The PASCAL system is a useful therapy for degenerative mitral regurgitation (DMR) with complex mitral valve anatomy, according to a new study.
The study results from the PASCAL IID Registry were reported by Jörg Hausleiter, MD, of the Klinikum der Universität München, Munich, and colleagues in a manuscript published Monday online and in the Feb. 7 issue of the Journal of the American College of Cardiology.
This registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system (manufactured by Edwards Lifesciences, which funded the study) in prohibitive-risk patients with significant symptomatic DMR and complex mitral valve anatomy. The device received U.S. Food and Drug Administration (FDA) approval to treat DMR in September.
Mitral valve transcatheter edge-to edge repair (M-TEER) is a safe and effective treatment for DMR in patients who are at prohibitive risk for surgery. However, M-TEER outcomes in patients with complex mitral valve anatomy can vary.
In EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), several mitral valve anatomic characteristics were proposed as predictors of procedural success with optimal mitral regurgitation (MR) reduction. These anatomic characteristics constituted the “on-label” indication for FDA approval of the MitraClip system (Abbott Vascular) in 2013 for treating prohibitive-risk DMR patients.
In 2020, the American College of Cardiology/American Heart Association valvular heart disease guidelines recommended M-TEER as a Class IIa indication for DMR patients at high or prohibitive risk with favorable mitral valve anatomy.
In 2021, the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery guidelines for the management of valvular heart disease broadly recommended M-TEER as a Class IIb indication for inoperable or high-surgical-risk DMR patients without anatomic limitations.
The study by Hausleiter and colleagues enrolled 98 patients (37.2% with <2 independent significant jets, 15.0% severe bileaflet/multi-scallop prolapse, 13.3% mitral valve orifice area <4.0 cm2, and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% of patients achieved MR <2+ and 56.1% achieved MR<1+ (P < 0.001 vs baseline). The 6-month Kaplan-Meier estimate for survival was 93.7%, freedom from major adverse events was 85.6%, and heart failure hospitalization was 92.6%. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001).
The PASCAL system demonstrated significant MR reduction and symptomatic improvement in patients with complex anatomic features historically considered less suitable for M-TEER. These results add to the growing body of evidence affirming the PASCAL system as a useful therapy to treat DMR in prohibitive-surgical-risk patients with complex mitral valve anatomy, the authors concluded.
Megan S. Joseph, MD and David S. Bach, MD from University of Michigan, wrote an accompanying editorial comment.
This study represents a promising step toward having more transcatheter options for patients with MR, the editorialists wrote.
The commenters mentioned that M-TEER can be an important therapeutic option for many patients with high or prohibitive surgical risk, but consideration for expanding the use of M-TEER among patients with DMR requires the critical assessment of individual surgical risk and the realistic assessment of anticipated outcomes of surgical mitral valve repair and of M-TEER, including the clinical implications of residual MR after M-TEER and the low likelihood of surgical repair after initial intervention with M-TEER.
Hausleiter J, Lim DS, Gillam LD, et al. Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation. J Am Coll Cardiol 2023;81:431–442.
Joseph MS, Bach DS. Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation With Complex Mitral Valve Anatomy. J Am Coll Cardiol 2023;81:443–445.
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