Implantable venous and electrical devices are prone to exposure and infection. Indications for management are controversial, but-especially if infected-exposed devices are often removed and an additional operation is needed to replace the device, causing a delay in chemotherapy and prolonging healing time. We present our protocol for device salvage, on which limited literature is available

CORDOVA, Adriana

D'ARPA, Salvatore

MOSCHELLA, Francesco

TOIA, Francesca

Plastic & Reconstructive Surgery Global Open

PubMed

Francesca Toia

Salvatore D’Arpa

Adriana Cordova

Francesco Moschella

Crossref

Exposed Subcutaneous Implantable Devices

Archivio istituzionale della ricerca - Università di Palermo

 www.PRSGlobalOpen.com 23Exposure of implantable venous and electrical de-vices is a relatively common event, mainly caused by inadequate tissue coverage. Bacterial con- tamination and subsequent infection follow exposure. Limited literature is available on exposure manage-ment, with contrasting recommendations, with remov-al and replacement in a secondary operation several months later1,2 often being advocated for pacemakers.Venous access ports are implanted in cancer pa-tients for IV chemotherapy delivery, and up to 11% of them require removal during treatment due to pocket infection or pressure necrosis3; subcutaneous electrical devices are also prone to exposure.4 Sec-ondary replacement of a removed device is respon-sible for significant patient discomfort, treatment delays or interruptions, and direct and indirect costs.Copyright © 2015 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons. All rights reserved. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.DOI: 10.1097/GOX.0000000000000303Background: Implantable venous and electrical devices are prone to exposure and infection. Indications for management are controversial, but—especially if infected—exposed devices are often removed and an additional operation is needed to replace the device, causing a delay in chemotherapy and prolong-ing healing time. We present our protocol for device salvage, on which limited literature is available.Methods: Between 2007 and 2013, 17 patients were treated (12 venous access ports, 3 cardiac pacemak-ers, and 2 subcutaneous neural stimulators). Most patients were operated within 7 days from exposure. All patients received only a single perioperative dose of prophylactic antibiotic. In cases of gross infection (n = 1), the device was immediately replaced. In the absence of clinical signs of infection:Complete capsulectomy and aggressive cleaning with an n-acetylcysteine solution and saline solution.Primary exposure of venous ports with sufficient skin coverage (n = 10): the device was covered with local skin flaps.Recurrent cases, cases with insufficient skin coverage or big devices (n = 7): the device was moved to a subpectoral pocket.Mean follow-up was 19 months.Results: Sixteen devices were saved. Only one grossly infected pacemaker was removed and replaced immedi-ately. Only in 1 case, exposure of a venous port recurred after 18 months and was successfully moved to a sub-pectoral pocket. Chemotherapy was always restarted as scheduled and electrical devices remained functional.Conclusions: This protocol allows—with a straightforward operation and simple measures—to save exposed devices even several days after exposure. Submuscular placement or immediate replace-ment is indicated only in selected cases. (Plast Reconstr Surg Glob Open 2015;3:e343; doi:10.1097/GOX.0000000000000303; Published online 30 March 2015.)Exposed Subcutaneous Implantable Devices: An Operative Protocol for Management and SalvageFrancesca Toia, MDSalvatore D’Arpa, MD, PhDAdriana Cordova, MDFrancesco Moschella, MDMeeting ProceedingsFrom the Plastic and Reconstructive Surgery, Department of Surgical, Oncological and Oral Sciences, University of Palermo, Palermo, Italy.Drs. Toia and D’Arpa contributed equally to this work.Presented at 25th Annual EURAPS Meeting, May 29–31, 2014, Ischia, Italy, and the 63rd SICPRE National Meeting (Società Italiana di Chirurgia Plastica Ricostruttiva ed Estetica, Italian Society of Plastic, Reconstructive and Aesthetic Surgery), October 12–15, 2014, Bergamo, Italy.SICPRE: La SICPRE, Società Italiana di Chirurgia Plastica Ricostruttiva ed Estetica, national meeting, in Bergamo, Italy on October 12-15, 