This secondary analysis of a randomized clinical trial examines whether adding posterior wall isolation to pulmonary vein isolation improves outcomes in patients with heart failure (HF) with reduced ejection fraction and atrial fibrillation (AF).
Key Points
Question
Does adding posterior wall isolation (PWI) to pulmonary vein isolation improve outcomes in patients with symptomatic heart failure with reduced ejection fraction (HFrEF) and persistent atrial fibrillation (AF) undergoing first-time catheter ablation?
Findings
In this substudy of the CAPLA randomized clinical trial involving 98 patients with symptomatic HFrEF and persistent AF, there was no difference in the rate of recurrent atrial arrhythmia 12 months after ablation between patients who underwent initial pulmonary vein isolation (PVI) plus PWI compared with PVI alone.
Meaning
The addition of PWI to PVI for initial catheter ablation in patients with persistent AF and symptomatic HFrEF does not improve freedom from atrial arrhythmia.
Abstract
Importance
Catheter ablation for patients with atrial fibrillation (AF) and heart failure with reduced ejection fraction (HFrEF) is associated with improved left ventricular ejection fraction (LVEF) and survival compared with medical therapy. Nonrandomized studies have reported improved success with posterior wall isolation (PWI).
Objective
To determine the impact of pulmonary vein isolation (PVI) with PWI vs PVI alone on outcomes in patients with HFrEF.
Design, Setting, and Participants
This was an ad hoc secondary analysis of the CAPLA trial, a multicenter, prospective, randomized control trial that involved 11 centers in 3 countries (Australia, Canada, and UK). CAPLA featured 338 patients with persistent AF randomized to either PVI plusPWI or PVI alone. This substudy included patients in the original CAPLA study who had symptomatic HFrEF (LVEF <50% and New York Heart Association class ≥II).
Interventions
Pulmonary vein isolation with PWI vs PVI alone.
Main Outcomes and Measures
The primary end point was freedom from any documented atrial arrhythmia greater than 30 seconds, after a single ablation procedure, without the use of antiarrhythmic drug (AAD) therapy at 12 months.
Results
A total of 98 patients with persistent AF and symptomatic HFrEF were identified (mean [SD] age, 62.1 [9.8] years; 79.5% men; and mean [SD] LVEF at baseline, 34.6% [7.9%]). After 12 months, 58.7% of patients with PVI plus PWI were free from recurrent atrial arrhythmia without the use of AAD therapy vs 61.5% with PVI alone (hazard ratio, 1.02; 95% CI, 0.54-1.91; P = .96). There were no significant differences in freedom from atrial arrhythmia with or without AAD therapy after multiple procedures (PVI plus PWI vs PVI alone, 60.9% vs 65.4%; P = .73) or AF burden (median, 0% in both groups; P = .78). Mean LVEF improved substantially in PVI plus PWI (∆ LVEF, 19.3% [13.0%; P < .01) and PVI alone (18.2% [14.1%; P < .01), with no difference between groups (P = .71). Normalization of LV function occurred in 65.2% of patients in the PVI plus PWI group and 50.0% of patients with PVI alone (P = .13).
Conclusions and Relevance
The results of this study indicate that addition of PWI to PVI did not improve freedom from arrhythmia recurrence or recovery of LVEF in patients with persistent AF and symptomatic HFrEF. Catheter ablation was associated with significant improvements in systolic function, irrespective of ablation strategy used. These results caution against the routine inclusion of PWI in patients with HFrEF undergoing first-time catheter ablation for persistent AF.
