SURGEONS CORNER
Salvage and Extracapsular Implantation for Penile Prosthesis Infection or Extrusion Osama Shaeer, MD, PhD,1,2 Kamal Shaeer, MD,1,2 and Islam Fathy Soliman AbdelRahman, MD, MRCS, FECSM, FEAA, FACS1,2
ABSTRACT
Introduction: When a penile prosthesis is implanted, a fibrous tissue capsule gradually forms around it. In case of penile prosthesis infection, salvage and immediate reimplantation into the same capsule that envelops the infected prosthesis is a trial to avoid the difficulty and shortening encountered with explantation and delayed reimplantation. Aim: We propose that, on salvage, the infected prosthesis be explanted, the capsule washed out and then abandoned, and the replacement prosthesis implanted in the extracapsular sinusoidal space, between the capsule and tunica albuginea. This aims at decreasing contact between the replacement implant and the pyogenic membrane in the capsule. Methods: This study was performed in a tertiary implantation center, involving 20 prospective cases referred with either an infected implant or pump erosion. Through a penoscrotal incision, lateral corporotomies were performed by superficial cuts, in a trial to identify the extracapsular sinusoidal space before opening the capsule. The capsule was then opened. All components of the implant were explanted, and the capsules were washed out. The extracapsular space within the corpora cavernosa was developed between the capsule and the tunica albuginea by sharp dissection initially, then bluntly dilated with a Hegar dilator. A malleable penile prosthesis was implanted in the extracapsular space bilaterally. Main Outcome Measures: The reinfection rate was evaluated though 7e38 months after surgery. Results: We were able to identify and dilate the extracapsular space in 18 of 20 cases. Reinfection occurred in 1 case (1 of 18, 5.6%). Development of the extracapsular space added approximately 10 minutes to the operative time. Clinical Implication: If salvage of an infected penile implant can be delayed until capsule maturation, extracapsular implantation may decrease the reinfection rate. Strength & Limitations: The limitations are the lack of a control group of intra-capsular classic salvage and the relatively limited sample number. Conclusion: On penile prosthesis salvage surgery, whether for infection or extrusion, implantation of the replacement prosthesis in the extracapsular sinusoidal tissue is associated with low infection rates, because it bypasses the capsule, which may still harbor bacterial contamination despite the wash-out. Shaeer O, Shaeer K, AbdelRahman IFS. Salvage and Extracapsular Implantation for Penile Prosthesis Infection or Extrusion. J Sex Med 2019;16:755e759. Copyright 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Key Words: Penile Prosthesis Infection; Pump Erosion; Penile Prosthesis Extrusion; Penile Prosthesis Salvage; Mulcahy Washout
INTRODUCTION
Received December 9, 2018. Accepted February 5, 2019. 1
Department of Andrology, Kasr El Aini Faculty of Medicine, Cairo University, Egypt;
2
Kamal Shaeer Hospital, Giza, Egypt
Copyright ª 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jsxm.2019.02.005
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Infection is 1 of the most serious sequelae of penile prosthesis implantation surgery, indicating explantation. Options for cases with definitive infection include explantation and delayed reimplantation, weeks after resolution of infection, or immediate salvage and reimplantation. In salvage procedures, all components of the device are removed from the surrounding fibrous tissue capsule that forms around any foreign object implanted in vivo. Mechanical lavage and irrigation with antimicrobial/antiseptic 755
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solutions are performed to wash out live bacteria and biofilm from the capsule. Gowns, gloves, drapes, and instruments are then changed, and a replacement prosthesis is implanted1 into the same capsule that enveloped the infected prosthesis. Delayed reimplantation has the advantage of confirmed clearance of infection. However, the consequent fibrosis may render this procedure difficult, risky, and frequently unsatisfactory with regard to the outcome in terms of penile size. An absorbable antibiotic-impregnated calcium sulphate component can possibly maintain the corporal space after removal of the prosthesis.2 On the other hand, salvage and immediate reimplantation may avoid the aforementioned difficulty with reimplantation into scarred corporal bodies. Salvage may