Left atrial decompression through unidirectional left-to-right interatrial shunt for the treatment of left heart failure: first-in-man experience with the V-Wave device
Bibliographic record
Abstract
AIMS: Elevated filling pressures of the left atrium (LA) are associated with poorer outcomes in patients with chronic heart failure. The V-Wave is a new percutaneously implanted device intended to decrease the LA pressure by the shunting of blood from the LA to the right atrium. This report describes the first-in-man experience with the V-Wave device. METHODS AND RESULTS: A 70-year-old man with a history of heart failure of ischaemic origin, left ventricular dysfunction (LVEF: 35%, pulmonary wedge: 19 mmHg), no right heart dysfunction, NYHA Class III and orthopnoea despite optimal treatment, was accepted for V-Wave device implantation. The device consists of an ePTFE encapsulated nitinol frame that is implanted at the level of the interatrial septum and contains a trileaflet pericardium tissue valve sutured inside which allows a unidirectional LA to right atrium shunt. The procedure was performed through a transfemoral venous approach under fluoroscopic and TEE guidance. The device was successfully implanted and the patient was discharged 24 hours after the procedure with no complications. At three-month follow-up a left-to-right shunt through the device was confirmed by TEE. The patient was in NYHA Class II, without orthopnoea, the Kansas City Cardiomyopathy index was 77.6 (from 39.1 at baseline) and NT-proBNP was 322 ng/mL (from 502 ng/mL at baseline). The QP/QS was 1.17 and the pulmonary wedge was 8 mmHg, with no changes in pulmonary pressure or right ventricular function. CONCLUSIONS: Left atrial decompression through a unidirectional left-to-right interatrial shunt represents a new concept for the treatment of patients with left ventricular failure. The present report shows the feasibility of applying this new therapy with the successful and uneventful implantation of the V-Wave device, which was associated with significant improvement in functional, quality of life and haemodynamic parameters at 90 days.
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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 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".