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Chapter 21
Chapter 21 The Artificial Bowel Sphincter in the Treatment
The Artificial Bowel Sphincter
in the Treatment
of Severe Fecal Incontinence in Adults
Guillaume Meurette, Paul-Antoine Lehur
297
21
Contents
21.1 Background 298
21.2 Description of the Acticon ABS Artificial Bowel Sphincter 298
21.3 Functioning of the Acticon ABS Artificial Bowel Sphincter 300
21.4 Implantation Technique – Perioperative Care . . . . . . . 300
21.5 Recommendations for Follow-up of Patients with Implants 302
21.6 Recently Published Results . . . . . . . . . . . . . . . . . . 304
21.6.1 Recently Published Results with the Acticon ABS
and Personal Series . . . . . . . . . . . . . . . . . . . . . . 305
21.6.2 Acticon ABS Reimplantation after Failure . . . . . . . . . 306
21.6.3 New Indications for Acticon ABS . . . . . . . . . . . . . . 307
21.7 Indications and Contraindications . . . . . . . . . . . . . 307
21.8 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . 308
References . . . . . . . . . . . . . . . . . . . . . . . . . . . 308
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Guillaume Meurette,Paul-Antoine Lehur
Fecal incontinence is a severe disability that deeply affects the quality of life of the afflicted patients. In the event of ineffective medical treatment and the inability or failure of conventional surgery,the only choice for these patients until recently was to accept their condition or opt for end-colostomy. However, technological progress has
opened up the prospect of effective therapy for severe fecal incontinence, both in
terms of performance and long-term reliability. Replacement of the sphincter function by an artificial bowel sphincter is one of the options presently available that has
shown promising results.
This study aims to provide an overview on the management of fecal incontinence
by the means of an artificial sphincter, describing the device and its functioning, the
present state of art of the implantation technique and recommendations to follow-up
of patients with implants, the most recently published results,and the present indications and contraindications of this treatment.
21.1 Background
Various passive prosthetic methods of anal encirclement have been proposed for the
treatment of fecal incontinence since the initial description of Thiersch’s wire more
than a century ago. The impossibility of achieving an anal opening led to abandoning
these methods, which in any event never gave good results. However,these techniques
provided the rationale for prosthetic treatment of fecal incontinence, which only
proved successful once a mechanism was added to allow anal opening. In the 1970s,
urologists developed different models of sphincter devices positioned around the urethra or the bladder neck, which were pressurized and could be opened by a control
pump.In 1987, the first use of a urinary artificial sphincter (AMS 800, AUS) in the perianal position was reported from Copenhagen,Denmark (Christiansen and Lorentzen
1987). French experience with anal devices began in 1990 in our center, thanks to the
know-how acquired by Prof.J.M. Buzelin,a urologist who had been using the AUS for
urinary incontinence since 1985. Our first results with this device were published in
1996 (Lehur et al.1996).
The development of a device specifically adapted to anal application, the Acticon
ABS (artificial bowel sphincter, American Medical Systems, Minneapolis, MN, USA),
was the next important step.The first implantation of this new device was performed
in Nantes, France, in May 1996. Since this time, experience has been acquired in numerous expert centers worldwide. In the US, FDA approval for the use of the device
was obtained in 1999 after completion of a multicenter trial (Wong et al. 2002).
At the same time,Scottish surgeons developed a sphincter device similar in its pressurization concept but of different design, being semicircular and providing an anorectal angulation to restore sphincteric mechanism (Hajivassiliou et al. 1997).
21.2 Description of the Acticon ABS Artificial Bowel Sphincter
The Acticon ABS artificial bowel sphincter is a totally implantable device made of solid silicone rubber. It comprises three parts: a perianal occlusive cuff, a control pump
with a septum, and a pressure-regulating balloon (Fig. 21.1). These three components
are linked together by subcutaneous kink-resistant tubing.
The occlusive cuff is implanted in the upper part of the anal canal. The closing
system incorporated into the cuff uses the initial part of the tubing. The cuff comes in
Chapter 21 The Artificial Bowel Sphincter in the Treatment
Fig. 21.1.
Overall view of the Acticon ABS artificial
bowel sphincter used in the treatment of
severe fecal incontinence
299
different models with respect to length (8–14 cm) and height (two sizes: 2.0 and
2.9 cm) (Table 21.1). The choice of the cuff, an important intraoperative consideration,
is determined by measurements made during the implantation procedure.
