Key result
MitraClip achieves ~91% procedural success in commercial practice with ~93% MR reduction.
Why the study?
Does commercial transcatheter mitral valve repair improve procedural success and reduce mitral regurgitation in prohibitive-risk patients with mitral regurgitation in the United States?
Observational (n=564)
Yes
Does commercial transcatheter mitral valve repair improve procedural success and reduce mitral regurgitation in prohibitive-risk patients with mitral regurgitation in the United States?
In the initial U.S. commercial experience, transcatheter mitral valve repair achieved high procedural success (90.6%) and reduced mitral regurgitation to moderate or less in 93.0% of high-risk patients.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“These results further support the indication for percutaneous MV repair in patients with primary MR who are at high risk for surgery, accepting that patients treated commercially are different to those enrolled in EVEREST II—they are older, are more frail, and have higher surgical risk estimates.”
“Notably, TMVR using the MitraClip device was available at 61 sites in the United States, meaning the results obtained from the multivariate model should be interpreted with caution given the low volume per site and high concentrations of patients at a few centers”
Initial US commercial TMVR registry experience supports feasibility; extends trial data but leaves open durability and selection criteria.
BACKGROUND: Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). OBJECTIVES: The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. METHODS: Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. RESULTS: Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade ≤2 in 93.0%. In-hospital mortality was 2.3%; 30-day mortality was 5.8%. Other 30-day events were stroke (1.8%), bleeding (2.6%), and device-related complications (1.4%). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0% patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. CONCLUSIONS: In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.
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Sorajja et al. (2016) conducted an observational in Primary mitral regurgitation (n=564). Transcatheter mitral valve repair with MitraClip was evaluated on Procedural success and reduction of mitral regurgitation to grade ≤2. Transcatheter mitral valve repair with MitraClip achieved 90.6% procedural success, reduced MR to grade ≤2 in 93.0% of patients, and had 5.8% 30-day mortality.
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