Nejvíce citovaný článek - PubMed ID 33933412
Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II
AIMS: Initial clinical studies of pulsed field ablation (PFA) to treat atrial fibrillation (AF) indicated a >90% durability rate of pulmonary vein isolation (PVI). However, these studies were largely conducted in single centres and involved a limited number of operators. We aimed to describe the electrophysiological findings and outcomes in patients undergoing repeat ablation after an initial PF ablation for AF. METHODS AND RESULTS: In the MANIFEST-REDO study, we investigated patients who underwent repeat ablation due to clinical recurrence-AF or atrial tachycardia (AT)-following first-ever PVI with a pentaspline PFA catheter (Farawave, Boston Scientific Inc.). At 22 centres, 427 patients (age 64 ± 11 years; 37% female) were included. Of note, the recurrent arrhythmia leading to the repeat ablation was paroxysmal AF (51%), persistent AF (30%), or AT (19%). At the repeat procedure, the PV reconnection rates were 30% (left superior pulmonary vein), 28% (left inferior pulmonary vein), 33% (right superior pulmonary vein), and 32% (right inferior pulmonary vein). In 45% of patients, all PVs were durably isolated at the beginning of the repeat procedure, with the previous use of any imaging or mapping modality being univariately associated with durable PVI. After a post-redo follow-up period of 284 (90-366) days, the primary effectiveness endpoint (freedom from documented AF/AT lasting ≥30 s after 3-month blanking without class I/III antiarrhythmic drugs or symptoms) was achieved in 65% of patients, with significant differences between groups (PAF 65% vs. PersAF 56% vs. AT 76%; P = 0.04). Persistent AF as recurrent arrhythmia after the initial PFA ablation predicted AT/AF recurrence after repeat ablation [hazard ratio 1.241 (95% confidence interval 1.534-1.005); P = 0.045]. The procedural complication rate was 2.8%. CONCLUSION: In repeat procedures for AF/AT performed after an index procedure with PFA for AF, PV reconnections are not uncommon. Repeat procedures can be performed safely and with an acceptable subsequent success rate.
- Klíčová slova
- Atrial fibrillation, Atrial tachycardia, Electroporation, Pulmonary vein isolation, Pulsed field ablation,
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Deep analgosedation (DAS) or general anesthesia is mandatory for pulsed-field ablation of atrial fibrillation. In contrast to DAS, general anesthesia (conventional or total intravenous anesthesia [TIVA]) requires airway management. To find the optimal sedation regimen, this study compared ketamine-remimazolam DAS and propofol-opioid TIVA with propofol-opioid DAS, focusing on sedation-related adverse events. METHODS: Patients indicated for atrial fibrillation catheter ablation were randomly assigned at a 1:1:1 ratio to: (1) DAS using intermittent propofol-opioid boluses (arm P), (2) continuous remimazolam-ketamine DAS (arm R), or (3) continuous propofol-opioid TIVA with secured airway (arm TIVA). Catheter ablation was performed using the FARAPULSE system (Boston Scientific, MA). The major exclusion criterion was obstructive sleep apnea syndrome. The primary end point was defined as a composite of hypoxemia, hypotensive, or hypertensive events requiring intervention or leading to procedure discontinuation. Secondary end points included hemodynamic instability events, procedure time, serious adverse events, and patient satisfaction. RESULTS: One-hundred twenty-seven patients (mean age 62.9±10.3 years, 35.1% women, 47.2% with paroxysmal atrial fibrillation) were enrolled and randomized to the P (n=42), R (n=43), or TIVA (n=42) arms. The primary end point occurred in 85.7% of P patients, 27.9% of R patients, and 66.7% of TIVA patients (P<0.001), driven by hypoxemia in the P arm (100% of patients with the primary end point) and by hypotension in the TIVA arm (100%). The R arm showed a similar distribution of hypoxemia (50%) and hypotensive (66.7%) events. No differences were observed in mean procedural time, rate of serious adverse events, and assessment of patient satisfaction. CONCLUSIONS: In pulsed-field ablation procedures for atrial fibrillation, remimazolam-ketamine DAS was superior to propofol-opioid regimens (either boluses or continuous) and had the lowest risk of hypoxemia and hypotensive events. More than 80% of patients undergoing conventional propofol-opioid analgosedation experienced hypoxemia. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06013345.