Trial Registration
http://anzctr.org.au Identifier: ACTRN12616001436460
Introduction
The combination of atrial fibrillation (AF) and heart failure with reduced ejection fraction (HFrEF) is associated with substantially increased morbidity and mortality compared with HFrEF alone.1,2 Atrial fibrillation ablation is highly effective in improving left ventricular (LV) systolic function and symptoms while reducing HF hospitalization and mortality.3,4 Persistent AF is more common than paroxysmal AF in the presence of HF.5 More important, the efficacy of catheter ablation is lower in patients with persistent AF compared with paroxysmal AF,6 with randomized studies of additional ablation failing to identify a strategy that improves outcomes beyond pulmonary vein isolation (PVI) alone.7,8,9
Posterior wall isolation (PWI) may be considered in addition to PVI. Proposed benefits include autonomic ganglia modification, atrial debulking, inclusion of regions of fibrosis or rotational activity, and reinforcement of PVI.10 Prior studies comparing AF ablation with medical therapy in patients with HF have variably included PWI in addition to PVI.3,4,11 The CAPLA study (Catheter Ablation for Persistent Atrial Fibrillation: A Multicentre Randomised Trial of Pulmonary Vein Isolation [PVI] vs PVI With Posterior Left Atrial Wall Isolation [PWI]) demonstrated that, in all comers with persistent AF undergoing first-time catheter ablation, the addition of PWI to PVI does not improve freedom from AF recurrence.7 However, whether the use of adjunctive PWI improves the efficacy of catheter ablation in patients with persistent AF and HFrEF remains uncertain.
In this ad hoc CAPLA subanalysis, we investigated the impact of PVI plus PWI compared with PVI alone on outcomes in patients with persistent AF and HFrEF.
Methods
The complete study protocol of the CAPLA study can be found in Supplement 1. In brief, patients with symptomatic persistent AF were prospectively recruited from 11 centers across 3 countries and randomly assigned to either PVI plus PWI or PVI alone. All patients provided written informed consent to participate. In this study, we analyzed the subset with symptomatic HFrEF, defined as LV ejection fraction (LVEF) of 50% or less and New York Heart Association (NYHA) functional class II to IV. The LVEF was determined by transthoracic echocardiogram completed within 6 months of enrollment, using either the Simpson biplane method or the visual estimate. Hypertrophic cardiomyopathy and significant valvular disease were excluded.7 The NYHA class was determined by physician assessment of patient’s self-reported symptoms.
Ablation Procedure
The ablation strategy has been previously described.10 Briefly, procedures were performed under general anesthesia with 3-dimensional electroanatomical multipolar mapping and irrigated contact force–sensing ablation catheters. Pulmonary vein isolation involved wide antral circumferential ablation with the end point of electrical isolation. Patients randomized to PWI underwent a box isolation approach. Additional ablation inside the box to achieve PWI was permitted if required.
Follow-up
Patients were followed up for a minimum of 12 months. Recurrence of AF was monitored with the following: (1) continuous monitoring from an implanted device, (2) twice-daily electrocardiographic transmissions using a mobile device (Kardia; AliveCor Inc), or (3) 24-hour Holter monitoring performed every 3 months. The primary end point was freedom from documented atrial arrhythmia (AA) exceeding 30 seconds at 12 months after a single ablation procedure, without the use of antiarrhythmic drug (AAD) therapy. The AF burden was calculated in all patients, as described in Supplement 1.
Statistical Analysis
Normally distributed continuous data were reported as mean (SD) and analyzed with the 2-sided t test. Skewed continuous data were reported as median and IQR and analyzed with the Mann-Whitney test. Time-to-event outcomes were analyzed using Kaplan-Meier survival curves in an intention-to-treat analysis. Hazard ratios (HRs) and CIs for time-to-event outcomes were estimated using univariate Cox proportional hazards regression.
Results
Study Population
Of 338 participants of the CAPLA study, 98 (29.0%) met criteria for symptomatic HFrEF, including 46 (46.9%) randomized to PVI plus PWI and 52 (53.1%) randomized to PVI alone. Of this subanalysis cohort, the mean [SD] age was 62.1 [9.8] years; 78 [79.6%] were men and 20 [20.4%] were women. Complete 12-month follow-up was available for 96 patients (98.0%). Baseline characteristics are provided in Table 1. Demographics and comorbidities were balanced between treatment arms. At baseline, mean (SD) LVEF was 34.6% (7.6%) in the PVI plus PWI group and 34.7% (8.3%) in the PVI alone group (P = .92).
