Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months

Matthew S. Johnson; James B. Spies; Katherine T. Scott; Bernet S. Kato; Xiangyu Mu; John E. Rectenwald; Rodney A. White; Robert J. Lewandowski; Minhaj S. Khaja; Darryl A. Zuckerman; Thomas Casciani; David L. Gillespie

doi:10.1016/j.jvsv.2022.11.002

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months

Matthew S. Johnson^*, James B. Spies, Katherine T. Scott, Bernet S. Kato, Xiangyu Mu, John E. Rectenwald, Rodney A. White, Robert J. Lewandowski, Minhaj S. Khaja, Darryl A. Zuckerman, Thomas Casciani, David L. Gillespie

^*Corresponding author for this work

Radiology

Research output: Contribution to journal › Article › peer-review

17 Scopus citations

Abstract

Objective: To determine the safety and effectiveness of vena cava filters (VCFs). Methods: A total of 1429 participants (62.7 ± 14.7 years old; 762 [53.3% male]) consented to enroll in this prospective, nonrandomized study at 54 sites in the United States between October 10, 2015, and March 31, 2019. They were evaluated at baseline and at 3, 6, 12, 18, and 24 months following VCF implantation. Participants whose VCFs were removed were followed for 1 month after retrieval. Follow-up was performed at 3, 12, and 24 months. Predetermined composite primary safety (freedom from perioperative serious adverse events [AEs] and from clinically significant perforation, VCF embolization, caval thrombotic occlusion, and/or new deep vein thrombosis [DVT] within 12-months) and effectiveness (composite comprising procedural and technical success and freedom from new symptomatic pulmonary embolism [PE] confirmed by imaging at 12-months in situ or 1 month postretrieval) end points were assessed. Results: VCFs were implanted in 1421 patients. Of these, 1019 (71.7%) had current DVT and/or PE. Anticoagulation therapy was contraindicated or had failed in 1159 (81.6%). One hundred twenty-six (8.9%) VCFs were prophylactic. Mean and median follow-up for the entire population and for those whose VCFs were not removed was 243.5 ± 243.3 days and 138 days and 332.6 ± 290 days and 235 days, respectively. VCFs were removed from 632 (44.5%) patients at a mean of 101.5 ± 72.2 days and median 86.3 days following implantation. The primary safety end point and primary effectiveness end point were both achieved. Procedural AEs were uncommon and usually minor, but one patient died during attempted VCF removal. Excluding strut perforation greater than 5 mm, which was demonstrated on 31 of 201 (15.4%) patients’ computed tomography scans available to the core laboratory, and of which only 3 (0.2%) were deemed clinically significant by the site investigators, VCF-related AEs were rare (7 of 1421, 0.5%). Postfilter, venous thromboembolic events (none fatal) occurred in 93 patients (6.5%), including DVT (80 events in 74 patients [5.2%]), PE (23 events in 23 patients [1.6%]), and/or caval thrombotic occlusions (15 events in 15 patients [1.1%]). No PE occurred in patients following prophylactic placement. Conclusions: Implantation of VCFs in patients with venous thromboembolism was associated with few AEs and with a low incidence of clinically significant PEs.

Original language	English (US)
Pages (from-to)	573-585.e6
Journal	Journal of Vascular Surgery: Venous and Lymphatic Disorders
Volume	11
Issue number	3
DOIs	https://doi.org/10.1016/j.jvsv.2022.11.002
State	Published - May 2023

