Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study

Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.Peer reviewe

Metodika analyzy netonovych slozek zvuku prirozenych zdroju hudebniho signalu.

Available from STL Prague, CZ / NTK - National Technical LibrarySIGLECZCzech Republi

General anesthesia or conscious sedation in paroxysmal atrial fibrillation catheter ablation

Background. Catheter ablation of paroxysmal atrial fibrillation (AF) can be performed under general anesthesia or conscious sedation. The influence of type of anesthesiology care on procedural characteristics and ablation outcome in patients in whom intracardiac echocardiography (ICE) and elimination of adenosine-mediated dormant conduction (DC) is used is not entirely known. Methods. 150 patients with paroxysmal AF were randomized to point-by-point radiofrequency catheter isolation of pulmonary veins (PVI) under general anesthesia (n=77) or conscious sedation (n=73). Adenosine-mediated dormant conduction was eliminated in all patients. Antiarrhythmic medication was discontinued after PVI. During twelve months of follow-up, all patients underwent four times 7-day ECG monitorings. Results. There was no difference between groups in AF recurrence (28.6% vs. 31.5%, P=0.695). Patients in conscious sedation had longer procedure times (160 ± 32.1 vs. 132 ± 31.5 min, P<0.001), longer RF energy application times (40 ± 15 vs. 29 ± 11 min, P<0.001) and longer fluoroscopy times (6.2 min ± 5.3 vs. 4.3 min ± 2.2, P<0.001) with similar complication rates. Conclusion. Conscious sedation is not inferior to general anesthesia in regard to arrhythmia recurrence or complication rates of catheter ablation of paroxysmal atrial fibrillation. However, it is associated with longer procedure times, longer time of radiofrequency energy application and longer fluoroscopy times