Proof of Concept: A New Solution for Low-Profile Transcatheter Implantation of Optimus-L Stents in Small Children
Bibliographic record
Abstract
BACKGROUND: There is no stent designed or approved for use in infants. We sought to obtain in vitro and in vivo data on a new concept conceived to implant Optimus-L stents at infant vessel diameters and offer a potential long term stent solution. METHODS: Nineteen Optimus-L stents were mounted on 8 types of angioplasty balloons with diameters 6, 8, and 10 mm with the use of an injection-moulded hand crimper. We evaluated balloon-stent unit (BSU) stability before insertion and advancement through short Terumo introducers with incremental French size and possibility of side-arm contrast injections. Three types of long sheaths were tested. Stents were inflated to balloon nominal diameters and re-expanded to 18 and 23 mm. Stent recoil, foreshortening, and fracture were evaluated. In vivo implantations were performed afterward. RESULTS: In vitro: Medtronic Evercross balloons and modified Terumo Destination sheaths were the best combination: BSUs were inserted in 6 F sheaths with possible injections (for 6 and 8 mm balloons), and 7 F sheaths without injections (for the 10 mm balloon). Retrieving BSUs inside the sheath required 1 additional F-size. Boston Scientific Sterling and Balton Lovix balloons, as well as APT Braidin L guiding sheaths showed unsatisfactory performance. Dilation up to 23 mm was possible, and stent shortening was < 24% at 18 mm and < 37% at 23 mm. Recoil was limited, and no stent fractured. In vivo: Optimus-L stents were used to treat 2 infants with aortic coarctation and 2 children with pulmonary artery stenosis with the use of 8 mm balloons and low-profile access. CONCLUSIONS: Optimus-L stents can be implanted safely in small patients with a low-profile approach. These stents have the potential to achieve adult size while maintaining structural integrity.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.002 |
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".