also avoid the loss in penile size that is more prone to occur with delayed reimplantation. In a series of 40 patients, those undergoing salvage exhibited a mean 0.6-cm loss in corporal length, in contrast to 3.7 cm with delayed reimplantation.3 The downside of salvage is the possibly residual infected tissue and biofilm that may result in reinfection. Reinfection rates for salvage range from 0e20%,1,4e8 considering that mechanical lavage is not guaranteed to treat the soft tissue infection and remove biofilm9 from the capsule that envelops the infected implant. The replacement implant is classically inserted into the very same capsule. There are ongoing efforts to decrease the overall infection rate of implantation surgery, reflecting on salvage procedures, including progress in device design and antibiotic coating and prophylaxis, a shorter operative time and advancement in corporal washout protocols. Lately, the spectrum of salvage has widened to successfully treat diabetic patients with purulence. In 1 study, 6 insulin-dependent diabetic patients with an infected implant were salvaged, with a malleable implant in 5 and an inflatable in 1, with no reinfection.10
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20 patients were selected from those referred to our tertiary center with an infected or extruded implant, over a period of 5 years (2012e2017). Selection for extracapsular implantation was on the basis of ability to delay intervention up to capsule maturation (as close as possible to the third month after implantation, with 1 month being the minimum), as well as patients’ written informed consent to participate in the study.
PREOPERATIVE PREPARATION Diabetic control and cessation of anticoagulation therapy are required. With regard to preoperative antibiotic therapy, the protocol depends on the time of presentation after the initial implantation, because capsule formation is time-dependent. For cases of delayed infection presenting beyond 6 weeks after surgery, we administer antibiotics 1 day before salvage surgery, either according to culture and sensitivity (15/20 cases showed bacterial growth: coagulase negative staphylococcus in 14 and methicillin-resistant Staphylococcus aureus in (1), or empirically as vancomycin/gentamicin and an antifungal, in case there is no bacterial growth (2 of 20). On the other hand, 3 of the 20 cases who consented to participating in the study presented earlier than 30 days after implantation, with moderate pain, fever <38.5 C, and mild to moderate purulent discharge. The 3 cases were successfully delayed to beyond the sixth week, on antibiotics, analgesics, and antipyretics, as well as local irrigation with povidone iodine and hydrogen peroxide. All 3 cases were culture negative. Empirical
In this work, we propose that, on salvage for implant infection, extrusion, or component failure, the replacement implant can be inserted into the cavernous tissue surrounding the capsule, between the capsule and tunica albuginea (extracapsular reimplantation), rather than intra-capsular. This may reduce contact between the replacement implant and the biofilm/ residual bacteria within the capsule, possibly decreasing the reinfection rate.
INDICATIONS FOR PROCEDURE This technique is indicated for cases with penile prosthesis infection, extrusion, or mechanical failure, candidate for replacement of the device. For cases of infection, contraindications include patients with uncontrolled diabetes, those with necrotic skin changes, and cases with toxic systemic manifestations (unresolving fever >38 C, progressively declining blood pressure, or progressively rising blood sugar), unless the systemic manifestation subsides.
Figure 1. The extracapsular sinusoidal tissue between the capsule and tunica albuginea. Figure 1 is available in color online at www. jsm.jsexmed.org. J Sex Med 2019;16:755e759
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Figure 2. Identifying the extracapsular sinusoidal tissue: (Panel A) Extracapsular sinusoidal tissue; (Panel B) Capsule; (Panel C) Infected implant. Figure 2 is available in color online at www.jsm. jsexmed.org. antibiotic therapy was initiated in the form of ceftriaxone/gentamycin, in addition to an antifungal. We preferred to reserve the more recent antibiotics with lower resistance profiles (such as vancomycin) until the salvage surgery, to avoid resistance formation. Nevertheless, there is no consensus or guidelines for this particular situation. Those patients were switched to vancomycin/Garamycin 1 day before salvage.
