Experience With Commercial Transcatheter Mitral Valve Repair
What is the initial U.S. commercial experience with transcatheter mitral valve (MV) repair?
The investigators analyzed data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry on patients commercially treated with the MitraClip. The primary outcome of interest was a composite endpoint of reduction of mitral regurgitation (MR) to moderate or less (grade ≤2), without conversion to cardiac surgery, and without in-hospital mortality. Logistic regression was used with final estimates and associated standard errors.
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 were 7.9% (4.7%, 12.2%) and 10.0% (6.3%, 14.5%) for mitral repair and replacement, respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease present in 90.8%. 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%). Median length of stay (interquartile range) was 3 (1, 6) days, with 84.0% of patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with MR reduction were end-diastolic dimension, MR severity, clip location, and case volume.
The authors concluded that available data support the effectiveness of transcatheter MV repair in appropriately selected high-risk patients in a commercial setting.
This study reports that transcatheter MV repair is being performed predominantly in patients at prohibitive surgical risk, with symptomatic severe MR due to degenerative disease. Procedural success, clinical outcomes, and the rate of adverse events were overall comparable to pre-approval research studies and other commercial registries. These data demonstrate the importance of the TVT registry for post-market surveillance, and support the continued role of transcatheter MV repair by multidisciplinary heart teams in the treatment of prohibitive risk patients with symptomatic MR. Additional studies with longer-term follow-up are indicated to assess long-term functional and cardiovascular outcomes.
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