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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

Článek

Arteriální hypertenze a fibrilace síní - zločinné spolčení
[Arterial hyperension and atrial fibrillation - a criminal conspiracy]

Kautzner, Josef, 1957-
Autor Autorita ORCID Klinika kardiologie, Institut klinické a experimentální medicíny, Praha

Remedia. 2024 ; 34 (1) : 82-88.

Remedia (Praha)
ISSN 0862-8947
Medvik
Zdroj

MeSH
diuretika farmakologie MeSH
fibrilace síní * terapie MeSH
hypertenze * farmakoterapie komplikace MeSH
katetrizační ablace metody MeSH
lidé MeSH
metaanalýza jako téma MeSH
mortalita MeSH
renin-angiotensin systém účinky léků MeSH
Check Tag
lidé MeSH
Publikační typ
práce podpořená grantem MeSH

Článek

Optimizing Energy Delivery in Cardioversion: A Randomized PROTOCOLENERGYTrial of 2 Different Algorithms in Patients With Atrial Fibrillation

Canadian journal of cardiology. 2024 ; 40 (11) : 2130-2141. [pub] 20240608

Can J Cardiol
ISSN 1916-7075
Medvik
Zdroj

BACKGROUND: The optimal energy protocol for direct current cardioversion of atrial fibrillation remains uncertain. The Rational vs Maximum Fixed Energy (PROTOCOLENERGY) randomized trial compared a stepwise escalating energy algorithm (RaA, 150 J, 360 J, and 360 J) with a maximum fixed energy algorithm (MfA, 3 x 360 J). METHODS: In a 1:1 randomized trial, 300 patients with atrial fibrillation received biphasic discharges via hand-held paddles in the anterolateral position. Primary endpoints were sinus rhythm at 1 minute and neurologic complications at 2 hours; secondary endpoints included sinus rhythm at 2 hours, skin changes and chest discomfort at 24 hours. RESULTS: Sinus rhythm at 1 minute was achieved in 92.7% of RaA and 94.0% of MfA patients (P = 0.643) and maintained at 2 hours in 91.3% of both groups. There were no neurologic complications. The protocols differed significantly after the first shock (72.7% in RaA vs 83.3% in MfA; P = 0.026) but equalized after subsequent maximum energy shocks. Fewer RaA patients experienced skin redness compared with MfA patients (19.3% vs 36.0%, P = 0.001), which was attributed to the lower initial 150-J shock and total energy delivered (r = 0.243, P < 0.0001). Chest discomfort at 24 hours was not different between groups (P = 0.378). In multivariate analysis, lower body mass index (P < 0.001, cutoff 29 to 34 kg/m2) was associated with cardioversion success after the initial 150-J shock. CONCLUSIONS: Both protocols showed similar high cumulative efficacy, but RaA with the initial 150-J shock proved to be beneficial in patients with body mass index less than 29 to 34 kg/m2 because of fewer skin complications. CLINICAL TRIAL REGISTRATION NO: NCT05148923.

Článek

Mýty kolem fibrilace síní

Medical tribune. 2024 ; 20 (8) : D6-D7. [pub] 20240528

Med. Trib. (Praha)
ISSN 1214-8911
Medvik
Zdroj

MeSH
antiarytmika terapeutické užití MeSH
fibrilace síní * komplikace mortalita terapie MeSH
hypertenze komplikace MeSH
katetrizační ablace metody MeSH
lidé MeSH
mozková hypoxie a ischemie etiologie MeSH
rizikové faktory kardiovaskulárních chorob MeSH
srdeční selhání etiologie komplikace MeSH
Check Tag
lidé MeSH
Publikační typ
novinové články MeSH

Článek

Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial

Nature medicine. 2024 ; 30 (8) : 2303-2310. [pub] 20240517

Nat Med
ISSN 1546-170X
Medvik
Zdroj

Clinical outcomes of catheter ablation for atrial fibrillation (AF) are suboptimal due, in part, to challenges in achieving durable lesions. Although focal point-by-point ablation allows for the creation of any required lesion set, this strategy necessitates the generation of contiguous lesions without gaps. A large-tip catheter, capable of creating wide-footprint ablation lesions, may increase ablation effectiveness and efficiency. In a randomized, single-blind, non-inferiority trial, 420 patients with persistent AF underwent ablation using a large-tip catheter with dual pulsed field and radiofrequency energies versus ablation using a conventional radiofrequency ablation system. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively (P < 0.0001 for non-inferiority). Major procedural or device-related complications occurred in three patients in the investigational arm and in two patients in the control arm (P < 0.0001 for non-inferiority). In a secondary analysis, procedural times were shorter in the investigational arm as compared to the control arm (P < 0.0001). These results demonstrate non-inferior safety and effectiveness of the dual-energy catheter for the treatment of persistent AF. Future large-scale studies are needed to gather real-world evidence on the impact of the focal dual-energy lattice catheter on the broader population of patients with AF. ClinicalTrials.gov identifier: NCT05120193 .

Článek

Comparing pulsed field electroporation and radiofrequency ablation for the treatment of paroxysmal atrial fibrillation: design and rationale of the BEAT PAROX-AF randomized clinical trial

Europace. 2024 ; 26 (5) : . [pub] 20240502

ISSN 1532-2092
Medvik
Zdroj

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.