TEN QUESTIONS
Clinical considerations for allied professionals: Optimizing outcomes: Surgical incision techniques and wound care in device implantation Melissa E. Harding, PA-C, CCDS, CEPS, Larry A. Chinitz, MD From the NYU Langone Medical Center, New York, New York. Whereas implanters of cardiovascular implantable electronic devices (CIED) consider implant procedures successful when lead measurements are adequate and the incision has healed without complication, patients often base their final opinion of the procedure on the cosmetic outcome. Fortunately, optimization of cosmetic results is strongly linked to minimization of wound complications as well as simple refinement of techniques and strategies throughout the peri-implant period.
1. What are the optimal methods for preparing the patient and skin prior to surgery? Patient Administered Antiseptic Wash (“PAAW”) Data supporting the benefits of preoperative PAAW have been largely inconsistent. Whereas some studies demonstrate benefit, others have shown no advantage over showering with standard soap.1 A 2012 Cochrane meta-analysis of the existing data failed to demonstrate significant benefit to the use of PAAW.2 Preoperative Hair Removal Although the available data are unclear regarding benefits of hair removal from operative sites, there are many practical justifications for the practice ranging from access to and visualization of the site, to dressing application. However, there is clear evidence demonstrating that if hair needs to be removed, removal by clippers results in significantly fewer surgical site infections than shaving with a razor.3 Peripheral IV Insertion Insertion, placement, and care of the peripheral IV are also integral to the overall outcome of an implant procedure. Proper hand hygiene must be observed prior to IV placement and aseptic technique, including preparation of the skin with M. Harding is a Cardiac Electrophysiology Physician Assistant with the Cardiac Electrophysiology Service at New York University Langone Medical Center. She is certified with the International Board of Heart Rhythm Examiners as a Cardiac Device Specialist and Electrophysiology Specialist and is a member of the IBHRE Allied Professionals Exam Writing Committee. Address reprint requests and correspondence: Melissa E. Harding, PA-C, CCDS, CEPS, NYU Langone Medical Center, Cardiac Electrophysiology/Heart Rhythm Center, 560 First Ave, New York, NY 10016. E-mail address: [email protected].
1547-5271/$-see front matter B 2014 Heart Rhythm Society. All rights reserved.
2% chlorhexidine solution. The “no touch” technique must be used during IV insertion to avoid introducing an additional source for device infection.4 Surgical Site Sterilization Surgical site preparation using a chlorhexidine–alcohol preparation provides superior protection against surgical site infection than iodine-based preparations.5 Chlorhexidine preparations should be applied according to specific product instructions, generally applying the solution to the operative site, extending just beyond the intended drape border, using back-and-forth strokes for a period of 30 seconds. It is extremely important that the preparation be allowed to dry completely before use of electrocautery because of its flammability.6 Perioperative Antibiotic Administration The current guidelines for surgical antimicrobial prophylaxis in CIED implant recommend cefazolin or cefuroxime as the first-line agent, at a dose of 2 g for most adults (3 g for adults weighing 4120 kg) and 30 mg/kg for pediatric patients. For patients with β-lactam allergy, vancomycin or clindamycin may be used, at a dose of 15 mg/kg or 900 mg (10 mg/kg for pediatric patients), respectively. Antibiotics should be administered within 60 minutes before incision. Vancomycin may be started within 120 minutes before the incision. Although it is common to give an additional antibiotic dose postoperatively, prophylactic antimicrobials should be continued no longer than 24 hours postoperatively.7
2. What surgical techniques facilitate the best aesthetic results? Surgical technique significantly impacts wound healing and the aesthetic outcome of the surgical site. Incision Simply making the incision parallel to natural skin creases improves scar quality.8 For device implants, the ideal incision is parallel to the deltopectoral groove. Smaller incisions are assumed to be superior cosmetically. However, a smaller incision decreases anatomic visualization and accessibility. As friction and tension is
http://dx.doi.org/10.1016/j.hrthm.2014.01.003
738 applied to an incision during retraction, damage is caused at the incision margins and surrounding tissue. This damage delays wound healing and can result in increased scar tissue formation and a less attractive scar.9 Instruments Intraoperative instrumentation can damage local tissue and microvasculature. Serrated (“atraumatic”) forceps, such as the standard DeBakey tissue forceps, are appropriate in deeper tissues, where vasculature is protected by surrounding tissue. However, on the skin, serrated forceps create a crushing force on local vessels, causing blood spillage into surrounding tissue. This can cause petechiae, increased edema, and frank ecchymosis, and increases the risk of unsightly, even hypertrophic, scarring. A toothed forceps, such as the rat-toothed forceps or Adson forceps with teeth, and the minimal necessary pressure should be used to secure and position the skin.10
3. What suture materials and methods are best for incision closure? In skin closure, the dermal layer of suture provides tensile strength, while the epidermal layer approximates wound edges and corrects for gaps or discrepancies in height.11 The recommended closure for the chest/breast area is 3-0 polyglactic 910 suture, commonly Vicryl, and a continuous 5-0 poliglecaprone, commonly Monocryl, for the epidermal layer.11 Suture Material Polyglactic 910 (Vicryl) is a synthetic, absorbable, braided suture. Vicryl generates less inflammatory response than biologic sutures, such as gut. It demonstrates good knot security and has excellent handling and workability. At 2 weeks postoperative, Vicryl maintains 65% of its tensile strength and 40% tensile strength at 3 weeks. It is most useful as a completely buried suture in deeper tissues.11 Poliglecaprone (Monocryl) is a synthetic, absorbable, monofilament suture. Monocryl creates less inflammatory response than any braided suture (synthetic or biologic), specifically in subcuticular closures, and has very low levels of bacterial adherence.12 The result is a more aesthetically pleasing scar with significantly less likelihood of scar hypertrophy.11 Suture Technique Suture technique plays a significant role in the final results of an incision. In the dermal layer, an interrupted suture provides the best tensile strength. A buried vertical mattress technique provides the strength of a simple interrupted suture, with the advantage of a deeply buried knot. In the epidermal layer, a running continuous suture provides approximation of the wound edges while distributing tension evenly along the length of the incision.11 In the epidermal layer, the suture should be anchored and terminated with a buried vertical mattress to prevent knot externalization.
