Repressurisation par remplissage du ballon sous contrôle de la pression urétrale ou changement de ballon du sphincter artificiel, dans la gestion de la perte secondaire d’efficacité de la prothèse sphinctérienne AMS800 ®

25 mars 2018

Auteurs : B. Maximilien, A. Aublea, A. Gillibert, C. Delcourt, P. Grise, J.-N. Cornu
Référence : Prog Urol, 2018, 4, 28, 209-214




 




Introduction


The artificial urinary sphincter (AUS) has become the "gold standard" in the treatment of moderate to severe male urinary incontinence (UI) after radical prostatectomy [1]. Hydraulically controlled AMS800® device (Boston Scientific, Boston, MA, USA) is one of the most frequent sphincter implanted all over the world, with excellent long-term results [2, 3]. AMS800® failure is defined by persistent or recurrent incontinence after device implantation. It is caused by mechanical or non-mechanical failure that can, sometimes, overlap [4]. Several techniques have been reported to treat AMS800® failure due to urethral atrophy and mechanical or non-mechanical failure without any consensus about whether to change all the device [5] or only one component of the device such as downsizing the cuff [6, 7], adding a second cuff, implanting transcorporal cuff [8] or repositioning the cuff to a more proximal or distal location [9]. However, changing the cuff implies another urethral surgery with an increased risk of urethral injury and erosion [10]. It is also possible to increase pressure around the urethra by inflating or changing the pressure regulating balloon (PRB) with a higher rating (61-70cm H2 0 to 71-80cm H2 0) without touching the cuff which could theoretically avoid urethral injury. In this study, we report the largest series in the literature that compare inflation of PRB with PRB upsizing to treat AMS800® failure.


Materials and methods


We retrospectively reviewed all patients implanted with AMS800®, who had their 61-70cm H2 0 PRB changed or inflated for persistent or recurrent incontinence, in our academic center, between 2005 and 2016. Clinical factors such as incontinence cause, radiation history, prior urethral surgery, incontinence surgery, number of pad use and pad test volume, and surgical details such as cuff size, PRB pressure and placement technique were computerized and analyzed. All devices were initially placed through a perineal incision. When AMS800® failure occurred, patients were evaluated with urinary analysis, fibroscopy to eliminate urethral erosion and to objective coaptation failure of the cuff and urodynamic study to analyze RCOP. Plain X-ray was also performed to look for a loss of fluid from the balloon or cuff. Patients had their 61-70 cm H2 0 PRB replaced with 71-80cm H2 0 PRB or their PRB refilled with 2 or 3mL of iso-osmotic contrast solution (Telebrix 12 or omnipaque 350, 53%, sterile water 47%). Surgery was made in dorsal position, under general anesthesia. The device was deactivated and an inguinal incision was performed. To refilled PRB, a Y connector was inserted between the balloon tube and the pump tube after previous clamping. A 12 Fr-foley catheter was introduced in the urethra and connected to a drip infusion vertical column to measure the retrograde cuff occlusion urethral pressure (RCOP) as previously described [11]. The refilling was conducted step by step, starting with 2mL injected in the balloon, then reconnection followed with a pump manoeuver. The volume of balloon filling was controlled after tubing reconnection in order to reach an 80cm H2 0 RCOP above the urethra level. If necessary, a refilling with 1mL was performed following the same procedure. Balloon filling was stopped when RCOP reached 80cm H2 0. No urinary drainage was used. All the patients were discharged at day 0 to 1 with their sphincter activated. Patients were eligible for either one of these techniques if urethral atrophy occurred without mechanical dysfunction. All AUS device implantation and revision were made by a single surgeon expert in the technique. PRB refilling was used for the first cases but, after ten cases, it was decided to change the PRB in all cases. Main clinical end point was the rate of reoperation after repressurizing. Secondary end points were the occurrence of urethral erosion, infection device or persistent or recurrent incontinence. Subjective continence was obtained if patient wore no pad or use only one security pad per day. Follow-up time refers to median time between the first revision and last medical consultation. Statistical analysis were made using Fisher exact test. All patients gave written informed consent to participate in the study. Given the retrospective nature of the study and the absence of experimental arm, the work was conducted in accordance with the provisions of the 1964 Declaration of Helsinki and its later amendments.


Results


The study population included 31 inflating balloon procedures, respectively 21 balloon upsizing (group 1) and 10 refilling (group 2). Demographics characteristics are listed in Table 1. Median preoperative RCOP was lower in refilling group than PRB upsizing group (25cm H2 0 [range 7-50] vs 53cm H2 0 [range 30-85]; P =0.002).


Peroperative


Study flow chart is shown in Figure 1. Median PRB refilling was 3mL (2-7). In patients who had their PRB upsized, 5 had lower volume in their PRB than when implanted (median 14mL [1-19]). However, one (who had only 1mL still in the device at the time of surgery) had his cuff changed two months later because of cuff leak. In refilled group, median peroperative RCOP was significantly higher than preoperative (72.5cm H2 0 [25-80] vs 25cm H2 0 [7-50]; P =0.002).


