E-42 | Multi-Center Clinical Outcomes of a No-Implant Interatrial Shunt for Heart Failure With Preserved and Reduced Ejection Fraction: Six-Month Outcomes from the ALLEVIATE-HF Feasibility Program
Bibliographic record
Abstract
Chronic heart failure (HFpEF and HFrEF) remains an important area of unmet need despite current best medical therapies available. Implantable interatrial shunt devices may improve quality of life and functional capacity with favorable safety signals but require permanent implantation to maintain patency. We report the 6-month clinical outcomes of a no-implant approach to interatrial shunting across three studies: ALLEVIATE-HF-1 and ALLEVIATE-HF-2 for HFpEF, and a dedicated HFrEF study. Patients aged ≥ 40 years, NYHA class II, III or ambulatory IV with elevated peak exercise PCWP were included in the study. Baseline screening included echocardiography, exercise right heart catheterization, KCCQ, and 6MWT. Femoral access was utilized and following transseptal puncture, the Alleviant System was used to excise a segment of the interatrial septum using a pulse of radiofrequency energy to create an interatrial shunt. Procedures were performed with fluoroscopic and echo guidance. A total of 28 HFpEF and 5 HFrEF patients were enrolled. Mean LVEF was 60 ± 8% and 30 ± 8% in HFpEF and HFrEF patients, respectively. Procedures were successful with no device or procedure-related adverse events. By 6 months, NT-proBNP was reduced by -372 ± 857 pg/ml (p=0.036) in HFpEF patients and -558 ± 139 pg/ml (p=0.004) in HFrEF patients; 6MWT distance increased by +101 ± 71 m (p<0.001) in HFpEF patients and +151 ± 76 m (p=0.029) in HFrEF patients; KCCQ overall summary score increased by 26 ± 19 points (p<0.001) in HFpEF patients and 19 ± 5 points (p=0.003) in HFrEF patients. TTE and CT confirmed all shunts assessed maintained patency (n=30). No device or procedure-related serious adverse events occurred upon discharge and through 6 months. This early feasibility clinical experience demonstrates procedural safety and feasibility of the Alleviant no-implant interatrial shunt creation with a promising efficacy signal through 6 months in patients with HFpEF and HFrEF. Enrollment for the forthcoming randomized sham-controlled pivotal study (ALLAY-HF) is anticipated to begin early 2023.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.123 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".