Merit Medical Embosphere Mode D'emploi page 5

• Improvement in bulk symptoms (pelvic pain, pelvic discomfort/
bloating, and urinary dysfunction) as measured using a patient
symptom questionnaire
• Improvement in quality of life as measured using the SF-12 Health
Status Questionnaire
Secondary Endpoints Included
• Other measures of changes in menstrual bleeding
• Reduction of uterus and fibroid size
• Hospitalization time
• Time to return to normal activities
• Evaluations of patient satisfaction with the procedure
Adverse events and complications were also evaluated with respect to
type, rate, and severity.
Eligibility criteria included age between 30 and 50 years, inclusive, infertile
or no plans to become pregnant, one or more symptomatic uterine
fibroids, uterine volume 250 cc or fibroid volume 4 cc, and baseline PBLAC
≥ 150. Women were excluded from the study if they were pregnant,
had a history of pelvic inflammatory disease, submucosal fibroid(s) with
more than 50% growth into the uterine cavity, pedunculated subserosal
fibroid(s) as the dominant fibroid(s), significant collateral feeding by
vessels other than uterine artery, adenomyosis as the dominant cause
of symptoms, endometrial or pre-malignant hyperplasia, any malignancy
of the pelvic region, any active infection of the pelvic region, known
allergy to IV contrast or gelatin, bleeding diathesis, immunocompromised,
post-menopausal or baseline FSH > 40 mIU/mL, or treatment with GnRH
agonist within the previous 3 months.
Pre-treatment evaluations included routine gynecological exam and
testing, standard laboratory testing, ultrasound or MRI, menstrual
bleeding record, and self-assessment questionnaires relating to overall
health (SF-12), menstrual bleeding, and fibroid symptoms.
Study Results
Of the 102 patients enrolled in the pivotal study, 96 patients had complete
baseline data and of these, 69 (72%) had known outcomes after 3 years
after UFE treatment. Not all patients provided all outcome measures at the
final follow-up interval, and the numbers providing follow-up are detailed
in each of the tables provided.
Procedure, Discharge, and Recovery Information
All UFE procedures performed in both the feasibility and pivotal studies
were technically successful with no intraoperative complications that
prevented completion of the procedure. The majority (77%) of the UFE
procedures were performed using a 5 Fr catheter with either a 4 Fr (19%)
or 3 Fr (3%) in the remainder. Seventy-two patients were treated with
500-700 micron spheres, 66 patients with 700-900 micron spheres and
18 patients with 900-1200 micron spheres. Many of the patients were
treated with more than one sphere size. The most common treatment
approach was to start with a smaller sphere size and then to increase the
size if necessary. The volume of spheres required varied inversely with the
sphere size as an average of 7.2 cc of 500-700 micron spheres was used
as compared to 6 cc of 700-900 micron spheres and 4.1 cc of 900-1200
micron spheres.
The majority of UFE patients underwent the procedure while under
conscious sedation with a local anesthetic given at the puncture site. No
UFE procedures were performed under general anesthesia. The average
UFE procedure time from first arterial puncture to final catheter removal
was 58 ± 28 minutes (range 10-140 minutes). Eighty-seven percent of the
UFE patients were discharged from the hospital on the day following the
embolization procedure and 12% on the same day as the procedure. UFE
patients were back to work or returned to normal daily activities in an
average of 10.7 days.
Primary Efficacy Endpoints
Menstrual Bleeding
To be eligible for UFE in the feasibility and pivotal studies, patients were
required to have abnormally heavy menstrual bleeding, with a baseline
score of ≥150 on the Pictorial Bleeding Assessment Chart (PBLAC) of
Janssen et al. (1995). Additional measures were also used to assess changes
in menstrual bleeding, including patient self-assessment of their bleeding
level and a menorrhagia questionnaire. Changes in menstrual bleeding
generally occurred quickly following UFE, with 92% of the patients showing
improvement by 3 months. Out of the 102 patients from the pivotal study,
only 48 patients completed the menorrhagia questionnaire at 36 months,
and paired data were available from only 41 patients However, the results
show a substantial and statistically significant improvement in scores (with
lower scores being better) and the mean scores remained improved for the
duration of the study (Table 1). These findings are well aligned with the
patient self-assessment of menstrual bleeding (Table 2). At baseline, 54%
of patients rated their bleeding as extremely heavy and 42% rated their
bleeding as moderately heavy. During the 36-month follow-up, only 3% or
less rated their bleeding as extremely heavy and less than 28% of patients
complained of moderately heavy bleeding. At 36 months after treatment,
22% of patients noted that they were not having menstrual periods.
Table 1 – Results of the Menorrhagia Questionnaire
Mean score
standard deviation
Before Treatment
47.9±13.1
(n =96)
3 mo (n =83) 24.5±13.1
6 mo (n =83) 21.03±11.9
12 mo (n =78) 17.1±10.1
24 mo (n =67) 19.7±11.8
36 mo (n= 48) 19.2±11
Note. —The difference between the scores at each time interval and that at baseline were statistically
significant (P <.001). P value was calculated with tests, paired tests, and sign tests.
* Paired data are from those patients who had data available at each follow-up interval (N 41).
Table 2 – Patient Assessment of Menstrual Bleeding
Extremely
heavy
Before Treatment
54 (57)
(n =96)
3 mo (n =87) 3 (3)
6 mo (n =88) 3 (3)
12 mo (n =83) 1 (1)
24 mo (n =71) 2 (3)
36 mo (n=59) 1 (2)
Note. —Data are given as numbers of patients. Numbers in parentheses are percentages.
Bulk Symptoms
Bulk symptoms of pain, discomfort and urinary problems (Table 3) were
substantially improved in most patients, although a smaller number of
patients had substantially improved urinary symptoms at each of the
data intervals.
Table 3 – Bulk Symptom Status: Proportion of Patients with
Moderate to Substantial Improvement after Embolization
Pelvic pain
3 mo (n =86) 63 (73)
6 mo (n =87) 68 (78)
12 mo (n =81) 77 (83)
24 mo (n =73) 60 (83)
36 mo (n =59) 49 (83)
Note. —Data are given as numbers of patients. Numbers in parentheses are percentages.
5
All Data Paired Data (n =41)*
Mean score
Range
standard deviation
14.29–83.33 45.2±13.5
7.1–64.3 22.9±10.7
7.1–64.3 18± 8.6
2.4–61.9 18.6±11.7
0–54.8 17.8±9.4
0–57.1 20.1± 10.7
Description of Bleeding
Moderately
Normal Light
heavy
40 (42) 1 (1) 0 (0)
38 (44) 27 (31) 13 (15)
25 (28) 37 (42) 18 (20)
17 (20) 38 (46) 21 (25)
17 (24) 33 (46) 15 (21)
14 (24) 27 (37) 9 (15)
Symptom
Pelvic discomfort Urinary problems
61 (71)
71 (82)
67 (81)
61 (83)
49 (83)
Range
14.3–83.3
7.1–54.8
7.1–52.4
2.4–61.9
0–54.8
0–57.1
No Periods
0 (0)
6 (7)
5 (6)
6 (7)
4 (6)
13 (22)
46 (53)
58 (66)
56 (69)
44 (62)
42 (69)