AF ablation using a novel "single-shot" map-and-ablate spherical array pulsed field ablation catheter: 1-Year outcomes of the first-in-human PULSE-EU trial
Language English Country United States Media print-electronic
Document type Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't
PubMed
38768840
DOI
10.1016/j.hrthm.2024.04.102
PII: S1547-5271(24)02536-0
Knihovny.cz E-resources
- Keywords
- Atrial fibrillation, Catheter ablation, Pulmonary vein isolation, Pulsed field ablation, Spherical array catheter,
- MeSH
- Time Factors MeSH
- Equipment Design MeSH
- Electrocardiography, Ambulatory methods MeSH
- Atrial Fibrillation * surgery physiopathology MeSH
- Catheter Ablation * methods instrumentation MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Heart Conduction System physiopathology MeSH
- Recurrence MeSH
- Aged MeSH
- Pulmonary Veins * surgery MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Research Support, Non-U.S. Gov't MeSH
BACKGROUND: During pulsed field ablation (PFA), electrode-tissue proximity optimizes lesion quality. A novel "single-shot" map-and-ablate spherical multielectrode PFA array catheter that is able to verify electrode-tissue contact was recently studied in a first-in-human trial of atrial fibrillation (AF). OBJECTIVE: The aim of this study was to report lesion durability data, safety, and 12-month effectiveness outcomes. METHODS: The spherical PFA catheter, an all-in-one mapping and ablation system, was used to render anatomy and to deliver biphasic pulses (ungated 1.7 kV pulses; ∼40 seconds/application). Ablation sites included pulmonary veins (PVs) and, in selected patients, posterior wall and mitral isthmus. Follow-up was invasive remapping at ∼3 months, electrocardiograms, Holter monitoring at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy end points were acute PV isolation (PVI), PVI durability, and atrial arrhythmia recurrence. RESULTS: In the 48-patient AF cohort (paroxysmal, 48%; persistent, 52%), lesion sets included PVI (n = 48; 1.2 applications/PV), posterior wall (n = 20; 3.6 applications/posterior wall), and mitral isthmus (n = 11; 2.9 applications/mitral isthmus). Lesions were acutely successful for all 187 of 187 PVs (100%), 20 of 20 posterior walls (100%), and 10 of 11 mitral isthmuses (91%). Pulse delivery time, left atrial catheter dwell time, and procedure time were 61.5 ± 32.8 seconds, 53.9 ± 26.5 minutes, and 87.8 ± 29.8 minutes, respectively. Remapping (43/48 patients [89.5%]) revealed that 158 of 169 PVs (93.5%) were durably isolated. The only complication was a drug-responsive pericarditis. The 1-year Kaplan-Meier estimates of freedom from atrial arrhythmia were 84.2% (paroxysmal AF) and 80.0% (persistent AF). CONCLUSION: The single-shot spherical array PFA catheter can safely achieve durable lesions, translating into good clinical efficacy.
Homolka Hospital Prague Czech Republic
Icahn School of Medicine at Mount Sinai New York New York
Icahn School of Medicine at Mount Sinai New York New York; Homolka Hospital Prague Czech Republic
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