Use of a Novel, Self-Expanding Coronary Sinus Reducer to Treat Symptomatic Epicardial and Microvascular Ischemic Heart Disease: Preclinical and First-in-Human Experience
Bibliographic record
Abstract
Background: A novel self-expanding, recapturable, repositionable hourglass nitinol-mesh coronary sinus reducer (CSR) has been designed to improve symptoms in patients with coronary microvascular dysfunction (CMD) or with obstructive epicardial coronary artery disease (CAD). We report the preclinical and first-in-human experience with a novel self-expanding CSR. Methods: Twelve symptomatic patients (mean age 66.8 years, 58% men) with either CMD (n = 6) or obstructive CAD (n = 6) were treated with the A-FLUX CSR. Patients were followed up at approximately 1, 3, and 6 months to assess safety and symptom improvements (Canadian Cardiovascular Society [CCS] angina class and Seattle Angina Questionnaire [SAQ]). Tissue healing responses were evaluated following A-FLUX CSR implantation in 7 mini-swine with coronary sinus angiography and intravascular ultrasound. Histological evaluation was performed at 3 and 6 months. Results: < .001) were observed at the 6-month follow-up. The preclinical experiments had a 100% procedural success rate, with no periprocedural or long-term complications. Histological evaluation showed optimal local tissue response to the CSR with favorable healing characteristics and fully endothelialized, mature neointima around the CSR. All CSR were found to be patent at the time of sacrifice without thrombosis. Conclusions: The A-FLUX CSR demonstrates preclinical and clinical procedural safety coupled with promising short-term clinical efficacy in persistently symptomatic patients with both CMD and obstructive CAD.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".