- Klíčová slova
- atrial fibrillation, catheter ablation, deep sedation, general anesthesia,
- MeSH
- anestetika intravenózní aplikace a dávkování škodlivé účinky MeSH
- celková anestezie metody škodlivé účinky MeSH
- fibrilace síní * chirurgie patofyziologie diagnóza MeSH
- hluboká sedace * metody škodlivé účinky MeSH
- hypnotika a sedativa aplikace a dávkování škodlivé účinky MeSH
- katetrizační ablace * metody škodlivé účinky MeSH
- ketamin * aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- opioidní analgetika aplikace a dávkování škodlivé účinky MeSH
- propofol * aplikace a dávkování škodlivé účinky MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- anestetika intravenózní MeSH
- hypnotika a sedativa MeSH
- ketamin * MeSH
- opioidní analgetika MeSH
- propofol * MeSH
INTRODUCTION: Atrial fibrillation (AF) can cause or aggravate heart failure (HF). Catheter ablation (CA) is an effective treatment for AF. This study focused on the feasibility and outcomes of emergent AF ablation performed during hospitalization for acute HF. METHODS AND RESULTS: We retrospectively investigated patients who underwent emergent CA for AF during hospitalization for acute HF in 2018-2024. Arrhythmia recurrence was the primary endpoint. The combination of arrhythmia recurrence, HF hospitalization, and all-cause death was the secondary endpoint. Patients were censored 1 year after the index procedure. We included 46 patients, 35% females, with median age of 67 [interquartile rage: 61, 72] years and left ventricular ejection fraction (LVEF) of 25 [23, 28]%. Thermal CA was performed in 14 patients, and pulsed field ablation (PFA) in 32 patients. Procedure time was significantly shorter with PFA compared to thermal CA (77 [57, 91] vs. 166 [142, 200] minutes, p < 0.001). Fluoroscopy time was longer with PFA (9.5 [7.6, 12.0] vs. 3.9 [2.9, 6.0] minutes, p < 0.001), with a borderline trend towards higher radiation dose (75 [53, 170] vs. 50 [30, 94] μGy.m2, p = 0.056). Extrapulmonary ablation was frequent (86% and 84% for thermal CA and PFA, p > 0.9). The estimated freedom from the primary endpoint was 79% after PFA and 64% after thermal CA (p = 0.44). The estimated freedom from the secondary endpoint was 76% after PFA and 57% after thermal CA (p = 0.43). LVEF improved by 24% ± 2% (p < 0.001) in patients with the first manifestation of HF and by 14% ± 4% (p = .004) in patients with decompensated HF diagnosed earlier. CONCLUSIONS: Emergent CA of AF during acute HF hospitalization is safe and associated with improved LVEF and good clinical outcomes. In the PFA era, the rate of these procedures is progressively increasing as they are readily available and easy to perform compared to thermal ablation.
- Klíčová slova
- acute heart failure, atrial fibrillation, catheter ablation, electroporation, posterior wall isolation, pulsed field ablation, thermal ablation,
- MeSH
- akční potenciály MeSH
- akutní nemoc MeSH
- časové faktory MeSH
- fibrilace síní * chirurgie patofyziologie mortalita diagnóza komplikace MeSH
- funkce levé komory srdeční MeSH
- hospitalizace * MeSH
- katetrizační ablace * škodlivé účinky mortalita metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- obnova funkce MeSH
- příjem pacientů * MeSH
- recidiva MeSH
- retrospektivní studie MeSH
- rizikové faktory MeSH
- senioři MeSH
- srdeční frekvence MeSH
- srdeční selhání * patofyziologie mortalita diagnóza terapie MeSH
- studie proveditelnosti MeSH
- tepový objem MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
PURPOSE: Variations in the anatomy of pulmonary veins can influence selection of approaches of atrial fibrillation catheter ablation. Therefore, preprocedural evaluation and knowledge of pulmonary veins anatomy is crucial for proper mapping and the successful ablation of atrial fibrillation. The aim of this observational study was to assess CT angiography scans and perform detailed analysis of pulmonary veins morphology in patients scheduled for catheter ablation of atrial fibrillation. METHODS: CT angiography was performed in 771 individuals (223 females, 548 males, mean age 58.4 ± 10.7 years). Pulmonary veins anatomy was evaluated using 3D models. The patterns used for evaluation included typical anatomy with four separate pulmonary veins, a common left ostium, and various types of accessory veins either alone or in combination with common left ostia. RESULTS: An anatomical variant with common left ostium was observed as the most prevalent anatomy (44%). The typical variant was observed in 34.8% of patients. Accessory pulmonary veins were observed predominantly on the right side. The prevalence of anatomical variants did not differ between sexes with the exception of the unclassifiable category U (4.4% vs. 9%, p < 0.05). CONCLUSIONS: Our study shows that a considerable number of atypical anatomies is present in patients undergoing AF catheter ablation. This knowledge may influence the choice of instrumentation. The data could be possibly helpful also in development of new ablation techniques.