The pressure-regulating balloon,which is implanted in a pocket created in the subperitoneal space, controls the level of pressure applied on the anal canal by cuff closure. Available pressures range from 80 to 120 cm H
O, with 10-cm steps (Table 21.1).
2
Thus,the occlusive effect of the cuff depends on its size (length and height), which determines whether it fits more or less tightly around the anal canal, and the pressure
level chosen for the balloon.
The control pump is implanted in subcutaneous tissues of the scrotum in men and
of the labia majora in women. The hard upper part of the pump contains a resistance
regulating the rate of fluid circulation throughout the system and a deactivation button allowing fluid cycling to be stopped by external action. The soft lower part of the
Table 21.1. Comparison of urinary (AUS) and anal (Acticon ABS) artificial sphincters
Components and Function AUS Acticon ABS
Cuff height (cm) 2.0 2.0, 2.9
Cuff length (cm) 3–11 9–14
Balloon volume (cc) 20 40
Pressure generated by the balloon (cm water) 40–90 80–120
Septum on the control pump No Yes
Reocclusion time lapse (min) 3–4 5–8
Note the changes made in the device to adapt it to restoring anorectal function.
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Guillaume Meurette,Paul-Antoine Lehur
pump is squeezed repeatedly to transfer fluid within the device.A septum placed at the
bottom of this soft part is intended for postoperative use in case a small amount of
liquid needs to be injected or withdrawn. The principle of this septum is similar to that
of an implantable Porta-Cath.
21.3 Functioning of the Acticon ABS Artificial Bowel Sphincter
The function of the Acticon ABS is semi-automatic (Fig. 21.2):
쐽 The cuff ensures anal closure automatically and continuously at low pres-
sures close to physiological values (resting anal pressures).The regulating
balloon transmits pressure to the occlusive cuff through the tubing,and the
pressure is applied uniformly and nearly circularly to the upper part of the
anal canal, restoring a barrier isolating the rectum from the external environment.
쐽 Defecation is initiated by the patient. Anal opening is achieved by transferring
the pressurized fluid from the cuff toward the balloon by means of the control
pump.The fluid is transferred by 5–15 squeezes on the pump,each evacuating
around 0.5 cc from the cuff,thereby lowering anal pressure and opening the
anal canal to expel feces. Suitable compliance allows the volume of the pressure-regulating balloon to increase transiently to receive the several cubic centimeters of fluid contained in the cuff.
쐽 Anal closure occurs again automatically in 5–8 min by passive fluid transfer and
a progressive return to base pressure in the cuff.The balloon recovers its initial
volume during this period,thereby restoring equal pressure throughout the
system.
The system can be deactivated temporarily to allow the cuff to be empty and the anal
canal continuously open. This arrangement can be used during the postoperative period to avoid manipulation of the cuff and pump during the healing period. Two
months of deactivation are desirable after implantation to ensure good integration of
the device. The system can then be activated simply by squeezing the pump firmly, a
procedure not requiring anesthesia that can be performed during a visit. Deactivation
of the cuff in open position is also necessary for transanal endoscopic procedures in
order to avoid any erosion or damage to the cuff during the passage of the endoscope.
Deactivation is a recent feature, and its absence in earlier models was responsible for
some initial failures.
21.4 Implantation Technique – Perioperative Care
Preoperative care includes careful cutaneous and bowel preparation over a 48-h period. Two douches of the operative field are performed daily with an iodinated solution,
and complete colonic preparation is done,including X-prep and enemas until fluid becomes clear. Colostomy is not essential if correct bowel preparation can be obtained,
except in the case of diarrheic patients who may contaminate the perineal wound by
too rapid a resumption of bowel movements. This position has now been adopted by
the vast majority of the teams implanting Acticon ABS. Antibiotic prophylaxis based
Chapter 21 The Artificial Bowel Sphincter in the Treatment
301
Fig. 21.2a–c. Functioning of the Acticon ABS artificial bowel sphincter. aAnal occlusion.Pressure
is equilibrated throughout the system, ensuring pressurization of the cuff and thus automatic
closure of the anal canal at a predetermined pressure level approximately equal to that of the
pressure-regulating balloon selected for implantation.b Anal opening,which is controlled by the
patient, allows regulated rectal evacuation.The pressure equilibrium in the system is interrupted by the active transfer (manipulation of the control pump) of the fluid from the cuff to the
pressure-regulating balloon. c Progressive anal closure (arrows indicate the direction of fluid
transfers within the system after defecation). Automatic return of the fluid (in approximately
7 min) gradually restores cuff inflation and anal closure pressure
on a third-generation cephalosporin and an aminoglycoside is administered in a single dose at the induction of anesthesia.
