Long-term outcomes in leadless Micra transcatheter pacemakers with elevated thresholds at implantation: Results from the Micra Transcatheter Pacing System Global Clinical Trial.

BACKGROUND: Device repositioning during Micra leadless pacemaker implantation may be required to achieve optimal pacing thresholds. OBJECTIVE: The purpose of this study was to describe the natural history of acute elevated Micra vs traditional transvenous lead thresholds. METHODS: Micra study VVI patients with threshold data (at 0.24 ms) at implant (n = 711) were compared with Capture study patients with de novo transvenous leads at 0.4 ms (n = 538). In both cohorts, high thresholds were defined as >1.0 V and very high as >1.5 V. Change in pacing threshold (0-6 months) with high (1.0 to ≤1.5 V) or very high (>1.5 V) thresholds were compared using the Wilcoxon signed-rank test. RESULTS: Of the 711 Micra patients, 83 (11.7%) had an implant threshold of >1.0 V at 0.24 ms. Of the 538 Capture patients, 50 (9.3%) had an implant threshold of >1.0 V at 0.40 ms. There were no significant differences in patient characteristics between those with and without an implant threshold of >1.0 V, with the exception of left ventricular ejection fraction in the Capture cohort (high vs low thresholds, 53% vs 58%; P = .011). Patients with an implant threshold of >1.0 V decreased significantly (P < .001) in both cohorts. Micra patients with high and very high thresholds decreased significantly (P < .01) by 1 month, with 87% and 85% having 6-month thresholds lower than the implant value. However, when the capture threshold at implant was >2 V, only 18.2% had a threshold of ≤1 V at 6 months and 45.5% had a capture threshold of >2 V. CONCLUSIONS: Pacing thresholds in most Micra patients with elevated thresholds decrease after implant. Micra device repositioning may not be necessary if the pacing threshold is ≤2 V.

Comparison of a standard versus accelerated dosing regimen for D,L-sotalol for the treatment of atrial and ventricular dysrhythmias.

BACKGROUND: The current recommended starting dose of sotalol is 80 mg orally twice per day, followed by a judicious increase in dosage every 3 days under continuous telemetry monitoring. We hypothesized that sotalol administered at a higher starting dose (120 or 160 mg twice daily) would allow a more rapid attainment of therapeutic response with an acceptable safety and comparable efficacy profile. METHODS: Two hundred nine inpatients with various atrial and ventricular dysrhythmias were begun on either a standard starting dose (80 mg b.i.d.) or an accelerated dose (120 or 160 mg b.i.d.) of sotalol. In-hospital occurrences of drug-related adverse effects (proarrhythmic and others), drug efficacy, and length of hospitalization were retrospectively compared between the two groups. RESULTS: Ten patients (9.3%) in the 80 mg b.i.d. starting dose group experienced a cardiac adverse effect of sotalol as compared to 15 patients (14.9%) in the accelerated dose group (P = 0.286). The mean amount of corrected QT (QTc) prolongation over baseline was not significantly different between the two groups at hospital discharge (22.5 ms vs 21.6 ms, P = 0.898). There was a trend toward more noncardiac side effects of sotalol in the accelerated dose group: 2 (1.9%) versus 7(6.9%), P = 0.092. The average length of hospital stay was similar in the two groups (6.8 days vs 7.4 days, P = 0.558). CONCLUSION: Initiating sotalol at 120-160 mg orally twice per day marginally increases the risk of cardiac and non-cardiac side effects compared to the standard starting regimen of 80 mg b.i.d. Such an accelerated dosing regimen neither shortened hospitalization nor had any effect on treatment efficacy in this retrospective analysis.