BACKGROUND: Strokes after left atrial appendage closure (LAAC) prophylaxis are generally less severe than those after warfarin prophylaxis-thought to be secondary to more hemorrhagic strokes with warfarin. Hemorrhagic strokes are similarly infrequent with direct oral anticoagulant (DOAC) prophylaxis, so the primary subtype after either LAAC or DOAC prophylaxis is ischemic stroke (IS). OBJECTIVES: The purpose of this study was to compare the severity of IS using the modified Rankin Scale in atrial fibrillation patients receiving prophylaxis with DOACs vs LAAC. METHODS: A retrospective analysis was performed of consecutive patients undergoing LAAC at 8 centers who developed an IS (ISLAAC) compared with contemporaneous consecutive patients who developed IS during treatment with DOACs (ISDOAC). The primary outcome was disabling/fatal stroke (modified Rankin Scale 3-5) at discharge and 3 months later. RESULTS: Compared with ISDOAC patients (n = 322), ISLAAC patients (n = 125) were older (age 77.2 ± 13.4 years vs 73.1 ± 11.9 years; P = 0.002), with higher HAS-BLED scores (3.0 vs 2.0; P = 0.004) and more frequent prior bleeding events (54.4% vs 23.6%; P < 0.001), but similar CHA2DS2-VASc scores (5.0 vs 5.0; P = 0.28). Strokes were less frequently disabling/fatal with ISLAAC than ISDOAC at both hospital discharge (38.3% vs 70.3%; P < 0.001) and 3 months later (33.3% vs 56.2%; P < 0.001). Differences in stroke severity persisted after propensity score matching. By multivariate regression analysis, ISLAAC was independently associated with fewer disabling/fatal strokes at discharge (OR: 0.22; 95% CI: 0.13-0.39; P < 0.001) and 3 months (OR: 0.25; 95% CI: 0.12-0.50; P < 0.001), and fewer deaths at 3 months (OR: 0.28; 95% CI: 0.12-0.64; P < 0.001). CONCLUSIONS: Ischemic strokes in patients with atrial fibrillation are less often disabling or fatal with LAAC than DOAC prophylaxis.
- MeSH
- antikoagulancia škodlivé účinky MeSH
- cévní mozková příhoda * epidemiologie etiologie prevence a kontrola MeSH
- fibrilace síní * komplikace farmakoterapie chirurgie MeSH
- hemoragická cévní mozková příhoda * chemicky indukované komplikace farmakoterapie MeSH
- ischemická cévní mozková příhoda * chemicky indukované komplikace farmakoterapie MeSH
- krvácení chemicky indukované MeSH
- lidé středního věku MeSH
- lidé MeSH
- retrospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- uzávěr ouška levé síně MeSH
- výsledek terapie MeSH
- warfarin škodlivé účinky MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
Aims: We aimed to compare patients' quality of life (QoL) after two types of atrial fibrillation (AF) treatment: a hybrid ablation strategy and a surgical CryoMaze procedure alone. Methods and results: Patients with non-paroxysmal AF undergoing coronary artery bypass grafting and/or valve repair/replacement with concomitant CryoMaze procedure were randomly assigned to undergo either radiofrequency catheter ablation after three months (Hybrid Group) or no further treatment (Surgery Group). QoL was compared using the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. The AFEQT score was converted to the scale of 0 to 100 per cent points, i.e., a score of 0 corresponds to complete disability (or responding "extremely" limited, difficult, or bothersome to all questions answered), and a score of 100 corresponds to no disability (or responding "not at all" limited, difficult, or bothersome to all questions answered). In 106 Hybrid Group patients and 109 Surgery Group patients, both baseline and 12-month AFEQT data were available for final analysis. Patients' QoL did not differ between the Hybrid and Surgery Groups at baseline. At 12 months post-procedure, QoL improved significantly in both groups (from 61.9 ± 16.3 to 86.5 ± 13.4 and from 58.6 ± 14.9 to 81.5 ± 16.7 in the Hybrid Group and Surgery Group, respectively, P < 0.001). The 12-month AFEQT score was significantly higher in the Hybrid Group compared to the Surgery Group (P = 0.017). In an analysis based on AF recurrence, the QoL at 12 months was significantly higher in patients without AF recurrences compared to patients with AF recurrences (86.2 ± 14.0 vs 80.2 ± 16.8, P = 0.005). Conclusion: Compared to the CryoMaze procedure alone, the hybrid ablation strategy was associated with higher QoL 12 months post-procedure in patients with non-paroxysmal AF undergoing cardiac surgery for structural heart disease. Arrhythmia recurrence was the most significant denominator of the QoL after concomitant AF surgery.
