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Prostatic Artery Embolization for Benign Prostatic Hyperplasia: Prospective Randomized Trial of 100–300 μm versus 300–500 μm versus 100- to 300-μm + 300- to 500-μm Embospheres

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Purpose: This study compared the safety and efficacy of prostatic arterial embolization (PAE) with that of trisacryl gelatin microspheres of different sizes for treatment of benign prostatic hyperplasia (BPH). Materials and methods: This study consisted of a single-center, randomized controlled clinical trial in 138 patients who underwent PAE for BPH between July 2015 and December 2016. Patients were randomized to PAE using microspheres of different sizes: group A patients were treated with microspheres 100-300 μm, group B with 300-500 μm, and group C with 100-300 μm followed by 300-500 μm. All patients were evaluated before and at 1, 3, 6, 12, and 18 months after PAE. Baseline data were comparable across the 3 groups, using the following mean International Prostate Symptom Score/quality of life (IPSS/QoL); prostate volume (PV) scores, respectively: 23.0/4.14; 87.9 cm3 (group A); 23.0/4.09; 89.0 cm3 (group B); and 24.2/4.29; 81.0 cm3 (group C) (P > 0.05). Results: Mean IPSS/QoL scores; PV after PAE were: 9.98/2.49; 65.1 cm3 (group A); 8.24/2.26; 63.1 cm3 (group B); and 10.1/2.69; 53.1 cm3 (group C) (P = 0.23; P = 0.39; P = 0.24). There were 26 clinical failures. The cumulative probabilities of clinical success at 18 months were 76.7% in group A, 82.6% in group B, and 83.3% in group C (P = 0.68). Nontarget embolization was prevented in 6 patients by coil embolization. All adverse events were mild and self-limited with rates of 86.0% in group A (37 of 43); 41.3% in group B (19 of 46); and 58.3% in group C (28 of 48) (P < 0.001). Dysuria was the most frequent adverse event (28 of 137 [20.4%]). Conclusions: PAE outcomes were not significantly different among microspheres of different sizes. The use of 100- to 300-μm microspheres was associated with an increased risk of minor adverse events.
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CLINICAL STUDY
Prostatic Artery Embolization for Benign
Prostatic Hyperplasia: Prospective
Randomized Trial of 100300 μm versus
300500 μm versus 100- to 300-μm
D300- to 500-μm Embospheres
Daniel Torres, MD, Nuno V. Costa, MD, Jo~
ao Pisco, MD, PhD,
Luis C. Pinheiro, MD, PhD, Antonio G. Oliveira, MD, PhD, and
Tiago Bilhim, MD, PhD, EBIR, FSIR, FCIRSE
ABSTRACT
Purpose: This study compared the safety and efcacy of prostatic arterial embolization (PAE) with that of trisacryl gelatin micro-
spheres of different sizes for treatment of benign prostatic hyperplasia (BPH).
Materials and Methods: This study consisted of a single-center, randomized controlled clinical trial in 138 patients who underwent
PAE for BPH between July 2015 and December 2016. Patients were randomized to PAE using microspheres of different sizes: group A
patients were treated with microspheres 100300 μm, group B with 300500 μm, and group C with 100300 μm followed by 300500
μm. All patients were evaluated before and at 1, 3, 6, 12, and 18 months after PAE. Baseline data were comparable across the 3 groups,
using the following mean International Prostate Symptom Score/quality of life (IPSS/QoL); prostate volume (PV) scores, respectively:
23.0/4.14; 87.9 cm
3
(group A); 23.0/4.09; 89.0 cm
3
(group B); and 24.2/4.29; 81.0 cm
3
(group C) (P>0.05).
Results: Mean IPSS/QoL scores; PV after PAE were: 9.98/2.49; 65.1 cm
3
(group A); 8.24/2.26; 63.1 cm
3
(group B); and 10.1/2.69;
53.1 cm
3
(group C) (P¼0.23; P¼0.39; P¼0.24). There were 26 clinical failures. The cumulative probabilities of clinical success at
18 months were 76.7% in group A, 82.6% in group B, and 83.3% in group C (P¼0.68). Nontarget embolization was prevented in 6
patients by coil embolization. All adverse events were mild and self-limited with rates of 86.0% in group A (37 of 43); 41.3% in group B
(19 of 46); and 58.3% in group C (28 of 48) (P<0.001). Dysuria was the most frequent adverse event (28 of 137 [20.4%]).
Conclusions: PAE outcomes were not signicantly different among microspheres of different sizes. The use of 100- to 300-μm
microspheres was associated with an increased risk of minor adverse events.
ABBREVIATIONS
BPH ¼benign prostatic hyperplasia, IIEF ¼International Index Erectile Function, IPSS ¼International Prostate Symptom Score,
PAE ¼prostatic artery embolization, PSA ¼prostate-specic antigen, PV ¼prostate volume, PVR ¼post-void residual volume,
Qmax ¼uroowmetry peak urinary owrate, QoL ¼quality of life
From the Department of Interventional Radiology (D.T., N.V.C., J.P., T.B.),
Hospital Saint Louis, Rua Luz Soriano No. 182, 1200-249, Lisbon, Portugal;
Urology Department (L.C.P.), Hospital S~
ao Jos
e, Centro Hospitalar Uni-
versit
ario de Lisboa Central (CHULC), Lisbon, Portugal; Departments of Radi-
ology (D.T., N.V.C, T.B.) NOVA Medical School, Faculdade de Ci^
encias
M
edicas, Universidade Nova de Lisboa, Lisbon, Portugal; Interventional Radi-
ology Unit (N.V.C.), Curry Cabral Hospital, Centro Hospitalar Universit
ario de
Lisboa Central (CHULC), Lisbon, P ortugal; and Departa mento d e Farm
acia
(A.G.O.), Universidade Federal do Rio Grande do Norte, Natal, Brazil.
Received September 10, 2018; final revision received February 8, 2019;
accepted February 11, 2019. Address correspondence to T.B.; E-mail:
tiagobilhim@hotmail.com
T.B. is a paid consultant for Terumo (Tokyo, Japan) and Merit Medical (South
Jordan, Utah), an advisory board member for Merit Medical, a paid speaker for
Philips (Eindhoven, The Netherlands), and a shareholder in Embolx (Sunnyvale,
California). None of the other authors have identied a conict of interest.
