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296
F. J. Bianco and G. Maiolino
laparoscopic appendectomy [31]. Moreover, the
number of outpatient procedures is estimated to
witness a 15% increase by 2028 [32]. Its widespread popularity is attributed to clinical, economic, and social benets [33, 34]. An example
of an efcient ofce procedure is third molar
extraction surgery, which is performed on over 5
million individuals in the US annually. While this
procedure was commonly done in hospitals in the
past, over 90% of them are currently performed
in ofce settings at 1/3 of the cost of hospitals or
ASCs. This shift was driven by the desire for
faster, safer, and more tolerable recovery, as well
as hard evidence data showing signicant
decreases in general anesthesia-related complications [35].
There is no standard denition of outpatient
surgery. A recent attempt to dene “outpatient
surgery” failed in nding a “universal” denition
[36] because contextual factors associated with
specic procedures are very important and different for any surgery. Moreover, there are many different settings where an outpatient procedure
could be performed: hospital outpatient services/
department, ASC, and medical ofce OfceBased Surgery(OBS).
The advantages of same-day discharge,
including a decreased risk of exposure to hospitalacquired infections, cost savings resulting from
decreased resource utilization, and enhanced
patient satisfaction stemming from the opportunity to recover in familiar surroundings [37], in
the OBS are enhanced: patients don’t experience
the hospital-admission and the relative stress, do
not have to worry about general anesthesia (a frequent issue for many patients), lose fewer working days (with more chance to schedule the date
of surgery) and, usually, they return to normal
activities in less time. Last but not the least, if
procedures performed in ASCs cost an average of
58% less than the same procedure in a hospital
outpatient setting, an ofce-based procedure
could be even more cost-effective [32].
Certainly, regulations and reimbursement vary
for each state within the United States and across
different countries. The analysis of complex regulatory frameworks and reimbursement rules is
outside the scope of this chapter, but it is a funda-
mental step for understanding TT performance in
the ofce setting. Any practitioner is encouraged
to do their due diligence. Nevertheless, for those
aspiring to embark on TT in the ofce setting, it
is essential to strictly adhere to local and/or
national safety and good practice guidelines, constantly develop and review safety protocols and
emergency management, appropriately select
patients, and ensure minimal intraoperative and
postoperative risk during FT or TT for prostate
cancer.
Procedure Selection
In OBS, the local anesthesia protocol is a key
step in ensuring the success of the procedure, as
well as patient satisfaction. Several reviews,
although based on retrospective studies, reported
similar risk proles in the ofce compared to
other practice locations [27]. Focal therapyor TT
is energy-driven, some require specic anesthesia protocols not amenable for safety reasons in
the ofce setting. Others are “optimal” and
proven safe in the ofce setting. In Table26.2, we
summarized the standard energies used in FT or
TT for PCa, their anesthesia requirements, and
their potential performance in the ofce setting.
HIFU requires general or spinal anesthesia
when used for FT for PCa [38]. The treatment is
programmed for a specic area of prostate tissue,
setting a precise focal distance and a series of
elementary lesions produced by ne movements
of the probe, thus generating a treatment area.
Since HIFU uses a remote probe positioned in the
rectum, accurate control of the probe and patient
position during treatment is necessary to avoid
misalignments between the target area and the
area treated. This means that even slight patient
movement would result in misalignment between
the area to be treated and the area treated. This is
mainly because HIFU, unlike other forms of
energy, does not use intraprostatic instruments
but rather a remote probe placed in the rectum.
The perfect immobilization of the patient is
obtained only with general/spinal anesthesia.