Heart Rhythm, Vol 11, No 4, April 2014 In all layers of closure, the suture needle should enter at a 901 angle to the target tissue and advance following the curve of the needle. Suture should be knotted only tightly enough to approximate the tissue and no tighter. Skin edges should be in direct contact and everted. Knots should be secured with a minimum of 3 throws and cut with 3-mm ends.11 Lastly, the more suture material used to close an incision (whether because of excessive individual throws or excessive knot size), the more dramatic the local inflammatory response and the greater the opportunity for bacterial colonization.11
4. Closing the outside: Traditional subcuticular suture, adhesive closure strips, or topical skin adhesive? After securing the subcutaneous tissue, most operators agree that superficial incision closure is necessary, but the best method of closure remains up for debate. Topical Skin Adhesives Topical skin adhesives (TSAs) are an alternative to subcuticular suture. Although TSAs are sometimes used as an adjunct to a subcuticular suture layer or staples in longer incisions, this is unnecessary with the length of incisions required for CIED implant. Patient perception of cosmetic results and wound discomfort is equivalent, if not better, with TSAs compared to subcuticular sutures. Operationally, TSAs are the most efficient method of superficial closure, are cost effective, and require no sharps handling.11 TSAs demonstrate similar results on outcomes such as infection, dehiscence, and scarring. They act as a microbial barrier, allowing the patient to shower almost immediately after application.11,13 TSAs should be applied in a thin layer to well approximated skin using a light brushing motion. A second layer should be applied 2 to 3 minutes later. The applicator tip should not be pressed onto the wound because TSA penetration into the wound can delay healing and result in poor cosmetic outcomes.14 Adhesive Closure Strips Adhesive closure strips (ACSs) also have advantages over subcuticular suturing. Cosmetic outcomes with ACSs are equivalent to those of subcuticular suturing. However, application of ACSs is more efficient and provides increased resistance to infection and decreased wound tension.11 ACSs also demonstrate less incisional erythema and edema than subcuticular suturing, indicating less local inflammation.15
5. How can patients most effectively care for incisions postoperatively? Providing patient education on proper incision care is a highly effective method for improving cosmetic (and overall) outcomes postoperatively. Patients can shower immediately after TSA application and 24 hours after ACS application. They should not directly
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Ten Questions
soak or scrub the area, and they should not swim or otherwise immerse the incision. The area should be gently patted dry after showering. Soaps, lotions, creams, and ointments can compromise the integrity of TSAs and ACSs and should not be used.16,17 Both TSAs and ACSs should be allowed to come off on their own, without picking or pulling. TSAs will slough off after approximately 2 weeks.14 ACSs will peel off over 1 to 2 weeks.16 Patients must not rub or scratch the incision, and they should generally avoid touching the area altogether. Patients should be instructed regarding activity while the incision is healing. The patient should avoid extending the ipsilateral shoulder beyond 901 (i.e., do not raise the elbow above the shoulder) and should not push, pull, or lift with the ipsilateral arm until the incision is healed. Trauma or friction at the incision area should be avoided during the healing period.
6. What can be done to prevent hematomas and how should hematomas be managed? The incidence of hematoma formation following CIED implant is estimated to be 2% to 5%.18 Hematomas can cause significant pain and interfere with proper wound healing. Hematomas are associated with prolonged length of stay and increased need for transfusion and reoperation for evacuation or pocket revision. They carry an increased risk of infection and may be associated with an increased occurrence of lead dislodgment and deep vein thrombosis.18 Hematoma prevention begins before an incision is made. In addition to being cognizant of comorbidities that cause coagulopathies, including primary hematologic disorders, chronic renal disease, hepatic disease, and malignancy, the preoperative management of anticoagulation therapy must be carefully considered.19 Warfarin Data specific to CIED implants significantly favor continuation of warfarin therapy through the implant procedure over bridging with heparin. In fact, continuing anticoagulation with warfarin does not increase the risk of hematoma compared to no anticoagulation, even with international normalized ratios international normalized ratios as high as 3.5.20 Antiplatelet Therapy Continuation of clopidogrel may be associated with increased risk of hematoma formation, which may be exacerbated in the setting of dual antiplatelet therapy18,21 However, the potential complications related to even temporary discontinuation of antiplatelet therapy, specifically in patients with intravascular or coronary stents, can be catastrophic. Based on current data, the decision to discontinue clopidogrel should be made on a case-by-case basis and should not be routine practice.20,21 Notably, aspirin therapy alone is not associated with increased hematoma risk.21 Other Anticoagulants Substantial data on management of newer anticoagulants such as dabigatran, rivaroxaban, and apixaban with regard to
739 device implant are not yet available. The current consensus advocates discontinuation 2 days before implant in patients with creatinine clearance 450 mL/min (3 days before for creatinine clearance 30–50 mL/min). Therapy can then be resumed 24 hours postoperatively for most patients, and 72 hours after implant for patients with increased bleeding risk.22 Emerging data may support uninterrupted therapy with these anticoagulants peri-implant. However, further study is needed in this regard.23 Hemostatic Agents The use of fibrin sealants and hemostatic matrix agents (e. g., thrombin, D-Stat, Surgicel) has shown a reduction in postoperative bleeding complications.24,25 However, care must be taken during application to ensure the agent is not applied to the incision itself because this can significantly inhibit proper wound healing.25 Hemostatic Suture Although data are scarce in this regard, application of a “pursestring” suture around the site of vascular access may reduce pocket hematomas. However, further investigation is needed to determine the true efficacy of this practice. Pressure Dressings Studies on the benefits of pressure dressing application have shown mixed results.19,26 If a pressure dressing is applied, the center of pressure should be over the pocket itself rather than the incision. In addition, adhesive tapes designed for pressure dressings can cause skin tearing. Applying a layer of transparent dressing material (e.g., Tegaderm) under the adhesive tape can help minimize skin damage during dressing removal. Hematomas are most likely to form in the first 24 to 72 hours postoperatively, and almost all hematomas develop within 1 week.19,27 They are more likely to occur after pocket or lead revision and less likely at initial implant or generator change without pocket revision. Hematomas range from small and relatively benign to large and extremely painful. When a hematoma starts to develop, early intervention is critical to prevent the need for reoperation and to minimize the impact on wound healing.27 Intervention depends on the size and rate of expansion of the hematoma. A small, gradually developing hematoma is most likely due to bleeding of a small vessel and can be managed conservatively with a pressure dressing and close monitoring. A large, rapidly expanding hematoma likely involves prolonged or continuous bleeding from a large vessel and may require immediate reopening of the pocket to ligate the vessel.27 Reoperation for hematoma evacuation is also indicated for persistent pain, compromise or impending compromise of the incision, or suspicion of infection.27 Hematomas are ideal harbors for bacterial. Antibiotic therapy should be started prophylactically for all patients with hematomas, and patients must be monitored closely for signs of pocket or systemic infection.19
