Merit Medical Embosphere Mode D'emploi page 7

and QOL scores post embolization, with reduction in prostate size as a
secondary objective. Safety was assessed from reported adverse events.
RESULTS
Mean age of the evaluated cohort was in the seventh decade, lower
urinary tract symptoms were severe as reflected in a mean IPSS score over
20, and quality of life was dissatisfied to unhappy. Fifty-four patients had
indwelling bladder catheters at baseline.
Table 7 – Baseline Characteristics of the Patient Population
Characteristic
Age (years)
IPSS
Quality of life
Prostate volume (gms)
PSA (ng/mL)
Qmax (mL/s)
The majority of patients underwent bilateral embolization.
Table 8 – Unilateral versus Bilateral Embolization
Embolization
Unilateral
Bilateral
No data
Mean symptom scores, which were severe at baseline, improved
compared to pretreatment values at every follow-up interval. Values at
the 9-16 month evaluation period were mildly symptomatic. A reduction
of IPSS by at least 3 points was achieved at this latest evaluation in 97% of
patients, and 90% dropped by at least 1 symptom category.
Table 9 – Mean IPSS at Baseline and Follow-up
Time Window
Baseline
1 to 3 months f/u
9 to 16 months f/u
Table 10 – Proportion of Patients Achieving ≥ 3 point Improvement
in IPSS
Time Window Proportion (95% CI)
1 to 3 months f/u 0.931 (0.883-0.964)
9 to 16 months f/u 0.967 (0.917-0.991)
Table 11 – Proportion of Patients Achieving ≥ 1 IPSS Category
Improvement
Time Point Proportion (95% CI)
1 to 3 months f/u 0.842 (0.782-0.891)
9 to 16 months f/u 0.897 (0.833-0.943)
Not surprisingly, the reduction of lower urinary tract symptoms reflected
in the IPSS changes affected mean quality of life. Mean QOL scores, which
were categorized as mostly dissatisfied to unhappy pre-embolization,
improved at every follow-up interval to pleased/mostly satisfied.
Table 12 – Mean Quality of Life at Baseline and Follow-up
Time Point
Baseline
1 to 3 months f/u
9 to 16 months f/u
Mean prostate size at baseline was 85.1g, and demonstrated reduction
throughout follow-up.
Table 13 – Mean Prostate Volume at Baseline and Follow-up
Time Point
Baseline
1 to 3 months f/u
9 to 16 months f/u
Mean ± SD n
67.7 ± 9.7 286
21.5 ± 6.8 251
4.8 ± 0.9 166
85.1 ± 38.3 265
5.4 ± 4.6 251
6.9 ± 3.8 175
Patients (%)
29 (10.1)
254 (88.9)
3 (1.0)
Mean ± SD n
21.5 ± 6.8 251
6.3 ± 5.8 190
6.2 ± 5.8 136
Mean ± SD n
4.8 ± 0.9 166
1.4 ± 1.2 165
1.4 ± 1.1 116
Mean ± SD n
85.1 ± 38.3 265
62.4 ± 27.1 193
65.2 ± 28.6 118
In addition to the overall Composite population, analyses were done
for subsets of patients age 80 or older, with prostates 90g or larger, and
those with indwelling catheters at baseline for management of acute
urinary retention. These categories are not mutually exclusive. Patients
in these groups were of particular interest because they frequently are
contraindicated for TURP: elderly patients have higher incidence rates
of comorbid conditions, patients with prostate size larger than 90g are
typically referred for open surgery, and patients in acute retention are
not generally treated by transurethral procedures. For these reasons the
successful outcomes from PAE in these cohorts is notable.
Other than being older, baseline evaluations of the ≥80 year subset were
similar to those of the Composite group, including IPSS reflecting severe
symptoms and mostly dissatisfied to unhappy quality of life.
Table 14 – Baseline Characteristics of Patients Age ≥ 80 Years
Characteristic
Age (years)
IPSS
Quality of life
Prostate volume (gms)
PSA (ng/mL)
* 13 of 39 patients (33.3%) had indwelling bladder catheters at baseline
Although elderly patients might be limited in treatment options and/
or might be more fragile due to comorbidities, this cohort achieved
reduction in LUTS at all follow-up intervals. Over 80% had at least a 3-point
reduction in IPSS and a substantial majority dropped by at least one
symptom category.
Table 15 – Mean IPSS at Baseline and Follow-up of Patients Age ≥ 80
Years
Time Window
Baseline
1 to 3 months f/u
9 to 16 months f/u
Table 16 – Proportion of Patients Age ≥ 80 Years Achieving ≥ 3 Point
IPSS Improvement
Time Window
1 to 3 months f/u
9 to 16 months f/u
Table 17 – Proportion of Patients Age ≥ 80 Years Achieving ≥ 1 IPSS
Category Improvement
Time Point
1 to 3 months f/u
9 to 16 months f/u
The mean quality of life for this group trended toward improvement from
mostly dissatisfied to mostly satisfied.
Table 18 – Mean Quality of Life at Baseline and Follow-up of Patients
Age ≥ 80 Years
Time Point
Baseline
1 to 3 months f/u
9 to 16 months f/u
Bilateral embolization was possible in 80% of this group, and prostate size
reduction was seen throughout follow-up.
Table 19 – Unilateral versus Bilateral Embolization in Patients Age
≥ 80 Years
Embolization
Unilateral
Bilateral
No data
7
Mean ± SD
84.6 ± 3.8
23.9 ± 9.9
4.6 ± 1.2
78.1 ± 37.0
3.9 ± 3.6
Mean ± SD
23.9 ± 9.9
13.4 ± 9.2
7.0 ± 2.9
Proportion (95% CI)
0.889 (0.518-0.997)
0.889 (0.518-0.997)
Proportion (95% CI)
0.778 (0.400-0.972)
0.667 (0.300-0.925)
Mean ± SD
4.6 ± 1.2
1.4 ± 1.9
1.1 ± 1.1
Patients (%)
8 (20.5)
31 (79.5)
0 (0)
n
39
32
17
34
22
n
32
9
9
n
17
8
10