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  1. Article ; Online: Sequential hybrid ablation vs. surgical CryoMaze alone for treatment of atrial fibrillation: results of multicentre randomized controlled trial.

    Bulava, Alan / Wichterle, Dan / Mokráček, Aleš / Osmančík, Pavel / Budera, Petr / Kačer, Petr / Vetešková, Linda / Němec, Petr / Skála, Tomáš / Šantavý, Petr / Chovančík, Jan / Branny, Piotr / Rizov, Vitalii / Kolesár, Miroslav / Šafaříková, Iva / Rybář, Marian

    Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology

    2024  Volume 26, Issue 2

    Abstract: Aims: Data on the hybrid atrial fibrillation (AF) treatment are lacking in patients with structural heart disease undergoing concomitant CryoMaze procedures. The aim was to assess whether the timely pre-emptive catheter ablation would achieve higher ... ...

    Abstract Aims: Data on the hybrid atrial fibrillation (AF) treatment are lacking in patients with structural heart disease undergoing concomitant CryoMaze procedures. The aim was to assess whether the timely pre-emptive catheter ablation would achieve higher freedom from AF or atrial tachycardia (AT) and be associated with better clinical outcomes than surgical ablation alone.
    Methods and results: The trial investigated patients with non-paroxysmal AF undergoing coronary artery bypass grafting and/or valve repair/replacement with mandatory concomitant CryoMaze procedure who were randomly assigned to undergo either radiofrequency catheter ablation [Hybrid Group (HG)] or no further treatment (Surgery Group). The primary efficacy endpoint was the first recurrence of AF/AT without class I or III antiarrhythmic drugs as assessed by implantable cardiac monitors. The primary clinical endpoint was a composite of hospitalization for arrhythmia recurrence, worsening of heart failure, cardioembolic event, or major bleeding. We analysed 113 and 116 patients in the Hybrid and Surgery Groups, respectively, with a median follow-up of 715 (IQR: 528-1072) days. The primary efficacy endpoint was significantly reduced in the HG [41.1% vs. 67.4%, hazard ratio (HR) = 0.38, 95% confidence interval (CI): 0.26-0.57, P < 0.001] as well as the primary clinical endpoint (19.9% vs. 40.1%, HR = 0.51, 95% CI: 0.29-0.86, P = 0.012). The trial groups did not differ in all-cause mortality (10.6% vs. 8.6%, HR = 1.17, 95%CI: 0.51-2.71, P = 0.71). The major complications of catheter ablation were infrequent (1.9%).
    Conclusion: Pre-emptively performed catheter ablation after the CryoMaze procedure was safe and associated with higher freedom from AF/AT and improved clinical outcomes.
    MeSH term(s) Humans ; Atrial Fibrillation/diagnosis ; Atrial Fibrillation/surgery ; Atrial Fibrillation/drug therapy ; Treatment Outcome ; Tachycardia, Supraventricular/surgery ; Anti-Arrhythmia Agents/therapeutic use ; Hemorrhage ; Catheter Ablation/adverse effects ; Catheter Ablation/methods ; Recurrence
    Chemical Substances Anti-Arrhythmia Agents
    Language English
    Publishing date 2024-02-19
    Publishing country England
    Document type Randomized Controlled Trial ; Multicenter Study ; Journal Article
    ZDB-ID 1449879-0
    ISSN 1532-2092 ; 1099-5129
    ISSN (online) 1532-2092
    ISSN 1099-5129
    DOI 10.1093/europace/euae040
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Changes in cognitive function after thoracoscopic and catheter ablation for atrial fibrillation.

    Herman, Dalibor / Javůrková, Alena / Raudenská, Jaroslava / Budera, Petr / Rizov, Vitalii / Kačer, Petr / Peisker, Tomáš / Malý, Marek / Osmančík, Pavel

    Pacing and clinical electrophysiology : PACE

    2022  

    Abstract: Background: Comparative data regarding the effect of percutaneous and thoracoscopic ablation of atrial fibrillation (AF) on cognitive function are very limited. The aim of the study was to determine and compare the effect of both types of ablations on ... ...

