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

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Abstract

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.

Key Words

mitral regurgitation
mitral repair
transcatheter

Abbreviations and Acronyms

ACC
American College of Cardiology
CI
confidence interval
CMS
Centers for Medicare and Medicaid Services
HF
heart failure
IMA
internal mammary artery
IQR
interquartile range
MR
mitral regurgitation
MV
mitral valve
OR
odds ratio
STS
Society of Thoracic Surgeons
STS-PROM
Society of Thoracic Surgeons Predicted Risk of Operative Mortality
TVT
Transcatheter Valve Therapy
VARC
Valve Academic Research Consortium

Cited by (0)

Dr. Sorajja has served on the speakers bureau and as a consultant for Abbott Vascular; and has served as a consultant for Medtronic and Lake Regions Medical. Dr. Mack served as the co-principal investigator for COAPT (Abbott Vascular) and PARTNER 3 (Edwards Lifesciences). Dr. Vemulapalli has received research grants from Abbott Vascular, Boston Scientific, and the American College of Cardiology. Dr. Kar has served as a consultant and speaker for Abbott Vascular, AGA Medical, Boston Scientific, Coherex Medical, Medtronic, and St. Jude Medical. Dr. Lim has served as a consultant to Abbott Vascular. Dr. Thourani has served on the advisory board for Abbott Vascular. Dr. McCarthy has served as a consultant for Edwards Lifesciences and Abbott Vascular. Dr. Grayburn has received a research grant from and served as a consultant to Abbott Vascular; has received research grants from Medtronic, Boston Scientific, and Tendyne; and has served as a consultant for Bracco, Edwards Lifesciences, and Valtech Cardio. Dr. Pedersen has served on the speakers bureau for Edwards Lifesciences and Abbott Vascular; has served as a consultant for and receives a royalty return from Lake Regions Medical; is co-founder of and has equity interest in Intervalve; and has stock in Medtronic. Dr. Ailawadi has served as a consultant and speaker for Abbott Vascular; and has served as a consultant for Atricure, Edwards Lifesciences, and St. Jude Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Presented at the 64th Scientific Sessions of the American College of Cardiology, March 8, 2015. Robert O. Bonow, MD, served as the Guest Editor for this paper.

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