© SIR, 2019
J Vasc Interv Radiol 2019; 30:638644
https://doi.org/10.1016/j.jvir.2019.02.014
Several embolic agents have been used for prostatic artery
embolization (PAE) such as nonspherical polyvinyl alcohol
(PVA) particles (Cook Medical Inc., Bloomington, Indiana);
spherical PVA (Bead Block, Biocompatibles UK Ltd.,
Farnham, United Kingdom); trisacryl gelatin microspheres
(Embospheres, Merit Medical Systems Inc., South Jordan,
Utah), and Polyzene-coated hydrogel microspheres (Embo-
zene, CeloNova BioSciences Inc., San Antonio, Texas)
(110). Particle sizes used for PAE range between 50 and
300 μm for nonspherical PVA particles and between 100 and
500 μm for spherical embolic agents. The best size with
which to obtain optimal clinical success is not known. PAE
with 100-μm PVA particles leads to a greater decrease in
prostate-specic antigen (PSA) post-void residual volume
(PVR) and a greater increase in uroowmetry peak urinary
ow (Qmax). However, a greater decrease in International
Prostate Symptom Score (IPSS) and in quality of life (QoL)
was observed with 200-μm PVA particles (7). These nd-
ings raised the potential benet of starting PAE with smaller
embolic agents and nishing with larger ones. Another
study (8) compared 100- to 300-μm with 300- to 500-μm
microspheres for PAE and concluded that clinical outcomes
were similar but that the smaller microspheres led to a
higher incidence of adverse events. The aim of the present
randomized clinical trial was to evaluate and compare the
safety and efcacy of PAE among different sizes of
microspheres.
MATERIALS AND METHODS
Study Population
This single center, open-label, randomized controlled clin-
ical trial in patients with moderate to severe lower urinary
tract symptoms due to benign prostatic hyperplasia (BPH)
receiving PAE with microspheres was approved by the
Institutional Review Board, and all patients signed an
informed consent form. Patients were blinded to the embolic
sizes used, whereas operators were not. The inclusion
criteria were male patients older than 45 years of age with
the diagnosis of BPH with moderate to severe lower urinary
tract symptoms (IPSS 18, and QoL response to IPSS
question 3), Qmax lower than 12 mL/sec, and with sexual
dysfunction or accepting the risk of developing sexual
dysfunction after treatment (11,12). All patients were
informed about the embolization and other therapeutic op-
tions for their clinical situation including transurethral
resection of the prostate, open surgery, and Holmium laser
enucleation of prostate (13). Exclusion criteria were malig-
nancy, secondary renal insufciency (due to prostatic
enlargement), large bladder diverticula or stones, urethra
stenosis, neurogenic bladder, detrusor failure, and active
urinary tract infection (14).
Patients who were eligible for the trial according to the
criteria underwent pelvic computed tomography (CT)
angiography to assess the degree of vascular calcication as
well as prostatic arterial anatomy. With CT angiography, the
degree of calcium and the prostatic artery origin were
assessed (15). On the basis of CT angiography, the patients
were informed of the difculties of the procedure and the
probability of technical success rate. Advanced atheroscle-
rosis and tortuosity of iliac arteries were additional exclu-
sion criteria. The technical details of the CT angiography
using sublingual nitroglycerin to identify the prostatic artery
anatomy have been previously described (15). Prostatic bi-
opsies were performed in all patients with suspected pros-
tatic malignancy based on a PSA level greater than 4 ng/mL,
a suspicious focal lesion detected with multiparametric
magnetic resonance imaging, transrectal ultrasonography, or
digital rectal examination. Eligible patients were random-
ized to embolization with trisacryl gelatin microspheres
(Embospheres, Merit Medical Systems Inc.) 100300 μm
(group A), 300500 μm (group B), or 100300 μm followed
by 300500μm (group C). Patients were allocated by simple
randomization to one of the 3 study groups. Randomization
was performed at the beginning of the study, and patient
allocations were decided on the day of the procedure, prior
to the embolization procedure.
Embolization Technique
Before, during, and after the procedure, the patients had the
same medications previously described (12,16). Patients
were admitted to the hospital 2 hours before the interven-
tion. The embolization was planned in advance, on the basis
of CT angiography, particularly the volume rendering CT
angiography reformats and the maximum intensity pro-
jections (15). These images were available in the angiog-
raphy suite during the procedure (14,15). Once the patients
were on the angiography table, they were allocated to one of
the study groups. Embolization was performed with the
patient under local anesthesia by the unilateral femoral
approach whenever feasible, mostly using the right common
femoral artery, by 3 interventional radiologists with 310
years of experience with PAE. A 5-F Roberts uterine cath-
eter (Cook Medical) was introduced into the right femoral
artery in order to catheterize the left internal iliac artery and
its anterior division (14,15). With the catheter at the prox-
imal internal iliac artery, a digital subtraction angiograph
EDITORSRESEARCH HIGHLIGHTS
This study reinforces the role of prostatic arterial
embolization (PAE) in the treatment of lower urinary
tract symptoms due to benign prostatic hyperplasia.
The authors reported no differences between the
clinical success rates using 100- to 300-μm-sized
particles and those using 300- to 500-μm particles at
18 months, although the incidence of minor self-
limiting complications such as dysuria was greater
with smaller particles.
Greater use of prophylactic coil embolization (4% in
this study) of rectal and accessory pudendal and
vesical arteries may allow a more aggressive particle
embolization with a lower clinical failure rate.
Volume 30 Number 5 May 2019 639
(DSA) was obtained in the ipsilateral anterior oblique view
(35) and 10caudocranial angulation, using 6 mL of
iodinated contrast medium (Iopamiro 300, Iomeron, Braco,
Italy) at 3 mL/sec, to visualize the prostatic arteries. After
the left prostatic arteries were identied, a road map was
obtained using the catheter at the origin of the artery in
which those arteries originated. Afterward, the prostatic
vessels were selectively catheterized using a 2.4-F Maestro
microcatheter (Merit Medical Systems Inc.). A DSA in
posteroanterior view was performed with the catheter in the
prostatic artery (5 mL; 2 mL/sec) in order to visualize the
prostate vascularization and vessels leading to potential
nontarget embolization (14). If anastomoses to penis,
rectum, or bladder were identied, with potential for
nontarget embolization, coil embolization was performed
(17) (Fig 1). Before embolization was started, 100200 μg
of nitroglycerin (Hospira UK Limited, Hurley,
Maidenhead, United Kingdom) was injected through the
microcatheter. The particles were slowly injected through
a 3-cm
3
syringe. In group C, the particles were delivered
sequentially (100300 μm followed by 300500 μm). The
endpoint chosen for embolization was near stasisin the
prostatic vessels with interruption of the arterial ow or
reux toward the origin of the prostatic artery or internal
pudendal artery (15,17). A similar procedure was performed
for the contralateral side (18).
Outcome Measurements
Technical success was dened as selective prostatic arterial
catheterization of 1 or both pelvic sides (12). The procedures
were performed on an outpatient basis, and all patients were
discharged 3 to 6 hours after PAE. Pain assessment was
evaluated after PAE and for a period of 36 hours after PAE at
discharge using a visual analog scale. Patients were asked to
rate their pain severity from 0 (no sensation of pain) to 10 (the
worst pain). The analysis of pain questionnaires was blinded.
