Abstract 12592: Sustained Clinical Benefit in Patients With Chronic Post-Infarction Heart Failure Treated With Shockwave-Facilitated Intracoronary Administration of Bone Marrow-Derived Cells: Long-Term Follow-Up of the Randomized, Placebo-Controlled Cellwave Trial
Bibliographic record
Abstract
The modest effects of initial clinical studies using intracoronary (i.c.) administration of autologous bone marrow-derived mononuclear cells (BMC) in patients with chronic post-infarction heart failure (CHF) have been attributed to impaired homing of the applied BMC to the target area. In the double-blind CELLWAVE trial, preconditioning of the target area by extracorporeal shockwave (SW) application resulted in a significant improvement in LVEF 4 months after i.c. BMC administration in patients with CHF. The present analysis reports the long-term clinical outcome after shockwave-facilitated BMC administration. Methods: 103 patients were randomized to either shockwave application targeted to the left ventricular anterior wall followed by followed by i.c. BMC application (n=43) or placebo (n=39) after 24 hours, or to placebo shockwave application followed by i.c. administration of BMC (n=21). Results: Complete follow-up data were obtained in 101 (98%) patients, 2 patients were lost-to-follow-up. Mean follow-up time was 45.7±17 months. A total of 18 patients died, 8 of 39 (21%) in the shockwave + Placebo group, 4 of 21 (19%) in the Placebo shockwave + BMC group and 6 of 43 (14%) in the shockwave +BMC group (p=0.72). The table summarizes the occurrence of individual major cardiovascular events (MACE) as well as the number of affected patients. The cumulative cardiovascular event burden including death, repeat myocardial infarction, rehospitalization for worsening heart failure, stroke and ventricular tachycardia was significantly lower in patients receiving shockwave + BMC compared to the Placebo-shockwave + BMC and the shockwave + Placebo group (p Conclusion: In patients with chronic post-infarction heart failure, the significant improvement of LVEF at 4 months induced by the use of shockwave-facilitated i.c. BMC administration is associated with sustained reduction of cumulative major adverse clinical events during long-term follow-up.
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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) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".