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7. How should wound dehiscence be managed? Risk factors for wound dehiscence include abnormal mechanical stress, as seen in women with large breasts and morbidly obese patients, malnourishment, and chronic steroid use. In these patients, intraoperative measures such as modifying suture technique to provide more tensile strength and using ACSs instead of TSAs to decrease incisional tension should be implemented.28 Small trials from the field of deep brain stimulator implantation show that isolated dehiscence, presenting early and absent any signs of infection, may be managed conservatively with wound washout, debridement, and a prophylactic course of antibiotics.29 However, few data are available regarding management of wound dehiscence after CIED implant. Experience suggests that a small, superficial dehiscence can be managed similarly, with wound washout, gentle debridement, and application of ACSs, followed by close monitoring and a course of antibiotics. For superficial dehiscence involving a greater length of the incision, nonabsorbable, synthetic, monofilament suture such as nylon or polypropylene can be used with a horizontal mattress or simple interrupted technique.11 ACSs can be used to reinforce the still-approximated portion of the incision medial and lateral to the area reapproximated with suture. Patients should be specifically instructed regarding proper care of the wound following a dehiscence. Keeping the incision dry, open to air, and free of soaps, lotions, creams, or any handling is essential. Any dehiscence involving subcutaneous tissue or exposure of the device generator should be treated as an infected device. These management techniques are based largely on experience, so formal investigation is needed to validate these practices.
8. How should incisional infections be managed? A fair amount has been published regarding pocket and device system infection, and the ultimate recommendation generally is total system extraction.30 However, essentially no data exist regarding management of a clearly localized, superficial infection of the incision itself. Based on experience alone, early intervention and close follow-up of an isolated incisional infection may ultimately salvage the implant and prevent a potentially high-risk extraction. With a suspected incision infection, the white blood cell count should be checked as a preliminary evaluation for systemic infection. If this value is within normal range and no other signs of pocket or systemic infection are present, including fever, chills, malaise, edema, erythema, or fluctuance of the pocket, it may be reasonable to start the patient on a course of antibiotics and commence weekly follow-up until the incision is fully healed. The patient should be provided with strict instructions on incision care and antibiotic compliance as well as directions to immediately report signs or symptoms of progressing infection.
Heart Rhythm, Vol 11, No 4, April 2014 This strategy is based solely on experience, and formal investigation is needed.
9. What can be done to prevent hypertrophic scar and keloid formation? Hypertrophic scars and keloids present a significant cosmetic challenge and may cause chronic discomfort for patients. Hypertrophic Scar Hypertrophic scars are overgrowth of fibrous tissue, which does not extend beyond the borders of the original wound. Although unattractive, they often resolve without intervention and are readily preventable by proper surgical and suturing techniques.31 Keloids Keloids are histologically distinct from normal scar tissue. They demonstrate thick, eosinophilic collagen bundles, higher blood vessel density, mesenchymal cells, and a thickened epidermal layer.31,32 Collagen synthesis in keloids is up to 20 times greater than in normal scar tissue. Keloids exhibit increased production of tumor necrosis factor (TNF)α, interferon (IFN)-β, and interleukin 6, all of which perpetuate scar formation.31 Keloid formation has a strong genetic basis, and patients with a personal or family history of keloids require special attention to optimize surgical results. Factors that contribute to both hypertrophic scars and keloids include mechanical force applied intraoperatively by the implanter or postoperatively by natural body movements, wound infection, and reaction to foreign bodies, such as suture material.32 These items have each been addressed in the prior topics.
10. How can keloids and hypertrophic scars be treated? Hypertrophic scars and keloids can be cosmetically displeasing as well as uncomfortable and even painful. Many hypertrophic scars will resolve as the scar matures. However, this can take as long as 2 to 5 years, which may not be acceptable to the patient. Keloids do not resolve without intervention.31 Several options exist for treatment of keloids and hypertrophic scars, many of which are viable options for patients with CIEDs. Gel Sheeting Gel sheeting, such as silicone dressings, can be used to accelerate maturation of hypertrophic scars, decreasing scar thickness and rigidity, pruritus, and pain.31 For keloids, gel sheeting cannot provide adequate treatment but can be used as an adjunct to other therapies.32 Corticosteroids Topical corticosteroid application is ineffective in reducing scar tissue. However, intradermal corticosteroid injection is first-line therapy for both hypertrophic scars and
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Ten Questions
keloids.31,32 Corticosteroids decrease inflammation, suppress fibroblast proliferation and collagen synthesis, and promote collagen degeneration. The negative effects of intradermal corticosteroids include dermal atrophy and hypopigmentation.31 Cryotherapy Cryotherapy is also first-line therapy in keloid treatment, although it is not routinely used for hypertrophic scars. Cryotherapy is administered as a topical spray or with a cryogenic probe. It can decrease keloid size by 50% to 75% after 2 applications.31 Cryotherapy also can result in hypopigmentation and skin atrophy.31,32 The cryoneedle is an emerging technology that has shown superior outcomes after a single session compared to topical and contact cryotherapy, with less pain and fewer adverse reactions.31 Laser Therapy Laser therapy is another first-line option for treatment of keloids. Pulse dyed laser (PDL) is the most effective, although some data demonstrate high recurrence rates when it is used as the sole therapy. Accordingly, laser therapy is often combined with corticosteroid injection.31 The depth of laser penetration is generally 0.5 to 1 mm, so contact with CIED components should not be of concern.32 Other Options Surgical resection or shave excision of keloids may be recommended in severe cases. In addition, immunosuppressive and antitumor agents such as imiquimod, 5-fluorourcil, bleomycin, and mitomycin-C can be used. However, many of these agents have been studied only in conjunction with surgical resection or shave excision of the scar.31 Given the proximity of the scar to the CIED components and the potential consequences of a complication, these methods should be avoided when treating keloids at CIED incisions.32
References 1. Martindale RG, Deveney CW. Preoperative risk reduction: strategies to optimize outcomes. Surg Clin North Am 2013;93:1041–1055. 2. Webster J, Osborne S. Preoperative bathing or showering with skin antiseptics to prevent surgical site infection. Cochrane Database Syst Rev 2012:9;CD004985 3. Tanner J, Norrie P, Melen K. Preoperative hair removal to reduce surgical site infection. Cochrane Database Syst Rev 2011;11;CD004122 4. O’Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related infections, 2011. Centers for Disease Control and Prevention. Healthcare Infection Control Practices Advisory Committee (HICPAC) 2011:7–14. 5. Darouiche RO, Wall MJ, Itani KM, et al. Chlorhexidine-alcohol versus povidoneiodine for surgical-site antisepsis. N Engl J Med 2010;362:18–26. 6. CareFusion. ChloraPrep One-Step Applicator. El Paso, TX: CareFusion Corporation, 2010.