- Klíčová slova
- CryoMaze,
- MeSH
- fibrilace síní * chirurgie MeSH
- kardiochirurgické výkony metody MeSH
- katetrizační ablace metody škodlivé účinky MeSH
- koronární bypass metody MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- maze procedura * metody MeSH
- průzkumy a dotazníky MeSH
- senioři MeSH
- statistika jako téma MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- práce podpořená grantem MeSH
- srovnávací studie 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).
- MeSH
- antiarytmika MeSH
- fibrilace síní * chirurgie MeSH
- katetrizační ablace * metody MeSH
- lidé MeSH
- píštěle * chirurgie MeSH
- prospektivní studie MeSH
- recidiva MeSH
- stenóza chirurgie MeSH
- tachykardie chirurgie MeSH
- venae pulmonales * chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
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
- antiarytmika terapeutické užití MeSH
- fibrilace síní * diagnóza chirurgie farmakoterapie MeSH
- katetrizační ablace * škodlivé účinky metody MeSH
- krvácení MeSH
- lidé MeSH
- recidiva MeSH
- supraventrikulární tachykardie * chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
IMPORTANCE: In treating atrial fibrillation, pulsed field ablation (PFA) is a novel energy modality with comparable efficacy to conventional thermal ablation, such as radiofrequency ablation (RFA), but with the benefit of some preferentiality to myocardial tissue ablation. Studies have demonstrated important safety advantages, including the absence of esophageal injury or pulmonary vein stenosis and only rare phrenic nerve injury. However, there is emerging evidence of coronary artery vasospasm provoked by PFA. OBJECTIVE: To compare the incidence and severity of left circumflex arterial vasospasm between PFA and RFA during adjacent ablation along the mitral isthmus. DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study enrolled consecutive adult patients receiving first-ever PFA or RFA of the mitral isthmus during catheter ablation of atrial fibrillation in 2022 with acute follow-up at a single referral European center. EXPOSURE: A posterolateral mitral isthmus line was created using either a multielectrode pentaspline PFA catheter (endocardial ablation) or a saline-irrigated RFA catheter. Simultaneous diagnostic coronary angiography was performed before, during, and after catheter ablation. Nitroglycerin was planned for spasm persisting beyond 20 minutes or for significant electrocardiographic changes. MAIN OUTCOMES AND MEASURES: The frequency and severity of left circumflex arterial vasospasm was assessed and monitored, as were time to remission and any need for nitroglycerin administration. RESULTS: Of 26 included patients, 19 (73%) were male, and the mean (SD) age was 65.5 (9.3) years. Patients underwent either PFA (n = 17) or RFA (n = 9) along the mitral isthmus. Coronary spasm was observed in 7 of 17 patients (41.2%) undergoing PFA: in 7 of 9 (77.8%) when the mitral isthmus ablation line was situated superiorly and in 0 of 8 when situated inferiorly. Conversely, coronary spasm did not occur in any of the 9 patients undergoing RFA. Of 5 patients in whom crossover PFA was performed after RFA failed to achieve conduction block, coronary spasm occurred in 3 (60%). Most instances of spasm (9 of 10 [90%]) were subclinical, with 2 (20%) requiring nitroglycerin administration. The median (range) time to resolution of spasm was 5 (5-25) minutes. CONCLUSION AND RELEVANCE: When creating a mitral isthmus ablation line during catheter ablation of atrial fibrillation, adjacent left circumflex arterial vasospasm frequently occurred with PFA and not RFA but was typically subclinical.
