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In a randomized trial involving patients with paroxysmal atrial fibrillation, pulsed field ablation was noninferior to thermal ablation with respect to freedom from a composite of procedural and arrhythmia events at 1 year.

Initial treatment of paroxysmal atrial fibrillation with cryoballoon ablation was associated with a lower incidence of persistent atrial fibrillation and other atrial tachyarrhythmias over 3 years than rhythm-control medications.

The role of catheter ablation in patients with symptomatic atrial fibrillation and end-stage heart failure is unknown. We conducted a single-center, open-label trial in Germany that involved patients with symptomatic atrial fibrillation and end-stage heart failure who were referred for heart transplantation evaluation. Patients were assigned to receive catheter ablation and guideline-directed medical therapy or medical therapy alone. The primary end point was a composite of death from any cause, implantation of a left ventricular assist device, or urgent heart transplantation. A total of 97 patients were assigned to the ablation group and 97 to the medical-therapy group. The trial was stopped for efficacy by the data and safety monitoring board 1 year after randomization was completed. Catheter ablation was performed in 81 of 97 patients (84%) in the ablation group and in 16 of 97 patients (16%) in the medical-therapy group. After a median follow-up of 18.0 months (interquartile range, 14.6 to 22.6), a primary end-point event had occurred in 8 patients (8%) in the ablation group and in 29 patients (30%) in the medical-therapy group (hazard ratio, 0.24; 95% confidence interval [CI], 0.11 to 0.52; P<0.001). Death from any cause occurred in 6 patients (6%) in the ablation group and in 19 patients (20%) in the medical-therapy group (hazard ratio, 0.29; 95% CI, 0.12 to 0.72). Procedure-related complications occurred in 3 patients in the ablation group and in 1 patient in the medical-therapy group. Among patients with atrial fibrillation and end-stage heart failure, the combination of catheter ablation and guideline-directed medical therapy was associated with a lower likelihood of a composite of death from any cause, implantation of a left ventricular assist device, or urgent heart transplantation than medical therapy alone. (Funded by Else Kröner-Fresenius-Stiftung; CASTLE-HTx ClinicalTrials.gov number, NCT04649801.).

Patients with symptomatic, paroxysmal, untreated atrial fibrillation were randomly assigned to antiarrhythmic drug therapy or cryoablation. At 1 year, there was a significantly lower rate of recurrence of atrial fibrillation with cryoablation than with drug therapy.

In patients with persistent atrial fibrillation, rates of recurrent atrial fibrillation at 18 months were not significantly different when linear ablation or ablation of complex fractionated electrograms was performed along with pulmonary-vein isolation. Percutaneous catheter ablation is an effective treatment for paroxysmal atrial fibrillation, 1 – 3 particularly in cases that are refractory to antiarrhythmic medications. 4 – 6 Most triggers for paroxysmal atrial fibrillation come from the pulmonary veins, so ablation involves creating circumferential lesions around the veins to electrically isolate them from the rest of the left atrium. 7 Catheter ablation for persistent atrial fibrillation is more challenging and is associated with less favorable outcomes. 8 , 9 To improve outcomes, ablation targeting the substrate that maintains fibrillation (i.e., substrate modification) is often added to pulmonary-vein isolation. 10 , 11 The two most common techniques for substrate modification are the . . .

In this multicenter trial involving patients with paroxysmal atrial fibrillation who had not previously received rhythm-control treatment, cryoballoon ablation resulted in a significantly higher percentage of patients with treatment success at 1 year than antiarrhythmic drug therapy, with a low incidence of procedure-related adverse events.

