One-Year Outcomes of M-TEER With the PASCAL System in Atrial and Ventricular FMR: Insights From the MiCLASP Postmarket Clinical Follow-Up Study.
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Mahabadi Amir A, Rassaf Tienush, Kister Tobias, Schmitz Thomas, Geisler Tobias, Lubos Edith, Hausleiter Jörg, Eitel Ingo, von Bardeleben Ralph Stephen, Berti Sergio, Linke Axel, Hengstenberg Christian, Rudolph Volker, Unsöld Bernhard, Denti Paolo, Baldus Stephan, Nickenig Georg, Möllman Helge, Spargias Konstantinos, Brambilla Nedy, Butter Christian, Rottbauer Wolfgang, Reinthaler Markus, Swaans Martin, Praz Fabien, Witkowski Adam, Van Mieghem Nicolas M, Buch Mamta, Wolf Frieder, Edelmann Frank, Marcoff Leo, Koulogiannis Konstantinos, Lurz Philipp, MiCLASP Study Investigators
Аннотация
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.