One-Year Outcomes of M-TEER With the PASCAL System in Atrial and Ventricular FMR: Insights From the MiCLASP Postmarket Clinical Follow-Up Study
Amir A. MahabadiTienush RassafTobias KisterThomas SchmitzTobias GeislerEdith LubosJörg HausleiterIngo EitelRalph Stephan von BardelebenSérgio BertiAxel LinkeChristian HengstenbergVolker RudolphBernhard UnsöldPaolo DentiStephan BaldusGeorg NickenigHelge MöllmannKonstantinos SpargiasNedy BrambillaChristian ButterWolfgang RottbauerMarkus ReinthalerMartin J. SwaansFabien PrazAdam WitkowskiNicolas M. Van MieghemMamta BuchFrieder WolfFrank EdelmannLeo MarcoffKonstantinos KoulogiannisPhilipp Lurzon behalf of the MiCLASP Study Investigators
Key result
PASCAL mitral TEER yields similar 1-year death or HF hospitalization rates in AFMR and VFMR.
- P=0.267
- n=295
Why the study?
Studies on mitral transcatheter edge-to-edge repair for atrial functional mitral regurgitation and ventricular functional mitral regurgitation are limited.
Does mitral transcatheter edge-to-edge repair with the PASCAL system improve outcomes in patients with atrial and ventricular functional mitral regurgitation?
Study Design
Type
Observational (n=295)
Multicenter
Yes
Structured PICO
Does mitral transcatheter edge-to-edge repair with the PASCAL system improve outcomes in patients with atrial and ventricular functional mitral regurgitation?
P
Population
295 patients with functional mitral regurgitation (AFMR or VFMR) undergoing mitral transcatheter edge-to-edge repair with the PASCAL system, followed for 1 year.
E
Exposure
Mitral transcatheter edge-to-edge repair (M-TEER) using the PASCAL transcatheter valve repair system
O
Outcome
Freedom from all-cause mortality or heart failure hospitalizations at 1 yearcomposite
Main Result
Absolute Event Rate: 79.3% vs 70.9%
p-value: p=0.267
M-TEER with the PASCAL system demonstrates comparable safety, echocardiographic, and functional improvements at 1 year for both atrial and ventricular functional mitral regurgitation.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
EDErwan DonalCardiologist, University of Rennes, CHU Rennes
“what remains challenging in clinical practice is the ability to predict which patients may have recurrent MR in the months and years following TEER. Although many TEER cases are intraprocedurally considered successful (≥50% reduction in baseline MR, or reduction in MR to grade ≤2+), this success is not always durable.”
MAMarianna AdamoInterventional cardiologist, University of Brescia
“a stratification by atrial versus ventricular aetiology would be of great interest in future randomised controlled studies (RCTs) assessing the role of M-TEER in patients with moderate SMR.”
“Current clinical guidelines do not recommend M-TEER for patients with moderate FMR, which may reflect an earlier phenotype in the disease spectrum. The MiCLASP study enrolled patients with symptomatic moderate FMR and provided a unique opportunity to evaluate the implications of M-TEER in this population.”
Implication
Real-world data support PASCAL safety and effectiveness in AFMR/VFMR; leaves open comparative efficacy versus alternatives pending randomized trials.
Abstract
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.
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Cite This Study
Mahabadi et al. (2026) conducted an observational in Functional mitral regurgitation (n=295). Atrial functional mitral regurgitation (AFMR) vs. Ventricular functional mitral regurgitation (VFMR) was evaluated on Freedom from all-cause mortality or heart failure hospitalizations (p=0.267). Mitral transcatheter edge-to-edge repair with the PASCAL system yielded 1-year freedom from all-cause mortality or heart failure hospitalizations of 79.3% in AFMR and 70.9% in VFMR (P=0.267).