Moreover, the dimension of the probe (the tip is
around 3.45 cm) and the further increase in size
26 Oce-Based Outpatient Focal Therapy Under Local Anesthesia
Table 26.2 Ofce-based eligibility based on energy source
Irreversible
High-intensity focal
ultrasound (HIFU) Cryotherapy
Anesthesia General
or
Spinal [38]
OBS Not optimal: main
limitations include
perfect patient
immobilization
during treatment
and the size of the
probe, both
necessitating
general or spinal
anesthesia. Safety
may be
compromised
General [39]
or
Spinal [40]
or
Local ± N2O
inhaled
[41–43]
Optimal: the
local perineal
block
developed by
Bianco [43] ±
N2O has been
conducted in
over 1700
patients
electroporation
(IRE)
General [44] General [45–47] General [48]
Not optimal:
maximal body
relaxation and
complete muscle
paralysis is
required and only
achieved with
general
anesthesia. Safety
may be
compromised
Laser-excited gold
nanoshell-localized
photothermal
ablation and vascular
targeted
photodynamic
(VTP)
Not optimal:
general anesthesia
was necessary for
complete muscle
relaxation as
advised; there are
other logistic
constraints in an
ofce setting
related to intraand postoperative
phototoxicity
(VTP)
297
Focal laser ablation
(FLA)
or
Local ± mild
sedation/N2O
inhaled [49]
Optimal: the
utilization of
MRI-TRUS fusion
FLA guidance
made FLA suitable
for the ofcesetting,
particularly when
conducted
transperineally
due to the water lling of the sheath that surrounds the probe tip would require complete
anesthesia of the rectal ampulla. For these reasons, HIFU is not currently an ideal ofce-based
TT.
Prostate Cryoablation has both FDA clearance
and labeling for the management of clinically
localized prostate cancer. It requires the insertion
of small cryoprobes transperineally into one or
more dened prostatic target(s), so multifocality
can be addressed. The precision, monitoring, and
safety of this procedure are greatly enhanced by
real-time MR/TRUS fusion imaging. It’s amenable to local anesthesia and optimal to be conducted in the ofce setting. Based on our data and
experience with over 1800 patients—since 2013,
targeted Cryotherapy in the ofce setting has
been a priority of our research group. Our ongoing clinical trial, “MRI/Ultrasound FusionGuided Prostate Cryotherapy (FIPC)”
(clinicaltrial.gov, NCT02381990), has started to
deliver real perspective and answers. We propose
that this treatment is less painful than a transperi-
neal biopsy procedure. Such a statement is supported by interim analysis reported during the
last years [41–43, 50–52]. We are now reading
validation reports such as the one by Basourakos
etal. [53], who in 2020 conrmed the possibility
of performing TT using cryotherapy with local
anesthesia and characterizing it as feasible, reproducible, and well-tolerated.
Irreversible electroporation (IRE), delivered
transperineally,usesneedle-like electrode probes
placed inside the prostate, is amenable to realtime image fusion, and our approach shares similar virtues attributed to either Cryoablation or
Fusion Laser Ablation (FLA). However, IRE
requires general anesthesia and full muscle paralysis to avoid contractions caused by the electrical
stimuli elicited by the electrodes [44]. For this
reason, IRE is not currently an ideal ofce-based
TT.
Laser excited Gold nanoshell-localized photothermal ablation [45] and Vascular Targeted
Photodynamic (VTP) [46, 47] as TT for PCa
share many features. One primordial is the need
298
F. J. Bianco and G. Maiolino
for general anesthesia, which is not optimal for
the ofce setting. They both require an initial IV
infusion of nanoparticles and padeliporn,
respectively, that are later activated with a luminescence device in the target area that results in
irreversible damage to the vascular endothelium,
followed rapidly by vessel occlusion due to
thrombosis, ultimately leading to tumor necrosis.
Both procedures use the transperineal route and
are amenable to real-time fusion, which adds precision and safety margins. Complete muscle
relaxation is advised but, above all, there are
many issues to performing VTP in the ofce setting: to avoid phototoxicity, patients must be protected from non-procedural light; postoperatively,
the patient is kept under dimmed light for >6 h
and then discharged after removal of the urinary
catheter, avoiding direct exposure to sunlight for
48 h [54].
We have demonstrated that FLA could be performed in OBS for the treatment of BPH [49].
