Introduction
Methods
German ablation registry structure
Patient cohort
Procedural methods for catheter ablation
Registry management and clinical follow-up
Outcomes
Statistical analysis
Results
Patient cohort and baseline parameters
Index (n = 3377) | Repeat (n = 738) | Odds ratio (95%-CI) or p-value | |
---|---|---|---|
Age (years) | 62 (54; 68) | 63 (55; 68) | P = 0.69 |
Female sex | 33.5% | 29.1% | 1.23 (1.03–1.46) |
Diabetes mellitus | 7.8% | 6.8% | 1.17 (0.86–1.60) |
Chronic kidney disease | 2.1% | 2.8% | 0.76 (0.21–2.72) |
Hypertension | 61.1% | 64.5% | 0.86 (0.56–1.32) |
Stroke | 5.6% | 4.6% | 1.24 (0.47–3.26) |
COPD | 1.2% | 2.8% | 0.44 (0.11–1.73) |
Cardiac device (PM, ICD, CRT) | 5.9% | 6.2% | 0.95 (0.68–1.32) |
Pacemaker | 4.4% | 5.3% | 1.20 (0.84 -1.72) |
ICD | 1.4% | 0.9% | 0.66 (0.30–1.47) |
CRT | 0.1% | 0.1% | 2.29 (0.21–25.28) |
Coronary artery disease | 18.2% | 16.1% | 1.15 (0.93–1.43) |
Prior myocardial infarction | 4.6% | 6.2% | 0.73 (0.52–1.03) |
Cardiomyopathy (HCM, DCM) | 3.9% | 3.8% | 1.04 (0.69–1.58) |
Valvular heart disease | 6.6% | 9.1% | 0.70 (0.53–0.94) |
LVEF preserved (> 50%) | 86.8% | 88.0% | 0.90 (0.69–1.17) |
CHA2DS2-VASc Score | 1.8 ± 1.3 | 1.7 ± 1.2 | P = 0.63 |
NYHA 2 + | 39.7% | 49.4% | 0.67 (0.51–0.88) |
Atrial fibrillation type | |||
Paroxysmal | 69.3% | 61.9% | P < 0.001 |
Persistent | 30.7% | 38.1% | P < 0.001 |
Procedural details
Index (n = 3377) | Repeat (n = 738) | p value | |
---|---|---|---|
Energy form used | |||
Radiofrequency | 77.0% | 94.6% | < 0.001 |
Cryoballoon | 21.7% | 5.4% | < 0.001 |
Rhythm before ablation | |||
Sinus rhythm | 68.5% | 68.2% | 0.85 |
Atrial fibrillation | 31.5% | 31.8% | 0.85 |
Pulmonary vein isolation | |||
Circumferential | 87.9% | 78.0% | < 0.001 |
Segmental | 12.4% | 16.0% | 0.008 |
Ablation strategy | |||
Linear lesion | 14.6% | 26.6% | < 0.001 |
Location LA | 49.2% | 60.7% | 0.006 |
Location RA | 56.7% | 57.7% | 0.82 |
Location CTI | 97.1% | 92.9% | 0.055 |
CFAE | 7.8% | 25.1% | < 0.001 |
Irrigated-tip catheters | 70.0% | 90.7% | < 0.001 |
Mapping, imaging, and study | |||
Conventional mapping | 39.3% | 40.2% | 0.63 |
EAM | 58.0% | 58.3% | 0.88 |
Pre-procedural imaging | 25.2% | 16.7% | < 0.001 |
Mean RF application duration (sec) | 2580 (1657; 3656) | 1960 (1038; 3405) | < 0.001 |
Mean fluoroscopy time (min) | 29 (20; 46) | 27 (17; 44) | < 0.001 |
Mean dose area product (cGY × cm2) | 3744 (1898; 7234) | 3325 (1754; 6229) | 0.001 |
Mean study duration (min) | 181.2 ± 71.9 | 163.6 ± 67.1 | < 0.001 |
In-hospital complications and safety