- Klíčová slova
- Atrial fibrillation, CT angiography, Pulmonary veins anatomy, Pulmonary veins morphology,
- MeSH
- CT angiografie MeSH
- fibrilace síní * chirurgie diagnostické zobrazování patofyziologie MeSH
- flebografie MeSH
- katetrizační ablace * MeSH
- lidé středního věku MeSH
- lidé MeSH
- prediktivní hodnota testů MeSH
- senioři MeSH
- venae pulmonales * chirurgie diagnostické zobrazování MeSH
- výsledek terapie MeSH
- zobrazování trojrozměrné MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie MeSH
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.
- MeSH
- fibrilace síní * chirurgie terapie MeSH
- katetrizační ablace * škodlivé účinky metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační komplikace epidemiologie etiologie MeSH
- senioři MeSH
- výsledek terapie 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
AIMS: Using thermal-based energy sources [radiofrequency (RF) energy/cryo energy] for catheter ablation is considered effective and safe when performing pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF). However, treatment success remains limited and complications can occur due to the propagation of thermal energy into non-target tissues. We aim to compare pulsed field ablation (PFA) with RF ablation in terms of efficacy and safety for patients with drug-resistant paroxysmal AF. METHODS AND RESULTS: The BEAT PAROX-AF trial is a European multicentre, superiority, open-label randomized clinical trial in two parallel groups. A total of 292 participants were recruited in 9 high-volume European clinical centres in 5 countries. Patients with paroxysmal AF were randomized to PFA (FARAPULSE Endocardial Ablation System©, Boston Scientific) or RF using the CLOSE protocol with contact force sensing catheter (SmartTouch© catheter and CARTO© Biosense Webster). The primary endpoint will be the 1-year recurrence of atrial arrhythmia, and the major secondary safety endpoint will be the occurrence of acute (<7 days) procedure-related serious adverse events, or pulmonary vein stenosis, or atrio-oesophageal fistula up to 12 months. Additionally, five sub-studies investigate the effect of PFA on oesophageal safety, cerebral lesions, cardiac autonomic nervous system, durability of PVI as assessed during redo ablation procedures, and atrial and ventricular function. The study began on 27 December 2021 and concluded recruitment on 17 January 2024. Results will be available in mid-2025. CONCLUSION: The BEAT PAROX-AF trial aims to provide critical insights into the optimal treatment approach for patients with paroxysmal AF.