20142014 SICPRE Congress Best AbstractsMeeting Proceedings 24PRS Global Open • 2015Recently, there is a tendency toward aggressive cleaning and salvage of exposed implants in breast surgery,5,6 which suggests that a conservative treat-ment might also be possible for subcutaneous im-plantable devices. Several authors have suggested device salvage and coverage if no gross infection is present, but many reports only include small groups, and different techniques have been reported.2,7–9We present our protocol for salvage of exposed subcutaneous implantable devices and propose it as a tool to speed healing time and avoid treatment delays.MATERIALS AND METHODSBetween 2007 and 2013, 17 patients with exposed devices were treated at a single institution. Among exposed devices, there were 12 venous access ports, 3 cardiac pacemakers, and 2 subcutaneous neural stim-ulators. Most patients were operated within 7 days (range, 2–27). All patients were operated under lo-cal anesthesia and received only a single preoperative dose of cefazoline (2 g) as antibiotic prophylaxis.10The following protocol was applied to all cases:•	 Gross infection: removal and immediate re-placement.•	 No signs of infection.A complete capsulectomy was performed for ev-ery type of device. The device and the surgical field were then washed with an n-acetylcysteine solution and later irrigated with saline solution (500 ml). Then, a different strategy was adopted for venous ports and for bigger devices:Venous ports (primary cases): Primary cases with adequate local tissue were covered with random flaps, propeller perforator flaps, or perforator-based flaps. The flap was deepithelialized and partially buried under the skin or folded on itself to provide additional coverage for the device.Recurrent cases, big device (cardiac pacemakers, neural stimulators) or cases with insufficient skin coverage (thin or debilitated patients): The device was moved to a subpectoral pocket and anchored to the surrounding tissues to avoid dis-placement and reduce patients’ discomfort.The wound was closed with buried, monofila-ment absorbable sutures to minimize risks of bac-terial colonization. Mean follow-up was 19 months (range, 6–50). Data on healing time, postoperative infection, recurrent exposure, and other complica-tions were recorded.According to Italian rules (art. 13, DLgs n. 196/03), this study did not require authorization by the Institutional Review Board.RESULTSThere were 11 primary exposures of venous ports, 10 of which were maintained in a subcutane-ous pocket: 4 were covered with a random flap, 2 with a propeller perforator flap, and 4 with a per-forator-based flap; only in 1 case of a debilitated patient with very thin skin, submuscular placement was needed. There were 5 primary exposures of electrical devices: a cardiac pacemaker, in the pres-ence of gross infection, was immediately replaced; all 5 devices were moved to a subpectoral pocket. One recurrent exposure of a venous access port was treated with placement in a subpectoral pocket.The protocol allowed salvage of all but one de-vice (16 of 17), which was immediately replaced. All patients healed uneventfully within 15 days. No patients developed a postoperative infection at a minimum follow-up of 6 months. One patient with a venous device had a reexposure 18 months after coverage. The device was saved again and moved to a subpectoral pocket. Submuscular placement caused early postoperative discomfort, which solved sponta-neously within 1 month. Chemotherapy was always restarted as scheduled (7–21 days), and electrical de-vices remained functional.DISCUSSIONThe results of this study show that most devices can be saved if treated before gross infection devel-ops, and only a minority needs removal and imme-diate replacement. The protocol we propose allows salvage of exposed devices in most cases, with a single straightforward operation and no risk for patients’ health. It avoids the need for secondary reposition-ing, thus preventing deleterious delays in treatment and unnecessary morbidity. Removal and immediate replacement is indicated only for grossly infected cases and seems effective in controlling infection if the above-mentioned measures are adopted.Literature on salvage of exposed subcutaneous devices is limited and mainly concerns pacemak-ers.2,4,7–9 When a clinical infection is