    Abstract Background: Comparative data regarding the effect of percutaneous and thoracoscopic ablation of atrial fibrillation (AF) on cognitive function are very limited. The aim of the study was to determine and compare the effect of both types of ablations on patient cognitive functions in the mid-term.
    Methods: Patients with AF indicated for ablation procedure were included. Forty-six patients underwent thoracoscopic, off-pump ablation using the COBRA Fusion radiofrequency system, followed by a catheter ablation three months afterward (Hybrid group). A comparative cohort of 53 AF patients underwent pulmonary vein isolation only (PVI group). Neuropsychological examinations were done before and nine months after the surgical or catheter ablation procedure. Neuropsychological testing comprised 13 subtests of seven domains, and the results were expressed as post-operative cognitive dysfunction (POCD) nine months after the procedure.
    Results: Patients in both groups were similar with respect to the baseline clinical characteristics; only non-paroxysmal AF was more common in the hybrid group (98% vs. 34%). Major POCD was present in eight (17.4%) of hybrid patients versus three (5.7%) of PVI patients (p = 0.11), combined (major/minor) worsened cognitive decline was present in 10 (21.7%) hybrid patients versus three (5.6%) PVI patients (p = 0.034). On the other hand, combined (major/minor) improvement was present in 15 (32.6%) hybrid patients versus nine (16.9%) patients in the PVI group (p = 0.099).
    Conclusion: Hybrid ablation, a combination of thoracoscopic and percutaneous ablation, is associated with a higher risk of cognitive decline compared to sole percutaneous ablation.
    Language English
    Publishing date 2022-11-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 424437-0
    ISSN 1540-8159 ; 0147-8389
    ISSN (online) 1540-8159
    ISSN 0147-8389
    DOI 10.1111/pace.14634
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Sequential hybrid ablation versus surgical CryoMaze alone for treatment of atrial fibrillation (SurHyb Trial): a protocol of the multicentre randomized controlled trial.

    Bulava, Alan / Mokracek, Ales / Wichterle, Dan / Budera, Petr / Osmancik, Pavel / Kacer, Petr / Veteskova, Linda / Nemec, Petr / Skala, Tomas / Santavy, Petr / Chovancik, Jan / Branny, Piotr / Rizov, Vitalii / Kolesar, Miroslav / Rybar, Marian

    Journal of applied biomedicine

    2023  Volume 21, Issue 2, Page(s) 67–72

    Abstract: Background: Atrial fibrillation is common in patients with structural heart disease who are undergoing cardiac surgery. Surgical CryoMaze has been shown to be an effective treatment in several trials, but success rates have varied considerably, between ... ...

    Abstract Background: Atrial fibrillation is common in patients with structural heart disease who are undergoing cardiac surgery. Surgical CryoMaze has been shown to be an effective treatment in several trials, but success rates have varied considerably, between 47-95%. The sequential hybrid approach, combining surgical CryoMaze followed by radiofrequency catheter ablation, can achieve high freedom from atrial arrhythmias. However, in patients with concomitant surgical atrial fibrillation treatment, data comparing the hybrid approach to CryoMaze alone are lacking.
    Methods: The SurHyb study was designed as a prospective, open-label, multicentre randomized trial. Patients with non-paroxysmal atrial fibrillation who were scheduled for coronary artery bypass grafting or valve repair/replacement were randomized to either surgical CryoMaze alone or surgical CryoMaze followed by radiofrequency catheter ablation 3 months post-surgery. The primary outcome measure was arrhythmia-free survival without class I or III antiarrhythmic drugs, which has been evaluated using implantable cardiac monitors.
    Conclusions: This is the first randomized study that compares concomitant surgical CryoMaze alone with the staged hybrid surgical CryoMaze followed by catheter ablation, in patients with non-paroxysmal atrial fibrillation using rigorous rhythm monitoring. The results may contribute to the optimization of the treatment in patients undergoing concomitant CryoMaze for atrial fibrillation.
    MeSH term(s) Humans ; Anti-Arrhythmia Agents/therapeutic use ; Atrial Fibrillation/surgery ; Atrial Fibrillation/drug therapy ; Cardiac Surgical Procedures/methods ; Catheter Ablation/methods ; Multicenter Studies as Topic ; Prospective Studies ; Randomized Controlled Trials as Topic ; Treatment Outcome
    Chemical Substances Anti-Arrhythmia Agents
    Language English
    Publishing date 2023-05-11
    Publishing country Poland
    Document type Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2171142-2
    ISSN 1214-0287 ; 1214-0287
    ISSN (online) 1214-0287
    ISSN 1214-0287
    DOI 10.32725/jab.2023.007
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Improvement in the quality of life of patients with persistent or long-standing persistent atrial fibrillation after hybrid ablation.