- Klíčová slova
- Atrial fibrillation, Catheter ablation, Pulmonary vein isolation, Pulsed field ablation, Radiofrequency current, Randomized trial,
- MeSH
- fibrilace síní * chirurgie patofyziologie diagnóza terapie MeSH
- katetrizační ablace * metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- recidiva MeSH
- venae pulmonales chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- protokol klinické studie MeSH
- srovnávací studie MeSH
- Geografické názvy
- Evropa MeSH
BACKGROUND: We previously presented the safety and early efficacy of the inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed-field Ablation [PFA] System With Irreversible Electroporation [IRE]). With the study's conclusion, we report the outcomes of the full pivotal study cohort, with an additional analysis of predictors of success. METHODS: InspIRE was a prospective, multicenter, single-arm clinical trial of drug-refractory paroxysmal atrial fibrillation. Pulmonary vein isolation was performed with a variable-loop circular catheter integrated with a 3-dimensional mapping system. Follow-up with 24-hour Holter was at 3, 6, and 12 months, as well as remote rhythm monitoring: weekly from 3 to 5 months, monthly from 6 to 12 months, and for symptoms. The primary effectiveness end point (PEE) was acute pulmonary vein isolation plus freedom from any atrial arrhythmia at 12 months. Additional subanalyses report predictors of PEE success. RESULTS: The patient cohort included 186 patients: aged 59±10 years, female 30%, and CHA2DS2-VASc 1.3±1.2. The previously reported primary adverse event rate was 0%. One serious procedure-related adverse event, urinary retention, was reported. The PEE was achieved in 75.6% (95% CI, 69.5%-81.8%). The clinical success of freedom from symptomatic recurrence was 81.7% (95% CI, 76.1%-87.2%). Simulating a monitoring method used in standard real-world practice (without protocol-driven remote rhythm monitoring), this translates to a freedom from all and symptomatic recurrence of 85.8% (95% CI, 80.8%-90.9%) or 94.0% (95% CI, 90.6%-97.5%), respectively. Multivariate analyses revealed that left ventricular ejection fraction ≥60% (adjusted odds ratio, 0.30) and patients receiving ≥48 PFA applications (adjusted odds ratio, 0.28) were independent predictors of PEE success. Moreover, PEE success was 79.2% in patients who received ≥12 PFA applications per vein compared with 57.1% in patients receiving fewer PFA applications. CONCLUSIONS: The inspIRE study confirms the safety and effectiveness of pulmonary vein isolation using the novel 3-dimensional mapping integrated circular loop catheter. An optimal number of PFA applications (≥48 total or ≥12 per vein) resulted in an improved 1-year success rate of ≈80%. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04524364.
- Klíčová slova
- atrial fibrillation, catheters, electroporation, pulmonary veins,
- MeSH
- akční potenciály MeSH
- časové faktory MeSH
- design vybavení MeSH
- elektrofyziologické techniky kardiologické MeSH
- elektrokardiografie ambulantní přístrojové vybavení MeSH
- fibrilace síní * chirurgie patofyziologie diagnóza MeSH
- katetrizační ablace * přístrojové vybavení metody škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- prediktivní hodnota testů MeSH
- prospektivní studie MeSH
- recidiva MeSH
- rizikové faktory MeSH
- senioři MeSH
- srdeční frekvence MeSH
- srdeční katétry MeSH
- venae pulmonales * chirurgie patofyziologie MeSH
- výsledek terapie MeSH
- zobrazování trojrozměrné MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
AIMS: Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8 Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system. METHODS AND RESULTS: After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 s per application; ∼4 applications per PV). Three waveforms were tested: PULSE1, PULSE2, and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted ∼75 days post-ablation. At three centres, PVI was performed by five operators in 85 patients using PULSE1 (n = 30), PULSE2 (n = 20), and PULSE3 (n = 35). Acute PVI was achieved in 100% of PVs using 3.9 ± 1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5 ± 21.6, 10.0 ± 6.0, 19.1 ± 9.3, and 5.7 ± 3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per-vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort. CONCLUSION: Pulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.
- Klíčová slova
- Atrial fibrillation, Catheter ablation, Electroanatomical mapping system, Lesion durability, Pulsed field ablation, Single-shot,
- MeSH
- akční potenciály MeSH
- časové faktory MeSH
- design vybavení MeSH
- elektrofyziologické techniky kardiologické MeSH
- fibrilace síní * chirurgie patofyziologie diagnóza MeSH
- katetrizační ablace * metody přístrojové vybavení MeSH
- lidé středního věku MeSH
- lidé MeSH
- recidiva * MeSH
- senioři MeSH
- srdeční frekvence MeSH
- srdeční katétry * MeSH
- venae pulmonales * chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
Atrial fibrillation (AF), the most common cardiac arrhythmia is associated with increased morbidity and mortality. The higher mortality is due to the risk of heart failure and cardioembolic events. This in-depth review focuses on the strategies and efficacy of catheter ablation for non-paroxysmal atrial fibrillation. The main medical databases were searched for contemporary studies on catheter ablation for non-paroxysmal AF. Catheter ablation is currently proven to be the most effective treatment for AF and consists of pulmonary vein isolation as the cornerstone plus additional ablations. In terms of SR maintenance, it is less effective in non-paroxysmal AF than in paroxysmal patients. but the clinical benefit in non-paroxysmal patients is substantially higher. Since pulmonary vein isolation is ineffective, a variety of techniques have been developed, e.g. linear ablations, ablation of complex atrial fractionated electrograms, etc. Another paradox consists in the technique of catheter ablation. Despite promising results in early observation studies, further randomized studies have not confirmed the initial enthusiasm. Recently, a new approach, pulsed-field ablation, appears promising. This is an in-depth summary of current technologies and techniques for the ablation of non-paroxysmal AF. We discuss the benefits, risks and implications in the treatment of patients with non-paroxysmal AF.
