Long-Term Follow-Up - Boston Scientific Contour Mode D'emploi

Table 3. Timing and Type of adverse Events Classified as UfE Procedure-related
Event Description
Hematoma
Post Embolization Syndrome
Prolapsed Fibroid
Urinary Tract Infection
Vaginal Discharge
Other*
*Other includes events with only one occurrence; amenorrhea, abdominal cramping, arteriospasm left
uterine artery, hot flashes, intractable pain, irregular period, ovarian failure, stinging pain on left side of
pelvic area during intercourse, superficial venous thrombosis – L) calf pain.

lOnG-TErM fOllOw-UP

long-term follow-up Subject accountability
Long-term follow-up information for the UFE cohort was collected at 1-year, 2-year
and 3-year time intervals. A total of 120/149 (80.5%) UFE subjects returned for the
1-year follow-up visit, 102/149 (68.5%) returned for 2-year follow-up visit, and 90/149
(60.4%) UFE subjects returned for the 3-year follow-up visit. Table # 4 summarizes
subject accountability throughout the 3-Year time period.
Table 4. Subject accountability
Intent To Treat (ITT) Population
6-Month Long-term Follow-up
Patient did not return for visit
Lost to Follow-up
12-Month Long-term Follow-up
Patient did not return for visit
Patients that classified as LTF earlier -
returned for 24-Month
Patients that voluntarily withdrew
Missed 12-Month Follow-up - returned
for 24-month
24-Month Long-term Follow-up
Lost to Follow-up
Subjects who missed 24-month & came
back for 36-month
36-Month Long-term Follow-up
# Events
2
4
3
4
2
9
Contour™ Embolization Particles
n
149
130
-1
-9
120
-5
2
-16
1
102
-17
5
90
10
long-term Effectiveness
As the primary endpoint of the study was at 6 months, the long-term follow-up (1, 2, and
3 years) data was collected only on complications, menstrual bleeding questionnaire
(Ruta), overall fibroid symptom component of the UFQOL questionnaire, new fibroid/
recurrence symptoms, additional treatments and pregnancy information.
Change from baseline in all of the specific UFQOL measures (except hot flashes) were
found to be statistically significant (p < 0.05) at 1 year, 2 year, and 3 year follow-up in the
UFE cohort of patients. This indicates the continuing trend in significant improvement
in UFQOL measures over baseline through 3 year follow-up. Table # 5 summarizes the
statistics on the Post-Market Change from Baseline Fibroid Specific Quality of Life
Assessments for the UFE cohort.
Table 5. Post-market Change from baseline fibroid Specific Quality of life assessments
Overall Symptoms* n Mean
3 Months 135 27.9**
6 Months 125 31.3**
1 Year 115 35.6**
2 Years 100 36.4**
3 Years 87 35.0**
Note: *Higher scores = Higher functioning/Less interference/Less symptoms/Less distress **Statistically
significant with p-value < 0.05.
Change from baseline in menorrhagia bleeding score was found to be statistically
significant (p < 0.05) at 1 year, 2 year, and 3 year follow-up in the UFE cohort of patients,
indicating a continued trend of significant improvement over baseline through
3 year follow-up. Table # 6 summarizes statistics on the Post-Market Menorrhagia
Questionnaire Bleeding Score Assessments for the UFE cohort.
Table 6. Post-Market Menorrhagia Questionnaire bleeding Score
Change from
baseline n Mean % Change Std Dev
Menorrhagia Score
3 Months 139 -24.5**
6 Months 129 -26.6**
1 Year 113 -28.6**
2 Years 94 -28.6**
3 Years 79 -28.9**
Note: **Statistically significant with p-value < 0.05.
Std Dev Min Max
17.6 -24.2 81.5
18.1 -35.4 84.8
17.1 2.3 79.0
19.5 -7.2 84.8
18.7 -5.7 79.9
Min Max p-value
-49.3% 16.7 -63.7 20.3 < 0.001
-55.3% 15.9 -65.8 11.5 < 0.001
-61.1% 15.1 -65.0 3.3 < 0.001
-61.0% 17.1 -85.7 9.0 < 0.001
-60.9% 17.3 -75.2 11.9 < 0.001
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