741 7. Bratzler DW, Dellinger EP, Olsen KM, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt) 2013;14:73–156. 8. Atiyeh BS, Ioannovich J, Al-amm CA, El-musa KA, Dham R. Improving scar quality: a prospective clinical study. Aesthetic Plast Surg 2002;26:470–476. 9. Han SE, Ryoo ST, Lim SY, Pyon JK, Bang SI, Oh KS, Mun GH. Minimizing surgical skin incision scars with a latex surgical glove. Aesthetic Plast Surg 2013;37:459–462. 10. Bhattacharya V, Mishra B, Mishra B, Kumar U, Bhattacharya S. Effect of surgical traumas on microcirculation. Indian J Plast Surg 2009;42:146–149. 11. Hochberg J, Meyer KM, Marion MD. Suture choice and other methods of skin closure. Surg Clin North Am 2009;89:627–641. 12. Masini BD, Stinner DJ, Waterman SM, Wenke JC. Bacterial adherence to suture materials. J Surg Educ 2011;68:101–104. 13. Yang YL, Xiang YY, Jin LP, Pan YF, Zhou SM, Zhang XH, Qu JM. Closure of skin incision after thyroidectomy through a supraclavicular approach: a comparison between tissue adhesive and staples. Scand J Surg 2013;102:234–240. 14. Ethicon. Dermabond Topical Skin Adhesive. Somerville, NJ: Ethicon, 2000. 15. Lazar HL, Mccann J, Fitzgerald CA, Cabral HJ. Adhesive strips versus subcuticular suture for mediansternotomy wound closure. J Card Surg 2011;26: 344–347. 16. 3M Health Care. 3M Steri-Strip Adhesive Skin Closures (reinforced): Commonly Asked Questions. St. Paul, MN: 3M Health Care, 2002. 17. Ethicon. Dermabond Advanced: Caring For Your Wound. Somerville, NJ: Ethicon, 2011. 18. Kutinsky IB, Jarandilla R, Jewett M, Haines DE. Risk of hematoma complications after device implant in the clopidogrel era. Circ Arrhythm Electrophysiol 2010;3:312–318. 19. Henley J, Brewer JD. Newer hemostatic agents used in the practice of dermatologic surgery. Dermatol Res Pract 2013;2013:279–289. 20. Thal S, Moukabary T, Boyella R, et al. The relationship between warfarin, aspirin, and clopidogrel continuation in the peri-procedural period and the incidence of hematoma formation after device implantation. Pacing Clin Electrophysiol 2010;33:385–388. 21. Bernard ML, Shotwell M, Nietert PJ, Gold MR. Meta-analysis of bleeding complications associated with cardiac rhythm device implantation. Circ Arrhythm Electrophysiol 2012;5:468–474. 22. Liew A, Douketis J. Perioperative management of patients who are receiving a novel oral anticoagulant. Intern Emerg Med 2013;8:477–484. 23. Rowley CP, Bernard ML, Brabham WW, et al. Safety of continuous anticoagulation with dabigatran during implantation of cardiac rhythm devices. Am J Cardiol 2013;111:1165–1168. 24. Milic DJ, Perisic ZD, Zivic SS, et al. Prevention of pocket related complications with fibrin sealant in patients undergoing pacemaker implantation who are receiving anticoagulant treatment. Europace 2005;7:374–379. 25. Glick JB, Kaur RR, Siegel D. Achieving hemostasis in dermatology-Part II: Topical hemostatic agents. Indian Dermatol Online J 2013;4:172–176. 26. Piromchai P, Vatanasapt P, Reechaipichitkul W, Phuttharak W, Thanaviratananich S. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study. BMC Ear Nose Throat Disord 2008;8:1. 27. Wiegand UK, LeJeune D, Boguschewski F, et al. Pocket hematoma after pacemaker or implantable cardioverter defibrillator surgery: influence of patient morbidity, operation strategy, and perioperative antiplatelet/anticoagulation therapy. Chest 2004;126:1177–1186. 28. Doughty DB. Preventing and managing surgical wound dehiscence. Adv Skin Wound Care 2005;18:319–322. 29. Fenoy AJ, Simpson RK. Management of device-related wound complications in deep brain stimulation surgery. J Neurosurg 2012;116:1324–1332. 30. Margey R, Mccann H, Blake G, et al. Contemporary management of and outcomes from cardiac device related infections. Europace 2010;12:64–70. 31. Love PB, Kundu RV. Keloids: an update on medical and surgical treatments. J Drugs Dermatol 2013;12:403–409. 32. Ogawa R. The most current algorithms for the treatment and prevention of hypertrophic scars and keloids. Plast Reconstr Surg 2010;125:557–568.
