Initial Experience With Commercial Transcatheter Mitral Valve Repair in the United States

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• 作者：Paul Sorajja ; MD^a ; ^{paul.sorajja@allina.com" class="auth_mail" title="E-mail the corresponding author} ; Michael Mack ; MD^b ; Sreekanth Vemulapalli ; MD^c ; David R. Holmes Jr. ; MD^d ; Amanda Stebbins ; MS^c ; Saibal Kar ; MD^e ; D. Scott Lim ; MD^f ; Vinod Thourani ; MD^g ; Patrick McCarthy ; MD^h ; Samir Kapadia ; MDⁱ ; Paul Grayburn ; MD^j ; Wesley A. Pedersen ; MD^a ; Gorav Ailawadi ; MD^f
• 关键词：mitral regurgitation ; mitral repair ; transcatheter
• 刊名：Journal of the American College of Cardiology
• 出版年：2016
• 出版时间：15 March 2016
• 年：2016
• 卷：67
• 期：10
• 页码：1129-1140
• 全文大小：826 K

文摘

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.