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A Simplified Stepwise Approach to Echo Guidance during Percutaneous Mitral Valve Repair
Published on: October 16, 2021
CLASP IID Trial and Registry: 2-Year Outcomes of Transcatheter Repair for Degenerative Mitral Regurgitation
Raj Makkar1, Firas Zahr2, Tarun Chakravarty1
1Cedars-Sinai Medical Center, Los Angeles, California, USA.
Background:
One-year outcomes from the CLASP IID Trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial; NCT03706833) and Registry established the PASCAL transcatheter valve repair system as a safe and effective treatment for prohibitive-risk degenerative mitral regurgitation (DMR). Longer-term follow-up is ongoing.
Objectives:
This paper reports the CLASP IID Trial and Registry 2-year outcomes.
Methods:
In the CLASP IID Trial, prohibitive-risk patients with 3+/4+ DMR, deemed suitable for both the PASCAL and MitraClip systems, were randomized 2:1 (PASCAL: n = 204; MitraClip: n = 96). Patients with complex anatomy deemed ineligible for randomization were enrolled in the CLASP IID Registry (N = 98) and treated with the PASCAL system.
Results:
In the randomized cohort, significant and sustained MR reduction was achieved at 2 years. MR ≤2+ rate was 95.0% (96/101) in the PASCAL group vs 91.5% (54/59) in the MitraClip group (P = 0.500), and MR ≤1+ rate was 77.2% (78/101) vs 67.8% (40/59) (P = 0.198), respectively. Kaplan-Meier estimates for freedom from all-cause mortality, cardiovascular mortality, heart failure hospitalization, and nonelective mitral valve reinterventions were 80.8% vs 86.2% (P = 0.216), 88.6% vs 90.4% (P = 0.666), 86.4% vs 94.3% (P = 0.058), and 97.9% vs 97.9% (P = 0.962), respectively. In the registry cohort, 91.9% (34/37) achieved MR ≤2+ and 64.9% (24/37) achieved MR ≤1+. Kaplan-Meier estimates for freedom from all-cause mortality, cardiovascular mortality, heart failure hospitalization, and nonelective mitral valve reinterventions were 77.2%, 84.0%, 85.1%, and 99.0%, respectively. Significant improvements in functional status and quality of life were observed in both cohorts.
Conclusions:
Two-year outcomes from the CLASP IID Trial and Registry show favorable survival, and significant and sustained MR reduction with functional and quality-of-life improvements, confirming sustained safety and effectiveness of the PASCAL system in treating a broad population of DMR patients.
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