Background-Animal models suggest that the neurotransmitter inhibitor, botulinum toxin, when injected into the epicardial fat pads can suppress atrial fibrillation inducibility. The aim of this prospective randomized double-blind study was to compare the efficacy and safety of botulinum toxin injection into epicardial fat pads for preventing atrial tachyarrhythmias. Methods and Results-Patients with history of paroxysmal atrial fibrillation and indication for coronary artery bypass graft surgery were randomized to botulinum toxin (Xeomin, Merz, Germany; 50 U/1 mL at each fat pad; n=30) or placebo (0.9% normal saline, 1 mL at each fat pad; n=30) injection into epicardial fat pads during surgery. Patients were followed for 1 year to assess maintenance of sinus rhythm using an implantable loop recorder. All patients in both groups had successful epicardial fat pad injections without complications. The incidence of early postoperative atrial fibrillation within 30 days after coronary artery bypass graft was 2 of 30 patients (7%) in the botulinum toxin group and 9 of 30 patients (30%) in the placebo group (P=0.024). Between 30 days and up to the 12-month follow-up examination, 7 of the 30 patients in the placebo group (27%) and none of the 30 patients in the botulinum toxin group (0%) had recurrent atrial fibrillation (P=0.002). There were no complications observed during the 1-year follow-up. Conclusions-Botulinum toxin injection into epicardial fat pads during coronary artery bypass graft provided substantial atrial tachyarrhythmia suppression both early as well as during 1-year follow-up, without any serious adverse events. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01842529.
OBJECTIVES
The objective of the study was to evaluate early and midterm outcomes after the frozen elephant trunk (FET) procedure with different proximal landing zones in patients with aortic dissection.
METHODS
Forty-four patients with type A and type B aortic dissection that extended down to the abdominal aorta were enrolled in the study. All of the patients had the FET procedure. The patients were divided in 2 groups according to the level of the proximal landing zone: the zone 2 (Z2) group and zone 3 (Z3) group. Early and midterm outcomes including the false lumen (FL) thrombosis rate were monitored in both groups.
RESULTS
The incidence of stroke, delirium and spinal cord ischaemia was 5.9% vs 3.7% (P = 0.533), 5.9% vs 7.4% (P = 0.903) and 5.9% vs 0 (P = 0.533) in the Z2 and Z3 groups, respectively. The 30-day mortality was 9.1% in both groups. The mean distal landing zone was T7.5 (T7; T9) in the Z2 group vs T9 (T8; T10) in the Z3 group (P = 0.668). The 2-year overall survival was 62.2% with no significant difference in the Z2 and Z3 groups (61.6% vs 64.2%; P = 0.940). There were no aortic-related deaths during the follow-up period. Freedom from reintervention at 24 months was 73% and was comparable between Z2 and Z3 (74.1% vs 91.7%; P = 0.123). The rate of early complete FL thrombosis was comparable in the Z2 and Z3 groups. By 24 months of observation in the Z3 group, the rate of complete FL thrombosis was significantly higher (60% vs 77%; P = 0.046).
CONCLUSIONS
No statistically significant differences were observed between landing zones 2 and 3 during the FET procedure with regard to early outcomes. Proximalization of the FET was associated with a shorter FL thrombosis in the midterm follow-up period that affected the distal aortic reintervention rate.
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