The IPSS/QoL scores were assessed at baseline and at 1, 3, 6,
12, and 18 months after the procedure. PV, Qmax, PVR, the
5-question version of the International Index of Erectile
Function 5 (IIEF-5), and the PSA test results were assessed
before PAE and at 1, 6, and 12 months after PAE. The
prostate volume (PV) was assessed with transrectal ultraso-
nography in all patients and was assessed using magnetic
resonance imaging in 17 patients (12,19,20). The primary
efcacy variable was clinical success, dened as improve-
ment of symptoms: IPSS reduction of at least 25% from
baseline score and 15 points and reduction of QoL of by at
Figure 1. Coil embolization of an accessory pudendal artery during PAE. (a) DSA of left prostatic artery (large arrow) giving rise to an
accessory pudendal artery (arrowhead) anastomosing with the penile artery (arrow) with retrograde opacication of the internal pu-
dendal artery. (b) Selective DSA of the anastomosis to the penile artery. (c) Selective angiography of anastomosis to the penile artery
with retrograde opacication of the internal pudendal artery (arrow). (d) Coils placed in the anastomosis to the penile artery (arrows).
640 Prostatic Artery Embolization for BPH Torres et al JVIR
least 1 point from baseline score or 3 points after PAE (12).
PAE in patients without clinical success was considered a
clinical failure. PAE was considered an initial failure if these
patients did not improve within 1 month after undergoing the
procedure. Short-term PAE failures occurred between 3 and
12 months, and medium-term PAE failures occurred after 1
year. Adverse events were classied according to Society of
Interventional Radiology criteria (11,21).
Statistical Analysis
Descriptive statistics are presented as means ±SD or ab-
solute and relative frequencies. Rates of clinical improve-
ment over time were analyzed using the Kaplan-Meier
method to account for incomplete follow-up times, and
differences between groups in the cumulative probability of
clinical success were tested with the log-rank test. Differ-
ences among groups over time in the response variables
(IPSS, QoL, Qmax, PVR, PSA, PV, and IIEF-5) were
analyzed using multilevel mixed effects linear regression,
with prostate volume, Qmax, and PSA logarithm values
transformed to obtain a normal distribution. Pvalues were
adjusted for multiple comparisons using the Holm-
Bonferroni procedure. Statistical differences were assumed
with a Pvalue <0.05. Stata 13 software (Stata Corp., Col-
lege Station, Texas) was used for all analyses.
RESULTS
Between July 2015 and December 2016, 144 patients with
moderate to severe lower urinary tract symptoms due to
BPH were included in this clinical trial. There were 6
screening failures not meeting the inclusion/exclusion
criteria, thus, 138 patients were allocated by simple
randomization to group A (44 patients), B (46 patients), or
C (48 patients). One patient from group A died of
myocardial infarction before any efcacy data could be
collected and was excluded from the analysis set. There-
fore, the study population consisted of 137 patients divided
into 3 groups: 43 patients in group A, 46 patients in group
B,and48patientsingroupC(Fig 2). The mean patient age
was 66.1 ±8.4 years old (range: 4786 years of age); mean
baseline IPSS was 23.4 ±5.2 (range: 1535); and the mean
Figure 2. CONSORT diagram showing ow of patients through the study.
Volume 30 Number 5 May 2019 641
baseline PV was 85.9 ±48.5 cm
3
(range: 21260 cm
3
). The
3 groups were comparable regarding the baseline values of
the study variables (P>0.05) (Tab l e 1 ).
The PAE procedure was performed with the patient under
local anesthesia, using a unilateral femoral approach in 135
and a bilateral approach in 2 patients. PAE was bilateral in
133 patients and unilateral in 4 patients. Mean procedure
time was 85 minutes (range: 22165 min). Mean uoros-
copy time was 24.5 minutes (range: 6.885 minutes). The
mean procedure pain score during PAE on a 010 visual
analog scale was 1.8 (range: 07); 113 patients (81.9%) did
not feel any pain. The mean pain score at discharge was 0.8
(range: 05).
There were 26 PAE clinical failures (19.0%). Twenty-two
failures (16.1%) were initial clinical failures: 9 in group A, 7
in group B, and 6 in group C. There were 2 failures at short-
term, 1 at 3 months from group C and 1 at 6 months from
group C. The other failure occurred at mid-term at 1 year
from group B. Cumulative probabilities of clinical success at
18 months were 76.7% (95% condence interval [CI]: 61.1
86.8%) for group A, 82.6% (95% CI: 68.290.9%)
for group B, and 83.3% (95% CI: 69.491.3%) for group C
(Fig 3). The differences are not statistically signicant
(P¼0.68). Table 2 shows the value of the study
variables at last observation and the percent change from
baseline. In all groups, there was a statistically signicant
decrease over time in IPSS, QoL, and PV and a
statistically signicant increase in Qmax. In all patients, a
statistically signicant improvement from baseline was
seen as early as 1 month after PAE. There were
statistically signicant decreases in PSA test results in
group C and no statistically signicant changes in IIEF
and PVR. However, there were no statistically signicant
differences among groups in any of the variables.
There were no major complications, and there was no
urinary incontinence or erectile dysfunction after PAE.
Changes in ejaculation were not assessed in this trial. Minor
adverse events were evaluated in all 137 patients who were
included in the nal analysis. With the exception of 1 fatal
myocardial infarction, which was unrelated to the proced-
ure, occurring 3 months after PAE, all adverse events were
of mild intensity (Table 3). Adverse events included dysuria
(28), frequency (26), hematuria (9), hematospermia (8),
rectal bleeding (6), inguinal hematoma (6), and glans
penis skin lesion (1). All adverse events were mild and
self-limited: 86% in group A (37 of 43); 41% in group B
(19 of 46), and 58% in group C (28 of 48) (P<0.001).
DISCUSSION
The aim of the present study was to investigate which size
microspheres were associated with better results and fewer
adverse events. Previous studies comparing different sizes
of PVA particles (7) or microspheres (8) failed to prove any
signicant differences in outcome measurements after PAE
for BPH. The rates of adverse events were not signicantly
different among the different sizes of PVA particles (7). The
results of PAE using 300- to 500-μm microspheres was
compared to PAE using 100- to 300-μm microspheres in 15
patients in each group (8). There were no statistically sig-
nicant differences in IPSS, QoL, PSA, or prostate volume
reduction between the 2 groups. The patients in whom the
smaller particle size was used showed a signicant regrowth
in prostate size from 3 to 12 months, and there was an in-
crease in minor adverse events in patients who underwent
PAE with smaller microspheres, although this was not sta-
tistically signicant. Both of the studies suggested that PAE
using larger particles may be better. The present study
conrms these ndings with a larger cohort, proving that the
use of 100- to 300-μm microspheres does not improve
clinical outcomes and leads to a higher rate of minor adverse
events. Data comparing different PVA particle sizes sug-
gested that the combination of sizes, starting with smaller
(80180 μm) and nishing with larger (180300 μm) PVA
Figure 3. Cumulative probability of clinical success by size of
microspheres.