Clinical considerations for allied professionals: Optimizing outcomes: Surgical incision techniques and wound care in device implantation Melissa E. Harding, PA-C, CCDS, CEPS, Larry A. Chinitz, MD From the NYU Langone Medical Center, New York, New York. Whereas implanters of cardiovascular implantable electronic devices (CIED) consider implant procedures successful when lead measurements are adequate and the incision has healed without complication, patients often base their final opinion of the procedure on the cosmetic outcome. Fortunately, optimization of cosmetic results is strongly linked to minimization of wound complications as well as simple refinement of techniques and strategies throughout the peri-implant period.
1. What are the optimal methods for preparing the patient and skin prior to surgery? Patient Administered Antiseptic Wash (“PAAW”) Data supporting the benefits of preoperative PAAW have been largely inconsistent. Whereas some studies demonstrate benefit, others have shown no advantage over showering with standard soap.1 A 2012 Cochrane meta-analysis of the existing data failed to demonstrate significant benefit to the use of PAAW.2 Preoperative Hair Removal Although the available data are unclear regarding benefits of hair removal from operative sites, there are many practical justifications for the practice ranging from access to and visualization of the site, to dressing application. However, there is clear evidence demonstrating that if hair needs to be removed, removal by clippers results in significantly fewer surgical site infections than shaving with a razor.3 Peripheral IV Insertion Insertion, placement, and care of the peripheral IV are also integral to the overall outcome of an implant procedure. Proper hand hygiene must be observed prior to IV placement and aseptic technique, including preparation of the skin with M. Harding is a Cardiac Electrophysiology Physician Assistant with the Cardiac Electrophysiology Service at New York University Langone Medical Center. She is certified with the International Board of Heart Rhythm Examiners as a Cardiac Device Specialist and Electrophysiology Specialist and is a member of the IBHRE Allied Professionals Exam Writing Committee. Address reprint requests and correspondence: Melissa E. Harding, PA-C, CCDS, CEPS, NYU Langone Medical Center, Cardiac Electrophysiology/Heart Rhythm Center, 560 First Ave, New York, NY 10016. E-mail address: [email protected].
1547-5271/$-see front matter B 2014 Heart Rhythm Society. All rights reserved.
2% chlorhexidine solution. The “no touch” technique must be used during IV insertion to avoid introducing an additional source for device infection.4 Surgical Site Sterilization Surgical site preparation using a chlorhexidine–alcohol preparation provides superior protection against surgical site infection than iodine-based preparations.5 Chlorhexidine preparations should be applied according to specific product instructions, generally applying the solution to the operative site, extending just beyond the intended drape border, using back-and-forth strokes for a period of 30 seconds. It is extremely important that the preparation be allowed to dry completely before use of electrocautery because of its flammability.6 Perioperative Antibiotic Administration The current guidelines for surgical antimicrobial prophylaxis in CIED implant recommend cefazolin or cefuroxime as the first-line agent, at a dose of 2 g for most adults (3 g for adults weighing 4120 kg) and 30 mg/kg for pediatric patients. For patients with β-lactam allergy, vancomycin or clindamycin may be used, at a dose of 15 mg/kg or 900 mg (10 mg/kg for pediatric patients), respectively. Antibiotics should be administered within 60 minutes before incision. Vancomycin may be started within 120 minutes before the incision. Although it is common to give an additional antibiotic dose postoperatively, prophylactic antimicrobials should be continued no longer than 24 hours postoperatively.7
2. What surgical techniques facilitate the best aesthetic results? Surgical technique significantly impacts wound healing and the aesthetic outcome of the surgical site. Incision Simply making the incision parallel to natural skin creases improves scar quality.8 For device implants, the ideal incision is parallel to the deltopectoral groove. Smaller incisions are assumed to be superior cosmetically. However, a smaller incision decreases anatomic visualization and accessibility. As friction and tension is
http://dx.doi.org/10.1016/j.hrthm.2014.01.003
738 applied to an incision during retraction, damage is caused at the incision margins and surrounding tissue. This damage delays wound healing and can result in increased scar tissue formation and a less attractive scar.9 Instruments Intraoperative instrumentation can damage local tissue and microvasculature. Serrated (“atraumatic”) forceps, such as the standard DeBakey tissue forceps, are appropriate in deeper tissues, where vasculature is protected by surrounding tissue. However, on the skin, serrated forceps create a crushing force on local vessels, causing blood spillage into surrounding tissue. This can cause petechiae, increased edema, and frank ecchymosis, and increases the risk of unsightly, even hypertrophic, scarring. A toothed forceps, such as the rat-toothed forceps or Adson forceps with teeth, and the minimal necessary pressure should be used to secure and position the skin.10
3. What suture materials and methods are best for incision closure? In skin closure, the dermal layer of suture provides tensile strength, while the epidermal layer approximates wound edges and corrects for gaps or discrepancies in height.11 The recommended closure for the chest/breast area is 3-0 polyglactic 910 suture, commonly Vicryl, and a continuous 5-0 poliglecaprone, commonly Monocryl, for the epidermal layer.11 Suture Material Polyglactic 910 (Vicryl) is a synthetic, absorbable, braided suture. Vicryl generates less inflammatory response than biologic sutures, such as gut. It demonstrates good knot security and has excellent handling and workability. At 2 weeks postoperative, Vicryl maintains 65% of its tensile strength and 40% tensile strength at 3 weeks. It is most useful as a completely buried suture in deeper tissues.11 Poliglecaprone (Monocryl) is a synthetic, absorbable, monofilament suture. Monocryl creates less inflammatory response than any braided suture (synthetic or biologic), specifically in subcuticular closures, and has very low levels of bacterial adherence.12 The result is a more aesthetically pleasing scar with significantly less likelihood of scar hypertrophy.11 Suture Technique Suture technique plays a significant role in the final results of an incision. In the dermal layer, an interrupted suture provides the best tensile strength. A buried vertical mattress technique provides the strength of a simple interrupted suture, with the advantage of a deeply buried knot. In the epidermal layer, a running continuous suture provides approximation of the wound edges while distributing tension evenly along the length of the incision.11 In the epidermal layer, the suture should be anchored and terminated with a buried vertical mattress to prevent knot externalization.
