Abstract 4371804: Restoring Function: Meta-Analysis of Functional and QoL Outcomes After PASCAL Mitral Valve Repair

Abstract

Background: Traditional TEER studies have prioritized anatomical and technical success, often underreporting the outcomes that matter most to patients—functional status and health-related quality of life (HRQoL). The PASCAL system, with its anatomic versatility, offers a unique opportunity to assess meaningful patient improvement beyond procedural endpoints. Objective: To quantify improvement in New York Heart Association (NYHA) class and Kansas City Cardiomyopathy Questionnaire (KCCQ) score following PASCAL transcatheter edge-to-edge repair (TEER) in patients with symptomatic mitral regurgitation. Methods: A systematic review and meta-analysis were conducted using prospective trials and large registries of patients undergoing PASCAL TEER. Studies were eligible if they reported either NYHA class improvement or change in KCCQ scores. Outcomes were extracted from CLASP, CLASP IID/F, Geis et al., Iberian study, Bartkowiak, and the Srinivasan review. For NYHA class, we calculated the proportion of patients in NYHA I/II at 30 days or 1 year. For KCCQ, mean score changes from baseline were pooled using inverse variance weighting. All analyses were performed using RStudio (v2024.03) with the meta and metafor packages. Random-effects models were applied, and 95% confidence intervals (CIs) were estimated using the Wilson and normal approximation methods, respectively. Results: Across six studies including 600+ patients, 83–91% achieved NYHA Class I/II post-procedure, with a pooled proportion of 86.4% (95% CI: 83.3–89.2%). Among the three studies reporting KCCQ scores (CLASP, CLASP IID/F, and Srinivasan), mean improvements ranged from +15.0 to +17.1, exceeding the clinically meaningful threshold of 10 points. No study showed regression in functional or QoL status. Heterogeneity was low (I 2 < 15%), and results were consistent across FMR and DMR populations. Conclusions: This is the first meta-analysis to comprehensively synthesize patient-reported functional and quality-of-life outcomes following PASCAL TEER. The device delivers robust and durable improvements in NYHA class and KCCQ scores—outcomes directly relevant to patients’ daily lives. These findings underscore the importance of integrating HRQoL metrics in future mitral valve device trials and shared decision-making.