INTRAOPERATIVE CONSIDERATIONS (SUPPLEMENTARY VIDEO 1) Through a penoscrotal incision, corporotomies are superficially cut through the tunica albuginea, identifying the extracapsular sinusoidal tissue underneath before proceeding down to the capsule. The direction of the scalpel is preferably maintained tangential to the implant and surrounding capsule rather than directly down to the implant (Figures 1 and 2). Having identified and discriminated between the tunica albuginea, extracapsular sinusoidal tissue and capsule, the capsule is now cut open. In case the sinusoidal tissue is too sparse around the corporotomies, the posterior wall of the capsule can be incised from within, and the extracapsular space developed posterior to it.
Figure 3. Dilation of the extracapsular space distally. Figure 3 is available in color online at www.jsm.jsexmed.org. Once the extracapsular space is developed and dilated, a replacement penile prosthesis is implanted in the extracapsular space bilaterally, and the capsule and corporotomies are closed. The girth of the implant compresses the capsules, obliterating
All components of the prosthesis are explanted, including reartip extenders, pump, and the reservoir (although the reservoir can be left behind when removal is difficult or risky).9 The capsules enclosing the cylinders, reservoir space, and pump are irrigated under pressure as per the Mulcahy salvage technique.1 Drapes, gloves, gowns, and instruments are changed. The extracapsular space is then developed: stay sutures are placed at the edges of both the capsule and corporotomy, and pulled apart, revealing the extracapsular space (Figure 1). The space is developed for a short distance by sharp dissection initially, then fully by inserting a metal dilator (Figure 3). This step can be assisted by a dilator within the capsule (Figures 3e5). This adds approximately 10 minutes to the operative time. Irrigation with antibiotic solution is maintained throughout the process. J Sex Med 2019;16:755e759
Figure 4. Demonstration of the capsular and extracapsular spaces: (Panel A) Hegar dilator in the left extracapsular space; (Panel B) Hegar dilator in the left capsule; (Panel C) Hegar dilator in the right capsule. Figure 4 is available in color online at www.jsm. jsexmed.org.
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low as 5.6%, in comparison to classic salvage where infection rates reached up to 20% in some reports. The concept of extracapsular implantation was first tested and proven feasible by Mulcahy, though for another purpose: re-routing for impending implant perforation.12 Capsule development is thought to take 3 months to become complete (matured).11 Accordingly, we prefer to delay salvage and extracapsular implantation for as long as possible toward the third month from the initial implantation, 1 month being the minimum. This is as long as the general condition of the patient can withstand it, there are no necrotic skin changes, and that the patient approves. In the meantime, a course of antibiotic is warranted to ameliorate systemic and local manifestations. The ISSM guidelines on penile prosthesis implantation are not against a trial of long-term antibiotics in some cases of suspected infection, with the exception of cases with severe sepsis or diabetic ketoacidosis where the implant should be removed urgently.9 Delayed intervention is commonly not a problem because most cases with infection present beyond the first month after implantation.
Figure 5. Dilation of the extracapsular space can be guided by a dilator in the capsule. Figure 5 is available in color online at www. jsm.jsexmed.org. them. In the current series, we used malleable implants as replacements.
POSTOPERATIVE MANAGEMENT AND FOLLOW-UP Patients continue on intravenous vancomycin for 7 days and intramuscular gentamicin for 4 days after surgery, unless culture results dictate otherwise. Patients were followed up for 7e38 months, recording reinfection—if any.
OUTCOMES We were able to identify and dilate the extracapsular space in 18 of 20 cases. In the remaining 2 cases, the capsule was too thin in 1. In the other, the capsule, the extracapsular space and tunica albuginea were amalgamated. Of the 18 cases of extracapsular reimplantation, reinfection occurred in 1 case (1/18, 5.6%). A capsule is a fibrous tissue membrane that forms around a foreign body implanted in vivo, in an attempt to wall it off,11 penile implants being no exception. In case of salvage for infection, the capsule may still contain bacterial contamination despite washout. Extracapsular implantation of the replacement prosthesis is a trial to avoid the potential residual infection and biofilm within the capsule. This resulted in a reinfection rate as
While we propose extracapsular reimplantation primarily for cases of infection and extrusion, there is some rationale for using it on implant replacement for mechanical failure. Clinically uninfected implants removed for revision were culture positive in 70%13 because of activation of bacterial biofilms, which were actually visible in some cases. This leads to the proposal of washout of all existing implant capsule spaces, leading to reduction of infection rates from 11.6e2.9%.14 We believe that extracapsular implantation of the replacement prosthesis in those cases can reduce infection rates even further.
