scholarly journals Paroxysmal and persistent atrial fibrillation ablation outcomes with the pulmonary vein ablation catheter GOLD duty-cycled phased radiofrequency ablation catheter: quality of life and 12-month efficacy results from the GOLD Atrial Fibrillation Registry

EP Europace ◽  
2020 ◽  
Vol 22 (6) ◽  
pp. 888-896 ◽  
Author(s):  
Lucas Boersma ◽  
Edward Koźluk ◽  
Giampiero Maglia ◽  
João de Sousa ◽  
Olaf Grebe ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Persistent Atrial Fibrillation ◽  
Rf Ablation ◽  
Ablation Catheter ◽  
Phased Radiofrequency ◽  
Pulmonary Vein Ablation Catheter ◽  
Af Recurrence

Abstract Aims The GOLD AF Registry has been designed to prospectively assess the population, indications, and outcomes using second-generation phased radiofrequency (RF) ablation (pulmonary vein ablation catheter GOLD) in a global examination of standard-of-care use for the treatment of paroxysmal and persistent atrial fibrillation (AF). Methods and results GOLD AF (NCT02433613) is a prospective, observational, multi-centre registry designed to characterize efficacy and safety of phased RF ablation in patients with AF. The primary endpoint was freedom from AF recurrence at 12-month follow-up after a 90-day blanking period. Ancillary objectives include safety, procedural efficiency, and quality of life (QoL). The QoL assessment using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and the European Heart Rhythm Association (EHRA) Score of AF-related symptoms was collected at baseline and 12 months. In total, 1054 patients were included in this analysis (age 60.6, 67.6% male, 26.5% PersAF). Kaplan–Meier estimate of freedom from AF recurrence was 77.7% at 12 months. Peri-procedural device or procedure-related complications were observed in 26 (2.5%) patients, with a low stroke rate of 0.3%. One-year post-ablation, the EHRA AF Symptom score decreased in 68% of patients. The AFEQT score improvement was observed in 88.4% and 90.4% of patients who completed the questionnaire in-person or interviewed by phone at 12 month follow-up, respectively. Conclusion Phased RF ablation for the treatment of paroxysmal and persistent AF demonstrated a 77.7% freedom from AF recurrence at 12 months in addition to a significant reduction in arrhythmia symptoms and clinically meaningful improved QoL. Low peri-procedural complication rate of <3% was reported.

scholarly journals Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results from the CABANA Trial

Circulation ◽  
2021 ◽  
Author(s):  
Douglas L. Packer ◽  
Jonathan P Piccini ◽  
Kristi H Monahan ◽  
Hussein R Al-Khalidi ◽  
Adam P Silverstein ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Atrial Fibrillation ◽  
Drug Therapy ◽  
Catheter Ablation ◽  
Left Ventricular ◽  
Relative Reduction ◽  
Af Recurrence

Background: In patients with heart failure (HF) and atrial fibrillation (AF), several clinical trials have reported improved outcomes, including freedom from AF recurrence, quality of life (QOL), and survival, with catheter ablation. This report describes the treatment-related outcomes of the AF patients with HF enrolled in the Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial. Methods: CABANA randomized 2204 patients with AF who were ≥65 years old or <65 with ≥1 risk factor for stroke at 126 sites to ablation with pulmonary vein isolation or drug therapy including rate/rhythm control drugs. Of these, 778 (35%) had NYHA class ≥ II at baseline and form the subject of this report. The CABANA primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Results: Of the 778 HF patients enrolled in CABANA, 378 were assigned to ablation and 400 to drug therapy. Ejection fraction (EF) at baseline was available for 571 patients (73%) and 9.3% of these had an EF <40%, while 11.7% had EFs between 40-50%. In the intention-to-treat analysis, the ablation arm had a 36% relative reduction in the primary composite endpoint (hazard ratio [HR] 0.64; 95% confidence interval [CI], 0.41 to 0.99) and a 43% relative reduction in all-cause mortality (HR 0.57; 95% CI, 0.33 to 0.96) compared to drug therapy alone over a median follow-up of 48.5 months. AF recurrence was decreased with ablation (HR 0.56; 95% CI, 0.42 to 0.74). The adjusted mean difference for the AF Effect on QOL (AFEQT) summary score averaged over the entire 60-month follow-up was 5.0 points favoring the ablation arm (95% CI, 2.5 to 7.4 points), and the Mayo AF-specific Symptom Inventory (MAFSI) frequency score difference was -2.0 points favoring ablation (95% CI, -2.9 to -1.2). Conclusions: In patients with atrial fibrillation enrolled in CABANA who had clinically diagnosed stable heart failure at trial entry, catheter ablation produced clinically important improvements in survival, freedom from AF recurrence, and quality of life relative to drug therapy. These results, obtained in a cohort most of whom had preserved left ventricular function, require independent trial verification. Clinical Trial Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT00911508

