INTRODUCTION: Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures. METHODS AND RESULTS: The REDUCE-TE Pilot was a prospective multicenter, single-arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold-tip, externally irrigated ablation catheter. After ablation, cerebral diffusion-weighted MRI and a postablation follow-up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA2 DS 2 -VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3-16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow-up. CONCLUSIONS: Ablation of AF using a novel gold-tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.
- MeSH
- akční potenciály MeSH
- asymptomatické nemoci MeSH
- časové faktory MeSH
- design vybavení MeSH
- difuzní magnetická rezonance MeSH
- fibrilace síní komplikace diagnóza patofyziologie chirurgie MeSH
- incidence MeSH
- intrakraniální embolie diagnostické zobrazování epidemiologie MeSH
- katetrizační ablace škodlivé účinky přístrojové vybavení MeSH
- kognice * MeSH
- léčebná irigace škodlivé účinky přístrojové vybavení MeSH
- lidé středního věku MeSH
- lidé MeSH
- pilotní projekty MeSH
- pooperační kognitivní dysfunkce diagnóza epidemiologie psychologie MeSH
- senioři MeSH
- srdeční frekvence MeSH
- srdeční katétry * MeSH
- testy pro posouzení mentálních funkcí a demence MeSH
- venae pulmonales patofyziologie chirurgie MeSH
- výsledek terapie MeSH
- zlato * MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Německo MeSH
