Atrial Fibrillation catheter Ablation Versus Surgical Ablation Treatment - FAST
The current trial sought to compare outcomes after catheter-based ablation (pulmonary vein isolation [PVI]) versus a minimally invasive surgical approach in patients with severe symptomatic drug-refractory atrial fibrillation (AF).
Minimally invasive surgical ablation would be superior to percutaneous PVI in patients with severe symptomatic drug-refractory AF.
- Placebo Controlled
- Drug-refractory AF, documented in the last 12 months
- Symptom duration >12 months
- High chance of catheter-based failure due to:
- LA diameter >40-44 mm with hypertension
- LA diameter ≥45 mm
- Failed prior catheter-based ablation
Number of enrollees: 129
Duration of follow-up: 2 years
Mean patient age: 56 years
Percentage female: 20%
Ejection fraction: 56%
- AF >1 year
- Catheter ablation or surgical procedure within 3 months
- Previous stroke/transient ischemic attack
- LA size >65 mm
- Left ventricular ejection fraction <45%
- Mitral or aortic regurgitation >2+
- Moderate to severe mitral stenosis or aortic stenosis
- Active infection or sepsis
- Unstable angina
- Myocardial infarction within 3 months
- AF secondary to electrolyte imbalance
- Thyroid disease
- History of blood clotting abnormalities
- Efficacy: Freedom of LA arrhythmia lasting >30 seconds, in the absence of AAD
- Safety: Significant adverse events, both acute and chronic
- Freedom of LA arrhythmia lasting >30 seconds, with AAD use
Eligible patients were randomized to a minimally invasive surgical approach (PVI, ganglionic plexi ablation, and left atrial appendage [LAA] excision) by VATS under GA, or catheter-based PVI with linear antral PVI, guided by 3-D mapping.
A total of 129 patients were enrolled at two centers, 61 to surgical approach and 63 to catheter-based PVI. Baseline characteristics were similar between the different arms. The mean LA diameter was 4.3 cm, and approximately 70% had a history of prior failed catheter-based ablation. Approximately 60% had paroxysmal AF, and about 40% had been on three or more antiarrhythmic drugs (ADDs) in the past. The total procedure time was higher in the surgical arm (188 vs. 163 minutes, p = 0.018). Two or more additional LA lines were necessary in about 19% of patients in both arms.
The primary efficacy (freedom from LA arrhythmia lasting >30 seconds, in the absence of AAD) was significantly higher in the surgical arm as compared with the catheter-based arm (65.6% vs. 36.5%, p = 0.0022). On allowing for AAD use, results were similar (42.9% vs. 78.7%, p < 0.0001). Results were also similar in the group that had failed catheter-based ablation before (68.2% vs. 36.8%, p = 0.0089). There were no deaths in either arm; all complications were significantly higher in the surgical arm (23% vs. 3.2%, p = 0.001), including six instances of pneumothorax.
The results of this trial indicate that a minimally invasive surgical approach involving PVI, ganglionic plexi ablation, and LAA excision was superior to a catheter-based approach involving PVI guided by 3-D mapping in reducing the primary endpoint of freedom from LA arrhythmia lasting >30 seconds in patients with drug-refractory symptomatic AF. The surgical approach was, however, associated with a significant increase in complications, including pneumothorax.
These results are interesting and applicable only to patients with severe refractory AF, most of whom had a prior attempt at catheter-based ablation, but unlikely to change practice soon, since longer studies with harder endpoints are necessary.
Boersma LV, Castella M, van Boven W, et al. Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment (FAST): A 2-Center Randomized Clinical Trial. Circulation 2011;Nov 14:[Epub ahead of print].
Presented by Dr. Lucas Boersma at the American Heart Association Scientific Sessions, Orlando, FL, November 14, 2011.
Keywords: Thoracic Surgery, Video-Assisted, Follow-Up Studies, Atrial Appendage, Pulmonary Veins, Pneumothorax, Electrophysiologic Techniques, Cardiac, Catheter Ablation, Hypertension
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