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The rate of major complications and mortality with transvenous lead extraction is similar in the real-world outcomes to that reported in recent single-center studies from high-volume centers. There is significant risk of urgent cardiac surgery, which carries a high mortality, and planning for appropriate cardiothoracic surgery backup is imperative.

BACKGROUND: Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications. METHODS: The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points. RESULTS: Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts. CONCLUSIONS: PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF.

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Background: Several clinical trials have investigated the impact of glucomannan on plasma lipids, body weight, fasting blood glucose (FBG), and blood pressure (BP), but have yielded conflicting results and had only modest sample sizes. Objective: The objective was to perform a meta-analysis of randomized controlled trials of glucomannan to better characterize its impact on plasma lipids, FBG, body weight, and BP. Design: A systematic literature search of MEDLINE, EMBASE, CINAHL, Web of Science, the Cochrane Library, and the Natural Medicines Comprehensive Database was conducted from the earliest possible date through November 2007. A random-effects model was used to calculate the weighted mean difference (WMD) and 95% CIs as the difference between the mean for the glucomannan and control groups. Standard methods for assessing statistical heterogeneity and publication bias were used. Results: Fourteen studies (n ҃ 531) met the inclusion criteria. The use of glucomannan significantly lowered total cholesterol [weighted mean difference (WMD): Ҁ19.28 mg/dL; 95% CI: Ҁ24.30, Ҁ14.26], LDL cholesterol (WMD: Ҁ15.99 mg/dL; 95% CI: Ҁ21.31, Ҁ10.67), triglycerides (WMD: Ҁ11.08 mg/dL; 95% CI: Ҁ22.07, Ҁ0.09), body weight (WMD: Ҁ0.79 kg; 95% CI: Ҁ1.53, Ҁ0.05), and FBG (WMD: Ҁ7.44 mg/dL; 95% CI: Ҁ14.16, Ҁ0.72). The use of glucomannan did not appear to significantly alter any other study endpoints. Pediatric patients, patients receiving dietary modification, and patients with impaired glucose metabolism did not benefit from glucomannan to the same degree. Conclusions: Glucomannan appears to beneficially affect total cholesterol, LDL cholesterol, triglycerides, body weight, and FBG, but not HDL cholesterol or BP.