Regarding prostate cancer treatment, FLA has
primarily developed as an MR-guided in-bore
treatment. Initially, some experiences were conducted transperineally with MRI-TRUS fusion
using the Indigo® Optima diode laser [48], but
most studies have focused on MR-guided in-bore
treatment, both transperineally and transrectally,
using the Visualase diode laser system
(Medtronic, Minneapolis, MN). Although positive experiences have been reported with only
local perineal/periprostatic anesthesia [55] and
the use of MRI-compatible thermosensors (without utilizing MR thermometry for intraprostatic
temperature monitoring) [56], laser procedures
conducted within an MRI tube, referred to as inbore procedures, are frequently burdensome,
costly, time-consuming, and resource- demanding.
Moreover, in-bore procedures are exclusively
conducted by radiologists with specialized training in the eld. In 2017, Natarajan etal. reported
the possibility of performing FLA using magnetic resonance-ultrasound fusion transrectally,
simplifying the procedure (no longer limited to
the MRI suite and radiologist). Natarajan
described all patients received a single intravenous dose of ketorolac (30 mg) and midazolam (4
mg) (minimal sedation) just prior to the proce-
dure and a US-guided periprostatic nerve block
using a 50–50 mixture of bupivacaine and 1%
lidocaine was performed: FLA has become a perfect candidate for ofce-based focal therapy [57].
In 2021, Brisbane etal. titled their work “Focal
Laser Ablation of Prostate Cancer: An Ofce
Procedure” [58], conrming the feasibility and
safety of ofce-based FLA.The introduction of
FLA performed with the Socralite Echolaser X4
system (Elesta, Florence, Italy), conrmed the
feasibilityin an OBS [59]. New systems are currently under investigation to perform FLA, and
all seem feasible in an ofce setting: ProFocal-Rx
(a focal laser ablation system via a transperineal
route and with an MRI/US fusion targeting platform) [60], TRANBERG® Transperineal MR/US
Fusion Laser-Induced Thermal Therapy for Men
With Prostate Cancer (TPF-LITT) (ClinicalTrials.
gov ID NCT05698576); TRANBERG®
Transperineal MicroUltrasound-guided laser
ablation of PCa (ClinicalTrials.gov ID
NCT05826470), Orion System (ClinicalTrials.
gov ID NCT04305925).
Many new energy modalities under investigation seem to embrace an “ultra-MIST concept”
applied to FT for PCa as feasible in an ofcebased setting. One such modality is transperineal
targeted microwave ablation (TMA) performed
with the TATO3 device (Biomedical Srl, Florence,
Italy) guided by 3D ultrasound/MRI fusion imaging, which is currently under investigation. While
the initial pilot studies were conducted under
general or spinal anesthesia, [61–63] the signicant similarities with FLA could potentially
facilitate its transformation into an ofce-based
procedure. Water vapor ablation using the
Vanquish device is currently being evaluated in
the VAPOR 2 trial, assessing the treatment in
patients with intermediate-risk, localized prostate
cancer (NCT05683691).
Fusion Platforms andTypes
ofProstate Image Fusion
The past decade witnessed growing clinical
demand for a more precise diagnosis of prostate
cancer lesions. The response was image registra-
26 Oce-Based Outpatient Focal Therapy Under Local Anesthesia
299
tion devices and techniques that allow multimodal image fusion data for the accurate targeting
of prostate lesions. Most of these molded to the
transrectal approach focused on biopsy procedures aiming to better characterize prostate cancer lesions and dene better surveillance
protocols. However, it is important to highlight a
critical fact related to procedures where transrectal ultrasound (TRUS) guidance is used: substantial gland deformation can occur due to TRUS
probe pressure. To overcome such challenges,
medical device fusion companies have focused
on the registration or co-registration process
between MRI and TRUS-obtained images [64].
There are three types of fusion strategies: deformable, elastic, and rigid. Table 26.1 provides a
thorough comparison of available fusion devices
that exist in the market today.
