Evaluation of inferior vena cava filter retrieval following implementation of dedicated tracking system.

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1 Evaluation of inferior vena cava filter retrieval following implementation of dedicated tracking system. Emily Johnson, Justin Siegal, Robert Crane, Elizabeth Thompson, C Craig Blackmore

2 Disclosures C Craig Blackmore Book royalties: Evidence Based Imaging Springer Publishing.

3 Purpose August US Food and Drug Administration safety communication Urge removal of vena cava filters (VCF) Nationally extremely low retrieval rates Safety concerns This study assesses the effectiveness of implementation of VCF registry and follow up protocol on VCF retrieval rates. 3

4 Quality Improvement Project Sept 2012-quality improvement project (QIP) begins Centralized registry for VCF patients Resolved Filter deemed permanent Filter removed Patient deceased Unresolved Pending clinical circumstances Lost to follow up 4

5 Quality Improvement Project Interventional Radiology VCF nurse coordinator Maintain VCF registry Add patients using HI-IQ database Update patient VCF status Review medical record to assess patient clinical status Standardized update to IR physician Date of filter placement Initial indication Referring provider information Standard options for response Standardized follow-up Potential retrieval discussed in consent process Post procedure information given to patient regarding retrieval Patient encouraged to contact referring provider Letter to referring provider 1 month post placement Communication between IR physician and referring provider 5

6 Method Retrospective cohort study All VCF January March 2014 Patient data collected through review of individual patient charts Analysis: Interrupted time series regression adjusted for autocorrelation 6

7 Results- Demographics Jan March filters placed Females - 51% Mean Age years QIP - Sept 2012 Year Total # Filters Female, # Female, % Mean Age, Years % % % % % % % % , total % , Pre % , Post % % % 69.7 Pre QIP % 67.6 Post QIP % 67.6 Total % 67.6 Table 1: Patient Demographics by Year

8 Results- Filter Types Year Total # Filters Bird's Nest Trapease Gunther Recovery Tulip Optease Option Celect Meridian Denali Table 2: Type of Filter by Year. Bird s Nest and Trapease type filters are non-retrievable by design and cannot be removed. The remainder of filter types are retrievable. 8

9 Results- Filter Types Graph 1: Number of retrievable and non-retrievable filters over time. Retrievable filters were introduced in Nationally, by 2006 retrievable filters made up half of the market and were increasing in numbers placed. 9

10 Results- Retrieval Retrievable Retrievable Remove Attempt Total # type filter type filter Remove Remove Attempt %, Retrievable type Time to Year Filters # % Attempt # %, All filters filters Retrieval, days % % 61.1% % % 30.0% % % 22.9% % % 27.1% % % 22.4% % % 35.2% % % 40.4% % % 33.3% , total % % 34.8% , pre % % 41.2% , post % % 28.1% % % 43.4% % % 35.3% 56.2 Pre QIP % % 34.8% 45.4 Post QIP % % 35.6% 65.7 Total % % 35.1% 46.9 Table 3: Filter Retrieval Attempts by Year. A trend is present for both proportion of retrievable stents placed over time as well as the number of attempted retrieval.

11 Results- Retrieval VCF retrieval rate: 18.3% in % last 4 quarters (April, 2013-March, 2014) Increase of 0.88 percentage points per quarter (p<.001, 95% CI: ). Graph 2: Proportion of all filters (retrievable and non-retrievable) with removal attempt. Open circles represent pre-qip and closed circles are post-qip. 11

Results- Retrieval However, after adjusting for filter type (retrievable vs non-retrievable) and the underlying temporal trend, there was no significant change in the retrieval rate with

12 Results- Retrieval However, after adjusting for filter type (retrievable vs non-retrievable) and the underlying temporal trend, there was no significant change in the retrieval rate with implementation of the QIP, p= No significant change if exclude filters placed prior to 2006, p= Graph 3: Proportion of retrievable type filters with removal attempt. Open circles represent pre-qip and closed circles are post-qip. Red open circles are filters placed before 2006 when retrievable filters made up <50% of all filters 12 placed.

13 Results Following the QIP Only 2.1% were lost to follow up 9.6% (18/187) failed retrieval rate Primarily due to thrombus in the IVC Time to retrieval Pre-QIP 45.4 days Post-QIP 65.7 days No statistical difference 13

Conclusion We observe a marked improvement in VCF filter retrieval rates between 2004 and 2014.

14 Conclusion We observe a marked improvement in VCF filter retrieval rates between 2004 and However, despite numerous publications citing the efficacy of creating a centralized database for improving VCF retrieval rates, after adjustment for underlying trends and filter type, we found no significant difference in retrieval rate before and after implementation of the QIP. By creating a centralized database, we were able to achieve a very high rate of patient follow up. 14

AGENDA. (Nitinol Nickel Titanium Alloy) 7/23/2015

AGENDA. (Nitinol Nickel Titanium Alloy) 7/23/2015 AGENDA What is an IVC filter/what does it do/where implanted? Who are the defendants? What are the injuries Problems? Intake Bard The bad guy story Efficiency/Efficacy Articles/Research FDA Warnings/Advisories