Table 1. Baseline Data
Variable Group
A(n¼43) B (n ¼46) C (n ¼48)
n Mean ±SD n Mean ±SD n Mean ±SD
Age, y 43 67.5 8.88 46 65.9 7.86 48 65.1 8.43
IPSS 43 23.0 5.62 46 23.0 5.15 48 24.2 4.89
QoL 43 4.14 1.23 46 4.09 1.07 48 4.29 1.09
PV, cm
3
43 87.9 49.6 46 89.0 51.8 48 81.0 44.8
PVR, mL 30 120.7 83.5 34 108.2 79.8 32 124.2 121.7
Qmax,
mL/min
42 8.23 2.59 44 7.71 2.92 47 8.10 2.88
IIEF 38 18.8 5.57 36 17.9 6.65 42 16.2 6.91
PSA,
ng/dL
43 3.97 2.90 44 4.25 3.09 47 3.74 3.23
IIEF ¼International Index Erectile Function; IPSS ¼Interna-
tional Prostate Symptom Score; PVR ¼post-void residual;
PSA ¼prostate-specic antigen; PV ¼prostate volume;
Qmax ¼uroowmetry peak urinary owrate; QoL ¼quality of
life.
642 Prostatic Artery Embolization for BPH Torres et al JVIR
particles could be benecial (7). Thus, in the present study, a
third group was included in whom 100- to 300-μm particles
were used rst, followed by 300- to 500-μm microspheres.
This combination of different sizes also failed to prove
benecial and was also associated with a higher rate of
adverse events. The number of minor adverse events was
signicantly lower in group B, where 100- to 300-μm mi-
crospheres were not used. The patients from groups A and
C, where 100- to 300-μm microspheres were used, had
higher numbers of minor adverse events. This can be
explained by the small size of the microspheres that could
penetrate more distally, causing more inammation and
necrosis. The glans penis skin lesion could be explained by
the penetration of microspheres 100300 μm through a
small collateral from an accessory pudendal artery to the
penile artery, as previously reported (12). Even though cone-
beam CT was not available at the time of the study,
preprocedural CT angiography was used to guide inter-
ventionalists during PAE (15), and anastomoses were eval-
uated with selective prostatic artery DSA before
embolization. The technique used was the same for the 3
groups, precluding any potential for procedural bias.
Other groups have shown encouraging results using 50-
μm followed by 100-μm PVA particles (10). More recently,
Table 2. Percent Change from Baseline in Secondary Clinical Variables
Variable by Group Last Observation % Change from Baseline Pvalue*
Mean ±SD Mean 95% CI
IPSS .23
A 9.98 6.67 57.6 64.8 50.5
B 8.24 6.57 64.3 72.7 55.9
C 10.1 5.90 57.9 64.6 51.3
QoL .39
A 2.49 1.20 39.2 47.3 31.0
B 2.26 0.85 43.9 49.0 38.7
C 2.69 0.95 36.6 42.1 31.1
PV, cm
3
.24
A 65.1 38.3 25.1 31.5 18.8
B 63.1 32.4 24.2 30.0 18.3
C 53.1 35.2 35.2 40.8 29.5
PVR, mL .43
A 75.5 65.4 21.2 48.0 5.62
B 68.2 44.9 41.8 65.7 149.2
C 77.1 60.7 279.2 100.4 658.7
Qmax, mL/min .47
A 11.8 3.28 56.1 35.8 76.3
B 12.9 5.29 70.5 51.7 89.2
C 13.8 4.18 81.9 61.4 102.5
IIEF .72
A 16.7 6.62 4.78 16.5 6.93
B 17.6 7.82 5.58 18.0 6.87
C 16.9 8.33 8.13 11.9 28.2
PSA, ng/dL .35
A 2.58 1.79 26.0 36.0 15.9
B 3.09 3.19 5.41 36.8 26.0
C 2.95 2.51 22.8 33.3 78.9
CI ¼condence interval; IIEF ¼International Index Erectile Function; IPSS ¼International Prostate Symptom Score; PV ¼prostate
volume; Qmax ¼uroowmetry peak urinary owrate; QoL ¼quality of life; RPV ¼post-void residual; PSA ¼prostate-specic antigen.
*Multiplicity-adjusted Pvalues >.99 in the comparison among groups in all variables.
Table 3. Adverse Events after PAE
Adverse events Group A
(n ¼43)
Group B
(n ¼46)
Group C
(n ¼48)
Total
(N ¼137)
Dysuria 12 7 9 28
Frequency 11 6 9 26
Hematuria 4 2 3 9
Hematospermia 4 1 3 8
Rectal bleeding 3 1 2 6
Inguinal hematoma 2 2 2 6
Glans penis
skin lesion
10 0 1
Total 37 (86.0) 19 (41.3) 28 (58.3) 84 (61.3)
PAE ¼prostatic artery embolization.
Volume 30 Number 5 May 2019 643
the use of 50-μm plus 100-μm PVA particles has shown
better outcomes than the use of 100-μm PVA particles alone
(22). The use of smaller PVA particle sizes led to greater
prostate ischemia, greater prostate volume reduction, and
greater clinical improvement, without a higher rate of
adverse events (22). Retrospective analysis looking at
spherical embolic agents has also shown that spherical
embolic agents <300 μm performed best (23,24). This po-
tential benet of using smaller sized embolic agents has to
be counterbalanced by the potentially higher rate of adverse
events and ejaculation disorders that have been overlooked
in most PAE studies (25).
Nearly all PAE clinical failures were initial failures,
occurring at 1 month after PAE in PAE nonresponder pa-
tients (12) from all studied groups. This highlights the fact
that patient-related and not procedure-related factors have a
main role in clinical outcomes. Despite the cumulative
probabilities of clinical success being higher in groups B
and C and lower in group A, these differences were not
statistically signicant. The potential benets of combining
smaller (50-μm) PVA particles with larger (100-μm) PVA
particles proven before (22) was not observed in the present
study, which failed to prove any potential benet of using
100- to 300-μm microspheres followed by 300- to 500-μm
microspheres. It will be exceedingly difcult to show a
statistically signicant superiority of 1 particle size over
another. In the present study in 137 patients, the difference
between the clinical success rate observed with the smaller
microspheres and that with the larger microspheres was
approximately 6%. In order to show a 6% increase in the
clinical success rate with 70% power, a clinical trial such as
this one, with a 12-month patient follow-up, would need to
observe approximately 570 events and an estimated sample
size of nearly 2900 patients. Also, the clinical relevance of
such statistical signicance could be disputed.
The present study has limitations. It was conducted at a
single center; it was not double-blind; the dropout rate was
signicant; there was no long-term follow-up; and ejacula-
tion was not assessed after PAE. More trials should be
performed to compare different embolic agents and particle
sizes to nd out the best embolic agent and size for PAE.