Intelligent Deformable Registration
andElastic Registration versus Rigid
Registration
A comprehensive discussion on the virtues of
each medical fusion device escapes the scope of
this chapter. However, we would like to provide a
brief discussion on what image fusion is and why
it is critical for the targeted management of prostate cancer lesions.
As covered, image fusion is the blend of two
imaging sources with precision intent. In theory,
when performed automatically by a computer
algorithm, nonrigid (Intelligent Deformable
Registration and Elastic Registration) image
fusion leads to more accurate alignment of MRI
and TRUS images since it can account for softtissue organ motion and deformation due to the
insertion of a TRUS probe into the rectum, which
exerts forces onto the prostate via the rectal wall.
Due to the varying degrees of prostate deformation among patients— inuenced by prostate
size, mechanical tissue properties, and procedural protocols (such as TRUS probe and sheath
orientation and diameter)—the quality of MRI/
TRUS images uctuates. Manual interaction is
necessary to delineate the prostate boundary on
both the MRI and TRUS images [65]. This step
introduces operator variability but remains preferable over nonrigid fusion-image overlapping,
which often fails to achieve accurate image alignment in practice. Investigators at the University
College of London demonstrated an improvement in the estimated registration accuracy in
approximately 50% of transperineal biopsy cases
[66]. Yet the differences were not statistically signicant. The lack of improvement in other cases
may be due to differences in the geometry of the
segmented prostate from MRI scans compared
with its appearance on TRUS images or an inadequate number or distribution of boundary points
identied on the TRUS images (for example, due
to poor TRUS image quality) to correctly deform
the MRI-derived model to t the TRUS image.
Moreover, other sources of needle targeting error,
such as organ motion, needle bending, and MRI
lesion localization error, are signicant in clinical
practice and are each on the order of 1–5 mm.
Therefore, in practice, the MRI-TRUS registration accuracy, which is typically on the order of
2–4 mm, is unlikely to be the dominant factor
affecting overall biopsy targeting accuracy and,
in turn, the detection rate for clinically signicant
prostate cancer. Importantly, for prostate biopsy,
there is no difference in terms of patient safety
when comparing rigid, elastic, or intelligent
deformable methods of operation for each device
in which an MRI-derived target region is displayed superimposed on the real-time TRUS
image [64–66]. The fundamental differences
come when a transrectal procedure is compared
to the transperineal approach.
We discourage a transrectal route for ofcebased procedures, either biopsy or treatment. A
transperineal route is imperative for MR/TRUS
Fusion treatments, as considered in this chapter.
When considering transperineal PCa lesion ablation, two major issues come to mind: (1) the ability of a statistical shape/motion model trained
using nite element simulations to predict and
compensate for this source of motion, and (2)
real-time fusion monitoring. The risks from
energy sources applied transperineally are signicantly greater than a biopsy procedure.
Therefore, fusion devices must ensure patient
safety and impeccable precision. We have found
300
F. J. Bianco and G. Maiolino
that registration using a statistical motion model
outperformed both elastic deformation methods
and rigid image overlapping in terms of accuracy
and robustness. Furthermore, deformable fusion
required substantially fewer surface points to
achieve a successful registration with a margin
oferror (based on anatomical landmarks) under
2mm.
Patients’ Selection
The ideal patient with prostate cancer who is a
candidate for FT has been extensively described
in previous chapters. As for What’s the ideal
patient candidate for treatment in an ofce setting? Essentially, the same patient candidate for
an ofce-based prostate biopsy. The main
requirement is patience, willingness, and ability
to collaborate. There are no criteria well-dened
to accept or refuse a patient for an ofce procedure, for example, age or specic general comorbidities such as diabetes, HTN, or heart disease.
However, we would caution patients who are
wheelchair-bound or harbor severe neurological
conditions. As a rule, determining suitability for
outpatient/ofce procedure surgery involves a
dynamic process inuenced by various factors,
including the nature of the surgical procedure,
ambulatory setting, patient comorbidities, patient
attitude, and the anesthetic approach, as well as
social factors like the availability of a caregiver to
assist the patient at home [67].
