176-19: Second generation cryoballoon ablation in paroxysmal atrial fibrillation patients: 12 month safety and efficacy from the STOP-AF post approval study
Bibliographic record
Abstract
Purpose: The purpose of this interim analysis was to report the safety and 12 month efficacy from the largest prospective multi-center trial evaluating cryoballoon ablation using the second generation cryoballoon (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. Safety data is presented on the final enrolled cohort of patients treated with CB2 (n = 345). Freedom from atrial fibrillation (AF) and symptomatic atrial flutter (AFL) / tachycardia (AT) is presented for patients who had a minimum of 12 months follow-up at the time of this interim analysis (n = 338). Kaplan-Meier estimate was utilized for calculating the primary endpoint. Documented AF lasting longer than 30 seconds and/or a repeat ablation after the 90-day blanking period were considered treatment failures. Results: Upon completion of enrollment, 345 patients were treated with CB2 for drug-refractory, recurrent symptomatic paroxysmal AF. Acute pulmonary vein isolation (PVI) was achieved in 99.4% (343/345) of patients. Of the 345 patients, 338 (98%) had a minimum of 12-months follow-up (mean follow-up 17 ± 7 months). Freedom from AF at 12 months was 82.8% (95% CI: 78.2% to 86.5%) and freedom from AF and symptomatic AFL/AT was 80.0% (95% CI: 75.3% to 84.0%). Phrenic nerve injury (PNI) was unresolved at hospital discharge in 11 patients (3.2%). PNI resolved in 8/11 patients (mean time to resolution = 125 days) and was still present after 12 months in 3 patients (0.9%). Other major events included: cerebrovascular accident (0.3%), PV stenosis (0.6%), pericardial effusion (0.6%), tamponade (0.3%), and hemoptysis (0.9%). No device or procedure related deaths occurred. Conclusions: PVI using the CB2 is a highly effective treatment for patients with drug-refractory recurrent symptomatic paroxysmal AF. This analysis reports freedom from AF of 82.8%, and freedom from all atrial arrhythmias of 80.0% at 12 months. PNI ongoing beyond 12 months is observed in less than 1% of patients.
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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 | 0.000 | 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".