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- Klug, D., et al. (2004). Local symptoms at the site of pacemaker implantation indicate latent systemic infection. Heart, 90(8), 882-886.
- Sohail, MR, et al. Management and outcome of permanent and implantable cardioverterdefibrillator infections. J Am Coll Cardiol. 2007;49:1851–1859
- Margey, R. et al. Contemporary management of and outcomes from cardiac device related infections Europace (2010) 12 (1): 64-70 first published online November 11,2009 doi:10.1093/ europace/eup362.
- del Rio, A, Anguera I, Miro JM, et al. Surgical treatment of pacemaker and defibrillator lead endocarditis: the impact of electrode lead extraction on outcome. Chest 2003;124:1451–9.
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- Hussein et al. Microbiology of Cardiac Implantable Electronic Device Infections. J Am CollCardiolEP 2016;2:498–505 CircArrhythmElectrophysiol.
- Wilkoff, B.L., et al. (2009). Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications and patient management. HeartRhythm, 6, 1085-1104.
- Klug, Didier, et al. “Involvement of adherence and adhesion Staphylococcus epidermidis genes in pacemaker lead-associated infections.” Journal of clinical microbiology 41.7 (2003): 3348-3350.
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GlideLight laser sheath
The GlideLight laser sheath is intended for use with other lead extraction tools in patients who are suitable candidates for removal of implanted pacemaker and defibrillator leads. The use of the GlideLight laser sheath may be unsafe in some patients, or with certain leads, or when the leads cannot be extracted through the superior veins (that is, when groin or surgical extraction is required). Rarely a patient undergoing lead extraction may require urgent surgical treatment for a complication; therefore, patients should not undergo lead extraction with a laser sheath in centers where emergency surgical procedures cannot be performed. Leads not intended for extraction may be damaged during the procedure and may require replacement. Ask your doctor if you are a candidate for lead extraction with the GlideLight laser sheath.
Potential minor adverse events associated with lead extraction procedures that may or may not require medical or surgical treatment include: a tear or damage to the blood vessels, the heart or its structures; bleeding at the surgical site; or collapsed lung. Rare but serious adverse events that require emergency medical or surgical procedures may include: a tear or damage to the blood vessels, the heart, lungs or their structures; blood clot or obstruction of the blood vessels or lungs by debris or lead fragments. Other serious complications may include: irregular heartbeat, weakened heart muscle, infection, respiratory failure or complications associated with anesthesia, stroke or death.
This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.
Bridge occlusion balloon
The Bridge occlusion balloon is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Use of the Bridge occlusion balloon in procedures other than those indicated is not recommended. The adverse events associated with an occlusion balloon procedure include, but are not limited to allergic reactions, death, embolization, hematoma, hemorrhage, sepsis/infection, short-term hemodynamic deterioration, thromboembolic episodes, vascular thrombosis, vessel dissection, vessel perforation, vessel spasm. In order to facilitate rapid delivery, it is recommended that a guidewire is in place in the superior vena cava prior to beginning the lead extraction procedure. Attempting to place the guidewire after a tear has occurred may:
• Result in an inability to traverse the superior vena cava with the guidewire
• Result in the guidewire exiting the vasculature at the tear site
• Result in an inability to place the Bridge occlusion balloon catheter
• Delay or prevent the ability to achieve occlusion
This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you