176-18: Impact of second generation cryoballoon ablation in paroxysmal atrial fibrillation patients: AF symptoms and quality of life at 12 months post ablation from the STOP-AF post approval study
Bibliographic record
Abstract
Purpose: The purpose of this interim analysis was to determine the impact of cryoballoon ablation, using the second generation cryoballoon, on AF symptoms and quality of life (QOL) at 12 months post-ablation in patients with drug-refractory recurrent symptomatic paroxysmal AF. Methods: The STOP-AF Post Approval Study (PAS) is a prospective, multi-center, non-randomized, single-arm, unblinded, condition of approval study, designed to provide long-term safety and efficacy data for cryoballoon ablation. A total of 402 patients at 39 sites from the United States and Canada are participating in the study. Changes in arrhythmic symptoms and QOL (using the SF-12 Health Survey) are assessed at baseline, 6 months, 12 months, and annually thereafter. Results: At the time of this interim analysis, 304 patients (67% male; 60 ± 10 years of age; with AF onset 4.7 ± 5.6 years prior to baseline) treated with the second generation cryoballoon for drug-refractory, recurrent symptomatic paroxysmal AF completed symptom evaluations at both baseline and 12 months. At 12 months post-ablation, there was a 56% reduction in arrhythmic symptoms. This symptomatic improvement was confirmed by significant improvement in SF-12 scores in patients reporting QOL at 12 months post-ablation. The SF-12 mean physical component score improved from 45.3 to 50.1 (p < 0.01) and the mental component scores improved from 49.4 to 53.0 (p < 0.01). Arrhythmia-related symptom reduction was statistically significant (p < 0.01) 12 months post-ablation for all patient symptoms: dizziness (35.5% to 6.3%), palpitations (74.0% to 25.0%), rapid heartbeat (39.5% to 9.2%), dyspnea (41.1% to 8.2%), fatigue (57.2% to 7.9%), and syncope (5.3% to 0.0%). Conclusions: Patients treated with the second generation cryoballoon demonstrated a significant improvement in arrhythmia related symptoms and QOL from baseline to 12 months post-ablation.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".