- Klíčová slova
- atrial fibrillation, catheter ablation, pulmonary vein isolation, radiofrequency ablation,
- MeSH
- elektrofyziologické techniky kardiologické metody MeSH
- fibrilace síní * MeSH
- katetrizační ablace * metody MeSH
- lidé MeSH
- recidiva MeSH
- venae pulmonales * chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
AIMS: Pulmonary vein isolation (PVI) is a well-established strategy for the treatment of paroxysmal atrial fibrillation (PAF). Despite randomized controlled trials and real-world data showing the promise of pulsed-field ablation (PFA) for this treatment, long-term efficacy and safety data demonstrating single-procedure outcomes off antiarrhythmic drugs remain limited. The aim of the FARA-Freedom Study was to evaluate the long-term efficacy and safety of PFA using the pentaspline catheter for PAF. METHODS AND RESULTS: FARA-Freedom, a prospective, non-randomized, multicentre study, enrolled patients with PAF undergoing de novo PVI with PFA, who were followed for 12 months with weekly transtelephonic monitoring and a 72-h Holter ECG at 6 and 12 months. The primary safety endpoint was a composite of device- or procedure-related serious adverse events out to 7 days post-ablation and PV stenosis or atrioesophageal (AE) fistula out to 12 months. Treatment success is a composite of acute PVI and chronic success, which includes freedom from any documented atrial tachyarrhythmia longer than 30 s, use of antiarrhythmic drugs or cardioversion after a 3-month blanking period, or use of amiodarone or repeat ablation at any time. The study enrolled 179 PAF patients (62 ± 10 years, 39% female) at 13 centres. At the index procedure, all PVs were successfully isolated with the pentaspline PFA catheter. Procedure and left atrial dwell times, with a 20-min waiting period, were 71.9 ± 17.6 and 41.0 ± 13.3 min, respectively. Fluoroscopy time was 11.5 ± 7.4 min. Notably, monitoring compliance was high, with 88.4 and 90.3% with weekly events and 72-h Holter monitors, respectively. Freedom from the composite primary effectiveness endpoint was 66.6%, and 41 patients had atrial tachyarrhythmia recurrence, mostly recurrent atrial fibrillation (31 patients). The composite safety endpoint occurred in two patients (1.1%), one tamponade and one transient ischaemic attack. There was no coronary spasm, PV stenosis, or AE fistula. There were four cases of transient phrenic nerve palsy, but all resolved during the index procedure. CONCLUSION: In this prospective, non-randomized, multicentre study, PVI using a pentaspline PFA catheter was effective in treating PAF patients despite rigourous endpoint definitions and high monitoring compliance and demonstrated favourable safety. REGISTRATION: Clinical Trials.gov Identifier: NCT05072964 (sponsor: Boston Scientific Corporation).
- Klíčová slova
- Atrial fibrillation, Paroxysmal atrial fibrillation, Pentaspline PFA catheter, Pulsed field ablation,
- MeSH
- antiarytmika MeSH
- fibrilace síní * chirurgie MeSH
- katetrizační ablace * metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- píštěle * chirurgie MeSH
- prospektivní studie MeSH
- recidiva MeSH
- senioři MeSH
- stenóza chirurgie MeSH
- tachykardie chirurgie MeSH
- venae pulmonales * chirurgie MeSH
- výsledek terapie 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
- Názvy látek
- antiarytmika MeSH