Table 1. Baseline Characteristicsa.
| Baseline characteristic | PVI plus PWI (n = 46) | PVI only (n = 52) | P value |
|---|---|---|---|
| Demographics | |||
| Age, mean (SD), y | 66.2 (11.3 | 61.7 (13.9 | .10 |
| Male sex, No. (%) | 34 (73.9) | 44 (84.6) | .19 |
| Female sex, No. (%) | 12 (26.1) | 8 (15.4) | .19 |
| BMI, mean (SD) | 27.7 (7.6) | 30.1 (6.0) | .13 |
| Longest AF duration, median (IQR), mo | 5 (3-9) | 6 (2-8) | .77 |
| CHA2DS2-VASc score, median (IQR) | 2 (1-3) | 2 (1-3) | .21 |
| No. of previous cardioversions for AF, median (IQR) | 1 (1-2) | 1 (1-2) | .90 |
| Echocardiographic parameters | |||
| LV ejection fraction, mean (SD), % | 34.6 (7.6) | 34.7 (8.3) | .92 |
| LV end-diastolic diameter, mean (SD), mm | 55.5 (7.6) | 59.4 (7.3) | .02 |
| Left atrial diameter, mean (SD), cm | 4.7 (0.6) | 4.7 (0.7) | .96 |
| Left atrial volume index, mean (SD), mL/m2 | 55.8 (16.3) | 56.1 (14.8) | .95 |
| E/e′ ratio, mean (SD) | 11.9 (4.3) | 11.4 (4.6) | .70 |
| Heart failure characteristics | |||
| Ischemic cardiomyopathy, No. (%) | 4 (8.7) | 6 (11.5) | .64 |
| Dilated cardiomyopathy, No. (%) | 42 (91.3) | 45 (86.5) | .64 |
| NYHA class, median (IQR) | 2 (2-3) | 2 (2-2.3) | .70 |
| Class I, No. (%) | 0 | 0 | NA |
| Class II, No. (%) | 33 (71.7) | 39 (75) | .72 |
| Class III, No. (%) | 10 (21.7) | 7 (13.5) | .28 |
| Ambulatory class IV, No. (%) | 2 (4.3) | 4 (7.7) | .49 |
| Comorbidities, No. (%) | |||
| Obesity (BMI >27) | 29 (63) | 39 (75) | .20 |
| Hypertension | 19 (41.3) | 19 (36.5) | .63 |
| Ischemic heart disease | 4 (8.7) | 7 (13.5) | .46 |
| Type 2 diabetes | 2 (4.3) | 4 (7.7) | .49 |
| Stroke | 3 (6.5) | 4 (7.7) | .82 |
| AAD therapy at time of enrollment, No. (%) | |||
| Amiodarone | 23 (50) | 27 (51.9) | .85 |
| Sotalol | 10 (21.7) | 5 (9.6) | .10 |
| Heart failure drug therapy, No. (%) | |||
| ACEI/ARB | 27 (58.7) | 31 (59.6) | .93 |
| β-Blocker | 34 (73.9) | 42 (80.8) | .42 |
| Spironolactone | 12 (26.1) | 16 (30.8) | .61 |
| Anticoagulants | 46 (100) | 51 (98.1) | .34 |
| Rhythm monitoring strategy, No. (%) | |||
| ILR/IECD | 12 (26.1) | 12 (23.1) | .73 |
| Daily ECG transmission (AliveCor) | 30 (65.2) | 38 (73.1) | .40 |
| 24-h Holter monitors | 4 (8.7) | 2 (3.8) | .32 |
Abbreviations: AAD, antiarrhythmic drug; ACEI, angiotensin-converting enzyme inhibitor; AF, atrial fibrillation; ARB, angiotensin receptor blocker; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CHA2DS2-VASc, congestive heart failure, hypertension, age 75 years (doubled), diabetes, stroke/transient ischemic attack/thromboembolism (doubled), vascular disease (prior myocardial infarction, peripheral artery disease, or aortic plaque), age 65 to 75 years; ECG, electrocardiographic; E/e′, ratio between early mitral inflow velocity and mitral annular early diastolic velocity; IECD, implantable electronic cardiac device; ILR, implantable loop recorder; IQR, interquartile range; LV, left ventricular; NA, not applicable; NYHA, New York Heart Association; PVI, pulmonary vein isolation; PWI, posterior wall isolation.
