In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).

Micra Transcatheter Pacing System Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873.

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AimsPermanent cardiac pacing is the only effective treatment for symptomatic bradycardia, but complications associated with conventional transvenous pacing systems are commonly related to the pacing lead and pocket. We describe the early performance of a novel self-contained miniaturized pacemaker.Methods and resultsPatients having Class I or II indication for VVI pacing underwent implantation of a Micra transcatheter pacing system, from the femoral vein and fixated in the right ventricle using four protractible nitinol tines. Prespecified objectives were >85% freedom from unanticipated serious adverse device events (safety) and <2 V 3-month mean pacing capture threshold at 0.24 ms pulse width (efficacy). Patients were implanted (n = 140) from 23 centres in 11 countries (61% male, age 77.0 ± 10.2 years) for atrioventricular block (66%) or sinus node dysfunction (29%) indications. During mean follow-up of 1.9 ± 1.8 months, the safety endpoint was met with no unanticipated serious adverse device events. Thirty adverse events related to the system or procedure occurred, mostly due to transient dysrhythmias or femoral access complications. One pericardial effusion without tamponade occurred after 18 device deployments. In 60 patients followed to 3 months, mean pacing threshold was 0.51 ± 0.22 V, and no threshold was ≥2 V, meeting the efficacy endpoint (P < 0.001). Average R-wave was 16.1 ± 5.2 mV and impedance was 650.7 ± 130 ohms.ConclusionEarly assessment shows the transcatheter pacemaker can safely and effectively be applied. Long-term safety and benefit of the pacemaker will further be evaluated in the trial.Clinical Trial RegistrationClinicalTrials.gov ID NCT02004873.

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Atrial fibrillation (AF) is an independent predictor of mortality after acute myocardial infarction (AMI). We analyzed the relationship between biomarkers linked to myocardial stretch [NT-pro-brain natriuretic peptide (NT-proBNP)], myocardial damage [Troponin-T (TnT)] and inflammation [high-sensitivity C-reactive protein (hsCRP)] and new-onset AF during AMI to identify patients at high risk for AF. In a prospective multicenter registry of AMI patients from (TRIUMPH), we measured NT-proBNP, TnT, and hsCRP in patients without a history of AF (N=2370). New-onset AF was defined as AF that occurred during the index hospitalization. Hierarchical multivariable logistic regression models were used to determine the association of biomarkers with new-onset AF, after adjusting for other covariates. New-onset AF was documented in 114 AMI patients (4.8%; mean age 58 years; 32% women). For each 2-fold increase in NT-proBNP, there was an 18% increase in the rate of AF (OR 1.18 95% CI 1.03-1.35; p<0.02). Similarly, for every 2-fold increase in hs-CRP, there was a 15% increase in the rate of AF (OR 1.15 95% CI 1.02-1.30; p=0.02). TnT was not independently associated with new-onset AF (OR 0.96 95% CI 0.85-1.07; p=0.3). NT-proBNP and hs-CRP were independently associated with new in-hospital AF after MI, in both men and women, irrespective of race. Our study suggests that markers of myocardial stretch and inflammation, but not the amount of myocardial necrosis, are important determinants of AF in the setting of AMI.

Background-Little is known about long-term outcomes of patients who survive inhospital cardiac arrest.