Transcatheter Closure of Patent Foramen Ovale in Older Patients With Cryptogenic Thromboembolic Events
Bibliographic record
Abstract
Background: The main randomized trials evaluating patent foramen ovale (PFO) closure after a presumed PFO-associated stroke excluded patients older than 60 years. We aimed to evaluate the early- and long-term clinical outcomes of transcatheter PFO closure in older (>60 years) patients with a cryptogenic ischemic event. Methods: This is a multicenter study including consecutive patients older than 60 years (mean age, 67±5 years) who had a PFO closure following a presumed PFO-related ischemic event. Patients ≤60 years old (mean age, 44±10 years) served as the control group. The primary end point was the occurrence of stroke, transient ischemic attack, or peripheral embolism over the follow-up period. New-onset atrial fibrillation was a secondary end point. Results: A total of 388 and 883 patients >60 and ≤60 years old were included, respectively. Procedural success rate was high (99.9%), and procedural-related complications low (<2%) in both groups. After a median follow-up of 3 (1–8) years, older patients exhibited an incidence of stroke/transient ischemic attack/peripheral embolism of 1.6 events per 100 patient-years (stroke: 0.6 events per 100 patient-years), lower than that expected according to the risk of paradoxical embolism score (observed-to-expected ratio, 0.31 [95% CI, 0.11–0.91]). However, the event rate in older patients was higher than that observed in their younger counterparts (incidence rate ratio, 4.7 [95% CI, 2.36–9.8]). De novo atrial fibrillation after the procedure was more frequent in older patients (2.66 per 100 patient-years versus 0.49 per 100 patient-years, P <0.001). Conclusions: In patients older than 60 years with a presumed PFO-related ischemic event, PFO closure was safe and associated with a relatively low incidence of recurrent ischemic events after a median follow-up of 3 years compared with historical cohorts of patients who did not undergo PFO closure. However, a higher risk of recurrent cerebrovascular events was observed in older patients compared to their younger counterparts. Randomized trials are warranted in this population.
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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 | 0.002 | 0.004 |
| 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 | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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".