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

Paul Sorajja; Michael Mack; Sreekanth Vemulapalli; David R Holmes Jr; Amanda Stebbins; Saibal Kar; D Scott Lim; Vinod Thourani; Patrick McCarthy; Samir Kapadia; Paul Grayburn; Wesley A Pedersen; Gorav Ailawadi

doi:10.1016/j.jacc.2015.12.054

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

J Am Coll Cardiol. 2016 Mar 15;67(10):1129-1140. doi: 10.1016/j.jacc.2015.12.054.

Authors

Affiliations

¹ Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota. Electronic address: paul.sorajja@allina.com.
² Baylor Heart Hospital, Plano, Texas.
³ Duke University, Durham, North Carolina.
⁴ Mayo Clinic, Rochester, Minnesota.
⁵ Cedars-Sinai Medical Center, Los Angeles, California.
⁶ University of Virginia, Charlottesville, Virginia.
⁷ Emory University, Atlanta, Georgia.
⁸ Northwestern University, Chicago, Illinois.
⁹ Cleveland Clinic, Cleveland, Ohio.
¹⁰ Baylor University Medical Center, Dallas, Texas.
¹¹ Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota.

PMID: 26965532
DOI: 10.1016/j.jacc.2015.12.054

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.

Keywords: mitral regurgitation; mitral repair; transcatheter.

Publication types

Multicenter Study

MeSH terms

Aged
Aged, 80 and over
Cardiac Catheterization / methods*
Female
Follow-Up Studies
Heart Valve Prosthesis Implantation / methods*
Hospital Mortality / trends
Humans
Male
Mitral Valve / surgery*
Mitral Valve Insufficiency / diagnosis
Mitral Valve Insufficiency / mortality
Mitral Valve Insufficiency / surgery*
Registries*
Retrospective Studies
Severity of Illness Index
Survival Rate / trends
Treatment Outcome
United States / epidemiology