In conclusion, use of 100- to 300-μm microspheres either
alone or before 300- to 500-μm microspheres did not lead to
signicant differences in clinical outcome and was associ-
ated with a higher rate of minor adverse events. There was
no evidence to support the use of 100- to 300-μm micro-
spheres for PAE.
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644 Prostatic Artery Embolization for BPH Torres et al JVIR
... Spherical polyvinyl alcohol (PVA) particles of varying diameters, notably within the ranges of 100-300 µm, 250-400 µm, or 300-500 µm, constitute the predominant embolic agents employed [45][46][47]. The optimal bead caliber remains a subject of ongoing discourse [48,49]. ...
... The main controversy remains in the choice of embolizing particle size [48,49,58]. Some studies support that large particles are more effective in clinical improvement as assessed by IPSS, while smaller particles act more markedly on the reduction in objective parameters, such as PSA [49]. ...
... The central point of contention within the field of PAE revolves around the selection of embolizing particle size, a topic extensively scrutinized in the literature [48,49,58]. Various studies have contributed to this discourse, presenting divergent perspectives on the efficacy of different particle sizes in achieving clinical improvement and mitigating adverse events. ...
Article
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Benign Prostatic Hyperplasia (BPH) is the most frequent cause of Lower Urinary Tract Symptoms (LUTSs) in elderly populations. Minimally invasive treatments of BPH are safe and effective and are gaining popularity among both professionals and patients. Prostate Artery Embolization (PAE) has proven to be effective in Trans-Urethral Resection of the Prostate (TURP) in terms of prostate volume reduction and LUTS relief. PAE entails the selective catheterization of the prostatic artery and later embolization of distal vessels with beads of various calibers. Universal consensus regarding the ideal particle size is yet to be defined. We retrospectively evaluated 24 consecutive patients (median age: 75 years; range: 59–86 years) treated with PAE at our institution from October 2015 to November 2022. Particles of different sizes were employed; 12 patients were treated with 40–120 µm particles, 5 with 100 µm, 5 with 100–300 µm and 2 with 250 µm. Technical success, defined as selective prostate artery catheterization and controlled release of embolizing beads, was achieved in all patients. Removal vs. retention of the urinary catheter at the first post-procedural urological visit was the main clinical objective. No major peri-procedural complications were recorded, with 56% of patients successfully removing the urinary catheter.
... Both of these options can reduce the LUTS significantly. However, with surgical therapies, there are always possible limitations (comorbidities of the patient that make surgical treatment impossible and various complications that can occur after the surgery) [24][25][26][27]. In recent years, more and more studies have been published introducing PAE as an alternative treatment method for BPH [4,8,[12][13][14]27,28]. Prostatic artery embolization (PAE) is performed under local anesthesia, using the femoral approach with no or minimal pain, so it can be performed for those patients that are not suitable for surgery or general anesthesia. ...
... However, with surgical therapies, there are always possible limitations (comorbidities of the patient that make surgical treatment impossible and various complications that can occur after the surgery) [24][25][26][27]. In recent years, more and more studies have been published introducing PAE as an alternative treatment method for BPH [4,8,[12][13][14]27,28]. Prostatic artery embolization (PAE) is performed under local anesthesia, using the femoral approach with no or minimal pain, so it can be performed for those patients that are not suitable for surgery or general anesthesia. ...
... These kinds of complications should be avoided as the experience of interventional radiologists grows in the future. We compared the improvement of BPH-related symptoms with other authors' results [8,12,14,19,27]. In our study at 6 months follow-up, the mean values of IPSS, QoL, IIEF, PV, and PVR improved similarly. ...
Article
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Background: The endovascular treatment of symptomatic benign prostate hypertrophy (BPH) by prostatic artery embolization (PAE) is one of the new treatments proposed. PAE is a minimally invasive alternative that has been shown to successfully treat lower urinary tract symptoms in BPH patients by causing infarction and necrosis of hyperplastic adenomatous tissue, which decompresses urethral impingement and improves obstructive symptoms. The aim of this study was to evaluate the effectiveness and efficacy of PAE in relieving symptoms in patients with symptomatic BPH. Materials and Methods: The material for the study was collected from 2019 to 2022. A total of 70 men with BPH and PAE were studied. Patients underwent an urological examination to measure the International Prostate Symptom Score (IPSS), Quality of Life score (QoL), International Index of Erectile Function short form (IIEF-5), uroflowmetry with Qmax, prostatic volume (PV), and post-void residual volume (PVR) measurements. Statistical analysis for dependent samples was applied. Measured parameters at 2 months and 6 months follow-up were compared to baseline. Results: At baseline, the age of the male (N = 70) subjects was 74 ± 9.6 years with a median of 73.8, but fluctuated from 53 to 90 years. The mean of PV was almost 111 mL and the Qmax was close to 7.7 mL/s. The average PVR was 107.6 mL. The IPSS score mean was 21.3 points and the QoL score was 4.53 points. The IIEF-5 questionnaire score was almost 1.8 points, which shows severe erectile dysfunction. The mean value of the PSA level was 5.8 ng/mL. After 2 and 6 months of PAE, all indicators and scores except erectile function significantly improved. Conclusions: The outcomes of our study show promising results for patients with benign prostatic hyperplasia after PAE. The main prostate-related parameters (PV, Qmax, PVR, IPSS) improved significantly 6 months after embolization.
... Similarly, the prior embolization of dangerous collaterals or the use of a protective balloon did not, according to Brown et al., prevent emboli outside the prostatic artery. The size of the particles also seems for some to influence the number of NTEs: the use of particles smaller than 300 μm would be associated with more complications [3,15,16]. In contrast, other authors [17,18] have shown that the use of large particles increases the risk of arterial reflux. ...
... In contrast, other authors [17,18] have shown that the use of large particles increases the risk of arterial reflux. A randomized trial [15] comparing the use of 100-300 vs. 300-500-micron calibre particles did not show a significant difference between the two groups and concluded that the ideal particle size was yet to be determined [4]. Prostate artery embolization using N-butyl cyanoacrylate has been reported in three recent series [19][20][21]. ...