scholarly journals Thoracoscopic surgical ablation versus catheter ablation as first-line treatment for long-standing persistent atrial fibrillation: the CASA-AF RCT

2021 ◽  
Vol 8 (18) ◽  
pp. 1-122
Author(s):  
Shouvik Haldar ◽  
Habib R Khan ◽  
Vennela Boyalla ◽  
Ines Kralj-Hans ◽  
Simon Jones ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Antiarrhythmic Drugs ◽  
Persistent Atrial Fibrillation ◽  
Loop Recorder ◽  
Surgical Ablation ◽  
Single Procedure

Background Standalone thoracoscopic surgical ablation may be more effective than catheter ablation in patients with long-standing persistent atrial fibrillation. Objectives To determine whether or not surgical ablation is clinically superior to catheter ablation as the first-line treatment strategy in long-standing persistent atrial fibrillation. Design This was a prospective, multicentre, randomised control trial. Setting Four NHS tertiary centres in England. Participants Adults with long-standing persistent atrial fibrillation, who had European Heart Rhythm Association symptom scores > 2 and who were naive to previous catheter ablation or thoracic/cardiac surgery. Interventions Minimally invasive thoracoscopic surgical ablation and conventional catheter ablation (control intervention). Main outcome measures The primary outcome was freedom from atrial fibrillation/tachycardia ≥ 30 seconds after a single procedure without antiarrhythmic drugs (class 1C/3) at 1 year, excluding a 3-month blanking period. The secondary outcomes include the intervention-related major complication rate; clinical success (≥ 75% reduction in arrhythmia burden); and changes in symptoms, quality of life and cost-effectiveness. Methods Patients (n = 120) were randomised to surgical ablation (n = 60) or catheter ablation (n = 60). An implanted loop recorder provided continuous cardiac monitoring following ablation. Follow-up visits were at 3, 6, 9 and 12 months. Loop recorder data were reviewed monthly by a physiologist who was blinded to the randomisation outcome. Results The study treatment was received by 55 patients in the surgical ablation arm and 60 patients in the catheter ablation arm; five patients withdrew from surgical ablation before treatment. Data from randomised and treated patients were analysed as per intention to treat. Patients had a mean age of 62.3 (standard deviation 9.6) years, were predominantly male (74%), had a mean left atrial diameter of 44.6 mm (standard deviation 6 mm) and were in continuous atrial fibrillation for 22 months (range 16–31 months). At 12 months, 26% of patients in the surgical ablation arm (14/54) and 28% of patients in the catheter ablation arm (17/60) were free from atrial arrhythmias after a single procedure without antiarrhythmic drugs (odds ratio 1.13, 95% confidence interval 0.46 to 2.83; p = 0.84). An arrhythmia burden reduction of ≥ 75% was seen in 36 out of 54 (67%) patients in the surgical ablation arm, compared with 46 out of 60 (77%) patients in the catheter ablation arm (odds ratio 1.64, 95% confidence interval 0.67 to 4.08; p = 0.3). Procedure-related serious complications within 30 days of the intervention occurred in 15% (8/55) of patients in the surgical ablation arm (including one death) compared with 10% (6/60) of patients in the catheter ablation arm (p = 0.46). Surgical ablation was associated with significantly higher costs (£23,221 vs. £18,186; p = 0.02) and fewer quality-adjusted life-years than catheter ablation (0.76 vs. 0.83; p = 0.02). Limitations This study was conducted in four highly specialised cardiology centres that have substantial experience in both treatment modalities; therefore, the results may not be widely generalisable. The study was not powered to detect small differences in efficacy. Conclusions We found no evidence to suggest that standalone thoracoscopic surgical ablation outcomes were superior to catheter ablation outcomes in achieving freedom from atrial arrhythmia after a single procedure without antiarrhythmic drugs. Moreover, surgical ablation is associated with a longer hospital stay, smaller improvements in quality of life and higher health-care costs than catheter ablation (standard care therapy). Future work Evaluation of the impact of ablation treatments on sinus rhythm maintenance and quality of life with extended follow-up to 3 years. Model-based economic analysis to estimate long-term benefits, harms and costs of surgical and catheter ablation compared with antiarrhythmic drug therapy in long-standing persistent atrial fibrillation patients. Trial registration Current Controlled Trials ISRCTN18250790 and ClinicalTrials.gov NCT02755688. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. This study was supported by the UK Clinical Research Collaboration-registered King’s Clinical Trials Unit at King’s Health Partners, which is part funded by the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London and the NIHR Evaluation, Trials and Studies Coordinating Centre. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 18. See the NIHR Journals Library website for further project information.

