Forceps vs. Snare for IVC Filter Removal in Deep Vein Thrombosis

Overseen By Pamela Lofton, RN, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Coagulopathy, Clotting disorder, Central venous occlusion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

100 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves a medical procedure, it's best to discuss your medications with the trial team or your doctor.

What data supports the idea that Forceps vs. Snare for IVC Filter Removal in Deep Vein Thrombosis is an effective treatment?

The available research shows that using forceps for IVC filter removal is effective, especially when standard techniques fail. One study highlights that the rigid forceps technique can successfully remove filters that are severely tilted and embedded, which are difficult to retrieve with standard methods. Another study reports that a novel approach using forceps and other tools successfully treated three patients without complications. Additionally, a long-term study involving 535 cases over 16 years supports the effectiveness of the forceps technique for removing embedded filters. This suggests that forceps may be a more reliable option compared to snares when dealing with challenging cases. ^{1 2 3 4 5}

What safety data exists for IVC filter removal techniques?

Safety data for IVC filter removal techniques includes a 5-year retrospective review of 536 retrievals, comparing complication rates between standard snare and forceps techniques. Advanced techniques, like rigid forceps, are used for challenging cases, such as wall-embedded filters, and have shown reduced failure rates. A novel approach combining snare and flexible forceps or laser devices has been successful without complications in difficult cases. Pre-retrieval CT can help predict complicated retrievals, indicating potential safety concerns. ^{1 5 6 7 8}

Is IVC filter removal a promising treatment for deep vein thrombosis?

Yes, IVC filter removal is a promising treatment because new techniques like using forceps make it easier and safer to remove filters that are stuck or tilted, which can help more patients successfully. ^{1 2 3 4 5}

What is the purpose of this trial?

IVC filters are mechanical filters placed in a patient's body to trap blood clots in the legs migrating to the lungs. When no longer indicated, interventional radiologists are consulted for IVC filter removal. Currently, many methods for extracting IVC filters exist. Two of the most common methods involve using an endovascular snare device or rigid forceps. We intend to prospectively compare these two methods in an attempt to see if one offers an advantage to the other. This will be compared by evaluating success rates and procedure time.

Research Team

Osmanuddin Ahmed, M.D.

Principal Investigator

UChicago Medicine

Eligibility Criteria

Adults over 18 needing an IVC filter removal, specifically those with Cook Celect or Argon Medical Option Elite filters implanted for less than 6 months at UCMC. Excludes pregnant women, individuals with clotting disorders, prior filter procedures, central venous occlusion, or coagulopathy.

Inclusion Criteria

I am not pregnant.

I am referred for a procedure to remove an IVC filter.

I'm sorry, but this criterion seems incomplete and does not provide enough information to be summarized. Could you please provide more context or detail so that I can better assist you?

Exclusion Criteria

Patients with outside hospital filter placement

You have had an implant in your body for more than 6 months.

Only Cook Celect or Argon Medical Option Elite filters are allowed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

IVC filter removal using either endovascular snare or rigid forceps

1 day

1 visit (in-person)

Immediate Post-Procedure Monitoring

Patients monitored for 2-4 hours in the interventional radiology recovery area for complications

2-4 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person), 1 call (telephone)

Treatment Details

Interventions

• IVC filter removal

Trial Overview The trial is comparing two common methods of IVC filter removal: using an endovascular snare device versus rigid forceps. The study aims to determine which method has higher success rates and shorter procedure times.

Participant Groups

Group I: Snare Active Control 1 Intervention

Subjects randomized to this cohort will have their IVC filter removed using an endovascular snare (like a lasso) device that is designed to catch the hook of the filter and allow it to be captured.

Group II: Forceps Active Control 1 Intervention

Subjects randomized to this cohort will have their IVC filter removed using a rigid forceps device that will be used to engage the filter apex directly and allow for the filter to be capture/removed.

IVC filter removal is already approved in United States, European Union, Canada for the following indications:

Approved in United States as IVC filter removal for:

• Prevention of pulmonary embolism
• Removal of temporary IVC filters

Approved in European Union as IVC filter removal for:

• Prevention of pulmonary embolism
• Removal of temporary IVC filters

Approved in Canada as IVC filter removal for:

• Prevention of pulmonary embolism
• Removal of temporary IVC filters

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

The rigid forceps technique for removing severely tilted and embedded inferior vena cava (IVC) filters achieved an 85% success rate in a study of 13 cases over 22 months, demonstrating its effectiveness in challenging retrieval situations.

