Vibrations used to extract EP leads in first-in-human study
As patients with implantable electrophysiology (EP) devices live longer and due to issues with malfunction or infection, there has been expanding use of lead management programs to remove old leads. However, there is still some apprehension due to risks of vessel perforation, bleeding and surrounding tissue collateral damage using tissue cutting and laser devices. JACC: Clinical Electrophysiology recently published details for a first-in-human study using vibrations to safely remove leads encased inside vessel walls.[1]
"This novel vibration-based extraction technique exhibited excellent safety and efficiency profiles in preclinical and initial human study, potentially offering a simple, rapid, and safe alternative to conventional extraction methods," wrote lead author Orr Tomer, MD, MSc, Department of Cardiology, Hadassah Medical Center and faculty of medicine, Hebrew University of Jerusalem, Israel.
The new technique uses a thin guide wire locking stylet that is inserted into the implanted wire to deliver vibrations. These vibrations loosen the wire from the surrounding scar tissue, allowing physicians to remove the wire with less resistance.
The prospective study was conducted at two academic medical centers, Hadassah Medical Center in Jerusalem, and Clinical Provincial Hospital No. 2 in Rzeszów, Poland. It enrolled 10 consecutive patients who needed a total of 18 lead extractions. The primary endpoints were complete procedural success and absence of major complications. The secondary endpoint was successful extraction of all leads without conventional tools.
Complete extraction was achieved in all 10 cases with no device-related complications during the procedure or at one-month follow-up. These cases included the extraction of 12 pacemaker leads, 4 implantable cardiac-defibrillator (ICD) leads, and 2 coronary sinus leads. The mean dwell time was 48.6 ± 21.74 months (21-78 months). Mean lead vibration time was 40 seconds (6-176 seconds).
Tomer et al said the new lead extraction technology has the potential to offer a simple, rapid and safe alternative to conventional extraction methods.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]