Funding

Funding / Support : This trial is sponsored by the Inferior Vena Cava Filter Study Group Foundation (IVCFSGF), a joint effort between the Society for Vascular Surgery and the Society of Interventional Radiology. Funding for this trial has been provided to the IVCFSGF by ALN Implants Chirurgicaux , Argon Medical Devices Inc , B. Braun Interventional Systems Inc , Cook Medical , C.R. Bard Peripheral Vascular Inc (a Becton Dickinson Company), Cordis Corporation (a Cardinal Health Company), and Philips Volcano . Author conflict of interest: This study was funded by the IVCFGSF, which was itself funded by the entities listed below. As such, all authors received support from the IVCFGSF. M.S.J. reported support for this study from ALN, Argon, B. Braun, Cook Medical, Inc, C.R. Bard, Inc. (a Becton Dickinson company), Cordis Corporation (a Cardinal Health company), and Philips Volcano; grants or contracts from Argon ; payment for expert testimony from Argon; support for attending meetings and/or travel from Adient; participation on a data safety monitoring board or an advisory board for Argon; and a leadership or fiduciary role in other board, society, committee, or advocacy groups, paid or unpaid, from the Society of Interventional Radiology. K.T.S. reported support for the present study from the Inferior Vena Cava Filter Study Group Foundation (IVCFSGF); grants or contracts from IVCFSGF ; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from IVCFSGF; support for attending meetings and/or travel from IVCFSGF; and board or advisory board participation for IVCFSGF. B.S.K. works for the Clinical Research Organization (HealthCore) and receives a salary from them. Time spent attending meetings and/or travel was billed to the sponsor. These activities were not dependent on the results, and no stipends (or other benefits) were received for these activities, as they are a normal part of the job. R.A.W. reported grants or contracts from Medtronic and Bolton Terumo ; consulting fees from W. L. Gore & Associates; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Medtronic and Bolton Terumo; and participation on a data safety monitoring board or advisory board from Intact Vascular and W. L. Gore & Associates. R.J.L. reported consulting fees from Boston Scientific and Becton Dickinson; support for attending meetings and/or travel from the Society of Interventional Radiology; and a leadership or fiduciary role in other board, society, committee, or advocacy groups, paid or unpaid, for the Society of Interventional Radiology. M.S.K. reported grants or contracts from Boston Scientific and the Society of Interventional Radiology Foundation ; consulting fees for Medtronic; honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events at Boston Scientific, Medtronic, and Penumbra; participated on a data safety monitoring board or advisory board for Boston Scientific and Medtronic; and a leadership or fiduciary role in other board, society, committee or advocacy groups, paid or unpaid, for the Association of Program Directors in Interventional Radiology. T.C. participated on a data safety monitoring board or advisory board for iMARC (DSMB). D.L.G., X.M., J.E.R., J.B.S., and D.A.Z. have no conflicts of interest.

Keywords

Deep vein thrombosis
Pulmonary embolus
Vena cava filter
Venous thromboembolism

ASJC Scopus subject areas

Surgery
Cardiology and Cardiovascular Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jvsv.2022.11.002

Cite this

Johnson, M. S., Spies, J. B., Scott, K. T., Kato, B. S., Mu, X., Rectenwald, J. E., White, R. A., Lewandowski, R. J., Khaja, M. S., Zuckerman, D. A., Casciani, T., & Gillespie, D. L. (2023). Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. Journal of Vascular Surgery: Venous and Lymphatic Disorders, 11(3), 573-585.e6. https://doi.org/10.1016/j.jvsv.2022.11.002