No major complications were reported during the procedure, indicating that this technique not only improves retrieval rates but also maintains a strong safety profile for patients with IVC filters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience using the rigid forceps technique to remove wall-embedded IVC filters. Avery, A., Stephens, M., Redmond, K., et al.[2016]

The endobronchial forceps technique for removing embedded inferior vena cava (IVC) filters was highly effective, achieving a success rate of 98.7% in 534 patients over 16 years, with 530 filters successfully retrieved.

The procedure had a low rate of adverse events, with only 6.3% minor and 2% major complications, none of which resulted in permanent harm, indicating it is a safe option for filter retrieval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial Forceps Retrieval of Embedded Inferior Vena Cava Filters: Retrieval of 535 Filters at a Single Center. Zhong, A., Trerotola, SO., Stavropoulos, SW.[2023]

In a study of 21 patients with embedded inferior vena cava (IVC) filters, the use of rigid endobronchial forceps successfully removed 20 filters, demonstrating a high efficacy of this technique.

The procedure was safe, with no major complications reported, indicating that rigid endobronchial forceps can be a reliable option for challenging IVC filter removals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embedded inferior vena cava filter removal: use of endobronchial forceps. Stavropoulos, SW., Dixon, RG., Burke, CT., et al.[2022]

In a study of 60 patients, rigid endobronchial forceps-assisted retrieval of inferior vena cava (IVC) filters achieved a high success rate of 96.7%, demonstrating its effectiveness when standard retrieval methods fail.

The use of forceps was associated with minimal complications, with only four significant issues reported, suggesting that this technique is both safe and reliable for removing problematic IVC filters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial forceps-assisted complex retrieval of inferior vena cava filters. Tavri, S., Patel, IJ., Kavali, P., et al.[2020]

A novel technique for removing retrievable inferior vena cava (IVC) filters has been developed, which involves snaring the filter and using flexible forceps or laser devices to detach it from the vein wall.

This method has been successfully applied in three patients who could not have their filters removed using standard techniques, and it was performed without any complications, highlighting its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel technique for inferior vena cava filter extraction. Johnston, EW., Rowe, LM., Brookes, J., et al.[2014]

In a study of 536 IVC filter retrievals, the overall success rate was very high at 97.9%, with standard snare techniques achieving a success rate of 99.4% and advanced forceps techniques at 98.8%.

While the endobronchial forceps technique had a higher complication rate (14.5%) compared to the standard snare technique (1.7%), this was attributed to longer dwell times and challenges with non-retrievable filters, indicating that forceps can still be a safe and effective option for difficult retrieval cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of inferior vena cava filter retrieval: a 5-year single center retrospective review from a tertiary care center. Schuchardt, P., Kis, L., Goloubev, A., et al.[2022]

Advanced inferior vena cava (IVC) filter retrieval techniques have a higher technical success rate (91.8%) compared to standard snare retrieval (86.8%), indicating they can be effective for challenging cases.

However, advanced retrieval methods are associated with significantly longer fluoroscopy times (23.1 min vs 4.3 min) and higher radiation exposure (557.2 mGy vs 156.9 mGy), as well as a greater risk of periprocedural complications, including major complications like filter fracture and embolization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single-Institutional Comparative Analysis of Advanced Versus Standard Snare Removal of Inferior Vena Cava Filters. Ahmed, O., Kim, YJ., Patel, MV., et al.[2020]

In a study of 76 patients undergoing IVC filter retrieval, complications during retrieval were significantly associated with filters that had been in place for over 45 days, particularly if they had a tilt greater than 15 degrees, tip embedding, or grade 2 perforation.

Pre-retrieval CT scans can be useful in predicting complications during the retrieval of IVC filters, especially for those that have been in place longer, helping to improve procedural safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Pre-Retrieval Computed Tomography Predict the Difficult Removal of an Implementing an Inferior Vena Cava Filter? Hong, S., Park, KM., Jeon, YS., et al.[2022]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Initial experience using the rigid forceps technique to remove wall-embedded IVC filters. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Endobronchial Forceps Retrieval of Embedded Inferior Vena Cava Filters: Retrieval of 535 Filters at a Single Center. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Embedded inferior vena cava filter removal: use of endobronchial forceps. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Endobronchial forceps-assisted complex retrieval of inferior vena cava filters. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A novel technique for inferior vena cava filter extraction. [2014]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and efficacy of inferior vena cava filter retrieval: a 5-year single center retrospective review from a tertiary care center. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Single-Institutional Comparative Analysis of Advanced Versus Standard Snare Removal of Inferior Vena Cava Filters. [2020]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Can Pre-Retrieval Computed Tomography Predict the Difficult Removal of an Implementing an Inferior Vena Cava Filter? [2022]