Heart Rhythm, Vol 11, No 4, April 2014 In all layers of closure, the suture needle should enter at a 901 angle to the target tissue and advance following the curve of the needle. Suture should be knotted only tightly enough to approximate the tissue and no tighter. Skin edges should be in direct contact and everted. Knots should be secured with a minimum of 3 throws and cut with 3-mm ends.11 Lastly, the more suture material used to close an incision (whether because of excessive individual throws or excessive knot size), the more dramatic the local inflammatory response and the greater the opportunity for bacterial colonization.11
4. Closing the outside: Traditional subcuticular suture, adhesive closure strips, or topical skin adhesive? After securing the subcutaneous tissue, most operators agree that superficial incision closure is necessary, but the best method of closure remains up for debate. Topical Skin Adhesives Topical skin adhesives (TSAs) are an alternative to subcuticular suture. Although TSAs are sometimes used as an adjunct to a subcuticular suture layer or staples in longer incisions, this is unnecessary with the length of incisions required for CIED implant. Patient perception of cosmetic results and wound discomfort is equivalent, if not better, with TSAs compared to subcuticular sutures. Operationally, TSAs are the most efficient method of superficial closure, are cost effective, and require no sharps handling.11 TSAs demonstrate similar results on outcomes such as infection, dehiscence, and scarring. They act as a microbial barrier, allowing the patient to shower almost immediately after application.11,13 TSAs should be applied in a thin layer to well approximated skin using a light brushing motion. A second layer should be applied 2 to 3 minutes later. The applicator tip should not be pressed onto the wound because TSA penetration into the wound can delay healing and result in poor cosmetic outcomes.14 Adhesive Closure Strips Adhesive closure strips (ACSs) also have advantages over subcuticular suturing. Cosmetic outcomes with ACSs are equivalent to those of subcuticular suturing. However, application of ACSs is more efficient and provides increased resistance to infection and decreased wound tension.11 ACSs also demonstrate less incisional erythema and edema than subcuticular suturing, indicating less local inflammation.15
5. How can patients most effectively care for incisions postoperatively? Providing patient education on proper incision care is a highly effective method for improving cosmetic (and overall) outcomes postoperatively. Patients can shower immediately after TSA application and 24 hours after ACS application. They should not directly
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Ten Questions
soak or scrub the area, and they should not swim or otherwise immerse the incision. The area should be gently patted dry after showering. Soaps, lotions, creams, and ointments can compromise the integrity of TSAs and ACSs and should not be used.16,17 Both TSAs and ACSs should be allowed to come off on their own, without picking or pulling. TSAs will slough off after approximately 2 weeks.14 ACSs will peel off over 1 to 2 weeks.16 Patients must not rub or scratch the incision, and they should generally avoid touching the area altogether. Patients should be instructed regarding activity while the incision is healing. The patient should avoid extending the ipsilateral shoulder beyond 901 (i.e., do not raise the elbow above the shoulder) and should not push, pull, or lift with the ipsilateral arm until the incision is healed. Trauma or friction at the incision area should be avoided during the healing period.
6. What can be done to prevent hematomas and how should hematomas be managed? The incidence of hematoma formation following CIED implant is estimated to be 2% to 5%.18 Hematomas can cause significant pain and interfere with proper wound healing. Hematomas are associated with prolonged length of stay and increased need for transfusion and reoperation for evacuation or pocket revision. They carry an increased risk of infection and may be associated with an increased occurrence of lead dislodgment and deep vein thrombosis.18 Hematoma prevention begins before an incision is made. In addition to being cognizant of comorbidities that cause coagulopathies, including primary hematologic disorders, chronic renal disease, hepatic disease, and malignancy, the preoperative management of anticoagulation therapy must be carefully considered.19 Warfarin Data specific to CIED implants significantly favor continuation of warfarin therapy through the implant procedure over bridging with heparin. In fact, continuing anticoagulation with warfarin does not increase the risk of hematoma compared to no anticoagulation, even with international normalized ratios international normalized ratios as high as 3.5.20 Antiplatelet Therapy Continuation of clopidogrel may be associated with increased risk of hematoma formation, which may be exacerbated in the setting of dual antiplatelet therapy18,21 However, the potential complications related to even temporary discontinuation of antiplatelet therapy, specifically in patients with intravascular or coronary stents, can be catastrophic. Based on current data, the decision to discontinue clopidogrel should be made on a case-by-case basis and should not be routine practice.20,21 Notably, aspirin therapy alone is not associated with increased hematoma risk.21 Other Anticoagulants Substantial data on management of newer anticoagulants such as dabigatran, rivaroxaban, and apixaban with regard to
739 device implant are not yet available. The current consensus advocates discontinuation 2 days before implant in patients with creatinine clearance 450 mL/min (3 days before for creatinine clearance 30–50 mL/min). Therapy can then be resumed 24 hours postoperatively for most patients, and 72 hours after implant for patients with increased bleeding risk.22 Emerging data may support uninterrupted therapy with these anticoagulants peri-implant. However, further study is needed in this regard.23 Hemostatic Agents The use of fibrin sealants and hemostatic matrix agents (e. g., thrombin, D-Stat, Surgicel) has shown a reduction in postoperative bleeding complications.24,25 However, care must be taken during application to ensure the agent is not applied to the incision itself because this can significantly inhibit proper wound healing.25 Hemostatic Suture Although data are scarce in this regard, application of a “pursestring” suture around the site of vascular access may reduce pocket hematomas. However, further investigation is needed to determine the true efficacy of this practice. Pressure Dressings Studies on the benefits of pressure dressing application have shown mixed results.19,26 If a pressure dressing is applied, the center of pressure should be over the pocket itself rather than the incision. In addition, adhesive tapes designed for pressure dressings can cause skin tearing. Applying a layer of transparent dressing material (e.g., Tegaderm) under the adhesive tape can help minimize skin damage during dressing removal. Hematomas are most likely to form in the first 24 to 72 hours postoperatively, and almost all hematomas develop within 1 week.19,27 They are more likely to occur after pocket or lead revision and less likely at initial implant or generator change without pocket revision. Hematomas range from small and relatively benign to large and extremely painful. When a hematoma starts to develop, early intervention is critical to prevent the need for reoperation and to minimize the impact on wound healing.27 Intervention depends on the size and rate of expansion of the hematoma. A small, gradually developing hematoma is most likely due to bleeding of a small vessel and can be managed conservatively with a pressure dressing and close monitoring. A large, rapidly expanding hematoma likely involves prolonged or continuous bleeding from a large vessel and may require immediate reopening of the pocket to ligate the vessel.27 Reoperation for hematoma evacuation is also indicated for persistent pain, compromise or impending compromise of the incision, or suspicion of infection.27 Hematomas are ideal harbors for bacterial. Antibiotic therapy should be started prophylactically for all patients with hematomas, and patients must be monitored closely for signs of pocket or systemic infection.19
