Varicose Veins and IVC Filter Registries Thomas Wakefield, University of Michigan David Dexter, Sentara Health System

Agenda: I. Overview of Inclusion/Exclusion Criteria II. A & P Overview III. Pertinent Device Overview IV. Live abstraction

IVC Filter: Inclusion/Exclusion Criteria Insertion of Inferior Vena Cava (IVC) filter, endovascular approach only, temporary or permanent. Placement can be in the iliac veins or any portion of the inferior vena cava. The IVC Filter follow-up form should be completed at the time of filter retrieval. If the filter is not retrieved, follow-up should be done greater than 9 months from the procedure date. Exclusions: o Superior Vena Cava filter o Open insertion of an IVC filter o Dissolvable IVCF placement (i.e. Novate Sentry IVC Filter) o Repositioning or Retrieval of IVC filter (this is captured on the follow-up form)

IVC Filter

IVC Filters

IVC Filters

IVC Filter failure

IVC Filter Retrieval Report

The IVC Filter Retrieval Report is a tool to identify IVC Filter procedures which require filter removal. If an IVC Filter procedure recorded the use of a temporary filter, the procedure will be listed on the report as requiring filter retrieval. If a follow-up form has been created recording either that the filter has been retrieved, attempt at retrieval or the decision was made not to retrieve it, then the procedure will be excluded from the report.

A physician would use the report to track individual procedures that require filter removal. A hospital manager would use the report at a high level to track all procedures requiring filter removal at their center/s. Users may utilize saved versions of the report to track retrieval intervals for individual device manufacturers. Users may apply conditional highlighting to the report to set visual identifiers against days since procedure. Users can set these visual indicators to view procedures that are approaching or are overdue for retrieval. The IVC Filter Retrieval Report is accessed in the Tools section under the Data Management tab in PATHWAYS.

Report Inclusion Criteria: The IVC Filter Retrieval Report will only include procedures at the user’s center where the IVC Filter procedure form has been submitted, Planned Duration is NOT Permanent, and Discharge Status is NOT Dead

Report Exclusion Criteria: Procedures will be excluded from the report if successful or failed attempt to retrieve has been recorded on a follow-up and the Reason Not Retrieved is NOT either Planned for Later Removal or Null, or when a follow-up has been submitted indicating No Follow-up Possible or that the patient is Dead

Tools tab:

Email notification in Tools:

Varicose Veins: Inclusion/Exclusion Criteria Percutaneous (closed) and/or cut-down (open) procedures to ablate or remove superficial truncal veins, perforating veins or varicose vein clusters in the lower extremity (C2 or greater venous disease, treated for medical reasons, not cosmetic). Exclusions: o Any treatment of deep veins of lower extremity. o Intervention done for trauma o Treatment of C0 or C1 venous disease, such as sclerotherapy for spider veins o All cosmetic sclerotherapy, regardless of CEAP level o Klippel-Trenaunay Syndrome and other Venous Malformations

Gloviczki P et al, J Vasc Surg 53:2S-48S, 2011 Anatomy and Physiology Gloviczki P et al, J Vasc Surg 53:2S-48S, 2011

VQI Total Procedure Volume Total Procedure Volume tab reflects net procedures added to the registry for the month

We have been monitoring the data from the first two scorecards that have been sent out. We have noted a number of issues that need to be addressed.

Problem 1….. VVR VQI is the only registry in the VQI that has different forms for early vs. late follow-up; also, complications that occur early (such as DVT and EHIT) will not be picked up if ultrasound is not performed early and the first follow-up is at 90 days (for example). Fix…..Make the follow-up form more universal, so that there is only one follow-up form. On the scorecard, make sure that DVT and EHIT rates are only included if there has been an early follow-up (in the first 14 days, for ex.) with an ultrasound study.  

Problem 2…. Procedures have different complication rates, depending on whether they are done separately or combined, and whether they are performed with thermal techniques or performed with sclerotherapy techniques. Fix…..separate procedures into ablation alone, sclerotherapy alone, phlebectomy alone, and combination procedures and then report data for complications.

Questions: 1. Did the patient have a complication? Yes or No; If yes, then there would be a drop down menu for each of the complications and its date of occurrence. 2. Did the patient obtain a duplex scan? Yes or No; If yes, the date of the scan. With the answer to these two questions, then you could know what the early DVT/EHIT rates was for those with a follow-up scan in the first 14 days. You would also know he date for follow-up and Dan could figure out early and late follow-up for all measures other than DVT and EHIT.

Physician Dashboard:

Physician Dashboard:

Registry changes (later 2019) Enter only information for the treated side. (This will simplify data entry) For History Section…..Adding a checkbox for unknown site, for History of Superficial Phlebitis and History of DVT For Demographics and History……Change “Prior Ablation Type” to “Prior Treatment Type” Add Reason for Anticoagulant? 1=VTE prophylactic, 2=VTE therapeutic, 3=Afib, 4=Other; Show only if on current Anticoagulant

Other changes (later 2019) Location and Diameter of clusters is being removed “Ablation Type” changed to “Treatment Type” options include: 1 = Thermal, RF,2 = Thermal, laser,3 = Mechanochemical,4 = Chemical,5 = Embolic adhesive,6 = Surgery (retire), 7 = High Ligation and stripping, 8 = Stripping, 9 = Stab phlebectomy, 10 = Trivex phlebectomy, 11 = Open ligation, 12 = Endoscopic ligation For Current Status…….Move “number of veins treated” and “side of treatment” from procedure tab to current status tab to control dependency of only reporting current status variables for the leg TREATED (R/L/Bilat)

Other changes : Change compression therapy days and remove details of stocking pressure and type of bandage For Follow-Up…….Adding Paresthesia and Pigmentation as Signs and Symptoms to Long Term Follow up Remove Admitted w/in 72 hours For Post Op…….Change Compression Therapy to No/Yes (remove stocking, bandage options) For Procedure……Number of Veins Treated and Side will auto populate from Current Status date entry

Case Abstraction: http://mockup.m2s.com/ User: m2sdemo@m2s.com Pass: mock4m2s!

Questions