Transcatheter Repair for MR: 2-Year CLASP Study Outcomes

Jul 21, 2021
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Authors:
Szerlip M, Spargias KS, Makkar R, et al.
Citation:
2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study. JACC Cardiovasc Interv 2021;14:1538-1548.
Summary By:
Debabrata Mukherjee, MD, FACC

Quick Takes

  • The PASCAL transcatheter mitral valve repair system showed high survival with remarkable reduction in annualized rate of HF hospitalization in the CLASP study.
  • Importantly, patients experienced sustained improved functional status, exercise capacity, and quality of life in both functional and degenerative mitral regurgitation groups.
  • Given the lack of a control group and small sample size, the results of the CLASP IID/IIF randomized pivotal trial are needed to confirm and validate the current study findings.

Study Questions:

What are the 2-year outcomes for transcatheter repair in patients with mitral regurgitation (MR) in the CLASP study?

Methods:

The investigators conducted the CLASP (Edwards PASCAL TrAnScatheter Mitral Valve RePair System) study, which assessed the safety and feasibility of the PASCAL transcatheter valve repair system. Key inclusion criteria were clinically significant MR ≥3+ as confirmed by the echocardiographic core laboratory and New York Heart Association (NYHA). Patients had clinically significant MR ≥3+ as evaluated by the echocardiographic core laboratory and were deemed candidates for transcatheter repair by the heart team. Assessments were performed by the clinical events committee to 1 year (site-reported thereafter) and core laboratory to 2 years. The primary performance endpoints included procedural and clinical success. Time-to-event variables were analyzed using Kaplan-Meier survival analysis, and the exponential Greenwood method was used to calculate standard error.

Results:

A total of 124 patients (69% functional MR [FMR], 31% degenerative MR [DMR]) were enrolled with a mean age of 75 years, 56% were male, 60% were NYHA functional class III-IVa, and 100% had MR ≥3+. At 2 years, Kaplan-Meier estimates showed 80% survival (72% FMR, 94% DMR) and 84% freedom from heart failure (HF) hospitalization (78% FMR, 97% DMR), with 85% reduction in annualized HF hospitalization rate (81% FMR, 98% DMR). MR ≤1+ was achieved in 78% of patients (84% FMR, 71% DMR) and MR ≤2+ was achieved in 97% (95% FMR, 100% DMR) (all p < 0.001). Left ventricular (LV) end-diastolic volume decreased by 33 ml (p < 0.001); 93% of patients were in NYHA functional class I-II (p < 0.001).

Conclusions:

The authors concluded that the PASCAL repair system demonstrated sustained favorable outcomes at 2 years in FMR and DMR patients.

Perspective:

The 2-year outcomes of the single-arm CLASP study show high survival with remarkable reduction in annualized rate of HF hospitalization. Furthermore, MR reduction was durable and accompanied with evidence of positive LV remodeling. Importantly, patients experienced sustained improved functional status, exercise capacity, and quality of life in both FMR and DMR groups. However, given the lack of a control group and small sample size, the results of the CLASP IID/IIF randomized pivotal trial are needed to confirm and validate the current study findings.

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound, Mitral Regurgitation

Keywords: Cardiac Surgical Procedures, Cardiology Interventions, Echocardiography, Exercise Tolerance, Geriatrics, Heart Failure, Heart Valve Diseases, Mitral Valve Insufficiency, Quality of Life, Secondary Prevention, Survival


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