Article
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Background This study evaluated nontarget embolization (NTE) during prostatic artery embolization (PAE) with ethylene vinyl alcohol copolymer (EVOH). Results Ten consecutive patients treated by PAE with EVOH for the presence of disabling benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS) between June 22 and January 2023 were included in this prospective study. The inclusion criteria were as follows: LUTS attributed to BPH, LUTS duration ≥ 6 months, failure to respond to standard pharmacotherapy, IPSS > 18 or QoL score > 2, and prostate volume > 40 mL. Embolization was performed under general anaesthesia. According to established techniques, a microcatheter was positioned bilaterally within the feeding arteries, and EVOH was injected slowly under X-ray control. Unenhanced pelvic computed tomography scans were carried out before and after embolization to assess the NTE. The safety of the prostatic embolization procedure with EVOH was assessed by collecting adverse effects over 3 months of evaluation that included the International Prostate Symptom Score (IPSS) and quality of life (QoL) score.-up evaluations, occurring at 3, 6, and 12months, included International Prostate Symptom Score. Bilateral PAE was technically successful in 9 patients, and unilateral injection was performed in one patient. The postoperative scanner showed a distribution of the embolization material in the two lobes of the prostate in all patients. The procedure time varied from 120 to 150 (mean: 132) minutes. Eight out of 10 patients developed pollakiuria within 24 h; none of the patients had postoperative pain. Two patients required catheterization for postoperative urinary retention. Catheters were removed successfully at the end of the first day for one of these patients and on the tenth day for the other. At the 3-month follow-up, patients showed significant improvement in the International Prostate Symptom Score ( n = 10; mean = -11,5; P < 0.01) and quality of life score ( n = 10; mean = -3,40; P < 0.01). Only one patient presented one asymptomatic muscular NTE. Conclusions PAE with EVOH is safe, effective, and associated with few NTEs and no postoperative pain. Prospective comparative studies with longer follow-ups are warranted. Trial registration IDRCB, 2021-AO29-56–35. Registered 27 May 2022, http://clinicaltrials.gov/study/NCT05395299?cond=embolization&term&rank=1 .
... 1-4). Frequently used embolic agents for PAE include nonspherical polyvinyl alcohol (PVA) particles of 100-300 µm (Bearing nsPVA, Merit Medical Systems, Inc.; Contour, Boston Scientific Corporation), spherical embolic agents such as 300-500 µm spherical PVA (BeadBlock, Boston Scientific Corporation), 100-300 or 300-500 µm trisacryl gelatin microspheres (Embosphere, Merit), and 250 or 400 µm polyzene-coated hydrogel microspheres (Embozene, Varian Medical Systems) [11][12][13][14][15]. Less frequently and more recently reported embolic options include polyethylene glycol microspheres (Hydropearls, Terumo) of 400 µm [16], radiopaque microspheres (Lumi, BTG) of 70-150 µm [17], and n-butyl cyanoacrylate [18]. ...
... Controversy exists regarding the added value of using smaller (100 µm) versus larger (200 µm) nonspherical PVA particles [14,15]. Smaller microspheres (< 300 µm) have consistently been shown to cause more adverse events while providing no clinical benefit [12,13]. Therefore, we recommend using either 100-300 µm nonspherical PVA particles or > 300 µm microspheres. ...
... Torres et al. compared 100-300 um with 300-500 um and with combination 100-300 plus 300-500-um particles and showed 86% minor adverse events in 100-300-um group, significantly more than 41% that was seen in 300-500-um group [3]. Therefore, the larger particle size used by Svarc et al. has likely helped PES in entire population, but still DEXA did not make a difference between groups. ...
... Moreover, the measurement error would be similar in both arms of the trial and are therefore unlikely to influence the conclusion of the trial. Further, all procedures were conducted using the relatively large particles, 300-500 microns, and there is some evidence suggesting that the use of smaller particles could cause more pronounced and more frequent PES symptoms [20,21]. Finally, no direct measurements of the extent of prostatic tissue infarction were collected during this trial. ...
Article
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Purpose To evaluate the efficacy of a single perioperative dose of dexamethasone in reducing postembolization syndrome following prostatic artery embolization. Materials and Methods We conducted a single-center double-blind randomized controlled trial from March 2021 to May 2022 (NCT04588857). Participants were randomized to receive either i.v. 24 mg dexamethasone or saline. The primary outcome measures were temperature, pain, and quality of life in the first 5 days following prostatic artery embolization. Sample size of 60 patients was needed for the assessment of primary outcomes. Participants were followed for 6 months and assessed for a variety of secondary outcome measures including inflammatory markers and lower urinary tract symptoms severity. Results Due to lack of clinical effect and mild symptoms in the control group, the trial was terminated early. 31 participants (16 dexamethasone vs. 15 control) were enrolled and analyzed. A difference in mean temperature was observed on day 1 (37.23 ± 0.64 °C control vs 36.74 ± 0.41 °C dexamethasone, p = 0.02, 95% CI 0.09–0.89). Difference in pain (score out of 10) was seen only on day 5 (1.48 ± 1.2 control vs. 2.9 ± 2.24 dexamethasone, p = 0.04, 95% CI − 2.78–− 0.04). A difference in C-reactive protein values was observed on day 2 (108 [54–161] mg/l control vs 10 [5–33] mg/l dexamethasone, p < 0.01). No significant differences in other outcomes were observed. No side effects were recorded. Conclusions Twenty-four milligrams of dexamethasone bolus is safe but does not reduce postembolization syndrome following prostatic artery embolization. Graphical Abstract
... Some authors discuss how the smaller size of the microspheres (100~300 µm) might experience more shrinkage in volume and probably undergo longer durations of being symptom-free but feature high rates of dysuria and penile ulcers compared with larger sized microspheres (300~500 µm). Despite the diameter of the microspheres for PAE procedures, small-sized or large-sized or mixed-sized microspheres all demonstrate the same clinical effectiveness [16]. ...
Article
Full-text available
Benign prostatic obstruction (BPH) is a common disease in males and surgical treatment is the gold standard for this symptomatic disease. Prostate artery embolization (PAE) is one of the emerging therapies which aims to minimize the lower urinary tract symptoms (LUTS) of BPH and the volume of enlarged prostates. We reported here a case of 100-year-old man with 90 cm3 prostate and severe symptoms secondary to BPH, who underwent a successful PAE through distal transradial access without any complications. The patient was satisfied with this treatment and no symptoms recurred after PAE. This demonstrated that PAE was a safe and effective treatment for BPH and was recommended for elderly/non-surgical candidates.
Article
Purpose: To evaluate safety and efficacy of prostatic artery embolization (PAE) using polyethylene glycol (PEG) microspheres in patients with moderate to severe benign prostatic hyperplasia (BPH). Materials and methods: A single center, prospective study of 30 patients undergoing PAE from August 2020 to December 2021 using PEG 400μm microspheres was conduct. Patient evaluation using International Prostate Symptom Score (IPSS), quality-of-life (QoL) score, prostate-specific antigen (PSA), peak urinary flow rate (Qmax), postvoid residual volume (PVR) and prostate volume (PV) at baseline, 3 and 12 months after PAE were obtained. Results: Bilateral PAE was performed in all patients. One patient had early clinical failure (3.3%) and another presented with lower urinary tract symptoms (LUTS) recurrence (3.3%) at 12-months follow-up. Twenty-eight patients (93.3%) experienced significant and persistent LUTS improvement. Mean absolute and relative improvement at 3 and 12-month were as follows, respectively: IPSS, 14.6 points (-69%) for both; QoL, 3.3 points (-70%) and 3.5 points (-74%); Qmax, 6.3mL/s (+78%) and 8.6mL/s (+100%); PSA reduction, 1.2ng/mL (-22%) and 1.0ng/mL (-15%); PVR reduction, 48mL (-56%) and 58.2mL (-49%); PV reduction, 23.4cm3 (-29%) and 19.6cm3 (-25%); (p < 0.05 for all). No major adverse events were observed. Minor adverse events included urinary tract infection (4/30, 13.3%), prostatic tissue elimination (3/30, 10%), penile punctiform ulcer (1/30, 3.3%) and urinary retention (1/30, 3.3%). Conclusion: PAE using PEG microspheres was observed to be effective with sustained LUTS improvement at the 12-months follow-up. The incidence of urinary infection and prostatic tissue elimination was higher than previously reported.
