Aims Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the ‘real world’ performance of the only approved PFA catheter, including acute effectiveness and safety—in particular, rare oesophageal effects and other unforeseen PFA-related complications. Methods and results This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7–291), full cohort included 1758 patients: mean age 61.6 years (range 19–92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9–100%). Procedure time was 65 min (38–215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). Conclusion In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of ‘generic’ catheter complications (tamponade, stroke) underscores the need for improvement.
Our findings suggest that the effect of beta-blockers on outcome in HF patients with reduced systolic LVEF who have AF is less than in those who have sinus rhythm.
AimsIt is unknown whether lenient rate control is an acceptable strategy in patients with AF and heart failure. We evaluated differences in outcome in patients with AF and heart failure treated with lenient or strict rate control. Methods and resultsThis post-hoc analysis of the RACE II trial included patients with an LVEF ≤ 40% at baseline or a previous hospitalization for heart failure or signs and symptoms of heart failure. Primary outcome was a composite of cardiovascular morbidity and mortality. Secondary endpoints were AF-related symptoms and quality of life. Two hundred and eighty-seven (46.7%) of the 614 patients had heart failure. Patients with heart failure had significantly higher NT-proBNP plasma levels, a lower LVEF, and more often used ACE inhibitors, ARBs, and diuretics. At 3 years follow-up, the primary outcome occurred more frequently in patients with heart failure (16.7% vs. 11.5%, P ¼ 0.04). In heart failure patients, the estimated cumulative incidence of the primary outcome was 15.0% (n ¼ 20) in the lenient and 18.2% (n ¼ 26) in the strict group (P ¼ 0.53). No differences were found in any of the primary outcome components, in either heart failure hospitalizations [8 (6.1%) vs. 9 (6.8%) patients in the lenient vs. strict group, respectively], symptoms, or quality of life. ConclusionIn patients with AF and heart failure with a predominantly preserved EF, the stringency of rate control seems to have no effect on cardiovascular morbidity and mortality, symptoms, and quality of life.--
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