Treatments & Devices
Cardiac Lead Removal
General Principle
A key challenge in removing a pacemaker or defribrillator lead from the heart is overcoming the fibrous tissue that grows around around the lead around the lead and adheres to it. The Spectranetics Laser Sheath (SLS II®) delivers ultraviolet light generated by the Spectranetics Excimer Laser system to free leads from this binding tissue.
A ring of laser energy gently breaks down the scar tissue into particles that are easily absorbed into the blood stream. This process frees the lead from the binding tissue and enables the physician to remove the lead in a controlled fashion.
Indications for lead removal
Why do Cardiac Leads need to be taken out?
- The lead is damaged.
The lead requires more energy to function than the device (pacemaker or ICD) is able to deliver.
There is an infection at the implant site of the lead.
The lead is interfering with blood flow back to the heart.
The lead is interfering with other leads or may interfere with new lead(s) that need to be placed in your heart.
An important recent development has been the importance of extraction
procedures to manage malfunctioning, abandoned, and infected leads. The Heart Rhythm Society in 2009 updated practice guidelines for transvenous lead extraction procedures. Although it has long been accepted that overtly infected leads can be managed only with extraction of all implanted hardware, the new guidelines emphasize that leads may need to be removed for the management of patients with chronic pocket pain, occult bacteremia, malfunctions, and to prevent abandonment when system revisions are necessary.
The Lead Removal Procedure
The laser is calibrated before the start of the procedure. An incision is made and the old device is removed. According to the size of the leads, an appropriate lead locking stylet is advanced to the tip of the lead and a suture string is deployed on the outer surface. The laser is deployed over the sheath and under fluoroscopic guidance, binding sites are ablated using short bursts of laser energy. Traction–countertraction is employed to remove the last embedded portion of the lead and if indicated, a new system can be re-implanted immediately after extraction. Major complications rarely occur with this technique, and include tamponade, hemothorax, pulmonary embolism, lead migration and death.
Image courtesy of The Spectranetics Corporation ©
Outcomes
Laser-assisted lead extraction has been shown to be highly successful with a low procedural complication rate. One of the largest initial studies was reported in 2000; this study examined 1684 patients who underwent lead extraction at one of 89 centers. Laser lead extraction was successful in 93% of cases, with a complication rate of 2%.
The PLEXUS trial compared laser assisted extraction with standard extraction. In 301 patients, complete lead removal was achieved in 94% with the Laser as opposed to only 64% in the standard group; the major complication rate was 1.96%.
A larger study has recently reported on the safety and efficacy of laser extraction in a more contemporary period. The LEXICON study, reported in early 2010, evaluated 1449 patients who underwent laser lead extraction and reported a clinical success rate of 97.7%, a complete lead removal rate of 96.5%, and a major complication rate of only 1.4%.
While lead extraction has historically been thought of as a procedure with significant morbidity and mortality, the development of new technologies is allowing the procedure to be performed with a very low complication rate. For example, the LExICon (Lead extraction in Contemporary Settings) study (1,449 patients at 13 centers) demonstrated that extraction using a laser sheath had a 98% clinical success rate with only 0.3% procedural mortality. The importance of lead management and the role of various transvenous .
The physicians of the Arrhythmia Institute are considered experts in the field of transvenous lead extraction techniques. Patients can be treated effectively with high clinical success rates and <1% major complication rates which are at par with other high volume extraction centers. Drs Mittal and Arshad also serve as proctors for these techniques nationally.
Source: © Heart Rhythm Society
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