OBJECTIVE: The purpose of this study was to evaluate the system's performance during treadmill tests to maximum exertion in a subset of patients within the Micra Transcatheter Pacing Study.
METHODS: Patients underwent treadmill testing at 3 or 6 months postimplant with algorithm programming at physician discretion. Normalized sensor rate (SenR) relative to the programmed upper sensor rate was modeled as a function of normalized workload in metabolic equivalents (METS) relative to maximum METS achieved during the test. A normalized METS and SenR were determined at the end of each 1-minute treadmill stage. The proportionality of SenR to workload was evaluated by comparing the slope from this relationship to the prospectively defined tolerance margin (0.65-1.35).
RESULTS: A total of 69 treadmill tests were attempted by 42 patients at 3 and 6 months postimplant. Thirty tests from 20 patients who completed ≥4 stages with an average slope of 0.86 (90% confidence interval 0.77-0.96) confirmed proportionality to workload. On an individual test basis, 25 of 30 point estimates (83.3%) had a normalized slope within the defined tolerance range (range 0.46-1.08).
CONCLUSION: Accelerometer-based rate adaptive pacing was proportional to workload, thus confirming rate adaptive pacing commensurate to workload is achievable with an entirely intracardiac pacing system.
METHODS: Vancomycin at various concentrations was added to JectOS and polymethyl methacrylate (PMMA). Then, the cement was molded into standardized dimensions for in vitro testing. Cylindrical vancomycin-JectOS samples were subjected to compressive strength. The results obtained were compared to PMMA-vancomycin compressive strength data attained from historical controls. The zone of inhibition was carried out using vancomycin-JectOS and vancomycin-PMMA disk on methicillin-resistant strain culture agar.
RESULTS: With the addition of 2.5%, 5%, and 10% vancomycin, the average compressive strengths reduced to 8.01 ± 0.95 MPa (24.6%), 7.52 ± 0.71 MPa (29.2%), and 7.23 ± 1.34 MPa (31.9%). Addition of vancomycin significantly weakened biomechanical properties of JectOS, but there was no significant difference in the compressive strength at increasing concentrations. The average diameters of zone of inhibition for JectOS-vancomycin were 24.7 ± 1.44 (2.5%) mm, 25.9 ± 0.85 mm (5%), and 26.8 ± 1.81 mm (10%), which outperformed PMMA.
CONCLUSION: JectOS has poor mechanical performance but superior elution property. JectOS-vancomycin cement is suitable as a void filler delivering high local concentration of vancomycin. We recommended using it for contained bone defects that do not require mechanical strength.