The surgeon plays a central part in the proper
selection of patients t for OBS.We do not perform a pre-procedural anesthesiologic evaluation
or medical clearance before ofce-based procedure TT.
Anesthesia
In OBS, the anesthesia protocol is a fundamental
step in ensuring the success of the procedure and
patient satisfaction. Several reviews, albeit based
on retrospective studies, reported similar risk
proles in the ofce compared to other practice
locations [27]. The ideal anesthesia for OBS is a
nonsedative procedure using pure local anesthesia. However, we have found the dissociating
agent nitrous oxide “N2O” to be very helpful in
most patients. Some providers may choose mild
general conscious sedation safely administered to
be of aid.
The use of oral mild sedation does not deny an
ofce-based procedure (for example, some studies offer and recommend Diazepam 10 mg PO
within 60 min prior to the procedure [58]).
However, the setting must have protocols in place
shall a longer convalescence be required. A recent
review evaluating the dissociating agent nitrous
oxide noted that it was underutilized in ambulatory urology. Research has indicated notable
enhancements in periprocedural pain and anxiety
compared to alternative (or no) analgesic methods. Adverse effects were uncommon and temporary. Increased adoption of N2O could lead to
cost reductions and improved patient tolerance
during outpatient procedures [68]. Because of
their sedative properties, opioids and benzodiazepines pose risks of side effects and necessitate
that patients have someone to accompany them
as they are unt to drive following the procedure.
Furthermore, even brief exposure to opioids and
other substances with potential for abuse exposes
patients to long-term risks. N2O is preferred due
to its extensively documented safety record, with
minimal risk of serious adverse effects, controlled and limited usage, and rapid elimination
from the body through exhalation [69]. A nonsedative procedure carries an expeditious recovery. For these reasons, we recommend and prefer
to use nitrous oxide (N2O) as an optional strategy
for infrequent patients who do not tolerate the
procedure with only local anesthesia.
Our OBS local anesthesia protocol has been
fully described by Bianco and is publicly available [43]. Briey, the perineum is rst inltrated
supercially with a 50/50 mixture of lidocaine
and bupivacaine, 10 cc of lidocaine starting from
each side: 10 and 2 on the clock from the anal
verge towards the raphe in a radial manner.
Subsequently, a transrectal ultrasound probe,
secured to a digital stepper, is advanced, and a
5 mm grid is attached and pressed against the
skin. A deep periprostatic block with 5–10 cc of
26 Oce-Based Outpatient Focal Therapy Under Local Anesthesia
301
lidocaine 1% or diluted 2% lidocaine is applied
under ultrasound or fusion system vision in sagittal view on each neurovascular bundle [49].
Perioperative Protocols
The ERAS protocol born for inpatient surgeries
is also described for outpatient patients.
According to Cukierman etal., the fundamentals
for ambulatory surgery are built upon ve key
pillars, which encompass preoperative patient
counseling, education, and optimization; employment of multimodal analgesia; implementation of
prophylaxis against infection; venous thromboembolism; and if applicable, nausea and vomiting. Finally, encouragement of early mobility is
critical [70].
Ofce-based FT or TT fullls ERAS criteria
and its cornerstones to guarantee a successful
procedure:
• Preoperative patient counseling, education,
and optimization: one of the most crucial ele-
ments is preoperative counseling, which is
aimed at reducing anxiety, setting realistic
surgical expectations, and optimizing the pre-
existing conditions of patients. A study involv-
ing 104 patients undergoing ambulatory
procedures demonstrated that preoperative
counseling effectively reduced anxiety levels
and enhanced patient satisfaction [71]. In our
experience, this is also valid for ofce-based
procedures.