COMPLICATIONS Reinfection occurred in 5.6% of cases of extracapsular reimplantation.
CONCLUSION On penile prosthesis salvage surgery, whether for infection or extrusion, implantation of the replacement prosthesis in the extracapsular sinusoidal tissue decreases reinfection rates, bypassing the capsule which may still harbor bacterial contamination despite the wash-out. Delaying intervention until capsule maturity (1 month) is recommended, unless the urgent intervention is required on account of systemic toxicity or necrotic skin changes. Corresponding Author: Prof. Dr. Osama Shaeer, MD, PhD, 21 Gaber Ibn Hayan Street, Dokki, Giza, Egypt. E-mail: dr.
[email protected] Conflict of Interest: The authors report no conflicts of interest. Funding: None. J Sex Med 2019;16:755e759
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STATEMENT OF AUTHORSHIP
5. Gross MS, Phillips EA, Balen A, et al. The malleable implant salvage technique: Infection outcomes after Mulcahy salvage procedure and replacement of infected inflatable penile prosthesis with malleable prosthesis. J Urol 2016;195:694-697.
Category 1 (a) Conception and Design Osama Shaeer (b) Acquisition of Data Osama Shaeer; Kamal Shaeer (c) Analysis and Interpretation of Data Osama Shaeer; Kamal Shaeer; Islam AbdelRahman
6. Kaufman JM, Kaufman JL, Borges FD. Immediate salvage procedure for infected penile prosthesis. J Urol 1998; 159:816-818. Fathy
Soliman
Category 2 (a) Drafting the Article Osama Shaeer; Kamal Shaeer; AbdelRahman (b) Revising It for Intellectual Content Osama Shaeer; Kamal Shaeer; AbdelRahman
Islam
Islam
Fathy
Fathy
Soliman
Soliman
Category 3 (a) Final Approval of the Completed Article Osama Shaeer; Kamal Shaeer; Islam AbdelRahman
Fathy
Soliman
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7. Brant MD, Ludlow JK, Mulcahy JJ. The prosthesis salvage operation: immediate replacement of the infected penile prosthesis. J Urol 1996;155:155-157. 8. Kohler TS, Modder JK, Dupree JM, et al. Malleable implant substitution for the management of penile prosthesis pump erosion: A pilot study. J Sex Med 2009;6:1474-1478. 9. Levine LA, Becher EF, Bella AJ, et al. Penile prosthesis surgery: Current recommendations from the International Consultation on Sexual Medicine. J Sex Med 2016; 13:489-518. 10. Peters CE, Carlos EC, Lentz AC. Purulent inflatable penile prostheses can be safely immediately salvaged in insulindependent diabetics. J Sex Med 2018;15:1673-1677. 11. Wilson SK. Pearls, perils and pitfalls of prosthetic urology. A troubleshooting guide for the physicians. Fort Smith, Arkansas: Calvert McBride, Inc.; 2008. 12. Mulcahy JJ. Distal corporoplasty for lateral extrusion of penile prosthesis cylinders. J Urol 1999;161:193-195. 13. Henry GD, Wilson SK, Delk JR, et al. Penile prosthesis cultures during revision surgery: A multicenter study. J Urol 2004; 172:153-156. 14. Henry GD, Carson CC, Wilson SK, et al. Revision washout decreases implant capsule tissue culture positivity: A multicenter study. J Urol 2008;179:186-190.
SUPPLEMENTARY DATA Supplementary data related to this article can be found at https://doi.org/10.1016/j.jsxm.2019.02.005.