The Safety and Effectiveness of the Retrievable Option Inferior Vena Cava Filter: A United States Prospective Multicenter Clinical Study

doi:10.1016/j.jvir.2010.04.004

Journal of Vascular and Interventional Radiology

Volume 21, Issue 8, August 2010, Pages 1173-1184

https://doi.org/10.1016/j.jvir.2010.04.004 Get rights and content

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, 1–175 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.

Section snippets

Study Design and Conduct

This was a single-arm, prospective, multicenter, nonrandomized clinical trial conducted in patients who were at permanent or temporary increased risk of PE and in whom IVC interruption was judged to be clinically indicated (clinicaltrials.gov identifier, NCT00488865). Subjects who met the selection criteria underwent implantation of the Option IVC filter. In the original protocol, filters were to be considered permanent if they were not removed within 90 days of placement. The protocol was

Filter Placement

One hundred filters were implanted—one filter per subject—with a mean filter placement procedure time of 23.6 minutes ± 11.8 (range, 5.0–99.0 minutes) and a mean fluoroscopy time of 3.7 minutes ± 2.6 (range, 0.6–15.1 minutes). The mean IVC diameter was 21.4 mm ± 3.5 (range, 15.3–31.0 mm). Most subjects (n = 97; 97%) had a normal caval anatomy. The three cases of abnormal caval anatomy were not considered exclusion criteria; these included a vena cava described as “tortuous,” a vena cava with a

Discussion

The data from this study met the primary objective to test the hypothesis that the one-sided lower limit of the 95% CI for the observed clinical success with the filter was greater than or equal to 80%. In this study, clinical success was achieved in 88% of subjects, with a one-sided lower limit of the 95% CI exactly equal to 81%. The definition of clinical success that was used in this study—technical success without subsequent PE, significant filter migration or embolization, symptomatic

Acknowledgments

The authors acknowledge the contribution of Krishna Kandarpa, MD, Professor of Radiology, University of Massachusetts Medical School (Worcester, Massachusetts), who served as the independent medical monitor for this study and was responsible for the review and validation of all reported adverse events that were considered serious or device- and/or procedure-related. The authors also acknowledge the contribution of Anneke Jonker, Senior Medical Writer, Angiotech Pharmaceuticals (Vancouver,

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Cited by (31)