• Employment of multimodal opioid-sparing
analgesia: use of preemptive analgesia is con-
troversial in the literature [72]. However, we
nd preemptive analgesia, as routinely done
for intra-abdominal procedures, to be effective
in the management of postoperative pain, and
this starts in the preoperative holding area.
Past experimental ndings have shown that
there is a component of central nervous sys-
tem involvement in heightened pain sensitiv-
ity following injury, and administering
preemptive analgesia before the actual injury
might potentially reduce this phenomenon of
pain sensitization; the aim of preemptive anal-
gesia is to desensitize pain receptors across
both the central (acetaminophen, gabapentin/
pregabalin) and peripheral nervous systems
(NSAID as Ibuprofen or Ketorolac, COX-2
inhibitors as meloxicam). Acetaminophen
1000mg PO and Ketorolac 30mg IM 60min
prior to FT procedures in an ofce-based setting have been suggested, yet it is quite an
expensive approach [58]. We usually use
Celecoxib 200mg.
• Antibiotic prophylaxis: clinically signicant
surgical site infections account for 3.09% per
1000 procedures at 14 days and 4.8 per 1000
procedures at 30 days. They are low relative to
all causes of postsurgical visits in outpatient
surgeries, but considering the number of outpatient surgeries, they could constitute a signicant number when considered collectively
[73]. Although it is possible that an IV preoperative antibiotic prophylaxis is considered
less invasive and more suitable for an ofce
procedure, a preoperative prophylaxis is performed intramuscularly or orally. In our daily
practice for MR Fusion Cryoablation or Laser
ablation, we administer a 250mg Ceftriaxone
IM (a broad-spectrum third-generation cephalosporin antibiotic with mean peak times
ranging from 1 to 2) and prescribe either a
daily quinolone or sulfa antibiotics during the
initial seven postoperative days. However,
when choosing the antibiotic, it is necessary to
evaluate the specic procedure and the local
resistance rates of common bacteria involved
in postoperative infections (for example,
UCLA protocol for FLA procedures uses 1 g
of Ertapenem administered intramuscularly
60 min prior to the procedure [58]) and the
patients’ allergies (for patients allergic to
beta-lactams we usually use a single intramuscular injection of 5–8 mg/kg Gentamicin).
• Rectal preparation: The patient prepares with
eet enemas the morning of the procedure.
This is fundamental for proper visualization
of ultrasound images, as well as reducing
infectious complications.
In Table26.3, we provide a synopsis of proto-
cols reported in the literature.
302
F. J. Bianco and G. Maiolino
Yes
Oral
acetaminophen and
celecoxib for 5
days
Oral TMP/SMX or
a quinolone until
the catheter is
O)
2
Nitrous oxide (N
or the short acting
opioid
antagonist—
subfentanil
Skin: 10 cc
intracutaneous perineal
50/50 lidocaine 1% +
bupivacaine
NVB/Periprostatic:
10–15 cc of lidocaine
1%
No
removed
antibiotic
Oral nonnarcotic
analgesics
Midazolam (4 mg) Oral quinolone
Intracutaneous perineal
lidocaine + prostatic
nerve block using a
50-50 mixture of
bupivacaine and 1%
lidocaine
volume tumor
NR Not in low
Short-acting oral
benzodiazepine
tissue, and periprostatic
nerves were blocked
NR NR
Diazepam 10mg PO,
60 minutes prior to
with 20 mL of 1%
lidocaine
10-20 mL of lidocaine/
marcaine at the junction
developed
urinary retention
NR Only if patients
the procedure
(optionally but
recommended)
optional conscious
sedation
of the prostate and
seminal vesicles
lidocaine 2%, 8 ml, and
a periprostatic block
(indwelling
catheter for 1
week)
with lidocaine 2%, up
to 15ml
Optional:
15mg IV
– Celecoxib
200mg PO on
arrival to ofce
– Ketorolac
Antibiotic prophylaxis Preempty analgesia Local Anesthesia ± Other anesthesia Postoperative Urinary catheter
250mg ceftriaxone
IM or 80mg
gentamicin
Cryotherapy/
FLA
Bianco etal.
