TY - JOUR
T1 - Initial Experience with Commercial Transcatheter Mitral Valve Repair in the United States
AU - Sorajja, Paul
AU - MacK, Michael
AU - Vemulapalli, Sreekanth
AU - Holmes, David R.
AU - Stebbins, Amanda
AU - Kar, Saibal
AU - Lim, D. Scott
AU - Thourani, Vinod
AU - McCarthy, Patrick
AU - Kapadia, Samir
AU - Grayburn, Paul
AU - Pedersen, Wesley A.
AU - Ailawadi, Gorav
N1 - Publisher Copyright:
© 2016 American College of Cardiology Foundation.
PY - 2016/3/15
Y1 - 2016/3/15
N2 - 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.
AB - 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.
KW - Key Words mitral regurgitation
KW - mitral repair
KW - transcatheter
UR - http://www.scopus.com/inward/record.url?scp=84961208097&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84961208097&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2015.12.054
DO - 10.1016/j.jacc.2015.12.054
M3 - Article
C2 - 26965532
AN - SCOPUS:84961208097
SN - 0735-1097
VL - 67
SP - 1129
EP - 1140
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 10
ER -