Index | Repeat | p value | |
---|---|---|---|
Severe complications | 1.2% (41/3373) | 0.5% (4/738) | 0.12 |
Myocardial infarction | 0.1% (2/3373) | 0.0% (0/738) | 1.00 |
Stroke | 0.2% (7/3373) | 0.0% (0/738) | 0.36 |
Major bleeding requiring intervention | 0.9% (32/3374) | 0.5% (4/738) | 0.38 |
Moderate complications | 3.2% (95/2970) | 2.2% (14/640) | 0.20 |
Transient ischemic attack | 0.1% (5/3373) | 0.0% (0/738) | 0.59 |
Cardiopulmonary resuscitation | 0.0% (0/3373) | 0.1% (1/737) | 0.18 |
Aneurysmal hematoma. AV fistula | 1.1% (38/3376) | 1.1% (8/738) | 1.00 |
Infection of puncture site | 0.0% (1/2969) | 0.0% (0/641) | 1.00 |
Pericardial effusion | 1.1% (33/2969) | 0.5% (3/641) | 0.19 |
Persistent AV block | 0.0% (0/2969) | 0.2% (1/641) | 0.18 |
AV block III | 0.1% (2/2969) | 0.0% (0/641) | 1.00 |
Sepsis | 0.0% (0/2969) | 0.0% (0/641) | |
Endocarditis | 0.0% (0/2969) | 0.0% (0/641) | |
Pulmonary embolism | 0.0% (1/2969) | 0.0% (0/641) | 1.00 |
Pneumothorax | 0.2% (7/2969) | 0.0% (0/641) | 0.62 |
Hemothorax | 0.1% (4/2969) | 0.0% (0/641) | 1.00 |
Emergent cardiac surgery | 0.1% (3/2969) | 0.0% (0/641) | 1.00 |
Phrenic nerve palsy | 0.5% (15/3013) | 0.0% (0/643) | 0.089 |
Pulmonary vein stenosis | 0.1% (2/2969) | 0.2% (1/641) | 0.44 |
Atrio-esophageal fistula | 0.0% (0/2969) | 0.0% (0/641) | |
Minor complications | 3.8% (113/2978) | 2.0% (13/641) | 0.024 |
Minor bleeding | 3.3% (112/3373) | 1.6% (12/737) | 0.012 |
New AV block I° or II° | 0.0% (1/2969) | 0.2% (1/641) | 0.32 |
New Right or left bundle branch block | 0.0% (0/2969) | 0.0% (0/641) |
Long-term follow-up: complication and safety
Long-term follow-up: symptoms, recurrence, and satisfaction
Medical therapy at discharge
Variable | Index (n = 3372) | Repeat (n = 735) | p value |
---|---|---|---|
Anti-arrhythmic drug (AAD) therapy | |||
Beta-blocker | 74.5% | 70.2% | 0.017 |
AAD class I | 32.6% (1099/3372) | 30.1% (221/735) | 0.18 |
AAD class III | 21.4% (722/3372) | 24.4% (179/735) | 0.081 |
Sotalol | 18.3% (132/722) | 18.4% (33/179) | 0.96 |
Amiodarone | 79.2% (572/722) | 78.8% (141/179) | 0.89 |
AAD class III (added after procedure) | 2.6% (19/722) | 2.8% (5/179) | 0.90 |
AAD class IV | 1.6% (53/3372) | 3.4% (25/735) | < 0.001 |
Antithrombotic therapy | |||
ASA | 9.0% (304/3372) | 6.7% (49/735) | 0.040 |
Clopidogrel | 2.7% (91/3372) | 2.0% (15/735) | 0.31 |
Vitamin K antagonist | 89.6% (3023/3373) | 91.0% (669/735) | 0.26 |
Heparin (UFH) | 8.3% (280/3372) | 3.9% (29/735) | < 0.001 |
Heparin (LMWH) | 63.3% (2136/3372) | 70.3% (517/735) | < 0.001 |