scholarly journals The fate of patients after failed epicardial ablation of atrial fibrillation

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Giuseppe Nasso ◽  
Roberto Lorusso ◽  
Arash Motekallemi ◽  
Angelo M. Dell’Aquila ◽  
Nicola Di Bari ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Long Term Outcome ◽  
Af Ablation ◽  
Af Recurrence

Abstract Background Much debate is still going on about the best ablation strategy—via endocardial or epicardial approach—in patients with atrial fibrillation (AF), and evidence gaps exist in current guidelines in this area. More specifically, there are no clear long-term outcome data after failed surgical AF ablation. Methods Since June 2008, 549 surgical AF ablation procedures through a right minithoracotomy were performed at our institution. From 2008 to 2011, a unipolar radiofrequency device was used (151 patients), whereas from 2011 to 2020 a bipolar radiofrequency device was used (398 patients). Patients were scheduled for surgery on the basis of the following criteria: recurrent episodes of paroxysmal or persistent lone AF refractory to maximally tolerated antiarrhythmic drug dosing and at least one failed cardioversion attempt. Besides the recommended follow-up by the local cardiologist, starting from 2021, surviving patients were asked to undergo assessment of left ventricular function and to complete a questionnaire addressing quality of life and predisposing factors for recurrent AF. Results At a mean follow-up of 77 months, the rate of AF recurrence was 20.7% (n = 114). On multivariate analysis, impaired left ventricular ejection fraction (58 patients, 51%, p = 0.002), worsening of European Heart Rhythm Association (EHRA) symptom class (37 patients, 32%, p = 0.003) and cognitive decline or depression (23 patients, 20%, p = 0.023) during follow-up were found to be significantly associated with AF recurrence. Conclusions Surgical AF ablation through a right minithoracotomy is safe, but a better outcome could be achieved using a hybrid approach. Patients after initial failed surgical AF ablation show worsening of cardiac function, clinical status and quality of life at follow-up compared to patients with successful AF ablation.

scholarly journals P6600Improvement in quality of life in patients that underwent catheter ablation for persistent atrial fibrillation

