P950Intramyocardial bone marrow mononuclear cell injection in patients with ischemic heart disease: a safety evaluation of 333 procedures
Bibliographic record
Abstract
Background: Cardiac cell therapy has been introduced as a novel treatment option for ischemic heart disease patients. Previously, we demonstrated in a RCT that intramyocardial bone marrow mononuclear cell (BMC) injection improves myocardial perfusion in no-option patients with refractory angina pectoris (RAP). Since 2010 this procedure is a standardized treatment for refractory angina patients with myocardial ischemia without options for revascularization. Methods: We assessed 333 patients (age 63±10years, male 88%) who underwent intramyocardial injection of BMC, mesenchymal stromal cells or placebo injection between 2005 and 2017, using the NOGA system. Periprocedural and 1 year follow-up adverse events were noted. Major events were defined as an additional intervention or a prolonged hospitalisation. Results: The patients treated for RAP showed improved Canadian Cardiovascular Society score from 3.1±0.6 at baseline to 2.2±0.7 at 3 months (P<0.001) whereas quality-of-life improved by22% (P<0.001). There were no fatalities as a result of the procedure. Indication for injection was RAP (n=289), ischemic heart failure (n=35), acute myocardial infarction (n=9). In 39 patients (11.7%) a procedural complication occurred. Of which 43,6% was defined as major event. Those existed of 3 patients with a stroke; 1 during the procedure, 1 several hours after the procedure and 1 patient had a transient ischemic attack. Six patients had a spurious aneurysm needing an intervention. Two patients had a periprocedural myocardial infarction and 2 had an asthma cardiale. One patient had pericardial effusion requiring pericardiocentesis, 1 had a ventricular tachycardia followed by electric cardioversion and 1 patient had an abdominal aortic dissection. In 4 patients the cell material was aggregated and couldn't be used. During 1 year follow-up no additional adverse events were observed.
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| 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 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".