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

Author(s):  
Douglas L. Packer ◽  
Jonathan P Piccini ◽  
Kristi H Monahan ◽  
Hussein R Al-Khalidi ◽  
Adam P Silverstein ◽  
...  

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

Author(s):  
M. Meshkova ◽  
A. Doronin

Atrial fibrillation (AF) is a worldwide epidemic that has hit about 33 million people. In clinical studies, the efficacy of antiarrhythmic therapy and catheter ablation in the treatment of AF was compared, and controversial results were obtained. Objective. To analyze three advanced publications in recent years, which, according to the authors, are of fundamental importance for the choice of radiofrequency catheter ablation as a treatment option for AF. Results and discussion. In the CABANA study catheter ablation was compared with antiarrhythmic therapy and showed significant improvement in the quality of life. Within 3 years, AF recurrence rate was 69% in the group of antiarrhythmic treatment and 50% in the catheter ablation group. The proportion of patients with non-paroxysmal AF decreased from 57% to 26% with antiarrhythmic treatment and up to 16% with catheter ablation. Among the serious complications in the catheter ablation group were tamponades (0.8%), minor hematomas (2.3%) and pseudoaneurysms (1.1%). Thyroid dysfunction (1.6%) and proarrhythmogenic effect (0.8%) were observed in the group of antiarrhythmic therapy. In the CASTLE-AF (HF) study, 179 patients were randomly selected for catheter ablation, and 184 for antiarrhythmic therapy. All of them were in NYHA class II, III or IV, had left ventricular ejection fraction 35% or less, and used implantable defibrillator. In the mean follow-up of 37.8 months, significantly less patients died after catheter ablation (24 [13.4%] versus 46 [25.0%]), and less were hospitalized due to worsening heart failure (37 [20.7%] versus 66 [35.9%]). ATTEST is the first randomized controlled trial that has demonstrated slowing down of the progression of AF after catheter ablation. Radiofrequency ablation was performed in 128 patients, antiarrhythmic therapy was applied in 127 patients. Within 3 years, the incidence of persistent AF or atrial tachycardia was lower in patients treated with ablation compared with patients on antiarrhythmic therapy (2.4% vs. 17.5%; P = 0.0009). Conclusions. The expected benefit of catheter ablation of AF in comparison with drug therapy is as follows: increase in the probability of maintaining sinus rhythm, improvement of the quality of life, decrease in the number of hospitalizations and all-cause mortality in patients with heart failure, decrease in fatigue.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Giuseppe Nasso ◽  
Roberto Lorusso ◽  
Arash Motekallemi ◽  
Angelo M. Dell’Aquila ◽  
Nicola Di Bari ◽  
...  

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.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Nobuaki Tanaka ◽  
KOICHI INOUE ◽  
Atsushi Kobori ◽  
Kazuaki Kaitani ◽  
Takeshi Morimoto ◽  
...  

Background: Heart failure (HF) is the leading cause of death in patients with atrial fibrillation (AF). Radiofrequency catheter ablation (RFCA) of AF is effective for maintaining sinus rhythm though its impact on heart failure still remains controversial. Purpose: We sought to elucidate whether AF recurrence following RFCA was associated with subsequent HF hospitalizations. Methods: We conducted a large-scale, prospective, multicenter, observational study. A total of 4931 consecutive patients who underwent an initial RFCA for AF with longer than 1-year of follow-up in 26 centers were enrolled (average age, 64±10 years; non-paroxysmal AF, 35.7%). The median follow-up duration was 2.9 years. The primary endpoint was an HF hospitalization more than 1-year after the index RFCA. We compared the patients without AF recurrences (group A) to those with AF recurrences within 1-year post RFCA (group B). Results: The 1-year cumulative incidence of AF recurrences after a single procedure was 30.7% (group A=3418, group B=1513 patients). Group B had a lower body mass index (group A vs. group B,24.1±3.6 vs. 23.8±3.4 kg/m 2 , p=0.014), longer history of AF (1.9 vs. 3.1 years, p<0.0001), higher prevalence of non-paroxysmal AF (32.1% vs. 33.9%, p<0.0001), and valvular heart disease (5.9% vs. 7.8%, p=0.013). They also had a lower ejection fraction (63.7±9.4% vs. 62.8±9.6%, p=0.0043) and larger left atrial dimeter (39.7±6.6 vs. 40.6±7.0 mm, p<0.0001) on echocardiography. Hospitalizations for HF were observed in 57 patients (1.14%) more than 1-year after the RFCA and were significantly higher in group B than group A (group A vs. group B, 0.91% vs 1.72%, log-rank p=0.019). Conclusions: Among AF patients receiving RFCA, those with AF recurrences were at a greater risk of subsequent heart failure hospitalizations than those without AF recurrences. Recognition that AF recurrence following RFCA is a risk factor for a subsequent HF-related hospitalization is appropriate in clinical practice.