@article{34eca97525994421a135c954039ec5bf,

title = "Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months",

abstract = "Objective: To determine the safety and effectiveness of vena cava filters (VCFs). Methods: A total of 1429 participants (62.7 ± 14.7 years old; 762 [53.3\% male]) consented to enroll in this prospective, nonrandomized study at 54 sites in the United States between October 10, 2015, and March 31, 2019. They were evaluated at baseline and at 3, 6, 12, 18, and 24 months following VCF implantation. Participants whose VCFs were removed were followed for 1 month after retrieval. Follow-up was performed at 3, 12, and 24 months. Predetermined composite primary safety (freedom from perioperative serious adverse events [AEs] and from clinically significant perforation, VCF embolization, caval thrombotic occlusion, and/or new deep vein thrombosis [DVT] within 12-months) and effectiveness (composite comprising procedural and technical success and freedom from new symptomatic pulmonary embolism [PE] confirmed by imaging at 12-months in situ or 1 month postretrieval) end points were assessed. Results: VCFs were implanted in 1421 patients. Of these, 1019 (71.7\%) had current DVT and/or PE. Anticoagulation therapy was contraindicated or had failed in 1159 (81.6\%). One hundred twenty-six (8.9\%) VCFs were prophylactic. Mean and median follow-up for the entire population and for those whose VCFs were not removed was 243.5 ± 243.3 days and 138 days and 332.6 ± 290 days and 235 days, respectively. VCFs were removed from 632 (44.5\%) patients at a mean of 101.5 ± 72.2 days and median 86.3 days following implantation. The primary safety end point and primary effectiveness end point were both achieved. Procedural AEs were uncommon and usually minor, but one patient died during attempted VCF removal. Excluding strut perforation greater than 5 mm, which was demonstrated on 31 of 201 (15.4\%) patients{\textquoteright} computed tomography scans available to the core laboratory, and of which only 3 (0.2\%) were deemed clinically significant by the site investigators, VCF-related AEs were rare (7 of 1421, 0.5\%). Postfilter, venous thromboembolic events (none fatal) occurred in 93 patients (6.5\%), including DVT (80 events in 74 patients [5.2\%]), PE (23 events in 23 patients [1.6\%]), and/or caval thrombotic occlusions (15 events in 15 patients [1.1\%]). No PE occurred in patients following prophylactic placement. Conclusions: Implantation of VCFs in patients with venous thromboembolism was associated with few AEs and with a low incidence of clinically significant PEs.",

keywords = "Deep vein thrombosis, Pulmonary embolus, Vena cava filter, Venous thromboembolism",

author = "Johnson, \{Matthew S.\} and Spies, \{James B.\} and Scott, \{Katherine T.\} and Kato, \{Bernet S.\} and Xiangyu Mu and Rectenwald, \{John E.\} and White, \{Rodney A.\} and Lewandowski, \{Robert J.\} and Khaja, \{Minhaj S.\} and Zuckerman, \{Darryl A.\} and Thomas Casciani and Gillespie, \{David L.\}",

note = "Publisher Copyright: {\textcopyright} 2023",

year = "2023",

month = may,

doi = "10.1016/j.jvsv.2022.11.002",

language = "English (US)",

volume = "11",

pages = "573--585.e6",

journal = "Journal of Vascular Surgery: Venous and Lymphatic Disorders",

issn = "2213-333X",

publisher = "Elsevier Inc.",

number = "3",

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Johnson, MS, Spies, JB, Scott, KT, Kato, BS, Mu, X, Rectenwald, JE, White, RA, Lewandowski, RJ, Khaja, MS, Zuckerman, DA, Casciani, T & Gillespie, DL 2023, 'Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months', Journal of Vascular Surgery: Venous and Lymphatic Disorders, vol. 11, no. 3, pp. 573-585.e6. https://doi.org/10.1016/j.jvsv.2022.11.002

TY - JOUR

T1 - Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE)

T2 - Outcomes at 12 months

AU - Johnson, Matthew S.

AU - Spies, James B.

AU - Scott, Katherine T.

AU - Kato, Bernet S.

AU - Mu, Xiangyu

AU - Rectenwald, John E.

AU - White, Rodney A.

AU - Lewandowski, Robert J.

AU - Khaja, Minhaj S.

AU - Zuckerman, Darryl A.

AU - Casciani, Thomas

AU - Gillespie, David L.

