Comparison of transseptal puncture using a dedicated RF wire versus a mechanical needle with and without electrification in an animal model
Bibliographic record
Abstract
INTRODUCTION: Mechanical force to achieve transseptal puncture (TSP) using a standard needle may lead to overshooting and injury, and can potentially be avoided using a radiofrequency (RF)-powered needle or wire. Applying electrocautery to needles and guidewires as an alternative to purpose-built RF systems has been associated with safety risks, such as tissue coring and thermal damage. The commercially available AcQCross needle-dilator system (Medtronic) features a sharp open-ended needle for mechanical puncture, as well as a built-in connector to enable energy delivery for RF puncture. This investigation compares the safety and efficacy of the AcQCross needle to the dedicated VersaCross RF wire system and generator (Baylis Medical/Boston Scientific). METHODS: In an ex vivo porcine model, VersaCross wire punctures were performed using 1 s, constant mode (approx. 10 W) with maximum two attempts. AcQCross punctures were performed by applying energy for 2 s using a standard electrosurgical generator at 10 W (max. five attempts), 20 W (max. two attempts), and 30 W (max. two attempts). Efficacy was assessed in terms of puncture success and a number of energy applications required for TSP. Safety was assessed quantitatively as force required for TSP, energy required to puncture, and incidence of tissue coring, as well as by qualitative assessment of puncture sites. Additional qualitative observation of tissue cores and debris were obtained from TSP performed in live swine. RESULTS: = 9223.5, p < .0001). Compared to RF puncture using the VersaCross system, mechanical puncture, alone, using the AcQcross needle required six times more force (8 mm additional forward device displacement) to perforate the septum. Qualitative assessment of puncture sites revealed larger defects and more tissue charring with the AcQCross needle at 30 W compared to punctures with VersaCross wire. Tissue coring with the open-ended AcQCross needle was observed in vivo and measured to occur in 57% of punctures using the ex vivo model; no coring was observed with the closed-tip VersaCross wire. CONCLUSIONS: The AcQCross needle frequently required higher energy of 30 W to achieve RF TSP and was associated with tissue coring and charring, which have been, previously, reported when electrifying a standard open-ended mechanical needle or guidewire. These findings may limit safety and effectiveness compared to the VersaCross system.
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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 | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".