The operative position of the patient should allow a combined perineal and abdominal approach. The legs should be spread and half-flexed, allowing access to the anus,
the scrotum or the vulva,and the subumbilical abdominal level. The first phase of the
operation involves the placement of the perianal occlusive cuff. A single preanal incision can be used, allowing rectovaginal or rectourethral separation (5–6 cm high),
from which a perianal tunnel can be created around the anal canal by blunt finger dissection. Alternatively, the incision can be made laterally on both sides of the anus, following the example of graciloplasty.A transvaginal approach has also been proposed
recently. The length of the occlusive cuff is then determined using a specially designed
21
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Guillaume Meurette,Paul-Antoine Lehur
sizer.The cuff should not narrow the anal canal, which would hinder defecation.Rectal examination is the best means of determining the caliber obtained. In the event of
accidental perforation of the vagina or the rectum at this point in the dissection, implantation of the artificial sphincter should be deferred or possibly abandoned.
Once the perianal tunnel has been made, the preparation of the Acticon ABSdevice
can begin on a sterile table intended for this purpose. Tissues, blood, and any potentially aggressive surgical material are excluded from this area in order to avoid possible alteration of the device.All three components of the system are carefully bled of
any air bubbles,which might prevent the cycling of the pressurization fluid.This rather delicate preparation should be entrusted to a nurse trained in the technique. The
pressurization fluid is an isotonic solution, since the walls of the artificial sphincter are
semipermeable membranes, and radiopaque to allow postoperative control of fluid
movements in the system. It is prepared extemporaneously and composed of Telebrix
12 Sodium (53%) and sterile water (47%) in our practice. Other possible solutions are
described by American Medical Systems.
The perianal cuff is the first component put in place. Tubing from the cuff is then
tunneled subcutaneously to the abdominal incision with a special atraumatic long
needle. The rectus abdominis is split to provide access to the subperitoneal space lateral to the bladder.A pocket is created in this space to lodge the pressure-regulating
balloon. The cuff is first pressurized with a 55-cc filled balloon connected directly to
the cuff. The amount of fluid kept in the cuff after pressurization is carefully measured
when emptying the balloon. It is usually between 4 and 8 cc. The balloon is then implanted empty and then filled in its lodge with 40 cc of fluid, a volume at which the
pressure delivered to the cuff corresponds to values determined by the manufacturer
(usually between 80 and 100 cm of water). The aponeurosis is carefully closed at this
step. The control pump is then positioned. As this is the only component that the patient will feel and manipulate, it needs to be perfectly accessible.The occlusive cuff and
the pressure-regulating balloon are connected to the pump. The kink-resistant tubes
are identified by a color code (black from the balloon and clear from the cuff). Connections are done with special Quick-connectors,preventing any air bubbles from entering the system.After assessing that cycling is correct, the incisions are closed without drainage. The device is deactivated at the end of the procedure by pressing firmly
on the deactivation button. In our experience, the entire procedure lasts around
90–120 min.
Immediately after the operation, a fluid diet only is allowed for 3 days to avoid too
early a resumption of bowel movements. The anal wound is cleaned regularly. The
mean length of hospital stay is 7–10 days if there are no complications. The patient is
discharged once defecation has become normal and the incisions are healed.The patient is readmitted 8 weeks later for 1 day during which the artificial sphincter is activated.A firm pressure on the control pump unblocks the deactivation button, allowing
the filling of the cuff, which can then play its occlusive role. The patient is given the
necessary instructions for opening the sphincter,allowing regular defecation, possibly
initiated with small enemas in case of difficulty.
21.5 Recommendations for Follow-up of Patients with Implants
Is it necessary to follow-up patients who have received implants? This is a debatable
point since the device is easy to operate and its use rapidly becomes natural for the patient. The patient could be instructed to return in the event of recurrence of inconti-
Chapter 21 The Artificial Bowel Sphincter in the Treatment
nence, which would be a good arrangement for persons living far from the implantation center. However, we require regular follow-up for our patients, not only for research purposes but also to check on the proper use of the device, its efficacy in restoring satisfactory anorectal function and the possible occurrence of complications.Postoperative evaluation is based on simple annual examinations (clinical, plain X-rays
and anorectal manometry).
