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8 záznamů v Medvik

Kniha

The EHRA book of interventional electrophysiology : case-based learning with multiple choice questions

Heidbüchel, Hein
Autor Autorita ORCID
Duytschaever, Mattias, 1970-
Autor Autorita ORCID
Burri, Haran, 1967-
Autor Autorita ORCID
European Heart Rhythm Association
Autor Autorita
Evropská kardiologická společnost
Autor Autorita

xii, 308 stran : barevné ilustrace ; 22 cm

MeSH
elektrofyziologické techniky kardiologické MeSH
srdeční arytmie chirurgie MeSH
srdeční elektrofyziologie metody MeSH
Publikační typ
kazuistiky MeSH
výukové testy MeSH

Článek

Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE

Circulation. Arrhythmia and electrophysiology. 2024 ; 17 (5) : e012667. [pub] 20240424

Circ Arrhythm Electrophysiol
ISSN 1941-3084
Medvik
Zdroj

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.

Článek

Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study

Europace. 2024 ; 26 (3) : . [pub] 20240301

ISSN 1532-2092
Medvik
Zdroj

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).

Článek

Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study

Circulation. Arrhythmia and electrophysiology. 2023 ; 16 (3) : e011780. [pub] 20230203

Circ Arrhythm Electrophysiol
ISSN 1941-3084
Medvik
Zdroj

BACKGROUND: The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed Field Ablation [PFA] System With Irreversible Electroporation [IRE]) evaluated safety and effectiveness of a fully integrated biphasic pulsed field ablation (PFA) system with a variable-loop circular catheter for the treatment of drug-refractory paroxysmal atrial fibrillation. METHODS: Subjects underwent pulmonary vein (PV) isolation with the PFA system, using at least 12 applications per vein; adenosine/isoproterenol was administered to confirm entrance block. Wave I assessed initial safety, including for esophageal lesions, silent cerebral lesions, and PV stenosis. Wave II (pivotal phase) tested (1) primary safety, incidence of early-onset primary adverse events, and (2) primary effectiveness, confirmed PV isolation with freedom from documented atrial arrhythmia at 12 months. The study design specified an interim analysis to determine early success once 30 subjects reached the 12-month follow-up and all subjects reached 3-month follow-up. RESULTS: Across 13 centers in Europe/Canada, 226 subjects were enrolled, met criteria for safety and effectiveness evaluations, and received PFA (Wave I, 40; Wave II, 186). Wave I demonstrated no esophageal thermal lesions or PV stenosis. Among 39 subjects with cerebral magnetic resonance imaging, silent cerebral lesions were detected in 4 of the first 6 subjects, after which workflow enhancements, including a 10-second pause between PFA applications, were implemented; subsequently, only 4 of 33 subjects had silent cerebral lesions. In the Wave II phase, no primary adverse events were reported. Upon declaring early success, 83 subjects reached 12-month follow-up. With 100% entrance block, PV isolation without acute reconnection was achieved in 97.1% of targeted veins. For Wave II, the primary effectiveness end point per Kaplan-Meier at the time of interim analysis was 70.9%; 12-month freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia recurrence and repeat ablation was 78.9% and 92.3%, respectively. Total procedure and transpired PFA times were 70.1±27.7 and 26.7±14.0 minutes, respectively. CONCLUSIONS: The inspIRE trial confirmed the safety and effectiveness of the novel mapping-integrated PFA system. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; unique identifier: NCT04524364.

MeSH
fibrilace síní * diagnóza chirurgie etiologie MeSH
katetrizační ablace * škodlivé účinky metody MeSH
katétry MeSH
lidé MeSH
recidiva MeSH
stenóza plicní žíly * etiologie MeSH
stenóza etiologie chirurgie MeSH
venae pulmonales * chirurgie MeSH
výsledek terapie MeSH
Check Tag
lidé MeSH
Publikační typ
časopisecké články MeSH
multicentrická studie MeSH
Geografické názvy
Evropa MeSH

Článek

Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial

JACC. Clinical electrophysiology. 2019 ; 5 (7) : 778-786. [pub] 20190508

JACC Clin Electrophysiol
ISSN 2405-5018
Medvik
Zdroj

OBJECTIVES: This study sought to evaluate the safety and short-term performance of a novel catheter for very high power-short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation. BACKGROUND: The vHPSD catheter is a novel contact force-sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90 W, 4 s lesions. METHODS: QDOT-FAST (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation. RESULTS: A total of 52 patients underwent ablation and completed follow-up. Pulmonary vein isolation was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 min and 6.6 ± 8.2 min, respectively. Most patients (n = 49; 94.2%) were in sinus rhythm at 3 months. Two primary adverse events were reported: 1 pseudoaneurysm; and 1 asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects. Six patients had identified silent cerebral lesions-all classified as asymptomatic without clinical or neurologic deficits. CONCLUSIONS: This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters. (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation [QDOT-FAST]; NCT03459196).

MeSH
design vybavení MeSH
fibrilace síní chirurgie MeSH
fluoroskopie MeSH
katetrizační ablace * škodlivé účinky přístrojové vybavení metody MeSH
katétry škodlivé účinky MeSH
léčebná irigace přístrojové vybavení MeSH
lidé středního věku MeSH
lidé MeSH
mikroelektrody MeSH
prospektivní studie MeSH
senioři 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
klinická studie MeSH
multicentrická studie MeSH
práce podpořená grantem MeSH

Článek

Characterization and significance of localized sources identified by a novel automated algorithm during mapping of human persistent atrial fibrillation

Journal of cardiovascular electrophysiology. 2018 ; 29 (11) : 1480-1488. [pub] 20181008

J Cardiovasc Electrophysiol
ISSN 1540-8167
Medvik
Zdroj

BACKGROUND: Automated algorithms may identify focal (FA) and rotational (RoA) activations during persistent atrial fibrillation (PeAF). OBJECTIVE: To evaluate an automated algorithm for characterizing and assessing significance of FA/RoA. METHODS: Eighty-six PeAF ablation patients (1411 maps) were analyzed. Maps were obtained with a 64-electrode basket using CARTOFINDER, which filters/annotates atrial unipolar electrograms over 30 seconds. Operators ablated FA/RoA followed by pulmonary vein isolation (PVI). The automated algorithm was retrospectively applied using QS patterns to identify FA and sequential activation gradients for RoA without phase mapping. Algorithm-identified FA and RoA were validated against blinded adjudicators. Ablation of algorithm-identified FA/RoA was related to procedural AF termination. RESULTS: 73% ± 18% of electrodes (65% ± 11% atrial surface area) were adequate for analysis. Compared with adjudicators, the algorithm had a sensitivity of 84% for FA and 86% for RoA. There were 4 ± 2 FA and 2 ± 2 RoA per patient. FA occurred 8 ± 6 times during the 30-second window (cumulative duration 8 ± 6 seconds). RoA occurred 5 ± 3 times (median 2, consecutive rotations) with a cumulative duration of 3 ± 2 seconds. Compared to patients without procedural AF termination, patients with termination had more FA ablated (75% vs 38%, P = 0.006). AF termination was not predicted by percentage of RoA ablated although there was a trend towards a higher percentage of left atrial RoA ablated ( P = 0.06). CONCLUSION: An automated algorithm had high sensitivity for FA and RoA. Acute AF termination was associated with FA ablation but not RoA ablation. Future studies need to define the significance of FA and RoA and whether they are overlapping or separate mechanisms.