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Objectives To identify predictors for different treatment outcomes after prostatic artery embolization (PAE) in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Patients and Methods A post hoc analysis of data derived from the 48 patients undergoing PAE in a randomized, open‐label, non‐inferiority trial was performed. Relative changes in the International Prostate Symptoms Score (IPSS), absolute changes in maximum urinary flow rate (Qmax), and relative changes in magnetic resonance imaging‐assessed prostate volume from baseline to 12 weeks were defined as the outcomes measures of interest. Their association with various baseline characteristics and measures, technical details of PAE, and early postoperative measures were analysed using Spearman rank correlations and Wilcoxon rank‐sum tests. The most promising predictors were further evaluated in receiver‐operating characteristic (ROC) curve analyses. Results Higher total prostate and central gland (i.e. central plus transitional zone) volumes were associated with more pronounced improvements in the IPSS (Spearman rank correlation [rs]: −0.35 and −0.34; P = 0.01 and P = 0.02, respectively) and the Qmax (rs: 0.31 and 0.39; P = 0.05 and P = 0.01, respectively). ROC curve analyses suggested that volumes of 39 and 38 mL for total prostate and central gland volume, respectively, would be the optimal thresholds with which to predict PAE success as measured by the IPSS. Other anatomical characteristics of the prostate, such as the central gland index, also showed an even more distinct correlation to the improvement in Qmax (rs: 0.46, P = 0.003). The relative changes in prostate volume were clearly dependent on the technical performance of PAE. Occurrence of postoperative pain and blood levels of prostate‐specific antigen and C‐reactive protein emerged as potential early‐stage outcome predictors after PAE. Conclusion Baseline and peri‐operative findings might help to guide patient selection and outcome prediction for PAE. Patients with larger prostates have a higher chance of success with PAE. Larger‐scale clinical trials including a longer follow‐up are warranted to further elucidate the most suitable patients for PAE.
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To confirm that prostatic artery embolization (PAE) has a positive medium- and long-term effect in symptomatic benign prostatic hyperplasia (BPH). Between March 2009 and October 2014, 630 consecutive patients with BPH and moderate-to-severe lower urinary tract symptoms refractory to medical therapy for at least 6 months or who refused any medical therapy underwent PAE. Outcome parameters were evaluated at baseline; 1, 3, and 6 months; every 6 months between 1 and 3 years; and yearly thereafter up to 6.5 years. Mean patient age was 65.1 years ± 8.0 (range, 40–89 y). There were 12 (1.9%) technical failures. Bilateral PAE was performed in 572 (92.6%) patients and unilateral PAE was performed in 46 (7.4%) patients. The cumulative clinical success rates at medium- and long-term follow-up were 81.9% (95% confidence interval [CI], 78.3%–84.9%) and 76.3% (95% CI, 68.6%–82.4%). There was a statistically significant (_P_ < .0001) change from baseline to last observed value in all clinical parameters: International Prostate Symptom Score (IPSS), quality-of-life (QOL), prostate volume, prostate-specific antigen, urinary maximal flow rate, postvoid residual, and International Index of Erectile Function. There were 2 major complications without sequelae. PAE had a positive effect on IPSS, QOL, and all objective outcomes in symptomatic BPH. The medium- (1–3 y) and long-term (> 3–6.5 y) clinical success rates were 81.9% and 76.3%, with no urinary incontinence or sexual dysfunction reported.
Article
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Purpose To assess predictors of outcome after prostate artery embolization (PAE) for benign prostatic hyperplasia with spherical particle polyvinyl alcohol (sPVA) and compare outcomes with the use of nonspherical particle polyvinyl alcohol (nsPVA). Materials and Methods This was a single-center retrospective institutional review board-approved study conducted from 2009 to 2015 in patients undergoing PAE with sPVA (n = 186; mean age ± standard deviation, 65.5 years ± 7.7) and nsPVA (n = 300; mean age, 65.3 years ± 7.6). The two cohorts were compared and analyzed for predictors of outcome with a Cox proportional hazards model and linear regression. Post-PAE prostate ischemia was measured with contrast material-enhanced magnetic resonance (MR) imaging in 23 patients with nsPVA and 25 patients with sPVA. The 24-hour post-PAE prostate-specific antigen (PSA) level was registered in 133 patients with sPVA. Prognostic values of MR imaging and PSA levels 24 hours after PAE were assessed with Cox and random-effects regressions. Results Predictors of clinical failure were older age (age over 65 years, P = .002), unilateral procedure (P = .002), and higher baseline International Prostate Symptom Score (IPSS, P = .033). Adjusted hazard ratio for clinical failure of sPVA was 1.273 (P = .16). Acute urinary retention was a predictor of lower IPSS after PAE (P = .002). The mean proportion of prostate ischemia was 11% with sPVA and 10% with nsPVA (P = .65). Lower IPSS after PAE was associated with a higher proportion of prostate ischemia (P = .009). Patients with a PSA level of at least 75 ng/mL (75 μg/L) 24 hours after PAE had a greater decrease in IPSS (P = .01). Prostate ischemic volume and PSA level 24 hours after PAE were correlated (Pearson r = 0.64, P = .014). Conclusion Clinical outcome was similar after PAE with sPVA and nsPVA. Younger age (up to 65 years), bilateral PAE, lower baseline IPSS, and acute urinary retention were predictors of better clinical outcome. The PSA level 24 hours after PAE correlated with prostate ischemia, and both correlated with clinical outcome. (©) RSNA, 2016.
