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Journal of Arrhythmia 30 (2014) 92–94

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Journal of Arrhythmia

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Review Pocket creation in the prepectoral subfascial position for the implantation of a cardiac implantable electrical device

Katsuhiko Imai n

Department of Cardiovascular Surgery, Hiroshima University Hospital, 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan

article info abstract

Article history: Pockets created in the prepectoral subcutaneous space in electrophysiology laboratories for the Received 14 January 2014 implantation of a cardiac implantable electrical device (CIED) have several advantages; however, lean Accepted 20 February 2014 or small subjects are thought to cause pocket erosion. To minimize such traumatic pocket complications, Available online 4 April 2014 prepectoral subfascial implantation has been employed since the early 1990s. In this paper, we introduce Keywords: a method for prepectoral subfascial pocket creation. Prepectoral subfascial pocket & 2014 Japanese Heart Rhythm Society. Published by Elsevier B.V. All rights reserved. Cardiac implantable electrical devices Implantation technique Complication Infection

Contents

1. Introduction ...... 92 2. Materials and methods ...... 93 2.1. Procedure...... 93 2.1.1. Incision...... 93 2.1.2. Pocket...... 93 3. Discussion ...... 93 Conflictofinterest...... 94 References...... 94

1. Introduction and radiological equipment. CIEDs can be implanted in pockets created in the prepectoral subcutaneous space. However, subcutaneous pocket In recent years, the development of transvenous electrodes and creation for lean or small objects thought to lead to pocket erosion, downsized generators has permitted electrophysiologists to implant especially in Japanese individuals, beneath the major pectoralis muscle cardiac implantable electrical devices (CIEDs), including high vol- has been recommended [6–8]. Because the creation of such pockets tage devices such as implantable cardioverter-defibrillators or requires deep dissection, traumatic injury of small vessels or , cardiac resynchronization therapy devices with defibrillators, using accidental bleeding, or postoperative hematoma may occur. Further, techniques similar to those employed for the insertion of perma- hematomas within the pockets, complicating CIED placement, have nent pacemakers [1–5]. Implantation of CIEDs by cardiologists in been identified as risk factors for pocket infections and have been electrophysiology laboratories has several advantages such as sup- associated with CIED replacement [9]. Thus, it is desirable to prevent port by a specialized staff and availability of appropriate monitoring hematoma formation during the procedure. To minimize traumatic pocket complications, prepectoral sub- fascial implantation has been employed mainly for large devices n Tel.: þ81 82 257 5216; fax: þ81 82 257 5219. since the early 1990s [10]. However, there are few data to support E-mail address: [email protected] this method of implantation. Because we also employ this

http://dx.doi.org/10.1016/j.joa.2014.02.008 1880-4276/& 2014 Japanese Heart Rhythm Society. Published by Elsevier B.V. All rights reserved. K. Imai / Journal of Arrhythmia 30 (2014) 92–94 93 procedure at our institute, we introduce our method for prepec- toral subfascial pocket creation in the present study. Small forceps

2. Materials and methods Subcutaneous fat 2.1. Procedure Skin 2.1.1. Incision (Deep) A poorly made incision can interfere with venous access, making pocket creation difficult, potentially leading to a poor cosmetic result. We usually employed the “horizontal” or “obli- que” incision line. For the “horizontal” incision, the cut was made starting approximately 1–2 cm below the junction of the middle and lateral thirds of the clavicle, extending laterally to cross the deltopectoral groove by approximately 1 cm. The “oblique” incision was made parallel and approximately 1–2 cm below the lateral third of the clavicle. The total length of the incision (4–5 cm) varies depending on the size of the device and thickness (Pectoral) muscle of the subcutaneous layer (a longer incision is required for thicker Fig. 2. By grasping and holding the caudal edge of the fascia using forceps (dotted tissue). Tracing the shape of the entire pocket and incision line arrow) so that the fascia is turned over and elevated, it is easier to separate it from before starting the procedure was useful to perform the operation the major pectoralis muscle using fingers or an electrical knife if access with fingers and avoid inappropriate skin pressure from the device (Fig. 1). becomes difficult. The tissues are gently spread apart medially and caudally along A local anesthetic was infiltrated along the length of the the skin mark. The solid arrows point to the correct layer. intended incision as well as more deeply and slightly medially in preparation for the device pocket creation. Although guidelines muscles into compartments. The high density of fibers is suggest a maximum dose of 3 mg/kg of 1% lidocaine (e.g., in a responsible for the strength and integrity of the deep fascia. The 50 kg person, this equals to 15 mL) to prevent chemical addiction, elastin fiber density in the fascia determines its extensibility and a higher dose may be needed to induce adequate anesthesia. We resilience. used diluted lidocaine for the prevention of addiction. After dissecting (or superficial fascia in the American classification), deep fascia was identified because of its 2.1.2. Pocket different texture. At first, the fascial incision, approximately 1 cm For the successful creation of a prepectoral subfascial pocket, an long, was made in the center of the wound. Then, the incision line understanding of the fascial structure is essential. A fascia is a layer was extended toward both edges of the incision parallel to the skin of connective tissue that surrounds muscles, muscle groups, blood incision line. The surgeon grasped the caudal edge of the fascia so vessels, and nerves, binding some structures together while that the fascia was turned over, raised it using two or more small allowing others to slide smoothly over each other. Therefore, fascia forceps, and held it in this position. Then the entire muscle was and muscle are not adhered firmly. Instead, loose connective tissue separated from the fascia using fingers (or an electrical knife, if lies in between. According to the American and British anatomical access with fingers became difficult) by gently spreading the tissue classifications, fasciae are categorized based on their distinct apart medially and caudally along the skin mark. Thus, the pocket layers, functions, and anatomical location: superficial, deep (or was created simply by separating the fascia and muscle muscle), and visceral (or parietal) fascia. According to the Japanese (Figs. 2 and 3). The cranial edge of the fascia was also exfoliated and German classifications, fascia is defined as deep (or muscle) to approximately 0.5–1 cm so that it adhered easily. fascia. Therefore, the “pectoral fascia” is considered deep fascia. After lead placement and control of bleeding, the pocket was Deep fascia (or muscle fascia) is a layer of fibrous connective tissue flushed with enough hypothermal normal saline. The fascia was that surrounds individual muscles, and also separates groups of first closed with a continuous absorbable suture (e.g., 3-0 vicryl), followed by subcutaneous tissue. Finally, the skin was closed intradermally with a straight absorbable suture (e.g., 4-0 poly- dioxanone suture). After skin closure was complete, steri-strips were applied and the wound was covered with gauze. The bandage was not removed until 48 h after the procedure, after which the patients were allowed to shower. The steri-strips were removed when bathing was permitted, and the site could be washed.