2018 ◽  
Vol 39 (suppl_1) ◽  
Author(s):  
K Nakajima ◽  
T Kimura ◽  
T Fujisawa ◽  
Y Katsumata ◽  
T Nishiyama ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Persistent Atrial Fibrillation

scholarly journals Rotational activity presence and its impact in persistent atrial fibrillation follow-up

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
G R Rios-Munoz ◽  
N Soto ◽  
P Avila ◽  
T Datino ◽  
F Atienza ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Treatment Success ◽  
Persistent Atrial Fibrillation ◽  
Recurrence Rates ◽  
National Budget ◽  
Funding Sources ◽  
Cycle Lengths ◽  
Public Grant ◽  
Af Recurrence

Abstract Introduction Treatment of atrial fibrillation (AF) remains sub-optimal, with low success in pulmonary vein isolation (PVI) ablation procedures in long-standing-persistent AF patients. The maintenance mechanisms of AF are still under debate. Rotational activity (RA) events, also known as rotors, may play a role in perpetuating AF. The characterisation of these drivers during electroanatomical (EA) guided ablation procedures in relationship with follow-up and recurrence ratios in AF patients is necessary to design new ablation strategies to improve the AF treatment success. Purpose We report an AF patient cohort of endocardial mapping and PVI ablation procedures with additional RA events detected during the EA study. We aim to study the presence and distribution of RA in AF patients and its impact on AF recurrence when only PVI ablation is performed. Methods 75 persistent consecutive AF patients (age 60.7±9.8, 74.7% men) underwent EA mapping and RA detection with an automatic algorithm. The presence of RA was annotated on the EA map based on the unipolar electrograms (EGMs) registered with a 20-pole catheter. RA presence was analysed at different left atrial locations (37.2±14.8 sites per patient). AF recurrence was evaluated in follow-up after treatment. Results At follow-up (9±5 months), 50% of the patients presented AF recurrence. Patients with RA had more dilated atria in terms of volumes (p=0.002) and areas (p=0.001). Patients with RA exhibited higher mean voltage EGMs 0.6±0.3 mV vs 0.5±0.2 mV (p=0.036), with shorter cycle lengths 169.1±26.0 ms vs. 188.4±44.2 ms (p=0.044). Finally, patients with RA presented more AF recurrence rates than patients with no RA events (p=0.007). No significant differences were found in terms of comorbidities, e.g., heart failure, hypertension, COPD, stroke, SHD, or diabetes mellitus. Conclusions The results show that patients with more RA events and those with RA outside the PVI ablated regions presented higher AF recurrence episodes than those with no RA or events inside the areas affected by radio-frequency ablation. The study suggests that further ablation treatment of the areas harboring RA might be necessary to reduce the recurrence ratio in AF patients. FUNDunding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Instituto de Salud Carlos III; Sociedad Española de Cardiología

scholarly journals Clinical success of cryoballoon pulmonary vein isolation in patients with atrial fibrillation

2019 ◽  
Vol 7 (4S) ◽  
pp. 6-14
Author(s):  
T. Y. Chichkova ◽  
S. E. Mamchur ◽  
E. A. Khomenko
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Direct Current ◽  
Clinical Success ◽  
Persistent Atrial Fibrillation ◽  
Cryoballoon Ablation ◽  
Clinical Effects ◽  
Rf Ablation

