PMID- 36841633 OWN - NLM STAT- MEDLINE DCOM- 20230331 LR - 20230331 IS - 1535-7732 (Electronic) IS - 1051-0443 (Linking) VI - 34 IP - 4 DP - 2023 Apr TI - Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. PG - 517-528.e6 LID - S1051-0443(22)01406-3 [pii] LID - 10.1016/j.jvir.2022.12.009 [doi] 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. CI - Copyright (c) 2023 Society of Interventional Radiology and Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. FAU - Johnson, Matthew S AU - Johnson MS AD - Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN. Electronic address: matjohns@iupui.edu. FAU - Spies, James B AU - Spies JB AD - Department of Radiology, MedStar Georgetown University Hospital, Washington, DC. FAU - Scott, Katherine T AU - Scott KT AD - HealthCore, Inc., Wilmington, DE. FAU - Kato, Bernet S AU - Kato BS AD - HealthCore, Inc., Wilmington, DE. FAU - Mu, Xiangyu AU - Mu X AD - HealthCore, Inc., Wilmington, DE. FAU - Rectenwald, John E AU - Rectenwald JE AD - Section of Vascular Surgery, Department of Surgery, University of Wisconsin, Madison, WI. FAU - White, Rodney A AU - White RA AD - Division of Vascular Surgery, Harbor-UCLA Medical Center, Torrance, CA; Heart and Vascular Institute, Long Beach Memorial Care, Long Beach, CA. FAU - Lewandowski, Robert J AU - Lewandowski RJ AD - Department of Radiology, Northwestern University, Chicago, IL. FAU - Khaja, Minhaj S AU - Khaja MS AD - Division of Vascular and Interventional Radiology, University of Michigan, Ann Arbor, MI; Department of Radiology and Medical Imaging, University of Virginia Health, Charlottesville, VA. FAU - Zuckerman, Darryl A AU - Zuckerman DA AD - Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, MO; Department of Radiology and Biomedical Imaging, Yale University School of Medicine, New Haven, CT. FAU - Casciani, Thomas AU - Casciani T AD - Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN. FAU - Gillespie, David L AU - Gillespie DL AD - Department of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Brockton, MA. LA - eng SI - ClinicalTrials.gov/NCT02381509 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230223 PL - United States TA - J Vasc Interv Radiol JT - Journal of vascular and interventional radiology : JVIR JID - 9203369 SB - IM MH - Humans MH - Male MH - Middle Aged MH - Aged MH - Female MH - *Vena Cava Filters/adverse effects MH - Prospective Studies MH - *Venous Thrombosis/diagnostic imaging/therapy/complications MH - *Pulmonary Embolism/diagnostic imaging/etiology/prevention & control MH - *Venous Thromboembolism/complications MH - Vena Cava, Inferior MH - Treatment Outcome OTO - NOTNLM OT - Deep vein thrombosis OT - Pulmonary embolus OT - Vena cava filter OT - Venous thromboembolism EDAT- 2023/02/26 06:00 MHDA- 2023/03/31 06:41 CRDT- 2023/02/25 22:00 PHST- 2022/08/31 00:00 [received] PHST- 2022/12/05 00:00 [revised] PHST- 2022/11/20 00:00 [accepted] PHST- 2023/03/31 06:41 [medline] PHST- 2023/02/26 06:00 [pubmed] PHST- 2023/02/25 22:00 [entrez] AID - S1051-0443(22)01406-3 [pii] AID - 10.1016/j.jvir.2022.12.009 [doi] PST - ppublish SO - J Vasc Interv Radiol. 2023 Apr;34(4):517-528.e6. doi: 10.1016/j.jvir.2022.12.009. Epub 2023 Feb 23.