Recent discussions have questioned the safety and efficacy of transvenous cardiac leads. However, the OPTIMUM Registry has evaluated the safety of the Optim lead, which houses an Optim (copolymer of polyurethane and silicone, St. Jude Medical) insulation material, and found very few adverse events related to lead use, according to results presented May 5 at the annual Heart Rhythm Society (HRS) meeting in San Francisco.
“Long-term performance data for implanted cardiac leads are very limited,” Steven M. Greenberg, MD, of the St. Francis Hospital in Roslyn, N.Y., and colleagues wrote. The OPTIMUM Registry aimed to evaluate the long-term outcomes and reliability of the new hybrid optim lead.
To do so, the researchers analyzed pacemaker and implantable cardioverter-defibrillator (ICD) patients implanted with at least one Optim lead. The mean follow-up for these patients was 24.7 months and demographics, thresholds and adverse events were reported.
Greenberg and colleagues defined adverse events as conductor fractures, lead dislodgements, insulation breaches and perforations and calculated for high voltage, low voltage right ventricle (RV) and right atrial (RA) leads. Greenberg et al calculated 24-month event-free survival rates for each lead.
The study included 13,982 patients who were implanted with a total of 20,806 leads. This included 5,946 high voltage leads and 14,860 low voltage leads. Of these leads, 6,254 were placed in the RV and 8,606 in the RA.
The researchers reported that conductor fracture occurred only in four leads and the rates for dislodgement was 0.89 percent. Additionally, insulation breaches and lead perforations occurred at rates of 0.03 percent and 0.12 percent, respectively. Event-rate survival was reported to be 98.5 percent for high voltage, 99.1 percent for low voltage RV and 99.1 percent for RA leads.
“The rate of acute and chronic lead related adverse events in optim leads is extremely low,” Greenberg reported. Additionally, he concluded that high voltage and low voltage leads showed similar reliability.