evident, removal and delayed replacement is advocated,11,12 although some authors suggest immediate replacement for exposed devices in the absence of gross infection.7,8Removal and delayed replacement, which can appear as a safer approach, is not devoid of compli-cations. For venous ports, it delays chemotherapy, pro-Disclosure: The authors have no financial interest to de-clare in relation to the content of this article. The article processing charge for this article was paid for by the Società Italiana di Chirurgia Plastica Ricostruttiva ed Estetica.25Salvage of Exposed Implantable Deviceslongs healing, and can impair prognosis, whereas for pacemaker, removal of leads from the endocardium can lead to acute cardiac problems; also, it requires the use of temporary or external pacing device.4Based on recent trends in breast and orthopedic surgery, we propose that a salvage attempt can be performed also for these devices.It is generally agreed that coverage should be as early as possible, “within 48 hours of identification of exposure when possible,”4 and we recommend treat-ment even for impeding exposure. However, in our series, 3 patients with an exposed venous port were referred between 13 and 27 days following exposure, and were successfully treated, suggesting that also devices with late referral and no clinical sign of in-fection deserve a salvage attempt.Several measures may be adopted to salvage ex-posed devices and minimize risks of infection or reexposure. As a small number of pathogens is nec-essary for developing an infection on an implant, complete capsulectomy and accurate cleaning of the pocket are mandatory. We routinely irrigate the pocket with an n-acetylcysteine solution. n-Acetylcys-teine is a glutathione precursor, which has shown to be effective in destroying bacterial biofilms and in-hibiting their formation.13,14 Its clinical use is still lim-ited, but existing experimental and clinical results are very promising, also on difficult bacteria as Pseu-domonas aeruginosa. Following irrigation with n-acet-ylcysteine, we do recommend a through mechanical washing of the pocket with a minimum of 500 ml of saline solution, a strategy that has shown to be ef-fective in the salvage of exposed breast implant.6 As for clean-contaminated surgery, a single dose of pre-operative prophylactic antibiotic was administered.10 There is contrasting evidence in the literature with regard to the need for antibiotic therapy4,8; however, it has been shown that even a positive culture in an exposed but clinically noninfected device does not correlate with reexposure.4 In our series, after irriga-tion and without postoperative antibiotics, no infec-tion was observed, despite no use of postoperative antibiotics.Several authors recommend pocket change and subpectoral placement,8,9 but there is no general agreement and different techniques have been sug-gested.2,7–9 Bonawitz,4 in their series of 16 patients with exposed pacemakers, report no difference in reexpo-sure rate for submuscular or subfascial placement, the latter having become their preferred choice. For pace-makers or other voluminous electrical devices, we do prefer submuscular placement because exposure in the absence of infection is often due to an imbalance between skin thickness and pressure exerted by the device; thus, once the primary cause of exposure is not eliminated, reexposure is more likely to happen. Also, submuscular placement of the pacemaker allows for a more pleasant aesthetic outcome and has been proposed as first choice even for primary pacemaker placement.15 In our series, subpectoral placement was associated with early discomfort and spasm, but it always solved within 1 month, as also reported by Bonawitz4 and Fayman et al.9Smaller devices, such as venous ports, can be left subcutaneously in most cases. These devices need an external access for their use, which is easier in case of subcutaneous placement. Thus, submuscu-lar placement should be limited to selected cases. When there is adequate local tissue, the port can be moved to a subcutaneous pocket in anatomical con-tinuity with the previous one. However, skin is often thin in cancer patients (often debilitated) with a ve-nous access port. To obtain thicker skin coverage, a local skin flap can be deepithelialized and partially buried under the skin overlying the device (Fig. 1) or