Figure 1
Figure 1. 

Study flow chart. PRB: pressure regulating balloon.




Postoperative


At last follow-up, overall reoperation rate was 48.3% (n =15), respectively 33% group 1 and 80% group 2 (Table 2).


Three patients who had their PRB refilled had persistent UI. One patient in each group had recurrent UI. Recurrent UI occurred within a median time of 20 months. Urethral erosion occurred 4 months after surgery for 1 out of 21 patient in the first group. Erosion occurred for 4 out of 10 in the second group with a median erosion time of 42 months (2-116). All patients with erosion had past history of surgery prior to AUS implantation (3 internal urethrotomy, including one after repressurizing, in one patient, 1 macroplastic injection, 1 erosion prior repressurizing, 1 TOMSâ„¢). Two eroded patients had also past history of radiation, three had no other comorbidities while one was diabetic and an active smoker and another was an active smoker with arteriopathy. Both infections occurred, in one patient with past history of TOMS and in one patient immunosuppressed because of malignant hemopathy.


Erosion and atrophy occurred more frequently after balloon repressurizing than after balloon upsizing (8 vs 2, P =0.03).


At the end of follow-up, overall subjective continence was significantly improved from preoperative period (P =0.012). Subjective continence was achieved for 3 patients (30%) after refilling and 8 patients (38%) after PRB replacement. Median pad use per day was significantly decreased in the PRB replacement group compared to PRB refilling group (1 vs 2, P =0.033). There was no difference in objective continence (50g [30-210] vs 50g [0-300], P =0.47).


Discussion


Best treatment option when AMS800® failure occurred is not known. We report the second largest series of PRB inflation or change for treatment of persistent or recurrent urinary incontinence after device implantation. In our study, reoperation rate was significantly lower when balloon was changed than when balloon was refilled, 33% (n =7) vs 80% (n =8) (P =0.024). When PRB was upsized, we found an infection/erosion rate of 14.2%. This is comparable to Eswara who found a 5.3% to 21.4% infection/erosion rate when comparing four types of revision after AUS failure (cuff downsizing, cuff relocation, tandem cuff placement and higher PRB replacement) [10]. There were no evidence of increased risk for urethral erosion within all techniques. Wang et al. compared 29 PRB replacement or upsizing alone to 15 revision of the existing cuff alone [12]. Indication for revision procedure was recurrent incontinence. Sixteen out of 29 patients (55.2%) underwent tertiary surgery after reservoir revision versus 8 out of 15 (53.3%) after cuff revision. Erosion rate was 27.8% (8/29), mechanical dysfunction occurred in 3 cases (10.3%) and recurrent incontinence in 13.7% of cases (4/29) after reservoir revision. Reservoir procedure was associated with higher erosion rates and less recurrent incontinence compared to cuff revision. Our results were also comparable to the 11.1% infection/erosion rate reported by Linder in patients who underwent entire device replacement [13]. Although we did not observe any infection in the refilling group, erosion rate was high (40%).


Refilling the balloon is a technique initially used by Maillet et al. in seven AUS revision procedures [11]. They did not observe any urethral erosion. However, three patients were reoperated on within 30 months for recurrent incontinence.


Theoretically, balloon repressurizing was justified by the hypo-osmotic fluid leakage through the silicone that has become porous through time [11]. It was also justified by the coating fibrosis that has developed around the balloon and the cuff, which alter their compliance and lead to increase the pressure transmitted to the urethra [11]. It was assumed to better control the pressure transmitted to the urethra compare to PRB upsizing. However, in our study, there might have been artefact in the RCOP measure leading to an overfilling of the PRB, and higher risk of erosion and atrophy, as pressure transmission from the balloon to the cuff is delayed by the pump resistance. This high erosion rate led us to abandon this technique. We used PRB change to a higher pressure rate (61-70 cm H2 0 to 71-80 cm H2 0) in order to better control the pressure delivered to the cuff.


Changing only one component expose the patient to mechanical failure of another component. Linder et al. [13] compared outcomes of single component revision versus entire device replacement and concluded that rate of tertiary surgery was not different between two groups (24% vs 13%, P =0.17). Moreover, three-year device survival without revision was not significantly different between entire device replacement and single component revision (76% vs 60%, P =0.11) [13]. It has been suggested that a term of 3 or 5 years since initial implantation could be used [14, 15] as a cut off to choose between two techniques (changing all device or just a component). However, Linder et al. [13], in 2016, failed to determine a significant interaction between time from device implantation to mechanical failure and type of revision performed in a cohort of 125 AMS800® revision. Interestingly, in our study, in both groups, only one patient (3%) had mechanical failure of another component (cuff leak) within follow-up. He had his AUS implanted for 2.2 years.


