (PE). MATERIALS AND METHODS: This was a prospective, multicenter, single-arm clinical trial. Subjects (N = 100) underwent implantation of the IVC filter and were followed for 180 days; subjects whose filters were later removed were followed for 30 days thereafter. The primary objective was to determine whether the one-sided lower limit of the 95{\%} CI for the observed clinical success rate was at least 80{\%}. Clinical success was defined as technical success (deployment of the filter such that it was judged suitable for mechanical protection from PE) without subsequent PE, significant filter migration or embolization, symptomatic caval thrombosis, or other complications. RESULTS: Technical success was achieved in 100{\%} of subjects. There were eight cases of recurrent PE, two cases of filter migration (23 mm), and three cases of symptomatic caval occlusion/thrombosis (one in a subject who also experienced filter migration). No filter embolization or fracture occurred. Clinical success was achieved in 88{\%} of subjects; the one-sided lower limit of the 95{\%} CI was 81{\%}. Retrieval was successful at a mean of 67.1 days after implantation (range, 1175 d) for 36 of 39 subjects (92.3{\%}). All deaths (n = 17) and deep vein thromboses (n = 18) were judged to have resulted from preexisting or intercurrent illnesses or interventions and unrelated to the filter device; all deaths were judged to be unrelated to PE. CONCLUSIONS: Placement and retrieval of the Option IVC filter were performed safely and with high rates of clinical success.",
keywords = "DVT, IVC, PE, deep vein thrombosis, inferior vena cava, pulmonary embolism",
author = "Johnson, {Matthew S.} and Nemcek, {Albert A.} and Benenati, {James F.} and Baumann, {Dirk S.} and Dolmatch, {Bart L.} and Kaufman, {John A.} and Garcia, {Mark J.} and Stecker, {Michael S.} and Venbrux, {Anthony C.} and Haskal, {Ziv J.} and Avelar, {Rui L.}",
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Johnson, MS, Nemcek, AA, Benenati, JF, Baumann, DS, Dolmatch, BL, Kaufman, JA, Garcia, MJ, Stecker, MS, Venbrux, AC, Haskal, ZJ & Avelar, RL 2010, 'The safety and effectiveness of the retrievable option inferior vena cava filter: A United States prospective multicenter clinical study', Journal of Vascular and Interventional Radiology, vol. 21, no. 8, pp. 1153-1163. https://doi.org/10.1016/j.jvir.2010.03.015

The safety and effectiveness of the retrievable option inferior vena cava filter : A United States prospective multicenter clinical study. / Johnson, Matthew S.; Nemcek, Albert A.; Benenati, James F.; Baumann, Dirk S.; Dolmatch, Bart L.; Kaufman, John A.; Garcia, Mark J.; Stecker, Michael S.; Venbrux, Anthony C.; Haskal, Ziv J.; Avelar, Rui L.

In: Journal of Vascular and Interventional Radiology, Vol. 21, No. 8, 2010, p. 1153-1163.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The safety and effectiveness of the retrievable option inferior vena cava filter

T2 - A United States prospective multicenter clinical study

AU - Johnson, Matthew S.

AU - Nemcek, Albert A.

AU - Benenati, James F.

AU - Baumann, Dirk S.

AU - Dolmatch, Bart L.

AU - Kaufman, John A.

AU - Garcia, Mark J.

AU - Stecker, Michael S.

AU - Venbrux, Anthony C.

AU - Haskal, Ziv J.

AU - Avelar, Rui L.

PY - 2010

Y1 - 2010

N2 - PURPOSE: To evaluate the safety and effectiveness of the retrievable Option inferior vena cava (IVC) filter in patients at risk for pulmonary embolism (PE). MATERIALS AND METHODS: This was a prospective, multicenter, single-arm clinical trial. Subjects (N = 100) underwent implantation of the IVC filter and were followed for 180 days; subjects whose filters were later removed were followed for 30 days thereafter. The primary objective was to determine whether the one-sided lower limit of the 95% CI for the observed clinical success rate was at least 80%. Clinical success was defined as technical success (deployment of the filter such that it was judged suitable for mechanical protection from PE) without subsequent PE, significant filter migration or embolization, symptomatic caval thrombosis, or other complications. RESULTS: Technical success was achieved in 100% of subjects. There were eight cases of recurrent PE, two cases of filter migration (23 mm), and three cases of symptomatic caval occlusion/thrombosis (one in a subject who also experienced filter migration). No filter embolization or fracture occurred. Clinical success was achieved in 88% of subjects; the one-sided lower limit of the 95% CI was 81%. Retrieval was successful at a mean of 67.1 days after implantation (range, 1175 d) for 36 of 39 subjects (92.3%). All deaths (n = 17) and deep vein thromboses (n = 18) were judged to have resulted from preexisting or intercurrent illnesses or interventions and unrelated to the filter device; all deaths were judged to be unrelated to PE. CONCLUSIONS: Placement and retrieval of the Option IVC filter were performed safely and with high rates of clinical success.

AB - PURPOSE: To evaluate the safety and effectiveness of the retrievable Option inferior vena cava (IVC) filter in patients at risk for pulmonary embolism (PE). MATERIALS AND METHODS: This was a prospective, multicenter, single-arm clinical trial. Subjects (N = 100) underwent implantation of the IVC filter and were followed for 180 days; subjects whose filters were later removed were followed for 30 days thereafter. The primary objective was to determine whether the one-sided lower limit of the 95% CI for the observed clinical success rate was at least 80%. Clinical success was defined as technical success (deployment of the filter such that it was judged suitable for mechanical protection from PE) without subsequent PE, significant filter migration or embolization, symptomatic caval thrombosis, or other complications. RESULTS: Technical success was achieved in 100% of subjects. There were eight cases of recurrent PE, two cases of filter migration (23 mm), and three cases of symptomatic caval occlusion/thrombosis (one in a subject who also experienced filter migration). No filter embolization or fracture occurred. Clinical success was achieved in 88% of subjects; the one-sided lower limit of the 95% CI was 81%. Retrieval was successful at a mean of 67.1 days after implantation (range, 1175 d) for 36 of 39 subjects (92.3%). All deaths (n = 17) and deep vein thromboses (n = 18) were judged to have resulted from preexisting or intercurrent illnesses or interventions and unrelated to the filter device; all deaths were judged to be unrelated to PE. CONCLUSIONS: Placement and retrieval of the Option IVC filter were performed safely and with high rates of clinical success.

KW - DVT

KW - IVC

KW - PE

KW - deep vein thrombosis

KW - inferior vena cava

KW - pulmonary embolism

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