PY - 2023/5

Y1 - 2023/5

N2 - Objective: To determine the safety and effectiveness of vena cava filters (VCFs). Methods: A total of 1429 participants (62.7 ± 14.7 years old; 762 [53.3% male]) consented to enroll in this prospective, nonrandomized study at 54 sites in the United States between October 10, 2015, and March 31, 2019. They were evaluated at baseline and at 3, 6, 12, 18, and 24 months following VCF implantation. Participants whose VCFs were removed were followed for 1 month after retrieval. Follow-up was performed at 3, 12, and 24 months. Predetermined composite primary safety (freedom from perioperative serious adverse events [AEs] and from clinically significant perforation, VCF embolization, caval thrombotic occlusion, and/or new deep vein thrombosis [DVT] within 12-months) and effectiveness (composite comprising procedural and technical success and freedom from new symptomatic pulmonary embolism [PE] confirmed by imaging at 12-months in situ or 1 month postretrieval) end points were assessed. Results: VCFs were implanted in 1421 patients. Of these, 1019 (71.7%) had current DVT and/or PE. Anticoagulation therapy was contraindicated or had failed in 1159 (81.6%). One hundred twenty-six (8.9%) VCFs were prophylactic. Mean and median follow-up for the entire population and for those whose VCFs were not removed was 243.5 ± 243.3 days and 138 days and 332.6 ± 290 days and 235 days, respectively. VCFs were removed from 632 (44.5%) patients at a mean of 101.5 ± 72.2 days and median 86.3 days following implantation. The primary safety end point and primary effectiveness end point were both achieved. Procedural AEs were uncommon and usually minor, but one patient died during attempted VCF removal. Excluding strut perforation greater than 5 mm, which was demonstrated on 31 of 201 (15.4%) patients’ computed tomography scans available to the core laboratory, and of which only 3 (0.2%) were deemed clinically significant by the site investigators, VCF-related AEs were rare (7 of 1421, 0.5%). Postfilter, venous thromboembolic events (none fatal) occurred in 93 patients (6.5%), including DVT (80 events in 74 patients [5.2%]), PE (23 events in 23 patients [1.6%]), and/or caval thrombotic occlusions (15 events in 15 patients [1.1%]). No PE occurred in patients following prophylactic placement. Conclusions: Implantation of VCFs in patients with venous thromboembolism was associated with few AEs and with a low incidence of clinically significant PEs.

AB - Objective: To determine the safety and effectiveness of vena cava filters (VCFs). Methods: A total of 1429 participants (62.7 ± 14.7 years old; 762 [53.3% male]) consented to enroll in this prospective, nonrandomized study at 54 sites in the United States between October 10, 2015, and March 31, 2019. They were evaluated at baseline and at 3, 6, 12, 18, and 24 months following VCF implantation. Participants whose VCFs were removed were followed for 1 month after retrieval. Follow-up was performed at 3, 12, and 24 months. Predetermined composite primary safety (freedom from perioperative serious adverse events [AEs] and from clinically significant perforation, VCF embolization, caval thrombotic occlusion, and/or new deep vein thrombosis [DVT] within 12-months) and effectiveness (composite comprising procedural and technical success and freedom from new symptomatic pulmonary embolism [PE] confirmed by imaging at 12-months in situ or 1 month postretrieval) end points were assessed. Results: VCFs were implanted in 1421 patients. Of these, 1019 (71.7%) had current DVT and/or PE. Anticoagulation therapy was contraindicated or had failed in 1159 (81.6%). One hundred twenty-six (8.9%) VCFs were prophylactic. Mean and median follow-up for the entire population and for those whose VCFs were not removed was 243.5 ± 243.3 days and 138 days and 332.6 ± 290 days and 235 days, respectively. VCFs were removed from 632 (44.5%) patients at a mean of 101.5 ± 72.2 days and median 86.3 days following implantation. The primary safety end point and primary effectiveness end point were both achieved. Procedural AEs were uncommon and usually minor, but one patient died during attempted VCF removal. Excluding strut perforation greater than 5 mm, which was demonstrated on 31 of 201 (15.4%) patients’ computed tomography scans available to the core laboratory, and of which only 3 (0.2%) were deemed clinically significant by the site investigators, VCF-related AEs were rare (7 of 1421, 0.5%). Postfilter, venous thromboembolic events (none fatal) occurred in 93 patients (6.5%), including DVT (80 events in 74 patients [5.2%]), PE (23 events in 23 patients [1.6%]), and/or caval thrombotic occlusions (15 events in 15 patients [1.1%]). No PE occurred in patients following prophylactic placement. Conclusions: Implantation of VCFs in patients with venous thromboembolism was associated with few AEs and with a low incidence of clinically significant PEs.

KW - Deep vein thrombosis

KW - Pulmonary embolus

KW - Vena cava filter

KW - Venous thromboembolism

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Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months

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UN SDGs

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