Urethral atrophy is one of the main cause of late AMS800® failure. It is responsible for 43.9% of all reoperation after primary AUS device implantation [16]. The urethral wall atrophy is difficult to appreciate and quantify with imaging, even with MRI technique, who appreciates better cuff location and filling. Therefore, urethral dissection might be better to evaluate urethral atrophy and to adapt surgical technique (cuff downsizing...) rather than arbitrarily increase urethral pressure with higher PRB. However, when considering recurrent incontinence, we should not misdiagnose mechanical failure that can occur in 29.3% of reoperation indications [16]. When low volume in the PRB was observed we should have seek for leak in other constituents when there was no leak observed in the balloon. However, we would not advocate for changing all the device when PRB has lower volume as, in our study, four patients had loss of fluid in the device without any leak, which is an argument to PRB malfunction and probable porosity of the system although we used iso-osmotic mixture. New techniques such as the ohmmeter [17] could be useful in the future to precisely assess the site of the leak and prevent entire device replacement.


We observed only 38% of subjective continence in patients who had their PRB replaced. Our results are inferior to those of DiMarco and Elliott [18], which found an overall 56% (10/18) rate of success with tandem cuff implantation. For Eswara et al. [10] tandem cuffs were superior to all other revision techniques concerning recurrent UI. However, it is difficult to compare subjective continence results, as postoperative pad use was not available for 33.3% of patients.


We are aware of the limitations of our study. It is a retrospective study with missing pad use data, urodynamics and RCUP measurements data. Patients' heterogeneity might have influenced clinical results. We did not use validated questionnaire to evaluate UI or patient satisfaction.


However, our study is interesting because, where other studies focused on urethra, we tried to determine whether touching only the PRB would be efficient and safe. As we know that changing one component exposes to other component failure and a tertiary surgery, we would advocate for changing all the devices in young population. However, changing only PRB could be an alternative with acceptable morbidity and reserved to fragile population in order to avoid another urethral dissection.


Conclusion


When AMS800® failure occurs, PRB upsizing is more efficient, less morbid and lead to less reoperation than PRB refilling. However, risk for failure of other components would advocate considering this technique for a selected population when minimal surgery is best indicated.


Disclosure of interest


The authors declare that they have no competing interest.




Table 1 - Patients' characteristics (n =31).
Age (years), Mean  71 (43-90) 
Incontinence etiology  
BPH surgery  4 (13) 
Radical prostatectomy  27 (87) 
Background    
Prior radiation  12 (38) 
PRB changed  9 (42) 
PRB refilled  3 (30) 
Internal urethrotomy  9 (29) 
PRB changed  7 (33) 
PRB refilled  2 (20) 
Urinary incontinence treatment prior AMS800 ®implantation device  
None  23 (74) 
Macroplastic injection  3 (9.6) 
Pro-ACTâ„¢ device  1 (3.2) 
TOMSâ„¢ sling  5 (16) 
Cuff location    
Peri-bulbar  18 (58) 
Transcorporal  13 (42) 
Median cuff size  5 (4-5.5) 
Median initial filling of PRB  24 (20-25) 
Median time from device implantation to repressurizing (months)  41 (6-157) 
Median follow-up after repressurizing (months)  23 (1-129) 
Median preoperative retrograde cuff occlusion pressure (RCOP) cm H 2 0, median  
PRB changed  53 (30-85) 
PRB refilled  25 (7-50) 
Median postoperative RCOP    
PRB changed  NA 
PRB refilled  72.5 (25-80) 
Median pre-repressurizing pad use per day  1.5 (1-4) 
Median pre-repressurizing pad test (g)  50 (30-210) 



Légende :
BPH: benign prostatic hyperplasia; PRB: pressure regulating balloon; RCOP: retrograde cuff occlusion urethral pressure.



Table 2 - Complications leading to surgery after initial repressurizing.
Complications  PRB upsizing to 71-80 cm H2 0
n =21 (%) 
PRB filled with sterile water
n =10 (%) 
P   Treatment 
Reoperation  7 (33)  8 (80)  0.024   
Urethral erosion  1 (4.7)  4 (40)  0.03  Device explantation 
Infection  2 (9.5)  0.34  Device explantation 1
Balloon explantation 1 
Urethral atrophy  1 (4.7)  4 (40)  0.0155  Transcorporal cuff 
Balloon migration  1 (4.7)  Balloon repositioned 
Leak on the balloon  1 (4.7)  Balloon changed 
Leak on the cuff  1 (4.7)  Cuff changed 



Légende :
PRB: pressure regulating balloon.


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1 
All authors contributed to this article by drafting and revising the article critically for important intellectual content. Pr Cornu Jean-Nicolas did final approval of the version to be published.




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Elsevier Masson SAS. Tous droits réservés.