OBJECTIVE: The purpose of this study was to report the worldwide experience with successful retrieval of the Micra TPS.
METHODS: A list of all successful retrievals of the currently available leadless pacemakers (LPs) was obtained from the manufacturer of Micra TPS. Pertinent details of retrieval, such as indication, days postimplantation, equipment used, complications, and postretrieval management, were obtained from the database collected by the manufacturer. Other procedural details were obtained directly from the operators at each participating site.
RESULTS: Data from the manufacturer consisted of 40 successful retrievals of the Micra TPS. Operators for 29 retrievals (73%) provided the consent and procedural details. Of the 29 retrievals, 11 patients underwent retrieval during the initial procedure (immediate retrieval); the other 18 patients underwent retrieval during a separate procedure (delayed retrieval). Median duration before delayed retrieval was 46 days (range 1-95 days). The most common reason for immediate retrieval was elevated pacing threshold after tether removal. The most common reasons for delayed retrieval included elevated pacing threshold at follow-up, endovascular infection, and need for transvenous device. Mean procedure duration was 63.11 ± 56 minutes. All retrievals involved snaring via a Micra TPS delivery catheter or steerable sheath. No serious complications occurred during the reported retrievals.
CONCLUSION: Early retrieval of the Micra TPS is feasible and safe.
OBJECTIVE: The purpose of this report was to describe the prespecified long-term safety objective of Micra at 12 months and electrical performance through 24 months.
METHODS: The Micra Transcatheter Pacing Study was a prospective single-arm study designed to assess the safety and efficacy of the Micra VVIR leadless/intracardiac pacemaker. Enrolled patients met class I or II guideline recommendations for de novo ventricular pacing. The long-term safety objective was freedom from a system- or procedure-related major complication at 12 months. A predefined historical control group of 2667 patients with transvenous pacemakers was used to compare major complication rates.
RESULTS: The long-term safety objective was achieved with a freedom from major complication rate of 96.0% at 12 months (95% confidence interval 94.2%-97.2%; P < .0001 vs performance goal). The risk of major complications for patients with Micra (N = 726) was 48% lower than that for patients with transvenous systems through 12 months postimplant (hazard ratio 0.52; 95% confidence interval 0.35-0.77; P = .001). Across subgroups of age, sex, and comorbidities, Micra reduced the risk of major complications compared to transvenous systems. Electrical performance was excellent through 24 months, with a projected battery longevity of 12.1 years.
CONCLUSION: Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months of follow-up, and all patient subgroups benefited as compared to transvenous pacemaker historical control group.
METHODS AND RESULTS: Sixty-two individuals (24 SARC+LVH-, 24 HCM, and 14 matched controls) were evaluated with multi-parametric CMR including stimulated echo acquisition mode DT-CMR, and blinded quantitative 12-lead ECG analysis. Mean diastolic fractional anisotropy (FA) was reduced in HCM compared with SARC+LVH- and controls (0.49 ± 0.05 vs. 0.52 ± 0.04 vs. 0.53 ± 0.04, P = 0.009), even after adjustment for differences in extracellular volume (ECV) (P = 0.038). Both HCM and SARC+LVH- had segments with significantly reduced diastolic FA relative to controls (54 vs. 25 vs. 0%, P = 0.002). Multiple repolarization parameters were prolonged in HCM and SARC+LVH-, with corrected JT interval (JTc) being most significant (354 ± 42 vs. 356 ± 26 vs. 314 ± 26 ms, P = 0.002). Among SARC+LVH-, JTc duration correlated negatively with mean diastolic FA (r = -0.6, P = 0.002). In HCM, the JTc interval showed a stronger association with ECV (r = 0.6 P = 0.019) than with mean diastolic FA (r = -0.1 P = 0.72). JTc discriminated SARC+LVH- from controls [area under the receiver operator curve 0.88, confidence interval 0.76-1.00, P < 0.001], and in HCM correlated with the European Society of Cardiology HCM sudden cardiac death risk score (r = 0.5, P = 0.014).
CONCLUSION: Low diastolic FA, suggestive of myocardial disarray, is present in both SARC+LVH- and HCM. Low FA and raised ECV were associated with repolarization prolongation. Myocardial disarray assessment using DT-CMR and repolarization parameters such as the JTc interval demonstrate significant potential as markers of disease activity in HCM.