Transcatheter closure of perimembranous ventricular septal defect with a new occluder: one-year follow-up
Bibliographic record
Abstract
Purpose: Transcatheter closure of peri-membranous ventricular septal defects (pmVSDs) has been associated with a significant risk of complete heart block, leading most groups to abandon the technique. We describe the initial world experience of pmVSD closure with a newly designed occluder. Methods: Patients with pmVSD underwent catheter closure using the Amplatzer® Membranous VSD Occluder 2 (St. Jude Medical, MN, USA). Results: Nineteen patients from the 4 centers initially involved worldwide were prospectively included and followed for a 12±3 months. Patients ranged in age from 1.4 to 62 years (median 6 years) and in weight from 9.3 to 96 kg (median26 kg). The Qp/Qs ratio was (mean ± SD) 1.9±1.6. The size of the defect on left ventricular side was (mean ± SD) 9.9±3.5 mm (range 4.6 – 16 mm) and the orifice on right ventricularside was 8.1±2.8 mm (range 3.9 – 14 mm) by echocardiography. Mean device size was 9.4±2.4 mm (range 5 – 14 mm). An eccentric device was used in 9 patients (47%) and a concentric device in 10 (53%). A device was successfully implanted in 18 patients (95%). Procedural time was 122±39 min (range 60 – 207 min). There were no significant procedural complications. Mild (0-2 mm) residual shunt was initially observed in 14 patients (78%). At last follow-up, mild residual shunt was still observed in only 3 patients (17%). There was no significant increase of aortic or tricuspid regurgitation, compared to pre-catheterization levels. No patient showed conduction abnormalities on the ECG, and 17 out of 18 had a Holter evaluation, which was normal in all. Conclusions: Transcatheter closure of pmVSD with the Amplatzer pmVSD Occluder 2 is safe and effective. No conduction abnormalities or any other complications were observed on short and one-year follow of this initial human series.
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.001 | 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".