Reducing the Risk of Transvenous Lead Damage During Pacemaker and ICD Generator Replacement

Reducing the Risk of Transvenous Lead Damage During Pacemaker and ICD Generator Replacement
Reducing the Risk of Transvenous Lead Damage During Pacemaker and ICD Generator Replacement
Reducing the Risk of Transvenous Lead Damage During Pacemaker and ICD Generator Replacement
Reducing the Risk of Transvenous Lead Damage During Pacemaker and ICD Generator Replacement
Reducing the Risk of Transvenous Lead Damage During Pacemaker and ICD Generator Replacement
Reducing the Risk of Transvenous Lead Damage During Pacemaker and ICD Generator Replacement
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Author(s): 

Joshua G. Vose, MD and Mark A. Marieb, MD*
*Clinical Director of Electrophysiology, Yale University School of Medicine, New Haven, Connecticut

The PEAK PlasmaBlade (PEAK Surgical, Inc., Palo Alto, CA) is a novel, low-temperature electrosurgical device originally designed for precision dissection with minimal thermal injury to adjacent tissue. However, there is an additional benefit for cardiologists and electrophysiologists: decreased potential for thermal damage to the insulation of indwelling leads.

In this article, we will discuss the differences between conventional electrosurgical systems and the PlasmaBlade, with a focus on thermal damage to indwelling pacer/defibrillator leads. We also summarize in vitro data regarding the differential effects of these instruments on transvenous lead insulation materials.

Indwelling Lead Damage: A Dangerous and Expensive Problem
Silicone rubber, polyurethane, and silicone-urethane copolymers are widely used in the production of transvenous pacing and defibrillator leads due to their favorable flexibility, insulative and tunneling characteristics. Though widely available and cost effective, they are susceptible to damage from high-temperature electrosurgical instruments.1,2 Clinically, this is of greatest concern during pacemaker and implantable defibrillator generator changes and replacements, where sufficient healing has occurred since the initial implantation so as to render the device and leads effectively embedded in the tissue. In such a situation, dissection using a conventional electrosurgical instrument simplifies device and lead removal compared to the use of surgical scissors; however, surgeons are routinely advised by generator and lead manufacturers to maintain operative vigilance and use low-power settings to avoid thermal damage.3 Unfortunately, this is not always practical or possible.

Damage to transvenous leads from high-temperature electrosurgical devices during generator replacement may be significantly underreported, despite having important consequences, as much of the damage may be microscopic. There are limited options for handling a damaged lead. One solution, lead extraction with reimplantation, carries significant morbidity and mortality and requires expertise and special equipment to carry out. Reimplantation alone is complicated by the frequent incidence of chronic venous occlusion in patients with indwelling pacer/defibrillator leads. Overall, the need for additional surgical intervention involves significant risk, including increased length of stay and death, as well as serious financial implications, averaging between $5,000 and $20,000 per incident.8

Expanding indications for defibrillator implantation, the growing market for pacemakers due to the overall aging population, and the fact that people are living longer with these indwelling devices mean that generator replacement procedures comprise an increasing portion of many electrophysiologists’ practices. Proficiency with appropriate repair and replacement techniques is necessary and critical, but technology that can decrease the potential for thermal damage to transvenous leads in the first place is even more desirable and of obvious benefit to both patient and electrophysiologist.

References: 

1.) Hollmann R, Hort CE, Kammer E, et al. Smoke in the operating theater: An unregarded source of danger. Plas Reconstr Surg 2004;114:458-463. 2.) Weisberg IL, Desai S, Davison P, et al. Effects of Pulsed RF Energy Compared to Standard Electrosurgery on Transvenous Lead Insulation Materials. Presentation at Heart Rhythm Society Annual Meeting, 2010. Denver, Colorado. 3.) DEXTRUS™ Pacing Lead: Prescriptive Information (Rev. C). Boston Scientific, Inc. http://www.bostonscientific.com/Device.bsci?page=ResourceDetail&navRelId.... Accessed: February 23, 2010. 4.) Manzoor Ali S, Iqbal K, Tramboo NA, et al. A novel way of repair of insulation breaks during pacemaker generator replacement. Indian Pacing Electrophysiol J 2009;9:276-277. 5.) Mahapatra S, Homoud MK, Wang PJ, et al. Durability of repaired sensing leads equivalent to that of new leads in implantable cardioverter defibrillator patients with sensing abnormalities. Pacing Clin Electrophysiol 2003;26:2225-2229. 6.) Lickfett L, Bitzen A, Arepally A, et al. Incidence of venous obstruction following insertion of an implantable cardioverter defibrillator. A study of systematic contrast venography on patients presenting for their first elective ICD generator replacement. Europace 2004;6:25-31. 7.) Oginosawa Y, Abe H, Nakashima Y. Prevalence of venous anatomic variants and occlusion among patients undergoing implantation of transvenous leads. Pacing Clin Electrophysiol 2005;28:425-428. 8.) Lim KK, Reddy S, Desai S, et al. Effects of electrocautery on transvenous lead insulation materials. J Cardiovasc Electrophysiol 2009;20:429-435. 9.) Bovie WT. New electro-surgical unit with preliminary note on new surgical current generator. Surg Gynecol Obstet 1928;47:751-784. 10.) Loh SA, Carlson GA, Chang EI, et al. Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. Plast Reconstr Surg 2009;124:1849-1859. 11.) Tipton WW, Garrick JG, Riggins RS. Healing of electrosurgical and scalpel wounds in rabbits. J Bone Joint Surg Am 1975;57:377-379. 12.) Palanker DV, Vankov A, Huie P. Electrosurgery with cellular precision. IEEE Trans Biomed Eng 2008;55:838-841. 13.) Rosenberg HL, Vose JG, Atmodjo DY, et al. A Randomized Controlled Trial of the PEAK PlasmaBlade in Abdominoplasty Compared to Scalpel and Traditional Electrosurgery. Presentation at the American College of Surgeons Annual Meeting, 2009. Chicago, Illinois. 14.) Vose JG, McAdara-Berkowitz J. Reducing scalpel injuries in the operating room. AORN J 2009;90:867-872.

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