Author

Fabien Praz

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Open access Aug 2026

One-Year Outcomes of M-TEER With the PASCAL System in Atrial and Ventricular FMR: Insights From the MiCLASP Postmarket Clinical Follow-Up Study.

BACKGROUND Studies on mitral transcatheter edge-to-edge repair for atrial functional mitral regurgitation (AFMR) and ventricular functional mitral regurgitation (VFMR) are limited. METHODS We report 1-year outcomes of mitral transcatheter edge-to-edge repair for AFMR and VFMR using the PASCAL transcatheter valve repair system in the MiCLASP multicenter European postmarket clinical follow-up study (REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04430075). RESULTS Analysis included 295 patients with functional mitral regurgitation (75.5±9.93 years old, 59.3% male) from the first 600 enrolled in the MiCLASP study, with AFMR in 17.6% (52) and VFMR in 82.4% (243). Patients with AFMR were older (79.7±6.67 versus 74.6±10.30 years), majority female (75.0% versus 33.3%), and had higher rates of hypertension (98.1% versus 82.3%) and atrial fibrillation (82.7% versus 60.1%) than patients with VFMR (all P<0.05). Patients with VFMR had higher NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels (3350.0 [1720.0-6564.0] versus 1562.0 [790.0-2286.0]; P<0.001) and more severe mitral regurgitation (≥3+) at baseline (71.9% versus 46.2%; P<0.001). Procedural success was high (AFMR, 96.2%; VFMR, 97.1%; P=0.661), and patients with AFMR had shorter procedure duration (73.5 versus 85.5 minutes; P=0.044). One-year Kaplan-Meier estimate of freedom from all-cause mortality or heart failure hospitalizations was 79.3% in AFMR and 70.9% in VFMR (P=0.267). Both AFMR and VFMR groups demonstrated significant mitral regurgitation reduction (mitral regurgitation ≤1+, 93.1% and 81.3%), low mean transmitral gradients (3.5 and 3.1 mm Hg), significant proportional reductions in left ventricular end-diastolic volume (-12.9% and -16.4%) and left atrial volume (-9.6% and -10.9%), high proportions at New York Heart Association class I/II (76.5% and 64.6%), and significant increases in Kansas City Cardiomyopathy Questionnaire Overall Summary score (+18.0 and +11.6 points), respectively (all P<0.05 from baseline). CONCLUSIONS One-year MiCLASP results support the safety of mitral transcatheter edge-to-edge repair with the PASCAL system in both AFMR and VFMR, with comparable echocardiographic, functional, and quality-of-life changes, despite baseline differences in clinical presentation.

A. Mahabadi, T. Rassaf, T. Kister et al. · Circulation. Cardiovascular... · 0 citations

Open access Aug 2026

Optimized Balloon-Expandable Transcatheter Aortic Valve Implantation and Clinical Outcomes.

BACKGROUND The expansion of transcatheter aortic valve replacement (TAVR) to younger patients with longer life expectancy requires procedural optimization to enhance long-term valve durability. OBJECTIVES To evaluate the relationship between fluoroscopic determinants of optimal transcatheter heart valve (THV) implantation-coaxiality, implantation depth, and expansion-and clinical and valve-related outcomes. METHODS In this cohort study, consecutive patients undergoing transfemoral TAVR with balloon-expandable prostheses (Sapien S3, Sapien S3 Ultra) between February 2014 and June 2022 were included. THV coaxiality, implantation depth, and expansion were assessed in the 3-cusp view following deployment using standardized protocols. Suboptimal implantation was defined as ≥1 unfavorable determinants (coaxiality ≥4.8°, depth ≥6 mm, or underexpansion ≥20%). Outcomes included the modified early safety endpoint, moderate or severe hemodynamic valve deterioration, and stage 2 bioprosthetic valve failure. RESULTS Among 1,032 patients (mean age 81 ± 6 years, 35.1% female), suboptimal THV implantation occurred in 443 (42.9%) patients and was driven by noncoaxial deployment (n = 240, 23.3%), excessive implantation depth (n = 261, 25.3%), and underexpansion (n = 54, 5.2%). Suboptimal implantation was associated with a higher likelihood of the modified early safety endpoint at 30 days (43.3% vs 19.9%; adjusted odds ratio: 3.05; 95% CI: 2.30-4.04) and stage 2 bioprosthetic valve failure at 5 years (subHR: 4.40; 95% CI: 1.25-13.59). Patients with ≥2 determinants demonstrated higher rates of hemodynamic valve deterioration at 5 years (subHR: 3.48; 95% CI: 1.24-9.80). CONCLUSIONS Optimal THV implantation was associated with improved early procedural safety and long-term THV durability in balloon-expandable TAVR. Systematic fluoroscopic assessment of optimized valve implantation may enhance patient outcomes.

L. Vitez, D. Angellotti, D. Tomii et al. · JACC: Advances · 0 citations