An Italian prospective multicentre registry with a large study population has demonstrated the safety and efficacy of a new hand-powered bidirectional rotational mechanical lead extraction sheath used in chronically implanted leads for more than a year.
The study, led by Patrizio Mazzone (Ospedale San Raffaele, Milan, Italy), Federico Migliore (University of Padova, Padova, Italy) and others evaluated the second generation Evolution RL mechanical extraction device (Cook Medical). This sheath, the authors comment, “has been fitted with a bidirectional rotational mechanism and a less aggressive tip, reducing the risk of damage to leads, vascular structures and myocardial tissue.”
A first generation of this device has a unidirectional rotational mechanism, which may cause a phenomenon called “lead wrapping”, especially in the presence of companion leads. This second generation device has been designed to address this issue, Mazzone et al note.
Between September 2013 and June 2016, 124 consecutive patients (84.7% male, mean age 65±14) underwent lead extraction at four centres in Italy. In total, 238 leads were removed, by using the new generation Evolution RL device, due to cardiac device infection (50.8%), lead malfunction (33.1%), upgrade (0.8%) and for other reasons (15.3%). The mean implant duration of the leads was 92.2±52.9 months. Sixty three leads had been implanted for more than 10 years.
The authors comment that all of the leads were extracted via the subclavian approach. Ninety one leads were from implantable cardioverter defibrillators (ICDs), 38 were right ventricular leads, 86 were right atrial leads and 23 were coronary sinus leads.
Mazzone et al reported that 91.6% of the leads were extracted completely with the Evolution RL alone. This success rate rose to 98.7% with the additional use of a snare. The overall clinical success rate was 100% and no complications related to the Evolution sheath were noted. The authors also highlight that there were no deaths or major complications. Five minor complications occurred: one pericardial effusion not requiring pericardiocentesis or surgical intervention, one pneumothorax and three haematoma at the pocket requiring drainage.
The authors note that initial single-centre experiences with a limited number of patients have shown promising results with the new Evolution mechanical extraction device. “Our multicentre registry with a larger study population confirmed and extended these observations, demonstrating that the new Evolution device is an effective lead extraction tool with high success rates with long-implanted leads,” they write. “The efficacy of this new extraction device is comparable with that of widely used devices and techniques.”
However, Mazzone et al suggest that larger-scale randomised prospective studies are needed to verify these findings and to compare the clinical success, safety and cost effectiveness of different mechanical lead extraction techniques and laser systems.