Clinical evaluation relative to fecal continence and rectal evacuation is performed
best by questionnaires. The efficacy of the device in restoring satisfactory quality of
life can also be assessed by specific questionnaires. Such evaluations currently in
progress appear to justify the financial investment involved in the use of artificial
sphincters (Lehur et al.2002). The clinical examination checks the proper positioning
of the control pump and its accessibility, the efficacy of anal closure (by rectal exam,
care being taken not to damage the device), and the quality of anal opening after manipulation of the pump by the patient.The local tolerance of the artificial sphincter is
also checked. It is important during the first postoperative months to detect any migration of the cuff. If it is too close to the anal margin,there is risk of skin damage and
erosion, leading to contamination of the material and explantation. If detected early
enough, this complication can be corrected by reoperation and repositioning of the
cuff higher in the pelvic floor. This can be achieved by redoing the perineal incision
and simply unbuttoning the deactivated cuff.
Pressurization of the Acticon ABS with a radiopaque fluid allows very simple radiological monitoring. In the immediate postoperative period, deactivation of the device
can be easily checked by plain X-rays focused on the pelvis. During activation,a series
of X-rays can be used to analyze fluid transfers through the device and thus visualize
the sphincter function obtained (Fig. 21.3).These images can also be used for reference
purposes in the event of subsequent dysfunction of the device. Endoanal ultrasonography can also be performed during the monitoring procedure. This examination,
though not carried out routinely, is considered to be a valid means of assessing the
thickness of the tissues encircled by the cuff and detecting any possible atrophy, which
would be suggestive of ulceration of the device in the anal canal.
Anal manometry, an important aspect of postimplantation monitoring, precisely
and objectively estimates the efficiency of the sphincter(Savoye et al. 2000). We con-
303
Fig. 21.3.
X-rays of an Acticon ABS
artificial bowel sphincter
implanted for postoperative fecal incontinence.
Filled occlusive cuff with a
closed anal canal
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Guillaume Meurette,Paul-Antoine Lehur
Fig. 21.4. Anal manometry: normal function of an Acticon ABS artificial bowel sphincter Measurements performed during the examination: (1) resting anal pressure with the cuff closed (pressurized), (2) resting anal pressure with the cuff open (empty), (3) time of anal closure
sider that it is important to determine three manometric parameters systematically
(Fig. 21.4):
쐽 Basal pressure with the sphincter closed indicates the capacity of the device
to create a high-pressure zone in the anal canal. A significant increase as
compared to preoperative values contributes to restoring fecal continence.
쐽 Basal pressure with the sphincter opened by the patient represents residual
anal pressure.When low,it is indicative of a wide anal opening and easy defecation, whereas a high residual pressure could account for postoperative
dyschezia.
쐽 The time required for the sphincter to close again after being opened is also
indicative of the quality of rectal evacuation. A sufficient period is needed to
obtain complete emptying. Some patients experience a rapid closure quicker
than that specified for the Acticon ABS (approximately 7 min normally), which
may be also responsible for dyschezia.
Anal manometry can be also used to check whether the patient is manipulating the device correctly.The quality of the pumping, which needs to be slow to be efficient,and
of the resulting anal opening can be evaluated on a screen image for the benefit of the
patient, as during biofeedback sessions.
21.6 Recently Published Results
The initial results obtained with the urinary type device have been previously reported and discussed. In this review,we have concentrated on the most recent and significant published data. Several centers in Europe, the United States and Australia have
adopted the Acticon ABS to treat severe fecal incontinence not amenable to local repair. Reports with larger numbers of cases and longer follow-up have recently appeared, providing a better assessment of this innovative technique and its present
place in the treatment strategy of incontinent patients.
Chapter 21 The Artificial Bowel Sphincter in the Treatment
21.6.1 Recently Published Results with the Acticon ABS
and Personal Series
We have analyzed the most recently published experiences with the Acticon ABS and
reviewed our own series of 32 patients (37 implants) in our institution, regarding the
main outcome endpoints including infection rate,revisional surgery and explant rate
(Table 21.2). The overall incidence of permanent explantation of the Acticon ABS in the
published series varies between 17% and 31% with follow-up periods of between 10
and 58 months. Revisional surgery with replacement of part or the entire device has
occurred in between 7% and 25% of the patients. The complications leading to explantation include perioperative infection, failure of wound healing, erosion of part of the
device through the skin or the anal canal, late infection and mechanical malfunction
of the device due to cuff or balloon rupture.As far as function is concerned, successful
results were obtained respectively in Spain, Italy, Minneapolis, MN (USA), Rouen
(France) and for us,in 15 out of 24 (62.5%), 21 out of 28 (75%), 17 out of 35 (49%),22 out
of 30 (73%) and 23 out of 32 (72%) cases. As others, we have found improvement in
quality of life after implantation of Acticon ABS.In a series of 16 patients consecutively receiving implants,with a follow-up of 25 months, a significant improvement in the
four separate quality-of-life domains explored in the Fecal Incontinence Quality of
Life Scale score was recorded,with a linear correlation between the improvement over
time in the quality-of-life index and the evaluation of continence measured by a clinical score (Lehur et al. 2002).