- MeSH
- dospělí MeSH
- fibrilace síní * chirurgie patofyziologie MeSH
- katetrizační ablace * škodlivé účinky MeSH
- koronární vazospasmus * etiologie MeSH
- lidé MeSH
- nitroglycerin MeSH
- prospektivní studie MeSH
- senioři MeSH
- srdeční síně patofyziologie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- komentáře MeSH
INTRODUCTION: Visually-guided laser balloon ablation (VGLA) currently requires careful manual rotation of the laser to create overlapping lesions. A novel semi-automated VGLA may reduce ablation times and lesion gaps. We aimed to compare semi-automated (SA) VGLA to that of manual (MN) VGLA. METHODS: Acute: Nine swine underwent right superior pulmonary vein isolation (PVI) using either SA (n = 3, 13-18 W), MN (n = 3, 8.5-12 W), or radiofrequency (RF, n = 3, 25-40 W) and were killed acutely. Chronic: 16 swine, underwent PVI using either SA (n = 8, 15 W) or MN (n = 8, 10 W), and were survived for 1 month before being killed. All hearts were then submitted for pathological evaluation. RESULTS: Acute: PVI was successful in all 9/9 swine with lesion counts significantly lower in the SA arm (5.3 ± 5.9, 33.7 ± 10.0, and 28.0 ± 4.4 in SA, MN, and RF arms; p = .007 for SA and MN). At necropsy, circumferentiality and transmurality were 98% and 94% in SA, 98% and 80% in MN, and 100% and 100% in RF arms. A single steam pop was noted on sectioning in the SA arm swine and occurred in the high dose (18 W) strategy. Chronic: PVI was acutely successful in 16/16 swine with no difference in PVI durability rates (62.5% vs. 75.0%), lesion transmurality (95.8 ± 17.4% vs.91.9 ± 25.9%), and circumferentiality (95.8 ± 6.6% vs. 94.8 ± 6.3%) between SA and MN arms. Catheter use time and lesion counts were lower in the SA arm compared to the MN arm (11.5 ± 12.7 vs. 21.8 ± 3.8 min, p = .046 and 4.8 ± 3.83 vs. 35.4 ± 4.4, p < .001). CONCLUSION: Motor-assisted semi-automated laser balloon ablation can improve upon procedural efficiency by reducing ablation time.
- MeSH
- fibrilace síní * diagnóza chirurgie MeSH
- katetrizační ablace * škodlivé účinky MeSH
- laserová terapie * škodlivé účinky MeSH
- prasata MeSH
- venae pulmonales * chirurgie MeSH
- výsledek terapie MeSH
- zvířata MeSH
- Check Tag
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
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.
- MeSH
- fibrilace síní * chirurgie MeSH
- katetrizační ablace * metody MeSH
- kognice MeSH
- kognitivní dysfunkce * etiologie MeSH
- lidé MeSH
- recidiva MeSH
- venae pulmonales * chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Radiofrekvenční energii bylo možné do současné doby považovat za zlatý standard katetrizační léčby fibrilace síní. Nicméně obecně s aplikací termické energie byla spojena řada limitací, jako je poškození kolaterálních struktur, časová náročnost a hlavně poměrně častá recidiva síňové arytmie, a to jak fibrilace síní, tak síňových tachykardií. Proto bylo potřeba hledat novou metodu s lepším bezpečnostním a výkonnostním profilem. Slibné výsledky přináší nově používaná ablace pomocí pulzního pole na principu ireverzibilní elektroporace, která na rozdíl od doposud použitých metod s termickým účinkem a tvorbou koagulační nekrózy způsobí převážně dezintegraci buněčné membrány. V tomto článku rozvádíme princip elektroporace, patofyziologické podklady i technické specifikace vývoje ablačních systémů využívajících pulzního pole. Dále jsou prezentovány výsledky prvních klinických studií ablační léčby s použitím metody pulzního pole u všech forem fibrilace síní a v neposlední řadě i první zkušenosti z praxe.
Catheter ablation of atrial fibrillation using radiofrequency energy has been the gold standard until these days. Nevertheless, there are limitations associated with the application of thermal energy such as damage to collateral structures, time-consuming nature, and, in particular, frequent recurrences of both atrial fibrillation and atrial tachycardias. Therefore, it was essential to find a brand new method with a better safety and efficiency profile. Promising results have been obtained with methods using pulsed field based on the principles of irreversible electroporation which, in comparison with the methods used so far that have a thermal effect and induce coagulation necrosis, predominantly cause disintegration of the cell membrane. This article deals with the principle of electroporation, pathophysiological background, and technical specification of the development of ablation systems using pulsed field energy. Also presented are the results of initial clinical trials with ablation treatment of all types of atrial fibrillation using the pulsed field method as well as the initial experience from the practice.
