Introduction: While several studies have reported on the reliability of cardiac pacing leads, there are limited comparative data on lead performance. We compared long-term performance of Abbott Tendril™ STS 2088TC (Tendril 2088) leads with competitive manufacturer (CM) pacing leads using novel real-world data analytic methods.
Methods: Medicare fee-for-service (FFS) claims and Abbott device registration databases were linked to identify patients implanted with single-chamber or dual-chamber pacemakers with the Abbott Tendril 2088 lead from January 1, 2014 to December 31, 2019 and were followed through December 31, 2021.
Background: Traditional post-approval study (PAS) designs have been accepted by regulatory authorities to fulfill postmarketing requirements for cardiac leads, but they have several limitations.
Objective: We conducted a proof-of-concept study of alternative methods that use real-world data (RWD) to evaluate lead safety in large populations of patients.
Methods: Abbott patient device databases were linked with Medicare Fee-For-Service (FFS) claims to identify lead complications in patients implanted with Abbott Optisure lead.
Background: The aminoglycoside apramycin has been proposed as a drug candidate for the treatment of critical Gram-negative systemic infections. However, the potential of apramycin in the treatment of drug-resistant bloodstream infections (BSIs) has not yet been assessed.
Methods: The resistance gene annotations of 40 888 blood-culture isolates were analysed.