The results from the multicenter cohort study conducted under FDA supervision
showed an 85% functional success rate in patients who retained their artificial sphincter (Wong et al. 2002). Of 112 patients included in the trial, 51 (46%) required a revisional operation, primarily because of infection and 41 (37%) required complete explantation.Accordingly,the overall intention-to-treat success rate was finally 53%,but
this includes for a majority of the centers their initial experience with the device. Parker and co-workers (2003) reported data from the University of Minnesota, one of the
leader groups in the use of the artificial bowel sphincter. They identified two patient
groups: those who received implants between 1989 and 1992 (n=10; mean follow-up,
91 months) and those who received implants between 1995 and 2001 (n=37; mean fol-
low-up, 39 months). The overall success rate in the former group was 60% (4/10 explants). The latter group had an overall success of 49%, with a revision and infection
rate of 37% and 34%, respectively. Those patients who had successful implant procedures enjoyed a 100% functional success rate at 2 years.
305
Table 21.2. Results with the Acticon ABS artificial bowel sphincter
N Infection Revisional Explant Mean FU
Wong et al. (2002) 112 25 46 37 18
Ortiz et al. (2002) 22 9 50 32 26
Altomare et al.(2001) 28 18 32 25 19
Parker et al.(2003) 37 34 37 40 39
Michot et al. (2003) 25 7 28 20 34
Our series (unpublished) 32 0 53 31 26
rate (%) surgery (%) rate (%) (months)
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Guillaume Meurette,Paul-Antoine Lehur
Acticon ABS has also been recently evaluated in a format of randomized control
trial (O’Brien et al. 2004).The authors compared a group of 14 patients randomly assigned to Acticon ABS to a similar group entering a program of best supportive care
for fecal incontinence. Explant occurred once in the operative group (14%).Improvement at 6 months was significant in the Acticon ABS in terms of continence,and not in
the control group.The Cleveland Continence Score was significantly altered in the Acticon ABS group (preoperative value, 19; postoperative value, 5%–75% overall improvement) compared to the control group (preoperative value, 17; postoperative value, 14).
Similar changes were observed in quality of life evaluated on different means (SF 36,
FIQL, Beck Depression Inventory).
As mentioned, anal manometry is an important part of the postoperative evaluation of the implanted device. The experience of the group from Rouen, France, gave
very similar results to our own findings (Table 21.3).
21.6.2 Acticon ABS Reimplantation after Failure
In many series, patients have undergone successful reimplantation after a failure of a
previous implantation related to infection, ulceration or mechanical breakdown. In
our own series, of 32 patients receiving implants, 10 were explanted but 5 have undergone reimplantation with success. Part of or all the device can be replaced when revision surgery is needed. For Parker et al.(2003),risk of infection following revision was
19%, lower than after primary implantation (34%). Their success rate in this setting
was 65% (13/21 cases).
Patients going for Acticon therapy must be aware of the risk of revision surgery.
They usually accept redo surgery in case of complications, as they greatly appreciate
the benefit obtained with the device.
Table 21.3. Manometric assessment after artificial anal sphincter implantation
Mean Range
Closed cuff
Anal resting pressure (cm H2O) 108 22
Maximum amplitude of voluntary contractions (cm H
Duration of voluntary contractions (s) 18 20
Open cuff
Total duration of opening phase (s) 113
Amplitude of decrease (% of basal pressure) 60 22
Residual pressure (cm H
Opening time (s) 14 3
From Savoye et al. 2000.
a
Total duration of the opening phase in patients with defecation difficulties was significantly
shorter (47 s; range, 0–65) than in patients without defecation difficulties (178 s; range,
100–320) (P=.002).
b
Correlated with the resting pressure recorded before implantation of the artificial sphincter.
O) 40
2
O) 26 31
2
a
b
8
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