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7. How should wound dehiscence be managed? Risk factors for wound dehiscence include abnormal mechanical stress, as seen in women with large breasts and morbidly obese patients, malnourishment, and chronic steroid use. In these patients, intraoperative measures such as modifying suture technique to provide more tensile strength and using ACSs instead of TSAs to decrease incisional tension should be implemented.28 Small trials from the field of deep brain stimulator implantation show that isolated dehiscence, presenting early and absent any signs of infection, may be managed conservatively with wound washout, debridement, and a prophylactic course of antibiotics.29 However, few data are available regarding management of wound dehiscence after CIED implant. Experience suggests that a small, superficial dehiscence can be managed similarly, with wound washout, gentle debridement, and application of ACSs, followed by close monitoring and a course of antibiotics. For superficial dehiscence involving a greater length of the incision, nonabsorbable, synthetic, monofilament suture such as nylon or polypropylene can be used with a horizontal mattress or simple interrupted technique.11 ACSs can be used to reinforce the still-approximated portion of the incision medial and lateral to the area reapproximated with suture. Patients should be specifically instructed regarding proper care of the wound following a dehiscence. Keeping the incision dry, open to air, and free of soaps, lotions, creams, or any handling is essential. Any dehiscence involving subcutaneous tissue or exposure of the device generator should be treated as an infected device. These management techniques are based largely on experience, so formal investigation is needed to validate these practices.
8. How should incisional infections be managed? A fair amount has been published regarding pocket and device system infection, and the ultimate recommendation generally is total system extraction.30 However, essentially no data exist regarding management of a clearly localized, superficial infection of the incision itself. Based on experience alone, early intervention and close follow-up of an isolated incisional infection may ultimately salvage the implant and prevent a potentially high-risk extraction. With a suspected incision infection, the white blood cell count should be checked as a preliminary evaluation for systemic infection. If this value is within normal range and no other signs of pocket or systemic infection are present, including fever, chills, malaise, edema, erythema, or fluctuance of the pocket, it may be reasonable to start the patient on a course of antibiotics and commence weekly follow-up until the incision is fully healed. The patient should be provided with strict instructions on incision care and antibiotic compliance as well as directions to immediately report signs or symptoms of progressing infection.
Heart Rhythm, Vol 11, No 4, April 2014 This strategy is based solely on experience, and formal investigation is needed.
9. What can be done to prevent hypertrophic scar and keloid formation? Hypertrophic scars and keloids present a significant cosmetic challenge and may cause chronic discomfort for patients. Hypertrophic Scar Hypertrophic scars are overgrowth of fibrous tissue, which does not extend beyond the borders of the original wound. Although unattractive, they often resolve without intervention and are readily preventable by proper surgical and suturing techniques.31 Keloids Keloids are histologically distinct from normal scar tissue. They demonstrate thick, eosinophilic collagen bundles, higher blood vessel density, mesenchymal cells, and a thickened epidermal layer.31,32 Collagen synthesis in keloids is up to 20 times greater than in normal scar tissue. Keloids exhibit increased production of tumor necrosis factor (TNF)α, interferon (IFN)-β, and interleukin 6, all of which perpetuate scar formation.31 Keloid formation has a strong genetic basis, and patients with a personal or family history of keloids require special attention to optimize surgical results. Factors that contribute to both hypertrophic scars and keloids include mechanical force applied intraoperatively by the implanter or postoperatively by natural body movements, wound infection, and reaction to foreign bodies, such as suture material.32 These items have each been addressed in the prior topics.
10. How can keloids and hypertrophic scars be treated? Hypertrophic scars and keloids can be cosmetically displeasing as well as uncomfortable and even painful. Many hypertrophic scars will resolve as the scar matures. However, this can take as long as 2 to 5 years, which may not be acceptable to the patient. Keloids do not resolve without intervention.31 Several options exist for treatment of keloids and hypertrophic scars, many of which are viable options for patients with CIEDs. Gel Sheeting Gel sheeting, such as silicone dressings, can be used to accelerate maturation of hypertrophic scars, decreasing scar thickness and rigidity, pruritus, and pain.31 For keloids, gel sheeting cannot provide adequate treatment but can be used as an adjunct to other therapies.32 Corticosteroids Topical corticosteroid application is ineffective in reducing scar tissue. However, intradermal corticosteroid injection is first-line therapy for both hypertrophic scars and
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keloids.31,32 Corticosteroids decrease inflammation, suppress fibroblast proliferation and collagen synthesis, and promote collagen degeneration. The negative effects of intradermal corticosteroids include dermal atrophy and hypopigmentation.31 Cryotherapy Cryotherapy is also first-line therapy in keloid treatment, although it is not routinely used for hypertrophic scars. Cryotherapy is administered as a topical spray or with a cryogenic probe. It can decrease keloid size by 50% to 75% after 2 applications.31 Cryotherapy also can result in hypopigmentation and skin atrophy.31,32 The cryoneedle is an emerging technology that has shown superior outcomes after a single session compared to topical and contact cryotherapy, with less pain and fewer adverse reactions.31 Laser Therapy Laser therapy is another first-line option for treatment of keloids. Pulse dyed laser (PDL) is the most effective, although some data demonstrate high recurrence rates when it is used as the sole therapy. Accordingly, laser therapy is often combined with corticosteroid injection.31 The depth of laser penetration is generally 0.5 to 1 mm, so contact with CIED components should not be of concern.32 Other Options Surgical resection or shave excision of keloids may be recommended in severe cases. In addition, immunosuppressive and antitumor agents such as imiquimod, 5-fluorourcil, bleomycin, and mitomycin-C can be used. However, many of these agents have been studied only in conjunction with surgical resection or shave excision of the scar.31 Given the proximity of the scar to the CIED components and the potential consequences of a complication, these methods should be avoided when treating keloids at CIED incisions.32
References 1. Martindale RG, Deveney CW. Preoperative risk reduction: strategies to optimize outcomes. Surg Clin North Am 2013;93:1041–1055. 2. Webster J, Osborne S. Preoperative bathing or showering with skin antiseptics to prevent surgical site infection. Cochrane Database Syst Rev 2012:9;CD004985 3. Tanner J, Norrie P, Melen K. Preoperative hair removal to reduce surgical site infection. Cochrane Database Syst Rev 2011;11;CD004122 4. O’Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related infections, 2011. Centers for Disease Control and Prevention. Healthcare Infection Control Practices Advisory Committee (HICPAC) 2011:7–14. 5. Darouiche RO, Wall MJ, Itani KM, et al. Chlorhexidine-alcohol versus povidoneiodine for surgical-site antisepsis. N Engl J Med 2010;362:18–26. 6. CareFusion. ChloraPrep One-Step Applicator. El Paso, TX: CareFusion Corporation, 2010.