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
S Seliutskii ◽  
N Savina ◽  
A Chapurnykh

Abstract Objective to compare the efficacy of radiofrequency ablation (RFA) and drug therapy in patients with atrial fibrillation (AFib) and heart failure (HF) within 12-month follow-up. Materials and methods 130 patients (men-75%, average age-62.8 ± 11.8 years) with AFib and HF with left ventricular ejection fraction (LVEF)&lt;50% were included in a prospective study. In 107 (82%) of the included patients, intermediate LVEF was detected (40-49%). At the time of inclusion, paroxysmal AFib (PaAFib) was recorded in 60 (46%) of patients and persistent AFib (PeAFib) in 70 (54%). AFib RFA was performed in 65 patients, 65 patients continued to receive optimal antiarrhythmic therapy. Prior to the intervention and after 12 months, all patients underwent transthoracic echocardiography and quality of life (QoL) assessment using the SF-36 questionnaire. Results the freedom from AFib within 12 months follow-up period was registred in 49 (75%) of patients in the RFA group and 26 (40%) in the drug therapy group. After 12 month follow-up period we revealed increase of LVEF (p &lt; 0.001), decrease of anteroposterior size (p &lt;0.001) and volume (p &lt; 0.001) of left atrium (LA), improvement of mental (p = 0.008) and physical (p = 0.048) health components according to the SF-36 questionnaire in the RFA group. In the group of drug rhythm control, after 12 months there was only the improvement of mental (p = 0.006) and physical p = 0.016) health components and it was much less than in RFA group (р&lt;0.001). Similar results were received in patients who were free from Afib within 12 months in both groups. Conclusions in patients with AFib and HF with LVEF &lt; 50%, restoration and maintenance of sinus rhythm using RFA was accompanied by an increase in LVEF, decrease of  LA size, and an improvement of QoL. In the group of drug therapy, there was a lower freedom from AFib and there was the slight improvement only in QoL.


2018 ◽  
Vol 64 (9) ◽  
pp. 853-860 ◽  
Author(s):  
Roberta da Silva Teixeira ◽  
Bruna Medeiros Gonçalves de Veras ◽  
Kátia Marie Simões e Senna ◽  
Rosângela Caetano

SUMMARY INTRODUCTION Heart failure due to an acute myocardial infarction is a very frequent event, with a tendency to increase according to improvements in the treatment of acute conditions which have led to larger numbers of infarction survivors. OBJECTIVE The aim of this study is to synthesize the evidence, through a systematic review, on efficacy and safety of the device in patients with this basic condition. METHODS Studies published between January 2002 and October 2016 were analysed, having as reference databases Embase, Medline, Cochrane Library, Lilacs, Web of Science and Scopus. The selection of studies, data extraction and methodological quality assessment of studies were examined by two independent reviewers, with disagreements resolved by consensus. RESULTS Only prospective studies without control group were identified. Six studies were included, with averages of 34 participants and follow-up of 13 months. Clinical, functional, hemodynamic and quality of life outcomes were evaluated. The highest mortality rate was 8.4% with 12-month follow-up for unspecified cardiovascular reasons, and heart failure rehospitalization was 29.4% with 36-month follow-up. Statistically significant improvements were found only in some of the studies which evaluating changes in left ventricular volume indices, the distance measured by the six-minute walk test, New York Heart Association functional classification, and quality of life, in pre and post-procedure analysis. CONCLUSIONS The present review indicates that no available quality evidence can assert efficacy and safety of PARACHUTE® in the treatment of heart failure after apical or anterior wall myocardial infarction.


2019 ◽  
Vol 27 (9) ◽  
pp. 929-952 ◽  
Author(s):  
Birna Bjarnason-Wehrens ◽  
R Nebel ◽  
K Jensen ◽  
M Hackbusch ◽  
M Grilli ◽  
...  