Normally distributed data are expressed as mean (SD), and nonnormally distributed data are expressed as median (IQR).
Procedure Characteristics
Procedural characteristics are shown in the eTable in Supplement 2. Successful PVI was achieved in all patients, whereas PWI was achieved in 40 of 46 patients (87.0%) in the PVI plus PWI group. There was 1 case of pericarditis in the PVI alone group.
Arrythmia Recurrence and Burden
Key outcome data are summarized in Table 2. At 12 months’ follow-up, freedom from recurrent AA after a single ablation procedure without AADs occurred in 27 patients (58.7%) in the PVI plus PWI group vs 32 patients (61.5%) in the PVI alone group (HR, 1.02; 95% CI, 0.54-1.91; P = .96; Figure).
Table 2. Outcome Dataa.
| Outcome | PVI plus PWI (n = 46) | PVI only (n = 52) | P value |
|---|---|---|---|
| Arrhythmia recurrence and burden | |||
| Freedom from atrial arrhythmia, without AAD, after 1 ablation procedure, No. (%) | 27 (58.7) | 32 (61.5) | .77 |
| Freedom from atrial arrhythmia, with or without AAD, after 1 or 2 ablation procedures, No. (%) | 28 (60.9) | 34 (65.4) | .64 |
| Freedom from AF, with or without AAD, after 1 or 2 ablation procedures, No. (%) | 29 (63.0) | 35 (67.3) | .66 |
| Freedom from symptomatic atrial arrhythmia, with or without AAD following last ablation procedure, No. (%) | 32 (69.6) | 39 (75.0) | .55 |
| AF burden, median (IQR), % | 0 (0-2.7) | 0 (0-3.1) | .80 |
| Echocardiographic parameters at 12 mo | |||
| LVEF, mean (SD), % | 53.9 (10.7) | 52.8 (10.6) | .65 |
| Δ LVEF, mean (SD), %b | 19.3 (13.0) | 18.2 (14.1) | .71 |
| Normalization in LVEF, No. (%)c | 30 (65.2) | 26 (50) | .13 |
| LV end-diastolic diameter, mean (SD), mm | 54.0 (6.9) | 55.5 (6.6) | .29 |
| Left atrial diameter, mean (SD), cm | 4.3 (0.8) | 4.3 (0.8) | .83 |
| Left atrial volume index, mean (SD), mL/m2 | 46.5 (19.4) | 44.6 (18.2) | .76 |
| E/e′ ratio, mean (SD) | 9.6 (4.9) | 11 (4.8) | .22 |
| Heart failure symptoms at 12 mo | |||
| NYHA class, median (IQR) | 1 (1-1) | 1 (1-2) | .27 |
| Class I, No. (%) | 31 (67.4) | 29 (55.8) | .24 |
| Class II, No. (%) | 6 (13) | 14 (26.9) | .09 |
| Class III, No. (%) | 4 (8.7) | 5 (9.6) | .87 |
| Ambulatory class IV, No. (%) | 0 | 0 | NA |
Abbreviations: AAD, antiarrhythmic drug; AF, atrial fibrillation; E/e′, ratio between early mitral inflow velocity and mitral annular early diastolic velocity; LV, left ventricular; LVEF, LV ejection fraction; NA, not applicable; NYHA, New York Heart Association; PVI, pulmonary vein isolation; PWI, posterior wall isolation.
Outcome data regarding arrhythmia recurrence rates and echocardiographic data at 12 months.
Change in LVEF between baseline and 12-month follow up (percentage).
Normalization defined as LVEF of 50% or greater.
Figure. Recurrent Atrial Arrhythmias Without the Use of Antiarrhythmic Drugs After a Single Procedure.
Kaplan-Meier curve demonstrates the primary outcome of recurrence of documented atrial arrhythmia episodes longer than 30 seconds following the 90-day blanking period to 12 months after ablation, without antiarrhythmic medication and from a single procedure. No significant difference is shown between pulmonary vein isolation (PVI) with posterior wall isolation (PWI) and PVI alone. HR indicates hazard ratio.
Similarly, there were no significant differences in overall AA recurrence between the 2 groups (with or without AAD therapy, after 1 or 2 ablation procedures) or in recurrence of symptomatic AA. Median AF burden was 0% in both groups (overall IQR: 0%-2.8%; IQR for PVI plus PWI vs PVI alone: 0%-2.7% vs 0%-3.1%; P = .80). These data are depicted in eFigures 1 and 2 in Supplement 2. There was no significant difference in the primary end point according to monitoring strategy.
HF Outcomes and Reverse Remodeling
At 12 months, there was an absolute mean (SD) improvement in LVEF of 19.3% (13.0%) with PVI plus PWI vs 18.2% (14.1%) with PVI alone (P = .71; eFigure 3 in Supplement 2). The mean (SD) improvement in LVEF overall was 18.7% (13.5%). Normalization in LVEF was demonstrated in 30 patients (65.2%) in the PVI plus PWI group and 26 patients (50%) in the PVI alone group (P = .13).
Median NYHA class at 12 months was 1 in both groups (IQR for PVI plus PWI group, 1-1; and for PVI alone group, 1-2; P = .27). Recovery to NYHA class I symptoms was reported in 31 patients (67.4%) in the PVI plus PWI group and 29 patients (55.8%) in the PVI alone group (P = .24) (Table 2).
Discussion
In the present study, the addition of PWI to PVI resulted in no significant difference in freedom from atrial arrhythmia at 12 months in patients with symptomatic persistent AF and HFrEF. Irrespective of ablation strategy, the median AF burden was 0% (IQR, 0%-2.8%). The absolute improvement in LVEF following ablation was 18.7% (13.5%), with no major complications, demonstrating the efficacy and safety of catheter ablation in patients with persistent AF and HFrEF.
Ablation Strategies in AF and HF
The benefits of catheter ablation for patients with concomitant AF and HFrEF have been confirmed by several prospective randomized trials.3,4,11 However, patients with HFrEF are more likely to have persistent AF, in which PVI is known to be less effective compared with paroxysmal AF. The quest continues to identify an ablation strategy that improves outcomes beyond PVI alone.
The allure to target the left atrial posterior wall is informed by considerable biological rationale. First, the posterior wall has been theorized to engender AF through several mechanisms, including focal triggered activity, parasympathetic innervation, and wave-front collisions mediated at the septopulmonary bundle.12,13 Second, patients with HFrEF are more likely to have low-voltage tissue and scar involving the posterior wall.14 Third, prior studies have supported the inclusion of PWI in the ablation lesion set in HFrEF. In the AATAC (Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD) trial, which compared catheter ablation with administration of amiodarone in patients with LVEF less than 40%, freedom from recurrent arrhythmia was significantly higher in patients who received PVI plus PWI (79%) compared with PVI alone (36%).11
However, despite biological plausibility and observational studies to support the role of PWI in HFrEF, the present analysis did not show an improvement in outcomes with the addition of PWI. There are several potential explanations. (1) Major randomized clinical trials have not shown improvement in outcomes with additional ablation beyond the PVIs for persistent AF, with the ineffectiveness of PWI again highlighting our incomplete understanding of persistent AF pathobiological features. (2) Although successful PWI was acutely achieved in the present study, the durability of PWI in the longer term is uncertain. Further studies will explore electroporation as potentially a more effective and safer alternative to radiofrequency ablation.
The ablation strategies in existing AF and HF trials have varied substantially, with no previous randomized trials comparing ablation approaches in this population. In the CAMERA-MRI (Catheter Ablation vs Medical Rate Control in Atrial Fibrillation and Systolic Dysfunction) study, adjunctive PWI was routinely performed for all patients, with a mean AF burden of 1.6% (5.0%).4 Conversely, PWI was not performed in any of the 151 patients in the CASTLE-AF (Catheter Ablation vs Standard Conventional Therapy in Patients with Left Ventricular Dysfunction and Atrial Fibrillation) study assigned to catheter ablation, in which ablation strategies beyond PVI were at the operator’s discretion, with significant variability.3 The heterogeneity of the ablation protocols in these previous trials highlights the lack of consensus around the optimal ablation strategy in patients with comorbid AF and HFrEF. Moving forward, the results of the present study caution against the routine addition of PWI for patients with HFrEF undergoing initial AF ablation.
Impact of AF Ablation in HF
This study again underscores the value of catheter ablation for the restoration of LV systolic function in patients with HFrEF and concomitant AF. The mean (SD) improvement in LVEF at 12 months after ablation across the 98 patients in this study was 19.3% (13.0%), with similar benefits in those who received PVI plus PWI and PVI alone. This is consistent with the results of the CAMERA-MRI study, in which the mean (SD) Δ LVEF was 18% (13%), compared with 4% (11%) for patients receiving rate control.4 Both studies largely included patients without ischemic or valvular heart disease, reinforcing the major impact of catheter ablation in patients with AF and otherwise unexplained LV systolic dysfunction.
Study Limitations
First, this study was a subgroup analysis of a relatively small cohort of patients with HFrEF and may be underpowered. However, a clinically meaningful difference between ablation strategies is unlikely given an HR of 1.02 (95% CI, 0.54-1.91; P = .96). Second, duration of HF, B-type natriuretic peptide levels, and follow-up changes in HF medication use were not assessed. Third, these results may not necessarily apply to patients with more severe HFrEF. Fourth, we await longer-term outcomes, including multiprocedure success.
Conclusions
The findings of this secondary analysis of a randomized clinical trial indicate that adjunctive PWI for patients with persistent AF and symptomatic HFrEF undergoing initial catheter ablation does not improve freedom from recurrent atrial arrhythmia. Catheter ablation is associated with significant improvement in LVEF, with no incremental benefit from the addition of PWI. These results caution against the routine inclusion of PWI in patients with HFrEF undergoing first-time catheter ablation for persistent AF.
Trial Protocol
eTable. Procedure Characteristics
eFigure 1. Kaplan-Meier Curves Demonstrating Event Rates for Secondary End Points Following 90-Day Blanking Period to 12 Months Post Ablation
eFigure 2. Percentage Burden of Atrial Arrhythmia at 12 Months Post Ablation
eFigure 3. Echocardiographic Changes Between Enrollment and 12 Months Post Ablation
Data Sharing Statement
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Trial Protocol
eTable. Procedure Characteristics
eFigure 1. Kaplan-Meier Curves Demonstrating Event Rates for Secondary End Points Following 90-Day Blanking Period to 12 Months Post Ablation
eFigure 2. Percentage Burden of Atrial Arrhythmia at 12 Months Post Ablation
eFigure 3. Echocardiographic Changes Between Enrollment and 12 Months Post Ablation
Data Sharing Statement