741 7. Bratzler DW, Dellinger EP, Olsen KM, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt) 2013;14:73–156. 8. Atiyeh BS, Ioannovich J, Al-amm CA, El-musa KA, Dham R. Improving scar quality: a prospective clinical study. Aesthetic Plast Surg 2002;26:470–476. 9. Han SE, Ryoo ST, Lim SY, Pyon JK, Bang SI, Oh KS, Mun GH. Minimizing surgical skin incision scars with a latex surgical glove. Aesthetic Plast Surg 2013;37:459–462. 10. Bhattacharya V, Mishra B, Mishra B, Kumar U, Bhattacharya S. Effect of surgical traumas on microcirculation. Indian J Plast Surg 2009;42:146–149. 11. Hochberg J, Meyer KM, Marion MD. Suture choice and other methods of skin closure. Surg Clin North Am 2009;89:627–641. 12. Masini BD, Stinner DJ, Waterman SM, Wenke JC. Bacterial adherence to suture materials. J Surg Educ 2011;68:101–104. 13. Yang YL, Xiang YY, Jin LP, Pan YF, Zhou SM, Zhang XH, Qu JM. Closure of skin incision after thyroidectomy through a supraclavicular approach: a comparison between tissue adhesive and staples. Scand J Surg 2013;102:234–240. 14. Ethicon. Dermabond Topical Skin Adhesive. Somerville, NJ: Ethicon, 2000. 15. Lazar HL, Mccann J, Fitzgerald CA, Cabral HJ. Adhesive strips versus subcuticular suture for mediansternotomy wound closure. J Card Surg 2011;26: 344–347. 16. 3M Health Care. 3M Steri-Strip Adhesive Skin Closures (reinforced): Commonly Asked Questions. St. Paul, MN: 3M Health Care, 2002. 17. Ethicon. Dermabond Advanced: Caring For Your Wound. Somerville, NJ: Ethicon, 2011. 18. Kutinsky IB, Jarandilla R, Jewett M, Haines DE. Risk of hematoma complications after device implant in the clopidogrel era. Circ Arrhythm Electrophysiol 2010;3:312–318. 19. Henley J, Brewer JD. Newer hemostatic agents used in the practice of dermatologic surgery. Dermatol Res Pract 2013;2013:279–289. 20. Thal S, Moukabary T, Boyella R, et al. The relationship between warfarin, aspirin, and clopidogrel continuation in the peri-procedural period and the incidence of hematoma formation after device implantation. Pacing Clin Electrophysiol 2010;33:385–388. 21. Bernard ML, Shotwell M, Nietert PJ, Gold MR. Meta-analysis of bleeding complications associated with cardiac rhythm device implantation. Circ Arrhythm Electrophysiol 2012;5:468–474. 22. Liew A, Douketis J. Perioperative management of patients who are receiving a novel oral anticoagulant. Intern Emerg Med 2013;8:477–484. 23. Rowley CP, Bernard ML, Brabham WW, et al. Safety of continuous anticoagulation with dabigatran during implantation of cardiac rhythm devices. Am J Cardiol 2013;111:1165–1168. 24. Milic DJ, Perisic ZD, Zivic SS, et al. Prevention of pocket related complications with fibrin sealant in patients undergoing pacemaker implantation who are receiving anticoagulant treatment. Europace 2005;7:374–379. 25. Glick JB, Kaur RR, Siegel D. Achieving hemostasis in dermatology-Part II: Topical hemostatic agents. Indian Dermatol Online J 2013;4:172–176. 26. Piromchai P, Vatanasapt P, Reechaipichitkul W, Phuttharak W, Thanaviratananich S. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study. BMC Ear Nose Throat Disord 2008;8:1. 27. Wiegand UK, LeJeune D, Boguschewski F, et al. Pocket hematoma after pacemaker or implantable cardioverter defibrillator surgery: influence of patient morbidity, operation strategy, and perioperative antiplatelet/anticoagulation therapy. Chest 2004;126:1177–1186. 28. Doughty DB. Preventing and managing surgical wound dehiscence. Adv Skin Wound Care 2005;18:319–322. 29. Fenoy AJ, Simpson RK. Management of device-related wound complications in deep brain stimulation surgery. J Neurosurg 2012;116:1324–1332. 30. Margey R, Mccann H, Blake G, et al. Contemporary management of and outcomes from cardiac device related infections. Europace 2010;12:64–70. 31. Love PB, Kundu RV. Keloids: an update on medical and surgical treatments. J Drugs Dermatol 2013;12:403–409. 32. Ogawa R. The most current algorithms for the treatment and prevention of hypertrophic scars and keloids. Plast Reconstr Surg 2010;125:557–568.
