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Background: No comparative study of outcomes in Riata and Sprint Fidelis leads undergoing lead extraction (LE), lead abandonment (LA), and generator change only (GC) has been published., Objectives: Determine outcomes (major complications [MC]; death, extended hospitalization, or rehospitalization within 60 days [RH]; lead malfunction) of LE, LA, and GC for recalled leads., Methods: Retrospective, multicenter, comparative study., Results: A total of 298 LE, 85 LA, and 310 GC were performed. In the clinical setting of a lead intervention, there was no difference in a composite of MC, death, RH, lead revision, inappropriate shocks, or device infection between LE and LA groups (15% vs 22%, P = .140). In the clinical setting of a device at elective replacement interval (ERI), there were significantly more acute events at 60 days (MC, death, and RH) in the LE and LA groups at 15.4% (4) and 15.4% (4), and this was significantly (P = .017) higher than the GC group at 5.1% (16). There was no difference (P = 1.000) in the composite of MC, death, RH, lead malfunction, lead revisions, device infections, or inappropriate shocks between LE, LA, and GC groups at 15.4% (4), 15.4% (4), and 17.4% (54), respectively. Following generator change, 14 of 175 Fidelis leads and 3 of 135 Riata leads failed over a total of 12,714 months of follow-up., Conclusions: The failure rate of recalled leads was substantially lower compared to previous reports. It may be prudent to perform generator change only when the device is at ERI, especially when the recalled lead has historical performance that likely outweighs the risks of extraction/abandonment., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Magnetic resonance imaging (MRI)-conditional pacemakers (M-PPMs) grant patients greater accessibility to MRI scans. The cost-effectiveness of implanting M-PPM is unknown., Objective: The purpose of this study was to determine the cost-effectiveness of M-PPM implantation., Methods: Cost-effectiveness analysis was performed on patients receiving a M-PPM across 4 institutions. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the sum of the total incremental cost of implanting a M-PPM vs a conventional pacemaker and the cost of MRI scans by the utility of MRI scans in terms of quality-adjusted life-years (QALY) gained. QALY and lifespan of M-PPM (7-11 years) data were obtained from the literature. The benchmark of <$100,000 per QALY was used as the threshold for cost-effectiveness. Computer modeling/simulations were used to calculate the percentage of patients required to achieve this benchmark, to extrapolate the cumulative projected percentage of patients utilizing MRI scans over the lifespan of a M-PPM via the Weibull parametric survival model, and to conduct univariate and multivariate, probabilistic sensitivity analyses., Results: The ICER during the follow-up period (21 ± 17 months) was $451,569. The cost-effectiveness ICER benchmark is reached 7.0 years postimplantation, when a projected 38% of recipients would receive MRI scans. The projected percentage of patients receiving MRI scans at 11 years was 58%, yielding an ICER of $74,221 per QALY. Henceforth, assuming increased MRI usage in regular PPM based on Centers for Medicare & Medicaid Services memo CAG00399R4 and decreased cost of M-PPM, M-PPM implantation is still cost-effective, with a lifetime ICER of $49,817 per QALY., Conclusion: M-PPM implantation is cost-effective over the lifespan of a M-PPM based on projected usage of MRI., (Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)