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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 - PowerPoint PPT Presentation
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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 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.
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.
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.
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.
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%).
The FIBROID RegistrySummary of Adverse Events
SIR Classification In- hospitalN (% of 3041)
30 - dayN (% of 2729)
A No therapy 29 (0.95%) 68 (2.09%)
B Nominal therapy, observation 45 (1.45%) 552 (20.23%)
A or B Minor events, either A or B 0 228 (8.34%)
C Required therapy, minor hospitalization (<48 hrs)
9 (0.30%) 100 (3.52%)
D Major therapy, prolonged hospitalization (>48 Hrs)
10 (0.33%) 34 (1.25%)
E Permanent adverse sequelae 1 (0.03%) 1 (0.04%)
F Death 0 (0%) 0 (0%)
The FIBROID RegistryIn-hospital Major Adverse Events
Major Events 20 (in 18 pts) 0.06 %
Nausea 4 0.1%
Drug Reaction 1 0.03%
Prolonged pain 6 0.2%
Vessel Injury 3 0.1%
Other Complications 4 0.1%
Urinary Retention 1 0.03%
Contrast Reaction 1 0.03%
The FIBROID RegistryPost-Discharge Major Adverse Events (Day 1-30)
Major Events 135 (In 111 pts) 4.1%
Persistent bleeding 7 0.2%
Infection 17 0.6%
New hot flashes 2 0.07%
Thromboembolism 4 0.15%
Recurrent pain 65 2.4%
Fibroid passage 19 0.7%
Spinal headache 1 0.03%
Other adverse event 20 0.7%
The FIBROID RegistryMultivariate Analysis of Adverse Events
N=2711
Variable OR 95% C. I. P-value
Any prior procedures (vs none) 1.235 1.102-1.383 0.0003
DVT prophylactic users (vs. non-users)
0.757 0.622-0.920 0.0052
Duration of procedure (min) 1.004 1.001-1.006 0.0086
African American (vs others) 1.129 1.019- 1.251 0.0206
Current or recent smoker (vs not) 1.141 1.007-1.293 0.038
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.
The FIBROID RegistryOne year outcomes: Summary
BaselineN = 2666
6 monthsN = 1797
12 monthsN = 1701
Normal population
score*
Symptom Score Mean (Std. Dev.) 59.83
(20.8)19.87 (18.6) 19.23 (17.9) 22.5 (21.1)
Median 59 15.6 15.6
Inter-quart.Range 44-72 6.2-28.1 6.2-28.1
HRQOL Score Mean (Std. Dev.) 47.32
(22.9)85.0 (20.1) 86.7 (18.1) 86.4 (17.7)
Median 47 93.9 93.9
Inter-quart.Range 30-65 79.3-99.1 81.9-100
*From original validation study, Spies J, Obstet and Gynecol 2002;99:290-300.
The FIBROID Registry
6 monthsN (% of 1798)
12 monthsN (% of 1701)
Worse than baseline 107 (5.95%) 89 (5.23%)
Equal to Baseline 9 (0.50%) 4 (0.24%)
Improved by less than 10% 45 (2.5%) 36 (2.12%)
Improved by greater than 10%. 1622 (90.21%) 1535 (90.24%)
Missing 15 (0.83%) 37 (2.18%)
UFS-QOL Symptom Score Change
The FIBROID RegistryUFS-QOL Symptom Score Change
Wors
e
Equal
<10
10-2
0
20-3
0
30-4
0
40-5
0
50-6
0
60-7
0
70-8
0
80-9
0
>90
0
5
10
15
20
25
% o
f P
atie
nts
% Change in Symptom Score from Baseline
% Change 6 months
% Change12 months
The FIBROID Registry
6 monthsN (% of 1798)
12 monthsN (% of 1701)
Worse than baseline 125 (6.96%) 83 (4.88%)
Equal to Baseline 2 (0.11%) 2 (0.12%)
Improved by less than 10% 104 (5.79%) 73 (4.29%)
Improved by greater than 10%. 1125 (85.36%) 1089 (87.42%)
Missing 32 (1.78%) 56 (3.29%)
UFS-QOL HR-QOL Score Change
The FIBROID RegistryUFS-QOL HRQOL Score Change
Wors
e
Equal
<10
10-2
0
20-3
0
30-4
0
40-5
0
50-6
0
60-7
0
70-8
0
80-9
0
>90
0
5
10
15
20
25
30
35
40
45
50
% o
f P
atie
nts
% Change in HRQOL Scores from Baseline
% Change 6 months
% Change 12 months
The FIBROID RegistryMultivariable Analysis of Failure at 12 months
N-2112 Hazard Ratio 95% CI P-value
Bilateral embo. 0.36 0.23-.-57 <0.001
Fibroid size (per cm) 1.086 1.043-1.131 <0.001
# of fibroids (per fibroid) 0.847 0.777-0.922 0.001
Age (per 10 year increase)
0.74 0.60-0.91 0.005
Smokers 1.34 1.04-1.74 0.024
AA race 0.77 0.60-0.99 0.043
The FIBROID RegistrySatisfaction with Outcome
Would recommend UAE to family and friends
6 monthsN = 1798
12 monthsN = 1701
Strongly Agree 1123 (62.4%) 997 (58.6%)
Agree 392 (21.8%) 398 (23.4%)
Undecided 191 (10.6%) 205 (12.1%)
Disagree 43 (2.4%) 42 (2.5%)
Strongly Disagree 32 (1.8%) 42 (2.5%)
The FIBROID Registry12 Month Follow-up: Procedures
Procedure 6 monthsN (% of 1797)
12 monthsN (% of 1701)
Myomectomy 8 (0.44%) 17 (1.0%)
Hysterectomy 22 (1.22%) 27 (1.59%)
Hysteroscopy 9 (0.50) 8 (0.47)
D and C 19 (1.06%) 14 (0.82)
Repeat UAE 10 (0.56%) 11 (0.65%)
Other Procedure 25 (1.39%) 35 (2.06%)
Any ER Visit 68 (3.78%) 20 (1.18%)
Any Hospitalization 52 (2.89%) 37 (2.18%)
The FIBROID RegistrySexual functioning
New unwanted changes in sexual function?
6 monthsN (% of 1797)
12 monthsN (% of 1701)
Strongly Agree 63 (3.5%) 60 (3.53%)
Agree 129 (7.17%) 151 (8.88%)
Undecided 226 (12.57%) 222 (13.05%)
Disagree 498 (27.70%) 451 (26.51%)
Strongly Disagree 847 (47.11%) 756 (44.44%)
* 60 pts with missing data at 6 months and 63 at 1 year
The FIBROID RegistryUFS QOL Sexual Functioning Scale Score
Wo
rse
Eq
ua
l
< 1
0
10
-20
20
-30
30
-40
40
-50
50
-60
60
-70
70
-80
80
-90
>9
0
0
5
10
15
20
25
30
35
40
45
50P
erc
en
t of P
atie
nts
Percent change from baseline
% Change 6 months
% Change 12 months
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.
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
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.
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.
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.
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.