    Osmancik, Pavel / Budera, Petr / Talavera, David / Herman, Dalibor / Vesela, Jana / Prochazkova, Radka / Rizov, Vitalii / Kacer, Petr

    Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing

    2019  Volume 57, Issue 3, Page(s) 435–442

    Abstract: Background: Hybrid ablation (i.e., a combination of a thoracoscopic surgical ablation followed by a catheter ablation) is a treatment option for patients with non-paroxysmal atrial fibrillation (AF). Despite its promising efficacy, it is a surgical ... ...

    Abstract Background: Hybrid ablation (i.e., a combination of a thoracoscopic surgical ablation followed by a catheter ablation) is a treatment option for patients with non-paroxysmal atrial fibrillation (AF). Despite its promising efficacy, it is a surgical procedure with a relatively high risk of complications that could affect the quality of life (QoL) of patients, even when sinus rhythm is restored.
    Objective: To describe changes in the QoL of patients with non-paroxysmal AF before and after a hybrid ablation.
    Methods: Patients after hybrid ablation for persistent or long-standing persistent AF were prospectively studied. Follow-up visits were scheduled at 1, 3, 6, 9, and 12 months. The maintenance of SR was assessed using 1-week Holter recordings at 6 and 12 months and 24-h Holter recordings at 3 and 9 months, or via an implantable loop recorder. QoL was assessed using the Atrial Fibrillation Effect on Quality-of-life (AFEQT) and the EuroQoL-5Dimensions (EQ-5D) questionnaires before and 12 months after ablation.
    Results: Seventy-five patients (49 men, age 62.9 ± 8.45 years, 48 (64%) with long-standing persistent AF) were enrolled. Fifty-two (69.3%, SR group) were AF-free during the 12-month follow-up, 16 (21.3%, PAROX group) had only paroxysms of AF after ablation, and 7 (9.3%, PERM group) were on rate control due to permanent AF reoccurrence. The AFEQT score increased significantly in the SR group from 59.9 ± 19.4 to 91.4 ± 10.8 (p < 0.001), and in the PAROX group from 58.8 ± 19.0 to 81.5 ± 14.1 (p = 0.002) but remained unchanged in the PERM group (44.6 ± 7.5 vs. 47.4 ± 5.5, p = 0.24). The EQ-5D score significantly decreased in the descriptive part (from 7.90 ± 2.61 to 6.64 ± 1.90, p = 0.0001) and increased on the visual analog scale (from 63.56 ± 19.11 to 79.30 ± 16.9, p < 0.0001) in the SR group. In the PAROX group, no significant change was present on either the descriptive part (p = 0.3) or in the visual analog scale (p = 0.48). Similarly, no significant changes were present on either the descriptive part (p = 0.93) or the visual analog scale (p = 0.4) in the PERM group.
    Conclusion: The QoL of patients with non-paroxysmal AF and patients with AF paroxysms, after successful hybrid ablation, improved significantly in patients with SR. No significant improvement was present in patients on rate control after an unsuccessful ablation.
    MeSH term(s) Atrial Fibrillation/surgery ; Catheter Ablation/methods ; Electrocardiography, Ambulatory ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Quality of Life ; Surveys and Questionnaires ; Thoracoscopy
    Language English
    Publishing date 2019-04-17
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1329179-8
    ISSN 1572-8595 ; 1383-875X
    ISSN (online) 1572-8595
    ISSN 1383-875X
    DOI 10.1007/s10840-019-00546-7
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  5. Article ; Online: The Efficacy and Safety of Hybrid Ablations for Atrial Fibrillation.

