LEXICON Study of Lead Extraction With Spectranetics Laser Catheter
February 5, 2010 (Washington, DC) — Transvenous extraction of implanted-device leads using a laser catheter is nearly always completed successfully and poses little risk of death or other major complications, although that risk goes up in patients getting the procedure because of endocarditis, sepsis, or infection of the device pocket, concluded an analysis based on >1400 consecutive cases at 13 major centers [1]. The presence of diabetes or renal dysfunction sent mortality climbing further.

"At these experienced centers, the mechanical risk of lead extraction was relatively low," senior author Dr Bruce L Wilkoff (Cleveland Clinic, OH) told heartwire, pointing to the 1.4% rate of in-hospital major adverse events, including a 0.28% mortality, that could be traced directly to the procedure. Still, centers with a lower lead-extraction case volume were less successful at it.

Overall, the mortality rate was 1.86%, but it rose to 4.3% in patients with device-related endocarditis (DRE), 7.9% in those with such endocarditis and diabetes (vs 2% with DRE and no diabetes; p=0.0075) and 12.4% in the presence of DRE and a creatinine level of 2.0 mg/dL or higher (vs 2.0% with DRE and creatinine <2.0 mg/dL; p<0.0001).

"Diabetes and really fairly minor renal disease really increased the mortality if there was also endocarditis or a systemic infection," Wilkoff observed, emphasizing that most of the risk in the procedure was tied to the comorbidities.

The procedure is not a lot safer or a lot more dangerous with the laser than with any other method, but this is predominantly how people are doing it these days.

So, he said, "if we're going to treat these people, we need to treat them aggressively and early, because the risk isn't from the extraction, the risk is from not getting an extraction [while] the infection goes from a pocket infection to a systemic infection."

The retrospective analysis of the Lead Extraction in Contemporary Settings (LEXICON) study was published in the February 9, 2010 issue of the Journal of the American College of Cardiology, with first author Dr Oussama Wazni (Cleveland Clinic).

A total of 2405 leads, predominantly from pacemakers, were extracted from the study's 1449 patients using a laser catheter system (Spectranetics, Colorado Springs, CO), but no other competing extraction technology, during the years 2004 through 2007. The indication for extraction was pocket infection in about 28%, device-related endocarditis (defined as all nonpocket infections, including persistent bacteremia or sepsis) in about 29%, venous stenosis in 4.5%, and nonfunctional or abandoned leads in about 38%.

Leads were completely removed in 96.5% of cases ("complete procedural success") and all but a small portion of the lead came out ("partial procedural success") another 2.3% of the time, report Wazni et al; 97.7% of cases were clinical successes ("achievement of all clinical goals associated with the indication for lead removal").

In multivariate analyses, >10 years since implantation of the extracted lead predicted failure to achieve procedural success, and a patient body-mass index <25 kg/m predicted failure to achieve clinical success. Center case volume <60 over the four years predicted both kinds of failure. (Wilkoff confirmed the accuracy of these data for heartwire; he said the section of the report in which they appear contains several misprints.)

The report applies only to laser-assisted lead extractions, Wilkoff observed, but there are other catheter-based techniques. "Quite frankly, the procedure is not a lot safer or a lot more dangerous with the laser than with any other method, but this is predominantly how people are doing it these days and probably one of the better ways of doing it."

The study was sponsored by Spectranetics, for which Wilkoff reports being on an advisory board. Disclosures for the other coauthors, which include several employees of the company, are in listed in the paper.