Abstract 9464: International Incidence of Complications After Catheter Ablation of Persistent Atrial Fibrillation (AF): Insights From the Multicenter, Prospective, Randomized STAR AF II Trial
Bibliographic record
Abstract
Background: Complication rates after AF ablation are mostly reported in single center experiences or surveys. Little international, multicenter, prospective data on the contemporary incidence of complications is available. We report the incidence of complications from the large STAR AF II randomized trial. Methods: The STAR AF II trial is an international, randomized trial comparing 3 different strategies for ablation of persistent AF: pulmonary vein isolation (PVI) alone, PVI + linear ablation, and PVI + ablation of complex fractionated electrograms. 48 centers were involved across Canada, Australia, Korea, China, & 8 countries in Europe. Post-ablation, patients were all followed for 18 months. All adverse events were reported by protocol and were classified as “serious” if it was fatal, life-threatening, disabling, or required/prolonged hospitalization. Adverse events were also reviewed by an independent data safety monitoring board and classified as either being related or unrelated to the ablation procedure. Adverse events related to the ablation procedure were included in this analysis. Results: Patients (n=589) were enrolled in the STAR AF II trial (age 60±10 years, 79% male, EF 56±10%, LA diameter 44±9 mm). The most common post-procedural complications were access site hematoma (n=16, 2.7%), fluid overload/pulmonary edema (n=16, 2.7%), and transient pericarditis (n=15, 2.5%). Access site arterio-venous fistulas or pseudoaneurysms occurred in 7 patients (1.2%). Complications related to sedation occurred in 5 patients (0.8%). Cardiac tamponade (n=3, 0.5%), stroke or transient ischemic attack (n=3, 0.5%), and symptomatic PV stenosis (n=1, 0.2%) were uncommon. None of the neurological events resulted in permanent deficit. There was one atrio-esophageal fistula complicated by stroke which was successfully stented, but the patient died of aspiration pneumonia three months later. Conclusions: The most common complications were access site hematoma, fluid overload, and transient pericarditis. The rates of serious adverse events such as tamponade, stroke and symptomatic PV stenosis were quite low. There was one atrio-esophageal fistula that caused late death despite successful repair.
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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 | 0.020 | 0.021 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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 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".