1152Second generation cryoballoon ablation in paroxysmal atrial fibrillation patients: 24 month safety and efficacy from the STOP-AF post approval study
Bibliographic record
Abstract
On behalf of: STOP AF PAS Study Investigators Funding Acknowledgements: Medtronic Background/Introduction: There is limited long-term, multicenter data reporting outcomes after catheter ablation for paroxysmal atrial fibrillation (pAF) using the second generation cryoballoon (CB2). Purpose: The purpose of this interim analysis was to report the safety and efficacy through 24 months from the largest prospective multi-center trial evaluating cryoballoon ablation using the CB2 in the United States and Canada. Methods: The STOP-AF post approval study is a prospective, multi-center, non-randomized study designed to provide long-term safety and efficacy data for cryoballoon ablation. Enrollment is complete with 344 eligible subjects with drug-refractory, recurrent symptomatic pAF undergoing CB2 ablation. 98.5% of subjects have been followed for at least 2 years. Procedure related safety data is presented, and freedom from atrial fibrillation (AF) and symptomatic atrial flutter (AFL) / atrial tachycardia (AT) at 1-year and 2-years is presented. Documented AF lasting longer than 30 seconds and/or a repeat ablation after the 90-day blanking period were considered treatment failures. Results: Acute pulmonary vein isolation (PVI) was achieved in 99.4% (342/344) of patients. Mean follow-up is 27 ± 9 months. Freedom from AF was 82.1% (95% CI: 77.6% to 85.8%) at 12 months and 75.4% (95% CI: 70.3% to 79.8%) at 24 months. Freedom from AF and symptomatic AFL/AT was 79.5%% (95% CI: 74.8% to 83.4%) at 12 months and 72.4% (95% CI: 67.2% to 77.0%) at 24 months. Phrenic nerve injury (PNI) was unresolved at hospital discharge in 11 patients (3.2%). PNI resolved in 10/11 patients (mean time to resolution = 209 days) and was still present after 24 months in 1 patient (0.3%). Other major events included: cerebrovascular accident (0.3%), asymptomatic pulmonary vein stenosis (0.6%), pericardial effusion (0.9%), and hemoptysis (0.9%). No device or procedure related deaths occurred. Conclusion: This is the largest multicenter study to report safety and efficacy of PVI using CB2 at 24 months follow-up. Freedom from AF of 82.1% at 12 months and 75.4% at 24 months, and freedom from all atrial arrhythmias of 79.5% at 12 months and 72.4% at 24 months. PNI ongoing beyond 12 months is observed in only one patient.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".