Feb 3 2010
Spectranetics Corporation (NASDAQ: SPNC) today announced publication of the four-year, retrospective LExICon (Lead Extraction in Contemporary Settings) study in the February 9th issue of the Journal of American College of Cardiology. The study evaluated the safety and efficacy of laser assisted lead removal using the Spectranetics laser sheath (SLS® II).
The LExICon study, an observational, multicenter, retrospective study, was designed to examine the safety and effectiveness of laser assisted lead removal and the indications, outcomes, and risk factors in a large series of consecutive patients. The study further sought to determine clinical and procedural success and complication types, and identify relationships between complication factors including duration of implant, lead type, lead position, center experience, age and gender. LExICon evaluated the removal of 2,405 leads in 1,449 patients at 13 centers experienced in lead extraction from the United States and Canada between January 2004 and December 2007.
Resulting key data points include:
- 97.7% clinical success rate
- 96.5% complete lead removal success rate
- 1.4% major adverse event rate
- 0.28% procedural mortality rate
- Procedural failure is highly associated with lead implant duration ≥10 years
“Indications for lead removal fall into three basic categories, infection, lead malfunction and access for new leads,” said Dr. Bruce Wilkoff, principal investigator of the study, and Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic. “Lead abandonment is still reasonable under some circumstance but it is no longer the clear standard of care. The LExICon study quantifies the risks of laser assisted lead removal and illustrates the clear benefits for many patients. It is the responsibility of physicians to be trained on all safe and effective lead management techniques to ensure patients receive the highest possible quality of care.”
Infection is a common reason for considering lead removal. In the LExICon study, infection was the most frequent indication for removal; 57% of procedures performed were due to infection. Even though patients with either a pocket infection or device-related endocarditis (DRE) including sepsis and bacteremia had a higher overall mortality than patients without infections, there was no statistical difference in extraction success or extraction procedure mortality for patients without infection, pocket infections or patients with DRE. Consequently, the data supported that there is often more risk from the infection, particularly in the setting of renal insufficiency or diabetes than there is from the lead removal in experienced extraction centers.
The study also examined the challenges of removing leads after increased time and found greater procedural failure when leads have been implanted for greater than or equal to 10 years. This illustrates the importance of a proactive lead management strategy that aligns with the 2009 Heart Rhythm Society Expert Consensus statement about lead removal.
“As an increasing number of patients receive implantable cardiac devices, lead management strategies are adapting to meet the needs of a vast patient population. The LExICon study demonstrates the safety and effectiveness of laser assisted lead removal,” said Emile J. Geisenheimer, Chairman, President and Chief Executive Officer of Spectranetics. “Spectranetics is working closely with the medical community to train physicians in this technique to ensure that all patients suffering from lead related malfunction, infection and other issues that may necessitate removal, have access to this proven technology.”