deepithelialized and folded on itself. A random or a perforator-based flap can be used in case of sufficient skin laxity; a propeller perforator flap is preferred when an increased freedom in design and movement is required.16Fig. 1. A, exposed venous access port. A perforator-based flap was planned for reconstruction. B, Following capsulectomy and aggressive cleaning of the pocket, the flap was deepithelialized and buried under the skin to provide additional cover-age. c, one-year postoperative result. the venous access port is still in place.26PRS Global Open • 2015Although the numbers are relatively small, they are comparable to all the other series previously pub-lished. Considering that the results of this study are promising and that large prospective studies are un-likely to be performed, we propose the application of our protocol for device management in the hope that it will be a useful tool for other plastic surgeons and that it could ultimately be validated by evalua-tion on a larger number of patients.CONCLUSIONThe protocol we propose allows—with a straight-forward operation and simple measures—saving of exposed devices even several days after exposure. Submuscular placement or immediate replacement is indicated only in selected cases. Francesca Toia, MDPlastic and Reconstructive Surgery Department of Surgical, Oncological and Oral Sciences University of PalermoVia del Vespro 129Palermo 90127, ItalyE-mail: francesca.toia@unipa.it REFERENCES 1. Jara FM, Toledo-Pereyra L, Lewis JW Jr, et al. The in-fected pacemaker pocket. J Thorac Cardiovasc Surg. 1979;78:298–300. 2. Garcia-Rinaldi R, Revuelta JM, Bonnington L, et al. The exposed cardiac pacemaker. Treatment by subfascial pock-et relocation. J Thorac Cardiovasc Surg. 1985;89:136–141. 3. Bassi KK, Giri AK, Pattanayak M, et al. Totally implantable venous access ports: retrospective review of long-term com-plications in 81 patients. Indian J Cancer 2012;49:114–118. 4. Bonawitz SC. Management of exposure of cardiac pace-maker systems. Ann Plast Surg. 2012;69:292–295. 5. Prince MD, Suber JS, Aya-Ay ML, et al. Prosthesis salvage in breast reconstruction patients with periprosthetic infec-tion and exposure. Plast Reconstr Surg. 2012;129:42–48. 6. Quilichini J, Guihard T, Le Masurier P. [Salvage of infect-ed prosthesis in breast reconstruction: about seven con-secutive cases]. Ann Chir Plast Esthet. 2010;55:578–582. 7. Kolker AR, Redstone JS, Tutela JP. Salvage of exposed im-plantable cardiac electrical devices and lead systems with pocket change and local flap coverage. Ann Plast Surg. 2007;59:26–29; discussion 30. 8. Griffith MJ, Mounsey JP, Bexton RS, et al. Mechanical, but not infective, pacemaker erosion may be successfully managed by re-implantation of pacemakers. Br Heart J. 1994;71:202–205. 9. Fayman MS, Chait LA, Orak F. A subpectoral pocket in the management of a patient with impending extrusion of a pulse generator. Plast Reconstr Surg. 1986;78:182–185. 10. Toia F, D’Arpa S, Massenti MF, et al. Perioperative an-tibiotic prophylaxis in plastic surgery: a prospective study of 1,100 adult patients. J Plast Reconstr Aesthet Surg. 2012;65:601–609. 11. Buch E, Boyle NG, Belott PH. Pacemaker and defibrilla-tor lead extraction. Circulation 2011;123:e378–e380. 12. Farooqi FM, Talsania S, Hamid S, et al. Extraction of cardiac rhythm devices: indications, techniques and out-comes for the removal of pacemaker and defibrillator leads. Int J Clin Pract. 2010;64:1140–1147. 13. Zhao T, Liu Y. N-acetylcysteine inhibit biofilms produced by Pseudomonas aeruginosa. BMC Microbiol. 2010;10:140. 14. Dinicola S, De Grazia S, Carlomagno G, et al. N-acetylcysteine as powerful molecule to destroy bacterial biofilms. A systematic review. Eur Rev Med Pharmacol Sci. 2014;18:2942–2948. 15. Persichetti P, Brunetti B, Cagli B, et al. Aesthetic subpec-toral placement of implantable cardioverter defibrilla-tors. Ann Plast Surg. 2014;72:188–192. 16. D’Arpa S, Toia F, Pirrello R, et al. Propeller flaps: a re-view of indications, technique, and results. Biomed Res Int. 2014;2014:986829.

Exposed subcutaneous implantable devices: an operative protocol for management and salvage

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Exposed subcutaneous implantable devices: an operative protocol for management and salvage

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