Inferior vena cava filters
2017, Journal of Thrombosis and Haemostasis
Use of inferior vena cava (IVC) filters has increased dramatically in recent decades, despite a lack of evidence that their use has impacted venous thromboembolism (VTE)‐related mortality. This increased use appears to be primarily driven by the insertion of retrievable filters for prophylactic indications. A growing body of evidence, however, suggests that IVC filters are frequently associated with clinically important adverse events, prompting a closer look at their role. We sought to narratively review the current evidence on the efficacy and safety of IVC filter placements. Inferior vena cava filters remain the only treatment option for patients with an acute (within 2–4 weeks) proximal deep vein thrombosis (DVT) or pulmonary embolism and an absolute contraindication to anticoagulation. In such patients, anticoagulation should be resumed and IVC filters removed as soon as the contraindication has passed. For all other indications, there is insufficient evidence to support the use of IVC filters and high‐quality trials are required. In patients where an IVC filter remains, regular follow‐up to reassess removal and screen for filter‐related complications should occur.
A quality improvement project to improve inferior vena cava filter retrieval
2017, Journal of Vascular Surgery: Venous and Lymphatic Disorders
Poor retrieval rates for retrievable inferior vena cava filters (R-IVCFs) have been reported throughout the literature, with poor follow-up a common cause. In 2009, we reported a retrieval rate of 18% despite an initial follow-up rate of 85%. Use of a registry has been shown to improve retrieval rates. As a quality improvement project, in May 2012, the vascular surgery fellowship implemented a reiterative registry to track R-IVCFs placed at Walter Reed National Military Medical Center to improve retrieval rates. We report the results in 125 patients after 38 months.
Patients receiving an R-IVCF were entered into a registry. All patients were reviewed monthly using an electronic health record. When there was no longer an indication for the R-IVCF, the patient was scheduled for an outpatient appointment with a vascular surgeon followed by retrieval. Rates of retrieval, technical success, dwell time, indication, complications, and demographics were collected.
There were 125 R-IVCFs placed between May 2012 and June 2015; 52 filters were placed for therapeutic and 73 for prophylactic indications. Our follow-up rate improved to 94%. A total of 79 filters were retrieved (63% absolute retrieval rate). Excluding patients who died before retrieval and patients with a permanent indication, 77% of filters were retrieved. The average dwell time was 101.5 days (7-460 days), and 63% of successful R-IVCF retrievals were within 3 months of placement. Technical success for retrieval was 92%. There were two major complications from retrievals (1.5% of retrievals).
The creation of an R-IVCF registry promoted ongoing follow-up with patients. In our earlier experience, retrieval rates were poor despite a high follow-up rate. The use of a reiterative registry improved our retrieval rate by 45% and increased our follow-up rate to 94%. These results emphasize the importance of repetitive follow-up for R-IVCFs. Despite a follow-up rate >90%, around a third of R-IVCFs were not retrieved.
Analysis of the Final DENALI Trial Data: A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter
2016, Journal of Vascular and Interventional Radiology
To report the final 2-year data on the efficacy and safety of a nitinol retrievable inferior vena cava (IVC) filter for protection against pulmonary embolism (PE).
This was a prospective multicenter trial of 200 patients with temporary indications for caval filtration who underwent implantation of the Denali IVC filter. After filter placement, all patients were followed for 2 years after placement or 30 days after filter retrieval. The primary endpoints were technical success of filter implantation in the intended location and clinical success of filter placement and retrieval. Secondary endpoints were incidence of clinically symptomatic recurrent PE, new or propagating deep vein thrombosis (DVT), and filter-related complications including migration, fracture, penetration, and tilt.
Filter placement was technically successful in 199 patients (99.5%). Filters were clinically successful in 190 patients (95%). The rate of PE was 3% (n = 6), with 5 patients having a small subsegmental PE and 1 having a lobar PE. New or worsening DVT was noted in 26 patients (13%). Filter retrieval was attempted 125 times in 124 patients and was technically successful in 121 patients (97.6%). The mean filter dwell time at retrieval was 200.8 days (range, 5–736 d). There were no instances of filter fracture, migration, or tilt greater than 15° at the time of filter retrieval or during follow-up.
The Denali IVC filter exhibited high success rates for filter placement and retrieval while maintaining a low complication rate in this clinical trial.
A comparison of retrievability: Celect versus option filter
2015, Journal of Vascular and Interventional Radiology
To compare the retrievability of 2 potentially retrievable inferior vena cava filter devices.
A retrospective, institutional review board–approved study of Celect (Cook, Inc, Bloomington, Indiana) and Option (Rex Medical, Conshohocken, Pennsylvania) filters was conducted over a 33-month period at a single institution. Fluoroscopy time, significant filter tilt, use of adjunctive retrieval technique, and strut perforation in the inferior vena cava were recorded on retrieval. Fisher exact test and Mann-Whitney-Wilcoxon test were used for comparison.
There were 99 Celect and 86 Option filters deployed. After an average of 2.09 months (range, 0.3–7.6 mo) and 1.94 months (range, 0.47–9.13 mo), respectively, 59% (n = 58) of patients with Celect filters and 74.7% (n = 65) of patients with Option filters presented for filter retrieval. Retrieval failure rates were 3.4% for Celect filters versus 7.7% for Option filters (P = .45). Median fluoroscopy retrieval times were 4.25 minutes for Celect filters versus 6 minutes for Option filters (P = .006). Adjunctive retrieval techniques were used in 5.4% of Celect filter retrievals versus 18.3% of Option filter retrievals (P = .045). The incidence of significant tilting was 8.9% for Celect filters versus 16.7% for Option filters (P = .27). The incidence of strut perforation was 43% for Celect filters versus 0% for Option filters (P < .0001).
Retrieval rates for the Celect and Option filters were not significantly different. However, retrieval of the Option filter required a significantly increased amount of fluoroscopy time compared with the Celect filter, and there was a significantly greater usage of adjunctive retrieval techniques for the Option filter. The Celect filter had a significantly higher rate of strut perforation.
The Denali trial: An interim analysis of a prospective, multicenter study of the Denali retrievable inferior vena cava filter
2014, Journal of Vascular and Interventional Radiology
Citation Excerpt :
The PE rate of 3% in the DENALI trial was within the established threshold value of 5% (19). PE rates from 1% to 6% have been reported in similar IVC filter trials (11,14,15,17). Significantly, there were no instances of IVC filter fracture, migration, or filter tilt greater than 15°.
To assess safety and effectiveness of a nitinol retrievable inferior vena cava (IVC) filter in patients who require caval interruption to protect against pulmonary embolism (PE).
Two hundred patients with temporary indications for an IVC filter were enrolled in this prospective, multicenter clinical study. Patients undergoing filter implantation were to be followed for 2 years or for 30 days after filter retrieval. At the time of the present interim report, all 200 patients had been enrolled in the study, and 160 had undergone a retrieval attempt or been followed to 6 months with their filter in place. Primary study endpoints included technical and clinical success of filter placement and retrieval. Patients were also evaluated for recurrent PE, new or worsening deep vein thrombosis, and filter migration, fracture, penetration, and tilt.
Clinical success of placement was achieved in 94.5% of patients (172 of 182), with a one-sided lower limit of the 95% confidence interval of 90.1%. Technical success rate of filter placement was 99.5%. Technical success rate of retrieval was 97.3%; 108 filters were retrieved in 111 attempts. In two cases, the filter apex could not be engaged with a snare, and one device was engaged but could not be removed. Filter retrievals occurred at a mean indwell time of 165 days (range, 5–632 d). There were no instances of filter fracture, migration, or tilt greater than 15° at the time of retrieval or 6-month follow-up.
In this interim report, the nitinol retrievable IVC filter provided protection against pulmonary embolism, and the device could be retrieved with a low rate of complications.
Pulmonary embolism after total joint arthroplasty: Cost and effectiveness of four treatment modalities
2014, Journal of Arthroplasty
Pulmonary embolism (PE) treatment relies on therapeutic anticoagulation and may be associated with severe complications. Inferior vena cava filters (IVCFs) are used as an alternative/adjunct to anticoagulation. In this study we evaluate 4 treatment protocols for clinical efficacy and cost. We reviewed over 27,000 total joint arthroplasty (TJA) patients. We retrospectively identified 294 patients with a documented, symptomatic PE within 90 days of surgery. All patients were treated with warfarin postoperatively. In addition, for the acute management, patients were divided into four treatment groups: (1) IVCF only, (2) IVCF with heparin, (3) heparin only and (4) no treatment. Complication rates, hospital stay and PE recurrence are reported. Among patients who received warfarin, IVCF was associated with fewer complications and lower overall hospital costs compared to the use of heparin for the treatment of PE after TJA.