3. Discussion

For those patients with inadequate subcutaneous tissue for satisfactory closure, creation of deep pockets beneath the major pectoralis muscle has been recommended to avoid pocket erosion. However, because intra- or submuscular pockets are associated with risks of structural trauma or bleeding, an alternative easier method is needed. The current leading method consists of sub- Fig. 1. [Marking] Before making the skin incision, the shape of the pocket should be cutaneous pocket creation directly over the fascia [11]. In this traced. This is useful to avoid inappropriate skin pressure from the device. method, the operator must find the proper plane between the 94 K. Imai / Journal of Arrhythmia 30 (2014) 92–94

Fig. 3. Intraoperative photograph showing the correct layer. F: (deep) fascia, M: (major pectoral) muscle. fascia and subcutaneous fat. In some patients, an incision within References the subcutaneous fat or between the skin and subcutaneous fat will not be much more difficult than in the accurate plane. [1] Camunas J, Mehta D, Ip J, et al. Total pectoral implantation: a new technique Inexperienced operators who do not identify the correct insertion for implantation of transvenous defibrillator lead systems and implantable fi – plane, may create the pocket incorrectly and perpetuate the error cardioverter-de brillator. Pacing Clin Electrophysiol 1993;16:1380 5. [2] Fitzpatrick AP, Lesh MD, Epstein LM, et al. Electrophysiological laboratory, by inserting the device. A subcuticular plane created by sharp electrophysiologist-implanted nonthoracotomy-implantable cardioverter/ dissection leads to device implantation between the skin and its defibrillators. Circulation 1994;89:2503–8. subcutaneous fat. Although not easily created, this plane results [3] Stanton MS, Hayes DL, Munger DM, et al. Consistent subcutaneous prepectoral fi from detachment of the skin from its fat. Consequently, device implantation of a new implantable cardioverter-de brillator. Mayo Clin Proc 1994;69:309–14. insertion in the subcuticular rather than the subcutaneous space [4] Zipes DP. The implantable cardioverter-defibrillator revolution continues. results in chronic pain. Mayo Clin Proc 1994;69:395–6. In contrast, the prepectoral subfascial pocket is simple and less [5] Tung RT, Bajaj AK. Safety of implantation of a cardioverter-defibrillator without general anesthesia in an electrophysiology laboratory. Am J Cardiol traumatic for CIED implantation because both the fascia (i.e., deep 1995;75:908–12. fascia by the American classification) and can be [6] Bardy GH, Raitt MH, Jones GK. Unipolar defibrillation systems. In: Singer I, located easily during the procedure. Even in a patient with a thin editor. Implantable cardioverter-defibrillator. Armonk, NY: Futura Publishing fatty layer, the prepectoral subfascial space allows comfortable Co; 1994. p. 365–76. [7] Foster AH. Technique for implantation of cardioverter-defibrillators in the implantation, whereas the subcuticular and subcutaneous spaces subpectoral position. Ann Thorac Surg 1995;59:764–7. do not. If subcuticular or subcutaneous placement results in pain, [8] Eastman DP, Selle JG, Reames Sr MK. Technique for subpectoral implantation the site of erroneous pacemaker placement should be reopened, of cardioverter-defibrillators. J Am Coll Surg 1995;181:475–6. and the pulse generator removed and repositioned in the proper [9] Lekkerkerker JC, van Nieuwkoop C, Trines SA, et al. Risk factors and time delay associated with cardiac device infections: Leiden Device Registry. Heart plane. This results in prompt pain relief. 2009;95:715–20. [10] Pacifico A, Wheelan RK, Nasir Jr N, et al. Long-term follow-up of cardioverter- defibrillator implanted under conscious sedation in prepectoral subfascial Conflict of interest position. Circulation 1997;95:946–50. [11] Furman S, Curtis BA, Conti JB. Recognition and correction of subcuticular malposition of pacemaker pulse generators. Pacing Clin Electrophysiol None of the authors has any conflict of interest with regard to 2001;24:1224–7. this study.