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The Fibroid Outcomes for Data (FIBROID) Registry for Uterine Artery Embolization

The Fibroid Outcomes for Data (FIBROID) Registry for Uterine Artery Embolization. For the FIBROID Investigators James B. Spies M.D. Professor of Radiology Georgetown University School of Medicine Washington DC. FIBROID Registry Steering Committee. Matthew Mauro, MD, Chairman

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The Fibroid Outcomes for Data (FIBROID) Registry for Uterine Artery Embolization

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  1. The Fibroid Outcomes for Data (FIBROID) Registry for Uterine Artery Embolization For the FIBROID Investigators James B. Spies M.D. Professor of Radiology Georgetown University School of Medicine Washington DC

  2. FIBROID RegistrySteering Committee • Matthew Mauro, MD, Chairman • Scott Goodwin, MD • Evan R. Myers, MD, MPH • Eric Peterson, MD, MPH • Gaylene Pron, PhD • Anne Roberts M.D. • James B. Spies, MD • Robert Worthington-Kirsch, MD.

  3. The FIBROID RegistryStructure • Cooperative effort by SIR, DCRI, industry supporters, and government. • Multi-center voluntary prospective registry of patients undergoing uterine embolization. • Steering Committee • Study structure, data forms, adjudication of adverse events, selection of sites and communication with sites, data analysis and publication plan, investigator training • DCRI • Maintained web data entry mechanism, did all follow-up beyond 30 days, maintained data records, completed data analysis.

  4. The FIBROID RegistryStructure Two types of sites: core and participating sites • Core sites • Greater experience (>24 cases), expected enrollment rates (5 per month) • Greater data requirements: complete baseline demographic data, gynecologic and reproductive history, symptoms, therapies and imaging findings. • Complete UFS-QOL • Final selection by the steering committee to ensure diversity of practice settings. • Participating sites • Member of SIR or international equivalent. • Willing to collect baseline data minimum.

  5. The FIBROID RegistryStructure • All sites collect data at baseline, from procedure and up to 30 days follow-up. • Short term outcome focused on technical aspects, adverse events and predictors of events. • Registry plan to obtain 6, 12, 24, and 36 month follow-up. • Primary long-term outcome measure: symptom score from UFS-QOL. • Other outcome measures: UFS-QOL Total Score, subsequent interventions, pregnancies.

  6. The FIBROID RegistryEnrollment • Initially, 3319 patients treated at 7 enrolling sites. • 3166 (95.4%) consented to Registry • Complete variables in 3005 (94.9%) • Thirty-day follow-up complete in 2729 (90%) • 2112 eligible for long-term follow-up. • Six month follow-up completed in 1797 (85.1%). • Twelve month follow-up completed in 1701 (83%).

  7. The FIBROID RegistrySummary of Adverse Events

  8. The FIBROID RegistryIn-hospital Major Adverse Events

  9. The FIBROID RegistryPost-Discharge Major Adverse Events (Day 1-30)

  10. The FIBROID RegistryMultivariate Analysis of Adverse Events

  11. Summary of Complications30 Day Outcome • Major complication rate (SIR C-F): • 0.66% in hospital, 4.8% day 1-30 • Includes any hospitalization > 48 hours, any return to ER or re-hospitalization. • Minor complication rate (SIR A or B) • 2.4% in hospital, 31.1 % day 1-30 • Minor or no therapy (e.g. UTI, hematoma, hot flashes). • No deaths, 2 permanent injuries.

  12. The FIBROID RegistryOne year outcomes: Summary *From original validation study, Spies J, Obstet and Gynecol 2002;99:290-300.

  13. The FIBROID Registry UFS-QOL Symptom Score Change

  14. The FIBROID RegistryUFS-QOL Symptom Score Change

  15. The FIBROID Registry UFS-QOL HR-QOL Score Change

  16. The FIBROID RegistryUFS-QOL HRQOL Score Change

  17. The FIBROID RegistryMultivariable Analysis of Failure at 12 months

  18. The FIBROID RegistrySatisfaction with Outcome

  19. The FIBROID Registry12 Month Follow-up: Procedures

  20. The FIBROID RegistrySexual functioning * 60 pts with missing data at 6 months and 63 at 1 year

  21. The FIBROID RegistryUFS QOLSexual Functioning Scale Score

  22. Registry SummaryOutcome at One Year • Striking, marked improvement in both symptom scores and quality of life scores. • Stable improvement from 6 to 12 months. • Few interventions, hospitalizations needed. • Patient satisfaction high: most believe treatment a success and would recommend.

