Optimizing transcatheter mitral valve replacement with direct, continuous transvalvular haemodynamic evaluation: first-in-man
Bibliographic record
Abstract
The recently developed SavvyWire® (OpSens, Canada) is the only 0.035″ guidewire explicitly designed for transcatheter aortic valve replacements: it is the only guidewire with continuous haemodynamic monitoring and dedicated rapid-pacing capabilities.1 An 85-year-old male with a history of mitral valve replacement with a 33 mm Epic® (Abbott, USA) had developed prosthetic mitral valve dysfunction with severe regurgitation. Due to his high surgical risk, the heart team elected to proceed with a transcatheter mitral valve replacement (TMVR). Several advantages of using the SavvyWire® were identified as follows: the direct pre- and post-procedural invasive evaluation, including transvalvular gradients (even more important in valve-in-valve procedures), waveforms analyses, TMVR results optimization, and dedicated left ventricle (LV) rapid pacing. Additionally, from a transaortic approach, this wire could be used to assess the obstruction of the neo-left ventricle outflow tract after a TMVR. However, numerous challenges were present as follows: its use in TMVR was never attempted before, its physical behaviour in TMVR was unknown, and its console was only calibrated for transaortic procedures, so its transmitral equalizing and procedural steps were not known. After several discussions with OpSens engineers, the first TMVR with the SavvyWire® was performed. Figure 1 describes the rationale behind the setting for the single-access TMVR live haemodynamic evaluation, a step-by-step guide for SavvyWire®’s use during TMVR procedures and first-in-man images of pre- and post-TMVR direct invasive real-time haemodynamic evaluation after implantation of a 29 mm + 4 mL Sapien S3® (Edwards Lifescience) valve. Although further data are necessary, this first-in-man case illustrates a potential new indication of the SavvyWire®. Supplementary data are not available at European Heart Journal online. All authors declare no conflict of interest for this contribution. No data were generated or analysed for this manuscript.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.003 |
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".