A Tale of Two Populations: A meta-analysis of hemodynamic, procedural, and clinical outcomes of PASCAL Ace for Mitral and Tricuspid Regurgitation
Bibliographic record
Abstract
Abstract Background Mitral and tricuspid regurgitation (MR, TR) cause significant morbidity and mortality, especially in high-surgical-risk patients. The PASCAL Ace transcatheter edge-to-edge repair (TEER) device shows promise for treating both, yet existing evidence is limited by single-center studies and heterogeneous cohorts. This single-arm meta-analysis systematically evaluates the safety, efficacy, and clinical impact of PASCAL Ace. Methods A comprehensive literature search (PubMed, Scopus, Embase) identified studies reporting hemodynamic, procedural, and clinical outcomes of PASCAL Ace for MR/TR. Observational cohorts and randomized trials were included; systematic reviews, case reports, studies with other devices, and non-English publications were excluded. Data extracted included demographics, baseline parameters, procedural details, and outcomes. Study quality was assessed (Newcastle-Ottawa Scale). Meta-analysis used a random-effects model to pool proportions and weighted mean differences, with heterogeneity (I²) evaluated. Significance was p<0.05 (Stata 18). Results Seven studies (324 patients: 195 MR, 129 TR) were included. Baseline symptom burden was high (nearly all NYHA III/IV: 100% TR, 94.9% MR). Pooled overall mortality was 4% (95% CI 1%–6%, I²=0.01%). Procedural success was 96% (95% CI 94%–99%, I²=12.53%). Post-procedure, 84% achieved NYHA I/II status (95% CI 77%–90%, I²=0.00%), alongside significant reductions in regurgitation severity. Major adverse events occurred in 4% (95% CI 1%–6%, I²=0.01%). Conclusions The PASCAL Ace device effectively improves functional status (evidenced by NYHA class reduction) in patients with MR and TR, though outcomes were comparatively more favorable in MR. The persistence of right heart dysfunction in TR underscores the need for studies on complementary therapies and long-term follow-up to optimize results. This meta-analysis supports PASCAL Ace as a safe and efficacious TEER option.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.026 | 0.039 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.017 | 0.067 |
| Bibliometrics | 0.005 | 0.005 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.005 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 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".