Table 26.3 Perioperative protocols in focal therapy performed (or potentially being performed) in ofce settings reported in the literature
[51]
Single intravenous
dose of ketorolac
(30 mg)
Oral quinolone and an
injection of
ceftriaxone or
ertapenem
FLA with
adapted
visualase diode
laser
Natarajan
etal. [57]
NR Skin, subcutaneous
Cryotherapy Oral antibiotic
Basourakos
1000mg PO,
(uroquinolone or
trimethoprim/
sulfamethoxazole)
1 g Ertapenem IM Acetaminophen
FLA with
adapted
etal. [53]
Brisbane,
etal. 2021
Ketorolac 30mg
IM
NR Perineal skin with
Single oral dose of
ciprooxacin 500mg
visualase diode
laser
FLA with
Socralite
[58]
van Riel
etal. 2022
1 h before
[59]
26 Oce-Based Outpatient Focal Therapy Under Local Anesthesia
303
Procedure
A full video description of how we conduct
Ofce MR Fusion Cryoablation has been published [74]. The pillars for TT are as follows:
1. If possible, it would be advisable to make
some logistical preparations before the
patient arrives at the clinic. This includes
pre-uploading the treatment plan onto the
fusion platform, which should be based on
the MRI and biopsy results. The plan should
clearly identify the targeted treatment area
and provide coordinates and locations for the
energy probes to cover it. The surgeon must
review and revise the plan as necessary.
Figures26.2 and 26.3 serve as examples of
TT plans for Cryoablation and FLA.
2. Upon arrival at the ofce, the patient is taken
into a room where he is consented, preempty
pain medications are given, and antibiotics
are administered. No IV is needed.
3. The patient is brought into the procedure
room, where he is comfortably settled. Then,
he is offered supplemental inhalation of
nitrous oxide or sublingual subfentanil based
on his eligibility.
4. The patient is placed in the lithotomy position, and the perineum is cleaned and then
draped.
5. A shallow “skin” block is administered.
6. A Foley catheter is inserted, xed to the leg,
and attached to a bag.
7. The ultrasound probe is inserted into the rectum and attached to a digital stepper device.
8. A grid is attached to the stepper apparatus,
and the ultrasound image is adjusted to calibrate with the fusion instrument.
9. A deep block is applied.
10. The prostate gland is examined with an ultrasound probe.
11. Co-registration is produced on the fusion
device.
12. The MRI of the prostate, outlining treatment
areas and probe targets, is fused to the ultrasound image in real-time mode.
13. The surgeon proceeds to manipulate the
probes, including thermocouples, as
necessary.
14. In case of its applicability, a urethral warmer
is inserted.
15. In real-time mode, fusion energy is administered to the treatment area.
16. The surgeon carefully monitors the treatment
to ensure that it is properly tolerated, delivered safely, and applied accurately to the
intended location.
17. All the equipment are carefully removed
after the procedure is complete, and the
patient is repositioned to a supine position,
then helped to sit up.
Fig. 26.3 1816 patients received MR fusion TT, either with laser or cryoablation. On the right side, the gure shows
the incremental growth of MR fusion cryoablation year by year
304
F. J. Bianco and G. Maiolino
18. Once the patient assures the physician and
the staff regarding their comfort, safety, and
well-being, they are transported to the recovery room.
19.
Postoperative Period
Following the procedure, the patient will be
transferred to the recovery facility, where a companion or family member may be present. The
patient will be under close monitoring until he
feels that he can leave. To ensure the patient’s
safety, a series of vital signs will be monitored
regularly. In addition, the patient will be given
instructions on how to use a foley bag, and a plug
that can be used during the daytime will be provided. Moreover, the patient will be informed
about where to go or whom to contact in case of
any issues. Lastly, the patient and their companion or family member will be advised on the
medication instructions. We make it a routine to
call the patients the following day to ensure that
they are doing well and to answer any questions
that they may have. Patients will return to the
ofce between 5–7 days later to have his catheter
removed, and a physical exam of the scrotum and
perineum is conducted as well.