There is no standard of care for adjuvant therapy for patients with hepatocellular carcinoma. This trial was designed to assess the efficacy and safety of sorafenib versus placebo as adjuvant therapy in patients with hepatocellular carcinoma after surgical resection or local ablation. We undertook this phase 3, double-blind, placebo-controlled study of patients with hepatocellular carcinoma with a complete radiological response after surgical resection (n=900) or local ablation (n=214) in 202 sites (hospitals and research centres) in 28 countries. Patients were randomly assigned (1:1) to receive 400 mg oral sorafenib or placebo twice a day, for a maximum of 4 years, according to a block randomisation scheme (block size of four) using an interactive voice-response system. Patients were stratified by curative treatment, geography, Child-Pugh status, and recurrence risk. The primary outcome was recurrence-free survival assessed after database cut-off on Nov 29, 2013. We analysed efficacy in the intention-to-treat population and safety in randomly assigned patients receiving at least one study dose. The final analysis is reported. This study is registered with ClinicalTrials.gov, number NCT00692770. We screened 1602 patients between Aug 15, 2008, and Nov 17, 2010, and randomly assigned 1114 patients. Of 556 patients in the sorafenib group, 553 (>99%) received the study treatment and 471 (85%) terminated treatment. Of 558 patients in the placebo group, 554 (99%) received the study treatment and 447 (80%) terminated treatment. Median duration of treatment and mean daily dose were 12·5 months (IQR 2·6–35·8) and 577 mg per day (SD 212·8) for sorafenib, compared with 22·2 months (8·1–38·8) and 778·0 mg per day (79·8) for placebo. Dose modification was reported for 497 (89%) of 559 patients in the sorafenib group and 206 (38%) of 548 patients in the placebo group. At final analysis, 464 recurrence-free survival events had occurred (270 in the placebo group and 194 in the sorafenib group). Median follow-up for recurrence-free survival was 8·5 months (IQR 2·9–19·5) in the sorafenib group and 8·4 months (2·9–19·8) in the placebo group. We noted no difference in median recurrence-free survival between the two groups (33·3 months in the sorafenib group vs 33·7 months in the placebo group; hazard ratio [HR] 0·940; 95% CI 0·780–1·134; one-sided p=0·26). The most common grade 3 or 4 adverse events were hand-foot skin reaction (154 [28%] of 559 patients in the sorafenib group vs four [<1%] of 548 patients in the placebo group) and diarrhoea (36 [6%] vs five [<1%] in the placebo group). Sorafenib-related serious adverse events included hand-foot skin reaction (ten [2%]), abnormal hepatic function (four [<1%]), and fatigue (three [<1%]). There were four (<1%) drug-related deaths in the sorafenib group and two (<1%) in the placebo group. Our data indicate that sorafenib is not an effective intervention in the adjuvant setting for hepatocellular carcinoma following resection or ablation. Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals.

In patients with ischemic cardiomyopathy and an implantable cardioverter–defibrillator who had ventricular tachycardia, catheter ablation was associated with a lower rate of death, ventricular tachycardia storm, or ICD shock at 28 months than an escalation in antiarrhythmic drugs. Ventricular tachycardia caused by the scarring that occurs after myocardial infarction carries a substantial risk of death, a risk that is significantly reduced by the placement of an implantable cardioverter–defibrillator (ICD). 1 ICDs are implanted in more than 100,000 patients annually in the United States. Of these patients, 15% are initially treated with concomitant antiarrhythmic drug (AAD) therapy, 2 and up to 38% receive an appropriate shock for ventricular arrhythmia within 5 years. 3 ICDs effectively terminate ventricular tachycardia, but recurrent arrhythmias and ICD shocks may cause impairment in the quality of life, 4 are associated with an increased risk of death, heart failure, . . .

BackgroundEndobiliary radiofrequency ablation (EB-RFA) has emerged as a palliative treatment for malignant biliary strictures (MBSs); however, concerns about complications related to thermal injury remain. In this study, we evaluated the efficacy and safety of EB-RFA with a novel catheter for MBS.MethodsPatients with inoperable cancer causing MBS were randomly assigned to either the radiofrequency ablation (RFA) group or the non-RFA group. The RFA group underwent EB-RFA at the stricture site with a temperature-controlled catheter (ELRA™; STARmed Co., Goyang, Korea) followed by deployment of a self-expanding metal stent (SEMS). For the non-RFA group, only SEMS placement was performed. The duration of stent patency, overall survival (OS), and 30-day complication rate were evaluated. This trial was registered at ClinicalTrials.gov (number NCT02646514).ResultsA total of 48 patients were enrolled (24 in each group). During a median follow-up period of 135.0 days (RFA group) and 119.5 days (non-RFA group), the 90-day stent patency rate, median duration of stent patency, and median OS were not different between the groups (58.3% vs. 45.8% [P = 0.386], 132.0 days vs. 116.0 days [P = 0.440], and 244.0 days vs. 180.0 days [P = 0.281], respectively). In the RFA group, procedure-related complications including thermal injury-related complications, such as bile duct perforation or hemobilia, were not reported. The early complication (< 7 days) rates were not different between the groups (4.2% vs. 12.5%, P = 0.609), and there were no late complications (7–30 days) in both groups.ConclusionEB-RFA with a temperature-controlled catheter followed by SEMS placement for patients with inoperable MBS can be safe and feasible with acceptable biliary patency.

In a randomized trial, pulsed field ablation was noninferior to cryoballoon ablation with respect to the incidence of a first recurrence of atrial tachyarrhythmia, as assessed by continuous rhythm monitoring.