The most serious subacute complication of cardiac implantable electronic device (CIED) implant, upgrade or replacement is infection requiring removal of all hardware. The incidence of such infections has recently reported to be increased from prior data reports, and is now as high as 2.4%.1
Risk factors for device infection have been described, and include renal insufficiency, length of procedure, multiple leads, male gender, diabetes, hematoma, and upgrade or generator replacement versus new implant. Financial ramifications of such infections are estimated to be as much as $146,000 per infection.1 In addition, CMS has recently indicated that these infections are considered avoidable — therefore, hospitals may not be reimbursed for expenses related to system removal and replacement. (Inpatient prospective payment system and fiscal year 2013-Final Rule, CMS.)
There is data that suggests the method of skin closure may be a contributing factor toward avoiding such complications. Options for skin closure include subcuticular reabsorbable suture (braided versus monofilament), surgical “glue”, and staples. A large meta-analysis of non-orthopedic cases comparing suture closure to staples in over 1,500 patients showed a significant reduction in infection with staple use, with an odds ratio of 2.02.2 In addition, closure with staples resulted in a 5.56-minute shorter average closure time. A prospective study of 368 patients by Spencker et al comparing suture versus skin adhesive showed an increase in several complications, including infection (p=0.02) in the adhesive group versus suture group.3
The use of staples has potential issues as well, including requiring “skills” to place and remove the staples as well as the need for and cost of a removal device. In addition, staples perforate the skin to a variable extent, adding to the potential for local infection, and the use of staples is associated with increased pain and patient anxiety, as discussed in the meta-analysis above. Staple skin closure may also contribute to potential long-term cosmetic issues.
Recently a new “non-invasive” device for skin closure (Zip® Surgical Skin Closure, ZipLine Medical, Inc.) was approved in 2012 for low-tension surgical wounds. The device is the brainchild of Dr. Amir Belson, a physician who searched for a better cosmetic solution to skin closure than staples during his OB/GYN rotation. It is a sterile single-use system that has two self-adhesive hydrocolloid pressure-sensitive strips that are linked with individually adjustable self-locking fasteners (Figure 1). The device uses an integrated linkage to provide uniform wound closure force distribution and stress shielding to help relieve potential forces on the surgical wound from patient-induced “distraction forces”. The Zip® is extremely easy to apply and leads to slight eversion of the skin edges, which is felt to be an advantage of traditional staples as well. After 9-14 post-op days, the device is simply peeled off. There is a cost upcharge of approximately $35 compared to suture closure, and $25 versus staple closure (including staple remover).
After fascia and subcutaneous closure have been performed, the surgical site is wiped clean and dry. The Zip® device is then trimmed to length, the exposed adhesive strips are placed over the wound, and gentle pressure is applied. The last step is to pull appropriate tension with the rings on the individual adjustable fasteners and the excess fastener pieces are cut off (Figure 2). As a final option, medical “glue” can be applied to the site.
The Zip® was formally evaluated by a dermatologist in 3 patients with melanoma excision; it was found to be comparable to suture and staple results with regard to any wound or patient issues, and has eliminated costs and patient anxiety associated with suture or staple removal.4 The device has been shown to save 5-8 minutes during incision closure.5
We have used this device in over 2 dozen device patients at The Cardiology Center (DSG) over the last 6 months, and there have been no procedure-related issues including infection, etc. Cosmetic results and patient satisfaction have been excellent. Figure 3 shows a healed incision 2 weeks post-device implant. Prospective studies to evaluate time, economic and cosmetic benefit of the device are currently underway.
In summary, this is a skin closure option that is easy and quick to apply and remove, and produces excellent cosmetic results. Although this new device is associated with a minimal expense upcharge, the benefits, including the potential for decrease in CIED infections, make it attractive and worth considering for skin closure in device patients, particularly those at increased risk of complications.
Disclosures: The authors have no conflicts of interest to report regarding the article herein.
- Greenspan A, Patel J, Lau E, et al. 16-Year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States. J Am Coll Cardiol. 2011;58:1001-1006.
- Iavazzo C, Gkegkes I, Vouloumanou F, et al. Sutures versus staples for the management of surgical wounds: A meta-analysis of randomized controlled trials. Am Surg. 2011;77(9):1206-1221.
- Spencker S, Coban N, Koch L, et al. Comparison of skin adhesive and absorbable intracutaneous suture for the implantation of cardiac rhythm devices. Europace. 2011;13:416-420.
- Gorsulowsky D. A novel non-invasive wound closure device as the final layer in skin closure: Excellent patient comfort and cosmetic results. ZipLine Medical, Inc. 2013.
- Data from ZipLine Medical, Inc.