Abstract 3052: Initial Human Experiences with a Non-Stented Coronary Sinus Device for the Treatment of Functional Mitral Regurgitation in Heart Failure Patients
Bibliographic record
Abstract
Recently, several approaches have been developed for percutaneous mitral valve repair. The percutaneous transvenous mitral annuloplasty system (PTMA TM , Viacor Inc., Wilmington, USA) is an indirect annuloplasty device deployed within the coronary sinus (CS). Its mechanism is based on reduction of the anterior-posterior diameter of the mitral annulus to decrease mitral regurgitation (MR) by reestablishing leaflet coaptation in functional MR. We report the ongoing first-in-human experience with this non-stented device. 27 heart failure patients (NYHA II–IV) with functional MR II–III were enrolled at 5 centers. Via subclavian access, a multi-lumen diagnostic catheter was positioned within the anterior interventricular vein of the CS. Nitinol rods of various length and stiffness patterns were subsequently introduced into the lumina in order to exert pressure to the posterior mitral leaflet and to reduce AP diameter. Under fluoroscopic and echo guidance, different rod combinations were evaluated for maximal effectiveness before exchanging the diagnostic system to the permanent device. After assuring significant MR reduction by the permanent implant, the whole device was implanted in a subcutaneous pocket. 8 patients were excluded prior procedure due to unfavorable CS anatomy. The remaining 19 patients proceeded through a complete diagnostic exam. While the device was ineffective in 6 cases, echocardiography revealed a significant reduction of MR in 13 patients. 9 of these patients underwent successful implantation of the permanent device. 4 devices were subsequently removed, one at 7 days due to device fracture and the other 3 when the patients were referred for annuloplasty surgery due to device migration or diminished efficacy. Sustained reduction in MR and AP dimensions was noted in the remaining 4 long-term implants. No procedure related adverse events with permanent sequelae were observed in all patients. Initial human experiences with the PTMA TM device demonstrate safety and feasibility of this method as well as sustained favorable geometric modifications of the mitral annulus with reduction of MR in responding patients.
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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) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 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".