    Osmancik, Pavel / Herman, Dalibor / Kacer, Petr / Rizov, Vitalii / Vesela, Jana / Rakova, Radka / Karch, Jakub / Susankova, Marketa / Znojilova, Lucie / Fojt, Richard / Prodanov, Petko / Kremenova, Karin / Malikova, Hana / Peisker, Tomas / Stros, Petr / Curila, Karol / Javurkova, Alena / Raudenska, Jaroslava / Budera, Petr

    JACC. Clinical electrophysiology

    2021  Volume 7, Issue 12, Page(s) 1519–1529

    Abstract: Objectives: This study sought to comprehensively determine the procedural safety and midterm efficacy of hybrid ablations.: Background: Hybrid ablation of atrial fibrillation (AF) (thoracoscopic ablation followed by catheter ablation) has been used ... ...

    Abstract Objectives: This study sought to comprehensively determine the procedural safety and midterm efficacy of hybrid ablations.
    Background: Hybrid ablation of atrial fibrillation (AF) (thoracoscopic ablation followed by catheter ablation) has been used for patients with nonparoxysmal AF; however, accurate data regarding efficacy and safety are still limited.
    Methods: Patients with nonparoxysmal AF underwent thoracoscopic, off-pump ablation using the COBRA Fusion radiofrequency system (Estech) followed by a catheter ablation 3 months afterward. The safety of the procedure was assessed using sequential brain magnetic resonance and neuropsychological examinations at baseline (1 day before), postoperatively (2-4 days for brain magnetic resonance imaging or 1 month for neuropsychological examination), and at 9 months after the surgical procedure. Implantable loop recorders were used to detect arrhythmia recurrence. Arrhythmia-free survival (the primary efficacy endpoint) was defined as no episodes of AF or atrial tachycardia while off antiarrhythmic drugs, redo ablations or cardioversions.
    Results: Fifty-nine patients (age: 62.5 ± 10.5 years) were enrolled, 37 (62.7%) were men, and the mean follow-up was 30.3 ± 10.8 months. Thoracoscopic ablation was successfully performed in 55 (93.2%) patients. On baseline magnetic resonance imaging, chronic ischemic brain lesions were present in 60.0% of patients. New ischemic lesions on postoperative magnetic resonance imaging were present in 44.4%. Major postoperative cognitive dysfunction was present in 27.0% and 17.6% at 1 and 9 months postoperatively, respectively. The probability of arrhythmia-free survival was 54.0% (95% CI: 41.3-66.8) at 1 year and 43.8% (95% CI: 30.7-57.0) at 2 years.
    Conclusions: The thoracoscopic ablation is associated with a high risk of silent cerebral ischemia. The midterm efficacy of hybrid ablations is moderate.
    MeSH term(s) Aged ; Anti-Arrhythmia Agents/therapeutic use ; Atrial Fibrillation/drug therapy ; Atrial Fibrillation/surgery ; Catheter Ablation/adverse effects ; Humans ; Male ; Middle Aged ; Tachycardia, Supraventricular/surgery ; Treatment Outcome
    Chemical Substances Anti-Arrhythmia Agents
    Language English
    Publishing date 2021-06-30
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2846739-5
    ISSN 2405-5018 ; 2405-500X ; 2405-500X
    ISSN (online) 2405-5018 ; 2405-500X
    ISSN 2405-500X
    DOI 10.1016/j.jacep.2021.04.013
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