BACKGROUND: The presented study investigates the application of bi-arterial 3D printed models to guide transseptal puncture (TSP) in left atrial appendage closure (LAAC). AIMS: The objectives are to (1) test the feasibility of 3D printing (3DP) for TSP guidance, (2) analyse the distribution of the optimal TSP locations, and (3) define a CT-derived 2D parameter suitable for predicting the optimal TSP locations. METHODS: Preprocedural planning included multiplanar CT reconstruction, 3D segmentation, and 3DP. TSP was preprocedurally simulated in vitro at six defined sites. Based on the position of the sheath, TSP sites were classified as optimal, suboptimal, or nonoptimal. The aim was to target the TSP in the recommended position during the procedure. Procedure progress was assessed post hoc by the operator. RESULTS: Of 68 screened patients, 60 patients in five centers (mean age of 74.68 ± 7.64 years, 71.66% males) were prospectively analyzed (3DP failed in one case, and seven patients did not finally undergo the procedure). In 55 patients (91.66%), TSP was performed in the optimal location as recommended by the 3DP. The optimal locations for TSP were postero-inferior in 45.3%, mid-inferior in 45.3%, and antero-inferior in 37.7%, with a mean number of optimal segments of 1.34 ± 0.51 per patient. When the optimal TSP location was achieved, the procedure was considered difficult in only two (3.6%) patients (but in both due to complicated LAA anatomy). Comparing anterior versus posterior TSP in 2D CCT, two parameters differed significantly: (1) the angle supplementary to the LAA ostium and the interatrial septum angle (160.83° ± 9.42° vs. 146.49° ± 8.67°; p = 0.001), and (2) the angle between the LAA ostium and the mitral annulus (95.02° ± 3.73° vs. 107.38° ± 6.76°; p < 0.001), both in the sagittal plane. CONCLUSIONS: In vitro TSP simulation accurately determined the optimal TSP locations for LAAC and facilitated the procedure. More than one-third of the optimal TSP sites were anterior.
- MeSH
- 3D tisk MeSH
- fibrilace síní * terapie chirurgie MeSH
- lidé MeSH
- počítačová rentgenová tomografie MeSH
- punkce metody MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- síňové ouško * diagnostické zobrazování chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
AIMS: Electro-anatomical mapping may be critical to identify atrial fibrillation (AF) subjects who require substrate modification beyond pulmonary vein isolation (PVI). The objective was to determine correlations between pre-ablation mapping characteristics and 12-month outcomes after a single PVI-only catheter ablation of AF. METHODS AND RESULTS: This study enrolled paroxysmal AF (PAF), early persistent AF (PsAF; 7 days-3 months), and non-early PsAF (>3-12 months) subjects undergoing de novo PVI-only radiofrequency catheter ablation. Sinus rhythm (SR) and AF voltage maps were created with the Advisor HD GridTM Mapping Catheter, Sensor EnabledTM for each subject, and the presence of low-voltage area (LVA) (low-voltage cutoffs: 0.1-1.5 mV) was investigated. Follow-up visits were at 3, 6, and 12 months, with a 24-h Holter monitor at 12 months. A Cox proportional hazards model identified associations between mapping data and 12-month recurrence after a single PVI procedure. The study enrolled 300 subjects (113 PAF, 86 early PsAF, and 101 non-early PsAF) at 18 centres. At 12 months, 75.5% of subjects were free from AF/atrial flutter (AFL)/atrial tachycardia (AT) recurrence. Univariate analysis found that arrhythmia recurrence did not correlate with AF diagnosis, but LVA was significantly correlated. Low-voltage area (<0.5 mV) >28% of the left atrium in SR [hazard ratio (HR): 4.82, 95% confidence interval (CI): 2.08-11.18; P = 0.0003] and >72% in AF (HR: 5.66, 95% CI: 2.34-13.69; P = 0.0001) was associated with a higher risk of AF/AFL/AT recurrence at 12 months. CONCLUSION: Larger extension of LVA was associated with an increased risk of arrhythmia recurrence. These subjects may benefit from substrate modification beyond PVI.
- MeSH
- časové faktory MeSH
- elektrofyziologické techniky kardiologické MeSH
- fibrilace síní * diagnóza chirurgie MeSH
- flutter síní * diagnóza chirurgie etiologie MeSH
- katetrizační ablace * škodlivé účinky metody MeSH
- lidé MeSH
- recidiva MeSH
- srdeční frekvence MeSH
- srdeční síně MeSH
- venae pulmonales * chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH