TY - JOUR
AU1 - Micaela, Ebert,
AU2 - Clara, Stegmann,
AU3 - Jedrzej, Kosiuk,
AU4 - Borislav, Dinov,
AU5 - Sergio, Richter,
AU6 - Arash, Arya,
AU7 - Andreas, Müssigbrodt,
AU8 - Philipp, Sommer,
AU9 - Gerhard, Hindricks,
AU1 - Andreas, Bollmann,
AB - Abstract Aims Electrical cardioversion (ECV) is frequently required for early atrial fibrillation (AF) recurrence after catheter ablation. However, in some cases, ECV is unsuccessful, and factors associated with long-term rhythm outcomes after failed ECV are unknown. This study aimed to identify possible predictors of ECV failure early after AF ablation and to analyse management and long-term rhythm outcome of these patients. Methods and results Between 2010 and 2012, 180 consecutive patients (mean age 63.7 ± 9.4 years, male 53.3%, persistent AF 60%) underwent successful radiofrequency AF ablation but required post-procedural ECV due to early AF recurrence (≤ 7 days). Of these, 120 patients were successful (Group A, n = 120, 66.7%) and 60 failed (Group B, n = 60, 33.3%). ECV failure was associated with diabetes [odds ratio (OR) 2.34, 95% confidence interval (CI) 1.154–4.763; P = 0.01] and lack of beta-blocker medication (OR 2.38, 95% CI 1.005–5.635; P = 0.04). In contrast, there were no significant differences in echocardiographic or procedure-related parameters. Atrial fibrillation recurrence was monitored with sequential 7 days of Holter electrocardiogram for 24 months (on average 10.8 ± 8.8 months) and was documented in 56%, n = 102 in total (Group A: 57%, n = 69 vs. Group B: 55%, n = 33; P = 0.75). Compared with successful ECV, ECV failure shortly after AF ablation had no predictive value on rhythm outcome in the long term (P = 0.98). The necessity of additional linear lesions during catheter ablation [hazard ratio (HR) 2.72, 95% CI 1.47–5.05; P = 0.001], AF duration (HR 1.08, 95% CI 1.04–1.12; P < 0.001), and a prolonged ablation time (HR 3.27, 95% CI 1.53–6.97; P = 0.002) were associated with long-term AF recurrence. Conclusion Patients with diabetes and absence of beta-blocker medication are at higher risk for ECV failure. Early post-ablation ECV failure is not associated with long-term rhythm outcome. Atrial fibrillation, Catheter ablation, Early recurrence, Cardioversion failure What’s new? This is the first study that analysed predictors, management, and outcomes of electrical cardioversion (ECV) failure early after atrial fibrillation (AF) catheter ablation. Presence of diabetes and lack of beta-blocker medication are significant predictors of ECV failure. Although early recurrence of AF after ablation is associated with poorer long-term rhythm outcomes, successful and failed ECVs did not impact on freedom from AF. Duration of AF prior to ablation, the necessity of additional (linear) lesions during ablation, and a prolonged ablation time are predictors for late recurrence of AF or atrial tachycardia during follow-up. Introduction Catheter ablation of atrial fibrillation (AF) has become a standard approach in rhythm control therapy of paroxysmal and persistent AF.1 Freedom from AF after ablation is described in about 57–78%.2,3 Within the first 3 months, especially the first 2 weeks, after catheter ablation, recurrence of AF may often be present.3,4 This phenomenon is most likely caused by the healing of the ablation-related atrial lesions, inflammation, and changes in neurohumoral status.5 Several studies have demonstrated that early AF recurrence (ERAF) after ablation may also be a predictor for late recurrence.6,7 In case of AF recurrence immediately after AF ablation, electrical cardioversion (ECV) is mostly favoured. However, some individuals do not respond to early ECV. There is little evidence about differences in baseline characteristics, management, and outcome of these patients, and there is considerable uncertainty regarding the possible predictors for early post-interventional ECV failure. Therefore, we aimed to reveal potential predictors of ECV failure early after AF ablation and to analyse management and factors that are associated with long-term rhythm outcome after failed ECV in these patients. Methods Study population Consecutive patients with ERAF after ablation were retrospectively enrolled. We defined ERAF as a documented sustained (>30 s) episode of AF within the first 7 days after catheter ablation. Type of AF (paroxysmal or persistent) was defined according to the current European guidelines.1 Depending on the ECV outcome, two groups were formed: Group A (ECV successful, n = 120) and Group B (ECV failed, n = 60). Management and outcome of all patients were analysed during a follow-up (FU) period of 24 months. The study was approved by the local ethics committee and was performed in accordance with the Declaration of Helsinki. Catheter ablation Left atrial catheter ablation was performed as previously described under sedation and monitoring of vital signs and oesophageal temperature.8 Trans-septal access and catheter navigation were performed using a steerable sheath (Agilis, St. Jude Medical, St Paul, MN, USA). The electroanatomical reconstruction of the pulmonary veins (PVs), 3D catheter orientation, and computerized tomography image integration were performed with NavX (St. Jude Medical) or CARTO (Biosense Webster, Diamond Bar, CA, USA). To achieve reduction of the local bipolar amplitude, defragmentation and/or loss of local capture the ablation catheter tip was dragged along the intended line. For isolation of the PV, circumferential applications of radiofrequency energy were performed at the antrum of the PV. Bidirectional conduction block of the circumferential ablation lines and non-inducibility (with burst pacing from the coronary sinus down to 200 ms) were defined as procedural endpoints. Bipolar scar and low-voltage areas (LVAs) were defined as areas with a bipolar voltage <0.2 and <0.5 mV and were targeted for possible substrate modification by regional radiofrequency catheter ablation. If regional ablation could not be performed due to potential collateral damage (e.g. in the atrial septum with the risk of atrioventricular nodal damage etc.) or if potential LVA homogenization was considered too extensive, additional strategic linear lesions (>two applications) were placed. These additional lines aimed to connect non-conducting tissues as, for example, the mitral annulus with the PV (septal line) or contralateral superior PV (roofline) traversing diseased areas or to encircle large LVAs to achieve isolation from the remaining healthy atrial tissue (e.g. posterior ‘box lesion’). Bidirectional conduction block was confirmed for PV encircling and additional ablation lines. After the ablation burst pacing was performed from the coronary sinus (10V; 2ms, decreasing cycle lengths by 20ms from 300ms until refractoriness). If atrial tachycardias were induced, those were mapped and ablated. The baseline and procedural parameters are shown in Table 1. Table 1 Baseline characteristics, procedure related data, and management Total (n = 180) Group A (n = 120) Group B (n = 60) P-value Age (years) 63.7 ± 9.4 64.2 ± 9.4 62.7 ± 9.3 0.31 Male, n (%) 96 (53.3) 62 (51.7) 34 (56.7) 0.52 Persistent AF, n (%) 108 (60) 69 (57.5) 39 (65) 0.33 Repeated ablation, n (%) 31 (17.2) 23 (19.2) 8 (13.3) 0.32 AF duration (years) 6.4 ± 6.6 6.3 ± 6.1 6.6 ± 7.5 0.79 BMI, n (%) 29.1 ± 5.7 29.1 ± 6.2 29.4 ± 4.7 0.70 Obesity, n (%) 66 (36.7) 38 (31.7) 28 (46.7) 0.04 Hypertension, n (%) 139 (77.2) 89 (74.2) 50 (83.3) 0.16 Diabetes, n (%) 45 (25) 23 (19.2) 22 (36.7) 0.01 Stroke/TIA, n (%) 21 (11.7) 13 (10.8) 8 (13.3) 0.62 Coronary heart disease, n (%) 22 (12.2) 11 (9.2) 11 (18.3) 0.07 PAOD, n (%) 2 (1.1) 2 (1.7) 0 (0) 0.55 Vascular diseases, n (%) 55 (30.6) 32 (26.7) 23 (38.3) 0.10 PM/ICD, n (%) 24 (13.3) 17 (14.2) 7 (11.7) 0.64 Beta-blockers, n (%) 153 (85) 106 (88.3) 47 (78.3) 0.07 Digitoxin, n (%) 39 (21.7) 24 (20) 15 (25) 0.44 ACE inhibitors, n (%) 72 (40) 49 (40.8) 23 (38.3) 0.74 Statins, n (%) 72 (40) 41 (34.2) 31 (51.7) 0.02 Diuretics, n (%) 78 (43.3) 51 (42.5) 27 (45) 0.75 AAD, n (%) 77 (42.8) 55 (45.8) 22 (36.7) 0.24 LVEF (%) 58 ± 10 57.8 ± 9.4 58.3 ± 11.1 0.74 LA (mm) 44.6 ± 6.6 44.5 ± 6.3 44.6 ± 7.2 0.95 Application of additional (linear) lesions, n (%) 122 (67.8) 79 (65.8) 43 (71.7) 0.43 ECV during ablation, n (%) 146 (81.1) 95 (79.2) 51 (85) 0.34 Inducibility, n (%) 66 (36.7) 41 (34.2) 25 (41.7) 0.32 Watt–second (per 1000 s) 83.403 ± 41.718 82.389 ± 41.937 85.498 ± 41.645 0.68 Ablation time (h) 0.708 ± 0.336 0.7 ± 0.342 0.724 ± 0.324 0.69 Shocks during ECV (n) 2.01 ± 1.2 1.39 ± 0.77 3.25 ± 0.9 <0.001 Energy during ECV (J) 284.2 ± 78.17 252.93 ± 73.15 344.67 ± 45.3 <0.001 Amiodarone during ECV, n (%) 56 (31.1) 19 (15.8) 37 (61.7) <0.001 Discharge with AAD, n (%) 93 (51.7) 46 (38.3) 47 (78.3) <0.001 Total (n = 180) Group A (n = 120) Group B (n = 60) P-value Age (years) 63.7 ± 9.4 64.2 ± 9.4 62.7 ± 9.3 0.31 Male, n (%) 96 (53.3) 62 (51.7) 34 (56.7) 0.52 Persistent AF, n (%) 108 (60) 69 (57.5) 39 (65) 0.33 Repeated ablation, n (%) 31 (17.2) 23 (19.2) 8 (13.3) 0.32 AF duration (years) 6.4 ± 6.6 6.3 ± 6.1 6.6 ± 7.5 0.79 BMI, n (%) 29.1 ± 5.7 29.1 ± 6.2 29.4 ± 4.7 0.70 Obesity, n (%) 66 (36.7) 38 (31.7) 28 (46.7) 0.04 Hypertension, n (%) 139 (77.2) 89 (74.2) 50 (83.3) 0.16 Diabetes, n (%) 45 (25) 23 (19.2) 22 (36.7) 0.01 Stroke/TIA, n (%) 21 (11.7) 13 (10.8) 8 (13.3) 0.62 Coronary heart disease, n (%) 22 (12.2) 11 (9.2) 11 (18.3) 0.07 PAOD, n (%) 2 (1.1) 2 (1.7) 0 (0) 0.55 Vascular diseases, n (%) 55 (30.6) 32 (26.7) 23 (38.3) 0.10 PM/ICD, n (%) 24 (13.3) 17 (14.2) 7 (11.7) 0.64 Beta-blockers, n (%) 153 (85) 106 (88.3) 47 (78.3) 0.07 Digitoxin, n (%) 39 (21.7) 24 (20) 15 (25) 0.44 ACE inhibitors, n (%) 72 (40) 49 (40.8) 23 (38.3) 0.74 Statins, n (%) 72 (40) 41 (34.2) 31 (51.7) 0.02 Diuretics, n (%) 78 (43.3) 51 (42.5) 27 (45) 0.75 AAD, n (%) 77 (42.8) 55 (45.8) 22 (36.7) 0.24 LVEF (%) 58 ± 10 57.8 ± 9.4 58.3 ± 11.1 0.74 LA (mm) 44.6 ± 6.6 44.5 ± 6.3 44.6 ± 7.2 0.95 Application of additional (linear) lesions, n (%) 122 (67.8) 79 (65.8) 43 (71.7) 0.43 ECV during ablation, n (%) 146 (81.1) 95 (79.2) 51 (85) 0.34 Inducibility, n (%) 66 (36.7) 41 (34.2) 25 (41.7) 0.32 Watt–second (per 1000 s) 83.403 ± 41.718 82.389 ± 41.937 85.498 ± 41.645 0.68 Ablation time (h) 0.708 ± 0.336 0.7 ± 0.342 0.724 ± 0.324 0.69 Shocks during ECV (n) 2.01 ± 1.2 1.39 ± 0.77 3.25 ± 0.9 <0.001 Energy during ECV (J) 284.2 ± 78.17 252.93 ± 73.15 344.67 ± 45.3 <0.001 Amiodarone during ECV, n (%) 56 (31.1) 19 (15.8) 37 (61.7) <0.001 Discharge with AAD, n (%) 93 (51.7) 46 (38.3) 47 (78.3) <0.001 Obesity indicates BMI >30. Vascular disease includes coronary artery disease or previous myocardial infarction, history of TIA/stroke, aortic plaque, and arterial embolism. AAD, antiarrhythmic drugs; BMI, body mass index; ECV, electrical cardioversion; ICD, implantable cardioverter defibrillator; LA, left atrium; LVEF, left ventricular ejection fraction; PAOD, peripheral arterial occlusive disease; PM, pacemaker; TIA, transient ischaemic attack. Table 1 Baseline characteristics, procedure related data, and management Total (n = 180) Group A (n = 120) Group B (n = 60) P-value Age (years) 63.7 ± 9.4 64.2 ± 9.4 62.7 ± 9.3 0.31 Male, n (%) 96 (53.3) 62 (51.7) 34 (56.7) 0.52 Persistent AF, n (%) 108 (60) 69 (57.5) 39 (65) 0.33 Repeated ablation, n (%) 31 (17.2) 23 (19.2) 8 (13.3) 0.32 AF duration (years) 6.4 ± 6.6 6.3 ± 6.1 6.6 ± 7.5 0.79 BMI, n (%) 29.1 ± 5.7 29.1 ± 6.2 29.4 ± 4.7 0.70 Obesity, n (%) 66 (36.7) 38 (31.7) 28 (46.7) 0.04 Hypertension, n (%) 139 (77.2) 89 (74.2) 50 (83.3) 0.16 Diabetes, n (%) 45 (25) 23 (19.2) 22 (36.7) 0.01 Stroke/TIA, n (%) 21 (11.7) 13 (10.8) 8 (13.3) 0.62 Coronary heart disease, n (%) 22 (12.2) 11 (9.2) 11 (18.3) 0.07 PAOD, n (%) 2 (1.1) 2 (1.7) 0 (0) 0.55 Vascular diseases, n (%) 55 (30.6) 32 (26.7) 23 (38.3) 0.10 PM/ICD, n (%) 24 (13.3) 17 (14.2) 7 (11.7) 0.64 Beta-blockers, n (%) 153 (85) 106 (88.3) 47 (78.3) 0.07 Digitoxin, n (%) 39 (21.7) 24 (20) 15 (25) 0.44 ACE inhibitors, n (%) 72 (40) 49 (40.8) 23 (38.3) 0.74 Statins, n (%) 72 (40) 41 (34.2) 31 (51.7) 0.02 Diuretics, n (%) 78 (43.3) 51 (42.5) 27 (45) 0.75 AAD, n (%) 77 (42.8) 55 (45.8) 22 (36.7) 0.24 LVEF (%) 58 ± 10 57.8 ± 9.4 58.3 ± 11.1 0.74 LA (mm) 44.6 ± 6.6 44.5 ± 6.3 44.6 ± 7.2 0.95 Application of additional (linear) lesions, n (%) 122 (67.8) 79 (65.8) 43 (71.7) 0.43 ECV during ablation, n (%) 146 (81.1) 95 (79.2) 51 (85) 0.34 Inducibility, n (%) 66 (36.7) 41 (34.2) 25 (41.7) 0.32 Watt–second (per 1000 s) 83.403 ± 41.718 82.389 ± 41.937 85.498 ± 41.645 0.68 Ablation time (h) 0.708 ± 0.336 0.7 ± 0.342 0.724 ± 0.324 0.69 Shocks during ECV (n) 2.01 ± 1.2 1.39 ± 0.77 3.25 ± 0.9 <0.001 Energy during ECV (J) 284.2 ± 78.17 252.93 ± 73.15 344.67 ± 45.3 <0.001 Amiodarone during ECV, n (%) 56 (31.1) 19 (15.8) 37 (61.7) <0.001 Discharge with AAD, n (%) 93 (51.7) 46 (38.3) 47 (78.3) <0.001 Total (n = 180) Group A (n = 120) Group B (n = 60) P-value Age (years) 63.7 ± 9.4 64.2 ± 9.4 62.7 ± 9.3 0.31 Male, n (%) 96 (53.3) 62 (51.7) 34 (56.7) 0.52 Persistent AF, n (%) 108 (60) 69 (57.5) 39 (65) 0.33 Repeated ablation, n (%) 31 (17.2) 23 (19.2) 8 (13.3) 0.32 AF duration (years) 6.4 ± 6.6 6.3 ± 6.1 6.6 ± 7.5 0.79 BMI, n (%) 29.1 ± 5.7 29.1 ± 6.2 29.4 ± 4.7 0.70 Obesity, n (%) 66 (36.7) 38 (31.7) 28 (46.7) 0.04 Hypertension, n (%) 139 (77.2) 89 (74.2) 50 (83.3) 0.16 Diabetes, n (%) 45 (25) 23 (19.2) 22 (36.7) 0.01 Stroke/TIA, n (%) 21 (11.7) 13 (10.8) 8 (13.3) 0.62 Coronary heart disease, n (%) 22 (12.2) 11 (9.2) 11 (18.3) 0.07 PAOD, n (%) 2 (1.1) 2 (1.7) 0 (0) 0.55 Vascular diseases, n (%) 55 (30.6) 32 (26.7) 23 (38.3) 0.10 PM/ICD, n (%) 24 (13.3) 17 (14.2) 7 (11.7) 0.64 Beta-blockers, n (%) 153 (85) 106 (88.3) 47 (78.3) 0.07 Digitoxin, n (%) 39 (21.7) 24 (20) 15 (25) 0.44 ACE inhibitors, n (%) 72 (40) 49 (40.8) 23 (38.3) 0.74 Statins, n (%) 72 (40) 41 (34.2) 31 (51.7) 0.02 Diuretics, n (%) 78 (43.3) 51 (42.5) 27 (45) 0.75 AAD, n (%) 77 (42.8) 55 (45.8) 22 (36.7) 0.24 LVEF (%) 58 ± 10 57.8 ± 9.4 58.3 ± 11.1 0.74 LA (mm) 44.6 ± 6.6 44.5 ± 6.3 44.6 ± 7.2 0.95 Application of additional (linear) lesions, n (%) 122 (67.8) 79 (65.8) 43 (71.7) 0.43 ECV during ablation, n (%) 146 (81.1) 95 (79.2) 51 (85) 0.34 Inducibility, n (%) 66 (36.7) 41 (34.2) 25 (41.7) 0.32 Watt–second (per 1000 s) 83.403 ± 41.718 82.389 ± 41.937 85.498 ± 41.645 0.68 Ablation time (h) 0.708 ± 0.336 0.7 ± 0.342 0.724 ± 0.324 0.69 Shocks during ECV (n) 2.01 ± 1.2 1.39 ± 0.77 3.25 ± 0.9 <0.001 Energy during ECV (J) 284.2 ± 78.17 252.93 ± 73.15 344.67 ± 45.3 <0.001 Amiodarone during ECV, n (%) 56 (31.1) 19 (15.8) 37 (61.7) <0.001 Discharge with AAD, n (%) 93 (51.7) 46 (38.3) 47 (78.3) <0.001 Obesity indicates BMI >30. Vascular disease includes coronary artery disease or previous myocardial infarction, history of TIA/stroke, aortic plaque, and arterial embolism. AAD, antiarrhythmic drugs; BMI, body mass index; ECV, electrical cardioversion; ICD, implantable cardioverter defibrillator; LA, left atrium; LVEF, left ventricular ejection fraction; PAOD, peripheral arterial occlusive disease; PM, pacemaker; TIA, transient ischaemic attack. Early recurrence of atrial fibrillation and electrical cardioversion In case of a documented persistent episode of ERAF, all patients directly underwent ECV to restore sinus rhythm. Electrical cardioversion was performed as depicted previously by our group.9 Therefore, patients were sedated with midazolam and etomidate. The endpoint was defined as restoration of sinus rhythm through the application of a first 200 J shock (biphasic, Medtronic LIFEPACK® 20, Redmond, WA, USA), being followed up to 300 or 360 J in case of previous ECV failure. In cases of unsuccessful ECV, an additional intravenous infusion of an antiarrhythmic drug (AAD), e.g. amiodarone (5 mg/kg) or vernakalant (3 mg/kg) over 10 min, was applied. Follow-up All patients underwent 7 days of Holter monitoring first day after AF ablation and during the 3, 6, and 12 months of FU at our institution. After 12 months, an electrocardiogram (ECG) was documented once a year. Additionally, all patients who presented to our centre due to AF recurrence between these regular check-up dates were registered. The FU was restricted to 24 months. Recurrence of a sustained (≥30 s) episode of AF and/or atypical atrial flutter was defined as endpoint. To demonstrate the differences in outcome of AF-free survival after ablation, the results of both groups (Groups A and B) from the present patient cohort were compared to a common AF ablation patient cohort, previously published by our group.8 This comparison group sought to assess the outcome of an individualized ablation approach targeting LVA with substrate modification after pulmonary vein isolation (PVI), if present. Therefore, two groups were formed: Group LVA (patients with LVA and additional targeted ablation) vs. Group no LVA (patients without LVA and PVI only). The baseline characteristics for comparison with the present group are shown in Table 2. Table 2 Baseline characteristics, procedure-related data of this study cohort compared with an AF ablation reference group from our centre, published in 2014 Entire present patient cohort Comparison group P-value Total LVA group No LVA group (n = 180) (n = 178) (n = 47) (n = 131) Age (years) 63.7 ± 9.4 61 ± 10 67 ± 8 59 ± 9 0.9 Male, n (%) 96 (53.3) 121 (68) 25 (53) 96 (73) 0.005 Persistent AF, n (%) 108 (60) 116 (65) 41 (87) 75 (57) 0.3 Repeated ablation, n (%) 31 (17.2) – – – NA AF duration (years) 6.4 ± 6.6 4.1 ± 2 2.9 ± 1.4 5.5 ± 2 1.0 BMI, n (%) 29.1 ± 5.7 29 ± 5 29 ± 5 29 ± 5 0.57 Hypertension, n (%) 139 (77.2) 131 (74) 40 (85) 91 (70) 0.43 Diabetes, n (%) 45 (25) 29 (16) 12 (26) 17 (13) 0.04 Beta-blockers, n (%) 153 (85) 129 (73) 36 (77) 93 (71) 0.004 Digitoxin, n (%) 39 (21.7) NA NA NA NA AAD, n (%) 77 (42.8) NA NA NA NA LVEF (%), median (mean) 60 (58) 60 (55) 60 (51) 60 (56) 0.5 LA (mm) 44.6 ± 6.6 44 ± 7 45 ± 8 43 ± 6 0.79 Application of additional (linear) lesions, n (%) 122 (67.8) 47 (26.4) 47 (100) − (PVI only) <0.01 ECV during ablation, n (%) 146 (81.1) NA NA NA NA Inducibility, n (%) 66 (36.7) NA NA NA NA Ablation time (h) 0.708 ± 0.336 0.633 ± 0.266 0.733 ± 0.266 0.583 ± 0.25 0.99 Discharge with AAD, n (%) 93 (51.7) NA NA NA NA Entire present patient cohort Comparison group P-value Total LVA group No LVA group (n = 180) (n = 178) (n = 47) (n = 131) Age (years) 63.7 ± 9.4 61 ± 10 67 ± 8 59 ± 9 0.9 Male, n (%) 96 (53.3) 121 (68) 25 (53) 96 (73) 0.005 Persistent AF, n (%) 108 (60) 116 (65) 41 (87) 75 (57) 0.3 Repeated ablation, n (%) 31 (17.2) – – – NA AF duration (years) 6.4 ± 6.6 4.1 ± 2 2.9 ± 1.4 5.5 ± 2 1.0 BMI, n (%) 29.1 ± 5.7 29 ± 5 29 ± 5 29 ± 5 0.57 Hypertension, n (%) 139 (77.2) 131 (74) 40 (85) 91 (70) 0.43 Diabetes, n (%) 45 (25) 29 (16) 12 (26) 17 (13) 0.04 Beta-blockers, n (%) 153 (85) 129 (73) 36 (77) 93 (71) 0.004 Digitoxin, n (%) 39 (21.7) NA NA NA NA AAD, n (%) 77 (42.8) NA NA NA NA LVEF (%), median (mean) 60 (58) 60 (55) 60 (51) 60 (56) 0.5 LA (mm) 44.6 ± 6.6 44 ± 7 45 ± 8 43 ± 6 0.79 Application of additional (linear) lesions, n (%) 122 (67.8) 47 (26.4) 47 (100) − (PVI only) <0.01 ECV during ablation, n (%) 146 (81.1) NA NA NA NA Inducibility, n (%) 66 (36.7) NA NA NA NA Ablation time (h) 0.708 ± 0.336 0.633 ± 0.266 0.733 ± 0.266 0.583 ± 0.25 0.99 Discharge with AAD, n (%) 93 (51.7) NA NA NA NA Obesity indicates BMI >30. Modified from Rolf et al.8 AAD, antiarrhythmic drugs; BMI, body mass index; ECV, electrical cardioversion; FU, follow-up; LA, left atrium; LVA, low voltage areas; LVEF, left ventricular ejection fraction; NA, not available; PVI, pulmonary vein isolation. Table 2 Baseline characteristics, procedure-related data of this study cohort compared with an AF ablation reference group from our centre, published in 2014 Entire present patient cohort Comparison group P-value Total LVA group No LVA group (n = 180) (n = 178) (n = 47) (n = 131) Age (years) 63.7 ± 9.4 61 ± 10 67 ± 8 59 ± 9 0.9 Male, n (%) 96 (53.3) 121 (68) 25 (53) 96 (73) 0.005 Persistent AF, n (%) 108 (60) 116 (65) 41 (87) 75 (57) 0.3 Repeated ablation, n (%) 31 (17.2) – – – NA AF duration (years) 6.4 ± 6.6 4.1 ± 2 2.9 ± 1.4 5.5 ± 2 1.0 BMI, n (%) 29.1 ± 5.7 29 ± 5 29 ± 5 29 ± 5 0.57 Hypertension, n (%) 139 (77.2) 131 (74) 40 (85) 91 (70) 0.43 Diabetes, n (%) 45 (25) 29 (16) 12 (26) 17 (13) 0.04 Beta-blockers, n (%) 153 (85) 129 (73) 36 (77) 93 (71) 0.004 Digitoxin, n (%) 39 (21.7) NA NA NA NA AAD, n (%) 77 (42.8) NA NA NA NA LVEF (%), median (mean) 60 (58) 60 (55) 60 (51) 60 (56) 0.5 LA (mm) 44.6 ± 6.6 44 ± 7 45 ± 8 43 ± 6 0.79 Application of additional (linear) lesions, n (%) 122 (67.8) 47 (26.4) 47 (100) − (PVI only) <0.01 ECV during ablation, n (%) 146 (81.1) NA NA NA NA Inducibility, n (%) 66 (36.7) NA NA NA NA Ablation time (h) 0.708 ± 0.336 0.633 ± 0.266 0.733 ± 0.266 0.583 ± 0.25 0.99 Discharge with AAD, n (%) 93 (51.7) NA NA NA NA Entire present patient cohort Comparison group P-value Total LVA group No LVA group (n = 180) (n = 178) (n = 47) (n = 131) Age (years) 63.7 ± 9.4 61 ± 10 67 ± 8 59 ± 9 0.9 Male, n (%) 96 (53.3) 121 (68) 25 (53) 96 (73) 0.005 Persistent AF, n (%) 108 (60) 116 (65) 41 (87) 75 (57) 0.3 Repeated ablation, n (%) 31 (17.2) – – – NA AF duration (years) 6.4 ± 6.6 4.1 ± 2 2.9 ± 1.4 5.5 ± 2 1.0 BMI, n (%) 29.1 ± 5.7 29 ± 5 29 ± 5 29 ± 5 0.57 Hypertension, n (%) 139 (77.2) 131 (74) 40 (85) 91 (70) 0.43 Diabetes, n (%) 45 (25) 29 (16) 12 (26) 17 (13) 0.04 Beta-blockers, n (%) 153 (85) 129 (73) 36 (77) 93 (71) 0.004 Digitoxin, n (%) 39 (21.7) NA NA NA NA AAD, n (%) 77 (42.8) NA NA NA NA LVEF (%), median (mean) 60 (58) 60 (55) 60 (51) 60 (56) 0.5 LA (mm) 44.6 ± 6.6 44 ± 7 45 ± 8 43 ± 6 0.79 Application of additional (linear) lesions, n (%) 122 (67.8) 47 (26.4) 47 (100) − (PVI only) <0.01 ECV during ablation, n (%) 146 (81.1) NA NA NA NA Inducibility, n (%) 66 (36.7) NA NA NA NA Ablation time (h) 0.708 ± 0.336 0.633 ± 0.266 0.733 ± 0.266 0.583 ± 0.25 0.99 Discharge with AAD, n (%) 93 (51.7) NA NA NA NA Obesity indicates BMI >30. Modified from Rolf et al.8 AAD, antiarrhythmic drugs; BMI, body mass index; ECV, electrical cardioversion; FU, follow-up; LA, left atrium; LVA, low voltage areas; LVEF, left ventricular ejection fraction; NA, not available; PVI, pulmonary vein isolation. Management in case of failed electrical cardioversion In case of failed ECV, additional treatment was necessary, consisting of an AAD, re-ECV, reablation, or a combination of these options. The individual strategy of choice was determined by the concerned physician according to the patient’s clinical history and preference. Statistical analysis Statistical analysis was executed with SPSS 23.0 package (SPSS Inc., Chicago, IL, USA). Continuous data are presented as mean ± standard deviation, whereas categorical data are presented as numbers and percentage. The differences between both study groups were compared with the Student’s t-test, χ2 test, and Fisher’s exact test. To reveal predictors of AF recurrence, multivariable binary logistic regression including univariate-analysed variables with a P-value <0.1 was used. Therefore, outcome of ECV was defined as dependent variable. A P-value < 0.05 was defined as statistically significant. To demonstrate AF recurrence during FU, survival curves were plotted by the use of the Kaplan–Meier-Method and analysed by the log-rank test. Considering the fact that AF recurrence after ablation within the first 3 months may appear frequently, a post-interventional blanking interval for 3 months was established for the assessment of the Kaplan–Meier curves for the total cohort, regardless of the time sinus rhythm was restored. Thus, the beginning of the analysis period was set 3 months after catheter ablation (Group A, successful ECV) or as soon as restoration of sinus rhythm could be documented (Group B, failed ECV). Occurrence of AF was defined as endpoint in all patients. To analyse the long-term rhythm outcome of both groups, multivariable Cox regression including univariate-analysed covariates with a P-value <0.1 was performed. A P-value < 0.05 was defined as statistically significant. Results Baseline characteristics From January 2010 to February 2012, a total of 180 patients who underwent ECV for ERAF after AF ablation procedure at the University Heart Center Leipzig were enrolled. Among all included individuals, 120 (66.7%) patients experienced successful ECV, whereas 60 (33.3%) patients did not. Clinical baseline characteristics of the whole study population (n = 180) and the two studied groups, Group A (n = 120) and Group B (n = 60), are demonstrated in Table 1. Absence of beta-blocker medication, coronary artery disease, obesity, and diabetes were found more frequently in patients with unsuccessful ECV. There were no significant differences in echocardiographic parameters (left atrial size or ejection fraction) and procedure-related data. Furthermore, AAD treatment (P = 0.24) had no significant influence on ECV outcome of the two groups. Complete PVI with bidirectional conduction block was achieved in all 180 patients. Predictors for early cardioversion failure Table 3 summarizes the results of the univariate and multivariate regression analyses. Multivariate analysis revealed diabetes [odds ratio (OR) 2.34, 95% confidence interval (CI) 1.154–4.763; P = 0.01] and the absence of beta-blocker medication (OR 2.38, 95% CI 1.005–5.635; P = 0.04) as significant predictors of early ECV (Table 3). Table 3 Predictors of failed ECV in univariate and multivariate analyses Univariate OR (95% CI) P-value Multivariate OR (95% CI) P-value Diabetes 2.44 (1.219–4.890) 0.012 2.34 (1.154–4.763) 0.01 Beta-blockers 2.09 (0.914–4.800) 0.081 2.38 (1.005–5.635) 0.04 Univariate OR (95% CI) P-value Multivariate OR (95% CI) P-value Diabetes 2.44 (1.219–4.890) 0.012 2.34 (1.154–4.763) 0.01 Beta-blockers 2.09 (0.914–4.800) 0.081 2.38 (1.005–5.635) 0.04 CI, confidence interval; OR, odds ratio. Table 3 Predictors of failed ECV in univariate and multivariate analyses Univariate OR (95% CI) P-value Multivariate OR (95% CI) P-value Diabetes 2.44 (1.219–4.890) 0.012 2.34 (1.154–4.763) 0.01 Beta-blockers 2.09 (0.914–4.800) 0.081 2.38 (1.005–5.635) 0.04 Univariate OR (95% CI) P-value Multivariate OR (95% CI) P-value Diabetes 2.44 (1.219–4.890) 0.012 2.34 (1.154–4.763) 0.01 Beta-blockers 2.09 (0.914–4.800) 0.081 2.38 (1.005–5.635) 0.04 CI, confidence interval; OR, odds ratio. Management of failed electrical cardioversion Electrical cardioversion was significantly more often performed with a higher number of shocks (P < 0.001), a higher release of energy (P < 0.001), and an additional intravenous injection of amiodarone (P < 0.001) in Group B patients (failed ECV). In case of ECV failure, patients were more frequently discharged with an AAD therapy (P < 0.01, Table 1). Within Group B, 91.7% (n = 55) of patients restored sinus rhythm at the end of the blanking interval (3 months). A spontaneous sinus rhythm restoration was observed in 67.3% (n = 37) of patients. Initiation or change of AAD treatment was necessary in 3.6% (n = 2) of the patients to achieve restoration of sinus rhythm. In some cases, an extended management in the form of a repeated ECV (18.2%, n = 10), a reablation (3.6%, n = 2), a combination of these options [AAD and re-ECV in 3.6% (n = 2) or reablation directly after re-ECV in 3.6% (n = 2)] was necessary to restore the sinus rhythm. Management of treatment during further FU (≥3 months) did not differ significantly in both groups. Outcome Despite the intention to achieve rhythm control for symptomatic AF in all included patients, five patients within Group B did not convert into sinus rhythm during FU. During the 3 months of blanking interval, five patients in Group A suffered from AF recurrence and could not convert into sinus rhythm at any time during the 24 months of evaluation period. Consequently, according to the defined inclusion criteria for outcome analysis, these 10 patients were excluded from the Kaplan–Meier computations (5.6%, five for each group; P = 0.25). Six (3.3%) patients were lost to FU. At the end of the FU, recurrence of AF was documented in 56% (n = 102) of the total group (Group A: 57%, n = 69 vs. Group B: 55%, n = 33; P = 0.75). Importantly patients with ERAF after failed post-ablation ECV had similar long-term rhythm outcomes compared to patients with successful ECV. The Kaplan–Meier analysis showed no significant difference in time to AF recurrence between both groups (P = 0.98, Figure 1). The average time to AF recurrence was not significantly different between both groups (Group A: 10.97 months vs. Group B 10.51 months; P = 0.74). However, it is noteworthy that independently of the ablation approach (PVI only or PVI with substrate-based additional ablation) compared with a usual AF ablation patient cohort (Figure 1, green line: patients without LVA and PVI only and blue line: patients with LVA and additional ablation, mean FU 15 ± 3 months) ERAF after ablation results in worse outcomes with regard to long-term rhythm outcome.8 Multivariate Cox regression analysis revealed the necessity of additional (linear) lesions [hazard ratio (HR) 2.72, 95% CI 1.47–5.05; P = 0.001], AF duration prior to ablation (HR 1.08, 95% CI 1.04–1.12; P < 0.001) and a prolonged ablation time (HR 3.27, 95% CI 1.53–6.97; P = 0.002) as potential predictors for AF recurrence in the long term (Table 4). Table 4 Predictors of AF recurrence in long-term rhythm outcome in univariate and multivariate analyses Univariate HR (95% CI) P-value Multivariate HR (95% CI) P-value AF duration 1.04 (1.011–1.065) 0.006 1.08 (1.040–1.122) <0.001 Application of additional lines 1.45 (0.946–2.282) 0.087 2.724 (1.470–5.048) 0.001 Ablation time 2.747 (1.464–5.155) 0.002 3.265 (1.528–6.974) 0.002 Univariate HR (95% CI) P-value Multivariate HR (95% CI) P-value AF duration 1.04 (1.011–1.065) 0.006 1.08 (1.040–1.122) <0.001 Application of additional lines 1.45 (0.946–2.282) 0.087 2.724 (1.470–5.048) 0.001 Ablation time 2.747 (1.464–5.155) 0.002 3.265 (1.528–6.974) 0.002 CI, confidence interval; HR, hazard ratio. Table 4 Predictors of AF recurrence in long-term rhythm outcome in univariate and multivariate analyses Univariate HR (95% CI) P-value Multivariate HR (95% CI) P-value AF duration 1.04 (1.011–1.065) 0.006 1.08 (1.040–1.122) <0.001 Application of additional lines 1.45 (0.946–2.282) 0.087 2.724 (1.470–5.048) 0.001 Ablation time 2.747 (1.464–5.155) 0.002 3.265 (1.528–6.974) 0.002 Univariate HR (95% CI) P-value Multivariate HR (95% CI) P-value AF duration 1.04 (1.011–1.065) 0.006 1.08 (1.040–1.122) <0.001 Application of additional lines 1.45 (0.946–2.282) 0.087 2.724 (1.470–5.048) 0.001 Ablation time 2.747 (1.464–5.155) 0.002 3.265 (1.528–6.974) 0.002 CI, confidence interval; HR, hazard ratio. Figure 1 View largeDownload slide Long-term rhythm outcome after ECV including 3 months of blanking interval. Group A: successful cardioversion, Group B: unsuccessful cardioversion. #The Kaplan–Meier curves start after 3 month of blanking interval. For comparison, the green* and blue lines† demonstrate the long-term outcome after catheter ablation of AF at the University Heart Center Leipzig in general [AF ablation results 2014, Heart Center Leipzig, the blue line† represents AT/AF free survival of patients (n = 47) with LVA and additional targeted ablation, the green line* represents AT/AF free survival of patients (n = 131) without LVA and PVI only]. Modified from Rolf et al.8 Figure 1 View largeDownload slide Long-term rhythm outcome after ECV including 3 months of blanking interval. Group A: successful cardioversion, Group B: unsuccessful cardioversion. #The Kaplan–Meier curves start after 3 month of blanking interval. For comparison, the green* and blue lines† demonstrate the long-term outcome after catheter ablation of AF at the University Heart Center Leipzig in general [AF ablation results 2014, Heart Center Leipzig, the blue line† represents AT/AF free survival of patients (n = 47) with LVA and additional targeted ablation, the green line* represents AT/AF free survival of patients (n = 131) without LVA and PVI only]. Modified from Rolf et al.8 Discussion Main findings To the best of our knowledge, this is the first study that analysed predictors, management, and outcome of ECV failure early after AF catheter ablation. The presence of diabetes and lack of beta-blocker medication are significant predictors of ECV failure. Although ERAF after ablation is associated with poorer long-term rhythm outcomes, successful and failed ECV did not impact on freedom from AF. In contrast, duration of AF prior to ablation, the necessity of additional (linear) lesions during ablation and a prolonged ablation time were predictors for late recurrence of AF during FU in this cohort. Predictors and risk factors for electrical cardioversion failure Our study revealed that ECV outcome was significantly better, when beta-blocker therapy was present. Until now, there are no previously published data for these findings in this specific patient population. However, in acute AF without prior ablation, Kühlkamp et al.10 showed that beta-blockers are suitable to maintain sinus rhythm after ECV. Blocking adrenoceptors might prevent induction and perpetuation of AF.11 The accurate mechanisms of prevention of AF relapse are uncertain. An improved control of the underlying disease, but also reduction of an increased sympathetic drive through beta-blockers, is discussed. In this context, prevention of ERAF following catheter ablation by intake of beta-blockers appears plausible. However, it remains remarkable that treatment with AAD, peri-interventional or during FU, had no significant influence on ECV outcome in our study. In contrast, the presence of diabetes was a strong predictor of ECV failure. The presence of diabetes is an established, independent risk factor for AF, in general.12 Similarly, there is evidence of a strong association between diabetes or impaired fasting glucose and AF recurrence after catheter ablation.13 It is therefore not surprising that diabetes was also associated with higher rates of unsuccessful ECV in our analysis. The pathophysiological relation between AF and diabetes remains theoretical.14 An increased cardiac autonomical neuropathy leading to sympathetic overactivity and neural remodelling resulting in increased cardiac autonomic activity triggering AF are discussed as possible pathomechanisms.15 Furthermore, pro-arrhythmogenic effects of increased presence of epicardial fat and lipid infiltration, increased atrial enlargement, atrial structural and electrical remodelling, and systemic inflammation are discussed as multifactorial reasons for AF occurrence in patients with diabetes.16,17 Furthermore, diabetes-related endothelial dysfunction and increased levels of pro-inflammatory mediators may play a crucial role in ablation-related lesion healing. These effects might therefore be responsible for the arrhythmogeneity and worse ECV outcomes in our particular study cohort.16 Interestingly, according to our data, an association of obesity and ECV failure after AF ablation was found only in univariate analysis. Multivariate analysis failed to prove the predictive value of obesity in ERAF. Other studies have shown that there is an increased risk for unsuccessful cardioversion in patients with acute AF when vascular and coronary artery disease are present.18 We find neither vascular nor coronary artery disease to be an independent predictor of ECV outcome. These differences are possibly related to the different pathomechanisms causing AF in our particular patient cohort. Management of failed electrical cardioversion Our aim, to restore sinus rhythm within the first 3 months after ablation in all Group B patients, was achieved in 91.7% of patients. Of these patients, 37% reached sinus rhythm spontaneously. Similar results were found in a study by Richter et al.,6 