Findings Published From United States Postmarket Registry of Abbott Vascular's MitraClip for TMVR

March 7, 2016—Findings from the United States postapproval registry of the MitraClip transcatheter mitral valve repair (TMVR) system (Abbott Vascular) were published by Paul Sorajja, MD, et al in the Journal of the American College of Cardiology (JACC, 2016;67:1129–1140). The data were first presented in March 2015 at the 64th annual scientific session of the American College of Cardiology (ACC) in San Diego, California.

The aim of this study was to report the initial United States commercial experience of TMVR with the MitraClip, which received US Food and Drug Administration approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR).

The study found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or lower MR. The investigators concluded that 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 TMVR in this patient population.

As summarized in JACC, the investigators analyzed 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. Of 564 patients (56% men; median age, 83 years), severe symptoms were present in 473 patients (86%).

The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for TMVR and replacement were 7.9% (interquartile range, 4.7%–12.2%) and 10% (interquartile range, 6.3%–14.5%), respectively. Frailty was noted in 323 patients (57.3%). TMVR was performed for degenerative disease, present in 90.8% of patients. 

Overall, MR was reduced to a grade of ≤ 2 in 93% of patients. 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, 1–6 days), with 84% patients discharged home. Overall, procedure success occurred in 90.6% of patients. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume, reported the investigators in JACC.