A Tale of Two Populations: A meta-analysis of hemodynamic, procedural, and clinical outcomes of PASCAL Ace for Mitral and Tricuspid Regurgitation
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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.