Outcomes
Procedure Feasibility
As referred before, in 2013, we began to conduct
a systematic prospective registration trial known
as "MRI/Ultrasound Fusion-Guided Prostate
Cryotherapy (FIPC)" to understand the impact of
this treatment modality on the natural progression of treated prostate cancer. The Human
Investigations Committee of the Urological
Research Network in Miami, FL, approved this
protocol, which was subsequently registered as
NCT02381990 on clinicaltrial.gov and is available to the public. Additionally, between 2022
and 2023, we registered a couple of clinical trials
for the use of FLA for TT in an ofce setting. The
respective identiers are NCT05241236 and
NCT05698576 on clinicaltrials.gov. Figure26.3
shows the number of patients treated via various
energy sources in an ofce setting under local
anesthesia between 2013 and 2023. Data were
collected prospectively from multiple sites
throughout the United States, Europe, and South
America, and no procedures have been terminated thus far, as shown in Fig.26.4. While most
procedures involved MR Fusion TT ablations,
other types of cryoablations (such as hemiablations, whole gland cryoablation, and multiple
targeted salvage procedures) were conducted and
well-tolerated by the patients. In Fig. 26.5, we
present the distribution of patients based on the
MRI PIRADS and their Gleason grade groups.
Notably, 95% of patients had a visible tumor,
which was subsequently treated. A little over
25% of patients were diagnosed with PIRADS 5
lesions. The distribution of Gleason grade groups
is presented here, with a striking similarity to
those randomized in the PIVOT trial. Over 25%
of the patients had high-grade tumors with
Gleason group 3 (4+3) or worse (Fig.26.6).
Adverse Events
Over the years, we have established a rigorous
follow-up, particularly during the initial postprocedure period. Our follow-up process commences with a phone call on the following day,
followed by the removal of the Foley catheter,
which usually happens between 4 and 7 days
after the procedure. Additionally, we make a
reassurance call at 30 days post-ablation. To
monitor any adverse event, we use the ClavienDindo AEs scale [75]. Based on Fig.26.7, the
AEs were predominantly limited to ClavienDindo Grade 1, and the occurrence is quite similar regardless of the energy type used, either Heat
(Laser) or Cold (Cryoablation).
During the MR Fusion TT procedure using
FLA, 11 patients experienced Adverse Events
26 Oce-Based Outpatient Focal Therapy Under Local Anesthesia
Fig. 26.4 Shows that
95% of the 1702 patients
treated using
cryoablation as energy
in the ofce setting used
cryoablation as their
initial management
approach. Of these 1609
patients, 85% received
MR fusion TT according
to our denition
305
Fig. 26.5 Distribution of MR fusion TT cryoablation patients according to the MRI PIRADS (left) and Gleason grade
groups (right)
(AE). Among these patients, eight had urinary
retention that lasted for two to four weeks postprocedure. In most cases, the issue was resolved
on its own, but one patient required a TURP procedure 35 days after their FLA.Similarly, during
the MR Fusion TT using cryoablation, urinary
retention was the most reported AE among the 63
patients. Out of these, 14 patients required a
TURP, which was only 1% of the complete cohort
for MRI Fusion TT Cryoablation (Fig. 26.8).
Eleven patients were identied with culturepositive urinary infections, out of which three
patients developed bacteremia (sepsis); all three
were successfully treated and discharged.
Prostatitis, epididymitis, and orchitis represented
the second most common group of AEs, which
comprised 20% of all the AE cases found in 1.6%
of the total cohort. The distribution of AEs by
Clavien-Dindo grades is shown in Fig. 26.9,
where 68% of all AEs were Grade 1. Finally,
Fig. 26.10 illustrates the outcome of all AEs,
where it can be noted that 75% of all and 6% of
the cohort were managed in the ofce without
requiring hospital evaluation.