Article
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Background: The clinical failure after prostatic artery embolization (PAE) with conventional particles was relatively high, in treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). We reported the results of PAE with combined polyvinyl alcohol particles 50 μm and 100 μm in size as a primary treatment in 24 patients with severe LUTS secondary to large BPH. Methods: From July 2012 to June 2014, we performed PAE in 24 patients (65-85 years, mean 74.5 years) with severe LUTS due to large BPH (≥80 cm 3 ) and refractory to medical therapy. Embolization was performed using combination of 50 μm and 100 μm in particles size. Clinical follow-up was performed using the International Prostate Symptom Score (IPSS), quality of life (QoL), peak urinary flow (Q max ), postvoid residual (PVR) volume, the International Index of Erectile Function (IIEF), prostatic specific antigen (PSA), and prostatic volume measured by magnetic resonance imaging at 1, 3, 6, and every 6-month thereafter. Technical success was defined when PAE was completed in at least one pelvic side. Clinical success was defined as the improvement of both symptoms and QoL. A Student's t-test for paired samples was used. Results: PAE was technically successful in 22 patients (92%). Bilateral PAE was performed in 19 (86%) patients and unilateral in 3 (14%) patients. Follow-up data were available for 22 patients observed for mean of 14 months. The clinical improvement at 1, 3, 6, and 12-month was 91%, 91%, 88%, and 83%, respectively. At 6-month follow-up, the mean IPSS, QoL, PVR, and Q max were from 27 to 8 (P = 0.001), from 4.5 to 2.0 (P = 0.002), from 140.0 ml to 55.0 ml (P = 0.002), and from 6.0 ml/s to 13.0 ml/s (P = 0.001), respectively. The mean prostate volume decreased from 110 cm 3 to 67.0 cm 3 (mean reduction of 39.1%; P = 0.001). The PSA and IIEF improvements after PAE did not differ from pre-PAE significantly. No major adverse events were noted. Conclusions: The combination of 50 μm and 100 μm particles for PAE is a safe and effective treatment method for patients with severe LUTS due to large BPH, which further improves the clinical results of PAE.
Article
Introduction The UK Registry of Prostate Artery Embolization (UK-ROPE) was a prospective, multicentre study comparing PAE against surgical therapies for symptomatic benign prostatic hyperplasia (BPH). A wealth of data was collected supplementary to the main study outcomes which provide a snapshot of UK PAE practice. We aimed to interpret these data in the hope of providing insight into factors which affect clinical outcome and radiation dose. Methods 216 patients (mean age 66, mean IPSS 21.3) undergoing PAE at 20 British centres from July 2014 to January 2016 were prospectively followed up to 12 months with retrospective analysis of the data. Technical outcome was evaluated based on procedural and fluoroscopy times, skin dose and dose area product (DAP). Clinical outcome was evaluated through collection of Qmax, IPSS reduction and prostate volume reduction. Multiple analysis of variance (MANOVA) was used to assess the significance of various patients and procedural factors on clinical outcome and patient dose. Results Significant predictors of technical outcome which affected patient skin dose included severity of CTA-detected atheroma (p < 0.001), the practitioner (p < 0.001) and use of protective coil embolization (p = 0.019). Predictors of clinical outcome included initial prostate size (dichotomized into groups > 80 ml and = <80 ml, d = 1, p = 0.0138), embolic agent (spherical particles < 300 nm performed best, p = 0.01) and number of arteries embolized (IPSS reduction of 32.9% in unilateral PAE versus 54.4% for bilateral PAE, p = 0.026). Conclusion We have identified several important factors which are associated with improved clinical outcome and increased patient dose which we hope will facilitate optimal patient selection and encourage improved embolization technique.
Article
Purpose To evaluate the safety and efficacy of prostatic artery embolization (PAE) using the combination of 50-μm and 100-μm polyvinyl alcohol (PVA) particles versus 100-μm PVA particles alone in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH). Materials and Methods Over a 5-year period, 120 patients treated with PAE for lower urinary tract symptoms (LUTS) secondary to BPH were randomized to undergo embolization with 50-μm plus 100-μm PVA particles (group A) or 100-μm PVA particles alone (group B). Mean follow-up time was 34 months (range, 12–57 mo). There were no differences between groups regarding baseline data. Primary outcome measurements included change in International Prostate Symptom Score (IPSS) and incidence of adverse events. Secondary outcome measurements included procedure-associated pain, prostate ischemia measured on magnetic resonance (MR) imaging 1 week after PAE, and changes over time in quality of life (QOL) questionnaire, peak urinary flow rate (Qmax), postvoid residual (PVR) volume, prostate volume (PV), prostate-specific antigen (PSA) level, and International Index of Erectile Function (IIEF) were evaluated. Recurrence of LUTS following PAE was defined as relief of LUTS temporally but increased IPSS ≥ 8 or QOL score ≥ 3 or decrease in Qmax to < 7 mL/s. Results Mean follow-up periods were 35 months ± 22 in group A and 33 months ± 25 in group B (P = .629). No differences between groups regarding procedural details, pain scores, or adverse events were noted (P > .05). At 24 month of follow-up, patients in group A had a greater decrease in mean IPSS (18.7 ± 12.5 vs 14.8 ± 13.5), QOL score (3.7 ± 1.5 vs 2.4 ± 1.8), Qmax (10.5 mL ± 9.5 vs 6.8 mL ± 5.0), PVR (92.0 mL ± 75.0 vs 60.0 mL ± 55.0), and PV (37.0 mL ± 19.5 vs 25.5 mL ± 15.0) compared with patients in group B (P < .05 for all). Mean ratios of prostate ischemic volume at 1 week after PAE were 70% ± 20 in group A and 41% ± 25 in group B (P = .021); mean PSA levels at 24 hour after PAE were 92.5 ng/mL ± 55.0 in group A and 77.5 ng/mL ± 45.0 in group B (P = .031); LUTS recurrence rates were 3.6% in group A and 14.6% in group B (P = .024). The mean IIEF-5 was not significantly different from baseline in either group. Conclusions PAE with 50-μm plus 100-μm PVA particles resulted in greater improvement in clinical and imaging outcomes and no significant differences in adverse events compared with 100-μm PVA particles alone.
Article
PurposeThe purpose of the study was to compare safety and efficacy outcomes following prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with 100–300 versus 300–500 μm tris-acryl gelatin microspheres. Materials and Methods Patients were prospectively treated between August 2011 and June 2013 to receive PAE with 100–300 μm (group A) or 300–500 μm (group B) tris-acryl gelatin microspheres. Patients were followed for a minimum of 12 months and were assessed for changes in International Prostate Symptom Score (IPSS), quality of life (QoL) index, prostate volume determined by magnetic resonance imaging, serum prostate specific antigen (PSA), and maximum urine flow rate (Qmax), as well as any treatment-related adverse events. ResultsFifteen patients were included in each group, and PAE was technically successful in all cases. Both groups experienced significant improvement in mean IPSS, QoL, prostate volume, PSA, and Qmax (p < 0.05 for all). The differences observed between the two groups included a marginally insignificant more adverse events (p = 0.066) and greater mean serum PSA reduction at 3 months of follow-up (p = 0.056) in group A. Conclusions Both 100–300 and 300–500 μm microspheres are safe and effective embolic agents for PAE to treat LUTS-related to BPH. Although functional and imaging outcomes did not differ significantly following use of the two embolic sizes, the greater incidence of adverse events with 100–300 μm microspheres suggests that 300–500 μm embolic materials may be more appropriate.