Cardio Trial Files: Flecainide for AA After PFO Closure, Pulmonary Vein Isolation in AFib, and Interatrial Shunt for HF
Flecainide to Prevent Atrial Arrhythmia after Patent Foramen Ovale Closure (AFLOAT)
Hauguel-Moreau M et al. Circulation (September 2024)
Bottom Line: AFLOAT was a prospective, multicentre, randomized, open-label, superiority trial with a blind evaluation of all endpoints. The study included 186 patients who underwent PFO closure and were randomized to receive flecainide for 3 or 6 months or standard-of-care for 6 months. The primary outcome was the percentage of patients with at least one episode of atrial arrhythmia (AA) (≥30s) within 3 months after PFO closure. The secondary outcome was the percentage of patients with at least one episode of AA (≥30s) within 3-6 months after PFO closure. AA occurred in 28.5% of cases, mostly within the first month after PFO closure. Flecainide did not prevent AA after PFO closure.
Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial Fibrillation (SHAM-PVI)
Dulai R et al. JAMA (September 2024)
Bottom Line: This double-blind randomized clinical trial, conducted at two tertiary centers in the UK, aimed to determine the effectiveness of pulmonary vein isolation for improving outcomes in patients with symptomatic paroxysmal or persistent atrial fibrillation. A total of 126 participants were randomly assigned to receive either pulmonary vein isolation with cryoablation or a sham procedure with phrenic nerve pacing. The primary outcome, atrial fibrillation burden at 6 months, showed a significant decrease in the intervention group compared to the comparator group (the absolute mean atrial fibrillation burden change from baseline to 6 months was 60.31% in the ablation group vs. 35.0% in the sham group). The study concluded that pulmonary vein isolation is more effective than a sham procedure for improving outcomes in atrial fibrillation.
Interatrial Shunt Treatment for Heart Failure (RELIEVE-HF)
Stone GW et al. Circulation (September 2024)
Bottom Line: This randomized clinical trial evaluated the effectiveness and safety of transcatheter interatrial shunt implantation in patients with symptomatic heart failure (HF) and any left ventricular ejection fraction (LVEF). A total of 508 patients were randomized 1:1 to receive either the shunt treatment (n=250) or a placebo procedure (n=258). The primary safety outcome was a composite of device-related or procedure-related major adverse cardiovascular or neurological events at 30 days. The primary effectiveness outcome was the hierarchical composite ranking of all-cause death, cardiac transplantation or left ventricular assist device implantation, HF hospitalization, outpatient worsening HF events, and change in quality of life from baseline measured by the Kansas City Cardiomyopathy Questionnaire overall summary score through maximum 2-year follow-up. The results showed that the shunt implantation was safe, but did not improve effectiveness outcomes (win ratio, 0.86 [95% CI, 0.61–1.22]; P=0.20). In conclusion, transcatheter interatrial shunt implantation was safe but did not improve outcomes in patients with HF. Further studies are needed to determine the effectiveness of this treatment in specific patient populations.
Cardio Trial Files Issue #CRD-2024-22
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