showing that approximately half of all patients with ERAF (within 48 h after ablation) presented with freedom of AF during a median FU of 12.7 months. Oral et al.4 described that 30% of patients with ERAF have no further symptomatic AF during long-term FU. Only a small part (3.6%) of the Group B patients received new AAD therapy. This might be due to the fact that a number of these patients (36.7%) were already on AAD previously to AF ablation and, in case of ERAF, were most commonly advised to continue AAD treatment. To restore sinus rhythm, 18.2% of our patients received a repeated ECV (solely or in combination with AAD) within the defined blanking interval. In some carefully selected individuals, reablation appears a reasonable option. Lellouche et al.7 demonstrated that early reablation can reduce incidence of further AF recurrence. This treatment option was successfully applied in four Group B patients of our study. Finally, an individualized patient-tailored therapeutic approach is required in this particular population. Outcome According to our findings, ERAF seems to be associated with higher rates of relapse into AF in the long term. But importantly there seems to be no difference in long-term rhythm outcome depending on the result of ECV failure in ERAF after catheter ablation. In our study, we did not consider any recurrence of AF during the first 3 months and started FU after a defined blanking interval of 3 months. Although there is more evidence for worse long-term ablation outcomes in ERAF after ablation in the literature, data from several recently published studies are inconclusive in terms of predicting long-term rhythm outcome. Joshi et al.5 pointed out that recurrence of AF within 3 months of blanking period is frequent and does not predict long-term success or failure of the procedure. However, they showed that freedom of AF recurrence within the first 2 weeks after catheter ablation was a significant predictor of long-term rhythm outcome, suggesting the importance of the timing of AF relapse. Several other studies showed that ERAF is associated with poorer AF ablation outcomes after 1 year and even predicts up to 79.5% higher rates of ablation failure in longer FU.6,7 However, data emphasizing worse long-term rhythm outcomes in patients with post-ablational ERAF are in line with our results, showing poor ablation success rates at the end of FU, especially, when compared with another AF ablation patient cohort from our centre (without ERAF) representing an everyday AF patient population.8 Predictors and risk factors for long-term ablation failure In terms of predictors for long-term ablation outcome, our analysis revealed that AF duration prior to ablation is a significant predictor for late recurrence of AF. There are numerous studies confirming our findings. In a study by Chang et al.,3 for example the impact of very ERAF (<2 days) after catheter ablation was analysed. The presence of non-paroxysmal AF was an independent risk factor for late recurrence of AF. Similar results were found by Fornengo et al.19 who showed that patients with a prolonged AF period of more than 3 months suffer from significantly higher AF recurrence rates after ECV than patients with only paroxysmal episodes. Although the type of AF (paroxysmal or persistent) had no predictive value on rhythm outcome in our data, it could be shown that there is an association of AF duration prior to ablation. In line with other studies, the need of additional lesions was a significant predictor for AF recurrence during FU.20 We could show that application of multiple (≥ two) additional (linear) lesions after PVI is a significant predictor of late AF recurrence. Similarly, a prolonged ablation time was associated with poorer ablation outcomes. Study limitations This study is mainly limited by its retrospective character, which can explain the missing FU data. The therapeutic approach was upon discretion of the operator and tailored according to the patient’s clinical history. The monitoring during FU was limited by serial ambulatory 7 days of Holter ECG after catheter ablation and can result in missed asymptomatic AF episodes. Furthermore, we did not assess possibly reversible reasons for cardioversion failure like abnormal potassium levels, haemodynamic factors, e.g. due to procedure-related fluid overload. Conclusions This study demonstrates that patients with diabetes and lack of beta-blockers are at higher risk for ECV failure early after AF catheter ablation, while echocardiographic parameters and peri-interventional AAD treatment have no impact on ECV outcome. Early post-ablational ECV failure is not associated with long-term rhythm outcome. Conflict of interest: none declared. 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TI - Predictors, management, and outcome of cardioversion failure early after atrial fibrillation ablation
JF - Europace
DO - 10.1093/europace/eux327
DA - 2018-09-01
UR - https://www.deepdyve.com/lp/oxford-university-press/predictors-management-and-outcome-of-cardioversion-failure-early-after-8A22mDnEuI
SP - 1428
VL - 20
IS - 9
DP - DeepDyve
ER -