Background In heart failure with reduced left ventricular ejection fraction (HFrEF) patients the effects of exercise-based cardiac rehabilitation on top of state-of-the-art pharmacological and device therapy on mortality, hospitalization, exercise capacity and quality-of-life are not well established. Design The design of this study involved a structured review and meta-analysis. Methods Evaluation of randomised controlled trials of exercise-based cardiac rehabilitation in HFrEF-patients with left ventricular ejection fraction ≤40% of any aetiology with a follow-up of ≥6 months published in 1999 or later. Results Out of 12,229 abstracts, 25 randomised controlled trials including 4481 HFrEF-patients were included in the final evaluation. Heterogeneity in study population, study design and exercise-based cardiac rehabilitation-intervention was evident. No significant difference in the effect of exercise-based cardiac rehabilitation on mortality compared to control-group was found (hazard ratio 0.75, 95% confidence interval 0.39–1.41, four studies; 12-months follow-up: relative risk 1.29, 95% confidence interval 0.66–2.49, eight studies; six-months follow-up: relative risk 0.91, 95% confidence interval 0.26–3.16, seven studies). In addition there was no significant difference between the groups with respect to ‘hospitalization-for-any-reason’ (12-months follow-up: relative risk 0.79, 95% confidence interval 0.41–1.53, four studies), or ‘hospitalization-due-to-heart-failure’ (12-months follow-up: relative risk 0.59, 95% confidence interval 0.12–2.91, four studies; six-months follow-up: relative risk 0.84, 95% confidence interval 0.07–9.71, three studies). All studies show improvement of exercise capacity. Participation in exercise-based cardiac rehabilitation significantly improved quality-of-life as evaluated with the Kansas City Cardiomyopathy Questionnaire: (six-months follow-up: mean difference 1.94, 95% confidence interval 0.35–3.56, two studies), but no significant results emerged for quality-of-life measured by the Minnesota Living with Heart Failure Questionnaire (nine-months or more follow-up: mean difference –4.19, 95% confidence interval –10.51–2.12, seven studies; six-months follow-up: mean difference –5.97, 95% confidence interval –16.17–4.23, four studies). Conclusion No association between exercise-based cardiac rehabilitation and mortality or hospitalisation could be observed in HFrEF patients but exercise-based cardiac rehabilitation is likely to improve exercise capacity and quality of life.


Author(s):  
Maryam E. Rettmann ◽  
David R. Holmes III ◽  
Kristi H. Monahan ◽  
Jerome F. Breen ◽  
Tristram D. Bahnson ◽  
...  

Background - The Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial was a randomized, prospective trial of left atrial catheter ablation versus drug therapy for treatment of atrial fibrillation (AF). As part of CABANA, a prospective imaging sub-study was conducted. The main objectives were to describe the patterns of changes in the dimensions of the left atrium (LA) and pulmonary veins (PVs), and the relationship between these changes with treatment assignment and clinical outcomes. Methods - CT or MRI was acquired at baseline and follow-up in 121 ablation (median follow-up 101 days) and 85 drug patients (median follow-up 97 days). Left atrial volume index (LAVI), mean PV ostial diameter (MPV) , and ostial diameters of each PV separately were computed. We examined the relationship between the change from baseline to follow-up with subsequent clinical outcomes (composite of death, disabling stroke, serious bleeding, or cardiac arrest [CABANA primary endpoint], total mortality or cardiovascular hospitalization, first AF recurrence after the 90 day blanking period, first AF/atrial flutter/ atrial tachycardia after the 90 day blanking period) using Cox proportional-hazards models. Results - The median (25 th , 75 th ) change from baseline for LAVI was -7.8 mL/m 2 (-16.4, 0.2), ablation arm and -3.5 mL/m 2 (-11.4, 2.6), drug therapy arm. The LAVI decreased in 52.9% of ablation patients versus 40.0% of drug therapy patients. Change for MPV was -2.7 mm (-4.2, -1.3) in the ablation arm versus -0.1 mm (-1.5, 0.8) in the drug therapy arm. Changes in LA and PV dimensions had no consistent relationship with the risk of developing the study primary endpoint. Reductions in LAVI, and in MPV diameter were associated with decreased risk of AF recurrence. Conclusions - Ablation patients demonstrated more frequent and larger atrial structural changes compared with drug patients. These changes suggest a critical relationship between structural features and AF generation.


2019 ◽  
Vol 40 (46) ◽  
pp. 3793-3799c ◽  
Author(s):  
Stephan Willems ◽  
Christian Meyer ◽  
Joseph de Bono ◽  
Axel Brandes ◽  
Lars Eckardt ◽  
...  

Abstract Recent innovations have the potential to improve rhythm control therapy in patients with atrial fibrillation (AF). Controlled trials provide new evidence on the effectiveness and safety of rhythm control therapy, particularly in patients with AF and heart failure. This review summarizes evidence supporting the use of rhythm control therapy in patients with AF for different outcomes, discusses implications for indications, and highlights remaining clinical gaps in evidence. Rhythm control therapy improves symptoms and quality of life in patients with symptomatic AF and can be safely delivered in elderly patients with comorbidities (mean age 70 years, 3–7% complications at 1 year). Atrial fibrillation ablation maintains sinus rhythm more effectively than antiarrhythmic drug therapy, but recurrent AF remains common, highlighting the need for better patient selection (precision medicine). Antiarrhythmic drugs remain effective after AF ablation, underpinning the synergistic mechanisms of action of AF ablation and antiarrhythmic drugs. Atrial fibrillation ablation appears to improve left ventricular function in a subset of patients with AF and heart failure. Data on the prognostic effect of rhythm control therapy are heterogeneous without a clear signal for either benefit or harm. Rhythm control therapy has acceptable safety and improves quality of life in patients with symptomatic AF, including in elderly populations with stroke risk factors. There is a clinical need to better stratify patients for rhythm control therapy. Further studies are needed to determine whether rhythm control therapy, and particularly AF ablation, improves left ventricular function and reduces AF-related complications.


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