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: From the SIR 2009 Annual Meeting.

: This study was sponsored by Rex Medical (Conshohocken, Pennsylvania). M.S.J. serves as a consultant to Rex Medical, CeloNova BioSciences (Newnan, Georgia), Cook (Bloomington, Indiana), Lutonix (Maple Grove, Minnesota), Boston Scientific Corporation (Natick, Massachusetts), MDS Nordion (Ottawa, Canada), and Sirtex Medical (Lane Cove NSW, Australia). A.A.N. serves as a consultant to B. Braun Interventional (Bethlehem, Pennsylvania). J.F.B serves on the medical advisory boards of Amaranth Medical (Mountain View, California), Cordis Endovascular (Miami Lakes, Florida), and EndoVention (San Francisco, California) and as the Chief Medical Officer for Endovascular Forum (Boston, Massachusetts); and is a stockholder of Ekos (Bothell, Washington). D.S.B. serves on the advisory board of Cordis Endovascular and as a consultant and speaker for Bard Peripheral Vascular (Tempe, Arizona). B.L.D. serves as a consultant and speaker for Bard Peripheral Vascular and as a consultant to Covidien (Mansfield, Massachusetts) and on the medical advisory boards of Vital Access (Salt Lake City, Utah) and Endovascular Forum. J.A.K. serves on the medical board of Hatch Medical (Duluth, Georgia) and as a consultant to AGA Medical (Plymouth, Minnesota) and receives research support from W.L. Gore and Associates (Flagstaff, Arizona), VNUS Medical Technologies (San Jose, California), LeMaitre Vascular (Burlington, Massachusetts), and Rex Medical. Z.JH. serves on the scientific advisory board of W.L. Gore and Associates and on the medical advisory boards of Endovascular Forum and Elcam Medical (Hackensack, New Jersey) and as a consultant for Bard Peripheral Vascular, and receives research support from Bard Peripheral Vascular. R.L.A. is an employee of, and stockholder in, Angiotech Pharmaceuticals (Vancouver, British Columbia, Canada). None of the other authors have identified a conflict of interest.

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Clinical studyThe Safety and Effectiveness of the Retrievable Option Inferior Vena Cava Filter: A United States Prospective Multicenter Clinical Study

Purpose

Materials and Methods

Results

Conclusions

Section snippets

Study Design and Conduct

Filter Placement

Discussion

Acknowledgments

J Vasc Interv Radiol

J Vasc Interv Radiol

Chest

J Vasc Interv Radiol

J Vasc Interv Radiol

J Vasc Interv Radiol

J Vasc Interv Radiol

J Vasc Interv Radiol

Semin Hematol

Clinical study
The Safety and Effectiveness of the Retrievable Option Inferior Vena Cava Filter: A United States Prospective Multicenter Clinical Study