Aim. To estimate the clinical success of cryoballoon pulmonary vein isolation (PVI).Methods.230 patients (males: 49.6%, mean age 57 (53; 62) with symptomatic paroxysmal and persistent atrial fibrillation (AF) resistant to antiarrhythmic therapy were included in a single-center prospective study. The patients were randomized into 2 groups to undergo either cryoballoon ablation (n = 122) or radiofrequency (RF) (n = 108) ablation. Both groups were comparable in baseline parameters. The follow-up period was 12 months. Clinical outcomes were estimated with the use of a three-stage scale. The rates of cardiovascular rehospitalizations, direct-current cardioversions and repeated ablations during were estimated within the follow-up. The quality of life (QoL) in the cryoablation group was measured using the AFEQT scale.Results.77% (n = 94) of patients in the cryoballoon ablation group and 71.3% (n = 77) of patients in the RF group (р = 0.71) demonstrated reported the optimal clinical effects. Both groups, cryo ablation and RF ablation, had similar rates of cardiovascular hospitalizations (23.8 vs 28.7%, OR 0.8, 95% CI 0.4–1.4; р = 0.39), direct-current cardioversions (12.3 vs 17.6%, OR 0.7, 95% CI 0.3–1.4; р = 0.26) and repeated ablations (9.8–11.1%, OR 0.9, 95% CI 0.4–2.0; р = 0.75). The patients treated with cryoballoon as opposed to RF ablation had significantly more successful usage of “pill-in-pocket” strategy – 14.8 vs 6.5% (OR 2.5, 95% CI 1.01–6.2; р = 0.04). Significant improvements of the QoL parameters with strong size effect have been found in the cryoablation group, i.e. global score (GS) increased by 8.9±6.9 (95% CI 6.6–10.1; dCohen 1.2; р<0.001), symptoms (S) – by 8.3±7.9 (95% CI 4.2–8.8; dCohen 1.5; р<0.001), daily activities (DA) – by 10.0±6.9 (95% CI = 6.4–10.6; dCohen 0.9; р<0.001), treatment concerns (TC) – by 5.5±6.0 (95% CI 6.3–9.2; dCohen 1.2; р<0.001) and treatment satisfaction (TS) – by 5.5±6.0 (95% CI 5.4–9.8; dCohen 0.9; р<0.001).Conclusion.The both catheter-based technologies had comparable clinical success. Cryoablation was characterized by improvement in all QoL parameters based on the AFEQT score.

scholarly journals Multi-catheter cryotherapy compared with radiofrequency ablation in long-standing persistent atrial fibrillation: a randomized clinical trial

EP Europace ◽  
2020 ◽  
Author(s):  
Mark M Gallagher ◽  
Gang Yi ◽  
Hanney Gonna ◽  
Lisa W M Leung ◽  
Idris Harding ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Sinus Rhythm ◽  
Persistent Atrial Fibrillation ◽  
Rf Ablation ◽  
Ablation Efficiency ◽  
Mapping System ◽  
3D Mapping System ◽  
Front Advance

Abstract Aims Restoring sinus rhythm (SR) by ablation alone is an endpoint used in radiofrequency (RF) ablation for long-standing persistent atrial fibrillation (AF) but not with cryotherapy. The simultaneous use of two cryotherapy catheters can improve ablation efficiency; we compared this with RF ablation in chronic persistent AF aiming for termination to SR by ablation alone. Methods and results Consecutive patients undergoing their first ablation for persistent AF of &gt;6 months duration were screened. A total of 100 participants were randomized 1:1 to multi-catheter cryotherapy or RF. For cryotherapy, a 28-mm Arctic Front Advance was used in tandem with focal cryoablation catheters. Open-irrigated, non-force sensing catheters were used in the RF group with a 3D mapping system. Pulmonary vein (PV) isolation and non-PV triggers were targeted. Participants were followed up at 6 and 12 months, then yearly. Acute PVI was achieved in all cases. More patients in the multi-catheter cryotherapy group were restored to SR by ablation alone, with a shorter procedure duration. Sinus rhythm continued to the last available follow-up in 16/49 patients (33%) in the multi-catheter at 3.0 ± 1.6 years post-ablation and in 12/50 patients (24%) in the RF group at 4.0 ± 1.2 years post-ablation. The yearly rate of arrhythmia recurrence was similar. Conclusion Multi-catheter cryotherapy can restore SR by ablation alone in more cases and more quickly than RF ablation. Long-term success is difficult to achieve by either methods and is similar with both.

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