Laser-based extraction of pacemaker or defibrillator leads could pose a higher risk of death than cutting sheath systems, according to a new meta-analysis study reported by Medscape.
In the analysis, researchers found a ninefold increase in mortality associated with the procedures when they were performed using a popular excimer laser lead-extraction sheath when compared against sheaths that use a metal blade. The team examined a total of nearly 9,000 cases in the meta-analysis, according to the report.
Results from the study were presented at the American College of Cardiology’s 2018 annual scientific sessions and covered transvenous lead extractions across 7,775 patients in 33 studies involving the laser sheath against 1,094 patients in 14 studies using the rotating cutting sheath, Medscape reports.
While only a single study, the results are “compelling” and should be a call to report more procedural data related to transvenous lead extractions, Dr. Raymond Schaerf of Burbank, Calif.’s Providence St. Joseph Medical Center said, according to the report.
“The major articles that talk about the risk wildly underestimate what the risk is,” Schaerf said, according to Medscape.
Other experts in the field disagreed, including Dr. Roger Carrillo of the University of Miami Miller School of Medicine, who commented on behalf of Royal Philips (NYSE:PHG) subsidiary Spectranetics, according to the report.
“The way this data is presented is not an effective way to compare two different sets of extraction tools,” he commented, according to MedScape.
Dr. Carrillo claims that the studies making up the meta-analysis use different methods of inconsistent entry criteria, leaving a potential for confounding.
Study senior author Dr. Byron Lee said that confounds wouldn’t account for the increased risk in the analysis, but admitted to some potential sources of bias in the study.
Such confounds included issues with patient selection and increase in recent availability for rotating-cutting-sheath procedures, Lee said according to Medscape.
The relative mortality risk with respect to cutting sheath systems was 0.09%, compared to 0.85% with laser sheaths, data from the study indicates, with findings turning out similar when the analysis was restricted to medium and high-volume transvenous lead extraction centers.
Potential complications from the laser-based systems could be due to combination of both thermal and mechanical trauma possible with the laser system, researchers commented in the report.