  23. Registry SummaryPublication Status • Three publications in preparation currently: • Registry Methods and Baseline Demographics • Describes the patient population • In review at Obstetrics and Gynecology • Short-term Outcomes • Focuses on safety in the first 30 days. • In review at Obstetrics and Gynecology • One-year Outcomes • Focuses on symptom and quality of life status at 12 months • In review at JAMA • Additional papers under consideration: • Additional analysis of subgroups/ quality of life outcomes at 12 months. • Pregnancy outcomes • 2 and 3 year outcome

  24. Conclusion • The FIBROID Registry represents the largest clinical outcomes study ever undertaken for a fibroid therapy. • This achievement is remarkable given that there was no funding support for investigators or sites. • The Steering Committee would like to congratulate the FIBROID Investigators and thank them for their dedication and generosity.

  25. Core Site Investigators • Anne Roberts, MD, Jeffrey Dieden, MD, Mahmood Razavi, MD, Michael Hines, MD, James Spies, MD, James Benenati, MD, Gerald Niedzwiecki, MD, John Lipman, MD, Robert Vogelzang, MD, Steven Smith, MD, Karen Ehrman, MD, Moises Yoselevitz, MD, David Brophy, MD, Rajinder Sharma, MD, William Romano, MD, David Hovespian, MD, Mark Garcia, MD, Gary Siskin, MD, Robert Min, MD, James Newman, MD, Robert Worthington-Kirsch, MD, Joseph Bonn, MD, Richard Schlansky-Goldberg, MD, Keith Sterling, MD, Joseph Gemmete, MD, Hyun Kim MD, David Siegel, MD.

  26. Participating Site InvestigatorsUnited States • Jackeline Gomez-Jorge MD, Steven Meranze MD, Abbas Chamsuddin MD, Steven D. Brantley MD, David J. Kastan MD, Bret N. Wiechmann MD, Gregory J. Dubel MD, Jan Brekke MD, Phillip Amatulle MD, Ever-Jan Verschuyl MD, Peter B. Hathaway MD, Howard M. Richard III MD, David A. Henry MD, Kurt H. Wetzler MD, Alan Zakheim MD,; Mark Cockerill MD, Darryl A. Zuckerman MD, Marcos Roffe MD, Linda Hughes MD, Laura J. Hodges MD, Joel Tennenhouse MD, Darren Hurst MD, Michael Miller MD, Adrian C. Moger MD, Brian Baghdady MD, James A. York MD, Efstathios Spinos MD, Gregory Karnaze MD, Keith Horton MD, Steven H. Peck MD, Corito S. Tolentino MD, Trevor N. Hooper, Gregory Gordon MD, Lee R. Christensen MD, Donald Ponec MD, Douglas Powell MD, Carroll C. Overton MD, Douglas C. Smith, Thomas Velling MD, Brian McInroy MD, Jonathan Uy MD, Paul M. Kiproff MD, John L. Nosher MD. Chad B. Kelman MD, John E. Sunderland, Brett Storm MD, Brian Morrow MD.

  27. Participating Site Investigators International • JG Moss MD, Gartnavel Hospital, Glasgow Scotland; Folco Scappaticci MD, Bristol Hospital, Bristol, England, Anthony A. Nicholson MD, Hull and East Yorkshire Hospitals Trust, Hull, England; Man-Kwong Chan MD, Queen Elizabeth Hospital, Hong Kong, China; Grant D.K. Urquhart MD, Southern General Hospital, Glasgow, Scotland; Neil Davies MD, Royal Free Hospital, London, England; Raymond Ashleigh MD, South Manchester University Hospitals NHA Trust, Manchester, England; John Clouston MD, Wesley Hospital, Australia; Simon Girling MD, Norfolk and Norwich University Hospital, Norfolk, England.

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